User fee re-authorization fuels generics’ outlook
Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”
The enactment in July of the Prescription Drug User Fee Act, or PDUFA, which by law must be re-authorized every five years, provides the Food and Drug Administration with much of the funding the agency needs to review and approve manufacturers’ new-drug applications.
This year, for the first time, the law included Generic Drug User Fee Amendments, thus creating a system of user fees for generic drug companies. The fees, which are projected to raise about $299 million per year over five years, will go toward hiring extra staff to help clear the agency’s estimated backlog of 2,500 generic drug approval applications awaiting review.
The new funding also will spur development of bioengineered and biosimilar medicines by providing the FDA “with the resources necessary to help build new scientific and regulatory capabilities … and promote ongoing biopharmaceutical innovation,” according to Castellani.
Telemedicine, mhealth apps gain ground
New applications based on advances in telemedicine and mobile health technology are proliferating as pharmacy providers, physicians and health plans find new ways to connect with patients who are homebound or in remote locations. The result is to extend access to care, improve convenience and lower health delivery costs.
Drug chain innovators like Thrifty White have offered prescription dispensing and telemedicine services for years to reach patients far from a brick-and-mortar store with pharmacy services, using either a kiosk or a pharmacy technician linked in real time via a live monitor to a pharmacist at a “hub” location. More recently, advances in mobile health applications for computers, remote site kiosks and smartphones have extended the ability of pharmacies and other health providers to reach patients where they live and work.
This fall, telemedicine and mobile health, or mhealth, applications reached another crescendo. Walgreens’ Take Care Health Systems announced a new collaboration with Blue Cross and Blue Shield of North Carolina. Called OnlineCareNC, the new collaborative service allows BCBSNC members to receive a telehealth consultation from a Take Care nurse practitioner, health coach or nutritionist via two-way video, secure text chat or phone.
Almost simultaneously, two other technology providers expanded their own mobile health commitments. SoloHealth unveiled plans to expand its FDA-approved SoloHealth Station health-and-wellness digital kiosks to more than 2,500 store locations by mid-2013 on the way to more than 4,000 locations by 2014. And kiosk maker PharmaSmart said it was partnering with the U.S Centers for Disease Control and Prevention’s “Team Up. Pressure Down.” program to promote blood pressure management among patients with hypertension.
WAG, ESI bury the hatchet
When Walgreens and Express Scripts finally came to terms and agreed to again do business with each other in mid-2012, it marked the formal end of one of the costliest disputes in the history of pharmacy retailing and managed care.
Walgreens and ESI announced July 19 that they had “reached a multiyear pharmacy network agreement that includes rates and terms” that both sides could live with, although those terms were not disclosed.
The resolution of the impasse ended an ugly chapter in the history of the sometimes- strained relationship between retail pharmacies and the PBM industry. But other disputes are inevitable as pharmacy providers jostle with PBMs over contracted payment rates for prescription dispensing and pharmacy services. And it was telling that many pharmacy operators — particularly smaller independent owner/ operators and small and regional pharmacy chains without the clout or market penetration of a Walgreens — had applauded the big chain for being determined enough and powerful enough to draw a line in the sand with ESI over reimbursement terms.
The new contract became effective Sept. 15. And Walgreens began the process of trying to woo back the millions of customers that were pried away by CVS/pharmacy, Rite Aid, Walmart and other competitors after the original Walgreens/ESI service contract expired at the beginning of this year.
Presumably, that means that Walgreens isn’t losing money by serving ESI customers, as it claimed it would have been forced to do under the original terms offered by ESI. Still to be resolved, however, are other questions. Among them: How many ESI members will Walgreens be able to win back to its own pharmacy counters now that they’ve been wooed away by its competitors? Will the two sides be able to negotiate agreeable terms when contracts again come up for renewal? And, on a broader front, will the retail pharmacy and PBM industries continue to forge workable relationships that serve not only their own business interests, but also the interests of payers and patients in an era of health reform, accountable care and outcomes-driven reimbursements?