<< Media Releases

Herceptin (trastuzumab)

Contents

• Government decision to fund 12 months Herceptin
• PHARMAC's recent work on Herceptin
• Patient Materials
• Timeline of PHARMAC's work on Herceptin
• International Commentary

Trastuzumab (Herceptin) is a monoclonal antibody used to treat Her2-positive breast cancer. PHARMAC has been assessing funding for Herceptin for use in HER 2 positive early breast cancer.

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Government decision to fund 12 months Herceptin

The Government has approved funding for a 12 month course of trastuzumab (Herceptin). Funding for 12 months treatment will be administered on behalf of the Government by the Ministry of Health. At the same time, PHARMAC will continue to administer and fund the nine-week course previously approved by PHARMAC. This provides a choice for women with HER2-positive early breast cancer.

You can read details of the decision on the Beehive website.

Answers to your questions, and guidance for patients and doctors about using 12 months Herceptin treatment are available on the Ministry of Health's cancer control page.

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PHARMAC's recent work on Herceptin

From April to July 2008, PHARMAC reconsidered funding of Herceptin following the direction of the High Court judgement (74 pages, 186 KB). This included seeking new advice from PTAC and its cancer treatments sub-committee, revising the budget impact and the cost-utility model for Herceptin (both concurrent 9 weeks and 12 months), as well as undertaking wide consultation (3 pages, 121 KB) which included face to face meetings with breast cancer patients and oncologists.

Following that process, PHARMAC maintained funding for nine weeks treatment with trastuzumab.

Information relevant to this decision:

• Notification letter August 2008 (2 pages, 168 KB)
• PHARMAC reaffirms confidence in 9 week Herceptin treatment (2 pages, 131 KB)
• Herceptin – questions and answers (3 pages, 127 KB)
• Herceptin – a summary of the evidence at August 2008 (15 pages, 199 KB)
• Public Summary of Submissions August 2008 (44 pages, 735 KB)
• 4 July 2008 Pharmacology & Therapeutics Advisory Committee minutes (9 pages, 127 KB)
• 13 June 2008 Cancer Treatments Subcommittee (CaTSoP) minutes (3 pages, 64 KB)
• Updated cost utility analysis July 2008 Further Supplementary Technology Assessment Report No. 75c (34 pages, 401 KB) with new appendices Appendix Seven: Relevant minutes of clinical advisory committees meetings since February 2007 (13 pages, 259 KB), Appendix Eight: detail of updates to clinical inputs for cost utility analysis (33 pages, 372 KB) and Appendix Nine: Updated* trastuzumab (Herceptin) clinical trial summaries** (1 page, 64 KB). Original TAR and Appendix 1-6 provided in Timeline below at 3 May 2007.

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Patient Materials

Pharmac has produced two patient guides about Herceptin for women with early breast cancer (note that these guides will be updated with new clinical evidence by the end of August 2008):

• Herceptin for early breast cancer (14 pages, 407 KB)
• Funding for Herceptin for early breast cancer (6 pages, 185 KB)

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Timeline of PHARMAC's work on Herceptin

The following summary outlines PHARMAC's work to date:

• July 2008: PHARMAC Board declines funding for 12 months Herceptin for HER 2 postive early breast cancer. Concurrent 9 week Herceptin treatment is a full treatment course and remains fully funded.
• 4 July 2008: PTAC considers new information on Herceptin. PTAC reconfirms its earler recommendation that funding for 12 months treatment be declined.
• 13 June 2008 CaTSoP considers new information on Herceptin.
• 10 June 2008: Consultation ends. More than 300 submissions are received. Media Release - Herceptin consultation ends (3 pages, 121 KB)
• 17 May 2008: Leading international medical journal The Lancet publishes a commentary by NZ and international clinicians and researchers (including the PTAC Chair and PHARMAC staff) about publication bias with Herceptin for HER 2 positive early breast cancer. The article claims that Herceptin, as used throughout much of the world (12 months sequential treatment) is much less effective than thought because important clinical trial data from nearly 1000 women are in effect missing. The Lancet 'Trastuzumab: possible publication bias' (8 pages, 137 KB), with the definitive version on the Lancet website
• 5 May 2008: Q&A Herceptin Background (5 pages, 57 KB)
• 5 May 2008: Media Release - Herceptin consultation underway (9 pages, 177 KB)
• 2 May 2008: PHARMAC consults on proposal to decline 12 months' Herceptin funding for HER 2 positive early breast cancer. Consultation on proposal regarding the funding of 12 months treatment with trastuzumab for HER 2 positive breast cancer (4 pages, 222 KB)
• 3 April 2008: High Court issues ruling on judicial review application, and upholds one of the 28 grounds for judicial review. PHARMAC is directed to consult on its decision not to funding 12 months' Herceptin in July 2006. qaodmasdkwaspemas4ajkqlsmdqpakldnzsdfls High Court judgement on judicial review of PHARMAC's Herceptin decisions (74 pages, 186 KB)
• February 2008: High Court hearing on judicial review application takes place over 6 days.
• 24 August 2007: The NZ Medical Journal publishes further material by PHARMAC staff responding about the basis for and evidence supporting the nine week concurrent Herceptin funding decision. PHARMAC responds to Isaacs et al in NZ Medical Journal. (7 pages, 103 KB)
• August 2007: High Court hears application for interim orders on these proceedings. Finds in favour of PHARMAC.
• 1 July 2007: Herceptin funded for women with HER 2 positive early breast cancer.
• 29 June 2007: Eight women file proceedings in the High Court seeking judicial review of PHARMAC's Herceptin decisions.
• 15 June 2007: The NZ Medical Journal publishes a Special Series article by PHARMAC staff about the funding of nine week concurrent Herceptin. New Zealand Medical Journal article (20 pages, 263 KB) (published 15 June 2007;120(1256), provided here with the Journal's permission). The appendices to the NZMJ article also give more information on HER2-positive early breast cancer and survival (Appendix 1 (6 pages, 67 KB)), epidemiology and ethnic disparities (Appendix 2 (6 pages, 61 KB)), clinical trials (Appendix 3 (1 page, 26 KB)), clinical effectiveness (Appendix 4 (41 pages, 1015 KB)), PTAC minutes (Appendix 5 (12 pages, 106 KB)), and compare the 12 month and 9 week regimens (Appendix 6 (3 pages, 28 KB)).

