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Hospital Circular 16 /2005

Date Issued: 27 July 2005

Distribution: Public Hospitals

Subject: Highly Specialised Drugs Program

Purpose: To advise hospitals of changes to the Highly Specialised Drugs Program, effective 1 August 2005.

We have had recent advice from the Commonwealth Government of changes to the Highly Specialised Drugs Program, effective 1 August 2005.

1. ADDED DRUG

EVEROLIMUS

CAUTION:
Careful monitoring of patients is mandatory.

Management of rejection, under the supervision and direction of a transplant unit, in patients receiving this drug for:
(a) Prophylaxis of renal allograft rejection. Management includes initiation, stabilisation and review of therapy as required;
(b) Prophylaxis of cardiac allograft rejection. Management includes initiation, stabilisation and review of therapy as required.

2. ADDED ITEM/DRUG FORM

CLOZAPINE

Schizophrenia in patients who are:
(a) non-responsive to other neuroleptic agents; or
(b) intolerant of other neuroleptic agents.

SIROLIMUS

CAUTION:
Careful monitoring of patients is mandatory.

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.

3. PRICE CHANGES

CLARITHROMYCIN

DOXORUBICIN HYDROCHLORIDE

4. AMENDED RESTRICTION

INFLIXIMAB

NOTE:
Any queries concerning the arrangements to prescribe infliximab may be directed to the Health Insurance Commission (HIC) on 1800 005 750 (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:

Health Insurance Commission
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001

Further prescribing information is on the HIC website at www.hic.gov.au

NOTE:
The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of etanercept and infliximab for adult patients with HLA-B27 positive, active ankylosing spondylitis only. It does not apply to the prescribing of adalimumab. Therefore, where the term 'tumour necrosis factor (TNF) alfa antagonists' appears in the following NOTES and restrictions, it only refers to etanercept and infliximab.

Patients are eligible for PBS-subsidised treatment with only 1 of the 2 TNF-alfa antagonists above at any 1 time.

From 1 August 2005, under the PBS, all patients will be able to commence a single treatment cycle where they may trial both of the PBS-subsidised TNF-alfa antagonists without having to experience a disease flare when swapping to the alternate agent. Under these interchangeability arrangements, within a single treatment cycle, patients may continue to receive long-term treatment with a TNF-alfa antagonist while they continue to show a response to therapy.

Once patients have either failed or ceased to respond to treatment up to 3 times, they are deemed to have completed a single treatment cycle and they must have, at a minimum, a 5 year break in PBS-subsidised TNF-alfa antagonist therapy before they are eligible to commence the next cycle. Within the same treatment cycle, patients are not allowed to trial and fail, or cease to respond to, the same PBS-subsidised TNF-alfa antagonist more than twice. Patients who have failed the same PBS-subsidised TNF-alfa antagonist twice must change to the alternate PBS-subsidised agent if they wish to continue PBS-subsidised TNF-alfa antagonist treatment.

The 5-year break in therapy will be measured from the date the last approval for PBS-subsidised TNF-alfa antagonist treatment was granted in the most recent cycle to the date of the first application for initial treatment with a TNF-alfa antagonist under the new cycle.

Where a period of less than 5 years duration has elapsed since the patient's previous course of PBS-subsidised TNF-alfa antagonist treatment, patients who have failed TNF-alfa antagonist therapy less than 3 times within a particular treatment cycle, as defined in the restriction, may commence a further course of treatment within that cycle.

Where a break in PBS-subsidised therapy of 5 years or more has occurred, patients who have failed TNF-alfa antagonist therapy less than 3 times within a particular treatment cycle, as defined in the restriction, are eligible to commence a new treatment cycle.

There is no limit to the number of treatment cycles a patient may undertake in their lifetime.

1. Patients 'grandfathered' onto PBS-subsidised treatment with infliximab and etanercept.

Both the infliximab and etanercept restrictions allow patients who commenced treatment prior to 1 March 2004 and 1 July 2004 respectively to commence treatment under a different set of criteria than those patients who commenced treatment after these dates (i.e. new patients). This means such patients were 'grandfathered' onto PBS-subsidised treatment. Consequently, the criteria to enable 'grandfather' patients to continue on PBS-subsidised treatment are also different to those for new patients.

Where patients who were 'grandfathered' onto PBS-subsidised treatment with 1 TNF-alfa antagonist wish to swap to the alternate agent, they can only do so using the restrictions that apply to 'grandfather' patients.

'Grandfather' arrangements will only apply for the first treatment cycle. For the second and subsequent cycles, 'grandfather' patients must requalify for initial treatment under the criteria that apply to new patients. See 'Re-commencement of treatment after a 5-year break in PBS-subsidised therapy' below for further details. Patients who commenced on PBS-subsidised etanercept or infliximab treatment prior to 1 August 2005 are deemed to be in their first cycle of therapy.

The first course of initial therapy for patients 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab will be limited to provide for 24 weeks of therapy. All subsequent initial treatment courses made under the 'grandfather' restriction will be limited to provide 6 weeks of therapy.

