NICE hails ‘breakthrough’ skin cancer treatments
pharmafile | November 2, 2012 | News story | Sales and Marketing | BMS, NICE, Roche, Yervoy, Zelboraf
Two new skin cancer drugs have been recommended by NICE, which hailed the drugs as ‘breakthrough treatments’.
Bristol-Myers Squibb’s Yervoy (ipilimumab) and Roche’s Zelboraf (vemurafenib) have both gained approval for use against advanced melanoma, despite their high cost.
Professor Carole Longson, Health Technology Evaluation Centre director at NICE said current treatments for advanced melanoma are very limited in their benefits, but added the two drugs were part of a wave of new treatments for the disease.
“These new draft recommendations represent really good news for skin cancer patients. 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.”
The positive outcome was not always assured for either product, however. NICE rejected Yervoy in its first draft appraisal, but BMS supplied additional data and analysis regarding the cost effectiveness of the drug, and also submitted a patient access scheme. NICE says this enabled its Committee to recommend the drug as a cost effective use of NHS resources.
Meanwhile the draft guidance on Zelboraf also called for further clarification on data before it could be recommended. Roche supplied the data to NICE’s satisfaction, resulting in a very rare situation of two new innovative cancer treatments being approved by the watchdog.
Yervoy costs on average around £20,000 per dose and each patient will receive four doses. Zelboraf costs around £1,750 per week, but the patient access scheme agreed between Roche and the Department of Health will mean the NHS will pay less.
The two rival drugs have shown a broadly similar efficacy, extending the median survival of patients by up to four months compared to existing chemotherapy treatment.
There are a number of key differences, however. The most obvious is that Zelboraf can only treat patients with the BRAF V600 gene. The gene mutation is expressed in around 50% of patients with inoperable metastatic melanoma, mutation positive unresectable or metastatic melanoma, which means they must undergo a diagnostic test to confirm they carry it.
Despite only being available for around half of all patients, Zelboraf has been shown to work very quickly against patients’ cancer. However this response does not usually last long, and is often followed by treatment resistance.
By contrast, Yervoy is slow to take effect, and only about one in four patients respond, but these responses can be very long-lasting.Yervoy could emerge as the better treatment for patients in earlier stages of disease, when immunotherapy has a better chance for success.
The drug is also unlikely to benefit patients who have aggressive disease or a large tumour, so Zelboraf is likely to be more beneficial to these patients. Both drugs can be used as first or second line treatment, but most analysts agree that Yervoy will be favoured as the front line treatment ahead of Zelboraf.
Yervoy was launched in August 2011 and Zelboraf in February 2012, and have been among the medicines used via the Cancer Drugs Fund (CDF), which operates in England only.
John Melville, managing director, Roche UK said: “Today is a landmark day for metastatic melanoma patients who will now have access to Zelboraf, a treatment that extends and improves quality of life. All patients should now be tested to see if they are BRAF mutation positive in order to determine eligibility for treatment with this personalised medicine.”
Malignant melanoma disproportionately affects young people and is now the second most common cancer in people aged 15-34 in the UK. Rates of malignant melanoma have risen faster than any other common cancer, with an estimated 2,000 people dying from the disease annually in this country. It is estimated that overall cases of melanoma will rise by 52% by 2030 – the biggest projected increase of any other cancer.
Related Content
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
Roche receives CE Mark for blood test to help rule out Alzheimer’s
Roche has been granted CE Mark approval for its Elecsys pTau181 test, the first in …
Roche candidate shows early promise for treating haemophilia A
Roche has announced encouraging early results from its phase 1/2 trial of NXT007, an investigational …
