Appendix 2: Drugs Covered by the Program - Page
7
Note: Drugs funded under the Highly Specialised Drugs Program provide
a subsidy for community patients only. Inpatients remain the responsibility
of the treating hospital.
Page 1 Abacavir Sulfate with Lamivudine (Kivexa) to Baclofen (Lioresal
Intrathecal)
Page 2 Boceprevir (Victrelis) to Bosentan Monohydrate
(Tracleer)
Page 3 Cidofovir
(Vistide) to Epoetin lamda (Novicrit)
Page 4 Epoprostenol
Sodium (Flolan)
Page 5 Etanercept
(Enbrel)
to Ibandronic Acid (Bondronat)
Page 6 Iloprost Trometamol
(Ventavis) to Indinavir Sulphate
(Crixivan)
Page 7 Infliximab (Remicade) to Sevelamer (Renagel)
Page 8 Sildenafil Citrate (Revatio)
Page 9 Sirolimus (Rapamune) to Zoledronic acid (Zometa)
Drug |
Date subsidised |
PBAC Clinical
Indications and other Restrictions |
Infliximab
(Remicade)
|
|
This drug needs prior approval by Medicare Australia.
More information and forms are available at
http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp
NOTE:
Any queries concerning the arrangements to prescribe infliximab may be directed
to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m.
EST Monday to Friday).
Written applications for authority to prescribe infliximab should be forwarded
to:
Medicare Australia
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001
Further prescribing information is on the Medicare Australia website at www.medicareaustralia.gov.au.
See attached PDF file for all Notes and Public Hospital Authority
requirements
 Infliximab - Treatment of adult patients with active ankylosing spondylitis (252kb, pdf)
Infliximab - Treatment of patients with Crohn's Disease (354kb, pdf)
Infliximab - Treatment of adult patients with severe active psoriatic arthritis (246kb, pdf)
 Infliximab - Treatment of adult patients with severe active rheumatoid arthritis - April 2012
Infliximab
- Treatment of adult patients with severe chronic plaque psoriasis
(279kb, pdf) |
Interferon Alfa
2a
(Roferon A)
|
Amended 1 March 2012 |
Caution:
Treatment with interferon alfa has been associated with depression and suicide in some
patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase; (3382)
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels – greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive , or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative – in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT: or
(b) Liver biopsy; (3961)
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA. (3962)
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding,
encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. |
Interferon Alfa
2b
(Intron A, Intron A Redipen)
|
Amended 1 March 2012 |
Caution:
Treatment with interferon alfa has been associated with depression and suicide in some
patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Adjunctive therapy of malignant melanoma following surgery in patients with nodal involvement; (3384)
Use in the treatment of Philadelphia chromosome positive myelogenous leukaemia in the chronic phase; (3382)
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels – greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) of HBeAG negative – in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by;
(a) Confirmed elevated serum ALT; or;
(b) Liver biopsy; (3961)
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA. (3962)
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. |
Interferon Gamma 1B (Imukin)
|
|
For the treatment of chronic granulomatous disease in patients with
frequent and severe infections despite adequate prophylaxis with
antimicrobial agents. (3385) |
Lamivudine (3TC, Lamivudine RBX, Lamivudine Alphapharm)
|
|
Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589) |
Lamivudine
(Zeffix, Zetlam)
|
Amended 1 March 2012 |
Chronic hepatitis B in a patient without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels – greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative – in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or:
(b) Liver biopsy. (3961)
Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA. (3962)
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. |
Lamivudine
with Zidovudine (Combivir)
|
|
Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589) |
|
Lanreotide acetate (Somatuline LA) (Somatuline Autogel)* |
|
Active acromegaly in a patient with persistent
elevation of mean growth hormone levels of greater than 2.5 micrograms
per litre AND
(a) after failure of other therapy including dopamine agonists; or
(b) as interim treatment while awaiting the effects of radiotherapy and where
treatment with dopamine agonists has failed; or
(c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy
is contraindicated.
In a patient treated with radiotherapy, treatment must cease if
there is biochemical evidence of remission (normal IGF1) after
lanreotide has been withdrawn for at least 4 weeks (6 weeks after
the last dose). Lanreotide should be withdrawn every 2 years in
the 10 years after radiotherapy for assessment of remission.