2. How to prescribe TNF-alfa antagonist therapy after 1 August 2005.

(a) Initial treatment.
Applications for initial treatment should be made where:
(i) patients have received no prior PBS-subsidised TNF-alfa antagonist treatment and wish to commence such therapy; or
(ii) patients have received prior PBS-subsidised (initial or continuing) TNF-alfa antagonist therapy and wish to trial an alternate agent [further details are under 'Swapping therapy' below]; or
(iii) patients have failed their most recent course of PBS-subsidised TNF-alfa antagonist therapy but wish to trial a further course of treatment with the same TNF-alfa antagonist (providing they have not failed that TNF-alfa antagonist more than once); or
(iv) patients wish to re-commence treatment with a specific TNF-alfa antagonist following a break in PBS-subsidised therapy with that specific agent.

All applications for initial treatment will be limited to provide for a maximum of 6 weeks of therapy except for the first application for 'grandfather' patients approved for PBS-subsidised treatment with etanercept and infliximab where up to 24 weeks of treatment will be approved.

In order to demonstrate a response to therapy, patients who have received an initial PBS-subsidised course of up to 6 weeks of treatment must be assessed no earlier than 4 weeks from the commencement of the initial therapy course. In order to demonstrate a response to therapy, patients who have received an initial PBS-subsidised course of up to 24 weeks must be assessed in the 4 weeks prior to treatment being ceased.

Assessments of response to a course of PBS-subsidised therapy must be submitted to the HIC no later than 4 weeks from the date that course was ceased.

Where a response assessment is not submitted to the HIC within these timeframes, patients will be deemed to have failed to respond to treatment with that TNF-alfa antagonist.

Prescribers should ensure that applications for second and subsequent courses of PBS-subsidised TNF-alfa antagonist treatment are submitted to the HIC before patients complete their previous treatment course to ensure uninterrupted treatment. Applications where no provisions to fax the prescription and application are made in the restriction should be posted to the HIC no later than 2 weeks prior to the patient completing their previous treatment course.

(b) Continuing treatment.
Following the completion of an initial treatment course with a specific TNF-alfa antagonist, patients may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. Patients are eligible to receive continuing TNF-alfa antagonist treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.

Assessments of response to a course of PBS-subsidised therapy must be submitted to the HIC no later than 4 weeks from the date that course was ceased.

Where a response assessment is not submitted to the HIC within these timeframes, patients will be deemed to have failed to respond to treatment with that TNF-alfa antagonist.

(c) How to apply for TNF-alfa antagonist treatment on or after 1 August 2005.
Patients for whom the first application for PBS-subsidised treatment with either etanercept or infliximab is made on or after 1 August 2005, will fall into 1 of the following categories:

(I) Patients who have not received any prior PBS-subsidised inflixmab or PBS-subsidised etanercept treatment.
This includes the following:
(i) Patients who have not received any prior treatment with infliximab or etanercept for ankylosing spondylitis.
(ii) Patients who have received non-PBS-subsidised treatment with infliximab after 1 March 2004.
(iii) Patients who have received non-PBS-subsidised treatment with etanercept after 1 July 2004.
(iv) Patients who have received non-PBS-subsidised infliximab treatment prior to 1 March 2004.
(v) Patients who have received non-PBS-subsidised etanercept treatment prior to 1 July 2004.

To commence PBS-subsidised treatment with etanercept or infliximab, all patients who fall into groups (i)-(iii) must qualify under the first initial restriction for new patients (i.e. the patient must meet the criteria with respect to the indices of severity and prior treatment regimens specified in the 'new patient' restriction).

To commence PBS-subsidised treatment with infliximab, all patients who fall into group (iv) must qualify under the first initial restriction for 'grandfather' patients (i.e. the patient must meet the criteria with respect to the indices of severity and prior treatment regimens specified in the 'grandfather' restriction).

To commence PBS-subsidised treatment with etanercept, all patients who fall into group (v) must qualify under the first initial restriction for 'grandfather' patients (i.e. the patient must meet the criteria with respect to the indices of severity and prior treatment regimens specified in the 'grandfather' restriction).

Patients in groups (iv) and (v) can not be 'grandfathered' onto treatment with the alternate agent. If they wish to commence PBS-subsidised therapy with the alternate agent, they must qualify under the first initial restriction for new patients (i.e. the patient must meet the criteria with respect to the indices of severity and prior treatment regimens specified in the 'new patient' restriction).

(II) Patients who have received PBS-subsidised etanercept only.
(III) Patients who have received PBS-subsidised infliximab only.
(IV) Patients who have received PBS-subsidised etanercept and non-PBS-subsidised infliximab.
(V) Patients who have received PBS-subsidised infliximab and non-PBS-subsidised etanercept.

To receive PBS-subsidised treatment with etanercept or infliximab, the patients in groups (II)-(V) do not need to requalify with respect to the indices of severity or prior treatment requirements. They use the second initial restriction for either 'new' or 'grandfather' patients (i.e. whichever was applicable for their first course of PBS-subsidised treatment).

