Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.
- The U.S. Department of Health and Human Services (HHS) officially withdraws proposal to remove anti-kickback statute safe harbor protections for drug manufacturer rebates
- Washington Post releases comprehensive report detailing the distribution of opioids between 2006 and 2012
- Reckitt Benckiser Group settles for $1.4 billion with the U.S. Department of Justice to resolve investigation into its role in the marketing of opioid addiction treatment Suboxone (buprenorphine/naloxone)
FDA approvals and launches
- FDA approves first generic formulations of Lyrica (pregabalin), a drug that produced $3.6 billion in U.S. revenue in 2018
- Amgen and Allergan launch biosimilar versions of Herceptin (trastuzumab) and Avastin (bevacizumab)
- Sandoz announces retail launch of Symjepi (epinephrine) auto-injector
- Accrufer (ferric maltol) is approved to treat iron deficiency
- Baqsimi (glucagon) nasal spray is approved to treat episodes of severe hypoglycemia.
- Nubeqa (darolutamide) is approved for the treatment of certain types of prostate cancer.
HHS officially withdraws proposal to remove safe harbor protections for drug manufacturer rebates
- The Congressional Budget Office estimated that the proposed rule would increase federal spending by about $177 billion over the 2020-2029 period.
Washington Post releases comprehensive report detailing the distribution of opioids between 2006 and 2012
- The report sources data from a Drug Enforcement Administration (DEA) database that tracks the path of every controlled substance from manufacturer to point of sale or distribution.
- The report found that “[t]he states that received the highest concentration of [opioid] pills per person per year were: West Virginia with 66.5, Kentucky with 63.3, South Carolina with 58…”
- During this time period, “the companies distributed enough pills to supply every adult and child in the country with 36 [pills] each year.”
Reckitt Benckiser Group settles for $1.4 billion with Department of Justice to resolve investigation into its role in the marketing of opioid addiction treatment Suboxone (buprenorphine/naloxone)
- The settlement addresses claims that the group improperly promoted the sale and use of the drug and falsely claimed that the product was less susceptible to diversion and abuse.
HHS publishes “Safe Importation Action Plan”
- The plan outlines pathways for the importation of drugs originally intended for distribution in foreign markets, with a goal of providing “safe, lower cost drugs to consumers.”
Trump administration working on a “favored nations” approach to drug pricing
- President Trump says the law will ensure Americans “pay whatever the lowest nation’s price is.”
Court of Appeals for Federal Circuit upholds ruling allowing the sale of generic versions of Suboxone (buprenorphine/naloxone) film
- Alvogen and Dr. Reddy’s launched “at-risk” generic versions of the drug in February 2019.
Oregon institutes new pharmacy benefit manager (PBM) regulations, signs HB 2185 into law
- Examples of items addressed in the bill include retroactive “clawback” fees, pharmacy “gag clauses,” mandatory use of mail-order pharmacies, and the definition of “specialty drug.”
Internal Revenue Service (IRS) issues notice expanding list of preventive care benefits provided by high-deductible health plans
- Expands list of preventive benefits to include low-cost care that maintains health status for patients with chronic conditions. Examples include:
- Angiotensin-converting enzyme (ACE) inhibitors for congestive heart failure, diabetes, and/or coronary artery disease
- Inhaled corticosteroids for asthma
- Insulin and other glucose-lowering agents for diabetes
FDA limits approved uses of 10mg Xeljanz (tofacitinib), adds Black Box Warning about increased risk of blood clots and mortality
- 10mg Xeljanz (tofacitinib) is indicated for the treatment of ulcerative colitis.
- Across all strengths, the drug produced $1.4 billion in U.S. revenue in 2018.
Mylan and Upjohn, a division of Pfizer, merge to create a new company
- The combined portfolio of the two businesses will include EpiPen (epinephrine) and several off-patent brand drugs such as Lipitor (atorvastatin) and Lyrica (pregabalin).
Clinical trials and research
BMJ study finds that only 25% of new drugs approved between 2011 and 2017 conferred considerable or major added benefit compared to existing therapies
- The study examined 216 drugs entering the German market following regulatory approval.
Institute for Clinical and Economic Review (ICER) analysis deems Xarelto (rivaroxaban) and Vascepa (icosapent ethyl) to be cost-effective options for managing cardiovascular disease
- Analysis used current pricing and evidence from available randomized and non-randomized clinical trials and data from conferences, regulatory documents, and manufacturer information.
World Health Organization (WHO) update HIV treatment guidelines to recommend dolutegravir as preferred first-line therapy in patients initiating therapy
- Drugs containing dolutegravir include Tivicay (dolutegravir), Triumeq (abacavir/dolutegravir/lamivudine), and Juluca (dolutegravir/rilpivirine).