Treatment must cease if IGF1 is not lower after 3 months treatment. (3387)
*Active acromegaly in a patient with persistent elevation of mean
growth hormone levels of greater than 2.5 micrograms per litre
AND
(a) after failure of other therapy including dopamine agonists;
or
(b) as interim treatment while awaiting the effects of radiotherapy
and where treatment with dopamine agonists has failed; or
(c) if the patient is unfit for or unwilling to undergo surgery
and where radiotherapy is contraindicated.
In a patient treated with radiotherapy, treatment must cease if
there is biochemical evidence of remission (normal IGF1) after
lanreotide has been withdrawn for at least 4 weeks (8 weeks after
the last dose). Lanreotide should be withdrawn every 2 years in
the 10 years after radiotherapy for assessment of remission.
Treatment must cease if IGF1 is not lower after 3 months treatment; (3388)
*Functional carcinoid tumour causing intractable symptoms. The
patient must have experienced on average over 1 week, 3 or more
episodes per day of diarrhoea and/or flushing, which persisted
despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea
agents, and surgery or antineoplastic therapy must have failed
or be inappropriate.
Treatment must cease if there is failure to produce a clinically
significant reduction in the frequency and severity of symptoms
after 3 months' therapy at a dose of 120 mg every 28 days. Dosage
and tolerance to the drug should be assessed regularly and the
dosage should be titrated slowly downwards to determine the minimum
effective dose. (3389) |
| Lanthanum carbonate hydrate (Fosrenol) |
|
Management of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy.
Management includes initiation, stabilisation and review of therapy as required; (3390)
Management of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy.
Management includes initiation, stabilisation and review of therapy as required. (3391)
Note: Not to be used in combination with sevelamer. |
Lenalidomide
(Revlimid) |
|
This drug needs prior approval by Medicare Australia.
More information and forms are available at
http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp
NOTE:
Any queries concerning the arrangements to prescribe Lenalidomide may be directed to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
Any queries concerning patients enrolled on the Lenalidomide Compassionate program may be directed to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
These patients must demonstrate they met initial criteria prior to commencing treatment on the compassionate program and also demonstrate they do not have progressive disease.
Baseline and current pathology reports must be submitted with the initial application.
Written applications for authority to prescribe Lenalidomide should be forwarded to:
Medicare Australia
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001
Further prescribing information is on the Medicare Australia website at www.medicareaustralia.gov.au .
See attached PDF file for all Notes and Public Hospital Authority requirements
Lenalidomide December 2012 |
Lenograstim (Granocyte)
|
|
Mobilisation of peripheral blood progenitor cells to facilitate harvest of such cells for reinfusion into patients with non-myeloid malignancies who have had myeloablative or myelosuppressive therapy; (3392)
Mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic transplantation to facilitate harvest of such cells in healthy donors; (3393)
Patients with non-myeloid malignancies receiving marrow ablative chemotherapy and subsequent peripheral blood progenitor cell or bone marrow transplantation; (3394)
Patients with breast cancer receiving standard dose adjuvant chemotherapy who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count below 1 x 109 per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned; (3395)
Patients receiving first line chemotherapy for Hodgkin's disease who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count below 1 x 109 per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned; (3396)
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia; (3397)
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Ewing's sarcoma; (3398)
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours; (3399)
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in infants and children with CNS tumours; (3400)
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma; (3401)
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (intermediate or high grade); (3402)
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in oestosarcoma; (3403)
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin's disease; (3404)
Patients being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in rhabdomyosarcoma. (3405)
|
| Levodopa with Carbidopa (Duodopa) |
|
Management of advanced Parkinson disease in a patient with severe disabling motor fluctuations not adequately controlled by oral therapy. (3704)
Treatment must be commenced in a hospital-based movement disorder clinic.
Note: Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.
