|  |  |  | | | | Leukaemia Research welcomes High Court ruling on availabilty of drug for myeloma patient | | | | |
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Release Date: 12 Sep 2008
Leukaemia Research welcomes the High Court ruling that Mr Colin Ross, who has myeloma, should receive treatment with Revlimid™. The case arose after a decision by West Sussex Primary Care Trust (PCT) that Mr Ross’s situation should not be treated as exceptional, even though his consultants at Royal Marsden Hospital had appealed to the Trust to allow him to receive the drug.
Mr Ross had previously been treated with thalidomide and a drug called Velcade™ but suffered such severe side effects that he was unable to continue treatment. So Revlimid was his last hope.
Revlimid is currently licensed for use for myeloma but there is presently no recommendation by the National Centre for Health and Clinical Excellence (NICE) on its cost-effectiveness for this use. A course of Revlimid costs just over £5,000, and Mr Ross’s doctors wished him to receive three or four courses to allow them to assess his response.
PCTs are often reluctant to authorize use of expensive drugs not recommended by NICE – this has been referred to as “NICE blight”. Even when a drug is not routinely available it is normal practice to allow its use in “exceptional” cases. A key element of the ruling by Judge Grenfell was that the definition of exceptional relied on by the PCT was so stringent that “it appeared to require applicants for treatment to be virtually unique” – he also considered that the PCT had “fallen into error” when considering cost-effectiveness.
Although it has been stressed in news reports that this ruling is not binding in other cases, it is to be hoped that it will influence other PCTs to be more flexible in considering similar applications. An irony of the case is that Velcade, which Mr Ross had received, is around the same cost as Revlimid and yet Mr Ross would have been able to continue to receive Velcade had he been able to tolerate the side-effects.
Reportedly Mr Ross’s health has deteriorated while he has been fighting the PCT ruling and it is now unclear how much benefit he will gain. While fully acknowledging the conflicting priorities facing PCTs, it is Leukaemia Research’s position that, where there is strong evidence for a drug’s effectiveness and clinician’s strongly recommend its use, patients should not be denied access merely because there is no NICE recommendation. Criteria for “exceptional” status should be applied flexibly and with compassion.
Technical note:
Revlimid belongs to a class of drugs collectively referred to as “imids”. These are derivatives of thalidomide, which are expected to be more clinically effective than thalidomide, while having less severe side effects. Although their mode of action is not fully understood, they appear to modulate the immune system’s behaviour (imid – refers to their “immunomodulatory” properties) and also influence the “cross-talk” between the malignant plasma cells and bone cells. There is evidence that they may also limit the growth of new blood vessels, which support the growth of myeloma masses in the marrow.
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