Spain: MOH reports on access to cancer drugs

The Ministry of Health (MOH, Ministerio de Sanidad) has published a report on the “evolution of funding and fixing of the price of oncology drugs in the SNS [sistema nacional de salud; national health service] (2016-2021)”. ?

According to the report, the financing of cancer drugs in Spain is “very high” with 90% of oncology drugs evaluated for financing subsequently approved for public funding.??

97% (151) of oncology medicines authorised at the EU level (156) are marketed in Spain: only five oncological active ingredients authorised at EU level are not registered in Spain (because the manufacturer has not yet requested authorisation in Spain). The report goes on to note that the “therapeutic arsenal for cancer treatment is higher” in Spain with an additional 46 oncology drugs authorised. As a result, as at March 2022 there are 197 oncological active ingredients authorised in Spain. Of these 197:?

• 81% (159 active ingredients) are funded in the SNS?
• 8% (16) are not funded?
• 11% (22) are being evaluated for funding.??

In 2021, 8 new active ingredients (15 presentations of oncology drugs) were granted funding along with a further 21 new indications of oncology drugs already funded in the SNS.??

In terms of timelines, according to the MOH:?

• The average time from European authorization to the manufacturer requesting marketing authorisation in Spain is 102.84 days.??
• The average time from the start of the financing and price study until the manufacturer submits the dossier with the first price proposal is 43.89 days. Companies make at least two pricing proposals, with 3-5 offers in each proposal.??
• The average time from submission of the first pricing proposal to a final decision from the Interministerial Commission on Medicines Prices (Comisión interministerial de precios de medicamentos, CIPM) is 269.25 days.??

In 2021, spending on oncology drugs (via hospitals and retail pharmacies) totalled €3,110 million, which corresponds to 17% of total public spending on medicines. At the hospital level, spending on cancer drugs in 2021 amounted to €2,898 million +18.3% compared to 2020.??

?Looking for more Pricing and Market Access Insight? Head over to our new library.