Scottish Medicines Consortium Not Convinced by Sanofi-Aventis’ Acomplia

Sanofi-Aventis' obesity treatment, Acomplia, does not offer value for money to the National Health Service (NHS), the Scottish Medicines Consortium (SMC) has concluded. The gatekeeper for prescribing of new medicines on the Scottish NHS said the economic case for Acomplia had not been demonstrated.

The evidence filed by Sanofi-Aventis, which intends to make a resubmission to the SMC, showed that Acomplia was associated with a reduction in mean weight of around 4-5 kg compared with placebo, the SMC noted. However, this weight generally went back on again within a year of stopping treatment. Moreover, there were no trials comparing Acomplia with the less expensive weight-loss treatments orlisat (Xenical, Roche, Switzerland) and sibutramine (Meridia/Reductil, Abbott, U.S.), both of which have been recommended for NHS use in England and Wales by the National Institute for Health and Clinical Excellence (NICE).

The SMC also criticised the cost-utility analyses submitted by Sanofi-Aventis for Acomplia, which offered comparisons for rimonabant plus diet-and-exercise advice versus advice alone or orlistat. In a base-case analysis, where 7% of patients had diabetes and none of them dyslipidaemia, the manufacturer estimated that adding Acomplia to diet and exercise would generate a cost per quality-adjusted life year (QALY) of £10,991 (US$21,355). For patients with dyslipidaemia the same regimen would result in a cost per QALY of £10,120 compared with diet and exercise alone and £9,186 compared with Xenical, Sanofi-Aventis calculated. For patients with diabetes, the cost per QALY would be £13,653 against diet and exercise alone and £10,491 compared with Xenical.

The SMC was not convinced, though. For one thing, it said, the comparator offered no active treatment for diabetes or dyslipidaemia, which "seems at odds with normal prescribing practice". Sanofi-Aventis had also used a wide variety of risk equations, and "the selections made were not always clearly explained", the SMC commented. Overall, it concluded, the economic case for Acomplia had not been shown "primarily because it was not clear the comparator reflected current practice".

No Joy for Sutent, Alimta, Betaferon

Acomplia was not the only drug to be turned down by the SMC in its latest batch of appraisal decisions. Previous decisions of the Consortium include:

• Rejection of Pfizer’s (U.S.) Sutent (sunitinib) as a treatment for advanced and/or metastatic renal cell carcinoma after failure of interferon-alpha or interleukin-2 therapy. This was despite evidence of tumour responses in clinical trials and Sutent's favourable cost versus Bayer's (Germany) Nexavar (sorafenib) for the same indication. The SMC turned down Nexavar for use on the Scottish NHS in November 2006 on cost-effectiveness grounds (seeUnited Kingdom: 16 November 2006: Scotland’s SMC Clears MabThera for Arthritis, Arimidex and Fludara for Cancer). The previous month it rejected Sutent for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (seeUnited Kingdom: 11 October 2006: Scottish Medicines Consortium Rejects Pfizer's Sutent, Solvay's Duodopa, Servier's Procoralan). Patient groups and oncologists have condemned the SMC's negative verdict in renal cell carcinoma.
  
  
• Rejection of Eli Lilly’s (U.S.) Alimta (pemetrexed) as monotherapy for second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, saying again that the economic case for the drug had not been demonstrated. A preliminary recommendation from NICE turned down Alimta in this indication last November (seeUnited Kingdom: 14 November 2006: NICE Preliminary Recommendation Rejects Tarceva for NSCLC).
  
  
• Rejection of Schering Health Care's (Germany) Betaferon (interferon beta-1b) for early signs of multiple sclerosis—specifically, patients "with a single demyelinating event with an active inflammatory process, severe enough to warrant treatment withy intravenous corticosteroids, where alternative diagnoses are excluded and who are determined to be at high risk of developing clinically definite multiple sclerosis".
  
  
• Approval of Novartis' (Switzerland) Exjade (deferasirox) for restricted use in the treatment of chronic iron overload associated with the treatment of rare acquired or inherited anaemia requiring current blood transfusions—but not for the treatment of patients with myelodysplastic syndromes.
  
  
• Approval of Astellas Pharma’s (Japan) Prograf (tacrolimus) for the prophylaxis of transplant rejection in heart allograft recipients.
  
  

Outlook and Implications

Despite Sanofi-Aventis' efforts to position Acomplia as more than a lifestyle drug, with solid evidence of its benefits in patients at risk of cardiovascular complications (see France: 15 January 2007: Sanofi to Challenge German Refusal to Subsidise Acomplia), clearly these—and the rising panic about obesity levels in the United Kingdom—were not persuasive enough for the Scottish Medicines Consortium. Nor were they for Germany’s Federal Joint Committee, whose decision to put Acomplia in the non-reimbursable drug category is being challenged by Sanofi-Aventis in court.

Sweden, on the other hand, has agreed to cover Acomplia, and it looks as though France will follow suit (see France: 5 February 2007: HAS Recommends Reimbursement for Sanofi-Aventis' Acomplia). Nonetheless, the SMC's verdict does not bode well for a NICE recommendation on Acomplia in England and Wales, which is not expected for more than a year yet, nor does it sit comfortably with Sanofi-Aventis' reliance on the obesity treatment to offset generic competition on other drugs—particularly coming so soon after the announcement of further delays to U.S. approval of Acomplia (see France: 13 February 2007: Strong Q4 at Sanofi-Aventis Overshadowed by U.S. Delays to Acomplia, Ketek Label-Changes).