Tocilizumab for rheumatoid arthritis – use in DHB hospitals

Medicines

Decision

PHARMAC is pleased to announce a decision to widen access to tocilizumab in DHB hospitals from 1 January 2015 for use in patients with severe rheumatoid arthritis who have received inadequate benefit from both a tumour necrosis factor (TNF)-alpha inhibitor (adalimumab or etanercept) and rituximab.

This was the subject of a consultation letter dated 13 November 2014.

The proposal was approved as consulted on.

Details of the decision

  • From 1 January 2015 the following restrictions will apply to tocilizumab inj 20 mg per ml, 4 ml, 10 ml and 20 ml vial (Actemra) for rheumatoid arthritis in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List, or HML)

Initiation —Rheumatoid Arthritis
Rheumatologist
Re-assessment required after 6 months

Either:

Continuation – Rheumatoid Arthritis
Rheumatologist
Re-assessment required after 6 months

Either:

  1. Following 6 months’ initial treatment, the patient has at least a 50% decrease in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician; or
  2. On subsequent reapplications, the patient demonstrates at least a continuing 30% improvement in active joint count from baseline and a clinically significant response to treatment in the opinion of the physician.
  • The price of tocilizumab, and the restrictions applying to tocilizumab for Adult-onset Still’s disease and systemic juvenile idiopathic arthritis, will remain unchanged.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 27 November 2014 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme Comment
Responders asked how patients can access tocilizumab under the new criteria if they have received one of the prerequisite prior treatments (i.e. a community TNF inhibitor or rituximab) in another setting (e.g. privately funded or overseas), or if one or both of these treatments are contraindicated. In either of these scenarios a NPPA application would need to be made as it would need to be demonstrated that the patient met the severity criteria required under the TNF inhibitor Special Authority and the rituximab HML restrictions (as applicable). These severity criteria are not specified on the tocilizumab restrictions as they are assumed to have been met when patients access the prior treatment according to the funding rules.
One responder asked about the funding of tocilizumab in multicentric Castleman’s disease. PHARMAC is seeking advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) in February 2015 in relation to an application for funding of tocilizumab in this setting.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.