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

Rheumatoid arthritis

Initial treatment

Must be treated by a rheumatologist; or

Must be treated by a consultant physician; AND

Patient must be an adult; AND

Patient must have active rheumatoid arthritis; AND

Patient must have a specific accepted war-caused or service-related disability of refractory rheumatoid arthritis; AND

Patient must have a proven raised erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) level; AND

Patient must have proven erosive rheumatoid arthritis without end-stage disease; AND

Patient must have failed an adequate trial of methotrexate and 2 other disease modifying anti-rheumatic drugs (such as sulfasalazine, hydroxychloroquine, leflunomide or ciclosporin), unless these drugs were contraindicated or intolerance developed; AND

Patient must have no history of active tuberculosis requiring treatment in the last 3 years; AND

Patient must have no history of opportunistic infection in the last 2 months; AND

The treatment must be in combination with methotrexate; AND

The treatment must be for the reduction of signs and symptoms and prevention of structural joint damage; AND

Patient must not be pregnant or breastfeeding; AND

Patient must be using an effective form of contraception if female and of child-bearing age.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Infliximab (Remicade) RPBS Authority Application - Supporting Information form (contact the VAPAC on 1800 552 580 for a copy of the form).

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

Rheumatoid arthritis

Continuing treatment

Must be treated by a rheumatologist; or

Must be treated by a consultant physician; AND

Patient must have a specific accepted war-caused or service-related disability of refractory rheumatoid arthritis; AND

Patient must have previously been issued with an authority prescription for this drug for the treatment of this condition; AND

Patient must have demonstrated an improvement in ESR and/or CRP level following the initial 3 dose course of therapy; AND

Patient must have achieved an ACR20 (American College of Rheumatology) response by 14 weeks after the commencement of the initial course of therapy; AND

The treatment must be in combination with methotrexate.

Applications for authorisation must be in writing and must include:

(1) a completed authority prescription form; and

(2) a completed Infliximab (Remicade) RPBS Authority Application - Supporting Information form (contact the VAPAC on 1800 552 580 for a copy of the form).