Brexit could hinder CAR-T reimbursement in Europe

1 February 2019

The UK NHS, NICE and the government have joined forces to make CAR-T therapies available to patients, working closely with manufacturers of approved therapies, Gilead and Novartis. However, there were concerns raised about how Brexit will affect matters across Europe at Kisaco Research’s CAR-T Congress EU, as NICE is already losing its influence as the UK prepares to leave Europe.

Fiona Thistlethwaite, medical oncology consultant at Christie NHS trust, mentioned the issue, referred to as “the B-word”, during a panel debate in the conference in London. She expressed fears that Brexit may hinder discussions across Europe on pricing, an area where NICE has traditionally been highly influential.

In addition to the concerns of Brexit, the rise in nationalism in Europe is also source of anxiety for the industry. Anna Prokupkova, policy and project officer at the Association of European Cancer Leagues, argued that this is preventing use of any pan-European health technology assessment (HTA) that could be used to make CAR-Ts more accessible in countries in Eastern Europe.

Currently, only the UK, Germany, France have reimbursed CAR-Ts in the EU, and Switzerland has separately decided to reimburse CAR-Ts too, leaving Eastern European members out in the cold. Prokupkova highlighted the need for joined-up HTA process across the EU to improve market access.

Until now, efforts to introduce pan-European HTA have been handled by EUnetHTA, a pan-European network that already produced assessments for conventional drugs. However, the system is not mandatory and thus pricing decisions are taken individually by member states, with both Germany and France having their own HTA systems in place. EUnetHTA is only in place until 2020 anyway, leaving the HTA and pricing landscape unclear.

Proposals for European HTA that are currently doing the rounds in Brussels could be dropped following a round of European Parliament elections. However, Prokupkova remains optimistic. “We are hopeful that the next commission will not withdraw the proposal,” she told the conference.

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