Trusts can take cost into account when deciding drug treatment

Trusts can take cost into account when deciding drug treatment, court rules

BMJ

Clare Dyer

legal correspondent

186;25;118

Last week’s Appeal Court judgment to force the NHS to pay for trastuzumab (Herceptin) will not oblige primary care trusts to fund the drug for every woman whose oncologist prescribes it—although most of the media reported that it would.

Three Appeal Court judges headed by the master of the rolls, Anthony Clarke, unanimously ruled that Swindon NHS Primary Care Trust irrationally and unlawfully refused to pay for the treatment for Ann Marie Rogers, 54, who has early stage HER2 positive breast cancer.

The drug has been licensed and assessed as cost effective so far only for late stage cancer, although the licensing and approval process for use of the drug in early cancer has been fast tracked and is expected to be completed within six months.

The judges ruled that the trust’s policy of funding early stage treatment only in exceptional cases was irrational because, once it decided that cost was irrelevant to its decision making, the only reasonable approach was to fund all patients who could benefit from the treatment and were prescribed it by their oncologist.

However, the judgment makes it clear that trusts may lawfully take account of budgetary constraints in deciding which patients should have their treatment funded.

The judges said there would be nothing arbitrary or irrational in an approach that balanced cost considerations against individual patients’ circumstances.

They said, “It could properly involve a decision by a trust which was subject to financial constraints and which decided that it could not fund all the patients who applied for funding for Herceptin treatment to make the difficult choice to fund treatment for a woman with, say, a disabled child and not for a woman in different personal circumstances.”

David Lock, a barrister and head of the healthcare practice at the law firm Mills & Reeve, said: “The decision does not mean that every PCT [primary care trust] is obliged to fund every request for Herceptin. The court makes very clear that a primary care trust is entitled to balance its books by rationing Herceptin.

“This means that PCTs are entitled to have regard to the cost of Herceptin in deciding whether to fund requests. The court has upheld the right of PCTs to manage their resources, and, properly applied, this case is not the green light for patients to demand every expensive off-licence drug whatever the clinical merits.”

The judges pointed out that guidance to trusts from the Department of Health had advised that decisions on funding the drug should not be based “solely” on cost grounds and not that financial constraints should be disregarded altogether. The department estimates that the cost of funding all the women with early stage cancer who could benefit could be as high as £100m (€145m; $175m) a year.

Peter Edwards, managing partner of the healthcare law firm Capsticks, said the judgment meant that PCTs “can continue to determine eligibility for Herceptin on the basis of the availability of resources, the clinical needs of the patient, and potentially personal and social circumstances.”

Jan Stubbings, chief executive of Swindon Primary Care Trust, said the trust, which has agreed to fund Ms Rogers’s full treatment, would “now revisit our policy taking into consideration the points made by the court.”

Gill Morgan, chief executive of the NHS Confederation, which represents most NHS trusts, said: “The ruling will have significant implications for the prescription of all unlicensed drugs—not just Herceptin. The NHS will need to take stock of the broader ramifications.”