NOTE:
Patients who have responded to their most recent course of etanercept therapy as specified in the restriction may:
— continue on etanercept treatment under the 'grandfather' or new patient restriction, whichever is applicable [see 'Patients 'grandfathered' onto PBS-subsidised treatment with infliximab and etanercept']; or
— swap to an initial course of infliximab treatment of up to 6 weeks under the 'grandfather' or new patient restriction, whichever is applicable [see Patients 'grandfathered' onto PBS-subsidised treatment with infliximab and etanercept'].

Patients who have failed to respond to their most recent course of etanercept treatment may:
— trial a further course of initial therapy of up to 6 weeks with etanercept; or
— swap to an initial course of infliximab treatment of up to 6 weeks.

Patients who have responded to their most recent course of infliximab therapy as specified in the restriction may:
— continue on infliximab treatment under the 'grandfather' or new patient restriction, whichever is applicable [see 'Patients 'grandfathered' onto PBS-subsidised treatment with infliximab and etanercept']; or
— swap to an initial course of etanercept treatment of up to 6 weeks under the 'grandfather' or new patient restriction, whichever is applicable [see 'Patients 'grandfathered' onto PBS-subsidised treatment with infliximab and etanercept'].

Patients who have failed to respond to their most recent course of infliximab treatment may:
— trial a further course of initial therapy of up to 6 weeks with infliximab; or
— swap to an initial course of etanercept treatment of up to 6 weeks.

3. Swapping therapy.

Once an authority for initial treatment with the first PBS-subsidised TNF-alfa antagonist is approved, patients may swap to the alternate TNF-alfa antagonist within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. the erythrocyte sedimentation rate (ESR), the C-reactive protein (CRP) levels and the BASDAI), or the prior NSAID therapy and exercise program requirements. This also applies to patients who fail to achieve or sustain a response to the first PBS-subsidised TNF-alfa antagonist approved and who wish to trial a further course of treatment with the same TNF-alfa antagonist.

Patients may trial an alternate TNF-alfa antagonist at any time, regardless of whether they are receiving therapy (initial or continuing) with a TNF-alfa antagonist at the time of the application or not. However, they cannot swap to a particular TNF-alfa antagonist if they have failed to respond to prior treatment with that particular drug more than twice in the same cycle.

To ensure patients receive the maximum treatment opportunities allowed under the interchangeability arrangements, it is important that they are assessed for response to every course of treatment approved, within the timeframes specified in the relevant restriction.

To avoid confusion, applications for patients who wish to swap to an alternate TNF-alfa antagonist should be accompanied by the approved authority prescription or remaining repeats for the TNF-alfa antagonist the patient is ceasing.

4. Baseline measurements to determine response.

The HIC will determine whether a response to treatment has been demonstrated based on the baseline measurements of the BASDAI, ESR and/or CRP submitted with the first authority application for a TNF-alfa antagonist. However, prescribers may provide new baseline measurements any time that an initial treatment authority is submitted within a treatment cycle and the HIC will assess response according to these revised baseline measurements.

For new patients, the first BASDAI result used to determine baseline must be provided while the patient is still receiving NSAID therapy. However, this is not required for any subsequent BASDAI results provided for these patients nor for patients who were 'grandfathered' onto TNF-alfa antagonist treatment.

To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications. Therefore, where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be provided to determine response.

5. Re-commencement of treatment after a 5-year break in PBS-subsidised therapy.

Patients who wish to trial a second or subsequent treatment cycle following a break in PBS-subsidised TNF-alfa antagonist therapy of at least 5 years, must requalify for initial treatment with respect to the indices of disease severity. Patients must have received treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months immediately prior to the time the BASDAI, ESR and/or CRP levels are measured.

Public and private hospital authority required
Initial 1 (new patients)
Application for the first course of initial PBS-subsidised treatment with infliximab, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who have not received any PBS-subsidised treatment with either etanercept or infliximab;
AND
(a) have at least 2 of the following:
(i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or
(ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI) [for further information on the BASMI please refer to the HIC website at www.hic.gov.au ; or
(iii) limitation of chest expansion relative to normal values for age and gender [for chest expansion normal values please refer to the HIC website at www.hic.gov.au ;
AND
(b) who have documented confirmation of HLA-B27 positive status;
AND
(c) who have failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) in combination with an appropriate exercise program for a total period of 3 months.

The application must include details of the NSAIDs trialled, their doses and duration of treatment. If the NSAID dose is less than the maximum recommended dose in the relevant TGA-approved Product Information, the application must include the reasons why a higher dose cannot be used.

For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the HIC website at www.hic.gov.au.

Patients who received treatment with infliximab prior to 1 March 2004 and wish to commence PBS-subsidised treatment with infliximab must qualify under the initial treatment restriction for 'grandfather' patients.

