Interchangeability between biological agents for adult patients with severe active psoriatic arthritis.
Authority to supply adalimumab (Humira®) etanercept (Enbrel®), golimumab (Simponi®) or infliximab (Remicade®) through the Pharmaceutical Benefits Scheme (PBS) for adults under Section 85 and Section 100 of the National Health Act 1953.
These items are only available to a patient who is attending:
- an approved private hospital
- a public participating hospital
- a public hospital
and is either a
- day admitted patient
- non-admitted patient
- patient on discharge.
These items are not available as a PBS benefit for in-patients of the hospital. The hospital provider number must be included on the application form.
Adult patients must satisfy the initial treatment criteria to be eligible to commence an interchangeability cycle. Applications to change, recommence or continue PBS subsidised treatment will only be considered after an initial treatment course.
All applications must be completed by the treating rheumatologist or clinical immunologist, with expertise in the management of psoriatic arthritis.
The restrictions for an interchangeability cycle are:
- initial PBS subsidised treatment with a biological agent
- initial PBS subsidised treatment, for continuing treatment with golimumab, for patients who commenced treatment prior to 1 March 2010. Contact Medicare Australia for advice about which form(s) to complete.
- continuing PBS subsidised treatment with a biological agent
- change to an alternate PBS subsidised treatment with a biological agent
- demonstration of a response to current PBS subsidised treatment.
Patients are eligible for PBS subsidised treatment with only one biological agent for psoriatic arthritis at any one time. Patients can start a biological treatment cycle where they may trial etanercept, adalimumab, golimumab or infliximab without the need to experience a disease flare, when swapping to an alternate agent. Within a single cycle, patients may receive long term treatment with a biological agent as long as they sustain a response to therapy.
Once patients have either failed or ceased to sustain a response to treatment three times, they are deemed to have completed a single cycle and they must have, at a minimum, a five year break in PBS subsidised biological therapy before they are eligible to start another cycle.
Within the same cycle, patients cannot fail or cease to respond to the same PBS subsidised biological agent more than once. If a patient fails to meet the response criteria for any biological agent, they must change to an alternate agent they have not previously failed to continue PBS subsidised biological treatment.
- Adalimumab (Humira®)
- Etanercept (Enbrel®) 25 mg
- Etanercept (Enbrel®) 50 mg
- Golimumab (Simponi®) 50mg
- Infliximab (Remicade®)
- a prefilled syringe containing 40 mg adalimumab 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 prefilled syringes or prefilled pens.
- 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.
- 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 either prefilled syringes or prefilled autoinjectors.
The dose for adult patients is one subcutaneous injection once weekly.
- a prefilled syringe
- a prefilled pen
The form of golimumab 50 mg required must be specified on the prescription as a pack of either prefilled syringes or prefilled pens.
The dose for adult patients is one subcutaneous injection every 4 weeks.
- a vial containing 100 mg of lypholised powder.
The dose for adult patients is 5 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.
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).
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the start of treatment with each initial treatment application, must be provided for all subsequent continuing treatment applications. All assessments must be within one month of application.
- Prescribers should provide both Erythrocyte Sedimentation Rate (ESR) and C-Reactive Protein (CRP) measurements with the initial application. Prescribers may choose to provide only one acute phase reactant measurement with continuing treatment applications. 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 (that is, 20 or more active joints), response will be determined according to a reduction in the total number of active joints. Where a patient has at least four active major joints and less than 20 total active joints, assessment of the major joints only will be used for all continuing applications.
It is recommended that patients who have had a minimum of 12 weeks of treatment, and who wish to have a temporary break in treatment for any reason, be reviewed immediately before, but no later than four weeks after stopping treatment. Failure to notify Medicare Australia of response means that this patient is deemed to have failed that particular biological agent.
For assessment purposes, please use form 4159 - Psoriatic arthritis PBS authority application [PDF, 242Kb]
Please fax your completed form to 1300 154 019 so it can be included in the patient’s treatment history.
Patients who wish to trial a second or subsequent treatment cycle following a break in PBS subsidised biological therapy of at least five years, must requalify for initial treatment with respect to the relevant criteria at that time.
To make sure the eligibility of patients can be fully assessed, a comprehensive list of toxicity descriptors is available. This should be used in conjunction with the application when demonstrating a patient's inability to tolerate methotrexate, sulfasalazine or leflunomide. The intolerance must be of a severity to necessitate permanent treatment withdrawal.
The postal address for all written applications is:
Prior written approval of specialised drugs
Reply Paid 9826
Hobart Tasmania 7001
(No stamp required if posted in Australia)
For more information call 1800 700 270** (option 4) between 8:00am and 5:00pm EST, Monday to Friday.
- Initial PBS subsidised treatment [PDF, 246Kb] (Form 4158)
Lodge this form for a patient starting initial PBS subsidised treatment with a biological agent. The patient and prescriber acknowledgements must be completed.
- Continuation, change or demonstration of response to PBS subsidised treatment for psoriatic arthritis [PDF, 242Kb] (Form 4159)
Lodge this form for a patient continuing, changing to an alternate agent, or demonstrating a response to PBS subsidised treatment with a biological agent.
** Call charges apply from mobile or pay phones only
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Last updated: 3 May, 2012