Scottish watchdog rejects Yervoy
Published on 14/05/12 at 02:55pm
The Scottish Medicines Consortium is not recommending Bristol-Myers Squibb’s melanoma treatment Yervoy.
The SMC said that Yervoy (ipilimumab), which is seeking a licence to treat advanced melanoma as a second line treatment, was too costly for the NHS in Scotland.
The SMC also said that Bristol-Myers Squibb did “not present a sufficiently robust economic case to gain acceptance by SMC”.
But the body did say that Yervoy could extend survival compared to an investigational gp100 peptide vaccine used in previously treated patients with advanced melanoma.
BMS offered a patient access scheme for the drug reducing its overall cost of £75,000 by an undisclosed amount, but this still wasn’t enough to sway the SMC.
Amadou Diarra, European VP and general manager, BMS UK and Ireland, said, “Ipilimumab is a prime example of an innovative medicine that has the potential to offer significantly improved outcomes.
“We are disappointed that the SMC has failed to recognise the value of Ipilimumab and we will continue to work closely with the authorities to try to find an outcome that will enable Scottish patients to access this potentially life-extending treatment.”
Leigh Smith, chair of Melanoma Action and Support Scotland, said: “Today’s announcement is incredibly disappointing.
“It leaves many Scottish patients suffering from this devastating disease with no option but to consider moving to England where funding for the treatment can potentially be accessed.
“We hope that the SMC will consider all options available that might enable Scottish patients to benefit from this treatment.”
The treatment is currently available to patients in England via the Cancer Drugs Fund, which pays for new cancer medicines that have not been recommended by NICE, or are undergoing an appraisal.
The £200 million Fund is not available to patients in Wales, Scotland or Northern Ireland.
NICE decision
NICE is currently minded not to recommend the drug in draft guidance, citing the treatment’s £75,000 cost as being too much for the NHS.
The watchdog was due to make its final draft decision on Yervoy last month, but BMS requested to make a further submission to NICE to include new clinical data that “may address uncertainties in the evidence base considered by watchdog”.
http://www.inpharm.com/news/172625/scottish-watchdog-rejects-yervoy?
NICE said this move was of an ‘exceptional nature’, but agreed that the appraisal can be referred back to the appraisal committee, extending the time of the drug’s review.
Monday, May 14, 2012
Let the Mediator mess begin
French trial opens in diabetes-diet drug scandal
NANTERRE, France (AP) -- The first French trial has begun over a diabetes drug that was also used to lose weight and is suspected in the deaths of at least 500 people.
The pharmaceutical group Servier is suspected of "aggravated deception" for hiding the fact that the drug known as Mediator contained an amphetamine called benfluorex - which was taken off the market in 2009 after being found to thicken heart valves.
However, another investigation is underway and lawyers for Servier were arguing Monday against holding the current trial claiming that the laboratory could be judged twice on the same grounds.
http://hosted.ap.org/dynamic/stories/E/EU_FRANCE_DIABETES_DRUG_?SITE=AP&SECTION;=HOME&TEMPLATE;=DEFAULT
NANTERRE, France (AP) -- The first French trial has begun over a diabetes drug that was also used to lose weight and is suspected in the deaths of at least 500 people.
The pharmaceutical group Servier is suspected of "aggravated deception" for hiding the fact that the drug known as Mediator contained an amphetamine called benfluorex - which was taken off the market in 2009 after being found to thicken heart valves.
However, another investigation is underway and lawyers for Servier were arguing Monday against holding the current trial claiming that the laboratory could be judged twice on the same grounds.
http://hosted.ap.org/dynamic/stories/E/EU_FRANCE_DIABETES_DRUG_?SITE=AP&SECTION;=HOME&TEMPLATE;=DEFAULT
Friday, May 11, 2012
The Pain Connection
U.S. Senate panel launches investigation of painkillers, drug companies
The U.S. Senate Committee on Finance has opened a bipartisan investigation into financial relationships between companies that make narcotic painkillers and various nonprofit organizations that have advocated their use for the treatment of pain.
Citing investigative reports by the Milwaukee Journal Sentinel/MedPage Today and others, the committee is seeking financial and marketing records from three companies that make opioid drugs, including Oxycontin and Vicodin, and seven national organizations.
"It is clear that the United States is suffering from an epidemic of accidental deaths and addiction resulting from increased use of powerful narcotic painkillers . . . ," said a joint statement from committee members, U.S. Sens. Chuck Grassley (R-Iowa) and Max Baucus (D-Mont.).
