Herceptin
Patient Materials
Pharmac has produced two patient guides about Herceptin for women with early breast cancer:
- Herceptin for early breast cancer (12 pages, 210 KB)
- Funding for Herceptin for early breast cancer (6 pages, 185 KB)
PHARMAC's work on Herceptin
Trastuzumab (Herceptin) is a monoclonal antibody used to treat Her2-positive breast cancer. PHARMAC has been assessing funding for Herceptin for use in early stage Her2-positive breast cancer.
This page summarises PHARMAC's work to date and some of the international commentary around this medicine, including the recent Lancet publication bias (7 pages, 350 KB) paper at 
http://www.thelancet.com/journals/lancet/article/PIIS0140673608607060/fulltext.
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)
More detailed information about the decision to fund Herceptin has been published in the New Zealand Medical Journal (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)).
- 9 June 2008: Media Release - Herceptin consultation ends (3 pages, 121 KB)
- 17 May 2008: The Lancet 'Trastuzumab: possible publication bias' (7 pages, 350 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)
- 5 May 2008: Herceptin timeline provided (2 pages, 32 KB)
- 5 May 2008: 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 judgement on judicial review of PHARMAC's Herceptin decisions (74 pages, 186 KB)
- August 2007: PHARMAC responds to Isaacs et al in NZ Medical Journal. (7 pages, 103 KB)
- 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)
- 20 March 2007: Public feedback is sought on a draft proposal (see consult letter (3 pages, 101 KB) and media release (3 pages, 114 KB)) to fund Herceptin.
- 22 February 2007 (22 pages, 186 KB): PTAC examines further information on Herceptin
- 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 Cancer Treatments sub-committee minute. PTAC recommends nine week treatment be funded (high priority). PTAC also notes more research is needed.
- October 2006: Cancer Treatment Sub-committee meets.
- August 2006 (16 pages, 198 KB): Further data on Herceptin considered by PTAC. PTAC asks the Cancer Treatments sub-committee to consider funding for a nine-week treatment of Herceptin.
- June/July 2006 (5 pages, 46 KB): DHBs and PHARMAC resolve not to list 12 months treatment with Herceptin at this time, and commit to an ongoing review of evidence on 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 Herceptin evidence.
- March-May 2006: Cost-utility analysis undertaken by PHARMAC.
- 23 March 2006: Medsafe grants provisional consent to Herceptin.
- 18 February 2006 (2 pages, 444 KB): The Pharmacology and Therapeutics Advisory Committee (PTAC) considers application for early breast cancer. 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 early breast cancer (an indication not then approved by Medsafe).
International Commentary
- 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 10 Jun 2008
Linked documents
Funding for Herceptin for early breast cancer (6 pages, 185 KB)
This booklet is about funding for trastuzumab (Herceptin) for the treatment of HER2-positive early breast cancer in New Zealand. It explains the treatment with Herceptin that District Health…
Question & Answers: Trastuzumab/Herceptin (3 pages, 133 KB)
What have PHARMAC and District Health Boards agreed to fund? PHARMAC and District Health Board have approved funding for Herceptin (trastuzumab), a monoclonal antibody drug, for the treatment of early HER2-positive…
New Zealand Medical Journal trastuzumab/Herceptin article (20 pages, 263 KB)
Vol 120 No 1256 ISSN 1175 8716 PHARMAC funding of 9-week concurrent trastuzumab (Herceptin) for HER2-positive early breast cancer Scott Metcalfe, Jackie Evans, Ginny Priest Abstract A 9-week regimen of trastuzumab (Herceptin®) given concurrently with…
Appendix 1 HER2 positive breast cancer, its treatment and prognosis (6 pages, 67 KB)
Appendix One. HER2-positive early breast cancer, its treatment and prognosis Breast cancer and HER2/neu over-expression Health need is one of PHARMAC’s nine decision criteria (http://www.pharmac.govt.nz/pdf/231205.pdf ‘The health needs of all eligible people within New Zealand (eligible as defined by the…
Appendix 2 Epidemiology of HER2 positive breast cancer in New Zealand (6 pages, 61 KB)
