Author: Peter

The U.S. FDA has awarded the first full approval for a COVID-19 vaccine to Pfizer and its German partner BioNTech, a historic decision that comes weeks ahead of its previously expected Labor Day deadline...Pfizer’s jab, now approved for people aged 16 and older, will remain under an emergency nod for adolescents aged 12 to 15...The agency’s full approval for Pfizer’s mRNA shot, now marketed as Comirnaty, is expected to spark a wave of vaccine mandates from companies, universities and organizations awaiting the agency’s final sign-off...READ MORE

England's cost-effectiveness watchdog, typically a fierce critic of pharma's launch prices, says it’s revamping the way it reviews new drugs, devices, diagnostics and more in a push to provide greater access, sooner...The National Institute for Health and Care Excellence, or NICE, rolled out its planned remodel...aimed at providing “faster, fairer” access to the drugs and devices it reviews for National Health Services (NHS) patients...READ MORE

UnitedHealthcare has lost an appeal in a case over Medicare Advantage overpayments...The health insurance giant initially won in lower federal court, but the Department of Health and Human Services filed an appeal in spring 2020. The ruling is the latest in the legal back-and-forth over a 2014 proposed rule that could change how much money MA plans have to pay the feds for diagnostic errors...READ MORE

A new study from Accenture shows a boomerang back to a familiar topic—drug costs...“We asked what would increase trust in the pharmaceutical industry, and for many people there’s a clear link between cost and trust,”...The top two answers specifically pointed to reduced medication costs (41%) and more transparency in pricing (39%) as measures that would make the respondents trust pharma companies more...An earlier Accenture report from May suggested the new economic reality for pharma meant companies would have to work at changing the cost narrative with customers. It suggests focusing on value and outcome-based pricing to build trust...READ MORE

During the COVID-19 pandemic many hospitals and health care services teams turned to telepharmacy to reduce delays in providing medications to patients while social distancing practices were in place. Hospitals quickly found that telepharmacy benefitted pharmacy services by providing patients with more efficient access to medical care and reducing costs. Thus, hospitals were able to focus more on patient care and less on logistics, which led to higher turnaround times and increased patient satisfaction...READ MORE

The New York Times reports that the Pfizer shot will be the first of the coronavirus jabs to be cleared by the FDA...According to the report, the FDA originally had planned to approve the vaccine before Labor Day, but decided to accelerate its ruling...The full approval of the shot also paves the way for employers and private companies to mandate employees and patrons to be vaccinated...READ MORE

The U.S. health department's inspector general will review how the Food and Drug Administration grants accelerated approvals of new drugs, announcing a broad investigation,,,after two months of scientific controversy over the agency's June decision to clear Biogen's Alzheimer's drug Aduhelm...The FDA's own leader had called for a federal review last month in response to reports detailing unusual aspects of the close collaboration between the agency and Biogen in assessing clinical trial evidence for the medicine...READ MORE

In response to U.S. prescription drug spending rapidly outpacing inflation, reaching an estimated $358.7 billion in 2020, President Biden last week demanded that Congress adopt strict federal price controls on prescription drugs...to cap annual out-of-pocket drug spending for Medicare beneficiaries, empowering the Secretary of Health and Human Services to choose pharmaceutical winners and losers, and financially crippling penalties for pharmaceutical companies that don’t acquiesce to price controls — are likely to have disastrous effects on the availability of critical medications. What’s more, they’re deeply unpopular with the overwhelming majority of Americans, and could prove to be a significant fiscal and health liability for our nation in the years to come...READ MORE

University Medical Center is notifying patients of a data breach that occurred in mid-June, and offering free identity protection services for those who were affected...The data breach was "by a well-known group of cybercriminals that seek to use the information for commercial gain," according to UMC...Letters received this week in the Las Vegas valley indicate that the breach occurred in June 14 and was shut down the following day, according to UMC officials...READ MORE

The archaic rules of the 340B program do not ensure that it serves the vulnerable patients it was intended to help...The 340B program reached $38 billion in sales at the discounted price in 2020. This is a 27% increase over sales in 2019, and the program is now more than four times the size it was in 2014. Unfortunately, despite pharmaceutical manufacturers paying more and more money in 340B discounts, there is no evidence that this growth in 340B translates into lower costs for patients taking prescription medicines...Part of the problem is that the hospitals that participate in the 340B program have no requirements to use revenue from 340B to help needy patients afford their medicines. In fact, both the Government Accountability Office and Office of Inspector General have found that 340B hospitals often charge uninsured patients the full price for medicines for which the hospital received a 340B discount...READ MORE