The senators said there was growing evidence that drug companies have promoted misleading information about the safety and effectiveness of the drugs with help from nonprofits they have donated to.
"Recent investigative reporting from the Milwaukee Journal Sentinel/MedPage Today and ProPublica revealed extensive ties between companies that manufacture and market opioids and non-profit organizations such as the American Pain Foundation, the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the University of Wisconsin Pain and Policy Studies Group and the Joint Commission," Grassley and Baucus wrote.
In addition to the pain organizations, the committee also sought records from three leading opioid companies: Purdue Pharma, Johnson & Johnson and Endo Pharmaceuticals. It also requested records from the Center for Practical Bioethics, a Kansas City, Mo. organization that has advocated for pain treatment.
The committee said it wants records dating back to 1997.
The letter noted that a February Journal Sentinel/MedPage Today story reported that a "network of national organizations and researchers with financial connections to the makers of narcotic painkillers helped create a body of dubious information" favoring opioids. The information was found in prescribing guidelines, patient literature, position statements, books and doctor education courses.
The newspaper reported that the nonprofits pushed for expanded use of the drugs while taking in millions of dollars from the companies that made them.
Last year, a separate Journal Sentinel/MedPage Today story found that the UW Pain Group had been a national force in helping liberalize the way opioids are prescribed and viewed. While pushing a pharmaceutical industry agenda that critics say was not supported by rigorous science, the organization took in $2.5 million over a decade from opioid companies.
After that story ran in April 2011, the UW Pain group said it would stop taking money from the drug industry.
This week the American Pain Foundation shut down, saying it "must cease to exist, immediately."
The organization said its board of directors voted May 3 to dissolve the organization, according to a message on its website. It cited a lack of financial resources and funds needed to remain operational.
It was unknown whether the decision was in any way related to the Senate investigation.
"The problem of opioid abuse is bad and getting worse," Grassley said in a statement. "Something has to change. A greater understanding of the extent to which drug makers underwrite literature on opioids is a good start. Doctors and patients should know if the medical literature and groups that guide the drugs' use are paid for by the drugs' manufacturers and if so, how much. Education on the proper use of pain medication is a key step in preventing abuse and misuse, so it's important to understand what material is out there."
Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said the pain groups, working on behalf of drug companies, applauded the Senate committee's move. Kolodny is chairman of psychiatry at Maimonides Medical Center in New York City.
"I think the Senate Finance Committee's investigation will ultimately save lives," said Kolodny, an addiction specialist. "By turning the lights on, it's going to be much harder for these groups to function. And it will be harder for them to pretend they're helping pain patients when it's the drug companies who pay them that they're really helping."
In addition to records of financial transactions between the drug companies and the pain groups, the committee also requested information about any federal funding the groups received.
The committee warned that none of the records it requested should be destroyed, modified or removed.
James Heins, a spokesman for Purdue Pharma, acknowledged receiving Baucus/Grassley letter and that the company was "in the process of reviewing it. We look forward to cooperating with the committee on this matter."
In an email, Phil Saigh, executive director of the American Academy of Pain Medicine, said the group supports the efforts of the U.S. Senate to address the crisis of prescription drug abuse and misuse as well as the crisis of undertreated pain.
The UW Pain Group and several of the other organizations named in the Senate investigation had not responded Wednesday morning to the Journal Sentinel.
Full series
You can find the full Side Effects series at jsonline.com/sideeffectsjsonline.com/sideeffects">http://www.jsonline.com/sideeffects
The U.S. Senate Committee on Finance has opened a bipartisan investigation into financial relationships between companies that make narcotic painkillers and various nonprofit organizations that have advocated their use for the treatment of pain.
Citing investigative reports by the Milwaukee Journal Sentinel/MedPage Today and others, the committee is seeking financial and marketing records from three companies that make opioid drugs, including Oxycontin and Vicodin, and seven national organizations.
"It is clear that the United States is suffering from an epidemic of accidental deaths and addiction resulting from increased use of powerful narcotic painkillers . . . ," said a joint statement from committee members, U.S. Sens. Chuck Grassley (R-Iowa) and Max Baucus (D-Mont.).
The senators said there was growing evidence that drug companies have promoted misleading information about the safety and effectiveness of the drugs with help from nonprofits they have donated to.
