Access to Trastuzumab and Pricing

South Africa, Johannesburg, 6 February 2017

Roche shares the concerns regarding access to innovative medicines such as trastuzumab1 and improving healthcare in South Africa. Our aim is for every person who needs Roche medicines to be able to access and benefit from them. We believe that in order to achieve this objective a collaborative approach is needed. Access to healthcare is a shared responsibility and commitment, which requires all stakeholders to work together.

We have seen this collaborative approach work successfully in other parts of the continent for example, Kenya, where Roche and the Kenyan government have collaborated to ensure that breast cancer patients who test positive for the HER2 gene2 have access to trastuzumab. Measures in Kenya represent a comprehensive approach to battling breast cancer, and complement the campaign from the African First Ladies, who are committed to expanding access to prevention and treatment services for women with breast cancer.

We have also partnered with the government of Madagascar to find solutions which allow patients to access innovative treatments. In Morocco, we have worked with the Princess Lalla Salma Foundation to help ensure lower income cancer patients gain access to innovative medicines like trastuzumab.

Roche has been in negotiations with the National Department of Health over the past year to improve equitable access to trastuzumab in the public sector. We have offered the National Department of Health a significantly reduced and cost-effective treatment option. This option supports the testing of breast cancer patients in the public sector, and if positive for the HER2 gene, makes trastuzumab available for the treatment of these patients.

A final agreement has however not yet been concluded. We reiterate our commitment to ensuring access to this life-saving medicine and we will continue to engage with the National Department of Health. Our proposal to the National Department of Health is on par with collaborative options adopted in low income countries such as India. We sincerely hope that we can reach a final agreement soon so that together we can ensure South African women benefit from this breast cancer treatment.

While price is certainly a factor, other enablers are necessary to ensure access to medicines, such as:

•    Awareness of the disease

•    Access to the services needed for diagnosis

•    Funding and

•    Treatment

Roche is working with a number of stakeholders, including patient groups, to ensure broad access for cancer patients and to find collaborative solutions to healthcare challenges.

We have met with the Fix the Patent Laws Alliance on more than one occasion over the past year, where we have shared with them the steps Roche has taken to achieve access to trastuzumab. We remain fully committed to working with patient groups, the National Department of Health and others to urgently reach a solution which improves the care and outcomes of women with HER2-positive breast cancer in South Africa. We believe that together we can do more for women suffering from breast cancer.

Roche holds patents on trastuzumab relating to specific technologies which were invented during its clinical development; these however do not intrinsically preclude trastuzumab biosimilars from entering the market. Roche will not necessarily oppose the entry of biosimilar versions of trastuzumab, provided that these medicines meet the appropriate regulatory standards as set out by the South African Medicines Regulatory Authority (Medicines Control Council). We do not believe that dropping patents will result in equitable access to trastuzumab, but rather we aim to improve access in a manner that delivers sustainable improvements to healthcare today while allowing us to continue to invest in new medical innovations. As a result, the discussion on patents is not relevant in the current context of increasing access to trastuzumab.

It is important to be aware that 'biosimilar' is a very specific regulatory classification used to describe a medicine that has been judged similar to a reference biotherapeutic in terms of its structure and how it works. The term biosimilar cannot be applied to all attempts to copy our medicines, rather it is a specific classification and the World Health Organization and regulators such as the Medicines Control Council, the U. S. Food and Drug Administration and the European Medicines Agency have outlined the evidence that needs to be in place to warrant it. Where Roche has taken legal action against companies and regulators introducing copies of our biotherapeutic medicines, we have done so because:

•    it was unclear whether or not the medicines met the strict standards set for biosimilars or

•    regulatory standards had not been adhered to or

•    companies had tried to pass off our data or information as their own.

We believe clarity is important for a number of reasons:

There is no room for uncertainty when it comes to cancer. People take our medicines because it offers them the opportunity to extend their lives or to cure them of disease. We have a duty to ensure that, if a company claims biosimilarity, that this really is the case.

Patients and physicians have a right to make informed treatment decisions. This can only be done if they have access to accurate information about medicines and clarity on whether or not they have met the requirements for biosimilars.

We remain committed to ensuring physicians and patients have access to the information they need to be able to make informed treatment decisions.














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Aadila Fakier

Public Policy, Communications and Market Access

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1    Trastuzumab is indicated for use in HER2-positive early and metastatic breast cancer in South Africa

2    Not all breast cancers are the same. HER2-positive breast cancer cells have more HER2 receptors (a particular protein found on the surface of cells) than normal breast cells. Having too many HER2 receptors may make the cancer cells grow and divide faster, creating more HER2-postive cancer cells. HER2- positive breast cancer is considered aggressive because it grows and spreads quickly.