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Rheumatoid arthritis

Guide to prescribing biological agents

Guide to prescribing biological agents [PDF, 206Kb]

Section 100 arrangements for abatacept, infliximab, rituximab and tocilizumab only

These items are only available to a patient who is attending:

an approved private hospital
a public participating hospital

a public hospital

and is a

day admitted patient
non-admitted patient

patient on discharge.

These items are not available as PBS benefits for in-patients of the hospital. The hospital provider number must be included on the application form.

Restriction details

Adult patients must satisfy the initial criteria before approval will be granted to prescribe PBS subsidised bDMARDs.

View a full transcript of the restriction details.

All applications must be completed by the treating rheumatologist, or clinical immunologist with expertise in the management of rheumatoid arthritis.

The restrictions are:

initial PBS subsidised treatment with a bDMARD—in combination with methotrexate where applicable, as defined in the restriction—of adults with severe active rheumatoid arthritis
initial PBS subsidised treatment, for continuing treatment of adults, in combination with methotrexate where applicable, with a documented history of severe active rheumatoid arthritis who started treatment with non PBS subsidised certolizumab pegol, golimumab and tocilizumab and who, at the time of application, have demonstrated an adequate response to treatment
change to an alternate bDMARD—in combination with methotrexate where applicable, as defined in the restriction—where the patient has already received PBS subsidised bDMARD treatment within this interchangeability cycle. This is for treatment with an alternate bDMARD for which the patient is eligible
continuing PBS subsidised treatment with a bDMARD—in combination with methotrexate where applicable, as defined in the restriction—of adults with a documented history of severe active rheumatoid arthritis and who, at the time of application have demonstrated an adequate response to treatment with the current bDMARD.

Notes on interchangeability

The following information applies to the prescribing under the PBS of the:

Tumour Necrosis Factor (TNF) α antagonists (adalimumab, certolizumab pegol, etanercept, golimumab and infliximab)
interleukin-6 inhibitor (tocilizumab)
chimeric anti-CD20 monoclonal antibody (rituximab)
T-cell co-stimulation modulator (abatacept).

Patients are eligible for PBS subsidised treatment with only one of the above bDMARDs at any one time.

The arrangements for prescribing bDMARDs on the PBS have been amended to allow patients to start a single lifetime cycle of bDMARD treatment that allows them to trial a number of bDMARDs, for which they are eligible, without having to experience a disease flare when swapping between alternate bDMARDs. Within a single lifetime treatment cycle, patients may continue to receive long term treatment with a bDMARD while they sustain a response to therapy.

Once patients have either failed, or ceased to respond to treatment with a maximum of five bDMARDs for which they are eligible, they can not receive further PBS-subsidised bDMARDs for the treatment of rheumatoid arthritis.

In order to receive PBS subsidised treatment with rituximab, a patient must have already failed to demonstrate a response to at least one course of treatment with a PBS subsidised TNF α antagonist.

If a patient fails to respond to a particular bDMARD, they are not eligible to receive further PBS subsidised treatment with that bDMARD for rheumatoid arthritis.

Information relevant to all patients

Initial applications

Applications for initial treatment should be made where patients have received no prior PBS subsidised bDMARD treatment and for patients who have had greater than 24 months break in bDMARD treatment.

All applications for initial treatment will be limited to provide for a maximum of:

16 weeks of therapy for abatacept, adalimumab, etanercept, golimumab and tocilizumab,
18 – 20 weeks of certolizumab pegol (depending upon the dosing regimen),
22 weeks of infliximab, and
2 infusions of rituximab

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 Medicare Australia no later than four weeks from the date that course was ceased. Where a response assessment is not submitted to Medicare Australia within these time frames, patients will be deemed to have failed to respond to treatment with that bDMARD.

Continuing applications

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. Subsequent applications for continuing treatment should be made after 20 weeks of treatment or within one month of stopping treatment.

