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Report: Patients facing growing challenges accessing orphan drugs

BY Michael Johnsen

BOSTON — Although the pace of approvals for new orphan drugs — medicines that treat relatively rare conditions — have increased in the United States and Europe in recent years, patients are facing growing challenges accessing those drugs, a newly completed study released last week by the Tufts Center for the Study of Drug Development at Tufts University has concluded.
 
During the 14-year period from 2000–13, 86 orphan drugs were approved in the United States, up from 65 during the prior 18-year period 1983–2000, while in Europe 96 orphan drugs were approved from 2000–13, more than double the 44 approved in the earlier period, according to Tufts CSDD.
 
Among the challenges that limit patient access to orphan drugs in the United States, relative to Europe, is higher cost-sharing by patients, which can lead to increased levels of non-compliance, according to Joshua Cohen, assistant professor at Tufts CSDD, who conducted the analysis.
 
“The encouraging news is that more orphan drugs are in development today than ever before, with more getting marketing approval — in 2013 alone, nine orphan drugs were approved in the United States, the most in a single year," he said. "But the high cost of these medicines is leading insurers to reassess their reimbursement policies, which likely will mean more out-of-pocket costs for patients.” 
 
Key findings from the study, reported in the July/August Tufts CSDD Impact Report, include the following:
 
  • Since 1983, 7% more orphan drugs have been approved in the United States than in Europe, and 17% more were approved first in the United States than were approved first in Europe;
  • There are fewer denials of orphan drug coverage by U.S. payers than by European payers; and
  • While U.S. payers often require prior authorization as a condition of reimbursement, European health authorities employ more stringent conditions, such as on-label indication restrictions, step edits and coverage with evidence development.

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P&G rumored to be preparing a re-entry into the incontinence market

BY Michael Johnsen

CINCINNATI — According to blogger Tom Wilson, co-founder and president of The CareGiver Partnership and former Kimberly-Clark executive, Procter & Gamble may be readying to re-enter the incontinence market as soon as this summer. 
 
"It is strongly rumored that Proctor & Gamble will re-enter the disposable incontinence category, a category they helped create in 1978 along with Kimberly-Clark (Depend and Poise). Their brand was Attends," Wilson wrote, suggesting that P&G will back the re-entry with a $150 million advertising campaign. "Assuming the rumors are true and they begin shipping this summer or early fall with a full line of 24 items (pads and pull on underwear for women in different pack counts), I expect they will target at least 25% of the market," he noted. "A claim 'absorbs in seconds' is all we are aware of at this point. They're also telling trade customers that the launch will be a sustained 3-year commitment."
 
Wilson is basing his premise in part on a June 18 presentation at the Duetsche Bank Global Consumer Conference, where P&G CFO Jon Moeller said that in the next six months P&G will be entering a new category. "He didn't divulge the category, but also eluded to the fact that they will introduce a new and far superior method of addressing a chronic consumer issue. Here is a link to his presentation — see slide 14," Wilson noted. "We think its possible the brand will be announced at their Aug. 1 earnings conference call that is being attended by chairman A. G. Lafely."

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KellyBrezoczky says:
Jul-16-2014 01:43 pm

P&G's entry into this category confirms the growing need for these personal hygiene products. It also echoes the past decade of peer reviewed studies showing both urinary and bowel leakage as real, everyday health and wellness issues for tens of millions of women and men as young as 40. My company recently launched a product for the single largest unaddressed consumer need in the category: accidental bowel leakage (ABL). While there have been pads for urinary leakage and disposable briefs for heavier bowel leakage, there haven’t been any products for light ABL.This is surprising since numerous studies confirm ABL is the single biggest unmet need in the category globally. To learn more, visit: www.ABLinfo.org. Butterfly Body Liners are the first patented product to offer discreet protection for ABL. They are the only personal hygiene product which adheres gently to the skin. Many women tell us the launch of Butterfly is as important as the invention of tampons. Men tell us they are grateful to have not been left out of the conversation. Butterfly’s innovation was recently recognized with the nonwovens industry 2014 INDA Vision Award, as well as an Edison Award. Increased conversation, education and innovative product solutions will lead to increased care and better wellness.

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Teva’s NDA for albuterol MDPI accepted by FDA

BY Ryan Chavis

 

JERUSALEM — Teva Pharmaceuticals on Monday announced that the Food and Drug Administration has accepted the company's new drug application for albuterol multi-dose dry-powder inhaler, a breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease. The inhaler also is indicated for the prevention of exercise-induced bronchospasm in patients 12 years of age and older, according to the company.

“We are extremely pleased the FDA has accepted for review the NDA for albuterol MDPI. If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients,” said Tushar Shah, M.D., SVP Teva global respiratory research and development. “As the current market-leader in asthma rescue inhalers, it is our hope that the new dry-powder innovation utilized with albuterol MDPI will help fill an unmet need in the existing asthma market.”

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