NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Interesting summary of policies across Europe for timely access of ATMPs. Table 8 shows which approved therapies are reimbursed in each country. Sweden's TLV says due to high uncertainty more follow up is needed for Kymriah, Luxturna, Yescarta and Alofisel.

HTA; health technology assessment (HTA)

European HTA recommendations for ATMPs available as of June 2019.

Advanced Therapy Medicinal Products (ATMPs) include cell therapies, gene therapies, and tissue engineered products.

As of June 2019, 14 ATMPs have been granted marketing authorization in Europe (2): seven gene therapies, three cell therapies, and four tissue engineered products. Marketing authorizations for the first four approved ATMPs have been withdrawn by their sponsors for commercial reasons.

To date, Germany is the country with the highest number of ATMPs that are or were reimbursed, with a total of six, four of which are still on the market. NICE England recommended the reimbursement of five, all of them currently available to patients. Four ATMPs were recommended for reimbursement by HTA bodies in France, while in Italy three are reimbursed and currently available to patients. Only one product was reimbursed in Spain before its withdrawal and no ATMPs have been reimbursed in Sweden.

https://heatinformatics.com/posts/review-atmp-hta-reports

See the full report here: https://heatinformatics.com/sites/default/files/images-videosFileContent/ARM-Market-Access-Report-FINAL.pdf

Advanced therapy medicinal products (ATMPs) have the potential to offer life-changing solutions for patients with few or no alternative treatments. However, their complexity and relative novelty present challenges to ensuring these therapies reach those in need.

This report provides an overview of the characteristics and benefits of ATMPs, and the current regulatory market and access frameworks in six European countries: France, Germany, Italy, Spain, Sweden, and the United Kingdom. It also identifies hurdles to adoption and makes EU-wide policy recommendations to address those challenges.

The report brings together the views of a number of European policy makers and experts, ARM member organizations, and other stakeholder groups. The report was funded by the Alliance for Regenerative Medicine (ARM).