Author: Peter

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.

Fentanyl is a big culprit, but there are also encouraging signs from states that have prioritized public health campaigns and addiction treatment...Drug overdoses killed about 72,000 Americans last year, a record number that reflects a rise of around 10 percent, according to new preliminary estimates from the Centers for Disease Control...Analysts pointed to two major reasons for the increase: A growing number of Americans are using opioids, and drugs are becoming more deadly. It is the second factor that most likely explains the bulk of the increased number of overdoses last year...During 2017, the president declared the opioid crisis a national public health emergency, and states began tapping a $1 billion grant program to help fight the problem...Because it’s a drug epidemic as opposed to an infectious disease epidemic...the response is slower...Because of the forces of stigma, the population is reluctant to seek care... The dominant factor is the changing drug supply...Strong synthetic opioids like fentanyl and its analogues have become mixed into black-market supplies of heroin, cocaine, methamphetamine and...benzodiazepines. Unlike heroin, which is derived from poppy plants, fentanyl can be manufactured in a laboratory, and it is often easier to transport because it is more concentrated...Unexpected combinations of those drugs can overwhelm even experienced drug users...

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment...a first-of-its-kind RNA-based therapy for treating peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients...Polyneuropathy caused by hATTR is a rare, debilitating, and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart, and other organs...“This approval is part of a broader wave of advances that allows us to treat disease by actually targeting the root cause, enabling us to arrest or reverse a condition, rather than only being able to slow its progression or treat its symptoms...“New technologies like RNA inhibitors that alter the genetic drivers of a disease, have the potential to transform medicine, so we can better confront and even cure debilitating illnesses.

Pfizer has joined three of its Big Pharma peers in a Department of Justice probe examining allegations that the companies paid bribes to a terrorist-run health ministry in Iraq...The Justice Department's inquiries stem from a lawsuit, filed last fall, in which veterans and their families accused Pfizer, AstraZeneca, Roche and Johnson & Johnson of paying bribes to win business from the Iraqi ministry of health at a time when the ministry was controlled by terrorists...The suit alleges the companies paid bribes to terrorists that "openly controlled the Iraqi ministry in charge of importing medical goods." The plaintiffs contend the drug companies "obtained lucrative contracts from that ministry by making corrupt payments to the terrorists who ran it."

...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...

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...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

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.

Activist investor Carl Icahn has given up his fight to block Cigna's proposed $67 billion acquisition of Express Scripts. Icahn just last week warned shareholders that the deal was among the "worst acquisitions in corporate history" in an open letter...Cigna responded to Icahn's criticism with a lengthy defense. In its response, Cigna called Icahn's opposition "misguided and short-sighted" and said it "demonstrates a clear lack of understanding of the dynamics of the healthcare industry."...Icahn had raised three primary arguments against the acquisition in his open letter to Cigna shareholders: The insurer is paying too much, it would be diving directly into a risky sector embroiled in a political debate over drug pricing, and would soon have to face off with Amazon, which is gearing up to take the industry by storm...Instead, the activist investor proposed an alternative to the acquisition: That Cigna engage in a multi-year partnership with Express Scripts until those regulatory and competitive concerns are ironed out.

Laura Joszt, host for Pharmacy Week in Review.