Limited Access to Breast Cancer Medicines in New Zealand
In recent years a number of innovative new medicines have become available for the treatment of early and advanced breast cancer. However, many of these medicines are not funded in New Zealand. Some are available privately if a patient is able to pay for them and many are available and publicly funded in Australia.
All these drugs offer potential advantages in quality and length of life for New Zealanders with breast cancer and would give oncologists additional options for optimising treatment of the different sub-types of breast cancer.
We also list some new medicines that are still being investigated in breast cancer clinical trials for effectiveness and safety.
Abraxane (nab-paclitaxel) - is used to treat advanced breast cancer in people who have already received other medicines. It is a taxane that fights cancer by interfering with cell division. Abraxane is a less toxic formulation of the taxane Taxol (paclitaxel), with the advantage of causing reduced side effects as it is delivered in protein nanoparticles rather than the toxic solvent that Taxol and another taxane Taxotere (docetaxel) are dissolved in. Abraxane is particularly helpful for patients who have an allergic reaction to Taxol or Taxotere.
Abraxane has been publicly funded in Australia since 2009 and has since become the preferred taxane, with 71% of Australian patients who use a taxane being treated with this drug by September 2011.
Abraxane is available and Medsafe registered, but not publicly funded in New Zealand. In February 2018 BCAC applied to PHARMAC to have this medicine funded. In May 2019 PHARMAC's Pharmacology and Therapeutics Advisory Committee (PTAC) recommended it be funded only if "cost-neutral" to weekly paclitaxel (the currently funded option). The potential supplier of nab-paclitaxel has advised BCAC that meeting this price requirement would be extremely difficult because of the higher cost of creating a humanised albumin bound (nab) paclitaxel compared with the other taxanes which are simply dissolved in toxic solvent.
Afinitor (everolimus) - is used in the treatment of hormone-receptor-positive, HER2-negative advanced breast cancer in post-menopausal women, in conjunction with the aromatase inhibitor Aromasin (exemestane) after failure of Femara (letrozole) or Arimidex (anastrozole). It is only used in patients whose tumour has tested negative to HER2. Afinitor stops a particular protein called mTOR from working properly. mTOR controls other proteins that trigger cancer cells to grow.
Afinitor is Medsafe registered but not publicly funded for breast cancer in New Zealand. It has been funded in Australia since 2014. In July 2018 BCAC appliced to PHARMAC to have this medicine publicly funded. In July 2019, BCAC was informed that this application had been declined by PHARMAC.
Faslodex (fulvestrant) - is used to treat hormone-receptor-positive advanced breast cancer in postmenopausal women with disease progression following anti-oestrogen therapy. BCAC applied to PHARMAC to fund this in May 2018. In February 2019, PTAC recommended it with "medium priority." In September 2019, BCAC was informed that PHARMAC would fund fulvestrant "as soon as possible" once its registration with Medsafe has been renewed. In November 2019, BCAC wrote to Medsafe urging them to fastrack this process.
Halaven (eribulin) - is used to treat late stage metastatic breast cancer that is hormone-receptor-positive and HER2-negative that has previously been treated with anthracycline and taxane chemotherapies. It is a “non-taxane microtubule inhibitor” that kills cancer cells by inhibiting cell division.
Halaven has been registered and publicly funded in Australia since 2013 and was recommended for inclusion on the New Zealand Pharmaceutical Schedule in 2012 but is not funded in New Zealand.
CDK 4/6 inhibitors - Ibrance (palbociclib), Kisquali (ribociclib), Verzenio (abemaciclib) - Ibrance is a new medicine for treating advanced oestrogen-receptor-positive, HER2-negative breast cancer. The drug was reviewed and approved under the USA’s Food and Drug Administration's (FDA) accelerated Priority Review and Breakthrough Therapy designation programs in 2015 (in combination with Femara (letrozole)). The PALOMA-2 clinical trial showed that adding Ibrance to letrozole on average increased the time to progression of the cancer to 24.8 months compared to 14.5 months in those who took letrozole alone.
Ibrance is a CDK4/6 inhibitor, a group of medicines that prevent over-proliferation of cancer cells. These drugs offer very promising new treatments for those with advanced oestrogen-receptor-positive breast cancer. Other CDK4/6 inhibitors are abemaciclib (Verzenio, Lilly) and ribociclib (Kisqali, Novartis). In November 2017 the UK drug funding agency NICE made both Ibrance and Kisqali available through the National Health Service.
Pfizer gained Medsafe registration for Ibrance in 2017 and applied for PHARMAC funding in February 2018. In March they established a Patient Assistance Programme that offers four months of Ibrance free to patients who have purchased eight months of Ibrance in New Zealand, as long as the treating oncologist confirms that the patient may benefit. Find out more here. Many clinical trials are under way with CDK4/6 inhibitors, including the Monarch-E trial which is testing the effects of adding Verzenio to hormonal therapy in early breast cancer. Some women being treated in Auckland, Waikato and Palmerston North are participating in this trial.
