Breast cancer patients welcome PHARMAC news
Breast Cancer Aotearoa Coalition (BCAC) is delighted to learn that fulvestrant (Faslodex) will be funded by PHARMAC in the New Year, BCAC Chair Libby Burgess says.
Fulvestrant is an important option in treating advanced oestrogen receptor positive (ER+) breast cancer, the most common subtype affecting around 61% of patients. It is an anti-oestrogen strategy used after disease progression on treatment with an aromatase inhibitor or tamoxifen. Fulvestrant delays the time before cytotoxic chemotherapy is needed and extends quality and length of life for women with this form of breast cancer.
Fulvestrant was approved as safe and efficacious by Medsafe, New Zealand’s medicines regulator, in 2004. The first funding application for fulvestrant went to PHARMAC in 2006, where it remained under consideration for many years. It had been approved in the USA in 2002 and the European Union in 2004. Pharmaceutical company AstraZeneca eventually gave up on their product ever being funded in New Zealand and allowed its Medsafe registration to lapse.
“Women with advanced ER+ breast cancer have not had any new treatments funded for more than 20 years,” Libby says. “Hoping to provide another treatment option, BCAC lodged a new application for fulvestrant funding with PHARMAC in May 2018. We provided updated clinical trial results showing the effectiveness of this medicine, noting the lack of treatment options for NZ women and shortened lifespans compared to other countries. New Zealand women with advanced breast cancer have a median survival of 16 months compared with 37 months in European countries such as Germany and France.”
PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) recommended funding in September 2018, so the medicine went onto PHARMAC’s prioritisation list. This is a list of over 100 medicines deemed worthy of funding by PHARMAC, known by patients as the waiting list. “Medicines may remain on the list for months or years and there is no ability to discover where a medicine sits in relation to other medicines on the list. But there was good news for fulvestrant when PHARMAC announced the intention to fund in September 2019,” Libby says.
On learning of this intention AstraZeneca worked on developing a new registration package for fulvestrant and they lodged this with MedSafe at the end of October. As soon as this package was submitted, AstraZeneca began providing the medicine free of charge to patients meeting PHARMAC’s criteria, i.e. women with advanced ER+ breast cancer previously treated with other hormone therapy. This is saving women over $1000 each month, helping to relieve the financial burden of staying well with advanced breast cancer and allowing more women to access the drug.
It’s great to know that PHARMAC funding will be put in place next year. Fulvestrant is often used as the ‘endocrine partner’ with the breakthrough medicines palbociclib (Ibrance) and ribociclib (Kisqali). PHARMAC recently issued a Request for Proposals for these medicines and we are looking forward to hearing good news about these in the near future.
“We were also very pleased to hear the announcement that PHARMAC assessment processes will be conducted at the same time as Medsafe’s for cancer medicines as this will certainly speed up the process. But the bottleneck in getting vital medicines to patients will remain until the Government provides sufficient funding to the medicines budget,” Libby says. “There should not be a waiting list of medicines that have been through PHARMAC’s rigorous processes and recommended as worthy of funding by PHARMAC’s own expert advisers.”
New Zealand sits at 35th of 36 OECD countries in per capita spend on medicines – only Mexico spends less. This has serious health impacts on New Zealanders, not only with breast cancer, but with a wide range of other diseases. “There’s a growing awareness of this issue across the motu and many people are demanding change. The medicines budget needs to be doubled to come close to Australia’s and tripled to reach the OECD average. We expect this to become an election issue next year,” Libby says.