Four Primary Care Trusts (PCTs) have abandoned their policy of using a cheaper cancer drug to treat patients with wet age-related macular degeneration (AMD) instead of Novartis' Lucentis (ranibizumab), which is licensed for this indication.
The policy, approved last September by the Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) PCT Cluster, made Roche's bowel cancer drug Avastin (bevacizumab) available for the treatment of wet AMD - for which it is not licensed - ahead of Lucentis, which is recommended for this use by the National Institute for Health and Clinical Excellence (NICE).
Following the PCT’s Cluster’s decision, Novartis had sought and obtained a judicial review of its commissioning policy.
The Board of the Cluster now says that this judicial review has made the policy difficult to implement. Also, consultant ophthalmologists have not taken it up in any meaningful way on the advice of their Royal College and, as a result, "the potential benefits we had envisaged, to both patients and the NHS, of offering Avastin as well as Lucentis, had not been realised," said the Board's chairman, Professor Jonathan Montgomery.The Board has also agreed that "taking advantage of the significant discounts now being made available by Novartis, which have been introduced since the policy was agreed, was in the best interests of local patients," he added.
The policy had been difficult to implement for a number of reasons, said the Board. The court challenge meant that, until legal proceedings were concluded, the Cluster was unable to exert its policy with commissioned providers. Also, with the PCTs handing over commissioning authority to the clinical commissioning groups (CCGs) next April, and given the potential length of time needed to complete legal proceedings, it would find it increasingly difficult to commit CCGs to the policy.
Should the judicial review not conclude before next April, or alternatively become the subject of an appeal, the PCT "would be leaving an undesirable legal legacy for its successors" - CCGs and the local area team of the National Commissioning Board," it added.
Also, while new evidence has emerged in the last year which shows both Avastin and Lucentis to be very effective and broadly equivalent in efficacy in the treatment of wet AMD, further evidence will not be available for another 12-18 months, when the IVAN study, which involves scientists and eye specialists from 23 hospitals and UK universities, reaches its two-year conclusion.And, following guidance from the Royal College of Ophthalmologists which supports the continued use of Lucentis under the circumstances allowed for by NICE guidance, NHS consultant ophthalmologists have, on the whole, chosen not to prescribe Avastin, it said.
Despite their ongoing legal proceedings, discussions between the PCT Cluster and Novartis have continued and resulted in agreement for "significant improvements" in the cost of prescribing Lucentis which form part of new arrangements under a national Patient Access Scheme (PAS) which Novartis can now make available to NHS providers across the country, the Board adds.
The Association of the British Pharmaceutical Industry (ABPI) said it welcomed the Board's decision to revoke a policy that had supported the use of a medicine which was unlicensed for the indication, in place of a licensed medicine which had already gained full regulatory approval."It continues to be our view that off-label and unlicensed prescribing should be strictly limited to those circumstances where there is no licensed alternative and where the clinician, in discussion with the patient, decides that this is in their best interests," said the Association's chief executive, Stephen Whitehead.
"Loosening the regulations in this area would not only put a patient's safety at risk, it would also undermine the entire regulatory process which is in place to protect public health," Mr Whitehead added.