A positive clinical response to Duodopa administered via a temporary nasoduodenal tube should be confirmed before a permanent percutaneous endoscopic gastrostomy (PEG) tube is inserted. |
Lopinavir
with Ritonaivr (Kaletra)
|
|
Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589)
|
| Mannitol
(bronchitol)
|
August 2012 |
Treatment of cystic fibrosis in a patient who satisfies all of the following criteria:
(1) Prior to mannitol therapy, the patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved PI mannitol initiation dose assessment. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
(2) Is 6 years of age or older;
(3) Has a FEV1 greater than 30% predicted for age, gender and height;
(4) Is intolerant or inadequately responsive to dornase alfa;
(5) Has evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
(6) Is participating in a 4 week trial, as detailed below, or has achieved a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) after a 4 week trial.
In order for patients to be eligible for participation in the HSD program, the following conditions must be met:
(1) Patients must be assessed at cystic fibrosis clinics/centres which are under the control of specialist respiratory physicians with experience and
expertise in the management of cystic fibrosis and the prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such units is not possible because of geographical isolation, management (including prescribing) may be by specialist physician or paediatrician in consultation with such a unit;
(2) The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at established lung
function testing laboratories, unless this is not possible because of geographical isolation;
(3) Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease;
(4) Initial therapy is limited to 4 weeks' treatment with mannitol at a dose of 400 mg twice daily;
(5) At or towards the end of the initial 4 weeks' trial, patients must be reassessed and a further FEV1 measurement be undertaken (single test under
conditions as above). Patients who achieve a 10% or greater improvement in FEV1 (compared to baseline established prior to mannitol treatment) are eligible for continued subsidy under the HSD program at a dose of 400mg twice daily;
(6) Patients who fail to meet a 10% or greater improvement in FEV1 after the initial 4 weeks' treatment at a dose of 400 mg twice daily, may have 1 further trial in the next 12 months but not before 3 months after the initial trial;
(7) Following an initial 6 months' therapy, a global assessment must be undertaken involving the patient, the patient's family (in the case of paediatric patients) and the treating physician(s) to establish that all agree that mannitol powder for inhalation treatment is continuing to produce worthwhile benefits. (Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.) Further reassessments are to be undertaken at six-monthly intervals;
(8) Other aspects of treatment, such as physiotherapy, must be continued;
(9) Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy (i.e. satisfied the criteria for the 4 week trial and achieved a 10% or greater improvement in FEV1) then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks
is considered a suitable wash-out period).
(4063)
Note
Mannitol is not PBS-subsidised for use in combination with PBS-subsidised dornase alfa.
It is highly desirable that all patients be included in the national cystic fibrosis patient database.
Grandfather - for patients who initiated mannitol treatment prior to 1 August 2012
Continuation of treatment of cystic fibrosis in a patient 6 years of age or older, who initiated treatment with mannitol prior to 1 August 2012 and for whom a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, documents agreement that mannitol treatment is continuing to produce worthwhile benefit. Further reassessments are to be
undertaken and documented yearly. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use.
(4064)
Note
Mannitol is not PBS-subsidised for use in combination with PBS- subsidised dornase alfa.
It is highly desirable that all patients be included in the national cystic fibrosis patient database.
|
| Maraviroc (Celsentri) |
|
Treatment, in addition to optimised background therapy in combination with other antiretroviral agents, of an antiretroviral experienced patient infected with only CCR5-tropic HIV-1, who, after each of a least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. A tropism assay to determine CCR5 only strain status is required prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity. (3599) |
| Methoxy polyethylene glycol-epoetin beta (Mircera) |
|
Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia. (3334) |
Mycophenalate
Mofetil (APO-Mycophenolate, CellCept, Ceptolate, Imulate, Mycophenolate Sandoz, Pharmacor Mycophenolate)
|
|
Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of renal allograft rejection. Management includes initiation, stabilisation and review of therapy as required; (3355)
Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for prophylaxis of cardiac allograft rejection. Management includes initiation, stabilisation and review of therapy as required. (3356)
CAUTION:
Careful monitoring of patients is mandatory. |
Mycophenolate
Sodium (Myfortic)
|
|
Prophylaxis of renal allograft rejection (4084)
Treatment Phase: Management
The Clinical criteria is: The treatment must be under the supervision and direction of a transplant unit.
WHO Class III, IV or V lupus nephritis (4095)
Treatment phase: Management
The Clinical criteria is: The condition must be proven by biopsy,
AND the Treatment criteria is:
Must be treated by a nephrologist or in consultation with a nephrologist. The name of the consulting nephrologist must be included in the patient medical records.
