The French Government has recently announced initiatives to reduce the time taken for patients to gain access to new drugs. At the Strategic Council of Health Industries (CSIS) in July 2018, the French Prime Minister Edouard Philippe announced the Government’s plans to reduce delays in pricing and market access for new drugs, as well as new indications for existing drugs. Philippe Lamoureux, the Director of LEEM (the French pharmaceutical industry association) described this as the most important CSIS since 2009 due to President Macron’s clear affirmation of his pro-business vision for the French healthcare system. In addition to implementing fast-track schemes for clinical trials of new drugs, the French Government’s plans to accelerate pricing and reimbursement can be divided into two main areas:
1. Improving adherence to the official 180-day market access timelines
2. Expanding and streamlining the Temporary Authorisation for Use (ATU) scheme.
Improving adherence to the official 180-day market access timelines
Currently, the average time between a drug receiving marketing authorisation from the European Medicines Agency (EMA) and a published price in the Official Journal is 530 days, which ranks France as 18th across the EU in terms of speed of pricing and market access. It also contravenes Transparency Directive 89/105/EEC of the European Commission, which states that both pricing and reimbursement decisions should be completed within 180 days.
The French Government has now committed to meet this 180-day timeline by 2022. It aims to achieve this through the following measures:
- Recruiting six additional employees for the Comité Economique des Produits de Santé (CEPS)
- Making improvements to the negotiation process between manufacturers and CEPS, with tighter timeframes based around the following:
- 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 the 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. Price negotiations for ASMR V drugs are now usually completed within two weeks.
Expanding and streamlining the Temporary Authorisation for Use (ATU) scheme
Since 1994, the ATU scheme has provided early access to promising new treatments that fulfil a public health need. In order to be authorised, the drug must be for a rare or serious disease with no satisfactory alternative treatments and a high medical need, and when the risk / benefit balance is presumed to be positive. There are two types of ATU:
- A named-patient ATU, issued for a single patient at the request of a prescribing physician
- A cohort ATU, issued at the request of the drug license holder for a group / sub-group of patients. The license holder must commit to submit a marketing authorisation application within a determined period, as well as collecting data for the duration of the ATU.
Almost 20,000 patients currently benefit from the ATU scheme annually. However, until recently the system for applying for named-patient ATUs was complex to use and lacked transparency. In addition, communications between physicians and the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) were made by fax, which is slow and suffers from potential security challenges. The French Government has recognised the need to modernise the process, and as of September 2018 has made the following changes:
- Introducing a single portal for physicians to apply for named-patient ATUs, in order to increase transparency and simplify the application process
- Publishing a reference list of drugs already covered within the ATU framework, which includes:
- The criteria for obtaining an ATU for each of these drugs, including conditions for use and a summary of product characteristics
- A new application form when adhering to those criteria (which will depend on the patient’s clinical situation)
- A set of best practices intended for health professionals.
In February 2019, a new e-Saturn web application will be piloted to replace the current fax system. This is intended to provide a range of benefits, including simplifying and speeding up exchanges between physicians and the ANSM, and allowing better tracking of requests and decisions. From March 2019 the system will be available to all physicians, and the previous fax system will be phased out in 2020. However, only health facilities equipped with professional health card readers will be able to authenticate, prescribe and deliver products via the ATU scheme once faxes have been abandoned.
Furthermore, under the current system only new drugs are eligible for ATUs. In the future it will be possible to apply for an ATU for new indications of an existing drug. This change will be particularly beneficial in oncology, where the number of indications being tested for immunotherapies is ever-expanding. In addition, previously ATUs were expected to end once a product received marketing authorisation. However, now the ATU will only end once the product has completed the pricing and reimbursement process, unless an equivalent product is recognised to have launched prior to this in France.
If the French Government is able to deliver on its pledges, pharmaceutical companies can look forward to potentially increased commercial success in France as a result of faster market access and the expansion and modernisation of the ATU scheme. However, our recent analysis showed that the National Institute for Health and Care Excellence (NICE) in the UK has struggled to meet its fast-track 90-day target for Final Appraisal Determination (FAD) publication for oncology drugs. This illustrates the challenges that the French Government will face in reducing its current market access timelines by almost 70% by 2022. It will be interesting to see moving forwards the extent to which the changes that have already been made will deliver faster patient access in practice.
In addition, while the changes to the ATU scheme are likely to result in significant long-term benefits to both physicians and patients, we anticipate some shorter-term difficulties as stakeholders adapt to the new system from one that they had been using for several decades previously.