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French Govt Announces Universal HCV Drug Access Plan
  Hepatitis C: announcing universal access to new treatments, Marisol Touraine ends a public health aberration.
National Day of fight against hepatitis

Today May 25, 2016, on the occasion of the national day against hepatitis, Health Minister Marisol Touraine announced the gradual implementation by September of universal access to new treatments against the hepatitis C. the first stage will take effect immediately with the inclusion of new beneficiaries, including the most vulnerable groups, before a generalization to all patients in September. This announcement follows two years of intensive mobilization of associations, and offers healing opportunities for hundreds of thousands of people living with hepatitis C in France. AIDES welcomes this decision and will be particularly vigilant as to its effective implementation.
It was one of the few black spots of public policies to fight against hepatitis C. While courageous steps [1] have been taken in recent months in the field of prevention, risk reduction and screening , access to new treatments was still not guaranteed for the vast majority of those affected. "We are two years into a totally absurd situation," explains Aurelien Beaucamp, president of AIDES. "So we finally all the necessary tools to prevent, detect and effectively treat hepatitis C, most of those affected are still denied access to new treatments. This announcement takes us out of the impasse. Implement universal access is to find ways to end definitively with the hepatitis C epidemic. "
Vulnerable and remote populations finally considered carefully prioritized.
AID also welcomes the willingness of the Minister to include today in access to treatment the most vulnerable to the epidemic, especially people-using drugs and prisoners. We do not doubt for a second that foreign immigrants will be included in the recommendations, we will anyway particularly vigilant on this point as on transcription into action the declaration of the minister. These populations, especially precarious and remote care, should have access without delay to these new treatments.
French government proposes "universal" access to new HCV medicines
Published: 5/26/2016
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.
"Today I decided to universal access to treatment of hepatitis C. The use of this treatment, as with any treatment, should depend only as an informed patient's choice, and his doctor, as part of their discussion . The patient should be able to decide according to its own assessment of the advantages and disadvantages of being treated, these advantages and disadvantages is for the doctor to explain. To enable universal access, the regulatory legal framework must be adapted. Regarding Stage 2 patients, transplant patients or those waiting for transplants and vulnerable populations in the fibrosis stage, insofar as they are the most exposed, I will sign the extension order, after receiving the notice the transparency Commission, in the next few days. For all other patients infected with HCV, the asymptomatic Stage 0 and 1, I took into consideration last week H.A.S. (High Govermnment Health Authority) whose opinion is mandatory. They must respond no later than, the month of September, its recommendations on the implementation modalities of universal access to treatment. I will then sign the new order. Beyond universal access, I also know that some patients, independent of management rules, are not yet processed because they are distant from our health care system. This situation is not acceptable. We must find the best way to access these patients for the treatment against hepatitis C, they can be more readily prescribed. Furthermore, treating patients in Stage 0 or 1 also the question of the evolution of treatment prescribing patterns against hepatitis C, including the role of multidisciplinary consultation meetings (RCP). So I presented these issues to the National Research Agency on AIDS and viral hepatitis, and the National Council of AIDS and viral hepatitis. (A.N.R.S.). " (excerpt from speech by French health Minister, Marisol Touriane) http://www.alamy.com/stock-photo-paris-france-french-minister-of-health-marisol-touraine-making-annoucement-104632473.html
IHS Life Sciences perspective
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 hepatites Federation, 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 (Comite Economique des Produits de Sante: 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 hepatites Federation 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.
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