- August 24 Pharmacy Week in Review: Contact Lens Hygiene, New Treatment for OCD (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- CVS adopts ICER metrics in shift to value-based drug pricing (biopharmadive.com)
CVS Caremark will use the value-based drug pricing system of the Institute for Clinical and Economic Review to exclude some high-cost drugs from plans...The pharmacy benefit manager will incorporate ICER's quality-adjusted life years measure. If a drug is priced greater than $100,000 per QALY at launch, CVS Caremark will allow its clients to exclude the drug from their plan...CVS is hoping the decision will give PBMs more power in pressuring drug prices lower, especially by targeting their launch prices...PhRMA...supports using "rigorous, objective evidence to guide formulary decision-making”...”At the same time, we strongly oppose misuse of subjective, one-size-fits-all cost effectiveness thresholds to deny patient access to life saving treatment options,"..."As many stakeholders have noted, blunt cost-effectiveness thresholds ignore what individual patient and providers value and conflict with the movement toward personalized, 21st century health care."
- FDA approves first generic of Mylan’s EpiPen (pharmaceutical-technology.com)
The Food and Drug Administration has approved the first generic version of the EpiPen and EpiPen Jr auto-injector for severe allergic attacks, including life-threatening anaphylaxis....The EpiPen was approved in 2007 and is marketed by Mylan. However, since then both the company and its product have been involved in a number of scandals. Notably the price of the EpiPen has increased from $57 in 2007 to approximately $600 in 2016 and in May, the FDA had to place Mylan’s EpiPen on its official shortages list as a result of manufacturing delays...The newly approved generic epinephrine auto-injector will be available in 0.3mg and 0.15mg strengths and is marketed by Teva. This the company’s second attempt to get its generic approved by the FDA; it was rejected in 2016...FDA commissioner Scott Gottlieb said: “Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.
- Walgreens, VA partner to improve care coordination (drugstorenews.com)
Walgreens and the Dept. of Veterans Affairs are working together to improve coordination of care for VA-enrolled patients. Through the partnership...VA providers will be able to see the entire medication and immunization history of the VA-enrolled patient if they receive prescriptions and immunizations at Walgreens...“This arrangement is the first of its kind, and it’s a strong collaboration,” said VA Sec. Robert Wilkie. “Partnerships like this will help VA continue to improve the way we care for Veterans.”...The VA-Walgreens exchange eliminates the need for providers to gather medication history from patients who fill their scripts at Walgreens...
- Exclusive: Pharma sector warns Saudis on German drug curbs (reuters.com)
European and U.S. pharmaceutical associations have waded into a diplomatic row between Germany and Saudi Arabia, warning that ongoing restrictions on German-made drugs could hurt Saudi patients and dampen future investment in the kingdom...In a strongly worded letter to Crown Prince Mohammed bin Salman....he associations highlighted the level of concern in Germany and elsewhere about restrictive procurement measures implemented by Riyadh in response to criticism of its policies...Germany’s foreign minister at the time, Sigmar Gabriel, condemned “adventurism” in the Middle East in comments perceived by some as an attack on increasingly assertive Saudi policies. Riyadh dismissed the comments as “shameful” and withdrew its ambassador to Germany...“For the past six months German healthcare companies have been having trouble doing business in Saudi Arabia,” said Oliver Oehms of the German chamber of commerce and industry in Riyadh. “It is not a general boycott, but the healthcare sector is clearly suffering.”...Saudi Arabia is the largest pharmaceuticals market in the Middle East and Africa, with sales of $7.6 billion last year, according to healthcare information company IQVIA...With a growing burden of chronic diseases tied to a more Western lifestyle, Saudi Arabia’s overall drugs market is growing at 10 percent a year and the tender sector is expanding by about 30 percent.
- Trump administration proposes production quota cuts for six opioids (reuters.com)Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2019 (justice.gov)
The Trump administration on Thursday proposed that U.S. drugmakers cut production quotas of the six most abused opioids by 10 percent next year to fight a nationwide addiction crisis....the U.S. Justice Department and Drug Enforcement Administration said the proposed cut would be in keeping with President Donald Trump’s effort to cut opioid prescription fills by one-third within three years...
