Spain considers QALY thresholds, dynamic drug evaluation, managed entry and broader reference pricing of medicines

Pharmaceutical pricing and reimbursement in Spain could be transformed by measures such as the adoption of a QALY threshold, revised reimbursement criteria, new policies on managed entry agreements, broader reference pricing and dynamic evaluation of medicines throughout their life cycles. These and other policy options will be explored in 2020 and 2021 by the Comité Asesor para la Financiación de la Prestación Farmacéutica del Sistema Nacional de Salud (CAPF; Advisory Committee for the Funding of the Pharmaceutical Benefit of the National Health System).

The CAFPF was established in March 2019 to support the decision-making process of the Comisión Interministerial de Precios de los Medicamentos (CIPM; Interministerial Commission on the Pricing of Medicines) and to increase the sustainability an efficiency of pharmaceutical provision in the Sistema Nacional de Salud (SNS; National Health System). The committee has set itself four broad and ambitious objectives in its work plan for the next two years (see table below). Some of the policies under consideration would, if adopted, represent radical departures for the Spanish pricing and reimbursement system.

Promoting increased competition

Reference pricing has been the cornerstone of cost containment in Spain for many years. The Spanish reference pricing system is somewhat unusual (though by no means unique) in not restricting reference pricing to off-patent drugs. Reference pricing can be imposed after a drug has been marketed in any EU member state for at least 10 years and/or if it faces generic or biosimilar competition in Spain. The system is already more aggressive than the reference pricing systems used in many other countries, but the CAPF would like to make it more “efficient”—whatever that may mean. The mention of “competition between active substances with similar therapeutic activity” will be particularly disturbing for the industry, suggesting a potential move to broaden reference pricing from the molecule level (ATC 5) to the pharmacological class (ATC 4) or therapeutic class (ATC 3) level. Such a change would be especially challenging if patent-protected drugs were included alongside off-patent molecules in reference pricing group.

Some of the other measures to promote competition—auctions, joint purchasing, centralised purchasing and prescribing by international non-proprietary name—are already common practice in Spain, or at least in certain regions (e.g., auctions in Andalusia). It will be interesting to see what changes the CAPF might propose to these policies.

Pricing transparency has been a hot topic in many countries in recent months. As a prominent member of the Valletta Declaration Group, and a sponsor of the resolution on transparency adopted by the World Health Assembly in May 2019, Spain is a leading voice in this international campaign.

Revising the criteria and procedures for pricing and reimbursing new drugs and indications

The industry will be anxious at the possibility of radical changes to the way pricing and reimbursement decisions are made. The prospect of Spain including incremental clinical benefit and incremental cost-effectiveness ratios in therapeutic positioning reports—and adopting a QALY ceiling for pricing and reimbursement decision making—will be of particular concern to pharmaceutical companies.

Drug manufacturers will hope that the CAPF’s interest in pricing and reimbursement criteria and procedures for drugs that are subject to EMA conditional marketing authorisations, as well as drugs that are associated with a high degree of uncertainty at launch, will not portend a more hostile market access environment for such products in the future.

Improving therapeutic positioning reports

Informes de posicionamiento terapéutico (IPTs; therapeutic positioning reports) have become an important element of the HTA process in Spain in recent years. Critics argue that IPTs have contributed to the long delays in access to new medicines in Spain—a mean delay of 414 days (median 352 days), according to new data from IQVIA. A recent analysis found that IPTs were taking an average of 265 days to produce—nearly triple the time allowed.

The pharmaceutical industry also criticises IPTs for limiting the use of new drugs. More than half of all reports impose prescribing restrictions relative to the drugs’ marketing authorisations.

The CAPF is looking to develop new tools to strengthen IPTs. In particular, the committee would like to take a more systematic approach to the evaluation of incremental clinical benefit, incremental cost-effectiveness and budget impact.

Developing a dynamic drug evaluation system

Spain has long allowed price adjustments in response to price changes in the extensive basket of countries it includes in its external reference pricing. The CAPF would also like to explore opportunities for a more-dynamic approach to drug evaluation. Post-marketing data efficacy, safety, effectiveness and cost-effectiveness will form the basis for reviewing pricing and reimbursement terms. The CAPF is interested in tracking prices throughout a drug’s life cycle, including product maturity.

The mention of “denominados acuerdos innovadores de acceso al mercado” (“so-called innovative market access agreements”) is noteworthy. Spain was a relative latecomer to managed entry. Historically, much of the activity was at the regional or local level (especially in Catalonia, Andalusia and the Balearic Islands). More recently, however, companies have begun to strike deals at the national level. In 2019, the Ministry of Health launched Valor Terapéutico en la Práctica Clínica Real de los Medicamentos de Alto Impacto Sanitario y Económico en el SNS (VALTERMED; Therapeutic Value in the Real-World Use in the NHS of Drugs With a High Clinical or Economic Impact), an online registry system for the collection of real-world data to tackle uncertainty associated with new drugs. In the future, the system will be expanded to incorporate other SNS data sources and patient-reported outcomes measures. The system will initially be used to measure outcomes for seven new outcomes-based agreements.

Implications for the pharmaceutical industry

The CAPF will spend two years on this review, suggesting that the exercise will be exhaustive in scope and the reforms could be profound. The work will coincide with a likely economic crisis resulting from the COVID-19 pandemic.

In the economic crisis that began in 2008, the Spanish government was forced to adopt aggressive cost-containment measures, many of which remain in effect to this day. As a result, outpatient pharmaceutical expenditure in Spain declined from a peak of €12.5 billion in 2009 to €9.2 billion in 2013, a decline of 22% in four years. A decade later, the market has yet to recover fully. The industry will be concerned that history could repeat itself if the CAPF’s review of pricing and reimbursement makes the Spanish market access environment more challenging in the next decade.

I have recently updated coverage of Spain and other major European markets in my multi-client training programme on market access environments. Please get in touch if you would like to know more about this flexible programme.