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Amazon is getting more serious about pharmacy...This announcement is much less disruptive than it appears to be. Amazon is copying the GoodRx discount card model—including GoodRx’s partnership with Express Scripts. At the same time, Amazon is launching a mail pharmacy that will accept insurance and be in PBM pharmacy networks...Amazon’s actions are another negative headwind for retail pharmacies, but not a fatal blow to the system. Perhaps Amazon will one day become a true disrupter...Amazon Pharmacy operates as a home delivery pharmacy. It is built on the backbone of PillPack, which Amazon acquired for $700 million in 2018...Just like any other pharmacy, Amazon relies on your pharmacy benefit plan to determine your out-of-pocket expenses. Nothing magical here...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

U.S. regulators...allowed emergency use of the first rapid coronavirus test that can be performed entirely at home and delivers results in 30 minutes...The announcement by the Food and Drug Administration represents an important step in U.S. efforts to expand testing options for COVID-19 beyond health care facilities and testing sites. However, the test will require a prescription, likely limiting its initial use...The FDA granted emergency authorization to the single-use test kit from Lucira Health, a California manufacturer...The company’s test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed as lights labeled positive or negative...READ MORE

On Monday before the stock market opened, Pfizer announced that its COVID-19 mRNA vaccine had proven 90% effective so far in its ongoing late-stage trial, lifting the company’s shares nearly 8% through the course of the day...The same day, in a stock sale Pfizer says was planned months ago, CEO Albert Bourla offloaded 132,508 shares—more than 60% of his total holdings—for $5.6 million...Insider trading? Nope. Extraordinarily lucky? To be sure. And no doubt the size and timing of this sale, coupled with Bourla's confidence over the last few months leading to Monday's data announcement, are enough to rile up critics of executive pay packages in Big Pharma...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

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

The online colossus opened an online pharmacy Tuesday that allows customers to order medication or prescription refills, and have them delivered to their front door in a couple of days...The potential impact of Amazon’s arrival in the pharmaceutical space rippled through that sector immediately. Before the opening bell, shares of CVS Health Corp. fell almost 9%. Walgreens and Rite Aid both tumbled more than 10%...Amazon will begin offering commonly prescribed medications Tuesday in the U.S., including creams, pills, as well as medications that need to stay refrigerated, like insulin. Shoppers have to set up a profile on Amazon’s website and have their doctors send prescriptions there. The company said it won’t ship medications that can be abused, including many opioids...READ MORE

As planning for the distribution of a COVID-19 vaccine begins in earnest, experts say policymakers should include value-based pricing in those considerations...Pricing for value would ensure drug companies and other firms are able to continue to innovate new ways to address the virus without lining their pockets with billions in profits off of a critical vaccine...The researchers say COVID-19 vaccines and therapies will likely require a hybrid pricing approach that cribs from multiple strategies, but measuring value is key for policymakers to "consider the full costs and benefits of products and the wide-ranging ramifications of their actions."...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

More good news emerged from the COVID-19 vaccine front, with Moderna Inc. reporting that its candidate, mRNA-1273, has met the statistical criteria pre-specified in the study protocol for efficacy in an interim analysis, with efficacy of 94.5%. The product is an mRNA vaccine encoding for a prefusion stabilized form of the Spike protein...Moderna plans to submit for an emergency use authorization from the FDA in the weeks ahead, and expects the application will be based on the final analysis of 151 cases with a median follow-up of more than two months. The study enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the NIH and the Biomedical Advanced Research and Development Authority...READ MORE