What will the impact be of the Therapeutic Positioning Report Policy Changes in Spain?
We take a closer look.
Historically, Spain has had one of the longest and most complicated reimbursement processes in Europe. This was seen to be due to its lengthy process in developing Therapeutic Positioning Reports (IPTs) and a lack of transparency in evaluation criteria. To counteract these claims, Spain is planning to reform its IPT process in 2021.
What Drove Spain to Change their IPT process?
IPTs, introduced in 2013, were initially expected to take 3 months for the Spanish Agency of Medicines & Health Products (AEMPS) research and analysis. However, in recent years AEMPS analysis has been taking over 9 months, plus additional time for evaluation by the autonomous communities (CCAAs) [1].
This delay has elongated the time from the European Medicines Agency’s (EMA) approval to the drug being reimbursed to 2-3 years, which is over 3 times longer than in France, as well as taking longer than many other EU countries [2]. This has resulted in more than 33,000 requests for compassionate use of medicine per year. In addition, there is currently no formal criteria for linking price to therapeutic value in Spain; although the law requires cost-effectiveness analysis to be considered, it does not dictate how it should be applied [3].
3 major changes are going to be made in 2021 to streamline the IPT process:
A new pharmaceutical evaluation network called REvalMed-SNS has been set up, to co-ordinate the IPT process. REvalMed-SNS comprises teams from General Directorate of Common Portfolio of Services of the National Health and Pharmacy System (DGCYF), AEMPS, and the CCAAs [4].
Improvement of methodology of IPTS, including development of a scoring system to prioritize reports to reduce timings.
Finally, incorporation of economic evaluation in IPTs, and a proposed cost-effectiveness threshold.
IPT Timeline
REvalMEd-SNS & IPT Timeline
REvalMed-SNS will be responsible for prioritizing IPTs based on key criteria and incorporating economic evaluations measuring cost-effectiveness. The prioritization list will then be approved by the Comisión Permanente de Farmacia (CPF).
The therapeutic evaluation will primarily be led by AEMPS and the pharmaco-economic evaluation will be led by the DGCYF, both with input from the CCAAs. 7 evaluation nodes provide expert reviewers from 7 distinct therapeutic areas and will rely on the co-ordination and leadership of 2 different CCAAs on a rotating basis, every 2 years.
Through the incorporation of these teams and evaluations working in parallel, REvalMed-SNS will reduce the IPT process to a targeted 90-95 working days. The process will consist of 12 steps which are outlined in the timeline below [5].
A pilot study with at least 1 drug per therapeutic area is being conducted in 2021 to test the feasibility of the process, before it is adopted.
Prioritization of IPT reports
A scorecard system has been developed where the drug under assessment will be scored according to the prioritization criteria, which includes therapeutic positioning, safety profile and indication expansions. The order of assessment will then prioritize those with the highest scores, and in the case of a draw, by the date of commercialization [6]..
IPT Prioritization Criteria
Incorporation of Cost-Effectiveness Evaluation
DGCYF will manage the pharmacoeconomic evaluation process; however, the guidelines will be developed by GENESIS (Groupo de Evaluación de Novedades), part of the SEFH (Hospital Pharmacy Committees). Manufacturers will be required to provide data for both their own drug and comparators on the following: acquisition price, dosing, cost per day or cycle, cost of full treatment or per year, associated direct costs, total cost or total cost per treatment year, and incremental cost differential [4].
This data will allow for cost-minimization analysis, cost-effectiveness analysis, long-term health costs and outcomes evaluation, and budget impact analysis at both a national and regional level.
GENESIS will eventually propose a cost-effectiveness threshold to be applied in the reports, which is currently to be determined. The therapeutic positioning criteria will be defined by both the incremental cost-effectiveness ratio (ICER) and budget impact.
In addition, proposed development of an independent authority called HispaNICE is currently under debate for the evaluation of cost-effectiveness in terms of health and social outcomes. The goal would be to add transparency to the relationship between health outcomes and pricing, institutionalize cost-effectiveness, and ensure the same level of development in all autonomous communities. If this project were to go ahead, Spain plan to use financing from the European Next Generation Project [7].
What Does the Future Look Like?
Not only will this new process shorten and streamline time to access at a national level, but it could also streamline local drug evaluations. Parallel therapeutic evaluation of national and regional committees is the step needed to minimize differentiation in reimbursement decisions and guidelines and centralize Spain’s HTA process.
In addition to greater economic data provided by manufacturers, the more robust IPTs will be structured in relation to current therapeutic alternatives. There will be a stronger emphasis on collecting secondary sources of evidence to be more scrupulous of manufacturer’s claims. Spain will also be more likely to investigate benefit in subpopulations, restricting the drug to those who would benefit most.
The introduction of a cost-effectiveness analysis could move Spain from a traditional budget impact archetype on the spectrum towards a health-economic archetype. This may provide further hurdles for manufacturers to prove their drug worthwhile of reimbursement; however, should provide greater and more equal opportunities for patients across regions to access innovative drugs in a timely manner.
Authored by Georgina Powell.
Get in touch to learn more, or discuss how we can help you.
Matt Storer, Managing Partner, Head of Europe matt.storer@windrosecg.com
Georgina Powell, Analyst Georgina.powell@windrosecg.com
Sources:
elmedicointeractivo.com
sciencedirect.com
sciencedirect.com
mscbs.gob.es
diariofarma.com
elglobal.es
elglobal.es