CAUTION: Careful monitoring of patients is mandatory.
Note: Management includes initiation, stabilisation and review of therapy as required. |
Natalizumab (Tysabri) |
|
CAUTION:
Progressive multifocal leukoencphalopathy has been reported with this drug.
Note:
Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.
Treatment, as monotherapy, by a neurologist, of clinically definite relapsing-remitting multiple sclerosis in an ambulatory (without assistance or support) patient 18 years of age or older, who has experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years.
The diagnosis must be confirmed by magnetic resonance imaging of the brain and/or spinal cord and the date of the scan included in the certification, unless an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Natalizumab must be ceased if there is continuing progression of disability while on treatment with natalizumab. For continued treatment the patient must demonstrate compliance with, and an ability to tolerate natalizumab. (3425) |
Nevirapine
(Viramune, Nevirapine Alphapharm)
Immediate release
9506H
9507J
|
|
Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589) |
Nevirapine
(Viramune XR)
Extended release
1132N
|
Added 1 April 2012 |
Initial treatment of HIV infection in combination with other antiretroviral agents in a patient who has been stabilised on nevirapine immediate release with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3995)
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589) |
Octreotide
Acetate
(Sandostatin, Hospira Pty Ltd, OctreotideMaxRx, Octreotide(SUN) and Sandostatin LAR*) |
|
Active acromegaly in a patient with persistent
elevation of mean growth hormone levels of greater than 2.5 micrograms
per litre AND
(a) after failure of other therapy including dopamine agonists; or
(b) as interim treatment while awaiting the effects of radiotherapy and where
treatment with dopamine agonists has failed; or
(c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy
is contraindicated.
In a patient treated with radiotherapy, treatment must cease if
there is biochemical evidence of remission (normal IGF1) after
octreotide has been withdrawn for at least 4 weeks. Octreotide
should be withdrawn every 2 years in the 10 years after radiotherapy
for assessment of remission.
Treatment must cease if IGF1 is not lower after 3 months treatment
at a dose of 100 micrograms 3 times daily; (3407)
Functional carcinoid tumour or vasoactive intestinal peptide secreting
tumour (VIPoma) causing intractable symptoms. The patient must
have experienced on average over 1 week, 3 or more episodes per
day of diarrhoea and/or flushing, which persisted despite the use
of anti-histamines, anti-serotonin agents and anti-diarrhoea agents,
and surgery or antineoplastic therapy must have failed or be inappropriate.
Treatment must cease if there is failure to produce a clinically
significant reduction in the frequency and severity of symptoms
after 2 months' therapy. Dosage and tolerance to the drug should
be assessed regularly and the dosage should be titrated slowly
downwards to determine the minimum effective dose. (3408)
* Acromegaly in a patient controlled on Sandostatin
subcutaneous injections.
In a patient treated with radiotherapy, treatment must cease if
there is biochemical evidence of remission (normal IGF1) after
octreotide has been withdrawn for at least 4 weeks (8 weeks after
the last dose). Octreotide should be withdrawn every 2 years in
the 10 years after radiotherapy for assessment of remission.
Treatment must cease if IGF1 is not lower after 3 months of treatment; (3409)
Functional carcinoid tumour or vasoactive intestinal peptide
secreting tumour (VIPoma) with symptom control on Sandostatin subcutaneous
injections.
Treatment must cease if there is failure to produce a clinically
significant reduction in the frequency and severity of symptoms after
3 months' therapy at a dose of 30 mg every 28 days and having allowed
adequate rescue therapy with Sandostatin subcutaneous injections.
