A potentially lifesaving or life-extending breast cancer medicine is available to public sector patients in several South African provinces, but not in the Western Cape, with the provincial Health Department there saying it is unaffordable and there is no budget for it.
The drug, trastuzumab, has often been in the headlines over the past decade. For several years activists campaigned to have the price reduced and earlier this year, South Africa’s Competition Commission said it was seeking to prosecute pharmaceutical company Roche for alleged excessive pricing of the drug, writes Elri Voigt in Spotlight.
Trastuzumab is used to treat a specific subset of breast cancers called HER2 positive (HER2+) breast cancer. It is given in addition to other treatments like chemotherapy and radiation and can significantly reduce the chance of the cancer recurring after treatment. It is administered either through an IV or subcutaneously.
Listed on the South African Essential Medicines List (EML) since 2017), it is currently only approved for early-stage HER2+ breast cancer. After its listing on the EML, trastuzumab should have theoretically been made available in all provinces with treatment centres for cancer that are linked to South Africa’s academic hospitals.
Trastuzumab was listed on the World Health Organisation’s Essential Medicines List in 2015, but access to it in the public sector in SA has been challenging, depending on where you live.
Public sector oncologists in the Northern Cape had successfully motivated for the budget to provide trastuzumab at Kimberly Hospital as early as 2011. The Cancer Alliance said the Department of Defence had been using trastuzumab in military hospitals since 2013.
Dr Mathabo Mathebula, CEO of Steve Biko Academic Hospital in Gauteng, said the drug has been provided in the province since 2017.
History of trastuzumab in SA
Salomé Meyer, project manager for the Cancer Alliance’s Access to Medicine Campaign, told Spotlight trastuzumab was available in Gauteng, the Free State, KwaZulu-Natal, the Northern Cape, and the Eastern Cape, although the Eastern Cape may be experiencing procurement problems.
She said the Western Cape Department of Health has never procured the drug, which has forced some patients to pay for their own treatment or go without.
This was confirmed by Professor Paul Ruff, Emeritus Professor and former Head of Medical Oncology in the School of Clinical Medicine in the Faculty of Health Sciences at the University of Witwatersrand.
While he says that he cannot be sure of exactly what the case is for all the other provinces, it is being routinely used in Gauteng. The Western Cape is the only province systematically restricting access to the medicine.
Ruff said the National Department of Health mandates what is on the Tertiary/Quaternary Essential Medicines List (TQEML) via its National Essential Medicines List Committee (NEMLC) and which medicines are on national tender, but that each province procures its own medicines using the budget assigned to it by National Treasury. The Constitution allows each province autonomy when it comes to healthcare provision.
He says trastuzumab has only been approved for use in SA for those with early-stage HER2+ breast cancer, although it is widely used in the private sector as well as in many countries, for advanced HER2+ breast cancer. It has been the standard of care in early breast cancer in most countries for more than 15 years.
Meyer says research in South Africa has shown that around 26% of women with breast cancer are HER2+, translating into a small population within the greater breast cancer population, but for them, she says, trastuzumab can be a lifesaving treatment that can extend their lives.
“Women are not equitably getting that treatment and not treated equally,” says Meyer. “Women in the Western Cape do not receive equal treatment (compared with) their sisters in other provinces. Are we then saying their lives are not important enough?”
Trastuzumab remains ‘unaffordable’
The Western Cape Government (WCG) Health and Wellness’ Provincial Pharmacy and Therapeutics Executive Committee confirmed to Spotlight that the province does not procure trastuzumab and that it (the WCG Health and Wellness’ Provincial Pharmacy and Therapeutics Committee) makes decisions on what medicine are procured in the province.
“Consultation with the Operations Executive Committee Meeting (OPEXCO) occurs for medicines which will have substantial impact on services or cost and budgets,” it said.
“The price of trastuzumab remains unaffordable. Although the National Department of Health included trastuzumab on the Essential Medicines List, no additional funding was made available to procure this medicine. The tertiary hospital budgets are fully allocated and additional funding is required for trastuzumab. The budget for oncology medicines is spent fully each year and either additional budget or lower prices are required to procure trastuzumab,” the committee says.
“Despite the improved outcome in a small subset of women, the cost remains unaffordable and an unfunded mandate. Unless additional funding is made available to oncology centers, trastuzumab remains unaffordable.”
Price changes
Trastuzumab was first approved by South Africa’s medicines regulator in 2001 under the brand name Herceptin®. Roche, the pharmaceutical company that produces and markets Herceptin, also received approval in 2012 for Herclon®, essentially the same product sold under a different name.
