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After more than a year of controversy, the federal government filed a lawsuit accusing Gilead Sciences of infringing patents on a pair of HIV prevention pills and unfairly reaping hundreds of millions of dollars from research funded by taxpayers...The patents are held by the Centers for Disease Control and Prevention, which helped fund academic research into HIV prevention that later formed the basis for a pair of pills — Truvada and Descovy — that are sold by the drug maker. The Department of Health and Human Services contended that Gilead refused to reach a licensing agreement despite “multiple attempts” at reaching a deal. “Gilead’s conduct was malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith,” the suit states...READ MORE

There is one drug-price policy that Republicans and Democrats can agree on: international reference pricing...Leaders from both parties have proposed the model, but with some differences...It’s an idea that works around the world. Nearly every member of the European Union uses some kind of international reference pricing model. Countries such as Australia, Brazil, Canada, Japan, New Zealand and South Africa also employ it to set prices for their government healthcare systems...a drug’s price would be based on the average cost in several countries. That price would then become the benchmark for U.S. prices...READ MORE

...Food and Drug Administration...downplayed the risk caused by contamination of the already recalled popular heartburn drug Zantac, and said its tests suggest it does not cause carcinogens to form after ingestion by patients...Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said...that the levels of the probable carcinogen N-nitrosodimethylamine it found in ranitidine...“are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”...Still, the FDA released results of its testing here on branded and generic ranitidine products that showed some versions of the over-the-counter medicine had as much as nine times the regulator's "acceptable limit" for NDMA...READ MORE

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.

According to the Association for Accessible Medicines 2019 report with data from IQVIA, generic drug savings totaled $293 billion in 2018, which resulted in a 10-year savings of almost $2 trillion. Other key findings include that 4 billion generic prescriptions were filled across the U.S. in 2018, which is 90% of all dispensed prescriptions. Additionally, 95% of generic prescriptions were filled at $20 or less with an average copay of $5.63 whereas the average brand copay is $40.65. In 2017, patients who were prescribed more expensive brand products were 2-3 times more likely to leave the pharmacy without their prescriptions...There were 68,353 pharmacy stores that provided cash prices for the study; results revealed that independent pharmacies and small chains had the highest cash prices for generic drugs, while big box pharmacies had the lowest prices compared with large chains...READ MORE

An inter-agency U.S. task force looking into drug shortages found "a broken marketplace" and issued a set of recommendations that includes creating a rating system for manufacturers...Medicines that fall into shortage are often relatively inexpensive and can become unprofitable for manufacturers...Creating a manufacturer ratings system might be one way to incentivize higher prices... the rating system for manufacturers would address one key aspect of the broken marketplace...Manufacturers who have gone beyond basic requirements and have a "mature" quality management system are more likely to have reliable production, and purchasers who can identify these manufacturers through ratings may be willing to pay more for their drugs...The task force also advocated new approaches to contracts that might include financial incentives to make steady production of critical drugs worthwhile for drugmakers. Purchasers could pay higher prices for medications made at top-rated facilities or require a certain rating before entering a contract...READ MORE

Drug shortages are a major challenge in healthcare. According to the U.S. Food and Drug Administration, the number of drug shortages is rising, with most shortage events lasting longer and resulting in a more adverse impact on public health, including added costs, delayed treatments or even death...Ultimately, drug shortages create uncertainty for a range of stakeholders: patients, hospitals, manufacturers, pharmacists and others. Especially in cases of shortages for lifesaving drugs, doctors must implement conservative efforts to ensure the patients that need it the most get their medication...Today, more than 100 lifesaving drugs are in shortage, and 70% of all hospital pharmacists report at least 50 shortages a year...READ MORE

With eight months of data under their belts, CVS Health is seeing strong performance out of its early HealthHUB retail stores in the Houston area...CEO Larry Merlo said on the company's earnings call...that these concept stores, which dedicate more than 20% of retail space to health services, outperform control retail pharmacies in script volume, MinuteClinic visits, front store sales, foot traffic and store margin..."rapid rollout" of the HealthHUB stores is proceeding on track, he said, with the healthcare giant expanding into three additional metro areas by the end of this year. CVS plans to transform 1,500 of its stores into HealthHUBs by 2021...READ MORE

The Trump administration finalized a hospital payment rule...that retains proposed cuts to off-campus clinics and the 340B drug discount program...The changes outlined in the hospital Outpatient Prospective Payment System rule come despite both cuts being struck down in legal challenges and amid major pushback from providers...The goal is to bring payments to off-campus clinics in line with standalone physicians' offices...“With the completion of the two-year phase-in, the cost sharing will be reduced to $9, saving beneficiaries an average of $14 each time they visit an off-campus department for a clinic visit in [calendar year] 2020,” the Centers for Medicare & Medicaid Services said...CMS also finalized a proposed cut for the 340B program that cuts payments by 22.5% in 2020...READ MORE

Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network