A UK High Court judge has overturned a Primary Care Trust (PCT)’s refusal to fund Celgene’s Revlimid (lenalidomide) as “exceptional need” treatment for a terminally-ill cancer patient, and has issued an emergency interim injunction to enable him to start receiving it immediately, pending any appeal.
On Wednesday, Judge Simon Grenfell quashed West Sussex PCT’s decision that the case of 55-year-old multiple myeloma sufferer Colin Ross was not “exceptional” and that treating him with Revlimid would not be cost-effective.
The Court ruled that the Trust’s exceptions policy was unlawful because it appeared to require applicants’ situations to be virtually unique rather than exceptional, and that its decision in Mr Ross’ case was unlawful because it contained material errors of fact concerning Revlimid’s cost-effectiveness. The decision “was one which no reasonable authority could have made, on the application before it,” said the judge.
Mr Ross was diagnosed with multiple myeloma in May 2004, and doctors treating him at the Royal Marsden Hospital in London had sought “exceptional need” funding from his PCT for up to four courses of Revlimid, totalling £20,000, after he could no longer tolerate the side effects of thalidomide and Johnson & Johnson’s Velcade (bortozemib). Richard Clayton QC, representing Mr Ross, told the court that his client was no longer on any life-extending treatment and that this was the “end of the road” for him; without Revlimid he would die within three months but treatment with the drug, if successful, could extend his life by three years. Mr Clayton also pointed out that if Mr Ross lived a mile and a half in either direction from where he does, the PCTs covering these areas would have supplied him with Revlimid, which is currently being assessed by the National Institute for Health and Clinical Excellence (NICE).
The interim junction enabled Mr Ross, who was too ill to attend court, to start treatment with the drug at the Royal Marsden on Thursday.
Yogi Amin, a partner in law firm Irwin Mitchell who represented Mr Ross, pointed out that it had taken his client “months, and a High Court legal battle,” to gain access to Revlimid, even though his doctor and a team of expert clinicians at the Royal Marsden had prescribed the drug for him as the only viable option available to extend his life.
“Mr Ross’ case demonstrates the devastating effect that the postcode lottery can have on people’s lives,” added Mr Amin.
The charity Myeloma UK welcomed the ruling which, it said, left the government with no option but to reconsider the use of exceptional case funding. “The ‘exceptional case’ policy is not fit for purpose, and the High Court ruling will help to strengthen the argument that it should be abolished,” said the charity’s chief executive, Eric Low.
Commenting on the decision, West Sussex PCT said it accepted the interim order requiring it to commission funding for a course of treatment for Mr Ross including Revlimid. The judge had asked it to review “some difficult and complex issues” and it would now consider “the full impact of his judgment,” the Trust added.
– To date, 60% of exceptional funding applications for Revlimid made to PCTs in England and Scotland have been granted. NICE is expected to issue its guidance on the drug next spring. In May, the Scottish Medicines Consortium (SMC) decided not to recommend Revlimid.
