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NHS postpone breakthrough 660-a-day hepatitis C drug
[sofosbuvir] over cost fears
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The NHS has faced criticism for intervening to delay the introduction of a costly but highly effective drug to combat hepatitis C
http://www.telegraph.co.uk/news/nhs/11349723/NHS-postpone-breakthrough-660-a-day-hepatitis-C-drug-over-cost-fears.html
By Telegraph Reporter
12:45AM GMT 16 Jan 2015
The NHS in England has made an unprecedented move to delay the introduction of a 660-a-day drug that could cure people with hepatitis C.
The National Institute of Health and Care Excellence (Nice) has approved the sofosbuvir on the grounds that it is a cost effective way to save the lives of people who would otherwise run up huge medical bills.
One in three hepatitis C sufferers will develop liver cirrhosis, leading to the need for a 50,000 live transfer, while others will get cancer.
But NHS England are understood to have delayed the introduction of the drug on the grounds that it will cost 1bn for every 20,000 treated. There are around 160,000 people in Britain with the disease, the Guardian reported.
Chief of executive of the Hepatitis C trust said: "It feels to me as if a whole new criterion has been invented by the backdoor. It is undoubtedly a high cost. The unfortunate thing is there are an awful lot of people who need it.
"We're talking about potentially hundreds of thousands of people. That becomes a massive budget-buster."
"Sofosbuvir has been hailed internationally as a miracle drug though worries about the high price tag are not unique to the UK."
The price given by the manufacturer to the NHS is around 35,000 for a 3 months course of treatment although many patients will need a 24-week course, costing 70,000.
Nice has said that the NHS in England will be able to postpone implementation of the drug for four months, until the end of July - not the original April target.
Indian regulators meanwhile refused to grant the drug's manufacturer a patent meaning that cheap generic versions could soon come to market.
The disclosure comes just days after the NHS announced plans to stop funding 25 treatments for cancer, including those for breast, prostate and bowel disease.
The NHS declined to comment.
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25 cancer drugs to be denied on NHS
Charities have expressed outrage as the NHS announced plans to stop funding 25 treatments for cancer, including those for breast, prostate and bowel disease
By Laura Donnelly and Gregory Walton
5:00PM GMT 12 Jan 2015
Eight thousand cancer patients are likely to have their lives cut short following a decision to withdraw NHS funding for 25 treatments.
Medication which offers a last chance to patients with cancer a year - including those with breast, prostate and bowel disease - will no longer be funded by the NHS, under plans to scale back spending from April.
Experts said that around two thirds of those who seek NHS treatment for advanced bowel cancer are likely to face an earlier death because of the decision.
Charities accused health officials of taking "a dramatic step backwards" and destroying a lifeline which prolongs the survival of thousands of cancer sufferers.
More than 3,000 patients a year with bowel cancer, and 1,700 patients with breast cancer are among those affected by the decision.
Drugs which will no longer receive funding have increased survival in some cases from eight months to two and a half years, charities said.
The Coalition introduced a special Cancer Drugs Fund in 2011, following a Conservative election manifesto pledge that treatments should no longer be denied on grounds of cost.
Although its budget was increased from 200 million to 280million, demand is such that it is now forecasting to have spent 380 million by the end of the financial year.
NHS England said it will increase the annual budget to 340 million but could not afford to continue paying for all the cancer treatments which are now funded.
Cases for whom funding is agreed before April will continue to receive the drugs on the NHS, which is likely to mean a desperate scrabble on behalf of terminally ill patients as the deadline looms.
The chairman of the fund said the review had taken "difficult decisions" to prioritise the drugs which offer the best value.
Of 84 treatments examined in the review, 59 will continue to be funded after March of this year, while 25 will be "delisted" - meaning they cannot normally be funded for NHS patients.
Five treatments for bowel cancer, four for leukaemia, three for breast cancer, three for lymphoma, three for sarcoma and drugs used to treat cancers of the prostate, ovaries, lung, pancreas and kidneys are among those which will no longer be funded.
Andrew Wilson, chief executive of the Rarer Cancers Foundation, said the decisions would be "devastating for patients".
He said: "If the Prime Minister is serious about his promise to cancer patients, he needs to bring together NHS England and the drugs companies to broker a deal to protect access to these drugs before the March deadline when patients will be denied treatment."
Mark Flannagan, chief executive of the charity Beating Bowel Cancer, said the decision meant around two thirds of patients with advanced bowel cancer were likely to face an earlier death.
He said: "These changes are a backward step in treatment for advanced bowel cancer. Doctors will be forced to tell their patients there are treatments that can prolong their lives but they will no longer be available."
He said some of the bowel cancer drugs had increased survival from 8 months to 30 months in some cases.
Prof Chris Bunce, research director at Leukaemia & Lymphoma Research, said decision to remove many effective drugs for blood cancers like leukaemia, lymphoma and myeloma from the list was a "dramatic step backwards."
He said: "Many of these treatments can significantly prolong survival times and provide a good quality of life for diseases that can have devastating symptoms."
