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Cancer drug 'too expensive for NHS' Cancer drug 'too expensive for NHS'
(about 4 hours later)
A drug hailed as a breakthrough in extending the lives of men with late-stage prostate cancer is too expensive for use on the NHS, a watchdog said on Thursday.A drug hailed as a breakthrough in extending the lives of men with late-stage prostate cancer is too expensive for use on the NHS, a watchdog said on Thursday.
Leading cancer experts said the decision regarding abiraterone (also called Zytiga) was "disappointing" and a "huge blow" to patients who have very few treatment options left.Leading cancer experts said the decision regarding abiraterone (also called Zytiga) was "disappointing" and a "huge blow" to patients who have very few treatment options left.
Cancer Research UK said the draft decision by the National Institute for Health and Clinical Excellence (Nice), which is still open to consultation, made "no sense" and Nice had used the wrong criteria to judge the drug.Cancer Research UK said the draft decision by the National Institute for Health and Clinical Excellence (Nice), which is still open to consultation, made "no sense" and Nice had used the wrong criteria to judge the drug.
Nice, however, said CRUK had got its facts wrong. Contrary to what the cancer charity suggested, it had judged the cost of the drug to the NHS according to the number of men likely to be treated. Figures from the drug's manufacturer, Janssen, showed that 3,300 men would currently be eligible for abiraterone, which would rise to 5,500 in 2013.
The relatively large number of men to be treated meant the drug falls outside the special government provisions under which the NHS will pay more for end-of-life drugs for rare diseases, said Nice.
"There is no set threshold cost per QALY (quality-adjusted life year) of drugs that meet the end of life criteria, but since the supplementary advice was introduced, the highest cost per QALY of a recommended drug has been £50,000 (for renal cell carcinoma). Therefore the £63,200 cost per QALY for abiraterone would still not be deemed a cost effective use of NHS resources," said a Nice statement.
Abiraterone was developed by scientists at the Institute of Cancer Research (ICR) and the Royal Marsden in London after the discovery that some prostate cancers can produce their own testosterone.Abiraterone was developed by scientists at the Institute of Cancer Research (ICR) and the Royal Marsden in London after the discovery that some prostate cancers can produce their own testosterone.
It works in a new way, by blocking the production of male hormones in all tissues, not just the testes, including both the adrenal glands and the tumours themselves.It works in a new way, by blocking the production of male hormones in all tissues, not just the testes, including both the adrenal glands and the tumours themselves.
A phase III trial, reported last year in the New England Journal of Medicine, involved 1,195 patients from 13 countries.A phase III trial, reported last year in the New England Journal of Medicine, involved 1,195 patients from 13 countries.
All had stopped responding to standard hormone therapies as well as second-line treatments such as the chemotherapy drug docetaxil.All had stopped responding to standard hormone therapies as well as second-line treatments such as the chemotherapy drug docetaxil.
It showed that men survived an average of four months longer and suffered far less pain with abiraterone compared with those taking a placebo.It showed that men survived an average of four months longer and suffered far less pain with abiraterone compared with those taking a placebo.
Although the average extended survival time was four months, some men did much better, including two who were still alive after starting the treatment in 2007.Although the average extended survival time was four months, some men did much better, including two who were still alive after starting the treatment in 2007.
Abiraterone has been regarded as a "success story" for the ICR following more than two decades of work to develop the drug.Abiraterone has been regarded as a "success story" for the ICR following more than two decades of work to develop the drug.
Experts said it has not only improved survival for men with prostate cancer but has also changed the way scientists think about the disease.Experts said it has not only improved survival for men with prostate cancer but has also changed the way scientists think about the disease.
Nice has ruled that although abiraterone is clinically effective, it is not good value for money for the NHS at the price set by the manufacturer, Janssen.Nice has ruled that although abiraterone is clinically effective, it is not good value for money for the NHS at the price set by the manufacturer, Janssen.
