A new approval of UK’s National Institute for Health and Clinical Excellence (NICE)

On the 26th March, Sanofi-Aventis, the third largest pharmaceutical manufacturer in the world, announced that the UK’s National Institute for Health and Clinical Excellence (NICE), had approved Acomplia for use in the National Health Service (NHS). NICE is a non-governmental organisation. It plays the role of a gatekeeper and, if it approves a medication, its use in the NHS is subsidised out of public funds. Up to now, Acomplia has had approval granted by the European Medicines Agency (EMEA) for use on private prescription only. So patients have had to pay the full retail price for Acomplia. This decision by NICE means that patients who have a BMI of 30 or more, or a BMI of 27 with associated risk factors, can now get treatment without having to pay for Acomplia (the change of diet and the introduction of physical exercise have no additional cost implications). This is a small step forward for Sanofi-Aventis which has a good product but has found it difficult to promote its use.

Because of the reluctance of regulatory authorities to add a “weight loss” medication to the list of approved medications, the sales of Acomplia have been only modest (around $120m last year). Relatively this is a good performance because European patients have been buying this product out of their own pockets. Nevertheless, it is disappointing that such a good product as Acomplia cannot be more widely accepted. For example, the German regulatory authority has refused to reimburse patients out of public funds because it views Acomplia as a lifestyle product.

This starkly contrasts with the public policy stance of the British government which has made the fight against obesity in the young one of its top medical priorities. This is a particularly positive move towards preventative medicine by a country that believes it is facing an “obesity crisis”. The more overweight you get, the greater the risks of heart disease or diabetes. Both of these represent long-term and expensive conditions to treat in a public health system. It is therefore good value for money to get as many as possible to use Acomplia and reduce their weight while young.

In the United states, the Food and Drug Administration has been reluctant to give any recognition to Acomplia after a link was made to one or two very rare cases in which individuals who happened to be taking Acomplia attempted suicide. So far, there is no clinical evidence to support a general link between Acomplia and suicide. More clinical trials are underway and Sanofi-Aventis expects to have new evidence to submit to the FDA in 2009. But this experience with Acomplia has become increasingly common. Many new and effective medications have been approved for the European market but have not received FDA approval. Several European manufacturers have indicated that they may ignore the US market in future even though it is the largest in the world. They all complain that the FDA’s demands for more and more clinical data prior to approval has become unreasonable.

It is not clear why the FDA has grown more demanding. It may be that the process has become more political in the US after the approval of Vioxx became the focus of litigation and hearings on Capitol Hill. There are also funding problems as the agency struggles to consider more applications for approval with a reducing budget. As it is, US television and print media are full of advertisements for medications. This is the land of the hard sell. Europe does not permit national advertising campaigns for prescription medications. In one sense, this makes Acomplia’s market penetration in Europe all the more impressive. Positive word-of-mouth has been selling the product. Thus, if you live in the UK, you can enjoy the benefits of Acomplia to reduce your weight on the NHS. Elsewhere, you can pay for this product confident that, in conjunction with a low calorie diet and physical exercise, it will significantly reduce your weight.