Proposal for various oncology medicines

Medicines Consultation Closed

PHARMAC is seeking feedback on a proposal for various oncology pharmaceuticals, including new listings and amendments to funding restrictions, to take effect from 1 July 2017.

In summary:

  • Erlotinib (Tarceva) and gefitinib (Iressa) funding criteria would be widened to permit patients with non-small cell lung cancer to switch between treatments at any time due to intolerance.
  • Nivolumab (Opdivo) and pembrolizumab (Keytruda) funding criteria for treatment of patients with advanced melanoma would be amended to add a requirement for patients to have an ECOG performance status score of 0-2.
  • Thalidomide (Thalomid) claiming category would be changed from “PCT only” to “Retail pharmacy”.
  • A new 15 mg capsule strength of lenalidomide (Revlimid) would be listed from 1 July 2017.

Details of these proposals can be found below.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm on Friday, 26 May 2017 to:

Danae Staples-Moon
Therapeutic Group Manager

Fax: 04 460 4995
Post: PO Box 10254, 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 proposals

Erlotinib and gefitinib – permit switching at any time for reasons of intolerance

  • The initial Special Authority criteria for erlotinib (Tarceva) 100 mg and 150 mg tablets would be amended in Section B of the Pharmaceutical Schedule from 1 July 2017 as follows (deletions in strikethrough):

Special Authority for Subsidy

Initial application only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 4 months for applications meeting the following criteria:

All of the following:

  1. Patient has locally advanced or metastatic, unresectable, non-squamous non small cell lung cancer (NSCLC); and
  2. There is documentation confirming that the disease expresses activating mutations of EGFR tyrosine kinase; and
  3. Either:
    1. Patient is treatment naive; or
    2. Both:
      1. The patient has discontinued gefitinib within 12 weeks of starting treatment due to intolerance; and
      2. The cancer did not progress while on gefitinib; and
  4. Erlotinib is to be given for a maximum of 3 months.
  • The current renewal criteria would remain unchanged.
  • The same change would be made to the initial Special Authority criteria for gefitinib (Iressa) 250 mg tablets in Section B of the Pharmaceutical Schedule from 1 July 2017 and similar changes would be made to the initiation restrictions for both pharmaceuticals in Part II of Section H of the Pharmaceutical Schedule.

Erlotinib and gefitinib background

Erlotinib and gefitinib are currently funded for patients with non-small cell lung cancer subject to similar Special Authority criteria. Switching between treatments for reasons of intolerance is permitted within the first 12 weeks of starting treatment, provided the patient’s disease has not progressed on the first treatment.

We are aware that there are a small number of patients (estimated at approximately 2-3 per year) who experience delayed toxicity without disease progression who could benefit from changing treatments after the first 12 weeks of treatment.

The Cancer Treatments Subcommittee of PTAC (CaTSoP) reviewed this issue at its most recent meeting in March 2017 and supported the proposed change. Minutes of the Subcommittee’s discussion will be published on PHARMAC’s website as soon as they are available.

Nivolumab and pembrolizumab – addition of performance status requirement

  • The initial Special Authority criteria for nivolumab injection (Opdivo) and pembrolizumab injection (Keytruda) would be amended in Section B of the Pharmaceutical Schedule from 1 July 2017 as follows (additions in bold):