In October 2018, BCAC committee member Terre Nicholson presented a petition to Parliament asking the Government to fund Ibrance. In November 2018 BCAC applied to PHARMAC to have palbociclib (Ibrance) funded for use in combination with fulvestrant for those who have received prior endocrine therapy (second-line use; Pfizer, the manufacturer, had already applied for first line use in February 2018).
In March 2019, Terre and many other women with advanced breast cancer presented their submissions on the petition to the Health Select Committee.
In April 2019 the supplier of ribociclib (Kisqali, Novartis) applied to PHARMAC for funding for this CDK 4/6 inhibitor.
In September 2019, PHARMAC put out a request for proposal for CDK 4/6 inhibitors to be provided first- and second-line. BCAC expects both Novartis and Pfizer will put up proposals for Kisqali (ribociclib) and Ibrance (palbociclib) respectively. Funding for the successful product is scheduled to begin in April 2020.
Perjeta (Pertuzumab) – is used for the treatment of HER2-positive metastatic breast cancer in conjunction with Herceptin and the chemotherapy medicine, Taxotere (docetaxel). Used as a “first line” treatment for advanced breast cancer, i.e. as the first treatment to be given once the cancer has advanced. It works in a complementary way with Herceptin, inhibiting different proteins that cause HER2-positive breast cancers to grow. Results from the CLEOPATRA clinical trial reported in October 2014 showed an extraordinary survival benefit of 15.7 months longer than for patients who did not receive the drug.
Perjeta was publicly funded in New Zealand from January 2017, 18 months after it was funded in Australia. BCAC petitioned PHARMAC to fund the drug for women whose HER2-positive cancers had already advanced, as was done in Australia, but PHARMAC declined to provide funding for this group of around 160 women. Some of those who missed out on Perjeta are fundraising to obtain it and there has been recent media coverage of their plight.
Kadcyla (ado-trastuzumab emtansine or T-DM1) – This drug is used in patients with HER2-positive advanced (or metastatic) breast cancer who have received prior therapy with Herceptin and a taxane. As it is used after earlier treatments for advanced disease it is known as a “second-line” strategy. Kadcyla is a combination of Herceptin (trastuzumab), an antibody that shuts down growth signalling pathways in HER-2-positive breast cancer, and a cytotoxic chemotherapy agent DM-1 (emtansine).
Herceptin targets the T-DM1 to the HER-2-positive tumours, delivering the toxin directly to the tumour cells and reducing effects on other normal cells in the body. Latest results from the international clinical trial EMILIA show patients receiving Kadcyla had a median overall survival benefit of 5.8 months (30.9 months vs. 25.1 months), compared to those given the combination of Xeloda (capecitabine) and Tykerb (lapatinib).
Kadcyla is available and Medsafe registered but is not yet publicly funded in New Zealand, although it was funded in Australia in 2015. Roche applied to PHARMAC for Kadcyla funding in August 2017 and it was recommended for funding, but with low priority.
Roche has established a patient access programme for Kadcyla. Under the Kadcyla Access Programme a number of doses or ‘cycles’ of the medicine are provided free (the cost of the Roche medicine only). The Kadcyla Access Programme also limits or caps the total amount you pay for this medicine at $63,000 (excl. GST), so only those who can afford this can be treated. This amount is for the drug cost only and other administration fees may apply. Once a patient reaches the cap, Roche will provide ongoing Kadcyla at no cost, for as long as you continue to respond to treatment, or until you experience disease progression.
See more information here http://cancerinfo.co.nz/accessing-treatment/funding-medicines
In October 2018, Metavivor Sue Wall-Cade presented her petition to fund Kadcyla to Parliament and in March 2019 she presented her submission on this petition to the Health Select Committee.
In August 2019, PHARMAC announced that Kadcyla would be funded from 1 December 2019. Roche announced that they would fund Kadcyla for all who needed it until that date.
Keytruda (pembrolizumab) is an antibody used in cancer immunotherapy. It is one of a number of new medicines called checkpoint inhibitors that support the body’s immune system to recognise and destroy cancer cells. Some types of cancers have a protein on the cell surface that masks the cancer from the body’s immune system. Keytruda and other similar new drugs are designed to lock onto and deactivate this protein, exposing the cancer cells to the body’s immune system, allowing the body’s T-cells to destroy the cancer. Breast cancer clinical trials currently under way with Keytruda (Keynote trials) and other similar drugs are producing very promising results, particularly in triple negative breast cancers that test positive for the tumour masking protein, PD-L1.
Keytruda has recently been funded in New Zealand for treating advanced melanoma.
Xgeva or Prolia (denosumab) is a monoclonal antibody that reduces tumour formation and growth in people whose cancer has spread to the bones. Recent Australian research has shown this drug also has the potential to prevent breast cancer in people with a BRCA gene mutation who are at high risk of getting breast cancer.
This medicine is Medsafe registered but not funded in New Zealand. It was approved by the US FDA in 2010 for prevention of skeletal events (fractures) in patients with bone metastases from solid tumours. It is funded in Australia for elderly patients with low bone density and people with osteoporosis who have had a fracture after minimal trauma.
Updated 6 Nov 2019