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 currently unfunded 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.
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. BCAC has heard that the patent on Afinitor is due to expire soon, potentially leading to a drop in price, increasing the likelihood that PHARMAC may fund this medicine for breast cancer.
Faslodex (fulvestrant) - is used to treat hormone-receptor-positive advanced breast cancer in postmenopausal women with disease progression following anti-oestrogen therapy.
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.
Ibrance (palbociclib) - 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 as a treatment (in combination with Femara (letrozole)). A potentially confirmatory phase 3 trial, PALOMA-2, was fully enrolled by Feb 2015. The PALOMA-2 trial reported positive results in April 2016 and the trial continues. Ibrance is a very promising new treatment that could provide a significant survival advantage for those with advanced oestrogen-receptor-positive breast cancer.
It is not yet registered or funded in New Zealand and current estimated costs are extremely high.
Perjeta (Pertuzumab) – 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 is available and Medsafe registered but is not yet publicly funded in New Zealand. Despite the remarkable effectiveness of this medicine in extending life for women with advanced HER2 positive breast cancer, PHARMAC originally classified Perjeta as “low priority” because of its cost. Perjeta has been publicly funded in Australia since 2015.
On 11th October 2016 PHARMAC released a consultation document on the possible funding of Perjeta from 1st January 2017. This is great news and we encourage everyone with an interest in HER2 positive breast cancer to write to PHARMAC in support of funding by the deadline of November 8th 2016 (https://www.pharmac.govt.nz/news/consultation-2016-10-11-multi-product-proposal/ ). While we welcome this positive announcement, we note that New Zealanders diagnosed with advanced HER2 positive breast cancer will have missed out on this breakthrough life-extending medicine for a full 18 months while Australians had access.
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). This medicine is available and Medsafe registered but not publicly funded in New Zealand. Kadcyla has been publicly funded in Australia since 2015.
Roche supplies Kadcyla and it has a patient access programme for the drug. 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 $83,000 over 12 months, so only those who can afford this can be treated. 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
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.