OBJECTIVES:

Chimeric Antigen Receptor-T (CAR-T) cells are biological agents that attack cancer cell antigens, specifically in patients with relapsed/refractory (R/R) B-cell malignancies. We aim to examine time to approval in four Nordic countries, after European Medicines Agency (EMA) market authorization.

METHODS:

CAR-T therapies authorized by the EMA until January 1, 2023, were identified using European Public Assessment Reports (EPARs). Approval dates were identified from published reports of the health agencies in four Nordic countries: Danish Medicines Council, Council for Choices in Health Care (Finland), Norwegian Medicines Agency and NT Council/Dental and Pharmaceutical Benefits Agency (Sweden). Time to approval, after EMA authorization, was estimated for each country.

RESULTS:

To date, six CAR-T therapies (Kymriah®, Yescarta®, Tecartus®, Abecma®, Breyanzi®, Carvykti®) have received EMA marketing authorization across different indications. Abecma®, Carvykti® and Tecartus® received a conditional marketing authorization.

Kymriah® was approved in Norway (116 days), Denmark (160 days), Finland (202 days), and Sweden (267 days) for R/R acute lymphoblastic leukemia. Kymriah® was not approved for adult R/R diffuse large B-cell lymphoma (DLBCL) as it was not deemed to be cost-effective.

Yescarta® was approved in Sweden (379 days), Finland (476 days) and Norway (1517 days) for adult patients with R/R DLBCL and primary B-cell lymphoma, but not in Denmark.

Tecartus® (indicated for mantle cell lymphoma) was approved in Finland and Sweden after 366 and 710 days respectively, and not yet in other countries.

Assessments of Abecma® and Carvykti® (indicated for R/R multiple myeloma) are either ongoing or no information was provided. In Sweden, negotiations for approval of Abecma® and Breyanzi® are currently paused due to limited manufacturing capacity.

CONCLUSIONS: Despite EMA authorization, there is considerable time (range 116-1517 days) for CAR-T therapy approval decisions with conflicting outcomes (approval vs. rejection), which may result in barriers to patient access and unequal provision of treatment options across the Nordic region.