R (Ross) v West Sussex Primary Care Trust
| Jurisdiction | England & Wales |
| Judgment Date | 10 September 2008 |
| Neutral Citation | [2008] EWHC 2252 (Admin) |
| Docket Number | Case No: CO/8257/2008 |
| Court | Queen's Bench Division (Administrative Court) |
| Date | 10 September 2008 |
[2008] EWHC 2252 (Admin)
IN THE HIGH COURT OF JUSTICE
QUEENS BENCH DIVISION
ADMINISTRATIVE COURT
Before : His Honour Judge S P Grenfell
Case No: CO/8257/2008
Mr Richard Clayton QC and Mr Vikram Sachdeva (instructed by Irwin Mitchell) for the claimant
Mr Martin Forde QC and Mr Matthew Barnes (instructed by Mills & Reeve) for the defendant
Hearing dates: 4 th and 8 th September 2008
His Honour Judge Grenfell:
The claimant, Colin Ross, a multiple myeloma sufferer, challenges the decision of the defendant, West Sussex Primary Care Trust (the “PCT”), not to fund the relatively new cancer drug, Lenalidomide, in a three drug combination. His clinical situation since the early part of this year has been that previous treatments of Velcade and latterly Thalidomide have resulted in peripheral neuropathy to the extent that it had to be stopped. That meant that, unless he could be treated with Lenalidomide, the only option was palliative treatment. It is accepted that without the chance of attempting the life extending properties of Lenalidomide in conjunction with one or two other drugs, which are themselves uncontroversial, his life expectancy is limited to the progress of the myeloma. The decision was taken by the PCT's Review Panel on 28 th May 2008, and confirmed on appeal on 23 rd June and finally reviewed and confirmed on the 22nd August.
The application for Judicial Review of the decision was made on the 1 st September when I directed that the application for permission with the full hearing to follow if granted be heard on the 4 th. On the 4 th September counsel indicated their acceptance that the grant of permission was inevitable. Accordingly I heard the arguments, supported by their written detailed grounds and submissions, on the 4 th and 8 th September. I record my appreciation of the co-operation and speed of counsel in mustering and mastering their detailed arguments in the short time available.
Lenalidomide has not yet been assessed by the National Institute for Health and Clinical Excellence (“NICE”) which is expected to make a decision in January 2009.
No one can completely put aside the human element of a case like this. Nevertheless, it cannot be allowed to dictate the result. My approach has to be to decide whether or not the decision can be successfully challenged on clear and laid down principles.
Guidance comes from Sir Thomas Bingham MR in R v Cambridge Health Authority ex parte B [1995] 1 WLR 898, in which he observed at 905B:
“… the courts are not, contrary to what is sometimes believed, arbiters as to the merits of cases of this kind. Were we to express opinions as to the likelihood of the effectiveness of medical treatment, or as to the merits of medical judgment, then we should be straying far from the sphere which under our constitution is accorded to us. We have one function only, which is to rule upon the lawfulness of decisions. That is a function to which we should strictly confine ourselves.”
and at page 906D to F:
“I have no doubt in a perfect world any treatment which a patient, or a patient's family, sought would be provided if doctors were willing to give it, no matter how much it cost, particularly when a life was potentially at stake. It would however, in my view, be shutting one's eyes to the real world if the court were to proceed on the basis that we do live in such a world. It is common knowledge that health authorities of all kinds are constantly pressed to make ends meet. They cannot pay their nurses as much as they would like; they cannot provide all the treatments they would like; they cannot purchase all the extremely expensive medical equipment they would like; they cannot carry out all the research they would like; they cannot build all the hospitals and specialist units they would like. Difficult and agonising judgments have to be made as to how a limited budget is best allocated to the maximum advantage of the maximum number of patients. That is not a judgment which the court can make.”
