Scottish watchdog rejects Yervoy
pharmafile | May 14, 2012 | News story | Sales and Marketing | BMS, Cancer, NICE, SMC, Yervoy, melanoma
The Scottish Medicines Consortium is not recommending Bristol-Myers Squibb’s melanoma treatment Yervoy.
The SMC said that Yervoy (ipilimumab), which has a licence to treat advanced melanoma as a second line treatment, was too costly for the NHS in Scotland.
The SMC also said that Bristol-Myers Squibb did “not present a sufficiently robust economic case to gain acceptance by SMC”.
But the body did say that Yervoy could extend survival compared to an investigational gp100 peptide vaccine used in previously treated patients with advanced melanoma.
BMS offered a patient access scheme for the drug reducing its overall cost of £75,000 by an undisclosed amount, but this still wasn’t enough to sway the SMC.
Amadou Diarra, European VP and general manager of BMS UK and Ireland, said:“Ipilimumab is a prime example of an innovative medicine that has the potential to offer significantly improved outcomes.
“We are disappointed that the SMC has failed to recognise the value of Ipilimumab and we will continue to work closely with the authorities to try to find an outcome that will enable Scottish patients to access this potentially life-extending treatment.”
Leigh Smith, chair of Melanoma Action and Support Scotland, said: “Today’s announcement is incredibly disappointing.
“It leaves many Scottish patients suffering from this devastating disease with no option but to consider moving to England where funding for the treatment can potentially be accessed.
“We hope that the SMC will consider all options available that might enable Scottish patients to benefit from this treatment.”
The treatment is currently available to patients in England via the Cancer Drugs Fund, which pays for new cancer medicines that have not been recommended by NICE, or are undergoing an appraisal.
The £200 million Fund is not available to patients in Wales, Scotland or Northern Ireland.
NICE decision
NICE is currently minded not to recommend the drug in draft guidance, citing the treatment’s £75,000 cost as being too much for the NHS.
The watchdog was due to make its final draft decision on Yervoy last month, but BMS requested to make a further submission to NICE to include new clinical data that “may address uncertainties in the evidence base considered by watchdog”.
NICE said this move was of an ‘exceptional nature’, but agreed that the appraisal can be referred back to the appraisal committee, extending the time of the drug’s review.
Yervoy is a T-cell potentiator that specifically blocks the inhibitory signal of cytotoxic T-lymphocyte antigen-4 (CTLA-4), resulting in T-cell activation, proliferation and lymphocyte infiltration into tumours, leading to cell death.
It has a novel mechanism of action, stimulating the body’s immune system to target and destroy the tumour – it is the first medicine to be licensed in the UK for the treatment of advanced melanoma in adults who have received prior therapy.
It is given by intravenous infusion every three weeks for a total of four doses, at a total cost of £75,000.
Ben Adams
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