A search of the SA Health Products Regulatory Authority’s registers shows that versions of trastuzumab made by Mylan and Adcock Ingram were approved in 2019 and 2020, respectively.
Meyer says the price of trastuzumab has gone down significantly in the past few years. In 2017, she says only the originator product Herceptin® and its clone product, Herclon® were available globally. Other biosimilars for Herceptin became available in 2019, causing the price of trastuzumab to drop. As trastuzumab is a biologic medicine, versions of the drug made by companies other than Roche (the originator) are referred to as biosimilars rather than generics.
According to the Cancer Alliance’s timeline on trastuzumab, in July 2017, before being on the national tender, Roche agreed to supply Herclon® to the National Department of Health for R117 569 per recommended 17-18 cycles (given over 12 months) each patient should receive. This translates to about R6 531 per treatment cycle.
However, Ruff says once it was put to tender in 2018, Herclon’s cost was reduced to about R6 500 per cycle. He adds that consequent tenders in 2020 were given to Mylan, for the biosimilar Ogiviri® which cost R4 978.36 per injection, according to the 2021 Master Product List. On the current (2022) Master Product List, Cipla South Africa Medpro is listed as supplying Cipla Trastuzumab® at R3 450 per 440mg injection.
Evidence of effectiveness
Ruff says there is a large body of evidence around the effectiveness of trastuzumab in patients with early HER2+ breast cancer, which the Western Cape Department of Health appears to have disregarded.
Results from four major international studies conducted in patients with HER2+ early breast cancer more than 15 years ago, including the BCIRG-006 and HERA trials, in which South Africa participated, all showed that trastuzumab can significantly reduce the risk of a patient’s HER2+ breast cancer reoccurring, says Ruff.
When it comes to risk reduction, studies describe both a relative reduction and an absolute reduction, he adds. The four clinical studies on trastuzumab all showed about a 40%-50% relative reduction in risk of cancer progression and between 5-8% absolute reduction, both of which in the cancer context are very significant.
One year of treatment with trastuzumab (17-18 cycles of treatment) used to be the accepted standard but has now been reduced to six months (8-9 cycles of treatment), according to Ruff.
This should drop the price even further as patients don’t need as many treatments as before.
The implications of the Western Cape Department of Health declining to procure trastuzumab are far-reaching, says Ruff. “By denying access [to trastuzumab] you are denying access to a treatment that can… prolong survival and potentially cure a reasonable subset of breast cancer patients.
“We live in a resource-constrained environment. We know it’s always better to spend our money on treatments that can cure people rather than treatments that are going to give patients only [a] few extra months [of] survival. We always push harder with treatments that are curative, which this is [for a subset of about 25% breast cancer patients] … It’s aimed at curing patients who then can lead a normal life as opposed to having their cancer coming back.”
At what cost?
However, the Western Cape committee says the benefit of trastuzumab for some patients will come at the cost of other cancer services if implemented.
“The additional cost is not affordable. This cost would be in addition to the cost of chemotherapy, surgery, radiotherapy, and endocrine therapy currently provided. It is an unfunded mandate and use will therefore be at the expense of other interventions, for example, radiological equipment to treat cancer or other medicines to treat other cancers,” the committee says.
By unfunded mandate, the committee says it means: “It is an unfunded mandate in that no additional money was provided by National Treasury in liaison with the National Department of Health to make provision for procurement of trastuzumab.”
According to the committee, trastuzumab will be considered in the Western Cape if there is “a significant further reduction in price as well as an increased capacity to administer in oncology units”.
Access in the private sector
But it’s not just patients in the public health sector in the Western Cape who have struggled to access trastuzumab. Some with private medical scheme coverage have also battled to access it, especially before 2020. Since then, trastuzumab has been included as a preferred minimum benefit (PMB) for some but not all HER2+ breast cancer patients diagnosed with early-stage breast cancer.
This means that for women who meet the eligibility criteria set out in the PMBs, medical schemes are now compelled to pay for the drug.
“The Cancer Alliance successfully pushed the Council for Medical Schemes to change the Prescribed Minimum Benefits (PMB). Because the principle is what is provided in government, in public [healthcare sector], must be provided in private. It took them two years, in fact, to approve trastuzumab as a PMB,” says Meyer.
NOTE: SECTION27 and the Treatment Action Campaign have been involved in trastuzumab-related advocacy. Spotlight is published by SECTION27 and the Treatment Action Campaign.
See more from MedicalBrief archives:
Unaffordable breast cancer medicines are killing SA women
SA weighs shorter treatment for patients on Roche cancer drug
UK’s NHS says breast cancer drug is too expensive