Patient dies after winning access to cancer drug
pharmafile | July 21, 2006 | News story | |Â Â Â
A Lancashire man with terminal lung cancer has died just days after winning a court battle to force his PCT to provide the new treatment, Tarceva.
Clinical trials suggest Roche's Tarceva can help prolong the lives of patients with advanced lung cancer compared to existing treatments, but its high price makes its use controversial.
The drug has been available in the UK since October 2005, but with NICE guidance not yet published, many patients must seek individual clearance from their PCTs to receive the drug.
Morecambe Bay PCT had previously refused to pay for 51-year-old Paul Bould's treatment with the drug, saying there was insufficient evidence to support the funding; Tarceva costs 1,631 pounds for one month's treatment, double the price of Taxotere, the drug recommended by NICE as a second-line treatment for non-small cell lung cancer.
Bould's solicitors, Irwin Mitchell, were granted an injunction in the High Court on Monday 17 July, forcing the PCT to fund the treatment pending a judicial review, but Mr Bould died two days later.
Chief executive of the PCT Leigh Griffin said: "While the PCT considers that it acted appropriately when considering Mr Bould's request to fund Tarceva, this is a personal human tragedy and we sympathise with Mr Bould's family."
Before coming to its original decision, the Trust had consulted with local PCTs and taken the advice of the Cumbria and Lancashire Cancer Network and the Northern Cancer Network.
This was the first request Morecambe Bay PCT had received to fund Tarceva, and Griffin said he was not aware of any neighbouring trust providing the drug.
He said the PCT wouldn't rule out funding the drug before NICE issued its guidance, but would consider patients seeking Tarceva treatment on a case-by-case basis.
"What we made clear throughout this process is that we will keep an open mind and consider any fresh evidence as it's made available."
The PCT's Drugs and Therapeutics Committee, which also supports the Cumbria and Lancashire Cancer Network, is to undertake some 'horizon scanning' to look at the emerging evidence base.
Tarceva (erlonitib) was approved in Europe in September 2005 to treat locally advanced or metastatic NSCLC after the failure of at least one prior chemotherapy regimen,but only a handful of PCTs in England and Wales are funding it ahead of the NICE decision.
Roche says the drug increases the likelihood of lung cancer patients being alive at one year by nearly half and that more than half of patients with non-small cell lung cancer (NSCLC) currently receive no life-prolonging treatment.
A spokesman for the company said: "While we are obviously saddened to hear of the death of Paul Bould and would like to extend our sympathy to his family, it wouldn't be right for us to comment on the case of an individual patient with whom we have had no prior contact."
He added: "It is clear policy from the Department of Health that the absence of NICE guidance on a treatment should not be used as a reason not to prescribe any treatment. When making decisions on whether to fund a treatment, many PCTs take into account any other existing guidance."
In June this year, the SMC (Scottish Medicines Consortium), the Scottish equivalent of NICE, gave Tarceva a limited recommendation, reversing an initial decision in December.
It said use of the drug in Scotland should be restricted to patients who can't otherwise be treated with Sanofi-Aventis' Taxotere.
Geraldine Smith, Labour MP for Morecambe and Lunesdale, raised Bould's case in the House of Commons in February, noting that around 50 NHS hospitals had already prescribed Tarceva to more than 100 patients.
Bould's case is only the second time the right to receive funding for prescribed drugs has gone to the High Court, the first being Ann-Marie Rogers and Roche's breast cancer drug Herceptin. As with Mr Bould, law firm Irwin Mitchell also represented Rogers.
