Around The World in HTAs: France – Three Core HTA Values

The health system in France

France has a mixed-type health system. Primarily based on social health insurance, it also incorporates elements of a national health system to ensure universality and solidarity in achieving national health goals under a single public payer. The Ministry of Health (MoH) plays a central role in implementing health policies within the framework of the Public Health Act, while the planning and financing of healthcare resources are shared mainly between the MoH, national insurance bodies, and regional health agencies.

Under the national health insurance, citizens receive universal coverage under the same “benefit basket”, which includes a wide range of explicitly listed medical services and goods. Approximately 85% of health expenditure is covered under public resources, with additional services such as certain medicines and medical devices, subject to out-of-pocket payments and/or supplementary insurance. 

As a country that spends a significant proportion of its national income on healthcare (around 12% of GDP) and prescription medicines (public coverage of more than 80% of pharmaceutical costs), France offers high accessibility to pharmaceutical and health innovation. Recent reforms, such as the 100% santé reform, aim to further enhance patient access by gradually expanding public coverage for additional services. 

A roadmap for new technologies

For a health technology to be reimbursed under national health insurance, it must first obtain marketing authorisation, undergo health technology assessment (HTA), and be included on the positive reimbursement list. HTA is conducted nationally, with some elements increasingly assessed collaboratively under the European HTA regulation (HTAR). 

The Haute Autorité de Santé (HAS) is responsible for the technology assessment, with its opinions informing reimbursement and pricing decisions. In most cases, reimbursement decisions are overseen by the MoH, while pricing is negotiated separately through discussions involving the MoH, the Economic Committee for Health Products (CEPS), insurance bodies, and the manufacturer.

Depending on the type of health technology, the HAS committee involved, the assessment criteria applied and the reimbursement pathway used will vary.

Assessment of medicines

Pharmaceuticals are evaluated by HAS’ Transparency Committee (TC), which assesses two core criteria: clinical added value (amélioration du service médical rendu, ASMR) and clinical benefit (service médical rendu, SMR). These criteria are classified into distinct categories, with ASMR being assessed relative to existing treatment alternatives.

SMR focuses on the drug’s role within the care pathway, its public health impact, and its therapeutic function (preventative, curative, or symptomatic). ASMR reflects improvements in efficacy, safety, and quality of life (QoL). Additionally, ASMR considers the magnitude of clinical impact on mortality and morbidity, the degree of unmet medical needs, disease severity, and the level of innovation. 

Randomised controlled trials (RCTs) with direct comparators are prioritised as evidence for HAS assessment of medicines where feasible. Observational studies may be accepted as complementary, but not as substitutes.  

While economic evaluation is not required for reimbursement in France, since 2013, HAS has mandated economic evaluations (cost-effectiveness analysis) for products

1. Claiming major, important or moderate ASMR (I to III) and
2. Meeting at least one of the following criteria:
   • Projected annual sales reach or exceed €20 million (including VAT); or
   • The manufacturer claims innovative status with an impact on the organisation of care, professional practices, or patient care conditions; or
   • The product is an advanced therapy medicinal product (AMTP).  

Following economic evaluation, reimbursement decisions for innovative medicines are based on SMR. Currently, economic evaluations are used in the process of price negotiation, involving the bodies of the MoH and care access, and manufacturers. The main public body involved in the process of price negotiation is the CEPS.  In addition to the assessment of economic evaluation performed by HAS, price negotiations consider the level of demonstrated ASMR, expected sales (i.e., budget impact), prices in other European countries, supply security considerations, and the need to maintain sustainable overall pharmaceutical expenditure. Currently, HAS does not define a formal cost-effectiveness threshold to inform pricing decisions. This has led to ongoing debate about whether introducing such a threshold could support a more consistent use of economic evaluations and value assessment within French HTA, as discussed by Ghabri., (2024).

In addition to the standard reimbursement pathway, manufacturers may apply to the Early Access Authorisation(Autorisation d’Acces Précoce, AAP) programme, managed by HAS, which allows access to promising therapies up to two years before market authorisation. Eligibility requires that efficacy and safety could be strongly presumed based on trial results, and four further conditions: (i) the disease is serious, rare, or disabling; (ii) no appropriate alternative exists; (iii) treatment cannot be deferred; and (iv) the product can be considered innovative, addressing an unmet medical need.

