FDA advisory committee recommends approval for Astellas overactive bladder drug
DEERFIELD, Ill. — A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.
The drug maker announced that the FDA Reproductive Health Drugs Advisory Committee voted 7-4 with one abstention that its assessment of the risks and benefits of the drug YM178 (mirabegron) supported the drug’s approval.
The FDA is not required to follow the recommendations of advisory committees, but usually does. The agency is expected to decide whether or not to approve the drug by June 29.
Retail pharmacies can play role in employer wellness programs
WHAT IT MEANS AND WHY IT’S IMPORTANT — It’s no secret that something has been afoot for the last few years: Retail pharmacies have gradually metamorphosed from places to pick up pills to destinations for health care — places to get everything from vaccines to care from nurses and even from physicians.
Given retail pharmacies’ evolving role, the growing number of employers starting wellness programs has opened up a number of possibilities, which some retail pharmacy companies have already started exploring.
(THE NEWS: More than half of employers include wellness program in health package. For the full story, click here.)
In November 2011, for example, computer networking company Cisco signed a deal with Walgreens’ Take Care Health Systems to operate the "LifeConnections Health Center" on Cisco’s San Jose, Calif., campus, providing Cisco employees and dependents with health-and-wellness services ranging from primary care, physical therapy, chiropractic care, acupuncture, vision, health coaching and an on-site Walgreens pharmacy.
More recently, in late March, Take Care announced the opening of the BeWell Center to provide wellness and preventive care, symptom care and lab services for Tufts University employees and contractors using the Tufts Health Plan, complementing a fitness center that Take Care also manages.
Meanwhile, in September 2011, Wellmark Blue Cross and Blue Shield named Hy-Vee Pharmacy Solutions, the chain’s specialty pharmacy division, as its preferred provider of specialty pharmacy benefits for members. The services include access to pharmacists who can address members’ questions or concerns, one-stop shopping for prescriptions and OTC medications and delivery of medications through Hy-Vee pharmacies or to patients’ homes, offices or other locations.
Employers have a vested interest in keeping employees healthy: It makes for more productive staff and keeps a lid on what they have to pay for health care. With retail pharmacies increasingly acting as extenders to physicians — and in some cases hiring physicians themselves, as Duane Reade has done — they’ll have a growing number of opportunities to be of service.
Pharmacy industry sizzles following FTC approval of Express Scripts-Medco merger
WHAT IT MEANS AND WHY IT’S IMPORTANT — You can’t uncrack an egg. That’s the preliminary reply Express Scripts gave to the district court hearing the case filed by the National Association of Chain Drug Stores and the National Community Pharmacist Association to block the merger between Express Scripts and Medco. The pharmacy industry’s concern, however, revolves around what kind of beast will hatch from this ESI-Medco merger if that cracked egg isn’t unscrambled.
(THE NEWS: Super PBM merger approved; NACDS, NCPA file emergency motion to block merger. For the full story, click here.)
The judge in that case on Thursday approved a request from ESI that the full response to the suit be submitted under seal, given the sensitivity of the newly merged business information they would need to share. So much for transparency. A hearing on an NACDS-NCPA preliminary injunction request will be heard April 10 in the afternoon, according to court documents. To weigh in on a DSN poll on whether or not the merger will be scuttled in the courts, click here.
Altogether, now that Express Scripts and Medco have received the Federal Trade Commission blessing, the consequences for retail pharmacy could be severe. Community pharmacists have testified over and over that the consolidation of these pharmacy benefit managers places more of their prescription business into one of two buckets — and that without either a competitive PBM marketplace or the economies of scale tipping into their favor, any take-it-or-leave-it-style negotiations over reimbursement rates will force those independents to pull their pharmacy shingles down altogether.
Though Express Scripts chairman, president and CEO George Paz did testify before Congress just before Christmas last year that it would not be the merged PBM’s intent to shut down independent pharmacists. On the contrary, the new Express Scripts Holdings would negotiate higher reimbursement rates for independents than they do with the "big-box retailers," he said.
"We believe our country needs those small pharmacies, and they don’t have the buying power. They don’t have the ability to do what the big, big pharmacy chains — the Walgreens, the CVSs, the Rite Aids in this world — can do, so our job is to go out and negotiate and try to get better deals for them so they can in fact stay in business," Paz testified. Nobody believes him — at least no one in the community pharmacy space.
That was before the United States Senate Committee on the Judiciary in December. (To view the video of that testimony, click here, Paz’s testimony quoted above is about 90 minutes into the 144-minute session.)
There also has been a lot of speculation on Wall Street as to how this will impact Walgreens, the one pharmacy that last year did walked out on Express Scripts’ pharmacy network, in part because of less-than-robust reimbursement rates. Express Scripts in 2011 represented 10.7% of Walgreens’ prescription business, and Walgreens’ Medco book of business was bigger still (125 million prescriptions in calendar 2011 and 108 million in calendar 2012 versus 88 million Express Scripts prescriptions in fiscal 2011. Not apples to apples comparisons but a sense as to the relative magnitudes).
Does a merged ESI-Medco call Walgreens’ participation in the Medco pharmacy network into question? Both Walgreens and Express Scripts Holdings have publicly stated no, contracts are in place and they will be honored. The street speculates that the closer Walgreens comes to the end of that Medco contract, the more pressure the Chicago chain will be under to accept any Express Scripts terms. However, the week before that merger was given the regulatory green light, Walgreens president and CEO Greg Wasson reiterated that Walgreens’ operating principle would remain the same: to be fairly reimbursed for the full cost of adjudicating a prescription.
Many analysts don’t believe Walgreens will walk away from both Express Scripts and Medco pharmacy networks, combined. But then again, they didn’t think Walgreens would exit the Express Scripts pharmacy network in January, either.
For Walgreens, this may become a proof of concept opportunity. Walgreens is banking on more payers and employers taking advantage of the kind of lower healthcare outcomes Walgreens has been able to drive through the totality of its operations — retail pharmacy, specialty pharmacy, retail clinics, worksite clinics, infusion and respiratory centers, and mail order. "We feel good about the value we’re offering as more and more PBMs, health plans and others approach us to develop unique member services and benefits that can be offered to clients," Wasson told analysts a week ago. "We’ve never been this busy this early in a [PBM selling] season and every indication is that this will be the most active selling season in recent memory."