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Rheumatoid arthritis

Guide to prescribing biological agents

Guide to prescribing biological agents [PDF, 52Kb]

Section 100 arrangements for abatacept, infliximab and rituximab 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

There are five restrictions under the bDMARD interchangeability cycle. Adult patients must satisfy the initial criteria before approval will be granted to prescribe PBS subsidised bDMARDs under the interchangeability cycle.

View a full transcript of the Schedule of Pharmaceutical Benefits (the Schedule) 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 with a documented history of severe active rheumatoid arthritis who started treatment with rituximab before 7 March 2007 and who, at the time of application, have demonstrated an adequate response to treatment
initial PBS subsidised continuing treatment for adult patients with a documented history of severe active rheumatoid arthritis who started treatment with abatacept before 1 November 2007 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, 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, etanercept and infliximab)
interleukin-1 inhibitor (anakinra)
chimeric anti-CD20 monoclonal antibody (rituximab) for adult patients with severe active rheumatoid arthritis
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 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 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 three bDMARDs, they are deemed to have completed a single treatment cycle. Patients must then have, at a minimum, a five year break in PBS subsidised bDMARD therapy before they are eligible to start the next cycle. The five year period will be measured from the date the last prescription for PBS subsidised bDMARD treatment was approved in the most recent cycle, and the date of the application for initial treatment with a bDMARD under the new cycle.

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

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

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

Within an interchangeability cycle, 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 within a single treatment cycle, they are not eligible to receive further PBS subsidised treatment with that drug until they start the next cycle.

Information relevant to all patients

Initial applications

Applications for initial treatment should be made where patients have received no prior PBS subsidised bDMARD treatment.

All applications for initial treatment will be limited to provide for a maximum of 16 weeks of therapy for abatacept, adalimumab, etanercept and anakinra, and 22 weeks for infliximab.

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.

Calculating next assessment dates

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

A letter confirming the approval will always be sent for patients commencing on a program and when a patient changes to an alternate agent.
The next assessment date will be provided in that letter (this assumes continuous treatment).
To calculate subsequent dates for assessment, assuming continuous treatment, add 24 weeks to the previous assessment date.

Swapping therapy—change and recommencement applications

Once an authority for initial treatment with the first PBS subsidised bDMARD is approved, 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 and who wish to recommence treatment, may submit a new baseline set of measurements.

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

16 weeks of therapy for abatacept, adalimumab, anakinra and etanercept
22 weeks for infliximab
24 weeks for rituximab

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. 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 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.

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 within a treatment cycle. 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.

Recommencement of treatment after a five 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 five years must requalify for initial treatment with respect to the indices of disease severity. Patients must have received treatment with at least one DMARD, at an adequate dose, for a minimum of three months immediately before the reapplication for a bDMARD and at the time the ESR or CRP levels and the active joint counts are measured.

Item details

Dose

Abatacept (Orencia®) is presented as:

a vial containing 250 mg of powder

The dose for adult patients is:

< 60 kg 2 vials

60–100 kg 3 vials

> 100 kg 4 vials

Initially patients are to be treated at days 0, 14, 28 and then every 28 days.

Adalimumab (Humira®) is presented as:

a prefilled syringe containing 40 mg adalumumab in 0.8 mL
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 required must be specified on the prescription as either a prefilled syringe or a prefilled pen.

Anakinra (Kineret®) is presented as:

a prefilled syringe containing 100 mg anakinra in 0.67 mL.

The dose for adult patients is one subcutaneous injection daily.

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:

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

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

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 then at 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.

Methotrexate dose

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

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 and rituximab only)

Where an eligible patient is a visitor from a country with which Australia has entered into a Reciprocal health care agreement, the supply will be limited to the original prescription only. Repeat prescriptions for these patients 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.

Lodgement

The postal address for all written applications is:

Medicare Australia
Prior written approval of specialised drugs
Reply paid 9826
GPO Box 9826
Hobart TAS 7001

(No stamp required if posted in Australia)

For more information please call 1800 700 270** and select option 2. (8 am to 5 pm EST Monday to Friday).

** Call charges apply from mobile or pay phones only.

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, 68Kb]

Application forms