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HDA Media And Political Bulletin – 26 September 2016

NICE must be reviewed and pharma industry must price ‘more responsibly’

22 September 2016, Pharmacy Business

 

The charity Breast Cancer Now has called upon the Department of Health to review the role of the National Institute for Health and Care Excellence (NICE), following concerns that patients are being denied cancer drugs. NICE has recently rejected numerous cancer drugs on cost grounds, causing the charity to also call upon the pharmaceutical industry to price their drugs more responsibly. Baroness Delyth Morgan, the Chief Executive of Breast Cancer Now, commented saying it is hard to see how any new and improved breast cancer treatments would reach patients in England with the current barriers.

 

Mylan CEO defends EpiPen pricing

22 September 2016, Pharmaphorum, Richard Staines

 

Heather Bresch, Chief Executive Officer of Mylan Pharmaceuticals, attended a hearing in front of the House Committee on Oversight and Government Reform in the U.S. She gave evidence on Mylan’s pricing of their Epipen, which has increased from $100 in 2008 to more than $600. Drug pricing is under intense scrutiny in the US, after it emerged that companies had inflated the price of some generic drugs. Bresch told the Committee that the high price of the original Epipen was the result of rising wholesale acquisition costs.

 

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NICE must be reviewed and pharma industry must price ‘more responsibly’

22 September 2016, Pharmacy Business

 

The charity Breast Cancer Now has called on the Department of Health to review the role of the National Institute for Health and Care Excellence and the pharmaceutical industry to price its medicines “more responsibly” amid continuing concerns that patients are being denied cancer drugs.

NICE’s refusal to allow numerous cancer treatments – 10 breast cancer drugs have recently been rejected – on cost grounds has caused an uproar among pharmaceutical companies, patient groups and charities.

Under its QALY (quality adjusted life year) system NICE estimates the remaining years of life of a patient after a particular treatment and assesses each year with a quality-of-life score. NICE, however, has been criticised for its approach to drug assessment.

Breast Cancer Now, whose chief executive Baroness Delyth Morgan, described NICE’s continued denial of cancer treatments as “intolerable,” identified the barriers hindering patient access to medicines in its Access to Medicines Summit report.

“The last 10 appraisals of breast cancer drugs by NICE have seen 10 rejections and this intolerable trend is leaving patients in England behind,” said Baroness Morgan.

“With the current barriers, it is hard to see how any new and improved breast cancer treatments would reach patients in England, despite the research progress being made.

“That said, we were highly encouraged by discussions at the Summit, which helped demonstrate the range of ideas and possibilities to fix this broken system. It has become crystal clear that we need the Department of Health to review the role of NICE and elements of the QALY process within the drug appraisal system.

“We must see industry price their drugs more responsibly, but much more flexibility is also needed in the way that modern and targeted drugs are assessed. 9,500 women in England are still losing their lives to breast cancer each year, and we must ensure that new innovations have the best chance of being made available at the best price for the NHS.”

Research carried out by Breast Cancer Now also found that thousands of women are missing out on cheap drugs called bisphosphonates, which could prevent the spread of breast cancer and cost as little as 43p a day on average, because of confusion over whether hospital trusts, Clinical Commissioning Groups or NHS England should fund them.

 

Mylan CEO defends EpiPen pricing

22 September 2016, Pharmaphorum, Richard Staines

 

Mylan’s CEO, Heather Bresch, has been forced to defend the pricing of its EpiPen under sceptical questioning from US politicians.

Bresch (pictured) was summoned to a hearing in front of the House Committee on Oversight and Government reform, to give evidence on Mylan’s pricing for Epipen (epinephrine), which is the company’s biggest selling product with annual sales exceeding $1 billion.

The price of the life-saving injection for people with severe allergies has increased from less than $100 for a pack of two in 2008, around the time Mylan acquired the product, to more than $600. This has prompted accusations that Mylan has taken advantage of a lack of competition for the drug.

Drug pricing is under intense scrutiny in the US, after it emerged that companies such as Valeant and Turing Pharmaceuticals had inflated the price of some generic drugs.

Mylan has responded to the widespread criticism by producing a generic version of EpiPen, priced at around $300.

The high price of the original EpiPen was down to rising wholesale acquisition cost, Bresch told the committee, who also made great play of Mylan’s decision to give 700,000 free EpiPens to more than 66,000 schools in the US.

She added that Mylan gets revenues of $274 for each pack after wholesale acquisition costs are deducted, although this has increased from net revenue of $235 two years ago.

After cost of goods and other costs are subtracted, Mylan make around $50 per pen, Bresch said.

She told the committee: “I know there is considerable concern and scepticism about the pricing of Epipens. Many people incorrectly assume that we make $600 off of each pen. It’s simply not true.”

But Republican committee chair, Jason Chaffetz, said Mylan would likely make more revenue from the generic Epipens, as they can be sold directly to the patient at $300 each.

Chaffetz was surprised that Mylan had not anticipated the controversy over the pricing of EpiPen. “You raised the price, what did you think was going to happen?”

Democrat Elijah Cummings, who also sits on the committee, noted that the company spends $97m on marketing for EpiPens. Cummings criticised Mylan for failing to provide details of costs related to EpiPen.

The committee also heard from Doug Throckmorton, Deputy Center Director for Regulatory Programs at the US Food and Drug Administration, said he was unable to give details of the number of EpiPen generic rivals that the regulator is waiting to approve.

The FDA reportedly faces a backlog of around 4,000 generic drugs filed and awaiting approval, although the agency denies this figure.

HDA Media And Political Bulletin – 26 September 2016

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