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• 3 May 2007: Cost utility analysis released under the Official Information Act: TAR 75 Trastuzumab (Herceptin) in HER-2 positive early breast cancer with 9 week regimen CUA (66 pages, 566 KB), Appendix 1 (8 pages, 164 KB), Appendix 2 (2 pages, 124 KB), Appendix 3 (1 page, 61 KB), Appendix 4 (3 pages, 63 KB), Appendix 5 (8 pages, 177 KB), Appendix 6 (14 pages, 511 KB).
• 3 May 2007: Notification of widened access to trastuzumab (Herceptin) and docetaxel (Taxotere) on the Pharmaceutical Schedule for adjuvant treatment of HER 2 positive early breast cancer (3 pages, 149 KB)
• 3 May 2007: Herceptin Questions and answers May 2007 (3 pages, 133 KB)
• 3 May 2007: media release: 350 women each year to benefit from Herceptin funding decision (2 pages, 73 KB)
• April 2007: PHARMAC Board approves funding for concurrent 9 weeks' treatment with Herceptin for HER 2 positive early breat cancer from 1 July 2007.
• Early March 2007: Following consultation with DHBs, public consultation occurs on a draft proposal (see consult letter (3 pages, 101 KB) and media release (3 pages, 114 KB)) to fund Herceptin (concurrent nine weeks). The Consumer Advisory Committee recommends the development of a patient resource relating to any funding decision.
• 22 February 2007 (22 pages, 186 KB): PTAC examines further information from Roche on Herceptin. Reiterates recommendation that concurrent nine weeks' treatment be funded.
• 16 Feruary 2007: PHARMAC commits to supporting the SOLD clinical trial.
• In early 2007: PHARMAC re-examined all the available evidence on Herceptin. This assessment is summarised in this PHARMAC presentation. Background information and answers to questions are available here (3 pages, 133 KB). qaodmasdkwaspemas6ajkqlsmdqpakldnzsdfls
• December-February 2006-07 (3 pages, 30 KB): Cost utility analysis of nine week treatment undertaken by PHARMAC; investigation of NZ participation in international clinical trial.
• November 2006 (18 pages, 150 KB): PTAC receives CaTSoP minute. PTAC recommends concurrent nine week treatment be funded (high priority). PTAC also notes more clinical research is needed (specifically a study comparing concurrent 12 months' treatment with 9 weeks').
• October 2006: CaTSoP meets. Recommends that in the absence of funding for 12 months, 9 weeks' Herceptin treatment would be reasonable.
• August 2006 (16 pages, 198 KB): Further data on Herceptin considered by PTAC. PTAC asks CaTSoP to consider clinical appropriateness of any funding regimen consistent with a nine-week treatment of Herceptin.
• June/July 2006 (5 pages, 46 KB): DHBs and PHARMAC decide not to fund Herceptin at that time, and commit to an ongoing review of Herceptin.
• 25 May 2006 (18 pages, 164 KB): CaTSOP recommendation provided to PTAC. PTAC considered there was insufficient evidence to justify a funding recommendation for 12 months treatment, and sought further information.
• April-June 2006: Negotiations occur with Roche regarding supply terms and pricing.
• April 2006: Cancer Treatments Sub-Committee (CaTSOP) reviews Roche's Herceptin application.
• March-May 2006: Cost-utility analysis of 12 months' treatment with Herceptin for HER 2 positive early breast cancer prepared by PHARMAC.
• 23 March 2006: Medsafe grants provisional consent to Herceptin for treatment for HER 2 positive early breast cancer.
• 18 February 2006 (2 pages, 444 KB): The Pharmacology and Therapeutics Advisory Committee (PTAC) considers application from Roche. PTAC recommends further information be sought from Roche and for Herceptin to be considered by the cancer treatments sub-committee, should Herceptin be approved by Medsafe.
• December 2005: PHARMAC receives application from Roche to fund Herceptin for 12 months' sequential treatment for HER 2 positive early breast cancer (an indication not then approved by Medsafe).

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International Commentary

• Lancet publication bias (8 pages, 137 KB) paper at http://www.thelancet.com/journals/lancet/article/PIIS0140673608607060/fulltext.
• In 2006 a Sheffield University report advised the British National Institute for Health and Clinical Excellence on Herceptin. The report is available here
• The Belgian Health Information Knowledge Centre issued this report in June 2006.
• In November 2006, the British Medical Journal published this article and this article as controversy continued in the UK over funding of Herceptin.

Page updated on 22 Dec 2008

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