The following initiation criteria indicate failure to achieve an adequate response and must be demonstrable in all patients at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale;
AND
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L.

The BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.

Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.

If treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the patient is exempted from demonstrating an inadequate response to the above treatment regimen. Where appropriate, evidence to support a contraindication must be provided. If adverse events of a severity necessitating permanent withdrawal develop during the relevant period of use of 2 NSAIDs, the patient may be exempted from demonstrating an inadequate response to the above treatment regimen. For details of the adverse events, including the severity, which will be accepted for the purposes of administering this restriction, please refer to the HIC website at www.hic.gov.au.

Authority applications must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed TNF-alfa antagonist PBS Authority Application for Use in the Treatment of Ankylosing Spondylitis - Supporting Information Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)] which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HLA-B27; and
(iii) a copy of the completed BASDAI Assessment Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)]; and
(iv) a copy of the signed patient acknowledgment form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)]. Completion of this form declares that the patient understands and acknowledges that PBS-subsidised treatment with the TNF-alfa antagonists (etanercept or infliximab) for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated.

The assessment of the patient's response to the initial course of treatment must be made no earlier than 4 weeks from the commencement of treatment and submitted to the HIC no later than 4 weeks from the cessation of that treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.

A maximum of 6 weeks of treatment with infliximab will be approved under this criterion.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for 2 infusions at a dose of 5 mg per kg. No repeats will be authorised.

Public and private hospital authority required
Initial 2 (new patients)
Application for an initial course of PBS-subsidised treatment with infliximab, by a rheumatologist, of adults with active ankylosing spondylitis who, in this treatment cycle, have received prior PBS-subsidised treatment with either etanercept or infliximab for this condition and have not failed PBS-subsidised therapy with infliximab more than once.

All applications for treatment must be accompanied by the results of the most recent course of TNF-alfa antagonist therapy within the timeframes specified below.

Where the most recent course of PBS-subsidised TNF-alfa antagonist treatment was approved under an initial treatment restriction for new patients, patients must have been assessed for response to that course no earlier than 4 weeks from the commencement of that course. This assessment must be provided to the HIC no later than 4 weeks from the date that course was ceased.

Where the most recent course of PBS-subsidised TNF-alfa antagonist treatment was approved under the continuing treatment criteria for new patients, patients must have been assessed for response to that course, and the assessment must be submitted to the HIC no later than 4 weeks from the date that course was ceased.

If the response assessments to the previous course of TNF-alfa antagonist treatment are not submitted as detailed above, patients will be deemed to have failed therapy with that particular course of TNF-alfa antagonist.

Authority applications must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed TNF-alfa antagonist PBS Authority Application for Use in the Treatment of Ankylosing Spondylitis - Supporting Information Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)] which includes a copy of the completed BASDAI Assessment Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)].

A maximum of 6 weeks of treatment with infliximab will be approved under this criterion.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for 2 infusions at a dose of 5 mg per kg. No repeats will be authorised.

Public and private hospital authority required
Continuing (new patients)
Continuing PBS-subsidised treatment, by a rheumatologist, of adults with active ankylosing spondylitis who:
(a) have received 6 weeks or more of PBS-subsidised treatment with infliximab; and
(b) have demonstrated a response to treatment with infliximab; and
(c) whose most recent course of PBS-subsidised therapy in this treatment cycle was with infliximab.

Response is defined as an improvement from baseline of at least 2 of the BASDAI and 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.

The same acute phase reactant measured at the relevant baseline must be measured in all subsequent continuing treatment applications.

The first application for continuing treatment following an initial treatment course must be made no earlier than 4 weeks from the commencement of the most recent initial treatment course with infliximab. This first authority application and a copy of the authority prescription may be faxed to the HIC on (03) 6215 5640 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) in order to seek approval for a maximum of 4 weeks' supply. The HIC will then contact the prescriber by telephone. The original document must then be posted to the HIC with a second authority prescription for the balance of 24 weeks of treatment.

Second and subsequent applications for continuing treatment must be made in writing and should be posted to the HIC no less than 2 weeks prior to the completion of the current treatment course.

Written applications for authorisation must include:
(a) a completed authority prescription form; and
(b) a completed TNF-alfa antagonist PBS Authority Application for Continuing Use in the Treatment of Ankylosing Spondylitis - Supporting Information Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)] which includes the following:
(i) a copy of the completed BASDAI Assessment Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)] including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment.

All measurements provided must be no more than 1 month old at the time of application.

A maximum of 24 weeks of treatment with infliximab will be authorised under this criterion.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. No applications for increased repeats will be authorised.

Where fewer than 3 repeats are initially requested with the authority prescription, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by telephone.

Public and private hospital authority required
Initial 1 ('grandfather' patients)
Application for an initial PBS-subsidised course of continuing treatment with infliximab, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were receiving treatment with infliximab prior to 1 March 2004;
AND
(a) are receiving treatment with infliximab at the time of application;
AND
(b) who have not received prior PBS-subsidised treatment with etanercept;
AND
(c) who have documented confirmation of HLA-B27 positive status;
AND
(d) whose Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score is less than or equal to 5 on a 0-10 scale;
AND
(e) who have:
(i) an ESR measurement no greater than 25 mm per hour; or
(ii) a CRP measurement no greater than 10 mg per L; or
(iii) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline.

