Herceptin Timeline

How Herceptin has changed our Lives

The fight to secure public funding for one year of Herceptin treatment took almost three years and became one of the most tenacious, lengthy and hard fought public campaigns ever waged over drug funding in New Zealand. One of a new class of immune-targeted breast cancer therapies, Herceptin has greatly improved survival rates for women diagnosed with HER2-Positive (her2+) breast cancer. Studies show that approximately 25 percent of breast cancer patients have tumors that are HER2+. 1998: Licensed by the US Food and Drug Administration (FDA), Herceptin (trastuzumab) was proven highly effective in the treatment of advanced HER2+ breast cancer.

June 2005: Preliminary information from three international trials (the HERceptin Adjuvant or HERA and two United States trials) showed astounding results for the drug’s use in the treatment of early stage breast cancer diagnosis. Both HERA and the combined analysis of two United States trials involved over 3,000 participants each and the results showed that one year of Herceptin offered unprecedented benefits for women diagnosed with early stage HER2+ breast cancer.

The preliminary data from a sub-study of a fourth trial (the FinHer trial, a small Finnish trial that had explored the nine week Herceptin regimen) suggested there may also be benefits using a shorter duration of nine weeks of treatment, but because the study involved just over 200 women there was uncertainty about the reliability of this result.
The results from the trials were so compelling that advocates throughout the world urged governments to fund the clinically recommended 12 month treatment course.
2005: Under the leadership of Chair, Libby Burgess, the Breast Cancer Aotearoa Coalition (BCAC) led the charge to bring Herceptin to New Zealand. Basing its work solely on the strength of the clinical data, BCAC went head-to- head with the Pharmaceutical Management Agency of New Zealand (PHARMAC) on several occasions throughout a long campaign.

December 2005: PHARMAC received an application from Roche to fund Herceptin for 12 months.

2006: 24 OECD countries had decided to fund one year of Herceptin, yet New Zealand, the first country to approve its use, was not among them.

8 February 2006: The Pharmacology and Therapeutics Advisory Committee (PTAC) considered Roche’s application for early breast cancer treatment?. PTAC recommended further information be sought from Roche and for Herceptin to be considered by the cancer treatments sub-committee, should Herceptin be approved by Medsafe.

March 2006: Anne Hayden was one of the first women to raise national awareness by presenting an 18,156 signature petition to Parliament.

23 March 2006: MedSafe, New Zealand’s drug safety body was the first in the world to respond to the HERA results by approving the 12 month treatment for use in early stage diagnosis.

July 2006: PHARMAC declined funding for one year of Herceptin, stating there was not enough clinical evidence to justify a favourable decision.

November 2006: Nine weeks of Herceptin treatment was recommended for funding.

2007: PHARMAC indicated it was looking at funding the shorter, less established and less rigorously tested nine week regimen.

February 2007: PHARMAC commits to supporting the international Short Or Long Duration (SOLD) clinical trial comparing nine weeks treatment with 12 months, and put $ 2.7 million dollars of sponsorship towards this trial. PHARMAC makes this commitment on a background of zero history of practical experience in trial design or in the running of clinical trials; without any opportunity to improve on the SOLD design, and prior to any indication of international support for the study to indicate that the SOLD trial has some chance of recruiting the number of women needed for the study to succeed.
June 2007: Eight women sought a High Court judicial review of PHARMAC’s Herceptin decision, which resulted in the High Court directing PHARMAC in April 2008 to re-consult on its decision not to fund 12 months. PHARMAC declined to change its decision.

August 2007: With assistance from MP Nick Smith, Nelson woman, Mandy Carter headlined a 27,464 signature petition, which was presented to Parliament urging the government to fund 12 months of treatment.

10 September 2007: Nine weeks of Herceptin funding was made available for patients with early stage HER2+ breast cancer, only when given in combination with chemotherapy preferably as per the FinHer trial protocol.

2007: Chris Walsh and the Herceptin Heroines gained nationwide attention when they filed a Judicial Review challenging PHARMAC’s decision-making processes in the High Court. The women committed their own money and raised thousands of dollars for their legal action, gaining solid national support but attracting criticism for being too ‘emotive.’

April 2008: High Court Judge Gendall ordered PHARMAC to reconsider its earlier nine-week funding decision.

July 2008: The PHARMAC Board declined funding for 12 months of Herceptin for HER2+ early breast cancer.

17 July 2008: PHARMAC’s Statement of Intent (their annual report) showed that over the three year period, 1 July, 2008 to 30 June, 2011, just under $20 million has been committed to the SOLD trial.

October 2008: The National Party announces its policy to fund 12 months of Herceptin for early stage HER2+ breast cancer, which is approved and implemented from 10 December 2008.

December 2008 to May 2009: 37 women elected to take the nine-week course and 135 elected to take the 12 month course as reported by District Health Boards. To date only 23 New Zealand women from two centres have elected to participate in the SOLD trial.

March 2009: An update on the FinHer trial is presented at the Saint Gallen Breast Cancer Conference. The five year follow-up data no longer showed a statistically significant benefit with regard to improving breast cancer free and overall survival, meaning there is no longer evidence to support a nine week regimen.

May 2009: The National Government’s 2009 budget announced a total of $185.7 million in new funding for subsidised medicines over the next four years. Shortly afterwards, the government also announced that a three person panel would review access to highly specialised medicines, funding mechanisms and to work with stakeholders to recommend ways to improve access and advise the Minister of Health by mid-2010.

July 2009: A group of New Zealand breast cancer specialists submitted a document to PHARMAC asking to review the funding criteria for Herceptin in early stage HER2+ breast cancer. Given the lack of scientific support for a nine week treatment regimen, they asked for the funding criteria to be changed. PHARMAC replied that CaTSoP (Cancer Treatment Subcommittee of PTAC) considered that the new data did not substantially change the evidential base for Herceptin and PHARMAC therefore decided not to change the current funding criteria of nine weeks.

Today: Four large scale clinical trials involving over 13,000 women worldwide have demonstrated significant survival benefits for early stage HER2+ breast cancer when Herceptin is given for a year.

Contributors: Jackie Blue (MP, National), Chris Walsh (Herceptin Heroines), Ian Campbell (Breast Surgeon, Waikato Hospital) and Marion Kuper (Medical Oncologist, Waikato Hospital).