Highlights
- OptumRx publishes Q3 2021 Regulatory Update and Drug Pipeline Insights reports
- Prime Therapeutics reports a 60% increase in number of members noticing and reporting false claims in prescription drug
- Senate passes H.R. 3684, delays Medicare Part D safe-harbor rebate rule until 2026
- Department of Health and Human Services (HHS) defers enforcement of Transparency in Coverage Final Rules
FDA Approvals and Launches
- Jardiance (empagliflozin) receives additional approval to treat certain forms of heart failure in patients with or without type 2 diabetes.
- Competitor Farxiga (dapagliflozin) was approved for this indication in May 2020.
- Nexviazyme (avalglucosidase alfa) is approved to treat Pompe disease, a rare, inherited disease that affects the heart and skeletal muscles.
- Xywav (calcium, magnesium, potassium, and sodium oxybates) receives additional approval to treat idiopathic hypersomnia.
- Skytrofa (lonapegsomatropin) is approved as a growth hormone to treat patients 1 year and older.
- Invega Hafyera (paliperidone palmitate) is approved as a twice-yearly treatment for schizophrenia.
News
OptumRx publishes Q3 2021 Regulatory Update and Drug Pipeline Insights reports
- The Regulatory Update includes summaries on both federal and state level legislation, as well as a short section on policies related to the practice of “white-bagging.”
- “White-bagging” refers to the practice of shipping specialty drugs directly to a patient’s provider for on-site administration at a later date.
- The Drug Pipeline Insights report covers drugs used to treat kidney disease in type 2 diabetes, chronic migraines, and liver disease.
Prime Therapeutics reports a 60% increase in number of members noticing and reporting false claims in prescription drug history
- Prime Therapeutics attributed this increase to an increased use of telemedicine during the pandemic.
Senate passes H.R. 3684, delays Medicare Part D safe-harbor rebate rule until 2026
- The rebate rule, originally set to go into effect in 2022, eliminated the safe-harbor provision for Medicare Part D rebates.
Department of Health and Human Services (HHS) defers enforcement of Transparency in Coverage Final Rules
- Publication of machine-readable files related to prescription drug pricing is deferred pending further rulemaking.
- Enforcement of all other machine-readable file provisions is deferred until July 1, 2022.
Texas House Bill 3459 goes into effect September 1st, reforms prior authorization requirements
- The bill institutes the policy of “gold carding,” allowing physicians with high prior authorization acceptance rates to bypass future prior authorization requirements for six months.
CardinalHealth compiles state-by-state biosimilar interchangeability laws
- Each state’s laws differ in regards to interchanging reference products with biosimilar products at a pharmacy level.
Department of Veteran Affairs (VA) excludes novel Alzheimer’s therapy Aduhelm (adacanumab) from formulary
- The VA recommends against the use of the drug, however, its patients may access the drug through an exception process.
FDA requires revisions to Boxed Warnings for Xeljanz, Olumiant, and Rinvoq, warns of dangerous heart-related risks
- The drugs are currently used to treat inflammatory disease such as arthritis and ulcerative colitis.
Clinical Trials
Head-to-head trial compares investigational drug abrocitinib and Dupixent (dupilumab)
- The study demonstrated statistical superiority of abrocitinib in treating patients with moderate to severe atopic dermatitis.