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CVS Health will ratchet up scrutiny of opioid prescriptions in an effort to reduce misuse and abuse of the overprescribed painkillers...CVS, which also operates one of the nation’s largest pharmacy benefit managers in Caremark, said it will roll out an “enhanced opioid utilization management approach for all commercial, health plan, employer and Medicaid clients as of February 1, 2018 unless the client chooses to opt out.”...CVS said its program will include “limiting to seven days the supply of opioids dispensed for certain acute prescriptions for patients who are new to therapy; limiting the daily dosage of opioids dispensed based on the strength of the opioid; and requiring the use of immediate-release formulations of opioids before extended-release opioids are dispensed.”...

The head of the U.S. Food and Drug Administration said...the agency is working on a new policy that would encourage more compounding pharmacies to register under...the Drug Quality and Security Act, which aimed to bring more compounding pharmacies...under the authority of the FDA rather than state pharmacy boards...The law created a category of “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk to hospitals and physician practices without prescriptions for individual patients...In exchange, those compounders would have to follow federal manufacturing standards and subject themselves to routine inspections...around 70 firms have registered as outsourcing facilities...compounders that did not register with the FDA would remain under state oversight, and...could only compound drugs based on prescriptions for specific patients...Gottlieb said that in order to encourage more compounders to register, the FDA would release draft guidance in the next two months reflecting its intention to adjust its enforcement priorities based on the size of registered compounders and the riskiness of their products...We’re looking at ways we can provide more of a gradation in our regulatory architecture so we don’t have a one-size-fits-all approach...

The drugmaker Allergan announced...that it had transferred its patents on a best-selling eye drug to the Saint Regis Mohawk Tribe in upstate New York — an unusual gambit to protect the drug from a patent dispute...Under the deal, which involves the dry-eye drug Restasis, Allergan will pay the tribe $13.75 million. In exchange, the tribe will claim sovereign immunity as grounds to dismiss a patent challenge through a unit of the United States Patent and Trademark Office. The tribe will lease the patents back to Allergan, and will receive $15 million in annual royalties as long as the patents remain valid...The surprising legal move rippled quickly through the pharmaceutical world...setting off speculation about whether other drug companies would soon follow suit in order to protect their patents from challenges through a patent-review process that the industry despises...If Allergan succeeds in holding onto its patents, “we will probably see multiple branded companies housing their patents with Indian tribes...

In a word: patents...The Biologics Price Competition and Innovation Act (2010) was...part of the Affordable Care Act. Its essential goal was to infuse competition and lower the prices of drugs that were made from living cells -- so-called biologics...Until the 2010 law, biologics had no fear of competition -- there was no legal way to introduce generic versions into the market -- so they were able to maintain their monopoly price even after their patents expired. The BPCIA was intended to establish mechanisms within the Food and Drug Administration, the Patent and Trademark Office, and the courts that would allow the introduction of "biosimilars." These drugs weren't exact replicas of biologics, but were similar enough, and safe enough, to be used instead of the brand-name drugs...Here we are seven years later. Guess how many biosimilars have made it to market?..Two...companies are forced to fight through thickets of patents to get a biosimilar to market, a law that was supposed to save the U.S. billions will continue to do just the opposite: make it easy for biologic makers to maintain unwarranted monopolies...

Rumors that Amazon is looking to parachute into the drug field are getting louder. Amazon is already in talks with pharmacy benefits managers...and that poses a larger threat to the pharma industry than some might realize...The retail giant has stayed quiet about its pharma ambitions... a report saying the category-killer is in talks with mid-size PBMs "in an effort to get into various contract arrangements,"...A potential entrance into the drug business could take 18 to 24 months...but Amazon could be a "bigger threat" to the pharmaceutical status quo than many appreciate...There's plenty of reason Amazon might want to get into the drug supply chain...the field is worth $125 billion each year, or 30% of U.S. net pharma spending. To start, the company might offer a strong user experience and a top-notch logistics network, later looking to change transparency dynamics on pricing...the company might partner with a PBM as a "path of least resistance." Other routes into pharma for Amazon would be as an online pharmacy, a retail plus online pharmacy, an integrated PBM or a distribution player to pharmacies...

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The pharmacy community is working to make sure Florida residents are prepared as Hurricane Irma bears down on the state. Gov. Rick Scott authorized pharmacies to dispense up to 30-day emergency prescription refills to patients...In addition, CVS Pharmacy and Walgreens are emphasizing the importance being prepared by keeping prescriptions stocked, or at least on-hand. "Prescription preparedness is one of the most important steps individuals and families can take in the lead up to potentially severe weather, and CVS Pharmacy is working to ensure that our patients have the medications they need in advance of the storm," says CVS Health EVP retail pharmacy and supply chain Kevin Hourican. Walgreens is reminding patients to follow evacuation orders and get to a safe location before refilling their prescriptions, noting that all locations can access a patient's records and that the Walgreens app can be used to refill prescriptions and pick them up nearby.

As many find themselves dealing with the devastating aftermath of yet another hurricane, the International Academy of Compounding Pharmacists wanted to highlight members who are working around the clock to help patients and other pharmacists, as well as provide you with invaluable pharmacy and legal resources that are available for you..

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Pharmacists in Washington State got SB 5557 passed in early 2015—a bill requiring commercial or private health care plans regulated by Washington State to enroll pharmacists into their provider networks, and it mandates that these plans pay pharmacists for services provided if they are within a pharmacist’s scope of practice...With more than 10,000 active collaborative practice agreements in existence for pharmacists in Washington State, Rochon said they wanted to “push the bar” even further and make sure pharmacists were compensated for their services. The process was long and involved and passage of the bill was achieved largely through several partnerships with stakeholders ranging from legislators to patient advocacy groups. Part of the process also involved legal maneuvering with an existing Washington State law having to do with providers and health care plans...Brad Tice, PharmD, MBA, FAPhA, Director, Product Strategy & Commercialization at Cardinal Health (22:11)