NHS drug battle heads for court

Cancer patient in landmark legal move.

Battle lines are being drawn in a landmark legal fight over the use of a multi-million-pound NHS cash fund.

The row centres on little-known charity war-chests, or endowment funds, that across Scotland’s 14 health boards add up to more than £200 million.

Increasing numbers of desperate cancer patients are turning to the funds after being denied costly drugs through normal NHS channels. But so far not a single plea for help has been successful

Now cancer patient Isabelle McManus whose appeal to endowment fund trustees to pay for the drug cetuximab was turned down last month is to challenge the decision in Scotland’s highest civil court. And last night her lawyer revealed it could prove to be a test case.

Solicitor Cameron Fyfe added: “If Isabelle’s court action is successful, it will allow many other patients in her position to seek payment from their health boards to pay for treatment.”

Endowment funds consist of cash donated to the health board trusts or left in wills. Traditionally, the money has been spent on patient equipment, staff training and even hospital gardens. But in these cash- strapped times, more and more patients are asking for help for treatment.

In July, we revealed how two cancer sufferers Sharon Graham and June Rankin had applied to the endowment funds to pay for drugs. Both had their pleas rejected.

Mum-of-two Isabelle, 50, of Stevenston, Ayrshire, was turned down by NHS Ayrshire and Arran’s endowment fund. They refused her after the health board itself had twice rejected her application for cetuximab through individual patient treatment requests.

This is despite the drug routinely being prescribed by the NHS in other health boards. The endowment fund did offer her some money but only to cover travel costs.

Solicitor Cameron revealed she is challenging the fund’s decision on the basis the trustees were acting outwith the purposes of their charter specifically the “improvement in the physical and mental health of the board’s population” when rejecting her application. He said if the health board failed to reconsider they were seeking to proceed with a judicial review and could challenge it under the Human Rights Act and Isabelle’s “right to life”.

The Glasgow-based solicitor said: “If Isabelle’s court action was successful it would allow many other patients in her position to seek payment from their health board to cover the cost of treatment”.

Margaret Watt, of Scotland’s Patient Association, labelled Isabelle’s battle “grossly unfair. This case could open the flood gates.”

Former factory worker Isabelle is currently paying privately for cetuximab after her family and friends chipped in to cover the £3,000 monthly bill to pay for the drug. But they don’t have enough money to cover a further round of treatment.

Last night her brother Matt, a print worker, said: “After a shaky start things have settled down. Its early days but her initial blood tests are encouraging.”

In Scotland, £7.2m a year is spent on prescriptions for paracetamol enough to give 200 patients a year’s supply of cetuximab.

NHS Ayrshire and Arran refused to comment on the case.

Last month the Scottish Government announced changes to the way drugs are evaluated. Currently, many drugs even ones approved in other parts of the UK can fall foul of approval in Scotland. Most commonly it comes downs to cost issues and value for money.

If a patient wants a drug not recommended by the Scottish Medicines Consortium, which decides which medication can be prescribed, they have to submit an Individual Patient Treatment Request, with a decision made by a group of health board bureaucrats.

But that system is to be binned by the Scottish Government. Instead, a new “peer approval system” will see doctors leading decisions, with more consideration of personal circumstances. The £20 million Rare Medicines Fund, launched earlier this year, has also been extended until 2016.

Health Secretary Alex Neil also said he was revamping the evaluating of approving treatments. A spokeswoman for the Scottish Government said it expected the SMC to report back by the start of next year.

American-designed Cetuximab, also known as Erbitux, was first put on sale in the early 1990s. The “biological” drug is different from many on the market. It works by slowing the growth of cancerous tumours by targeting crucial growth-promoting proteins.

But in 2001 the drug faced the prospect of sinking without trace. America’s Food and Drug Agency refused to accept the application, questioning the clinical data. But the day before the announcement a number of big investors in the drug company, Imclone Systems, sold their shares amid claims of inside trading. That included US lifestyle guru Martha Stewart. The TV star came under intense public scrutiny and after a government inquiry ended up being charged and sent to prison.

Since then Martha has enjoyed a public renaissance as has Cetuximab. The drug was approved in the US in 2004 and soon afterwards across Europe. European trials have since shown it can reduce tumours by over 20%.