Dosage and tolerance to the drug should be assessed regularly and
the dosage should be titrated slowly downwards to determine the minimum
effective dose. (3410) |
| Omalizumab (Xolair)
|
|
This drug needs prior approval by Medicare Australia. More information and forms are available at http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp
OMALIZUMAB July 2011
|
Pamidronate disodium (Aredia, Pamisol, Pamidronate Strides)
Codes: 5670K, 5703E |
Amended 1 February 2003
Amended 1 December 2006 |
Multiple myeloma. (3341)
Bone metastases from breast cancer. (3343)
NOTE:
The concentrated injection and powder for I.V. infusion (after reconstitution) are bioequivalent. |
Pamidronate disodium (Aredia, Pamisol, Pamidronate Strides)
Codes: 5667G, 5668H, 5669J, 5670K, 5701C, 5702D, 5703E |
Amended 1 February 2003
Amended 1 December 2006 |
Treatment of hypercalcaemia of malignancy refractory to anti-neoplastic therapy.(3341)
NOTE:
The concentrated injection and powder for I.V. infusion (after reconstitution) are bioequivalent. |
Pegfilgrastim
(Neulasta)
|
|
For use in patients undergoing induction and consolidation therapy for acute myeloid leukaemia; (3357)
A patient with breast cancer receiving standard dose adjuvant chemotherapy who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned; (3362)
A patient receiving chemotherapy for B-cell chronic lymphocytic leukaemia with fludarabine and cyclophosphamide who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned; (3363)
A patient receiving first-line chemotherapy for Hodgkin's disease who have had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned;(3364)
A patient receiving chemotherapy for myeloma who have had a prior episode of febrile neutropenia, and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned.(3365)
A patient with inoperable Stage III, IVa or IVb squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx receiving neoadjuvant treatment with docetaxel in combination with cisplatin and fluorouracil who has had a prior episode of febrile neutropenia or prolonged severe neutropenia (neutrophil count of less than 1,000 million cells per litre), and for whom there is clinical justification for wishing to continue therapy with the same drug combination, dosage and treatment schedule, and for whom a good response to treatment is anticipated providing chemotherapy can be delivered as planned. (3369)
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in acute lymphoblastic leukaemia; (3370)
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in breast cancer (adjuvant chemotherapy with docetaxel in combination with an anthracyline and cyclophosphamide); (3371)
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in germ cell tumours; (3372)
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in infants and children with CNS tumours; (3373)
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in neuroblastoma; (3374)
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in non-Hodgkin's lymphoma (aggessive grades; or low grade receiving an anthracycline-containing regimen); (3375)
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in relapsed Hodgkin's disease; (3376)
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in sarcoma. (3377)
A patient being treated with aggressive chemotherapy with the intention of achieving a cure or substantial remission in Hodgkin disease (first-line chemotherapy with escalated BEACOPP). (3834) |
| Peginterferon
Alfa-2a (Pegasys) |
Amended 1 March 2012 |
CAUTION:
Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis who satisfies all of the following criteria:
(1) Elevated HBV DNA levels – greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative – in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or;
(b) Liver biopsy;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B; (3977)
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who has detectable HBV DNA. (3978)
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks.
Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and have a contraindication to ribavirin, who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
The treatment course is limited to up to 48 weeks.
Patients may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (3412)
NOTE:
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24 hour access by patients to medical advice; and
(c) an established liver clinic; and
(d) facilities for safe liver biopsy. |
Peginterferon alfa-2b
(PEG-Intron Redipen)
|
|
CAUTION:
Treatment with peginterferon alfa has been associated with depression and suicide
in some patients. Patients with a history of suicidal ideation or depressive
illness should be warned of the risks. Psychiatric status during therapy
should be monitored.
Treatment, managed by an accredited treatment centre, of chronic
hepatitis C in patients 18 years or older who have compensated
liver disease and who have received no prior interferon alfa or
peginterferon alfa treatment for hepatitis C and have a contraindication
to ribavirin, who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV
positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not
breast-feeding, and are using an effective form of contraception.
The treatment course is limited to up to 48 weeks.
