Bristol-Myers Squibb has expressed its disappointment after the Scottish Medicines Consortium (SMC) failed to recommend its skin cancer drug Yervoy (ipilimumab).
The SMC decided against approving the treatment for advanced (unresectable or metastatic) melanoma in adults who have received prior therapy after questioning its clinical benefits in relation to its cost.
Amadou Diarra, European Vice-President and General Manager, BMS UK and Ireland, said the company would continue to work with the SMC to “enable Scottish patients to access this potentially life-extending treatment.”
Around 1,200 people in Scotland are diagnosed with malignant melanoma each year. Its incidence is rising in the country at an epidemic rate.
Within the appraisal submitted by BMS, the SMC recognised how Yervoy is the first licensed medicine in the UK to demonstrate survival benefits in patients with skin cancer who have received prior treatment.
Data from a pivotal Phase III trial demonstrated how almost half (46%) of patients treated with Yervoy were still alive after 12 months of treatment compared to 25% taking the vaccine gp100.
The median overall survival was 10.1 months in those receiving Yervoy, compared with 6.4 months among those receiving gp100.
However, despite BMS also providing the treatment under the terms of a Patient Access Scheme to reduce the cost of Yervoy, the SMC did not believe it offered value for money to the NHS in Scotland.
“Ipilimumab is a prime example of an innovative medicine that has the potential to offer significantly improved outcomes,” said Amadou Diarra. “We are disappointed that the SMC has failed to recognise the value of Ipilimumab.”
Since it was licensed in Europe in July last year, eligible patients in England have been able to receive the treatment. During the same period, a number of patients have attempted to access Yervoy through an Individual Patient Treatment Request (IPTR). But, as far as BMS is aware, no IPTRs have been approved.
Leigh Smith, Chair of the Melanoma Action and Support Scotland, called the decision “incredibly disappointing” and said the decision by the SMC will drive patients south of the border.
“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,” she said. “We hope that the SMC will consider all options available that might enable Scottish patients to benefit from this treatment.”
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