- Moody’s: CMS proposed changes to Medicare’s outpatient prospective payment system could hurt hospitals (healthcarefinancenews.com)
...the Centers for Medicare and Medicaid Services' proposed changes to outpatient services, including site neutral clinic visits, 340B policy changes and broadening the list of surgeries covered at ambulatory surgical centers, would generally be credit negative and hurt hospital margins.
- Changes include no longer paying more for clinic visits in off-campus hospital or provider-based department clinics compared to a physician's office...
- Proposed changes to the 340B policy could also impact certain hospitals...CMS lowered reimbursement for Part B drugs to the drug's average selling price, minus 22.5 percent from the ASP, plus 6 percent. CMS said this would save Medicare about about $1.6 billion...
- CMS has proposed adding some nonsurgical procedures to those covered at ambulatory surgical centers, which are located off-campus, but are not hospital outpatient surgery centers...
- U.S. appeals court says GSK cannot be sued over generic drug suicide (reuters.com)
U.S. appeals court...tossed a $3 million verdict against GlaxoSmithKline over the suicide of an attorney who took a generic version of the company’s antidepressant Paxil, finding the company could not be held liable for injuries allegedly caused by a generic copy...The case weighing whether brand-name manufacturers can be sued for injuries blamed on generic drug versions was closely watched within the pharmaceutical and legal industries...Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels...decision follows a series of state court rulings in similar cases. The top courts of Massachusetts and California ruled brand-name manufacturers could be sued by generic drug users...West Virginia’s Supreme Court...rejected liability claims against brand-name manufacturers for alleged failures to warn over a generic company’s drug.
- The People vs Big Pharma: tackling the industry’s trust issues (pharmaceutical-technology.com)
Price hikes, manipulative patent litigation and a rampant opioid addiction epidemic have steadily soured the public’s view of the pharmaceutical industry. Does Big Pharma has (have) a crisis of public trust on its hands, and if so, how might it restore its credibility in the eyes of patients, policymakers and the rest of the taxpaying public?...“I sort of view Big Pharma, as an industry, as an octopus with many tentacles, and at the end of every tentacle is a wad of cash,” says David Mitchell, president...of...Patients for Affordable Drugs...“It reaches into academic medical centres, professional organisations, patient organisations, state houses, campaigns, Congress – they’re everywhere.”...Mitchell’s description sounds more suited to some sinister political conspiracy than an industry whose business is saving lives and curing diseases. But despite the pharma sector’s noble clinical goals, many of the industry’s business practices – monopoly pricing, blocking generics and biosimilars, spending heavily on political lobbying, an arguably relentless focus on profit – have eroded public trust in its credibility and motives.
- Survey data confirms pharma’s trust issues
- Pharma trust: a varied global picture
- Particular challenges in the US
- Trust exercises: the road to redemption
- Predicting the Risk for Five Deadly Diseases (ptcommunity.com)
Scientists have created a powerful new tool to calculate a person’s inherited risks for heart disease, breast cancer, type 2 diabetes, chronic inflammatory bowel disease, and atrial fibrillation...By surveying changes in DNA at 6.6 million places in the human genome, investigators at the Broad Institute and Harvard University were able to identify many more people at risk than do the usual genetic tests, which take into account very few genes...The researchers are now building a website that will allow anyone to upload genetic data from a company like 23andMe or Ancestry.com. Users will receive risk scores for the five aforementioned diseases. A risk score, including obtaining the genetic data, should cost less than $100...The study began because there was general agreement among researchers that many common diseases are linked not to one mutation, but rather to thousands or millions of mutations...scientists have cataloged more than 6 million tiny changes in DNA that slightly affect the chances that people will get various diseases. Each of those genetic alterations has such a small effect—approximately a 1 percent increase or decrease in a person’s odds of getting a disease — that it would not be helpful to test for each one in isolation...But...to combine data on all of the small DNA changes to construct an individual risk score. To do that, the researchers needed a new algorithm that would weigh the significance of the variations in the genes.