"Recent investigative reporting from the Milwaukee Journal Sentinel/MedPage Today and ProPublica revealed extensive ties between companies that manufacture and market opioids and non-profit organizations such as the American Pain Foundation, the American Pain Society, the American Academy of Pain Medicine, the Federation of State Medical Boards, the University of Wisconsin Pain and Policy Studies Group and the Joint Commission," Grassley and Baucus wrote.
In addition to the pain organizations, the committee also sought records from three leading opioid companies: Purdue Pharma, Johnson & Johnson and Endo Pharmaceuticals. It also requested records from the Center for Practical Bioethics, a Kansas City, Mo. organization that has advocated for pain treatment.
The committee said it wants records dating back to 1997.
The letter noted that a February Journal Sentinel/MedPage Today story reported that a "network of national organizations and researchers with financial connections to the makers of narcotic painkillers helped create a body of dubious information" favoring opioids. The information was found in prescribing guidelines, patient literature, position statements, books and doctor education courses.
The newspaper reported that the nonprofits pushed for expanded use of the drugs while taking in millions of dollars from the companies that made them.
Last year, a separate Journal Sentinel/MedPage Today story found that the UW Pain Group had been a national force in helping liberalize the way opioids are prescribed and viewed. While pushing a pharmaceutical industry agenda that critics say was not supported by rigorous science, the organization took in $2.5 million over a decade from opioid companies.
After that story ran in April 2011, the UW Pain group said it would stop taking money from the drug industry.
This week the American Pain Foundation shut down, saying it "must cease to exist, immediately."
The organization said its board of directors voted May 3 to dissolve the organization, according to a message on its website. It cited a lack of financial resources and funds needed to remain operational.
It was unknown whether the decision was in any way related to the Senate investigation.
"The problem of opioid abuse is bad and getting worse," Grassley said in a statement. "Something has to change. A greater understanding of the extent to which drug makers underwrite literature on opioids is a good start. Doctors and patients should know if the medical literature and groups that guide the drugs' use are paid for by the drugs' manufacturers and if so, how much. Education on the proper use of pain medication is a key step in preventing abuse and misuse, so it's important to understand what material is out there."
Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said the pain groups, working on behalf of drug companies, applauded the Senate committee's move. Kolodny is chairman of psychiatry at Maimonides Medical Center in New York City.
"I think the Senate Finance Committee's investigation will ultimately save lives," said Kolodny, an addiction specialist. "By turning the lights on, it's going to be much harder for these groups to function. And it will be harder for them to pretend they're helping pain patients when it's the drug companies who pay them that they're really helping."
In addition to records of financial transactions between the drug companies and the pain groups, the committee also requested information about any federal funding the groups received.
The committee warned that none of the records it requested should be destroyed, modified or removed.
James Heins, a spokesman for Purdue Pharma, acknowledged receiving Baucus/Grassley letter and that the company was "in the process of reviewing it. We look forward to cooperating with the committee on this matter."
In an email, Phil Saigh, executive director of the American Academy of Pain Medicine, said the group supports the efforts of the U.S. Senate to address the crisis of prescription drug abuse and misuse as well as the crisis of undertreated pain.
The UW Pain Group and several of the other organizations named in the Senate investigation had not responded Wednesday morning to the Journal Sentinel.
Full series
You can find the full Side Effects series at jsonline.com/sideeffectsjsonline.com/sideeffects">http://www.jsonline.com/sideeffects
UK is The Land of Nod
NHS sleeping pill spend leaps to £50m | Society | guardian.co.uk
A sharp rise in the use of sleeping pills led to NHS spending on the drugs reaching nearly £50m last year, figures reveal.
Some 15.3m prescriptions were handed out in 2010/11, compared with 14.5m in 2007/08, according to NHS figures obtained by the Co-operative Pharmacy.
A freedom of information request revealed health trusts spent £49.2m on the drugs in 2010/11, up from £42m three years previously – an increase of more than 17%.
The highest number of prescriptions for sleeping pills were dispensed in the north-west, which spent more than £8.5m on almost 2.5m sleeping medication items.
Zoplicone was given to more than 5.2m patients nationally, making it the most popular sleeping tablet.
Around a third of people in the UK are thought to have bouts of insomnia, which can become a debilitating problem for some.
Health chiefs have voiced concerns that frequent use of sleeping pills can lead to "psychological dependency".
