NICE has reversed its opinion on the use of Bristol-Myers Squibb’s Yervoy (ipilimumab) and Roche’s Zelboraf (vemurafenib) for the treatment of advanced malignant melanoma.

The new final draft guidance recommends the use of Yervoy in people who have received prior chemotherapy.

Zelboraf is also recommended for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma.

The U-turn came after both manufacturers agreed to supply the treatments at a discounted rate under the terms of separate patient access schemes with the Department of Health.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the updated guidance was “really good news” for patients with skin cancer.

“Vemurafenib and ipilimumab are breakthrough treatments that can potentially significantly affect prognosis for these patients and we are very pleased that the manufacturers have worked with us so that we are now able to recommend both ipilimumab and vemurafenib,” said Professor Longson.

Since the publication of the first draft guidance, which NICE failed to recommend the use Yervoy due to its £80,000 price tag, BMS provided additional data and analysis surrounding the cost-effectiveness of the drug.

Roche also supplied additional analysis on the effectiveness of the drug in relation to its clinical and cost effectiveness.

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.”

NICE has failed to recommend Bristol-Myers Squibb’s (BMS) Yervoy (ipilimumab) for advanced melanoma, deeming its £80,000 price tag too costly.

NICE’s Appraisal Committee based its decision on clinical data that suggested the drug could be very effective for a small percentage of patients with advanced skin cancer who have received prior chemotherapy – but it was unknown how long this effect would last.

Sir Andrew Dillon, Chief Executive of NICE said: “We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost the NHS is being asked to pay.”

Clinical specialists said that approximately 30% of people treated with the medicine would have improved survival, with 10% potentially experiencing long-term benefits.

Sir Andrew added: “Unfortunately, no patient characteristics or biomarkers have yet been identified to help identify this small group of people most likely to gain long-term benefit from receiving ipilimumab.”

The Committee also cited that Yervoy is associated with a number of adverse reactions including diarrhoea, rash, fatigue, nausea, vomiting, decreased appetite, and abdominal pain.

BMS expressed its disappointment at NICE’s rejection, and have stated it will submit further evidence “in the hope that NICE will reconsider this decision so that all patients with metastatic melanoma can access this potentially life‐extending treatment”.

“In a deadly disease with no standard of care, where inclusion in a clinical trial has been considered one of the few treatment options available to patients, Yervoy represents a significant innovation in treatment,” said Amadou Diarra, European Vice President and General Manager at BMS UK.

Dr Pippa Corrie, Consultant Medical Oncologist at Cambridge University Hospitals NHS Foundation Trust, commented: “Treatment for metastatic melanoma is a huge unmet need, with many patients facing a life expectancy of 6‐9 months. It is essential that we all work to avoid any negative impact on facilitating patient access to this drug. Our patients have waited too long already.”

Consultees are now able to comment on the preliminary recommendations which are available for public consultation. The manufacturer will be able to reduce the acquisition cost of £80,000 to the NHS for ipilimumab by proposing a Patient Access Scheme.

BMS gained approval to market Yervoy in the US in March 2011, with an approval from the European Commission in July. The drug was launched in the UK in August 2011, becoming the first licensed treatment for advanced skin cancer since the 1970s.

There are approximately 40,000 deaths worldwide from skin cancer, with the number of cases predicted to double from 138,000 a year to 227,000 by 2019.

Yervoy (ipilimumab, pictured) has become the first licensed treatment for advanced skin cancer launched in the UK since the 1970s.

The Bristol-Myers Squibb drug has been shown to almost double life expectancy after a year in Phase III trials and works by stimulating the body’s own immune system to fight cancer.

Dr Paul Lorigan, Senior Lecturer in Medical Oncology, the Christie NHS Foundation Trust, says the license ‘represents a real advance’ in treating skin cancer.

NICE is still conducting its appraisal of Yervoy for use on the NHS, although patients can apply to the Government’s Cancer Drugs Fund to receive the injection.

In the pivotal Phase III clinical trial, almost half (46%) of patients were still alive after a year when receiving Yervoy, compared to a quarter who were treated with a vaccine called gp1003.

Patients are injected four times with Yervoy at a cost of around £75,000. Despite the high cost of the treatment, Dr Lorigan insists the authorisation by the EMA is a “stride forward” for patients.

“The authorisation of ipilimumab represents a real advance in the treatment of patients with advanced melanoma because it is the first treatment to be licensed in the UK for 30 years that may extend patients’ life expectancy,” said Dr Lorigan.

The current standard of treatment, dacarbazine, has been used in the UK for the last three decades.

Yervoy has also been approved by the FDA in the US.

Bristol-Myers Squibb (BMS) has received approval from the European Commission for Yervoy (ipilimumab), to treat patients with previously-treated advanced melanoma.

Yervoy, an immunotherapy, demonstrated long-term survival in patients with advanced melanoma in a randomised, double-blind Phase III study.

The new treatment uses immuno-oncology to indirectly target the tumour by stimulating the patient’s immune system to recognise and eliminate cancer cells.

Ron Cooper, President of Bristol-Myers Squibb Europe, stated: “The European Union approval of Yervoy is a milestone for patients with advanced disease and is the first outcome of Bristol-Myers Squibb's commitment to immuno-oncology.”

The one and two-year estimated survival rates for patients treated with Yervoy were 46% and 24% respectively.

BMS will now work with local health authorities to make Yervoy available across the European Union.

Prior to approval, BMS provided Yervoy to almost 3,000 patients throughout Europe through Compassionate Use/Named Patients Programmes.