Breast cancer remains the leading cancer affecting South Africa women. It is not only under-diagnosed but many will die needlessly because the most effective drugs are too expensive, writes Salomé Meyer, activist and Cancer Alliance Access to Medicine Project Manager, in Maverick Citizen.
Sadly, where you live will determine when and if you get a cancer diagnosis and with that also the outcome of the disease – much like the inequalities for most of the diseases in South Africa.
For many women being diagnosed with HER2+ breast cancer is even more scary., since HER2+ is a more aggressive cancer and is often associated with higher recurrence rates and higher mortality.
In 1979, the pioneering cancer researcher Robert Weinberg identified the gene – now known as HER-2 – which is involved in multiple cancer pathways. With a combination of public grants, private funding and industry funding, the drug trastuzumab, more commonly known by its brand name Herceptin, was developed. Herceptin is described as a lifesaving treatment and since 2015 has been listed on the World Health Organisations’ (WHO) Essential Medicines List for early and advanced breast cancer.
It was registered and patented in 1998 by Roche, the marketing arm of Genentech, and one of the largest and most profitable pharmaceutical companies globally. Under the current South African patent law these patents are valid until 2033.
However, simply because of these patents trastuzumab has remained unaffordable for most women diagnosed as HER2+. For many, the drug, which has to be taken for 12 months, was a whopping R23,562 per treatment dose or R424,116 for one year’s treatment of 18 cycles. This made it unaffordable in both the public and private sector.
Medical schemes at first denied access to this treatment. However, Samantha Galliet won her case against Discovery Health Medical Scheme which forced them to pay the cost of coverage for her treatment with Herceptin in 2006. Despite this many other medical schemes continue to refuse women access, based on affordability; many families were pushed into financial death as a result of paying the costs out of their own pockets. Herceptin was the second-highest driver of private sector expenditure in 2014 and 2015, reaping millions in profit.
Women in the public sector, however, have fewer choices. In 2011, the Northern Cape health department approved trastuzumab for women and thus started a trajectory of advocacy for equitable access for women that qualify clinically for treatment. This was made possible after Roche made available their clone drug (a clone is, in essence, an identical medicine made by the same company that manufactured the original biologic. This is a strategy to compete with other companies). Herclon is sold to the public sector at a negotiated price of R10,596 per treatment dose, still considered unaffordable for government to consider as an essential medicine. Treatment of one patient would cost R190,242.
This inequity in access and exorbitant price for a lifesaving drug became the dedicated advocacy focus of a campaign by the Fix the Patent Law/Cancer Alliance from 2016. Tobeka Daki from East London, who had been denied access by her medical scheme, became the face behind an aggressive advocacy campaign locally and globally. She died two years after her diagnosis without seeing her two sons grow up and grandchildren playing at her feet. The trastuzumab access campaign was renamed after Tobeka Daki.
In April 2017, then Minister of Health Dr Aaron Motsoaledi announced the approval of the Breast Cancer Policy, paving the way for trastuzumab to be added to the South African Essential Medicine List for the treatment of early breast cancer. An agreement between Roche and the National Department of Health now makes Herclon available to women in the public sector at a “reduced” price of R117,568.98 for 18 cycles. However, this price is still considered unaffordable by the Western Cape Health Department who classify this as an unfunded mandate and argue that treating one woman with trastuzumab will be affecting many cancer patients who will have to go untreated.
However, Roche remains steadfast in refusing to make the clone version available for women in the private sector.
As a result of their profiteering from people’s desperate need for cancer treatment, they recorded a record of $88.2-billion accrued sales income in 2017 on trastuzumab alone. In countries such as India and South Africa, at this price, the cost of treatment is equivalent to 10 years of earnings.
With the main US base patent expiring in 2018, everyone was carefully watching the regulatory approval of biosimilars for trastuzumab globally and locally.
The South African Health Products Regulatory Authority (SAHPRA) approved a biosimilar produced by the drug company Mylan on 15 May 2019. This was good news for women diagnosed with HER2+ breast cancer. Not only does this mean there is now the possibility of a safe, quality and effective biosimilar product, it also hails the start of an era of competition in the market that will see more affordable prices for this medicine. The Mylan product Ogivri is available at more than 35% less than the Herceptin subcutaneous product. Since then Roche has also announced they will make Herclon available to the private sector.
The Cancer Alliance is aware that another three companies have filed for trastuzumab biosimilar registration at SAHPRA and have called for an expedited review of these applications to stimulate competition and affordable access.
Roche already had an agreement in place with Mylan that they will not oppose biosimilar entry into the market. The question remains whether they would honour this and what would their follow-on strategy be. True to form, in 2018 Roche released their subcutaneous product patented till 2033 in South Africa and most countries. Which medical scheme would not opt for a cheaper product? This became another best-seller, being listed in the top five products prescribed in 2018.
With trastuzumab treatment listed as an essential medicine as part of an approved breast cancer policy, this treatment is now listed as a Prescribed Minimum Benefit (PMB). This means that in theory, medical schemes can no longer deny women access. However, this practice is still very much enforced on uninformed women. It succeeds because many are too scared to challenge their medical schemes and many not informed of their right to treatment.
Will the National Health Department consider including advanced breast cancer as an indication for treatment with trastuzumab now that the medicine is more affordable? Certainly, Cancer Alliance and Advocates for Breast Cancer together with other advocacy organisations will advocate for this inclusion as it would benefit the majority of women in the public sector.
Will National Health Insurance cover cancer treatment in the public sector?
Activists also ask how many companies will eventually have the chutzpah to bring their biosimilars to the market in an environment where the market is small and the originator company has a clear market advantage?
Because of the crisis described in this article the focus of the Fix the Patent Law (FTPL) campaign is to advocate for the amendment of the South African Patent Law that is not promoting the health of its citizens.
[link url="https://www.dailymaverick.co.za/article/2019-10-24-dying-for-treatment-the-struggle-for-affordable-breast-cancer-medicines-in-south-africa/"]The full Daily Maverick report[/link]