- U.S. Supreme Court agrees to hear dispute over biologic drug sales (reuters.com)
The U.S. Supreme Court...agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them...an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the...company from selling its biosimilar version of...Amgen Inc's $1-billion-a-year Neupogen until six months after the Food and Drug Administration approved it. The case could determine how quickly patients have access to biosimilar medicines at potentially cheaper prices...The dispute arose when Amgen sued Sandoz...alleging patent infringement and violations of the law governing biosimilars. The companies disagreed on how to apply the law's requirement that a biosimilar drug maker give the brand-name manufacturer 180 days notice before launching its copycat version...The justices...also agreed to resolve Amgen's appeal in the same case over whether biosimilar makers must give brand-name manufacturers a copy of their application to make a copycat drug after it is submitted to the FDA.
- This Week in Managed Care: January 13, 2017 (ajmc.com)
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
- Nevada State Board of Pharmacy – Newsletter January 2017 (bop.nv.gov)
- Changing Faces
- Bowl of Hygeia Awarded to Adam Porath, PharmD
- No Prescription Needed!
- FDA Issues Final Rule Amending List of Drug Products That May Not Be Compounded
- Selected Medication Risks to Manage in 2017
- Environmental Factors, Workflow, and Staffing Patterns – Poor Quality Lighting
- DEA to Decrease Manufacturing Amount of Opioid Controlled Substances in 2017
- New CDC Brochure Offers Pharmacists Tips for Addressing Prescription Opioid Abuse and Overdose
- FDA Requires Boxed Warnings and Patient Focused Medication Guides Indicating Serious Risks Related to Combined Use of Certain Opioid Medications and Benzodiazepines
- FDA’s Division of Drug Information Offers CE Webinars for Students and Clinicians
- FDA Approves Labeling Changes for All Prescription Testosterone Products
- Latest FDA Drug Info Rounds Training Videos Available
- Inspector's Corner
- Ghost Towns and Medicines
- NHS England announces extra £112m for expansion of GP-based pharmacist scheme (pharmaceutical-journal.com)
The roll out of the pilot will see a further 1,500 pharmacists working in general practice by 2020-2021...NHS (National Health Service) England has announced an additional £112m ($137m) investment to roll out a pilot scheme embedding clinical pharmacists in GP surgeries...a commitment set out in the ‘General practice forward view’...The expansion...follows a “successful” pilot that involved 490 clinical pharmacists working in approximately 650 general practices across 90 sites...The goal of the scheme is to ease pressure on the NHS by increasing capacity in general practice, which will free up GP time as well as ensure safer prescribing by offering specialist advice and support for patients with chronic diseases…The success of the initial pilots has shown the benefits of having more clinical pharmacists in general practice, reducing GP workload and helping ensure patients are seen by the right professional in a more convenient and timely way...the scheme was welcomed by the Royal Pharmaceutical Society, which says it is a “significant step” towards its shared vision with the RCGP ( Royal College of General Practitioners) that every GP practice should have access to the expertise of a pharmacist...
- New York takes drug pricing into its own hands with new clampdown (fiercepharma.com)
New York Governor Andrew Cuomo has...unveiled a first-of-a-kind proposal to curb “exorbitant” prescription prices in the Empire State...New York will create a “review board” to determine the “fair price” for certain expensive drugs under the plan...and then the state will mandate that Medicaid won’t pay more than that amount for its purchases. When a company charges Medicaid more than the board’s set price, it’ll owe a “rebate for any amount” in excess...The proposal would also impact private markets. If a pharma company sells into the state at a price higher than the board’s set amount, that sale will be hit with a surcharge; the government will collect that money and reallocate it “back to the insurance providers to reduce the cost of insurance.”…Lastly, Cuomo's proposal includes new restrictions on pharmacy benefit managers, forcing them to register with the state and disclose “financial incentives or benefits for promoting the use of certain drugs, as well as other financial arrangements affecting customers,”...Then, under the plan, PBMs must have a license beginning in 2019 and the state could revoke those licenses for “deceptive, unfair, or abusive business practices.”...
- Pharmacy Week in Review: January 13, 2017 (pharmacytimes.com)
Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Pharmacy Week in Review: January 6, 2017 (pharmacytimes.com)
Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Hospital Fined $510,000 After Pharmacist’s Illicit Prescription Drug Diversion (pharmacytimes.com)
A Pennsylvania hospital has agreed to pay $510,000 in fines after an inpatient pharmacist stole controlled substances. The pharmacist, Renata Dul, was found to have stolen more than 35,000 units of a controlled substance, including oxycodone….Abington Memorial Hospital disclosed the pharmacist’s actions to the DEA after detecting a discrepancy during inventory, which prompted an investigation that revealed pill count discrepancies, missing or incomplete medication inventories, and altered or missing drug records. An internal investigation pinpointed Dul’s ability to exploit a gap in the software used to track prescription medications...AMH agreed to pay a fine in response to allegations that their failures in control and practices enabled Dul to divert controlled substances for illegal, non-medical uses...
- NCPA suggests any changes to ACA maintain Rx coverage and pharmacy access (drugstorenews.com)
The National Community Pharmacists Associatio...reached out to Republican congressional leaders to provide the community pharmacist perspective on repeal and replacement of the Affordable Care Act and potential Medicaid changes...Specifically, NCPA recommended any repeal and replacement of ACA include the following provisions:
- Preserve prescription drug coverage as an essential benefit to help reduce overall health costs;
- Require a robust pharmacy network that includes meaningful access to retail pharmacies, including independent pharmacies, for patients to fill their prescriptions and promote proper adherence;
- Maintain current definition for Average Manufacturer Price that is used to determine Medicaid reimbursements;
- Retain sections of the ACA that were dedicated to improving Medicare Part D medication therapy management programs, including an annual comprehensive medications review, and build upon it to further integrate pharmacists into the health care delivery system; and
- Keep transparency provisions requiring pharmacy benefit managers serving exchange plans and Medicare Part D to disclose to HHS the generic dispensing rate for retail and mail order pharmacies, the amount of the rebates collected, the amount passed onto the health plan and the total difference between what the PBM charged the plan and what it paid out to pharmacies
- This Week in Managed Care: January 6, 2017 (ajmc.com)
Laura Joszt, with The American Journal of Managed Care. Welcome to This Week in Managed Care, from the Managed Markets News Network.