Mandeep Mudhar, NHS business director at the Co-operative Pharmacy, said: "Our research shows that millions of people suffer from a lack of sleep each year and are seeking medical help for the problem.
"While usage has risen steadily, the costs to the NHS have risen disproportionately, with costs going up at a greater rate.
"However, some sleeping drugs are only recommended for short-term use because they can lead to psychological dependency and lose their effectiveness over time.
"We would urge people who are suffering with insomnia or their use of sleeping pills to discuss their concerns with a pharmacist or their doctor."
Research published in February found sleeping pills commonly prescribed in the UK may increase the risk of death more than fourfold.
A wide range of drugs was analysed for the study of more than 10,500 people.
They included drugs used in the UK, such as temazepam and zolpidem.
The research, from experts at the Jackson Hole Centre for Preventive Medicine in Wyoming and the Scripps Clinic Viterbi Family Sleep Centre in California, found that people prescribed sleeping pills were 4.6 times more likely to die during a two-and-a-half-year period compared with those not on the drugs.
http://www.guardian.co.uk/society/2012/may/11/nhs-spending-sleeping-pills-50m?newsfeed=true
A sharp rise in the use of sleeping pills led to NHS spending on the drugs reaching nearly £50m last year, figures reveal.
Some 15.3m prescriptions were handed out in 2010/11, compared with 14.5m in 2007/08, according to NHS figures obtained by the Co-operative Pharmacy.
A freedom of information request revealed health trusts spent £49.2m on the drugs in 2010/11, up from £42m three years previously – an increase of more than 17%.
The highest number of prescriptions for sleeping pills were dispensed in the north-west, which spent more than £8.5m on almost 2.5m sleeping medication items.
Zoplicone was given to more than 5.2m patients nationally, making it the most popular sleeping tablet.
Around a third of people in the UK are thought to have bouts of insomnia, which can become a debilitating problem for some.
Health chiefs have voiced concerns that frequent use of sleeping pills can lead to "psychological dependency".
Mandeep Mudhar, NHS business director at the Co-operative Pharmacy, said: "Our research shows that millions of people suffer from a lack of sleep each year and are seeking medical help for the problem.
"While usage has risen steadily, the costs to the NHS have risen disproportionately, with costs going up at a greater rate.
"However, some sleeping drugs are only recommended for short-term use because they can lead to psychological dependency and lose their effectiveness over time.
"We would urge people who are suffering with insomnia or their use of sleeping pills to discuss their concerns with a pharmacist or their doctor."
Research published in February found sleeping pills commonly prescribed in the UK may increase the risk of death more than fourfold.
A wide range of drugs was analysed for the study of more than 10,500 people.
They included drugs used in the UK, such as temazepam and zolpidem.
The research, from experts at the Jackson Hole Centre for Preventive Medicine in Wyoming and the Scripps Clinic Viterbi Family Sleep Centre in California, found that people prescribed sleeping pills were 4.6 times more likely to die during a two-and-a-half-year period compared with those not on the drugs.
http://www.guardian.co.uk/society/2012/may/11/nhs-spending-sleeping-pills-50m?newsfeed=true
Wednesday, May 09, 2012
Glaxo goes hostile
GSK to go hostile with $2.6 billion Human Genome tender
By Ben Hirschler
LONDON | Wed May 9, 2012 1:42pm BST
(Reuters) - GlaxoSmithKline will take its $2.6 billion (1.6 billion pounds) bid for Human Genome Sciences direct to shareholders this week, after its takeover offer was rejected last month by the U.S. biotech group's board.
The decision to go hostile with the $13 a share cash tender offer sets GSK up for a potentially lengthy battle with those Human Genome investors who believe it is not offering enough.
http://uk.reuters.com/article/2012/05/09/uk-humangenome-gsk-idUKBRE84808M20120509?rpc=401&feedType;=RSS&feedName;=businessNews&rpc;=401
By Ben Hirschler
LONDON | Wed May 9, 2012 1:42pm BST
(Reuters) - GlaxoSmithKline will take its $2.6 billion (1.6 billion pounds) bid for Human Genome Sciences direct to shareholders this week, after its takeover offer was rejected last month by the U.S. biotech group's board.
