French health officials have announced plans to renegotiate reimbursement prices for high-cost innovative hepatitis C virus (HCV) medicines with a view to extending access to wider circles of patients. In a statement, French health minister Marisol Touraine indicated that the government plans to establish "universal" access to new HCV treatments, and urged pharmaceutical companies to co-operate on the upcoming pricing negotiations.
Implications | French government plans could mean that HCV-diagnosed patients benefit from access to appropriate innovative therapies regardless of HCV severity type. Full "universal" access to second-generation HCV medicines is predicated on entering new negotiations to secure lower drug prices. As a first step, treatment will be made available to fibrosis stage 2 patients, who are not currently reimbursed. |
Outlook | The initiative has been cautiously welcomed by patients' groups. However, it remains unclear how France's social security system would meet the projected cost of establishing "universal" access. To that end, the Economic Committee for Health Products (CEPS) has been tasked with conducting a budget impact assessment and preparing pricing negotiations with the pharmaceutical industry. Precedent suggests that pricing and reimbursement discussions with the pharmaceutical sector are likely to be protracted. |
French health minister Marisol Touraine announced new measures on 25 May intended to increase access to innovative hepatitis C virus (HCV) direct-acting anti-viral (DAA) therapies. The envisaged "universal" access to second-generation HCV medicines is predicated on entering new negotiations to lower pharmaceutical prices with manufacturers. However, as an interim step, the minister announced that the guidance for reimbursement criteria would be extended to patients at intermediary fibrosis stages. France previously mandated treatment preference for the most severely ill HCV patients (fibrosis stages F3 to F4); at the time, this was based on the conclusion that healthcare resources were not sufficient to allow for treatment of the totality of HCV patients regardless of disease severity. The new proposals mark the beginning of what is likely to prove a long-term project to change the regulatory framework with a view to enabling access for patients with less advanced forms of HCV. According to patient organisation SOS hépatites Fédération, there are a total of 50,000 less-severe HCV patients that do not currently meet reimbursement criteria and are awaiting access to innovative HCV drugs. From September 2016, the Economic Committee for Health Products (Comité Economique des Produits de Santé: CEPS) is expected to recommend methods to deliver "universal" access for other fibrosis stages (F0 to F1), including proposals to renegotiate the prices of high-cost HCV medicines with manufacturers. This would be dependent on addressing the salient pricing issues, and requires co-operation from manufacturers.
The government initiative follows the recent intervention of two lobbyist groups in the drug pricing debate, most notably a controversial petition by the SOS hépatites Fédération proposing the introduction of a "statutory licence" for the manufacture of generic HCV medicines (see France: 19 May 2016: French patient association warns of increase in generic and parallel-imported HCV drugs, and France: 23 May 2016: French National AIDS and Viral Hepatitis Council calls for wider access to HCV therapies). The head of the SOS, Fabienne Godard, is reported as stating that latest initiative is on the "right track", but that the patient organisation would remain vigilant.
An estimated 32,000 French patients have received access to new HCV drugs in France in recent years. However, in a statement published on the French health ministry website (available here) Touraine is reported as saying that the government needs to "give hope to [the 230,000] people" living with HCV infection and that this needed a comprehensive strategy to "guarantee access for all patients".
Outlook and implications
To ensure that France's social security system can meet the huge cost of establishing "universal access", the country will task the CEPS with conducting a budget impact assessment followed by rounds of renegotiating reimbursed prices with manufacturers on the basis of higher volume. France's expenditure on innovative HCV drugs amounted to USD1.7 billion for the 12-month period to June 2015 for the worst-affected patients. Pharmaceutical companies may be amenable to a price moderation, given the potential uplift in sales volume, and in order to stave off potential problems of parallel imports of generic HCV medicines that were recently threatened by patients groups.
The initiative would have a significant impact on pricing and reimbursement (P&R) activity in France. Furthermore, the development will be watched closely by a number of European Union (EU) countries, most notably Italy. If the move comes to fruition, it would potentially create the conditions for one of the more comprehensive access systems to HCV medicines of any comparable EU country.
The draft government decrees, once implemented, would have clear therapeutic benefits for individual HCV patients in France. The end of treatment restrictions for HCV patients – envisaged in early 2017 according to government plans – would conceivably benefit approximately 150,000 patients. However, the vagueness of the details concerning funding for the proposals provides grounds for concern, and it is clear that France will continue to impose tight administration of spending controls and the prescription of HCV medicines under the new system.