A spokeswoman for the ICR said: "We are obviously disappointed with this preliminary decision.A spokeswoman for the ICR said: "We are obviously disappointed with this preliminary decision.
"We hope Nice will now work with the drug manufacturer to reach a solution that will make the drug more widely available to patients with advanced prostate cancer."We hope Nice will now work with the drug manufacturer to reach a solution that will make the drug more widely available to patients with advanced prostate cancer.
"An estimated 10,500 men in the UK have advanced prostate cancer that has become resistant to standard hormone treatments."An estimated 10,500 men in the UK have advanced prostate cancer that has become resistant to standard hormone treatments.
"We have had much success in the past few years in developing new drugs for advanced prostate cancer."We have had much success in the past few years in developing new drugs for advanced prostate cancer.
"Five new drugs have been shown in phase III testing to significantly extend life for men with advanced prostate cancer, and the ICR helped develop four of these, including abiraterone which was discovered at the ICR."Five new drugs have been shown in phase III testing to significantly extend life for men with advanced prostate cancer, and the ICR helped develop four of these, including abiraterone which was discovered at the ICR.
"None of these drugs are yet routinely available on the NHS."None of these drugs are yet routinely available on the NHS.
"With the real progress we are making towards personalised cancer medicine, it may now be time for a wider conversation about how we can make sure the right drugs are available for the right patients.""With the real progress we are making towards personalised cancer medicine, it may now be time for a wider conversation about how we can make sure the right drugs are available for the right patients."
Prof Peter Johnson, Cancer Research UK's chief clinician, said patients had been accessing abiraterone through the Cancer Drugs Fund, set up by the government to pay for treatments not approved by Nice.Prof Peter Johnson, Cancer Research UK's chief clinician, said patients had been accessing abiraterone through the Cancer Drugs Fund, set up by the government to pay for treatments not approved by Nice.
"This decision makes no sense," Johnson said. "Since it became available in the UK, abiraterone has been one of the most requested treatments from the Cancer Drugs Fund."This decision makes no sense," Johnson said. "Since it became available in the UK, abiraterone has been one of the most requested treatments from the Cancer Drugs Fund.
"This is because patients and doctors value the extra months of life it can give if prostate cancer has come back after chemotherapy. We need to find a way for it to be routinely available through the NHS."This is because patients and doctors value the extra months of life it can give if prostate cancer has come back after chemotherapy. We need to find a way for it to be routinely available through the NHS.
"At the moment it is too expensive and Nice must find a better way to ensure drugs that are already working for patients get approved.""At the moment it is too expensive and Nice must find a better way to ensure drugs that are already working for patients get approved."
He said the Cancer Drugs Fund is only available until 2014 and applies in England, preventing patients in Wales, Scotland and Northern Ireland accessing it.He said the Cancer Drugs Fund is only available until 2014 and applies in England, preventing patients in Wales, Scotland and Northern Ireland accessing it.
Johnson also questioned Nice's methodology, saying it used its usual criteria – the total number of men who would benefit and the cost posed by the manufacturer.Johnson also questioned Nice's methodology, saying it used its usual criteria – the total number of men who would benefit and the cost posed by the manufacturer.
But this decision should have only considered men who have the drug after chemotherapy, he said. Because fewer than 7,000 men would be given abiraterone after chemotherapy, the drug should have been judged according to Nice's end-of-life drugs criteria.But this decision should have only considered men who have the drug after chemotherapy, he said. Because fewer than 7,000 men would be given abiraterone after chemotherapy, the drug should have been judged according to Nice's end-of-life drugs criteria.
Johnson said: "Not only have Nice rejected an effective drug, they've also used the wrong criteria to judge its cost effectiveness.Johnson said: "Not only have Nice rejected an effective drug, they've also used the wrong criteria to judge its cost effectiveness.
"If they looked carefully at how many men would benefit, the overall cost could be more manageable than Nice's initial calculations indicated.""If they looked carefully at how many men would benefit, the overall cost could be more manageable than Nice's initial calculations indicated."