Patients may only continue treatment after the first 12 weeks
if the result of an HCV RNA quantitative assay (performed at the
same laboratory using the same test) shows that the plasma HCV
RNA has become undetectable or the viral load has decreased by
at least a 2 log drop. (3412)
NOTE:
Treatment centres are required to have access to the following
appropriate specialist facilities for the provision of clinical
support services for hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24 hour access by patients to medical advice; and
(c) an established liver clinic; and
(d) facilities for safe liver biopsy. |
Raltegravir Potassium (Isentress) |
|
Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589) |
Peginterferon alfa-2a & Ribavirin (Pegasys RBV)
|
Amended 1 April 2013 |
Authority required (STREAMLINED)
4184
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated),
AND the Clinical criteria is:
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and
ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple
combination therapy with telaprevir,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with
telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12;
OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with
boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay
at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor;
OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with
boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA
is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic
cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with
telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA
quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative
assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's
medical records.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4197
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with
telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with
boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor;
OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy
with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA
qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy
with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or
equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA
quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the
viral load has decreased by at least a 2 log drop,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative
assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at
week 24 is unnecessary.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4206
Chronic non-genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C,
AND the Clinical criteria is:
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated),
AND the Clinical criteria is:
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 48 weeks,
AND the Clinical criteria is:
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4187
Chronic non-genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,
AND the Clinical criteria is:
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or
bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging
fibrosis,
AND the Clinical criteria is:
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed
at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log
drop,
AND the Clinical criteria is:
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary.
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral
response by week 12.
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed.
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed.
Caution
Ribavirin is a category X drug and must not be given to pregnant women. Pregnancy in female patients or in the partners of male patients must be
avoided during treatment and during the 6 months period after cessation of treatment.
Caution
Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or
depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic. |
Peginterferon alfa-2b & Ribavirin (Pegatron)
9529M – (112x ribavirin 200mg with 4x peginterferon alfa-2b 50mcg)
9530N – (84x ribavirin 200mg with 4x peginterferon alfa-2b 80mcg)
9534T – (112x ribavirin 200mg with 4x peginterferon alfa-2b 100mcg) |
|
Authority required (STREAMLINED)
4189
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated),
AND the Clinical criteria is:
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 48 weeks,
AND the Clinical criteria is:
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12,
AND the Population criteria is:
Patient must weigh at least 27 kg,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's
medical records.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4198
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 48 weeks,
AND the Clinical criteria is:
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test)
show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop,
AND the Population criteria is:
Patient must weigh at least 27 kg,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4199
Chronic non-genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C,
AND the Clinical criteria is:
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated),
AND the Clinical criteria is:
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 48 weeks,
AND the Clinical criteria is:
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12,
AND the Population criteria is:
Patient must weigh at least 27 kg,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4192
Chronic non-genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,
AND the Clinical criteria is:
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or
bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging
fibrosis,
AND the Clinical criteria is:
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed
at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log
drop,
AND the Clinical criteria is: The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24,
AND the Population criteria is:
Patient must weigh at least 27 kg,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary.
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral
response by week 12.
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed.
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4184
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated),
AND the Clinical criteria is:
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and
ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple
combination therapy with telaprevir,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with
telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12;
OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with
boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay
at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor;
OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with
boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA
is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic
cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with
telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA
quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative
assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's
medical records.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4197
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with
telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with
boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor;
OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy
with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA
qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy
with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or
equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA
quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the
viral load has decreased by at least a 2 log drop,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative
assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at
week 24 is unnecessary.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4206
Chronic non-genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C,
AND the Clinical criteria is:
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated),
AND the Clinical criteria is:
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 48 weeks,
AND the Clinical criteria is:
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4187
Chronic non-genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,
AND the Clinical criteria is:
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or
bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging
fibrosis,
AND the Clinical criteria is:
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed
at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log
drop,
AND the Clinical criteria is:
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary.
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral
response by week 12.
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed.
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed.
Caution
Ribavirin is a category X drug and must not be given to pregnant women. Pregnancy in female patients or in the partners of male patients must be
avoided during treatment and during the 6 months period after cessation of treatment.
