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Women who petitioned Parliament get nothing from PHARMAC

Women who petitioned Parliament get nothing from PHARMAC’s Santa

Women who stood on the steps of Parliament in October to present petitions to MPs calling for the funding of two important breast cancer medicines have been given a setback by PHARMAC for Christmas.

The petitions called for funding for Ibrance and Kadcyla, and were presented after a march to Parliament by more than 100 women representing Metavivors, a group of women with advanced breast cancer seeking access to vital medicines, and their supporters.

The PHARMAC clinical committee that initially considers applications for medicines funding has given a mixed bag of recommendations on the medicines. The minutes from the September meeting of PHARMAC’s Cancer Treatments Sub-committee of PTAC (CaTSoP) were released on 18th December and will be considered at PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) meeting in February 2019.

Palbociclib (Ibrance)

Palbociclib (Ibrance), has been recommended for funding for women with hormone receptor positive metastatic breast cancer who haven’t already received a hormonal treatment such as tamoxifen or an aromatase inhibitor. This means that, if recommended by PTAC and then finally approved by PHARMAC’s Board, it will only be provided to those who are newly diagnosed. All those already on treatment who petitioned Parliament for funding will be excluded.

Breast Cancer Aotearoa Coalition (BCAC) Chairperson Libby Burgess says: “Exclusion of those already being treated for this form of breast cancer is cruel and heartless. There certainly is evidence that this group would benefit, which is the reason oncologists are recommending the treatment. Women who can afford it are accessing Ibrance while most go without. This widens inequities for New Zealand’s most economically vulnerable citizens.”

Ibrance manufacturer Pfizer made the case only for newly diagnosed patients in their original application to PHARMAC, so BCAC formally applied in November for Ibrance to be funded for those currently being treated. The CaTSoP minutes noted that PHARMAC wants more advice from its clinical experts on this use and BCAC’s application will elicit this advice. However, as PHARMAC is not bound by any timeframe it could take months or years to consider the application and provide advice.

T-DM1 (Kadcyla)

The committee’s recommendation for T-DM1 (Kadcyla) also limits its use to an exclusive group of patients with metastatic HER2 positive breast cancer. Women must have had prior treatment with trastuzumab (Herceptin) and a taxane to qualify, but exclusions include those who have received pertuzumab (Perjeta) or have cancer deposits in the brain. As Perjeta has been funded in New Zealand for newly diagnosed women since 1 January 2017 all women diagnosed over the last two years will miss out, as will those who have been self-funding Perjeta. The committee noted that there would be a small number of people in New Zealand (100 or less) who will not have been treated with Perjeta, and would therefore be eligible for Kadcyla.

Slow PHARMAC processes unacceptable

Libby says: “The inexplicably slow processes that PHARMAC uses for considering medicines is one of the fatal flaws of the PHARMAC process that urgently needs to be independently reviewed and reformed. Medicines applications are referred between multiple committees and minutes take several months to be published. These latest minutes, released in December, are from a September meeting. In the meantime, women are dying of breast cancer and suffering more than they should.

“Even when PTAC makes a positive recommendation that a medicine should be funded, it goes onto PHARMAC’s long list of medicines (currently over 100) recommended for funding. Then it goes into a non-transparent holding pattern where no-one knows if and when it might be funded. Given the paltry size of New Zealand’s medicines budget it could be years, if at all.

“Fulvestrant provides an example. It was initially applied for and approved for funding in 2006, but it never reached the top of PHARMAC’s waiting list so was never funded. This drug is playing an increasingly important part in the treatment of metastatic hormone receptor positive breast cancer, so BCAC formally applied for it to be funded again in 2018. CaTSoP gave it a medium priority for funding, but notes that the Medsafe registration has expired for fulvestrant so it may remain out of reach of desperate women”.

Perjeta with Herceptin as a ‘second-line’ treatment

Along with BCFNZ, BCAC asked PHARMAC to fund Perjeta with Herceptin as a ‘second-line’ treatment for women whose metastatic HER2 positive breast cancer progresses on or after ‘first-line’ Herceptin treatment. The committee has again recommended an exclusive group for funding and only assigned low priority to this use. The committee’s recommendation is that it should only be funded for those who have not received any further treatment after disease progression on Herceptin, thus excluding all current patients who will have received other therapies. This will include almost everyone who currently has this form of metastatic disease, as the normal strategy when cancer progresses is to provide the next available treatment, so again most of the women who petitioned Parliament and others in need will miss out.

Nab-paclitaxel (Abraxane)

BCAC applied in February for funding for nab-paclitaxel (Abraxane), a gentler form of taxane chemotherapy, and PHARMAC indicated this would be considered along with the other breast cancer medicines by CaTSoP in September. However there was no mention of this in the minutes, so this drug has fallen through the ever widening cracks in PHARMAC’s processes.

Health Select Committee hearings

In response to Metavivors’ presentation of Ibrance and Kadcyla petitions, along with a request for an independent inquiry into PHARMAC, the Health Select Committee (HSC) heard submissions from petitioners, Wiki Malton Mulholland and Malcolm Mulholland and Terre Nicholson in early December. After this, the HSC opened a briefing, requesting input from PHARMAC and the Ministry of Health. The HSC has now invited submissions from Metavivors on the impact of unfunded medicines on their lives and those of their families. These will be heard in February.

BCAC Chair Libby Burgess says: “It’s great that Metavivors will have their day in front of the HSC, but for each of them time is precious. As the months tick by with effective medicines held out of reach, these women know their time is running out. PHARMAC must be reformed to become a person-centred organisation that shows empathy and compassion, with its performance measured in human benefit rather than cost savings. New Zealanders with a raft of other diseases are suffering in the same way and also need their day in court to call for change. The HSC should urgently announce an independent inquiry into PHARMAC that is open to all patients and their representative groups. There is a deep systemic problem with the way New Zealand funds medicines that needs immediate remedy. We simply can’t stand by and watch our people suffer and die needlessly”.

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