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The new final draft guidance recommends the use of Yervoy in people who have received prior chemotherapy.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Since the publication of the first draft guidance, which NICE failed to recommend the use Yervoy due to its £80,000 price tag, BMS provided additional data and analysis surrounding the cost-effectiveness of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.

NICE has again requested more information from Roche on its skin cancer drug Zelboraf (vemurafenib) after failing to recommend the treatment for a second time in draft guidance.

Its independent Appraisal Committee raised concerns over the evidence supplied from the BRIM3 study and questioned the drug’s long-term benefits.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said the Committee required “further clarification” in order to make a final recommendation to the NHS.

Further analysis was requested by NICE during an earlier draft guidance published in June 2012. Roche provided additional information on the cost effectiveness of the drug – as well as agreeing terms with the DH to supply Zelboraf as part of a patient access scheme.

However, NICE concluded that further data is still needed on the effectiveness of the drug in relation to its cost. It has now asked Roche to supply evidence on disease progression and additional scenario analysis when compared to existing treatments.

“We hope that Roche will be able to provide this additional information so that the Committee can consider it at its next meeting on the topic,” said Professor Longson.

NICE has failed to recommend Roche’s cancer drug Zelboraf (vemurafenib) for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma in draft guidance.

Its independent Appraisal Committee had uncertainties over the evidence supplied by NICE and deemed the treatment too expensive.

Sir Andrew Dillon, Chief Executive of NICE, said Zelboraf is an “expensive drug” and that its “long term benefits are difficult to quantify”.

Roche’s data came from the BRIM3 trial which compared Zelboraf with a current treatment, dacarbazine. Results showed how Zelboraf was effective for patients with skin cancer with the BRAF 600 mutation.

But its long-term effectiveness was “uncertain”, NICE said, due to patients receiving dacarbazine taking other treatments after their disease had progressed.

Roche had agreed a Patient Access Scheme for the use of Zelboraf on the NHS. However, the discount failed to convince NICE the treatment offers value for money.

It’s estimated that less than 1,000 people in England and Wales each year would be eligible for treatment with Zelboraf.

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.”

Roche has launched its skin cancer drug Zelboraf (vemurafenib) in the UK for adults with unresectable or metastatic melanoma who test positive for the BRAF V600 genetic mutation.

The treatment was licensed by the European Commission last month for use as a single-agent therapy after it demonstrated in clinical trials that patients lived an average of 13.2 months longer than with standard chemotherapy.

Professor Alan Ashworth, CEO, Institute of Cancer Research, said it was pleasing that patients would be able to benefit from the personalised medicine.

Alongside Zelboraf, Roche has also launched a companion biomarker test to identify patients who could benefit from the advanced melanoma treatment.

In clinical trials conducted in the UK, patients with BRAF-mutant advanced cancers were shown to be almost nine times more likely to respond to Zelboraf than to standard chemotherapy.

The FDA approved the use of the cancer drug for a similar indication in August 2011. NICE is currently appraising the treatment with guidance expected to be issued in October.

Analysts have already predicted that annual sales of the drug may reach up to $1.5bn.