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

Rituximab only:

The assessment for each continuing application should be made following a minimum of 12 weeks after the first infusion of the patient’s most recent treatment with rituximab.

Swapping therapy—change and recommencement applications

Once an authority for initial treatment with the first PBS subsidised bDMARD is approved, and provided the patient has not had a greater than 24 month break in bDMARD treatment, patients may swap to an alternate bDMARD, for which they are eligible, without having to requalify with respect to either the:

indices of disease severity (i.e. Erythrocyte Sedimentation Rate (ESR) or C-Reactive Protein (CRP) levels and active joint count)

prior therapy requirements.

However, the requirement for concomitant treatment with methotrexate, where it applies, must be met for each bDMARD trialled.

In order to receive PBS subsidised treatment with rituximab, a patient must have already failed to demonstrate a response to at least one course of treatment with a PBS subsidised TNF α antagonist. Patients who have not had a response assessment submitted to Medicare Australia within the required time frames and who are therefore deemed to have failed bDMARD treatment do not qualify for rituximab.

Patients who have had a break in PBS subsidised treatment:

less than 24 months, who demonstrated a response to that treatment and who wish to recommence treatment, may submit a new baseline set of measurements.
greater than 24 months must reapply as an initial patient

All applications for change treatment will be limited to provide for a maximum of :

16 weeks of therapy for abatacept, adalimumab, etanercept, golimumab and tocilizumab,
18 – 20 weeks of certolizumab pegol (depending upon the dosing regimen),
22 weeks of infliximab, and
2 infusions of rituximab

Patients may swap to an alternate bDMARD, regardless of whether they are receiving therapy (initial or continuing) with a bDMARD at the time of the application. Patients may alternate between therapy with any bDMARD, for which they are eligible (one at a time) providing they have:

not received PBS subsidised treatment with that particular bDMARD previously

demonstrated an adequate response to that particular bDMARD if they have previously trialled it on the PBS.

Therefore, to maximise the choice of bDMARDs patients may alternate between, 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 delay, 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.

Baseline measurements to determine response

Medicare Australia will determine whether a response to treatment has been demonstrated 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. Medicare Australia will assess response according to these revised baseline measurements.

To ensure consistency in determining response, the same indices of disease severity used to establish the baseline 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. Patients with less than 20 active joints, will be assessed on major joints only for continuing treatment.

Item details

Dose

Abatacept (Orencia®) is available as:

a vial containing 250 mg of powder for IV infusion
a prefilled syringe 125mg/mL

The dose for adult patients is:

< 60 kg 2 vials

60–100 kg 3 vials

> 100 kg 4 vials

For patients receiving treatment by:

IV infusions—doses are to be given at weeks zero, two and four then every four weeks.
SC injections—dose is administered weekly, with or without an IV loading dose. For a patient starting therapy with an IV loading dose, abatacept should be started with a single intravenous infusion based on the table above, followed by the first 125mg SC injection. Further doses should be administered weekly by SC injection. A separate authority prescription is needed for both the IV and SC dose.

Patients transitioning from abatacept IV to abatacept SC should have the first SC dose instead of the next scheduled IV dose.

Initially patients are to be treated at weeks zero, two and four then every 4 weeks.

Adalimumab (Humira®) is presented as either:

a prefilled syringe containing 40 mg adalimumab in 0.8 mL, or
a prefilled pen containing 40 mg adalimumab in 0.8 mL.

The dose for adult patients is one subcutaneous injection fortnightly.

The form of adalimumab 40 mg must be specified on the prescription as prefilled syringes or prefilled pens.

Certolizumab pegol (Cimzia®) is presented as:

a prefilled syringe containing 200 mg in 1 mL.

The dose for adult patients is two subcutaneous injections at weeks zero, two and four then:

one injection every 2 weeks, or
two injections every 4 weeks.

Etanercept (Enbrel®) 25 mg is presented as:

a set of four vials of powder for injection 25 mg and four prefilled syringes of solvent 1 mL.