The BASDAI assessment and ESR and/or CRP measurements must be no more than 1 month old at the time of application. The same acute phase reactant measured in the first application for PBS-subsidised treatment must be measured in all subsequent continuing treatment applications.

Authority applications must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed TNF-alfa antagonist PBS Authority Application for Use in the Treatment of Ankylosing Spondylitis - Supporting Information Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)] which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a copy of the pathology report from an Approved Pathology Authority confirming the presence of HLA-B27; and
(iii) a copy of the completed BASDAI Assessment Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)]; and
(iv) a copy of the signed patient acknowledgment form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)]. Completion of this form declares that the patient understands and acknowledges that PBS-subsidised treatment with the TNF-alfa antagonists (etanercept or infliximab) for ankylosing spondylitis will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated.

The assessment of the patient's response to this initial course of therapy must be made within the 4 weeks prior to completion of the course in order to ensure continuity of treatment.

Those patients ceasing treatment or swapping to an alternate agent and wishing to demonstrate a response to treatment, must be assessed no earlier than 4 weeks from the commencement of PBS-subsidised treatment. This assessment must be provided to the HIC no later than 4 weeks from the date that course was ceased. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.

A maximum of 24 weeks of treatment with infliximab will be authorised under this criterion.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. No applications for increased repeats will be authorised.

Where fewer than 3 repeats are initially requested with the authority prescription, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by telephone.

Patients may only qualify for PBS-subsidised treatment under this criterion once.

Public and private hospital authority required
Initial 2 ('grandfather' patients)
Application for an initial course of PBS-subsidised treatment with infliximab, by a rheumatologist, of adults with active ankylosing spondylitis who have radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, who were 'grandfathered' onto PBS-subsidised treatment with etanercept or infliximab and who have not failed PBS-subsidised therapy with infliximab more than once.

Where the most recent course of PBS-subsidised TNF-alfa antagonist treatment was approved under an initial treatment restriction for 'grandfather' patients, patients must have been assessed for response to that course no earlier than 4 weeks from the commencement of that course. This assessment must be provided to the HIC no later than 4 weeks from the date that course was ceased.

Where the most recent course of PBS-subsidised TNF-alfa antagonist treatment was approved under the continuing treatment criteria for 'grandfather' patients, patients must have been assessed for response to that course, and the assessment must be submitted to the HIC no later than 4 weeks from the date that course was ceased.

If the response assessments to the previous course of TNF-alfa antagonist treatment are not submitted as detailed above, patients will be deemed to have failed therapy with that particular course of TNF-alfa antagonist.

Authority applications must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed TNF-alfa antagonist PBS Authority Application for Use in the Treatment of Ankylosing Spondylitis - Supporting Information Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)] which includes a copy of the completed BASDAI Assessment Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)].

A maximum of 6 weeks of treatment with infliximab will be approved under this criterion.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for 2 infusions at a dose of 5 mg per kg. No repeats will be authorised.

Public and private hospital authority required
Continuing ('grandfather' patients)
Continuing PBS-subsidised treatment, by a rheumatologist, of adults with active ankylosing spondylitis who were 'grandfathered' onto PBS-subsidised treatment with a TNF-alfa antagonist and who:
(a) have received 6 weeks or more of PBS-subsidised treatment with infliximab; and
(b) have demonstrated a response to treatment with infliximab; and
(c) whose most recent course of PBS-subsidised therapy in this treatment cycle was with infliximab.

Response to treatment is defined as a BASDAI score no more than 20% greater than the score included in the initial application for PBS-subsidised treatment;
AND
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from pre-treatment baseline.

The same acute phase reactant measured at the relevant baseline must be measured in all subsequent continuing treatment applications.

The first application for continuing treatment following an initial treatment course must be made no earlier than 4 weeks from the commencement of the most recent initial treatment course with infliximab. This first authority application and a copy of the authority prescription may be faxed to the HIC on (03) 6215 5640 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) in order to seek approval for a maximum of 4 weeks' supply. The HIC will then contact the prescriber by telephone. The original document must then be posted to the HIC with a second authority prescription for the balance of 24 weeks of treatment.

Second and subsequent applications for continuing treatment must be made in writing and should be posted to the HIC no less than 2 weeks prior to the completion of the current treatment course.

In order to demonstrate a response to treatment where the patient is ceasing or swapping to an alternate agent, the assessment must be provided to the HIC no later than 4 weeks from the date that course was ceased.

Written applications for authorisation must include:
(a) a completed authority prescription form; and
(b) a completed TNF-alfa antagonist PBS Authority Application for Continuing Use in the Treatment of Ankylosing Spondylitis - Supporting Information Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)] which includes the following:
(i) a copy of the completed BASDAI Assessment Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)] including certification by the prescriber and the patient that the patient did not have access to their baseline BASDAI at the time of their continuing treatment assessment.

