Trastuzumab is finally listed as a PMB

Salomé Meyer updates us on the new guidelines from The Council of Medical Schemes that now recommends trastuzumab as a prescribed minimum benefit (PMB) for early breast cancer.

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The Council of Medical Schemes (CMS), which rules all 75 medical schemes in the private sector, published the new definition guidelines for early and locally advanced breast cancer on 2 April 2020. 

This guideline now finally recommends trastuzumab as an adjuvant systematic therapy given every three weeks for six months for early breast cancer. This is in line with the National Department of Health’s Breast Cancer Guidelines of 2017.  

The exclusions are:

• Patients with locally advanced or metastatic breast cancer
• T1N0M0 
• Patients with clinically significant comorbid diseases
• Cardiac ejection fraction < 55%
• Significant hepatic or renal dysfunction
• ECOG Performance Status > 1
• Patients who have only received adjuvant hormonal therapy with no adjuvant chemotherapy
• Pregnancy or lactation

In 2017, the National Department of Health approved trastuzumab treatment for patients in the public sector and added this to the Essential Medicines List. 

The initial treatment cycle approved in the Breast Cancer Policy was 12 months. However, they adjusted the treatment cycle in line with the Persephone international study, recommending six-month treatment cycles. 

A win for the Advocates for Breast Cancer

This latest recommendation, by the CMS, is a significant win for the Advocates for Breast Cancer (ABC), as part of the Cancer Alliance. 

Advocacy for equitable and affordable access to this essential medicine started as early as 2015 and the campaign was renamed, after the passing of Tobeka Daki, in November 2016. 

The Access to Medicine Campaign appealed to the CMS, in June 2018, for the inclusion of trastuzumab for early breast cancer. Early in 2019, the CMS initiated a PMB review process and this was finalised and adopted in April 2020. The ABC formed part of the review process and was represented by Louise Turner of the Breast Health Foundation. 

Great progress made but more is needed

Much has happened with trastuzumab access since we started:

• We have seen the acknowledgement of this treatment as an essential medicine. 
• We have seen the approval of trastuzumab biosimilars in SA which has facilitated a significant reduction in price. 

The history of trastuzumab access in SA makes for interesting reading and confirms how originator pharmaceutical companies maintain their stronghold and patent rights, affecting affordable and equitable access for South Africans.

The availability of trastuzumab biosimilars is further welcoming news for patients in the private sector as the price decreased and the changes of treatment cycles now allows for more affordable treatment options. 

Many patients, however, will still face financial toxicity as their medical aid’s cancer plan may not be enough to cover all the treatments associated with their cancer. This aspect is a further worry for many patients and clinicians in the private sector as cancer plans over the last 10 years haven’t increased significantly in proportions to the costs associated with drugs and treatment modalities. Thus, leaving patients to fork out more for their cancer care. Cancer Alliance will be investigating this. 

The next step

For ABC, our next step is to advocate for the inclusion of trastuzumab for locally advanced HER2+ breast cancer. This will be in line with the World Health Organisation (WHO) recommendations of June 2015. 

The reality in SA is that most women in the public sector are diagnosed with locally advanced and/or late stage disease. 

The reduction in price and shorter treatment cycle should essentially make it more affordable to treat HER2+ breast cancer. 

However, it’s not as plain sailing as that, as provincial departments of health, independently, must budget for treatment of cancer patients and these budgets are extremely challenged. COVID-19 will, apart from the proposed NHI, play havoc with cancer budgets in the future. 

In the private sector, most women are fortunate enough to be diagnosed at an early stage. Price reduction and PMB status for trastuzumab means that more women will now be able to be treated. 

A significant increase in usage of trastuzumab has already been recorded since the PMB approval. That is enough proof that our advocacy is targeted on the right issues. We will continue to fight for equitable and affordable access to healthcare services as it is a basic human right.

Header image by Freepik