European hospitals look to cut the cost of cell therapies by 80%

Leading hospitals around Europe are increasingly working together to develop the capacity to produce cell therapies locally to accelerate treatment, improve quality and cut costs by as much as 80%. The trend presents a significant challenge for life sciences companies developing cell therapies.

The Clínic Barcelona in Spain is a pioneer in this field. Since July 2017, the hospital, along with four other centres, has treated 55 cancer patients in clinical trials. Researchers note two important clinical advantages to local production: (1) faster treatment (two weeks instead of four) and (2) avoidance of the cell damage associated with cryopreservation required for international transportation of patients’ cells. The Clínic Barcelona has recently applied to the Agencia Espa?ola de Medicamentos y Productos Sanitarios (Spanish Medicines and Health Products Agency) to treat patients outside of clinical trials by using hospital exemption, which would allow the healthcare system to reimburse the costs of treatment. The cost of therapy is reportedly just one fifth of commercial prices of approximately $300,000.

The University Hospital of Heidelberg has also established a production facility for CAR-T-cell therapies and is reportedly in close contact with the Barcelona team. Oncologists in Heidelberg hope to follow the Catalan example by applying to the Paul-Ehrlich-Institut for authorisation to produce CAR-T-cell therapies under hospital exemption. They have support from health insurance funds, medical societies and university clinics. “We are able to produce the cell therapies considerably cheaper,” says Carsten Müller-Tidow, Medical Director of the Department of Haematology, Oncology and Rheumatology in Heidelberg.

Italy’s Alleanza Contro il Cancro (ACC; Alliance against Cancer) has established a national network of 18 university hospitals to expand capacity and reduce the cost of producing CAR-T-cell therapies by standardising and automating processes. The ACC was created by the Italian Ministry of Health and has been awarded an initial two-year grant of €10 million. The Bambino Gesu? Hospital in Rome is one of the hospitals in the ACC network: it expects to be able to offer CAR-T-cell therapies for €50,000-60,000. Interestingly, the alliance would like pharmaceutical companies to join its initiative to widen access to CAR-T-cell therapy in Italy.

The Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung (SAKK; Swiss Association for Clinical Cancer Research) has received funding of CHF5 million to build a platform to connect university hospitals for the production of cell therapies. Aside from haematological cancers, the initiative will explore the potential of cell therapies for breast, colon, lung, ovarian and skin cancers. The SAKK believes it can cut costs from the current commercial rate of around CHF300,000 to CHF150,000-200,000. Santésuisse, the organisation that represents Swiss health insurers, has welcomed this venture and discussions regarding funding of the programme are reportedly being held with the Schweizer Bundesamt für Gesundheit (Federal Office of Health).

Implications for the pharmaceutical industry

Cell therapies are one of the most innovative and promising areas of pharmaceutical research, offering the prospect of significant therapeutic advances. However, their cost is a potential barrier to their use and has attracted widespread attention.

Interest in developing new cell therapies in major hospitals is evidently growing across Europe, boosted by support from government agencies, health insurers and medical charities. The research, particularly in more-challenging solid tumours, will help to advance understanding of the potential applications of this technology and drive medical progress. However, it is apparent that an important motive for these initiatives is cutting costs. A common perception is that commercial cell therapies are unaffordable.

In some instances, the objective seems to be to bypass the pharmaceutical companies, but initiatives such as the ACC in Italy seek collaboration with the industry. Faced with growing resistance to the cost of cell therapies, pharma needs to consider how to respond to the growth of hospital-based development of cell therapies.

Are you aware of similar hospital-based programmes in other countries in Europe (or beyond)? What impact will they have on the life sciences industry?