Region: EUROPE | Type: Policy | Keywords: #biosimilars #capf #drugevaluation #generics #hta #innovation #irp #newindications #pricesetting #referencepricing #therapeuticpositioningreports
- The Advisory Committee for the Financing of Pharmaceutical Provisions (CAPF) under the National Health Service (SNS) has put forth a series of proposals to address, in the medium term, the pricing and financing strategies of medicines in Spain
- The below plan for CAPF will be addressed over the next two years
- In no particular order, CAPF is focusing on promoting increased competition, revising the criteria for pricing and reimbursing new medicines and indications, improving Spain’s therapeutic positioning reports, and developing a dynamic evaluation system that considers not only new medicines but also those with a high degree of uncertainty
MADRID, Spain – The Advisory Committee for the Financing of Pharmaceutical Provisions (CAPF) under the National Health Service (SNS) supports the progress being made regarding public financing and the pricing of pharmaceuticals in Spain but believes the practices related to these issues need a boost.
As such, CAPF has put forth a series of proposals to address, in the medium term, the pricing and financing strategies of medicines, in line with practices in other advanced countries. The committee believes these measures should be adopted as they are of “the utmost importance” when it comes to the efficiency and sustainability of Spain’s health system.
The below plan for CAPF will be addressed over the next two years.
First, Spain needs qualified personnel to carry out a review of the pricing and financing of medicines, with consideration of technical recommendations. This will require a survey of technical resources in the country.
To promote increased price competition in Spain, CAPF is calling for a review of the current reference price system, specifically its strengths and weaknesses. There is a need for other analyses, including of auctioning, joint purchasing, centralized purchasing, transparency measures, and prescription by active ingredient, as well.
Spain should zero in on competition between active ingredients with similar therapeutic activity and find alternatives for the entry pricing of generics and biosimilars, with the aim of increasing competition in this area.
CAPF also considered price setting criteria and procedures for financing new medicines and indications. The committee is promoting analysis of price setting mechanisms, especially how incremental clinical benefit and incremental cost-effectiveness ratios are accounted for when it comes to therapeutic reports for new medicines or indications.
Likewise, this entails an analysis of the criteria for inclusion of the medicine in the SNS, as well as coverage of new indications. The analysis should extend to medicines granted conditional marketing authorization by the European Medicines Agency (EMA) and how to finance them.
CAPF will issue recommendations for medicines with a high degree of uncertainty, safety, and efficacy and, separately, suggestions for setting costs per QALY, which can be used for pricing and financing decisions. Going forward, there should be a way for medicines to be evaluated once more data become available.
With the review of pricing and financing decisions in mind, CAPF has also suggested improvements to therapeutic positioning reports. This would entail developing tools for the evaluation of incremental clinical benefit and cost-effectiveness ratios for a medicine’s indication(s) and budget impact, and how to incorporate efficiency in therapeutic positioning reports.
Lastly, CAPF wants to ensure the development of a dynamic evaluation system in Spain. For this to come into fruition, CAPF aims to produce guidelines for the monitoring of results from managed entry agreements (MEAs), define the criteria to evaluate the health outcomes of high-priced medicines, set criteria for the review of prices at launch and upon biosimilar or generic competition, review criteria for the pricing of new indications of a medicine, and assess the criteria for reviewing the pricing and reimbursement status of a medicine when new information of efficacy and cost-effectiveness arise.
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