Auld LJ in R v North West Lancashire Health Authority [2000] 1 WLR 977 at 991E to F stated the principle:
“As illustrated in the Cambridge Health Authority and Coughlan cases, it is an unhappy but unavoidable feature of state funded health care that Regional Health Authorities have to establish certain priorities in funding different treatments from their finite resources. It is natural that each Authority, in establishing its own priorities, will give greater priority to life-threatening and other grave illnesses than to others obviously less demanding of medical intervention. The precise allocation and weighting of priorities is clearly a matter of judgment for each Authority, keeping well in mind its statutory obligations to meet the reasonable requirements of all those within its area for which it is responsible. It makes sense to have a policy for the purpose – indeed, it might well be irrational not to have one—and it makes sense too that, in settling on such a policy, an Authority would normally place treatment of transsexualism lower in its scale of priorities than, say, cancer or heart disease or kidney failure.”
These principles are of particular application to the present case against the background of the information that other PCTs have granted funding for Lenalidomide where others have not. It follows that each PCT is entitled, provided it does so rationally, logically and lawfully, to set its own policy for making such difficult decisions.
The general background in respect of the drug Lenalidomide is as follows. It is structurally similar to Thalidomide, but more potent, and largely without the side effect of peripheral neuropathy. Lenalidomide is freely available in mainland Europe. The recommendation in a position paper of the British Committee for Standards in Haematology is that where side effects prevent the administration of Thalidomide, Lenalidomide should be given. In a recent survey, I am told, 60% of the applications made for exceptional funding of Lenalidomide in England and Scotland have succeeded. The relevance of this information is to dispel any ideas that the prescription of Lenalidomide is somehow breaking new ground. The London Cancer New Drugs Group Briefing of May 2008 estimates that between 1.6 and 2.8 patients per 100,000 population could receive Lenalidomide every year. The significance of these factors is that a decision on this application in the claimant's favour is unlikely open any 'flood gates' of further applications, each of which are in any event likely to be considered on its own merits.
On 17 th September 2007, Dr Stern, a Consultant Haematologist, made an application to the Surrey, West Sussex and Hampshire Cancer Network Chemotherapy Group for a new drug policy and guideline in respect of the use of lenalidomide in combination with dexamethasone for the treatment of patients with multiple myeloma who had received at least one prior therapy. That application set out that lenalidomide had been launched commercially in the UK following the grant of a licence by the European Medicines Agency on 19 th June 2007 and approval by the Medicines and Healthcare Products Regulatory Agency.
The Chemotherapy Group on 27th November 2007 concluded:
“The current evidence was not felt to be adequate to support the standard use of lenalidomide in patients failing to respond to thalidomide based regimens ie, as a third or fourth line option. This will need a separate application/business case as it is clearly a significant service development with potentially substantial associated costs as this would be a further treatment option which would apply to many more myeloma patients/
“Application supported as an alternative second line option for patients who have responded to thalidomide but who develop unacceptable neuropathy. Details to be included in Horizon Scanning for the PCTs as a formal business case will be required.”
On 13 th December 2007, the Surrey, West Sussex and Hampshire Cancer Network Haematology Tumour Group considered the use of Lenalidomide. and noted:
“… that the network chemotherapy group had given support for this treatment option for patients unable to receive thalidomide as a standard alternative due to side effects. SS noted that this did not include patients unresponsive/resistant to thalidomide – a proportion will show sensitivity to lenalidomide. It was agreed that the network chemotherapy group should be asked to reassess this specific subgroup as a separate application.”
No application has been made by the Cancer Networks for funding approval for lenalidomide. In fact, it does not appear that the Cancer Networks, other than their sub groups, have reached a concluded position on the funding of lenalidomide. Accordingly, the process of considering funding lenalidomide has not yet reached the second stage of the process.
It is however, worth observing that in what is termed the 'hierarchy of evidence' in support of a new drug the stage of randomised controlled trials comes 2 nd to highest. This assumes importance when the evidence presented to the PCT in respect of clinical efficacy is considered.
I take the factual background from the Statement of Facts.
The Claimant was first diagnosed with multiple myeloma in 2004, and has been treated with a variety of chemotherapy treatments. He responded to all of them, but is now on his third relapse.
His most recent treatment was composed of Thalidomide, but...
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