The Pharmaceutical Journal Vol 267 No 7172 p632
3 November 2001

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Money-back guarantees for new drugs

Multiple sclerosis patients with the relapsing form of the disease may see a light at the end of the beta-interferon tunnel. Reports suggest that a deal may be struck between the manufacturers of the drug (Biogen, Serono and Schering Health) and the Department of Health which will enable all these patients to try a course of treatment and, if it does not work, then the National Health Service will get its money back (see news item).

This looks like an imaginative solution to the problem of prescribing beta-interferon for all people with multiple sclerosis. The evidence suggests that three in 10 patients with the relapsing form of the disease may benefit from the therapy, which reduces the relapse rate. The trouble is identifying those susceptible individuals. The National Institute of Clinical Excellence is expected to announce in December, after prolonged and delayed deliberations, that the NHS cannot afford to give all patients beta-interferon.

This money-back concept may be new to the United Kingdom but was used in the United States in 1994 to encourage the prescribing of finasteride (Proscar) for benign prostatic hyperplasia when it first came on the market. The managing director of Merck Sharp & Dohme at the time, Vincent Lawton, was quoted in the British Medical Journal: "It is a terrific waste of resources when medicines are not used properly, with inadequate doses and poor compliance ... This would be a guarantee of efficacy and a real sharing of risk with real effects if promises are not kept."

This model is worth looking at in depth for all new products. When a new drug is launched, the number of patients who have been involved in pre-launch trials is small. If a pharmaceutical company were confident that a new product was going to offer additional benefits, greater efficacy or fewer side effects than established products it, surely, would be happy to strike a Merck-type deal. The money back promise would come into force for treatment that was discontinued (for whatever reason), say, for the first year post-launch.

Patients would be warned in advance that they would not be able to have the new product if there was no perceived benefit (which might be an aid to compliance). Doctors might be more inclined to try new products, and so speed up the process of establishing genuinely useful drugs as well as revealing problems more quickly. Pharmacists could have a role (financed by the pharmaceutical company) monitoring patients and the progress of the disease and dealing with the administration of the scheme. After a year, NICE would have more evidence on which to base its assessments and everyone would be happy.

If the product did not live up to its promises, the main loser would be the company — but that's business.

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