Opposition to Kymriah® patent

The next generation of gene therapies used for treating cancer are now available on the market – with the first two CAR-T cell therapies priced at 320,000 and 350,000 euros. As was the case with hepatitis C drugs, these exorbitant prices reveal yet again the extent of the financialisation of the pharmaceutical market that puts profit ahead of medical treatment. Seeking to condemn the abuses associated with these prices, enable governments to negotiate lower prices or organise the use of similar treatments and ensure universal access to optimum medical care in sustainable health systems, Médecins du Monde – Doctors of the World (MdM) and Public Eye, have decided to oppose the patent of one of these two anti-cancer therapies, Novartis' Kymriah®.


treatments for blood cancers

In August 2018, two CAR-T therapies received marketing authorisation for Europe – Novartis’ Kymriah® (tisagenlecleucel) and Gilead Sciences’ Yescarta® (axicabtagene ciloleucel)1. Used to treat blood cancers by genetically modifying patients’ T-lymphocyte cells to recognise and attack cancer cells, these gene therapies bring significant hope to cancer sufferers, their families and health professionals. Indeed, for patients with particular life-threatening lymphomas, available clinical studies show estimated one-year survival rates are 40% for Kymriah® and 60% for Yescarta®.

But, at 320,000 or 350,000 euros per patient, the price of hope and highly personalised approach offered by this innovative medical technology is exorbitant.

Such prices can be justified neither by costs of production, nor investments in research and development, as these are largely supported by US and European public funds. As the World Health Organization noted in a recent report on the cost of cancer drugs, they appear to reflect solely the commercial interests of the pharmaceutical industry.

How much longer is it going to take the government to review the criteria regarding access to anti-cancer drugs?

"In 2014, the price of sofosbuvir, a drug used to treat hepatitis C that cost 41,000 euros per patient, forced countries to ration access for a certain number of patients," recalls Philippe de Botton, President of Médecins du Monde. "As for the price of new anti-cancer drugs, and in particular CAR-T therapies, they take the price issue to a whole new level. How much longer is it going to take the government to review the criteria regarding access to anti-cancer drugs?"


Denounce excessive prices reducing access to care

Currently used to treat rare and very specific types of cancer, CAR-T therapies are undergoing clinical trials for a range of other indications. In the future, health systems may adopt this therapeutic approach more widely. However, at these price levels, they won’t be able to ensure universal access to optimum medical care without compromising their financial viability.

MdM has decided to denounce these extortionate prices by opposing the patent of one of these therapies, Kymriah®. Patents protecting these therapies prevent competition, which also allows companies to set exorbitant prices. By accepting these monopolies, countries agree to high prices without ever calling them into question.


“CAR-T therapy patents include modified cells from actual patients, and it’s these cells that are being sold at a cost of over 300,000 euros", comments Olivier Maguet, head of the Drug Prices and Health System Mission at MdM, "It’s legitimate to query the status of CAR-T therapy. Is it a drug? A medical procedure? The implications in terms of patents, the rights of companies and governments regarding production of the drug, and therefore its price, are considerable. These are some of the issues we want to bring to the public debate."

By opposing the patent, MdM and Public Eye are seeking to alert governments and civil society to the prices of these drugs and the threat they pose, now and in the future, to access to medical treatment – an initiative already undertaken on two previous occasions when the organisation opposed sofosbuvir’s patent.

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