All measurements provided must be no more than 1 month old at the time of application.

A maximum of 24 weeks of treatment with infliximab will be authorised under this criterion.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. No applications for increased repeats will be authorised.

Where fewer than 3 repeats are initially requested with the authority prescription, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by telephone.

6448J Powder for I.V. infusion 100 mg 1 $875.00 Remicade SH

NOTE:
The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the tumour necrosis factor (TNF) alfa antagonists (adalimumab, etanercept and infliximab) and the interleukin-1 inhibitor (anakinra) for adult patients with severe rheumatoid arthritis.

Patients are eligible for PBS-subsidised treatment with only 1 of the above biological disease modifying anti-rheumatic drugs (bDMARDs) at any 1 time.

1. Patients who have received no prior PBS-subsidised bDMARD treatment at 1 December 2004.

From 1 December 2004, the arrangements for prescribing the bDMARDs on the PBS have been amended to allow patients to commence a single cycle of bDMARD treatment that allows them to trial any number of bDMARDs without having to experience a disease flare when swapping between alternate bDMARDs. Within a single treatment cycle, patients may continue to receive long-term treatment with a bDMARD while they continue to show a response to therapy.

Once patients have either failed, or ceased to respond to, treatment with a maximum of 3 bDMARDs, they are deemed to have completed a single treatment cycle and they must have, at a minimum, a 5 year break in PBS-subsidised bDMARD therapy before they are eligible to commence the next cycle. The 5-year period will be measured from the date the last prescription for PBS-subsidised bDMARD treatment was approved in the most recent cycle to the date of the application for initial treatment with a bDMARD under the new cycle.

Patients who have failed treatment with fewer than 3 bDMARDs within a particular treatment cycle, and where a period of less than 5 years duration has elapsed since the patient's previous course of PBS-subsidised bDMARD treatment in that cycle, may commence a further course of bDMARD treatment within that same treatment cycle.

Patients who have failed treatment with fewer than 3 bDMARDs within a particular treatment cycle, and who have had a break in PBS-subsidised therapy of 5 years or more, are eligible to commence a new treatment cycle.

There is no limit to the number of treatment cycles a patient may undertake in their lifetime.

If patients fail to respond to a particular bDMARD within a single treatment cycle, they are not eligible to receive further PBS-subsidised treatment with that drug until they commence the next cycle.

2. Patients who have received PBS-subsidised TNF-alfa antagonist treatment prior to 1 December 2004.

Patients who commenced PBS-subsidised TNF-alfa antagonist therapy prior to 1 December 2004 are considered to be in their first cycle of bDMARD treatment on 1 December 2004.

Patients who have failed to respond to prior PBS-subsidised treatment with fewer than 3 TNF-alfa antagonists at the time the first application for treatment is made on or after 1 December 2004, will be subject to the same conditions applying to new patients detailed above.

Therefore, patients who have failed:
(a) 1 TNF-alfa antagonist will be eligible to trial further PBS-subsidised treatment with a bDMARD they have not failed in their first treatment cycle, until they fail to demonstrate a response to no more than another 2 bDMARDs;
(b) 2 TNF-alfa antagonists will be eligible to trial further PBS-subsidised treatment with a bDMARD they have not failed in their first treatment cycle, until they fail to demonstrate a response to no more than 1 other bDMARD.

Patients who have failed PBS-subsidised treatment with 3 TNF-alfa antagonists prior to 1 December 2004 or at the first assessment required after this date, will be eligible to trial PBS-subsidised treatment with anakinra if they wish. However, if they fail to demonstrate a response to anakinra, they will not be able to trial any further PBS-subsidised bDMARD treatment until a minimum of 5 years has elapsed from the date that the prescription for the last course of anakinra therapy was approved. Arrangements to allow these patients to fail 4 bDMARDs will only be in place for the first treatment cycle. For subsequent cycles, patients will cease to be eligible to receive PBS-subsidised bDMARD treatment once they have failed to demonstrate a response to a maximum of 3 bDMARDs.

Any queries on these arrangements should be forwarded to the HIC.

3. Information relevant to all patients.

(a) Initial treatment.
Applications for initial treatment should be made where:
(i) patients have received no prior PBS-subsidised bDMARD treatment and wish to commence such therapy; or
(ii) patients have received prior PBS-subsidised (initial or continuing) bDMARD therapy and wish to trial an alternate agent [further details are under 'Swapping therapy' below]; or
(iii) patients wish to re-commence treatment with a specific bDMARD following a break in PBS-subsidised therapy with that specific agent.

All applications for initial treatment will be limited to provide for a maximum of 16 weeks of therapy for all agents except for infliximab, for which a maximum of 22 weeks will be authorised. It is recommended that patients be reviewed in the month prior to completing their course of initial treatment to ensure uninterrupted bDMARD supply.