The decision to go hostile with the $13 a share cash tender offer sets GSK up for a potentially lengthy battle with those Human Genome investors who believe it is not offering enough.
http://uk.reuters.com/article/2012/05/09/uk-humangenome-gsk-idUKBRE84808M20120509?rpc=401&feedType;=RSS&feedName;=businessNews&rpc;=401
Tuesday, May 08, 2012
Abbott settle Depakote claims for $1.6 billion
http://www.inpharm.com/news/172515/abbott-pays-16-billion-settle-depakote-claims?
The $1.6 billion will settle claims by the US government that allege the firm illegally marketed Depakote for uses outside of its licence.
This includes marketing for: agitation and aggression in patients with dementia, autism, sexual compulsion, and other disorders.
The drug is currently licensed for the treatment of epilepsy, prevention of migraines, and treating acute manic episodes in bipolar patients. Promoting the drug off-label for any other indication is illegal in the US.
The acting associate attorney general Tony West said in a Justice Department statement: “Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies.
“As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.”
This is the second highest payout from a pharma firm for the illegal marketing of a drug – behind Pfizer’s $2.3 billion for the illegal marketing of its Bextra painkiller.
The claims were originally brought by an ex-Abbott marketer, who said earlier this year that sales of Depakote “rocketed to over $1.4 billion per year” as a result of improper marketing.
The company will pay $800 million to resolve civil allegations split among federal and state governments, and $700 million for a criminal penalty, the Justice Department said in a statement.
An extra $100 million will also be paid to a number of states to resolve consumer protection matters, the Department added.
Abbott said it would also have to enter into a Corporate Integrity Agreement (CIA) with the office of inspector general of the US Department of Health and Human Services.
The CIA will govern Abbott’s compliance programme for a period of five years. The CIA will also transfer to Abbott’s new drug spin-off firm AbbVie upon its separation next year.
“We are pleased to resolve this matter and are confident we have the programmes in place to satisfy the requirements of this settlement,” said Laura Schumacher, executive vice president, general counsel.
“The company takes its responsibility to patients and healthcare providers seriously and has established robust compliance programmes to ensure its marketing programmes meet the needs of healthcare providers and legal requirements.”
The firm said it had already set aside these funds in expectation of today’s settlement.
The settlement results from a four-year-old investigation into Abbott sales practices that began in 1998.
The $1.6 billion will settle claims by the US government that allege the firm illegally marketed Depakote for uses outside of its licence.
This includes marketing for: agitation and aggression in patients with dementia, autism, sexual compulsion, and other disorders.
The drug is currently licensed for the treatment of epilepsy, prevention of migraines, and treating acute manic episodes in bipolar patients. Promoting the drug off-label for any other indication is illegal in the US.
The acting associate attorney general Tony West said in a Justice Department statement: “Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies.
“As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.”
This is the second highest payout from a pharma firm for the illegal marketing of a drug – behind Pfizer’s $2.3 billion for the illegal marketing of its Bextra painkiller.
The claims were originally brought by an ex-Abbott marketer, who said earlier this year that sales of Depakote “rocketed to over $1.4 billion per year” as a result of improper marketing.
The company will pay $800 million to resolve civil allegations split among federal and state governments, and $700 million for a criminal penalty, the Justice Department said in a statement.
An extra $100 million will also be paid to a number of states to resolve consumer protection matters, the Department added.
Abbott said it would also have to enter into a Corporate Integrity Agreement (CIA) with the office of inspector general of the US Department of Health and Human Services.
The CIA will govern Abbott’s compliance programme for a period of five years. The CIA will also transfer to Abbott’s new drug spin-off firm AbbVie upon its separation next year.
“We are pleased to resolve this matter and are confident we have the programmes in place to satisfy the requirements of this settlement,” said Laura Schumacher, executive vice president, general counsel.
“The company takes its responsibility to patients and healthcare providers seriously and has established robust compliance programmes to ensure its marketing programmes meet the needs of healthcare providers and legal requirements.”
The firm said it had already set aside these funds in expectation of today’s settlement.
The settlement results from a four-year-old investigation into Abbott sales practices that began in 1998.
Monday, May 07, 2012
Saturday, May 05, 2012
We Need You to Serve on an FDA Advisory Committee | Union of Concerned Scientists
via ucsusa.org
Congress is looking to relax conflict of interest standards for Food and Drug Administration (FDA) advisory committees that assess the safety and efficacy of drugs and medical devices. They claim that it is too difficult to recruit truly independent experts to serve on the FDA's scientific panels.
Help us prove Congress wrong by joining a group of scientists and medical doctors who will apply to serve on one of those critical committees.
