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CVS Caremark is setting limits on the quantities of certain medications being used off label to treat coronavirus disease symptoms...The pharmacy benefit manager will set new “appropriate” limits on the quantity of hydroxychloroquine (Plaquenil) and azithromycin (Zithromax Z-Pak), along with 1 protease inhibitor and albuterol inhalers...However, CVS Caremark members who already take the treatments—which are approved for the treatment of lupus, bacterial infections, HIV, rheumatoid arthritis, and asthma—can bypass the new quantity limits...CVS Caremark is “working with clients to implement new measures to balance the burgeoning interest in off-label use of certain medicines to treat COVID-19 pneumonia with the ongoing needs of members who use these drugs for chronic conditions,”READ MORE

Following the first approved Medicaid section 1135 waiver for Florida, the Centers for Medicare and Medicaid Services has approved 33 more waiver requests in the last 2 weeks....The waivers are intended to provide the states with relief during the coronavirus disease 2019 pandemic by providing states the flexibility to focus resources on managing the outbreak. Some waivers available under Section 1135 of the Social Security Act include temporary suspension of prior authorization requirements; extension of existing authorizations; modified timeline requirements for state fair hearings and appeals; and relaxed provider enrollment requirements to allow states to quickly enroll out-of-state or other new providers...READ MORE

Overwhelmed by demand for an experimental treatment for coronavirus, the drug maker Gilead abruptly shut down its emergency access program, leaving doctors and families scrambling for answers...The company said it was setting up a broader access program that could try to help more people, but some said the transition is delaying remedies for very ill patients who have few options...Gilead said emergency requests had “flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic.”...Gilead said it was switching to a broader program because it could not handle individual requests. “Due to overwhelming demand over the last several days, during this transition period we are unable to accept new individual compassionate use requests,” the company said on Sunday, with the exception of pregnant women and children under 18. “This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients,” the company said...READ MORE

As efforts to discover new COVID-19 medicines roll on, President Donald Trump and others this week focused attention on the decades-old malaria drug chloroquine. Bayer got things rolling with an initial donation of the drug, and now Novartis, Mylan and Teva are taking steps to deliver tens of millions of tablets...Chloroquine and hydroxychloroquine, a more tolerable formulation, are not approved to treat COVID-19. Still, U.S. authorities and others are exploring their potential following encouraging preliminary results...In response, Novartis has pledged a global donation of up to 130 million hydroxychloroquine tablets, pending regulatory approvals for COVID-19. Mylan is ramping up production at its West Virginia Facility with enough supplies to make 50 million tablets. Teva is donating 16 million tablets to hospitals around the U.S...READ MORE

In the recent flap over chloroquine and its relative hydroxychloroquine, drugs seen as promising in many quarters for use in treating COVID-19 patients, one commentator typical of many sternly proclaimed that these compounds “have NOT been proven effective against” the novel coronavirus. Implication: These are drugs no reasonable person would want to take, nor a reasonable doctor prescribe...And yet, as Arizona physician Jeffrey Singer notes, “Doctors around the globe, including the U.S., are using these and other drugs to treat their patients, and reporting on their findings in the peer-reviewed medical literature.” It’s both legal and utterly routine for doctors to prescribe a drug for indications other than the one for which it has been approved — so-called “off-label prescribing.”...In fact, an estimated 20% of pharmaceuticals reach patients that way. And this will be true almost by definition for a newly emergent malady, for which there will be no compounds proven effective yet...READ MORE

In a joint statement, the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists have communicated concerns regarding the inappropriate ordering, prescribing, or dispensing of treatments for COVID-19...The AMA, APhA, and ASHP collectively applaud the selflessness of health care professionals during the COVID-19 crisis, and alternatively caution against providers “prophylactically prescribing medications currently identified as potential treatments for COVID-19 for themselves, their families, or their colleagues,” noting that “some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment.”...“In a time of national pandemic, now is not the time for states to issue conflicting guidance, however well-intentioned, that could lead to unintended consequences,”...READ MORE

AbbVie has released an update on its pending acquisition of Allergan, announcing that the companies have entered into a consent decree agreement with staff of the US Federal Trade Commission regarding the deal...AbbVie claimed that the primary aim of the merger is to achieve a "diversified product portfolio [that] meets our strategic goal to reduce reliance on Humira", as Humira – AbbVie’s blockbuster and also the world’s best-selling drug – gradually loses its patenting around the world, starting in Europe last year...READ MORE

Matthew Gavidia, welcome to This Week in Managed Care

Doctors are hoarding medications touted as possible coronavirus treatments by writing prescriptions for themselves and family members, according to pharmacy boards in states across the country...The stockpiling has become so worrisome in Idaho, Kentucky, Ohio, Nevada, Oklahoma, North Carolina, and Texas that the boards in those states have issued emergency restrictions or guidelines on how the drugs can be dispensed at pharmacies. More states are expected to follow suit...None of the drugs have been approved by the U.S. Food and Drug Administration for that use. Some of them — including chloroquine and hydroxychloroquine — are commonly used to treat malaria, lupus, rheumatoid arthritis and other conditions...Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said state boards across the country were “trying to stop the hoarding and inappropriate prescribing, but balancing what patients need.”...READ MORE

A Biogen employee who allegedly concealed her coronavirus symptoms on a flight back to China may face criminal charges. But first, the biotech has decided it wants nothing to do with the rogue staffer...“She is no longer an employee of Biogen,” a company spokesperson told FiercePharma...According to Biogen, the former employee, a woman surnamed Li, ignored health experts’ guidance and “made the personal decision to travel to China without informing the company.”...Li told local authorities she attended the ill-fated Biogen management meeting at the Marriott Long Wharf hotel in Boston on Feb. 26 and Feb. 27, which as of Thursday has been linked to 97 COVID-19 cases in Massachusetts and multiple cases in other states. But the people at Biogen said Li did not attend the meeting because it wasn't an event for her...READ MORE