Patients must be assessed for response to any course of PBS-subsidised initial treatment following a minimum of 12 weeks of therapy and this assessment must be submitted to the HIC no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to the HIC within these timeframes, patients will be deemed to have failed to respond to treatment with that bDMARD.

(b) Continuing treatment.
Following the completion of an initial treatment course with a specific bDMARD, patients may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. Patients are eligible to receive continuing bDMARD treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.

Patients must be assessed for response to a course of continuing therapy, and the assessment must be submitted to the HIC no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to the HIC within these timeframes, patients will be deemed to have failed to respond to treatment with that bDMARD.

(c) Swapping therapy.
Once an authority for initial treatment with the first PBS-subsidised bDMARD is approved, patients may swap to an alternate bDMARD without having to re-qualify with respect to either the indices of disease severity (i.e. erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) level, and active joint count) or the prior non-bDMARD therapy requirements. However, the requirement for concomitant treatment with methotrexate, where it applies, must be met for each bDMARD trialed.

Patients may swap to an alternate bDMARD at any time, regardless of whether they are receiving therapy (initial or continuing) with a bDMARD at the time of the application or not.

Patients may alternate between therapy with any bDMARD of their choice (1 at a time) providing:
(i) they have not received PBS-subsidised treatment with that particular bDMARD previously; or
(ii) they have demonstrated an adequate response to that particular bDMARD if they have previously trialed it on the PBS.

Therefore, to maximise the choice of bDMARD patients may alternate between, it is important that patients are assessed for response to every course of treatment approved, within the timeframes specified in the relevant restriction.

To avoid confusion, applications for patients who wish to swap to an alternate bDMARD should be accompanied by the approved authority prescription or remaining repeats for the bDMARD the patient is ceasing.

(d) Baseline measurements to determine response.
The HIC will determine whether a response to treatment has been demonstrated based on the baseline measurements of the indices of disease severity submitted with the first authority application for a bDMARD. However, prescribers may provide new baseline measurements any time that an initial treatment authority is submitted within a treatment cycle and the HIC will assess response according to these revised baseline measurements.

To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications. Therefore, where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be provided to determine response. Similarly, where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to a reduction in the total number of active joints.

(e) Re-commencement of treatment after a 5-year break in PBS-subsidised therapy.
Patients who wish to trial a second or subsequent treatment cycle following a break in PBS-subsidised bDMARD therapy of at least 5 years, must re-qualify for initial treatment with respect to both the indices of disease severity. Patients must have received treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months at the time the ESR or CRP levels and the active joint counts are measured.

Public and private hospital authority required
Application for initial PBS-subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no prior PBS-subsidised treatment with a bDMARD for this condition in this treatment cycle; and
(c) have failed to achieve an adequate response to the following treatments:
(i) methotrexate at a dose of at least 20 mg weekly; and
(ii) methotrexate (at a minimum dose of 7.5 mg weekly), in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs), for a minimum of 3 months;
and
(iii) a minimum of 3 months' treatment with:
— leflunomide alone; or
— leflunomide in combination with methotrexate; or
— cyclosporin.

If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, the patient is exempted from demonstrating an inadequate response to that particular agent(s) only. Details of the contraindications or intolerance, including the degree of toxicity, must be provided at the time of application.

The following initiation criteria indicate failure to achieve an adequate response and must be demonstrable in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L;
AND either
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
— shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Biological DMARD PBS Authority Application for Use in the Treatment of Rheumatoid Arthritis - Supporting Information Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)] which includes details of the patient's ESR and CRP measurements and the patient's active joint count which must have been assessed no earlier than 1 month prior to the date of application;
and
(3) a copy of the signed patient acknowledgement form which may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm). Completion of this form declares that the patient understands and acknowledges that, within a single treatment cycle, PBS-subsidised treatment with any biological DMARD will cease if they do not demonstrate the response to treatment required to support continuation of PBS-subsidised treatment at any assessment where a response must be demonstrated.

At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 3 mg per kg. Up to a maximum of 3 repeats may be authorised.

Where fewer than 3 repeats are requested at the time of the initial application, authority approvals for sufficient repeats to complete a maximum of 22 weeks of treatment may be requested by telephone by contacting the HIC on 1800 005 750 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Patients who fail to demonstrate a response to treatment with infliximab under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug, in this treatment cycle. Patients may re-trial infliximab after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under the new cycle.

Public and private hospital authority required
Application for an initial course of PBS-subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised bDMARD treatment for this condition in this treatment cycle and are eligible to receive further bDMARD therapy.

Patients who were commenced on treatment with infliximab prior to 1 December 2004 and who have received methotrexate at a dose of less than 7.5 mg per week will be able to continue to receive PBS-subsidised treatment with infliximab in combination with methotrexate at this lower dose for the duration of the first bDMARD treatment cycle. For subsequent treatment cycles, patients must receive concomitant methotrexate at a dose of at least 7.5 mg weekly.

