Neil Grubert: Dramatic differences in access to Advanced Therapy Medicinal Products (ATMP) across Europe

Neil Grubert, Independent Global Market Access Consultant, shared on LinkedIn:

“Dramatic differences in access to Advanced Therapy Medicinal Products (ATMPs) across Europe are highlighted in a new analysis based on data from 11 national pharmaceutical associations. The report is available exclusively to association members, but the Danish Association of the Pharmaceutical Industry (Lif) has published the top-line data on the number of cell and gene therapies that had full or restricted access in each of the markets under review as of 31st December 2023 (see accompanying chart).

The study covered 18 medicines: Abecma, Alofisel, Breyanzi, Carvykti, Ebvallo, Hemgenix, Holoclar, Imlygic, Kymriah, Libmeldy, Luxturna, Roctavian, Spherox, Strimvelis, Tecartus, Upstaza, Yescarta and Zolgensma.

Germany reimbursed by far the largest number of ATMPs—16 out of 18 drugs. The United Kingdom ranked second: eight treatments had full access and a further three restricted access. In all of the other countries included in the study, fewer than half of ATMPs had access. The Netherlands granted eight ATMPs full access, while Belgium gave three products full access and five restricted access. Greece had by far the lowest coverage of ATMPs among the 11 countries, with just one product granted full access and a second having restricted access. In Denmark, just two cell and gene therapies had full access and three restricted access. On average, the time from marketing authorisation to recommendation by the Danish Medicines Council was 807 days.

Camilla Lund-Cramer, Chief Consultant at Lif, said: “We are concerned that Denmark adopts an ambitious and national approach to treatment with advanced therapies. An ATMP can be seen as the ultimate personal medicine. ATMPs are a paradigm shift, as the treatment has a curative aim and can potentially replace the patient’s need for lifelong continuous treatment.”

Looking ahead, Lund-Cramer predicted: ‘Within a few years, EMA expects 10-20 ATMP applications per year. This emphasises that there is significant development in the area, which we must ensure that the Danish healthcare system is ready for. We have a strong professional foundation in Denmark and good health data. But development in the area is moving fast, so it is crucial that we act in a timely manner and get the healthcare system set up so that the adoption of new therapies can take place as efficiently as possible.’

Denmark is by no means the only market about which the industry has voiced concerns in relation to access. It will be interesting to see how policymakers and payers respond to the projected increase in the number of new ATMPs reaching the market in the years ahead.”

Source: Neil Grubert/LinkedIn