“Pembrolizumab is a treatment for advanced skin cancer and is the first medicine to be approved through the Early Access to Medicines scheme (EAMS), launched in England last April.
“The idea is to get pioneering drugs to severely ill patients much sooner.
“Drugs signed off through EAMS have been scrutinised by regulators, weighing the risks and benefits.
“A green light by the Medicines and Healthcare products Regulatory Agency (MHRA) means doctors anywhere in the UK can prescribe the drug in question before normal licensing procedures – which can take years – are complete.”
“It is looking likely that patients with prostate cancer will, in certain circumstances, get ‘routine’ access to treatment with Bayer’s Xofigo (radium 223) on the National Health Service in England and Wales.
“The National Institute for Health and Care Excellence has published draft guideline’s endorsing the drug as an option to treat adults with hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases.
“But this only extends to patients who have already been treated with docetaxel, and the recommendation is contingent upon on Bayer providing the drug with a confidential discount agreed in a patient access scheme.
“Xofigo is a radio-pharmaceutical agent designed to directly deliver alpha radiation to bone metastases without affecting normal bone marrow. Bayer estimates the average cost for a six-month course with the drug (administered intravenously every four weeks) to be around £24,240.”
“Experts say that cancer patients are being failed as new figures show waiting time targets for treatment have been missed for the third consecutive quarter.
“The figures show that between July and September this year more than five thousand cancer patients have waited more than 62 days for treatment.
“The ’62-day-wait’ target was introduced to set a cap on the time between GP referral and the start of treatment for cancer patients.
“The target in England is for 85 per cent of patients to start their treatment within 62 days of their urgent referral.
“But today’s figures from NHS England show that for the last quarter only 83.5 per cent of patients began treatment within this window. This follows a worrying downward trend from 84.4 per cent and 84.1 per cent in the previous two quarters.
“Since the third quarter of last year (October – December 2013) there has been a 2.3 per cent fall in patients being treated within the two month target.
“Sarah Woolnough, Cancer Research UK’s executive director of policy and information, said: ‘This isn’t just about missed targets – consecutive breaches mean thousands of patients are being failed.’ “
“UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending UK pharma giant GlaxoSmithKline’s (LSE: GSK) Tafinlar (dabrafenib) for the treatment of melanoma which has spread or can’t be completely removed by surgery and tests positive for the BRAF V600 mutation.
“NICE proposes recommending dabrafenib on the basis that GSK provides the drug to the National Health Service with a discount on the list price. The size of the discount is commercial in confidence.
“Carole Longson, Centre for Health Technology Evaluation director at NICE, said: ‘For a long time the treatments available for skin cancer which has spread have been very limited. However, in recent years a number of breakthrough treatments that can potentially significantly improve the prognosis for some people with malignant melanoma have become available. NICE has already recommended vemurafenib and ipilimumab and we hope to add dabrafenib to the list of options available. The information provided by GlaxoSmithKline, who markets the drug, suggested that dabrafenib works just as well as vemurafenib which also targets melanoma with the BRAF V600 mutation. Drugs like dabrafenib are also thought to have very rapid positive effect for patients, even in those who are very unwell or bed-ridden. In some cases, it has enabled people to resume everyday activities.’ ”
Editor’s note: Tafinlar is a targeted drug used to treat patients whose melanoma has spread (metastasized) or cannot be removed by surgery, and has a mutation called BRAF V600, as detected by molecular testing.
“Patients with advanced skin cancer will be disappointed with news that cost regulators are planning to bar ‘routine’ first-line access to Bristol-Myers Squibb’s Yervoy (ipilimumab) on the National Health Service in England and Wales.
“The National Institute for Health and Care Excellence (NICE) has published draft guidelines recommending that the skin cancer treatment only be used by the NHS for patients in clinical trials, because current evidence is lacking.
“The Institute has already endorsed Yervoy as a second-line treatment for advanced malignant melanoma, but says the evidence provided by B-MS fails to conclusively show the degree to which the drug can extend life in previously untreated patients when compared with current standard care.”