Caution
Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or
depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic. |
Peginterferon alfa-2b & Ribavirin (Pegatron)
9531P – (140x ribavirin 200mg with 4x peginterferon alfa-2b 80mcg
9536X – (140x ribavirin 200mg with 4x peginterferon alfa-2b 120mcg)
9538B - (140x ribavirin 200mg with 4x peginterferon alfa-2b 150mcg)
9539C – (168x ribavirin 200mg with 4x peginterferon alfa-2b 150mcg)
9540D - (196x ribavirin 200mg with 4x peginterferon alfa-2b 150mcg) |
Amended 1 April 2013 |
Authority required (STREAMLINED)
4184
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated),
AND the Clinical criteria is:
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and
ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple
combination therapy with telaprevir,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with
telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12;
OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with
boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay
at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor;
OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with
boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA
is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic
cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with
telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA
quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative
assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's
medical records.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4197
Chronic genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with
telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with
boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor;
OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy
with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA
qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy
with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or
equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA
quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the
viral load has decreased by at least a 2 log drop,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative
assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 12,
AND the Clinical criteria is:
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA
qualitative assay at week 24,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at
week 24 is unnecessary.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4206
Chronic non-genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C,
AND the Clinical criteria is:
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated),
AND the Clinical criteria is:
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 48 weeks,
AND the Clinical criteria is:
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
Note
No increase in the maximum quantity or number of units may be authorised.
Note
No increase in the maximum number of repeats may be authorised.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic.
Authority required (STREAMLINED)
4187
Chronic non-genotype 1 hepatitis C infection
The Treatment criteria is:
Must be treated in an accredited treatment centre,
AND the Clinical criteria is:
The treatment must be the sole PBS-subsidised treatment for hepatitis C,
AND the Clinical criteria is:
Patient must have compensated liver disease,
AND the Clinical criteria is:
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C,
AND the Clinical criteria is:
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C,
AND the Clinical criteria is:
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or
bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging
fibrosis,
AND the Clinical criteria is:
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed
at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log
drop,
AND the Clinical criteria is:
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24,
AND the Population criteria is:
Patient must be aged 18 years or older,
AND the Population criteria is:
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be
using an effective form of contraception if of child-bearing age.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary.
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral
response by week 12.
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed.
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed.
Caution
Ribavirin is a category X drug and must not be given to pregnant women. Pregnancy in female patients or in the partners of male patients must be
avoided during treatment and during the 6 months period after cessation of treatment.
Caution
Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or
depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Note
Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for
hepatitis C:
(a) a nurse educator/counsellor for patients; and
(b) 24-hour access by patients to medical advice; and
(c) an established liver clinic. |
Rifabutin
(Mycobutin)
|
|
Treatment of Mycobacterium avium complex infections
in HIV positive patients. (3415)
Prophylaxis against Mycobacterium avium complex infections in
HIV positive patients with CD4 cell counts of less than 75 per
mm3. (3317)
|
Rilpivirine
(Edurant)
|
Added 1 April 2012 |
Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589)
|
Ritonavir
(Norvir)
|
|
Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589) |
Rituximab
(Mabthera)
|
|
This drug needs prior approval by Medicare Australia.
More information and forms are available at
http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp
NOTE:
Any queries concerning the arrangements to prescribe infliximab may
be directed to Medicare Australia on 1800 700 270 (hours of operation
8 a.m. to 5 p.m. EST Monday to Friday).
Written applications for authority to prescribe infliximab should
be forwarded to:
Medicare Australia
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001
Further prescribing information is on the Medicare Australia website
at: www.medicare.gov.au/provider/pbs/drugs/index.shtml
See attached PDF file for all Notes and Public Hospital
Authority requirements
Rituximab - April 2012
|
Romiplostim (Nplate) |
|
This drug needs prior approval by Medicare Australia.
More information and forms are available at
http://www.medicareaustralia.gov.au/provider/pbs/highly-specialised-drugs/complex-authority-drugs.jsp
NOTE:
Any queries concerning the arrangements to prescribe romiplostim may be directed to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday
to Friday).
Written applications for authority to prescribe romiplostim should be forwarded to:
Medicare Australia
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001
See attached PDF file for all Notes and Public Hospital Authority requirements
Romiplostim (Nplate) (84kb, pdf) |
Saquinavir
Mesylate (Invirase)
|
|
Initial treatment of HIV infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease (3588)
Continuing treatment of HIV infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection (3589) |
Sevelamer (Renagel) |
|
Management of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on other products and where serum phosphate is greater than 1.6mmol per L at the commencement of therapy. Management includes initiation, stabilisation and review of therapy as required. (3390)
Management of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on other products and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy. Management includes initiation, stabilisation and review of therapy as required. (3391)
Note: Not to be used in combination with lanthanum. |
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