Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe active rheumatoid arthritis

First continuing treatment

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

Patient must have demonstrated an adequate response to treatment with this drug; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Patient must be at least 18 years of age.

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:

(a) 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

(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:

(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or

(ii) 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).

Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe active rheumatoid arthritis

First continuing treatment - balance of supply

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND

Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND

The treatment must provide no more than the balance of up to 24 weeks treatment.