Dr Harpal Kumar, chief executive of Cancer Research UK, said: "We're hugely frustrated that Nice felt the drug wasn't good value for money.Dr Harpal Kumar, chief executive of Cancer Research UK, said: "We're hugely frustrated that Nice felt the drug wasn't good value for money.
"Generous public donations to Cancer Research UK and other organisations paid for the initial development of the drug and we feel extremely let down that the drug's manufacturer couldn't offer Nice a price they could agree on."Generous public donations to Cancer Research UK and other organisations paid for the initial development of the drug and we feel extremely let down that the drug's manufacturer couldn't offer Nice a price they could agree on.
"Nice should take another look at the way they have reviewed the cost-effectiveness of abiraterone."Nice should take another look at the way they have reviewed the cost-effectiveness of abiraterone.
"We hope this, and a revised offer from the manufacturer, will result in the drug being available to patients who desperately need it.""We hope this, and a revised offer from the manufacturer, will result in the drug being available to patients who desperately need it."
Owen Sharp, chief executive of the Prostate Cancer Charity, said: "Quite simply, abiraterone prolongs the life of men with incurable prostate cancer.Owen Sharp, chief executive of the Prostate Cancer Charity, said: "Quite simply, abiraterone prolongs the life of men with incurable prostate cancer.
"This draft decision is a bitter blow to thousands of men and their families, and must be overturned."This draft decision is a bitter blow to thousands of men and their families, and must be overturned.
"The drug is one of the biggest breakthroughs in the treatment of the disease for many years, and it will be devastating if this drug remains out of their reach when they need it the most."The drug is one of the biggest breakthroughs in the treatment of the disease for many years, and it will be devastating if this drug remains out of their reach when they need it the most.
"Abiraterone can increase the amount of time a man with advanced prostate cancer has left to live by an average of about four months and in a very human currency, this may give him the chance to walk his daughter down the aisle or see the birth of a grandchild.""Abiraterone can increase the amount of time a man with advanced prostate cancer has left to live by an average of about four months and in a very human currency, this may give him the chance to walk his daughter down the aisle or see the birth of a grandchild."
Sir Andrew Dillon, chief executive of Nice, said one of the key benefits of abiraterone is that it can be taken orally at home. "We are therefore disappointed not to be able to recommend it for use on the NHS.Sir Andrew Dillon, chief executive of Nice, said one of the key benefits of abiraterone is that it can be taken orally at home. "We are therefore disappointed not to be able to recommend it for use on the NHS.
"However, it is an expensive drug and the independent advisory committee that made this decision did not feel the drug provided enough benefit to patients to justify the price the NHS is being asked to pay, even with the discount that the manufacturer has offered.""However, it is an expensive drug and the independent advisory committee that made this decision did not feel the drug provided enough benefit to patients to justify the price the NHS is being asked to pay, even with the discount that the manufacturer has offered."
Nice said the drug was not appraised under end-of-life criteria because the population for which it is licensed "cannot be considered to be small".Nice said the drug was not appraised under end-of-life criteria because the population for which it is licensed "cannot be considered to be small".
Data on another drug for late-stage prostate cancer, MDV3100, is being presented on Thursday at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco.Data on another drug for late-stage prostate cancer, MDV3100, is being presented on Thursday at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco.
It has been shown to extend lives by almost five months and was also developed with the help of experts at the ICR and Royal Marsden.It has been shown to extend lives by almost five months and was also developed with the help of experts at the ICR and Royal Marsden.
A further drug, cabazitaxel (Jevtana) was rejected by Nice in January because of concerns about side-effects.A further drug, cabazitaxel (Jevtana) was rejected by Nice in January because of concerns about side-effects.
Each year about 37,000 men in the UK are diagnosed with prostate cancer and 10,000 die from the disease.Each year about 37,000 men in the UK are diagnosed with prostate cancer and 10,000 die from the disease.