Applications for patients who have received PBS-subsidised treatment with infliximab within this treatment cycle and who wish to re-commence therapy with this drug within this same cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised infliximab treatment, within the timeframes specified below.

Where the most recent course of PBS-subsidised infliximab treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised bDMARD therapy or, under this restriction, for patients who have received previous PBS-subsidised bDMARD therapy), patients must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be provided to the HIC no later than 4 weeks from the date that course was ceased.

Where the most recent course of PBS-subsidised infliximab treatment was approved under the continuing treatment criteria, patients must have been assessed for response, and the assessment must be submitted to the HIC no later than 4 weeks from the date that course was ceased.

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Biological DMARD PBS Authority Application for Use in the Treatment of Rheumatoid Arthritis - Supporting Information Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)].

At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 3 mg per kg. Up to a maximum of 3 repeats may be authorised.

Where fewer than 3 repeats are requested at the time of the initial application, authority approvals for sufficient repeats to complete a maximum of 22 weeks of treatment may be requested by telephone by contacting the HIC on 1800 005 750 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Patients who fail to demonstrate a response to treatment with infliximab under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug, in this treatment cycle. Patients may re-trial infliximab after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under the new cycle.

Once patients fail to respond to treatment with 3 bDMARDs, they are deemed to have completed this treatment cycle and must cease PBS-subsidised therapy. These patients may re-commence a new bDMARD treatment cycle after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under the new cycle.

Public and private hospital authority required
Initial PBS-subsidised supply for continuing treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) were receiving treatment with infliximab prior to 1 March 2005; and
(c) failed to qualify for PBS-subsidised therapy after 1 November 2003 due to testing negative for rheumatoid factor; and
(d) have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with infliximab.

Medical practitioners who wish to apply for authority to prescribe a bDMARD for patients who commenced treatment with infliximab prior to 1 March 2005 and who have not demonstrated a response to treatment should contact the HIC on 1800 005 750.

The authority application must be in writing and must include sufficient information to determine the patient's eligibility. The date of assessment must be provided.

At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 3 mg per kg. Up to a maximum of 2 repeats may be authorised.

Patients who fail to demonstrate a response to treatment with infliximab under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug, in this treatment cycle. Patients may re-trial infliximab after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under the new cycle.

Once patients fail to respond to treatment with 3 bDMARDs, they are deemed to have completed this treatment cycle and must cease PBS-subsidised therapy. These patients may re-commence a new bDMARD treatment cycle after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under the new cycle.

Public and private hospital authority required
Continuing PBS-subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with infliximab; and
(c) whose most recent course of PBS-subsidised bDMARD treatment in this treatment cycle was with infliximab.

An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
— shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

Patients who were commenced on treatment with infliximab prior to 1 December 2004 and who have received methotrexate at a dose of less than 7.5 mg per week will be able to continue to receive PBS-subsidised treatment with infliximab in combination with methotrexate at this lower dose for the duration of the first bDMARD treatment cycle. For subsequent treatment cycles, patients must receive concomitant methotrexate at a dose of at least 7.5 mg weekly.

The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Biological DMARD PBS Authority Application for Use in the Treatment of Rheumatoid Arthritis - Supporting Information Form [may be downloaded from the HIC website (www.hic.gov.au/providers/forms/pbs/medical_practitioners.htm)].

All applications for continuing treatment with infliximab must include a measurement of response to the prior course of therapy. This assessment must be provided to the HIC no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with infliximab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.

At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 3 mg per kg. Up to a maximum of 2 repeats may be authorised.

Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by telephone by contacting the HIC on 1800 005 750 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Patients who fail to demonstrate a response to treatment with infliximab under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug, in this treatment cycle. Patients may re-trial infliximab after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under the new cycle.

Once patients fail to respond to treatment with 3 bDMARDs, they are deemed to have completed this treatment cycle and must cease PBS-subsidised therapy. These patients may re-commence a new bDMARD treatment cycle after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised bDMARD was approved in this cycle and the date of the first application under the new cycle.

5. DELETIONS

RIBAVIRIN AND INTERFERON ALFA 2b (Removal from HSD Program)

6261M Pack containing 84 capsules ribavirin 200 mg and 2 multi-dose
injection pens interferon alfa-2b solution for injection 18,000,000
i.u. in 1.2 mL ‡1 $988.24 Rebetron Combination Therapy SH

6262N Pack containing 140 capsules ribavirin 200 mg and 2 multi-dose
injection pens interferon alfa-2b solution for injection 18,000,000
i.u. in 1.2 mL ‡1 $1,450.00 Rebetron Combination Therapy SH

6263P Pack containing 168 capsules ribavirin 200 mg and 2 multi-dose
injection pens interferon alfa-2b solution for injection 18,000,000
i.u. in 1.2 mL ‡1 $1,677.06 Rebetron Combination Therapy SH

Items discontinued at the request of the manufacturer.

Elise Davies
Acting Director, Programs
Metropolitan Health & Aged Care Services