Cancer patients have expressed disappointment after the NHS drugs rationing body, Nice, refuses to recommend a bowel cancer drug for NHS patients.
The drug’s manufacturer’s, Roche, offered a complex deal which would see the price of the drug fixed at £20,800 for a year and would then be provided for free, along with a drug to be taken alongside it. When this was turned down Roche offered, in addition, to pay a payment to the NHS every time a new patient was started on the drug.
However, a panel of advisers at Nice, said this was a complex scheme that was likely to be expensive to administer and this threw into doubt the cost effectiveness of Avastin, also known as bevacizumab, for advanced bowel cancer.
Nice said the drug extended life by six weeks when compared with placebo.
Avastin
Roche claiming that Avastin often shrank tumours sufficiently to enable them to be removed by surgery.
The health watchdog NICE says the cost of avastin – at about £21,000 per patient – does not justify its benefits.
It offers patients with advanced bowel cancer the chance of a few extra weeks or months of life.
Cancer charities hope the new cancer drug fund set up by the government will give greater access to the treatment.
Avastin, also known as bevacizumab, works by reducing the blood supply to a tumour, causing it to shrink or stop growing.
Avastin can extend the lives of bowel cancer sufferers by at least two years and often much longer.
However, the Government rationing body NICE ruled yesterday that it must stay banned because it is too expensive.
The result is that thousands of sufferers with the advanced form of the disease will not get the drug on the NHS – despite the fact that those living in France, Germany, Italy, Scandinavia, Australia and Canada are all prescribed it for free.
The veto could mean that Avastin is one of the first treatments to be paid for by the Government’s new emergency cancer drugs’ fund, which it has pledged to launch in October.
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Drugs rationing body Nice was condemned as ‘completely discredited’ last night after it denied a life-extending drug to bowel cancer sufferers despite an offer by its maker to cut the price.
The decision to deny Avastin means patients will now be at the mercy of the new £250million cancer drugs fund, which was set up to provide ‘banned’ medicines.
The NHS is likely to miss out on the cut-price deal if it grants the drug under the new fund. Had Nice – the National Institute for Health and Clinical Excellence – accepted the risk-sharing offer from manufacturer Roche, the health service could potentially have saved millions of pounds.
Avastin is rated by oncologists as an important treatment, with ten times as many private patients receiving it as those on the NHS.
Although Nice looked at data showing the drug offered just six weeks’ extra life, specialists in other countries where it is readily available report a survival benefit close to eight months.
The U.S., Australia, Canada, Scandinavia, France, Germany, Italy and almost all EU countries meet the cost of Avastin. Surveys show the UK has a much lower uptake of new cancer drugs than other countries, and our survival rates lag behind.
The actual cost of supplying Avastin, also known as bevacizumab, is around £21,000 per patient.
But a complex formula used by Nice, which looks at quality of life and overall cost-effectiveness, hiked up the figure to £70,000.
Roche proposed a patient access scheme where the drug would cost the NHS £20,800 per patient for one year and would be free after 12 months.
Professor Karol Sikora, one of the UK’s leading cancer specialists, said the Nice rejection of the offer was ‘madness’.
The professor, who is director of Cancer Partners UK, a private provider of cancer services that works with the NHS, said: ‘Patients lose out all ways. Nice is completely discredited by this decision and has shown itself to be a bunch of bureaucrats that do not consider the best interests of the NHS or patients.’
In response to frequent criticism of Nice decisions, the Government has tabled proposals to strip the organisation of its role in rationing new drugs, transferring the function to GPs.
The new cancer fund has £50million to spend by March – and a further £200million next year – on drugs that are deemed necessary for patients by their doctors. It is thought up to 6,500 Britons a year with advanced bowel cancer could benefit from Avastin. Nice chief executive Sir Andrew Dillon said: ‘Bevacizumab is a very expensive drug and so patients and the NHS should expect substantial benefits from using it.
‘The evidence we have suggests that patients receiving bevacizumab and chemotherapy may survive on average for six weeks longer than patients receiving chemotherapy and placebo.’
Roche’s blockbuster drug Avastin helps women with ovarian cancer live longer without their disease getting worse, but its effect peaks at 12 months and then diminishes, researchers said on Monday.
Overall, the drug extends the time patients live without their disease getting worse by 1.5 months, Dr. Tim Perren from Leeds Teaching Hospitals NHS Trust, England, told the European Society for Medical Oncology (ESMO) congress.
There have been no significant new drugs for ovarian cancer since the mid-1990s and cancer doctors said Avastin could represent a step forward in managing the disease, although it is not the only new option being considered.
Other drugs are also starting to show encouraging signs in tests, including Amgen’s AMG 386.
Mondher Mahjoubi, Roche’s head of oncology, said ovarian cancer could add between 500 million Swiss francs and 1 billion ($500 million to $1 billion) to peak annual sales of Avastin, a product which sold some $6 billion worldwide in 2009 as a treatment for bowel, breast, lung and other cancers.
The bid by the world’s largest maker of cancer drugs to expand the reach of Avastin has run into problems this year, following unsuccessful trials in prostate and gastric cancer, and doubts about its use in breast cancer.
Success in ovarian cancer may offset those setbacks, although there is some uncertainty about how willing doctors and healthcare providers will be to use the drug widely in this setting, given its high cost.
Roche announced in July that Avastin as a first-line treatment after surgery helped women with ovarian cancer live longer without their disease getting worse in the so-called ICON-7 study, but full results were only unveiled in Milan.
An earlier U.S. study in June had also shown women lived longer without cancer growth.
U.S. regulators have extended by three months a review of Roche Holding AG’s blockbuster drug Avastin in breast cancer, the company said on Friday.
The Food and Drug Administration has made no decision on whether to revoke Avastin’s approval for treating breast cancer patients as an advisory panel has recommended, the FDA and the company said.
Roche unit Genentech said it had submitted additional information to the FDA on two applications to expand Avastin’s approved breast cancer uses to include combining the drug with other types of chemotherapy.
The new information prompted the FDA to extend the review of those uses until December 17, a Genentech statement said.
An FDA advisory panel that met in July urged the agency to reject those applications and to remove the drug’s current approval for breast cancer. There is no set timeline for an FDA ruling on whether to revoke the breast cancer approval, Genentech spokeswoman Charlotte Arnold said.
Avastin won U.S. clearance for breast cancer in 2008 based on a study showing the drug stalled cancer growth by 5.5 months. The FDA required Roche to run follow-up studies to confirm the drug worked. Later studies found only a one- to three-month delay in breast cancer growth.
http://www.reuters.com/article/idUSTRE68G5D820100917