Availability of pharmacological treatments for multiple myeloma in Spain

The treatment of multiple myeloma (MM) has changed substantially in the last two decades due to many therapeutic innovations. This study aims to analyse the authorization trends of drug regimens for the treatment of MM in Spain and evaluate their availability within the Spanish National Health System (NHS).

Drug regimens authorized in the European Union (EU) and/or in Spain for MM treatment between April 2004 and November 2024 were identified through regulatory agencies' websites. Authorization trends were analysed by number of components, line of treatment and approval frequency. Reimbursement information was extracted from the Spanish Ministry of Health website.

A total of 48 drug regimens were authorized for MM treatment in the EU and/or in Spain. Of these, 25% were monotherapies, 25% doublets, 40% triplets, and 6% quadruplets. One-third were indicated for the first line of treatment and two-thirds for the relapsed/refractory disease. Approvals increased from six in 2004-2009 to 18 in 2020-2024. Notably, 86% of authorizations in 2004-2014 were standard, while 53% were conditional in 2015-2024. All drug regimens authorized in 2004-2014 were reimbursed, compared to 22 out of 36 (61%) in 2015-2024. The average time to first reimbursement decision was 449 days.

MM drug regimens approved in the EU and Spain have increased from 2004 to 2024, with a shift towards combinations, conditional authorizations and a more selective reimbursement in recent years. Most authorized treatments are available in the Spanish NHS, though the reimbursement rate has decreased in the last decade.