Proposal to maintain full subsidy for gefitinib (Iressa) from 1 April 2017

Medicines Consultation Closed

PHARMAC is seeking feedback on a proposal to amend the contractual terms of funding for gefitinib (Iressa, tab 250 mg) through a provisional agreement with AstraZeneca Limited, which would result in gefitinib remaining fully funded at its current subsidy from 1 April 2017.

This would in effect reverse a previous decision to reduce the subsidy for gefitinib from 1 April 2017, as notified on 5 December 2016 [PDF, 187 KB], meaning that gefitinib would remain fully funded.

In summary:

  • The subsidy for gefitinib tab 250 mg would remain the same as it is now from 1 April 2017, rather than being reduced as previously notified, and it would be fully funded for all eligible patients.
  • The net price for gefitinib tab 250 mg would reduce from 1 April 2017 via confidential rebate.
  • Iressa would have protection from subsidy reduction and delisting until 31 December 2019.
  • There would be no changes to the current Special Authority criteria or hospital restrictions for gefitinib.
  • Some of the previously notified changes to the Special Authority for erlotinib (Tarceva) would not be implemented on 1 April 2017 as these would only be required if gefitinib was not fully funded at 1 April 2017.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Wednesday, 25  January 2017 to:

Geraldine MacGibbon
Senior Therapeutic Group Manager
PHARMAC

Email: consult@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

  • Iressa, tab 250 mg, would remain listed in Section B and Part II of Section H of the Pharmaceutical Schedule.
  • From 1 April 2017, the subsidy for gefitinib 250 mg (Iressa) would remain the same as it is currently as follows (ex-manufacturer, excluding GST):
    Chemical and presentation Brand Pack size Current subsidy and price Subsidy (and price) from
    1 April 2017*    		 Proposed price and subsidy from
    1 April 2017
    Gefitinib
    tab 250 mg    		 Iressa 30 $1,700.00 $1,146.00
    ($1,700.00)    		 $1,700.00
    *The subsidy for Iressa tab 250 mg is due to reduce from 1 April 2017 under a previous decision. This proposal is to reverse the previous decision.
  • From 1 April 2017 a confidential rebate would apply to gefitinib 250 mg (Iressa) that would reduce its net price.
  • Iressa would have protection from subsidy reduction and delisting until 31 December 2019.
  • There would be no changes to the current Special Authority criteria or hospital restrictions for gefitinib.
  • The Special Authority criteria for erlotinib would be amended from 1 April 2017 as outlined below (deletions in strikethrough). Note that we recently notified [PDF, 187 KB] changes to the erlotinib Special Authority that are due to take effect from 1 April 2017. The changes shown below are to the notified criteria. The same changes would be made to the hospital restrictions.

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. Any of the following: 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; or and
    3. Both:
      1. Patient has had treatment with gefitinib prior to 1 April 2017; and
      2. Patient’s disease has not progressed; and
  4. Erlotinib is to be given for a maximum of 3 months.

Background

Gefitinib (Iressa, supplied by AstraZeneca) is an oral inhibitor of EGFR tyrosine kinase, also known as a tyrosine kinase inhibitor (TKI). TKIs are associated with increased activity in cancers that have activating EGFR tyrosine kinase mutations.

Gefitinib and another TKI, erlotinib (Tarceva, supplied by Roche), are currently funded as first-line treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR tyrosine kinase mutations.

We recently notified [PDF, 187 KB] a decision to reduce the subsidy of gefitinib to the level of the subsidy for erlotinib via the application of reference pricing from 1 April 2017, which will result in gefitinib becoming only partially funded. At the time, we advised that if the supplier of gefitinib does not reduce the price to match the new subsidy, patients on gefitinib will need to change to erlotinib in order to remain on a fully funded product.

We have now reached a commercially acceptable agreement with AstraZeneca that would result in gefitinib remaining fully funded for eligible patients from 1 April 2017.