Appendix Two. Epidemiology of HER2-positive breast cancer in New Zealand— including regional and ethnic disparties Health need is one of PHARMAC’s nine decision criteria (http://www.pharmac.govt.nz/pdf/231205.pdf ‘The health needs of all eligible people within New Zealand (eligible as defined by the…
Appendix 3 to NZMJ Herceptin - table of trials (1 page, 26 KB)
Appendix Three. Trials reporting outcomes for adjuvant trastuzumab against vs. standard treatment in HER2-positive early breast cancer Sequential treatment trials, long duration (12 month)1 regimens HERA Trial N9831 (Arm B) Patient Numbers Observation: 1,693 Trastuzumab (1 yr): 1,694 Trastuzumab (2…
Appendix 4 to NZMJ Herceptin - Clinical#2 (41 pages, 1015 KB)
Appendix Four. Clinical effectiveness Contents 1. Treatment regimens and available trial data ….. 1 Treatment regimes in randomised controlled trials… 1 Trial outcomes as reported….. 10 2. Increasing uncertainty around sequence and durations …. 13 Non-publication of data for 12…
Appendix 5 to NZMJ Herceptin - PTAC Herceptin minutes (12 pages, 106 KB)
Appendix Five. PTAC minutes relating to trastuzumab for early breast cancer at its February, May, August and November 2006 and February 2007 meetings. PTAC Meeting – 15 & 16 February 2006 (paragraph 20.19 as amended by PTAC in May 2006)…
Appendix 6 to NZMJ Herceptin - comparisons between 12-month and 9-week regimens (3 pages, 28 KB)
Appendix Six. Comparisons between 12-month and 9-week trastuzumab regimens for HER2-positive early breast cancer Comparisons of eligible patient pools and treatment regimens 12 months sequential treatment Eligible patient population 9 weeks concurrent treatment Eligible patients were those presenting with HER-2…
Herceptin consultation ends (3 pages, 121 KB)
Consultation on PHARMAC’s proposal to decline funding for 12 months treatment with the breast cancer drug Herceptin ends today, with more than 300 submissions received. CEO Matthew Brougham says that given the…
Herceptin consultation underway (9 pages, 177 KB)
PHARMAC has today begun consulting on a proposal to decline funding for 12 months’ treatment for HER2 positive early breast cancer with Herceptin. The consultation is a result of the High Court…
Proposal for 12 months trastuzumab (Herceptin) treatment (4 pages, 222 KB)
Recently the High Court ruled on a Judicial Review of PHARMAC’s processes surrounding its decisions to fund a…
Trastuzumab/Herceptin Judgement 3 April 2008 (74 pages, 186 KB)
IN THE HIGH COURT OF NEW ZEALAND WELLINGTON REGISTRY CIV 2007-485-1386 UNDER IN THE MATTER OF JUDICATURE AMENDMENT ACT 1972 THE NEW ZEALAND PUBLIC HEALTH & DISABILITY ACT 2000 CHRISTINE MARY MIRIAM WALSH, AMANDA LEIGH RUDD, DIANE BARBARA MCCORMACK, DIANE…
PHARMAC responds on Herceptin assumptions and decisions (7 pages, 103 KB)
THE NEW ZEALAND MEDICAL JOURNAL Vol 120 No 1260 ISSN 1175 8716 PHARMAC responds on Herceptin assumptions and decisions We welcome the comments of Drs Richard Isaacs, Chris Frampton, and Marion Kuper-Hommel about the funding in New Zealand of adjuvant…
Technology Assessment Report No. 75, with supplementary analysis 75b (66 pages, 566 KB)
Trastuzumab (Herceptin) in HER-2 positive early stage primary breast cancer Part 1: 12-month sequential trastuzumab treatment (“Trastuzumab (Herceptin) in HER-2 positive early breast cancer ”), August 2006 Part 2: 9 week…
Appendix One: Relevant minutes of clinical advisory committees meetings since mid 2006 (8 pages, 164 KB)
PTAC further considered trastuzumab in August 2006, and then the cancer treatments subcommittee of PTAC (CaTSoP) considered the FinHer study in November 2006. Subsequently PTAC have discussed this…
Appendix Two: Rapid update of TAR 75 for HERA 23 month follow-up information (2 pages, 124 KB)
Updated Clinical Information – 12 months trastuzumab sequential regimen The cost-utility analysis for 12 months sequential trastuzumab treatment has not been updated to include the new evidence…
Appendix Three: Trastuzumab (Herceptin) Clinical Trial Summaries (1 page, 61 KB)
Sequential treatment trials, long duration (12 month)1 regimens HERA Trial N9831 (Arm B) Patient Numbers Observation: 1,693 Trastuzumab (1 yr): 1,694 1 Trastuzumab (2 yr): 1,694 1 loading dose (8mg/kg) trastuzumab, then 6mg/kg…
Comparison of eligible patient pool and treatment regimen 12 months sequential treatment (3 pages, 63 KB)
Eligible patient population 9 weeks concurrent treatment Eligible patients were those presenting with HER-2 positive early breast cancer, with acceptable heart function (assumes some patients excluded from treatment…
