MOHs and HAs are shifting their views. We need to be nimble, strategically conditional, and up to date with the patients’ needs. The EU- HAs and FDA are definitely coming around. Read below:
The pharmaceutical industry has enthusiastically welcomed new plans by the French government to improve the market access environment and boost the life sciences sector in France. The wide-ranging reforms include policies to slash market access delays, accelerate patient access to drugs that are being developed for new indications, extend opportunities for medicines to undergo health economic evaluation, increase pharmaceutical expenditure (especially on innovative medicines) and replace the current system for drug evaluation with a new measure of valeur thérapeutique relative (VTR; relative therapeutic value).
The reform plans were announced by Edouard Philippe, the French Prime Minister, at the eighth Conseil stratégique des industries de santé (CSIS; Strategic Council for the Healthcare Industries), held in Paris on 10th July 2018. Several other government ministers, along with 30 heads of global pharmaceutical companies, were present at the event. Les entreprises du médicament (Leem; Pharmaceutical Companies), the association that represents the French pharmaceutical industry, hailed the meeting as “a turning point in the process of dialogue between the French state and pharmaceutical companies,” an event that was “unlike its predecessors both in terms of content and method.”
The government’s strategy for the French life sciences industry includes plans to boost investment in R&D, support pharmaceutical innovation and establish a Health Data Hub, one of the largest health databases in the world. However, the proposed changes to the country’s market access environment are among the most interesting reforms unveiled by the Prime Minister.
Faster market access
At present, delays between the marketing authorisation of a new medicine and the publication of its price in the Journal Officiel (Official Journal) average 530 days, ranking France 18th in the EU in terms of speed of market access. Such long delays are in contravention of the 180-day limit stipulated in the Transparency Directive 89/105/EEC, the EU legislation that defines the regulatory framework for national pharmaceutical pricing and reimbursement systems. However, the government has now pledged to meet the 180-day deadline by 2022. To that end, the government will recruit six additional employees for the Comité Economique des Produits de Santé (CEPS; Economic Committee for Healthcare Products). In addition, the negotiation process between manufacturers and the CEPS will be improved by means of the following procedural changes:
- Within two weeks of a decision by the Commission de la Transparence (CT; Transparency Committee), notes of economic interest addressed by manufacturers to the CEPS will be systematically updated.
- The delay between submission of a pricing dossier by a manufacturer and the CEPS’s initial response will not exceed one month.
- A recent trial for fast-track processing of drugs with an amélioration du service médical rendu (ASMR; improvement in medical benefit) rating of V will be adopted as permanent practice.
Expansion of the system of temporary authorisations for use France prides itself on its system of autorisations temporaires d’utilisation (ATUs; temporary authorisations for use), which facilitates early access to treatments for serious or rare diseases for which no appropriate registered therapy is available and for which there is an urgent medical need. The benefit-risk balance of these drugs is presumed to be positive. ATU medicines are fully reimbursed, and manufacturers may be able to take advantage of the fact that these drugs are monopoly treatments for serious or rare diseases to set prices at a relatively high level.
At present, only new medicines are eligible for ATUs. In the future, however, it will be possible to apply for an ATU for new indications of a drug that is already in use. The government believes that this change will be particularly beneficial in the field of oncology, where the growth of immunotherapies is transforming clinical practice.
Increased use of health economic evaluation
Since October 2013, the French government requires new medicines to undergo health economic evaluation if they meet both of the following conditions:
- The manufacturer proposes an ASMR rating of I-III.
- The drug is expected to have a significant impact on social security spending (i.e., annual expenditure of ≥ €20 million after two years on the market), healthcare providers' professional practices or patient care.
health economic data to support reimbursement applications for drugs that have lower projected budget impact. However, health economic evaluation will not be mandatory for drugs below the budget impact threshold. Adjustments to pharmaceutical expenditure growth limits
The French government sets an annual cap on pharmaceutical expenditure growth, known as the Taux L (L rate). In 2018, the cap is set at 0% for outpatient medicines and 3% for inpatient drugs. Beginning in 2019, however, the government intends to simplify the method for calculating any refunds that individual companies have to make, based on their sales.
For each of the next three years, overall pharmaceutical expenditure will be permitted to grow by a minimum of 0.5% (equivalent to 1% of reimbursed expenditure). Spending on innovative drugs will be permitted to increase by at least 3% per year. These changes are intended to ensure that French patients have ready access to the latest therapies.
Changes to the evaluation of medicines
In the course of summer 2018, the government will adjust the way the CEPS negotiates with drug manufacturers. In particular, there are plans to change the methodology for setting the prices of drugs that have an ASMR rating of IV (i.e., minor improvement in medical benefit): it will no longer be obligatory to use the lowest-priced therapy as the comparator.
More radically, the government is exploring the possibility of replacing the long-standing dual system of drug evaluation—based on a product’s service médical rendu (SMR; medical benefit) and its ASMR—with a single measure known as valeur thérapeutique relative (VTR; relative therapeutic value). The objective of this reform would be to make a clearer determination of a new drug’s value relative to that of agents already on the market. Work is already in progress on this reform, with results due to be announced in spring 2019.
Other reforms with implications for market access in France
The government has plans to establish a national horizon scanning system to enable the French healthcare system to prepare better for the launch of new medicines. The focus would be on therapies that are expected to have a major budgetary or organisational impact.
The inpatient reimbursement system, known as groupes homogènes de séjour (GHSs; uniform hospitalisation groups), will be overhauled. The objective of this reform is to accelerate the adoption of innovative health technologies—in particular, medical devices—in French hospitals.\
The wealth of data available in the French healthcare system will be used to build a Health Data Hub. Among the benefits to be derived from this innovation will be the use of real-world data to refine reimbursement decisions.
Procedures for authorising clinical trials will be streamlined. The aim is to approve pharmaceutical trials in an average of 45 days, with a target of 110 days for advanced therapies.
The industry is optimistic about its future in France
As noted earlier, the pharmaceutical industry has welcomed many of the reforms proposed by the CSIS. Patrick Errard, the Chairman of Leem, has said that “this CSIS lays the foundations for a far-reaching transformation in the process of dialogue between the French state and the industry. These are undoubtedly substantive announcements that can become rapidly operational, but above all they constitute a long-term roadmap for an industrial policy that will reinstate France as a centre of innovation and excellence in health going forward. We will work closely with the French state to ensure that the measures announced at this CSIS are implemented as quickly and efficiently as possible. Nevertheless, we will continue as strongly as ever to make the case for a return to growth, which is the essential prerequisite to ensuring that France regains its rightful position in the community of innovative nations.”
Pharmaceutical companies will benefit particularly from the relaxation of tough restrictions on pharmaceutical expenditure growth, faster market access and the expansion of the ATU system. The potential consequences of more-extensive use of health economic evaluation and the introduction of the new VTR system for evaluating new medicines are less clear-cut at present. The industry will wait eagerly for further details of the reforms in the coming months.