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A new Aetna pilot program aims to harness its parent company's pharmacy reach to help address members' social needs...Through the HealthTag initiative, CVS Health pharmacists and pharmacy employees are empowered to offer more personalized information when Aetna Medicaid members come to pick up prescriptions, providing the members with health information beyond how to take their medications appropriately...Inside the prescription bag, members are provided additional details on how to access community services to address social concerns like food, housing or transportation. The network of these organizations is backed by Unite Us, a social care coordination program...Aetna will pilot the program at CVS pharmacies in West Virginia and Louisiana...READ MORE

Regeneron’s COVID-19 antibody cocktail, one of the drugs President Donald Trump was given after he was infected with the SARS-CoV-02 virus, has been cleared for emergency use by the FDA. And, despite looming rollout of vaccines, one analyst still sees the therapy as a steady $1 billion-plus business...The emergency use authorization for REGN-COV2, a combination of monoclonal antibodies casirivimab and imdevimab, marks the second for an antibody therapy. The first one went to Eli Lilly’s bamlanivimab, which was given an EUA a few days ago...READ MORE

With Moderna and Pfizer both reporting sky-high response rates to their COVID-19 vaccines, the pressure is on federal health officials to ensure a rapid—but smooth—rollout. Wednesday, they unveiled a detailed timeline that provides some clues about when most Americans can expect to be vaccinated...High-priority populations such as healthcare workers and nursing home residents could obtain COVID-19 vaccines in December...The key to distributing the vaccines to older Americans quickly is a distribution deal the government struck with Walgreens and CVS last month. Last week, more agreements were formed with pharmacy chains and independent pharmacies...Warp Speed has been fostering the development of six additional COVID-19 vaccines...Moderna expects to ship 20 million doses for use in the U.S. by the end of this year and up to 1 billion worldwide next year. Pfizer is gearing up to ship 50 million doses this year...READ MORE

Moderna reported...that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started a rolling review of mRNA-1273...CHMP’s decision to commence the rolling review of data on mRNA-1273 has been based on the preliminary results from non-clinical and early clinical studies, which have suggested the vaccine has an efficacy of 94.5%. The rolling review will be performed by the committee until there is sufficient data to support a formal marketing authorization application...READ MORE

Starting Friday, November 27, 2020, pharmacies must buy and sell only products with a required “product identifier” on their packages. This requirement is part of the phased-in implementation of the Drug Supply Chain Security Act of 2013, also known as the “track-and-trace” law. By Friday, dispensers should be familiar with this requirement and know what to do if a product identifier is not on the package when they receive products that require it. The product identifier is on most drug packages in both human-readable format and on a machine-readable 2D data matrix barcode...“The challenge for dispensers is that not all drug product packages are required to have a product identifier, and there is no central database to check if a product should have one,”...READ MORE

As a tide of late-stage data rolls in on COVID-19 vaccines from Pfizer, Moderna and AstraZeneca, the U.S. is gearing up for reviews that could see a vaccine authorized and deployed before the year is out. On Saturday, the chief of the White House's Operation Warp Speed effort laid out a definitive timeline, setting expectations for when the public could expect at least two shots to become available...Moderna will file for an emergency nod for its mRNA-based vaccine candidate before the month is out, Moncef Slaoui, Ph.D., head of "Warp Speed" and former vaccine chief at GlaxoSmithKline, said...That submission will segue straight into a Dec .17 data review, with the aim to ship vaccines to distributors within 24 hours of approval and potentially start vaccinations two days after the advisory panel makes its call, Slaoui said...READ MORE

The Department of Health and Human Services recently released a final rule requiring health insurers to disclose drug pricing and cost-sharing information...“Under this final rule, more than 200 million Americans with private-sector insurance (both individual-market and employer-based) will have access to a list of real-time price information, including cost-sharing, enabling them to know how much care will cost them before going in for treatment,”...“We want every American to be able to work with their doctor to decide on the healthcare that makes sense for them, and those conversations can’t take place in a shadowy system where prices are hidden,” said HHS Secretary Alex Azar, MD,. “With more than 70% of the most costly healthcare services being shoppable, Americans will have vastly more control over their care...Although the Pharmaceutical Care Management Association is still reviewing the final rule, “we would warn regulators to guard against giving away competitive pricing information to drug manufacturers and pharmacies,”...READ MORE

Indian Prime Minister Narendra Modi has urged states that are witnessing a surge in coronavirus cases to establish cold storage facilities for COVID-19 vaccines...India is home to some of the world’s biggest vaccine makers and there are five vaccine candidates under different phases of trial here. But the state-run cold chain facilities used to keep some vaccines consistently refrigerated would be inadequate for the enormous challenge of rolling out a COVID-19 vaccine...READ MORE

NHS England is preparing for the huge task of delivering COVID-19 vaccines, including through community pharmacies...Delivery of a COVID-19 vaccine to the public will require the participation of “as many of the workforce who are trained in vaccination as possible” from community pharmacy...Jill Loader, deputy director of pharmacy commissioning at NHS England and NHS Improvement, said there were “a number of different ways community pharmacy can get involved” in the COVID-19 vaccine delivery programme, with some community pharmacies expected to be commissioned as a vaccination site through a locally enhanced service...“We anticipate that we are going to need to use as many of the workforce who are trained in vaccination as possible,” she said...READ MORE

Several years after saying the pharmaceutical industry was “getting away with murder,” President Donald Trump appears poised to unveil new drug pricing rules that could shake up U.S. pricing dynamics in a big way. But it remains to be seen exactly how the implementation will play out...Trump plans to unveil two major measures—an international pricing index and a rule to crack down on drug rebates...The international pricing index—also called the “most-favored-nations" clause—would tie U.S. prices in Medicare to lower prices abroad. The pharmaceutical industry has intensely resisted the proposal. Eli Lilly CEO David Ricks, for one, characterized it as “horrible” policy, and Pfizer CEO Albert Bourla, Ph.D., said the president’s summer executive orders on drug pricing were “an enormous distraction” amid the COVID-19 fight and threatened American jobs...READ MORE