UK – NHS can procure drugs for use outside of their approved indications if it’s cheaper, court says

Pharmaceutical companies will have less control over how their medicines are used, as the Court of Appeal rubber-stamps a controversial cost-cutting policy for the NHS.

In a recent decision, the Court of Appeal ruled that, where there is adequate clinical evidence, healthcare providers can procure and regularly use medicines « off-label » on grounds of cost, despite authorised alternatives being available. The Court of Appeal also followed the Court of Justice of the European Union (CJEU)’s approach by allowing for compounding (aliquoting) of a medicine when done in a pharmacy on the basis of a prescription, and ruling it does not constitute « placing on the market » nor requires a marketing or a manufacturing authorisation.

Until now, the circumstances in which a medicine might be used outside of its approved indications were thought to be one-off, special cases – eg where there is no known alternative, or that alternative is impossible to procure. UK health providers may now be prepared to do it on a larger scale.