For years, like many off-label medicines, ketamine has been a valuable but hard-to-obtain therapy. This has driven the growth of ketamine clinics in America and Europe. In Britain Oxford Health, a unit within the National Health Service , will provide it. But theas a whole does not cover it because it is not approved for this use, so patients must pay £795 for three infusions;Several issues dog reusing generic medicines in new indications.
Trials are costly, but the benefits can be huge. The Drugs for Neglected Diseases Initiative, a Swiss non-profit research group, supportedinto fexinidazole, which was abandoned by a pharma firm at an early stage but was then found to show anti-parasitic qualities. This January, after years of work, it was approved for sleeping sickness in the Democratic Republic of Congo. It is the first oral medicine for the disease, and works for all stages of it.
The Anticancer Fund believes that the path to wider uptake of repurposed drugs is through approval and relabelling by drug regulators for new treatments. Although difficult and expensive, Mr Pantziarka says it unleashes a cascade of important events. When a regulator licenses a drug, clinical guidelines are updated, drug formularies are changed, reimbursement should follow more smoothly and clinicians gain experience using it.
Finance is not the only obstacle. Only the makers or original developers of a drug are permitted to adjust its label. Sanofi, based in Paris, was the firm that requested regulatory review of fexinidazole for sleeping sickness—although thewas a charitable effort. But drug firms are not obliged to support non-commercial efforts to repurpose drugs. And outside the industry it is hard to find the legal expertise to manage the necessary paperwork.
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