Assessment of medical devices

Medical devices are assessed by HAS’s National Committee for the Evaluation of Medical Devices (CNEDiMTS), which reviews clinical benefit, while the Economic and Public Health Evaluation Committee (CEESP) performs economic evaluations. Technologies considered of diagnostic, prognostic and predictive nature are evaluated by the Diagnostic, Prognostic and Predictive Health Technologies Evaluation Committee (CEDiag) and/or CNEDiMTS.

For more details on HAS assessment processes, please consult the Transparency Committee doctrine, the Methods for Economic Evaluation, and the Assessment Guide for Early Access, the Assessment Principles of Medical Devices.

Current challenges of HTA

Two decades after its establishment, HAS continues its mission to ensure the quality, sustainability, and efficiency of the French healthcare system. However, several emerging challenges may place pressure on these core principles.  

Defining ‘true’ innovation. With an increasing number of therapies seeking innovative status, assessments are complicated by the absence of a shared definition of ‘innovation’, despite the existence of evaluation criteria. Balancing rapid access with patient safety and the ethical implications of novel therapies remains essential.

Managing uncertainty. In recent years, HAS has expanded and adapted its reimbursement procedures, reflecting France’s commitment to incentivising innovation. Submissions through the AAP pathway have increased. However, expedited access often relies on preliminary, non-comparative trials with short follow-up periods and limited long-term outcomes. Such early evidence can generate considerable uncertainty in assessing clinical benefits and in subsequent economic evaluations. Developing robust strategies to address this uncertainty is therefore crucial, particularly for supporting price negotiations within budget constraints.

Adapting to the European HTA regulation (HTAR). The introduction of a common clinical effectiveness assessment at the European level is expected to bring several benefits through the Joint Clinical Assessment (JCA). These include reducing duplication of national HTA efforts, generating high-quality and timely scientific reports, and accelerating patient access to novel therapies. As a leading agency in Europe with distinct evaluation criteria, HAS may face additional complexity and will likely need to adjust its processes and provide a new basis for its opinions to align with HTAR. The full impact of these changes remains to be seen. Nevertheless, value-added assessment and reimbursement decisions will continue to be determined at the national level.

Next steps for the French HTA

With rising innovation costs and increasing complexity of health technologies, France’s HTA approach is at a crossroads. This has prompted a re-evaluation of how value-for-money is defined and how uncertainty is managed. In its 2025-2030 strategic plan, HAS highlights the need to redefine principles for assessing cost-effectiveness, alongside revisions to HTA methodologies and strengthening approaches to uncertainty management to ensure more robust and transparent evaluations. Collectively, these reforms can reinforce and increase the use of economic evaluations as a key input into price negotiations for pharmaceuticals and medical devices, supporting more value-based and sustainable pricing decisions.

Since the enactment of the Social Security Financing Act (2012), the remit of economic evaluation in both health and public health decision-making at HAS has steadily expanded. The recent Cooperation Charter signed between HAS and the Agency for Health Innovation (AIS) marks a strategic alignment between HTA and improving access to innovative health technologies, within the French Health Innovation Plan 2023.

Emerging proposals include new methodological guidance on the use of alternative evidence to RCTs and indirect comparisons for demonstrating ASMR. As part of its roadmap, HAS will also support AIS in prospective monitoring of high-impact health innovations, taking into account system-wide budgetary implications. The Charter’s emphasis on prevention and innovation reflects a growing role for economic evaluation and a renewed focus on health system efficiency.

As France expands the role of economic evaluation in HTA, its mature system faces the ongoing challenge of balancing clinical benefit assessment with affordability, timely access, and evidentiary uncertainty, while adapting to greater European harmonisation efforts. How HAS reconciles national decision-making autonomy with JCA, clarifies expectations around innovation and value-for-money, and preserves its core principles of scientific rigour, independence, and transparency will be critical in supporting the sustainability of the French HTA framework in the years ahead.