Friday, May 04, 2012
Thursday, May 03, 2012
Tell the VA: No More Drug-Induced Veteran Deaths! - The Petition Site
Hundreds of young military veterans suffering from Post-Traumatic Stress Disorder are going to sleep and never waking up.Why? Because their doctors are prescribing them the drug Seroquel for insomnia--and it may be causing them to die of Sudden Cardiac Death.
Manufactured by Astra Zeneca, Seroquel was first introduced in 1997 to treat Bipolar Disorder and Schizophrenia, not PTSD. Since that time, Astra Zeneca has been found guilty of marketing the drug for conditions not approved of by the FDA.
To make matters worse, Seroquel should not be given to patients who are taking anti-depressants as this increases the risk of its side effects--side effects that include death. With anti-depressants being the first line of defense in treating PTSD, this puts our troops at an even higher risk of drug interaction complications.
Please sign this petition telling the House Committee on Veteran’s Affairs to thoroughly investigate the use of Seroquel for our nation's military.
GSK rejects idea of buying AstraZeneca | Reuters
via reuters.com
May 3 (Reuters) - Britain's biggest drugmaker GlaxoSmithKline has no interest in buying its smaller British rival AstraZeneca, GSK's chief executive said on Thursday.
AstraZeneca's future is in flux, following the planned early exit of its CEO David Brennan from June 1, leading some analysts to speculate it might become a takeover target.
GSK CEO Andrew Witty, however, told shareholders at the company's AGM that buying a big company like AstraZeneca would be "very distracting".
Novartis action over off-label Avastin backed by ABPI | PJ Online
Novartis is "fundamentally right" to be taking action against a primary care trust cluster that endorsed the off-label prescribing of bevacizumab, and is destined to win the legal challenge, according to Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry.
Novartis is seeking a judicial review of Southampton City, Hampshire, Isle of Wight and Portsmouth City (SHIP) PCT cluster’s decision to allow bevacizumab (Avastin; Roche) to be prescribed for the treatment of wet age-related macular degeneration — an indication for which it is not licensed, but works out ten times cheaper than the licensed alternative, ranibizumab (Lucentis; Novartis).
Speaking at the ABPI conference last week (26 April 2012), Mr Whitehead said: "I think Novartis’s action is absolutely, fundamentally right. There is a National Institute for Health and Clinical Excellence recommendation behind [ranibizumab for wet AMD]."
NICE has advised the industry to pursue legal avenues if its recommendations are not being adopted, including using the media to draw attention to the issue and put pressure on, he said.
"The Lucentis issue is a complex issue. It’s not simply about not adopting a new medicine, it’s also substitution of off-label medicines, which is fundamentally dangerous and undermines the whole regulatory process," he added.
"Why go through clinical trials if healthcare professionals — or, more importantly, healthcare funders . . . — use medicines that are off-label and off-licence."
Asked what the implications will be if Novartis loses the judicial review, he said simply: "I don’t think Novartis will lose."
Case will prove intriguing, says NICE’s Sir Andrew
NICE chief executive Sir Andrew Dillon said he understands why individual clinicians might choose to prescribe off-label, and the logic behind SHIP PCT cluster’s decision to support the practice.
"Equally, it’s not without risk. It is unlicensed use, so the studies, though there are clinical trials under way, haven’t been through that formal evaluation," he said, stressing that the it’s a difficult and complex decision making process that factors in both safety and pricing issues.
Sir Andrew said NICE does not take a view on the ongoing legal battle, but said the case will prove an intriguing one.
"It’s actually a fascinating story, because it weaves together all sorts of interesting strands around drug development, the regulatory process, the origin of the ownership of individual molecules, the physical relationships between the pharmaceutical companies and the politics of the NHS.
"And the heart of it, of course, is what is the right thing to do for individual patients."
via pjonline.com
More drug price cuts in Australia
>via pharmatimes.com
13 medicines on Australia's Pharmaceutical Benefits Scheme (PBS), accounting for more than 200 brands, have taken new price cuts of between 11% and 77%, as part of the ongoing price disclosure scheme agreed between the government and industry group Medicines Australia.
The biggest price reduction is for GlaxoSmithKline's anti-nausea treatment Zofran (ondansetron), which is reduced by 77%, while Sanofi's cancer drug Eloxatin (oxaliplatin) will take a 51% price cut.
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