Trastuzumab: The challenge of equitable and affordable access.

Salomé Meyer, from Cancer Alliance, helps us understand the continued fight for trastuzumab to be more affordable, even though it is available in public sector now.

What is trastuzumab?

Trastuzumab (Herceptin) is a biologic therapy that is recommended as an adjuvant therapy (given in addition to local surgical treatment) in combination with chemotherapy for the treatment of early HER2 positive breast cancer. 

Trastuzumab is a monoclonal antibody that binds to the human epidermal growth factor receptor (HER2) that is overexpressed in individuals with HER2 positive breast cancer – inhibiting the growth of tumour cells. Trastuzumab thereby reduces the risk of tumour recurrence and mortality in patients with HER2 positive early breast cancer. 

Essential medicine list

The estimated lifetime risk of developing breast cancer of women in South Africa is 1 in 36.  HER2, which is overexpressed in around 20-30% of breast cancers, is associated with a more aggressive disease, a higher recurrence rate, and increased mortality.  

In 2015, the WHO included trastuzumab on the essential medicines list (EML) for early and metastatic breast cancer. The National Department of Health approved the Breast Cancer Prevention and Control Policy in April 2017 and this paved the way for the inclusion of trastuzumab on the EML list of the National Department of Health in July 2017. 

This opened the door for women in the public sector to access this life-saving medicine. The tender for trastuzumab was awarded to Roche for their clone Herclon at a price of R6531,61. Roche is also the manufacturer of Herceptin.

Treatment with this life-saving medicine is in accordance with the clinical guidelines of the Breast Cancer Policy which also follows international standards. 

Only women that are eligible for treatment are selected for treatment. 

To date, between 25-29 women, have successfully been treated in the public sector. 

This is directly linked to the approved breast centres: Charlotte Maxeke Johannesburg Academic Hospital in Gauteng; Frere Hospital in Eastern Cape; Grey’s Hospital in Kwa-Zulu Natal, Universitas Hospital in Free State as well as 2 Military Hospital in Cape Town. Kimberley Hospital has been able to provide this treatment for several years already and continues to do so. 

Tender price still too high

Groote Schuur Hospital in the Western Cape remains the only accredited hospital where this treatment is not available. The Western Cape Government has indicated that they’re unable to fund this treatment due to the high cost of this life-saving medicine. 

The reality remains that even at the tender price it remains unaffordable. If this treatment has to be provided, it would mean that other cancer patients who are earmarked for other life-saving cancer treatments must forfeit their treatment to benefit patients that are eligible for trastuzumab treatment. 

The harsh reality is that the tender price is not the real cost. There are many other hidden factors that are not considered. Each patient must be tested for the HER2 gene. Once eligibility is confirmed, women will undergo this treatment which requires chemotherapy equipment; dedicated chemo rooms with safe storage facilities; qualified healthcare professionals to administer the treatment, such as an oncology pharmacist, oncology nurses, apart from the multi-disciplinary team members that take care of the patient throughout her journey. 

The amount of these costs remains an unknown and is often not taken into account when we compare the price government negotiates for their medicines against the price of private sector. 

Delay at SAHPRA

Our question remains – is this an affordable option? The current price remains unaffordable! There is no question about that. The good thing though is there are other affordable options available. 

Several biosimilars are available to enter the market. At least three biosimilar dossiers are pending at South African Health Products Regulatory Authority (SAHPRA). These dossiers have been approved by other health regulatory authorities, such as the Food and Drug Administration (FDA), European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA). 

Cancer Alliance sent an open letter to SAHPRA in December 2018. There is a deafening silence from the regulatory office. Why the delay? Competition is healthy and would stimulate price reduction. 

SAHPRA’s delay is not favouring women in the public or private sector. Instead it is denying women access and sending women in the private sector into financial hardship because only the originator product, Herceptin IV and Herceptin SQ, is available in the private sector. Herceptin IV is sold at a price of R23,769 for a 440mg vial whilst Herceptin SQ is sold at 20% less to the consumer.

Cancer Alliance will continue to advocate for more affordable options of trastsuzumab to improve equitable and affordable access to women in South Africa. 


References:

  1. Department of Health. Breast Cancer Control Policy 2017.
  2. https://www.herceptin.com/breast/metastatic
  3. Vorobiof, D. A., F. Sitas, and G. Vorobiof. “Breast Cancer Incidence in South Africa.” Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology 19, no. 18 Suppl (September 15, 2001): 125S – 127S.
  4. Mitri Z, Constantine T, O’Regan R. The HER2 Receptor in Breast Cancer: Pathophysiology, Clinical Use, and New Advances in Therapy. Chemotherapy Research and Practice. 2012;2012:743193. doi:10.1155/2012/743193.
  5. https://www.canceralliance.co.za/open-letter-to-sahpra-affordable-access-to-trastuzumab/

Salomé Meyer is: the project manager for: Access to Medicine campaign and Advocates for Breast Cancer (ABC); an independent cancer advocate; and an EXCO member of Cancer Alliance.

MEET OUR EXPERT – Salomé Meyer

Salomé Meyer is the project manager for: Access to Medicine campaign and Advocates for Breast Cancer (ABC); an independent cancer advocate; and an EXCO member of Cancer Alliance.


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