Three drugs currently used to treat advanced breast cancer - Halaven, Tyverb and Afinitor - will no longer be funded.
More than 800 women a year are funded for Halaven, which extends the life of women with an especially aggressive form of the disease by almost five months on average.
Around half of women live longer than a year after receiving the drug, which costs around 10,000 for a six-month course of treatment, and is prescribed as standard care in 55 countries.
Samia al Qadhi, chief executive at Breast Cancer Care, said: "Thousands of breast cancer patients have today been denied the chance of improved quality of life and extra time with their loved-ones. This news is devastating for them."
She said the fund was "falling apart" while health officials and the pharmaceutical industry had failed to find any long-term solution to how to pay for cancer treatment.
Clinicians can still apply for their patient to receive a drug not available through the CDF on an "exceptional basis" - which means they have to demonstrate that their patient will gain more benefit from it than another given the same drug.
Just three new drugs will be funded, following the review: Panitumumab, a treatment for bowel cancer; Ibrutinib, a treatment for Mantle cell lymphoma, a type of non-Hodgkin lymphoma; and Ibrutinib for use in chronic lymphocytic leukaemia.
Professor Peter Clark, chairman of the fund, said: "We have been through a robust, evidence-based process to ensure the drugs available offer the best clinical benefit, getting the most for patients from every pound."
He said: "These are difficult decisions, but if we don't prioritise the drugs that offer the best value, many people could miss out on promising, more effective treatments that are in the pipeline."
The decisions follow a review by a national panel - comprising oncologists, pharmacists and patient representatives, which independently reviewed the drug indications currently available through the fund, plus new applications.
They assessment looked at at clinical benefit, survival and quality of life, the toxicity and safety of the treatment, the level of unmet need and the median cost per patient. In cases where the high cost of a drug would lead to its exclusion from CDF, manufacturers were given an opportunity to reduce prices.
Prof Lesley Fallowfield, Director of the Sussex Health Outcomes Research & Education in Cancer, University of Sussex, said she did not agree with the fund's existence, and said it was not clear why some drugs had stayed on the list, while others were delisted.
She said: "The latest list as far as I can see contains some surprising exclusions and inclusions and I can see why desperate patients, their families and clinicians are outraged."
"This whole issue of who wins when one has infinite demands on a finite budget can only be resolved with sane debate. This is unlikely to happen with a general election in the offing and all parties jostling for position as the most cancer patient friendly."
Lord Darzi, a former Labour health minister, said on Monday that the NHS should stop needlessly treating dying patients, to help finance the soaring cost of new cancer drugs.
He told The Times that cutting down on unnecessary tests and treatments with little chance of success would free money to spend on the expensive modern medicines that the health service struggles to afford.
The drugs which will no longer normally receive NHS funding:
Bowel cancer
Aflibercept for metatstatic bowel cancers
Bevacizumab as a first line treatment for advanced bowel cancer
Cetuximab as a second or third line treatment for metasatic bowel cancer
Breast cancer
Lapatinib, for advanced breast cancer.
Eribulin for advanced breast cancer
Everolimus for advanced breast cancer
Kidney
Everolimus for metastatic kidney cancers
Leukaemia
Bosutinib when used in the treatment of some Chronic Myelois leukaemia, including where patients have an intolerance for other treatments
Dasatinib, for lymphoid blast crisis chronic myeloid leukaemia
Ofatumumab, for chronic lymphocytic leukaemia
Lung cancer
Pemetrexed when used to treat advanced non-squamous non-small cell lung cancer
Lymphoma
Bendamustine for some cases of non-Hodgkin's lymphoma
Bortezomib in treatment of relapsed/refractory mantle cell lymphoma
Bortezomib for relapsed Waldenstrom macroglobulinaemia, a rare type of non-Hodgkin lymphoma
Myeloma:
Bortezomib for some cases of relapsed multiple myeloma
Pancreatic cancer
Everolimus for some pancreatic cancers
Prostate
Cabazitaxel for advanced hormone-resistant advanced prostate cancer, when disease has progressed in spite of chemotherapy.
Reproductive cancers
Bevacizumab as a second-line treatment for advanced ovarian and Fallopian cancers
Sarcoma
Pazopanib for soft-tissue sarcomas
Pegylated Liposomal Doxorubicin for some sarcomas
Regorafenib for gastro-intestinal stromal tumours, a rare type of sarcoma
Number of patients who will be affected by the new restrictions:
Breast cancer 1765
Colorectal cancer 3239
Lung cancer 573
Prostate cancer 465
Sarcoma 262
Kidney cancer 284
Ovarian cancer 403
Myeloma 106
Lymphoma 373
Leukaemia 119
Neuroendocrine 116
Total number of cancer patients affected: 7705
Analysis by The Rarer Cancers Foundation, which calculated the projected impact of the decision to remove 25 treatments from the Cancer Drugs Fund using NHS England's figures of the number of patients who received these treatments through the fund in 2013/14.
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