Proposal to widen access to tocilizumab for treatment of rheumatoid arthritis in DHB hospitals

Medicines

Consultation Closed

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

Details of the proposed changes and background information can be found below and on the following pages.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm on Thursday, 27 November 2014 to:

Geraldine MacGibbon
Senior Therapeutic Group Manager
PHARMAC

Email: geraldine.macgibbon@pharmac.govt.nz
Fax:     04 460 4995
Post:    PO Box 10 254, Wellington 6143

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld.  PHARMAC will give due consideration to any such request.

Details of the proposal

  • From 1 January 2015 the restrictions in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List, or HML) applying to tocilizumab inj 20 mg per ml, 4 ml, 10 ml and 20 ml vial (Actemra) for rheumatoid arthritis would be amended as follows (additions in bold, deletions in strikethrough, existing restrictions renumbered for clarity):

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

Either:

Continuation
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.
  • No other changes to the listing of tocilizumab on the HML are proposed (i.e. there would be no changes to the price or to the restrictions applying to tocilizumab for Adult-onset Still’s disease or systemic juvenile idiopathic arthritis).

Further information

Tocilizumab is a recombinant humanised monoclonal antibody that binds specifically to both soluble and membrane-bound interleukin (IL)-6 receptors, thereby inhibiting IL-6 receptor-mediated signaling. It is used to suppress the immune system in diseases including rheumatoid arthritis. It is administered by intravenous infusion.

Tocilizumab is currently listed on the HML for use in rheumatoid arthritis (as monotherapy in patients who are unable to be treated with methotrexate), adult-onset Still’s disease and systemic juvenile idiopathic arthritis.

The Pharmacology and Therapeutics Advisory Committee (PTAC) and the Rheumatology Subcommittee have considered tocilizumab as a last-line treatment for rheumatoid arthritis. The proposed criteria are in line with the advice received, which can be found on PHARMAC’s website at: https://connect.pharmac.govt.nz/apptracker/s/global-search/tocilizumab(external link)

We anticipate that approximately 80 to 180 additional patients per year would have access to tocilizumab as a result of this proposal. Feedback on this assumption would be appreciated.