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Drugs watchdog thwarting UK progress in stem cell therapy, report says Drugs watchdog thwarting UK progress in stem cell therapy, report says
(3 months later)
Britain's hopes of leading the world in revolutionary therapies that regenerate damaged body parts are under threat because the NHS drugs watchdog cannot properly evaluate them, a report says.Britain's hopes of leading the world in revolutionary therapies that regenerate damaged body parts are under threat because the NHS drugs watchdog cannot properly evaluate them, a report says.
The National Institute for Health and Care Excellence (Nice) decides which treatments are made available on the NHS but has no effective means to assess the value of expensive one-off interventions that are likely to cure patients, a Lords inquiry found.The National Institute for Health and Care Excellence (Nice) decides which treatments are made available on the NHS but has no effective means to assess the value of expensive one-off interventions that are likely to cure patients, a Lords inquiry found.
The situation leaves companies and researchers in the dark about how much the NHS would pay for the new treatments, and casts uncertainty over whether they can earn enough to recoup their costs, the report says.The situation leaves companies and researchers in the dark about how much the NHS would pay for the new treatments, and casts uncertainty over whether they can earn enough to recoup their costs, the report says.
The lack of assurances will discourage investors in the UK and slow progress in a field that the chancellor, George Osborne, is banking on to be one of the eight great technologies that rescue the economy.The lack of assurances will discourage investors in the UK and slow progress in a field that the chancellor, George Osborne, is banking on to be one of the eight great technologies that rescue the economy.
Clinical trials with stem cells and other cell-based techniques are under way to treat a range of diseases that are largely incurable with modern medicine, including common forms of blindness, cancer, heart disease and HIV.Clinical trials with stem cells and other cell-based techniques are under way to treat a range of diseases that are largely incurable with modern medicine, including common forms of blindness, cancer, heart disease and HIV.
But the peers' report says the UK is underprepared for the new era of medicine. It claims the economic models used by Nice are inappropriate and fail to consider the financial benefits of cures that free patients from ongoing medical care and in many cases may allow them to return to work.But the peers' report says the UK is underprepared for the new era of medicine. It claims the economic models used by Nice are inappropriate and fail to consider the financial benefits of cures that free patients from ongoing medical care and in many cases may allow them to return to work.
"Under the current evaluation mechanism, a cure would only be considered affordable if it cost no more than two years of conventional therapy," the report says. "This situation is clearly unacceptable.""Under the current evaluation mechanism, a cure would only be considered affordable if it cost no more than two years of conventional therapy," the report says. "This situation is clearly unacceptable."
The problem arises because Nice mostly deals with drugs that are taken over time, and often many years, which spreads out the costs to the NHS. But stem cell and other cell-based therapies are expected to be single-shot treatments that cost more up front but save money in the long run.The problem arises because Nice mostly deals with drugs that are taken over time, and often many years, which spreads out the costs to the NHS. But stem cell and other cell-based therapies are expected to be single-shot treatments that cost more up front but save money in the long run.
Sir John Krebs, chair of the Lords science and technology committee, said Nice must find new ways to assess the affordability of regenerative medicines, to ensure worthwhile treatments are developed and make it into clinics. Other countries such as France, Germany, Italy and Spain already allow higher prices for innovative new treatments.Sir John Krebs, chair of the Lords science and technology committee, said Nice must find new ways to assess the affordability of regenerative medicines, to ensure worthwhile treatments are developed and make it into clinics. Other countries such as France, Germany, Italy and Spain already allow higher prices for innovative new treatments.
"They need a new approach to the way they look at therapies that are truly transformative," said Chris Mason, professor of regenerative medicine at UCL. "Nice is not geared up for anything other than a pill every day for life, and that's where the system breaks down.""They need a new approach to the way they look at therapies that are truly transformative," said Chris Mason, professor of regenerative medicine at UCL. "Nice is not geared up for anything other than a pill every day for life, and that's where the system breaks down."
Mason cited as an example Gaucher's disease, an inherited disorder that causes fatty deposits to build up in certain organs and tissues. The annual cost of treatment is $200,000 (£130,000), and patients may live for tens of years. A $1m cell-based therapy that cured the disease would be cost-effective after just five years, but such an expensive upfront cost would make Nice baulk.Mason cited as an example Gaucher's disease, an inherited disorder that causes fatty deposits to build up in certain organs and tissues. The annual cost of treatment is $200,000 (£130,000), and patients may live for tens of years. A $1m cell-based therapy that cured the disease would be cost-effective after just five years, but such an expensive upfront cost would make Nice baulk.
The peers said changes at the watchdog must happen alongside a major effort to encourage the NHS to adopt regenerative medicines. "Without the market pull of the NHS and clearer reimbursement there will be no UK cell therapy industry," Mason told the Guardian.The peers said changes at the watchdog must happen alongside a major effort to encourage the NHS to adopt regenerative medicines. "Without the market pull of the NHS and clearer reimbursement there will be no UK cell therapy industry," Mason told the Guardian.
The report goes on to criticise the UK's "labyrinthine" regulatory system, which is so complex that researchers seeking approval for a therapy might go through 11 separate UK and European bodies to gain the green light for a treatment. Researchers who gave evidence to the inquiry said the system was so tortuous it had a demoralising effect on workers in the field.The report goes on to criticise the UK's "labyrinthine" regulatory system, which is so complex that researchers seeking approval for a therapy might go through 11 separate UK and European bodies to gain the green light for a treatment. Researchers who gave evidence to the inquiry said the system was so tortuous it had a demoralising effect on workers in the field.
To reduce bureaucracy, the peers call on the Health Research Authority to streamline the regulatory process as a matter of urgency and immediately set up an advice service to help researchers and companies navigate the system in the meantime.To reduce bureaucracy, the peers call on the Health Research Authority to streamline the regulatory process as a matter of urgency and immediately set up an advice service to help researchers and companies navigate the system in the meantime.
Though cell therapies hold real promise for patients, the peers urge the government to create a website that gives details of untested and potentially dangerous treatments offered around the world. The site would be run along the same lines as the Foreign and Commonwealth Office's travel advice web pages.Though cell therapies hold real promise for patients, the peers urge the government to create a website that gives details of untested and potentially dangerous treatments offered around the world. The site would be run along the same lines as the Foreign and Commonwealth Office's travel advice web pages.
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