Appendix Five: Summary and interpretation of the Clinical information (8 pages, 177 KB)
Appendix Five Clinical information for trastuzumab – summary, interpretation and policy implications District health boards (DHBs) and PHARMAC decided in July not to fund trastuzumab, as adjuvant treatment of early HER2-positive breast cancer as a 12-month regimen, at that time,…
Appendix Six: Clinical data (14 pages, 511 KB)
1. Efficacy of sequential and concurrent treatments Key to graphic: Ö statistically significant improvement in disease-free survival (DFS) ´ no statistically significant improvement in DFS ? results awaited 2. Treatment regimens and available trial data To…
Notification: Trastuzumab (Herceptin) (3 pages, 149 KB)
Notification of widened access to trastuzumab (Herceptin) and docetaxel (Taxotere) on the Pharmaceutical Schedule for adjuvant treatment of HER 2 positive early breast cancer. PHARMAC is…
Questions & Answers: Trastuzumab/Herceptin (3 pages, 133 KB)
Funding of Herceptin What have PHARMAC and District Health Boards agreed to fund? PHARMAC and District Health Board have approved funding for Herceptin (trastuzumab), a monoclonal antibody drug, for the treatment of early HER2-positive…
Media Release: 350 women each year to benefit from Herceptin funding decision (2 pages, 73 KB)
About 350 women are set to benefit each year from the decision to fund Herceptin for early HER2-positive breast cancer. Funding will be available from…
Consultation: Trastuzumab (Herceptin) & docetaxel (Taxotere) (3 pages, 101 KB)
The funding proposal PHARMAC is seeking feedback on a proposal to widen the access to trastuzumab and docetaxel to include adjuvant use for HER 2 positive early breast cancer. If this proposal is approved by the PHARMAC Board it would result in PHARMAC subsidising treatment with trastuzumab for HER 2 positive early breast cancer patients when it is administered for 9 weeks concurrently with taxane chemotherapy.
Media Release: PHARMAC asking for public views on Herceptin funding proposal (3 pages, 114 KB)
Breast cancer drug Herceptin is a step closer to being more accessible for NZ women, with PHARMAC today seeking feedback on a proposal…
2007-02 PTAC Minutes (22 pages, 186 KB)
PTAC minutes for web publishing PTAC minutes are published in accordance with the following definitions from the PTAC Guidelines 2002: ““Minute” means that part of the record of a PTAC or Sub-committee meeting (including meetings by teleconference and…
Media Release: PHARMAC supporting international assessment of funding options trial & continuing assessment of funding options (3 pages, 30 KB)
PHARMAC has announced its financial support for an international trial that will further examine whether 9 weeks or 12 months is the better treatment option for Herceptin. In addition, PHARMAC is continuing assessment of funding options, including the 9 week treatment option.
2006-11 PTAC Minutes (18 pages, 150 KB)
PTAC minutes for web publishing PTAC minutes are published in accordance with the following definitions from the PTAC Guidelines 2002: ““Minute” means that part of the record of a PTAC or Sub-committee meeting (including meetings by teleconference and…
2006-08 PTAC Minutes (16 pages, 198 KB)
August 2006: PTAC minutes for web publishing PTAC minutes are published in accordance with the following definitions from the PTAC Guidelines 2002: “Minute” means that part of the record of a PTAC or Sub-committee meeting (including meetings by teleconference and…
Media Release: Herceptin not funded, under continuing review (5 pages, 46 KB)
Funding has not yet been approved for breast cancer drug Herceptin, but will be kept under review by Government drug-funding agency PHARMAC as new information emerges. The available clinical data is not…
2006-05 PTAC Minutes (18 pages, 164 KB)
PTAC minutes for web publishing PTAC minutes are published in accordance with the following definitions from the PTAC Guidelines 2002: ““Minute” means that part of the record of a PTAC or Sub-committee meeting (including meetings by teleconference and…
2006-11 PTAC Minutes (Item 25.4 Trastuzumab/Herceptin) (2 pages, 444 KB)
Part (Item 25.4) of the Record of the Pharmacology and Therapeutics Advisory Committee Meeting held on 15 & 16 November 2006 25.4 Cancer Treatments Subcommittee (CaTSoP) – 26 / 27 October 2006 25.4.1 PTAC noted and accepted the minutes of…