The dose for adult patients is one subcutaneous injection twice weekly.

Etanercept (Enbrel®) 50 mg is presented as either:

a pack of four single use prefilled syringes containing etanercept 50 mg in 1 mL.

a pack of four single use prefilled autoinjectors containing etanercept 50 mg in 1 mL.

The form of etanercept 50 mg required must be specified on the prescription as a pack of prefilled syringes or prefilled autoinjectors.

The dose for adult patients is one subcutaneous injection once a week.

Golimumab (Simponi®) is presented as:

a prefilled syringe containing 50 mg in 0.5 mL

a prefilled pen containing 50 mg in 0.5 mL

The form of golimumab 50 mg required must be specified on the prescription as a pack of prefilled syringes or prefilled autoinjectors.

The dose for adult patients is one subcutaneous injection every four weeks.

Infliximab (Remicade®) is presented as:

a vial containing 100 mg of lypholised powder.

The dose for adult patients is 3 mg per kg given intravenously.

Initially patients are to be treated at week zero, week two and week six. Subsequent infusions are at eight weekly intervals.

Rituximab (Mabthera®) is presented as:

a solution for IV infusion 500 mg in 50 mL.

Patients are to be treated at week zero and week two. The patient remains eligible to receive a course of treatment of rituximab every 24 weeks, providing they continue to demonstrate response as specified in the restriction.

The dose is 1000mg at week zero and week two.

Tocilizumab (Actemra®) is presented as:

80 mg/4 mL I.V. solution
200 mg/10 mL I.V.solution
400 mg/20 mL I.V. solution

The dose for patients is 8 mg/kg every 4 weeks. Prescribers should request the appropriate quantity of vials of appropriate strength, based on the weight of the patient, to provide for a single infusion at a dose of 8 mg per kg up to a maximum of 800mg. A separate authority prescription is required for each strength.

Methotrexate dose

Concomitant methotrexate therapy at a dose of at least 7.5 mg weekly must be given with PBS subsidised abatacept, golimumab, infliximab and rituximab therapy.

Calculating next assessment dates

To assist with calculating the next assessment for patients continuing on the same biological agent:

The first assessment of the patient after starting treatment must be after the patient has had at least 12 weeks of treatment. This date can be calculated by adding 12 weeks to the patient’s first dispensing of the approved authority prescription.
Patients should then be assessed at 24 week intervals (assuming continuous treatment)

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.

Who is eligible for the PBS?

Reciprocal Health Care Agreement (abatacept, infliximab, rituximab and tocilizumab only)

Where an eligible patient is a visitor from a country with which Australia has entered into a Reciprocal Health Care Agreement, the supply of abatacept, infliximab, rituximab and tocilizumab will be limited to the original prescription only. Repeat prescriptions for abatacept, infliximab, rituximab and tocilizumab are not permitted.

Demonstration of response

Prescribers with patients who wish to temporarily cease treatment with a bDMARD must submit a demonstration of response to current treatment within one month of the cessation of treatment.

Please fax your completed form to 1300 154 019 so that it can be included in the patient’s treatment history.

Patients who have a break in PBS subsidised treatment of greater than 24 months must reapply as an initial patient.

Lodgement

The address for all written applications is:

Department of Human Services
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001

(No stamp required if posted in Australia)

For more information call 1800 700 270** (option 2) Monday to Friday, 8.00am to 5.00pm EST.

Toxicity and severity descriptors

To ensure that the eligibility of patients can be fully assessed, a comprehensive list of toxicity and severity descriptors which should be used in conjunction with the application when demonstrating a patient’s inability to tolerate Disease Modifying Anti Rheumatic Drugs (DMARDs) is attached. This list has been prepared in consultation with the Australian Rheumatology Association.

Rheumatoid Arthritis (RA) PBS DMARD toxicity criteria and severity descriptors [PDF, 139Kb] (These have been amended for 1 August)

Application forms