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Demand for generics and biosimilars is growing. In 2017, generic drugs generated $265 billion in savings. New biosimilars could play a major role in increasing competition and driving down costs...Drug Topics spoke with officials from the FDA’s Office of Generic Drugs (OGD)and from the Therapeutic Biologics and Biosimilars team (TBB) about how the agency is helping accelerate generics to market, and the role pharmacists play in educating patients about the safety, effectiveness, and quality of generics and biosimilars.

• DT: How is the FDA accelerating generics to market? What are some of the obstacles? What does the generic market look like going forward into 2019 in terms of approvals?
• DT: As more generic drugs enter the market, what role can pharmacists play in educating healthcare providers about using generics? How are pharmacists positioned for this task? How does the FDA disseminate information/reports to the pharmacy community on generic drug development and review?
• DT: What is the status of biosimilars in regard to lowering healthcare costs?
• DT: What do you see as the biggest challenge for the healthcare industry as the new forms of drugs are introduced?
• DT: What else might be important for our readers to consider regarding biosimilars?

CVS Caremark will use the value-based drug pricing system of the Institute for Clinical and Economic Review to exclude some high-cost drugs from plans...The pharmacy benefit manager will incorporate ICER's quality-adjusted life years measure. If a drug is priced greater than $100,000 per QALY at launch, CVS Caremark will allow its clients to exclude the drug from their plan...CVS is hoping the decision will give PBMs more power in pressuring drug prices lower, especially by targeting their launch prices...PhRMA...supports using "rigorous, objective evidence to guide formulary decision-making”...”At the same time, we strongly oppose misuse of subjective, one-size-fits-all cost effectiveness thresholds to deny patient access to life saving treatment options,"..."As many stakeholders have noted, blunt cost-effectiveness thresholds ignore what individual patient and providers value and conflict with the movement toward personalized, 21st century health care."

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

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

...the Centers for Medicare and Medicaid Services' proposed changes to outpatient services, including site neutral clinic visits, 340B policy changes and broadening the list of surgeries covered at ambulatory surgical centers, would generally be credit negative and hurt hospital margins.

• Changes include no longer paying more for clinic visits in off-campus hospital or provider-based department clinics compared to a physician's office...
• Proposed changes to the 340B policy could also impact certain hospitals...CMS lowered reimbursement for Part B drugs to the drug's average selling price, minus 22.5 percent from the ASP, plus 6 percent. CMS said this would save Medicare about about $1.6 billion...
• CMS has proposed adding some nonsurgical procedures to those covered at ambulatory surgical centers, which are located off-campus, but are not hospital outpatient surgery centers...

Laura Joszt, host for Pharmacy Week in Review.

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Walgreens and the Dept. of Veterans Affairs are working together to improve coordination of care for VA-enrolled patients. Through the partnership...VA providers will be able to see the entire medication and immunization history of the VA-enrolled patient if they receive prescriptions and immunizations at Walgreens...“This arrangement is the first of its kind, and it’s a strong collaboration,” said VA Sec. Robert Wilkie. “Partnerships like this will help VA continue to improve the way we care for Veterans.”...The VA-Walgreens exchange eliminates the need for providers to gather medication history from patients who fill their scripts at Walgreens...

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