Significant changes are on the horizon for Spain’s healthcare sector, encompassing funding trends and regulatory updates. Find out how pharmaceutical funding decisions are changing, the recent patterns in funding approvals, and what proactive steps manufacturers can take to navigate these shifts effectively.
In the near term, the access of medicines and health products in Spain may witness notable shifts, marked by evolving funding trends and regulatory changes. This article aims to explore emerging funding patterns and ongoing updates to policies in Spain impacting drug evaluation and funding.
How have funding trends for drugs evolved in recent years?
At Simon-Kucher, we have studied and analyzed national funding resolutions for new innovative drugs entering the market and existing drugs expanding therapeutic indications. Our research looks at the pricing and reimbursement (P&R) conditions accompanying these funding approvals, such as access restrictions, cost-containment measures, and negotiated managed entry agreements (MEA). Key observations are outlined below:
Increasing positive funding decisions through extended timings
Out of the total number of funding resolutions issued between January and December 2023 (193), 58 percent (111) received a positive funding resolution, while 42 percent (82) were negative. This represents a noticeable increase in the rate of positive funding decisions compared to 2022 and 2021, where only 45 percent (114) and 44 percent (82) decisions had a positive outcome.
In 2023, nearly half of all positive decisions were made in the first Comisión Interministerial de Precios de los Medicamentos (CIPM) meeting, the decision-making body for P&R at national level in Spain, down from 62 percent in 2022. For positive funding outcomes requiring multiple CIPM sessions, the median time to funding after an initial rejection averaged 224 days vs. 120 days in 2022 and 111 days in 2021.
Recurring use of cost-containment measures
The rationalization of the public expenditure and budgetary impact continues to be a key criterion for pharmaceutical funding. In that regard, cost containment measures have once again been widely implemented this past year. As seen in 2022 and 2021, 100 percent of the positive agreements have at least one of these conditions in place. Among them, the most common are still the "annual review of sales and prices", which again apply to 94 percent (104) of the positive decisions.
Additionally, the implementation of funding restrictions beyond the EMA-authorized therapeutic indication continues to be common in 2023. Their use has remained generally stable for hospital products vs. previous years, with 40 percent (37) of positive funding decisions being subject to this type of condition.
Preference for financial vs. outcome-based agreements
During 2023, 18 percent (20) of all positive funding decisions were subject to some type of MEA. A notable trend toward the implementation of purely financial agreements was observed, with 14 (70 percent) budget caps and 3 (15 percent) caps per patient negotiated, compared to a single price-volume agreement and two outcome-based agreements. This shows that MEAs are key for products with a high budgetary impact or those that generate clinical or budgetary uncertainty, like advanced therapies.
And now, where is the Spanish healthcare system heading?
Numerous regulatory initiatives are underway to optimize drug evaluation and P&R processes in the Spanish National Healthcare System (NHS). These developments are being closely monitored through press releases and interviews with key decision makers. However, significant uncertainty remains around the final content of these new legislations, with no official proposals yet published.
End of REvalMed and updated Health Technology Assessment process
The National Court’s annulment of REvalMed (entity formerly responsible for preparing Therapeutic Positioning Reports (IPT) for drugs) has prompted key stakeholders within the Ministry of Health (MoH) to seek a new evaluation system to address the limitations of the current process.
With that purpose, the development of a new Spanish Royal Decree regulating the Health Technology Assessment (HTA) has emerged as a solution to meet the evaluation needs of the healthcare system through a different working model.
It seems the new regulation is expected to establish a process consisting of three clearly defined consecutive steps: evaluation, therapeutic positioning, and P&R decision-making. The main goal of the reform is to ensure objectivity of the process and to grant transparency to all relevant stakeholders, with clear responsibilities and competencies assigned to each level:
Evaluation:
In the short term, the EU Joint Clinical Assessment (JCA) is expected to serve as the foundation for the evaluation of innovative products in Spain, for oncology and Advanced Therapy Medicinal Products (ATMPs). For any other therapy, a local IPT assessment will likely still be developed by the Spanish Agency of Medicines and Medical Devices (AEMPS). The evaluation process will likely be consolidated when JCA development is extended to all European products.
The Advisory Committee for the Funding of Pharmaceutical Products in the National Health System (CAPF) has developed formal guidelines for the economic assessment, which are expected to set the basis of the new Royal Decree on HTA. Though the responsible body is yet to be defined, it is expected to fall within the competencies of the AEMPS and possibly supported by an external expert network.
Therapeutic positioning:
Placement of new products within the therapeutic strategy or disease landscape is expected to be determined based on social, ethical, clinical, and pharmacoeconomic parameters, among others. Even if the responsible commission and its competencies are yet to be determined, participation of diverse stakeholders (healthcare professionals, patient associations, autonomous communities, etc.) is anticipated.
P&R decision-making:
The CIPM is expected to remain the main decision-making body, issuing final P&R resolutions based on the prior evaluation and therapeutic positioning granted by the corresponding commissions, yet to be determined. No changes to that positioning should be expected by CIPM while issuing the P&R resolution.
- Royal Decree on pricing and funding of medicines and health products
- Include new health products in the NHS pharmaceutical provision, revise the pricing of existing products, and exclude those in the NHS provision that are not currently marketed.
- Establish a price setting system for health products similar to that of pharmaceutical drugs, with corresponding margins for distribution and retail pharmacy purchasing.
- Law on guarantees and rational use of medicines and medical devices
- Modification of the reference pricing system: The current system leads to rapid price reductions, followed by stagnation, creating disparities with other European countries. Therefore, the priority is to introduce greater flexibility into the system for promoting innovation and effective competition between generics and originator molecules.
- Extension of the sixth additional provision to hospital medicines: This provision, understood as the annual volume that the pharmaceutical industry must contribute based on its annual sales to the NHS, is currently capped at 2 percent of annual sales at the hospital level.
What impact could the upcoming regulatory reforms have on the P&R observations?
The Spanish healthcare system is anticipated to undergo important updates aiming to reshape and optimize various aspects of its current functioning. While these changes could hold the potential to accelerate funding timelines or enhance efficiency in the P&R process, their overall impact is uncertain. Definite conclusions on the true implications of these planned reforms can only be drawn once the formal proposals are published.
Ongoing monitoring is critical for adapting to the evolving landscape and optimizing drug access within the new Spanish framework. However, manufacturers can be proactive and leverage opportunities presented by these systemic changes. For example:
- Conduct early mapping of key stakeholders to navigate the new landscape:
- Understand stakeholder priorities and key decision-drivers in each phase of the new process
- Identify potential uncertainties or concerns ahead of launch, both clinical and economic
- Prepare possible mitigation strategies or objection handling to address these concerns
- Ensure all evidence aligns with the new landscape, including a P&R dossier for product evaluation according to the most updated guidelines and criteria and an economic model in accordance with the CAPF guidelines, or
- Define a clear and strong negotiation route with thoroughly evaluated steps and trade-off assessments.
Reach out to our industry experts for more information.
Thanks to contributions by Elena Aldareguia and Hugo Olazabal!
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