|Title:||Availability of TNF-Alpha Inhibitor Drugs for the Treatment of Severe Rheumatoid Arthritis in Adult Patients|
|Document ID:||Operational Circular OP 1750/04|
|Date of issue:||Thursday, 18 March 2004|
|Status:||NO LONGER APPLICABLE|
|Description:||The Western Australian Therapeutic Advisory Group (WATAG) recommends that tumour necrosis factor (TNF) - alpha inhibitors, etanercept and infliximab, be listed on the formularies of public hospitals for the treatment of adults with severe rheumatoid arthritis according to PBS criteria, plus additional criteria for public hospital use.|
|Applicable to:||Clinical staff, pharmacists and managers|
|Period of effect:||from 4 March 2004|
|Authorised by:||Dr Andrew Robertson, Director, Clinical Policy and Programs, 14-Mar-2004|
|Print version:||View print version|
Availability of TNF-Alpha Inhibitor Drugs for the Treatment of Severe Rheumatoid Arthritis in Adult Patients
Upon the recommendation of the Western Australian Therapeutic Advisory Group (WATAG), the Department of Health has resolved that:
Tumour necrosis factor (TNF) - alpha inhibitors, etanercept and infliximab, shall be listed on the formularies of public hospitals (where specialist services are provided) for the treatment of adults with severe rheumatoid arthritis, subject to the same criteria as used by the Pharmaceutical Benefits Scheme (PBS), plus additional criteria for public hospital use.
Two TNF-alpha inhibitors (etanercept (Enbrel®) and infliximab (Remicade®)) are on the Australian market for the treatment of severe rheumatoid arthritis. Etanercept and infliximab are approved for treatment of public hospital adult patients with severe arthritis, strictly according to PBS criteria. Additional criteria also apply to public hospital use.
Conditions in addition to PBS criteria
Adopting the same criteria as the PBS when commencing or continuing TNF-alpha inhibitor therapy provides continuity of treatment between hospitals and the community. However, the following additional conditions shall also apply for public hospital use.
Background information and cost considerations
Infliximab is available for treatment of severe active seropositive rheumatoid arthritis by a rheumatologist or immunologist through the Highly Specialised Drug Program, subject to stringent conditions as per the PBS Schedule. Infliximab is administered as an intravenous infusion at 0, 2, and 6 weeks from the start of therapy, and then 8 weekly, within a health facility, usually on a day-patient (i.e. outpatient) basis. The PBS S100 listing of infliximab allows the cost of the drug ($20,000/year), when used in public hospital outpatients according to PBS criteria, to be reimbursed through the Highly Specialised Drug Program.
The incidental costs of dispensing, infusion and day patient care expenses are not reimbursed and will be borne by each health service. The cost of inpatient use of infliximab will also be borne within each health service.
Etanercept is also available for treatment of severe active seropositive rheumatoid arthritis by a rheumatologist or immunologist under the same general restrictions as infliximab. Etanercept is administered twice weekly by sub-cutaneous injection and does not necessarily require a hospital visit for administration. Etanercept was previously listed at WA public hospitals on the basis that its efficacy and cost-effectiveness (as judged by WATAG) was greater than infliximab. For adult patients (> 18 years), etanercept is now listed under S85 of the PBS, which generally means that prescription from public hospital outpatient clinics is not reimbursable via the PBS (unless participating in a PBS "trial"). However, a rheumatologist or immunologist at a public hospital outpatient clinic is able to apply for an authority prescription from the Health Insurance Commission (HIC) for supply through a community pharmacy for adult patients meeting the PBS criteria. For patients less than 18 years, the supply of etanercept from a public hospital is reimbursable, through the Highly Specialised Drugs Program when used according to the PBS criteria.
The cost of inpatient use of etanercept will be borne within each health service.
Dr Andrew Robertson
This circular last updated: Thursday, 18 March 2004 at 12:00am