Global Insight Perspective | |
Significance | Germany's Ministry of Health has ratified the recommendation of the German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) to classify Acomplia (rimonabant) among non-reimbursable drugs. |
Implications | This classification of Acomplia as a 'comfort' drug under Section 34 of the Social Code Volume V effectively denies the drug eligibility for any form of reimbursement. |
Outlook | Sanofi may succeed in securing a reclassification through the courts by utilising clinical evidence that demonstrates Acomplia's benefits for cardiovascular patients. However, the German decision will delay Acomplia's achievement of blockbuster status, due to slow sales build-up in Germany and the use of Germany as a reference country in price setting by other European countries. |
Sanofi Gears up to Defend Acomplia
French drug-maker Sanofi-Aventis said in a statement that it will take the German Ministry of Health (MoH) to court in a bid to reverse an unfavourable reimbursement decision affecting potential blockbuster drug Acomplia. The announcement was made immediately after the German MoH confirmed its decision to endorse the G-BA recommendation to classify Acomplia under Section 34 of the Social Code Volume V.
The G-BA recommendation, issued in October, provided an early indication that Acomplia may face reimbursement problems (see France: 19 October 2006: Sanofi-Aventis' Acomplia Reimbursement Rejected in Germany, but FDA Approves Paediatric Allegra). Priced at 80.32 euro (US$100.7) for a one-month supply of tablets, the drug remains out of reach for many Germans. The fact that it has been deemed to be non-reimbursable would further discourage prescribing by German physicians even if the latter are aware of its solid record of cardiovascular benefits found in clinical trials.
The drug has been touted as a treatment for cardiovascular metabolic syndrome—a new disease area that the French company was accused of inventing in order to create a sizeable market for its new treatment. However, terminology aside, the French company has accumulated solid evidence of the benefits of Acomplia for patients at risk of cardiovascular complications. In particular, Acomplia has been found to produce the following benefits:
- reduction in both body mass index (BMI) and waist circumference (the latter was found to be a better predictor of cardiovascular complications than just BMI);
- improvement in metabolic risk factors in patients by increasing good cholesterol levels and reducing triglycerides—independently of weight reduction; and
- improvement of the body's response to insulin in patients with Type 2 diabetes.
Given these therapeutic benefits the company has argued that Acomplia is qualitatively different from other anti-obesity drugs. With its ability to reduce cardiovascular complications and, consequently, to cut the need for expensive hospital care, it would seem that the drug is a prime candidate for reimbursement (see France: 15 April 2006: Acomplia's First-Year Results in European Obesity Study Published in Medical Journal).
In the years that Acomplia has been in development, however, the reimbursement climate in Europe has been deteriorating for branded manufacturers. Approval and listing delays and provision of limited reimbursement for narrow patient groups are increasingly used as cost-containment tools. Germany has set the tone in cost-containment and its pricing and reimbursement decisions continue to affect the decision-making of other European states using it as a reference market.
Outlook and Implications
Given the importance of the German market—both in terms of its own size (i.e., largest in Europe) and its influence on other EU countries—a reversal of the unfavourable reimbursement decision is of key importance for Sanofi-Aventis. The company has some solid evidence to back its claim for reimbursement of the drug, but the German reimbursement delay—even if it proves short-lived—will take its toll on Acomplia sales. The achievement of peak annual sales, projected to be in the range of 3 billion euro (US$3.8 billion), is now expected to be delayed, under the dual pressure of reimbursement delays and an approval delay in the important U.S. market. U.S. approval has been delayed until April 2007 after the FDA (Food and Drug Administration) issued an approvable letter for Acomplia last February. Meanwhile, the drug is yet to be granted a price in France, and the German non-reimbursement decision could affect the French market considering that Germany is one of the France's reference states for pharmaceutical price setting.