Highlights
- CVS Health and OptumRx announce formulary updates effective January 1, 2022
- White House reveals COVID-19 action plan
- Department of Health and Human Services (HHS) publishes “Comprehensive Plan for Addressing High Drug Prices”
- FDA authorizes booster doses of COVID-19 vaccine for certain populations
FDA Approvals and Launches
- Byooviz (ranibizumab-nuna) receives approval as a biosimilar to Lucentis (ranibizumab), the first ophthalmic biosimilar.
- Opzelura (ruxolitinib) cream receives approval as a topical treatment for atopic dermatitis.
- Qulipta (atogepant) receives approval to treat episodic migraines.
- Livmarli (maralixibat) receives approval to treat certain symptoms of Alagille syndrome, a rare liver disorder.
News
CVS Health and OptumRx announce formulary updates effective January 1, 2022
- 20 drugs will be excluded from the CVS formulary, two drugs will be added to Tier 1.
- CVS Health estimates that the formulary removals will not affect 99.61% of members.
- 20 drugs will be excluded from the OptumRx Premium Formulary, four drugs will be downtiered, and three drugs will be uptiered.
White House reveals COVID-19 action plan
- The plan includes an Occupational Safety and Health Administration (OSHA) rule mandating that all employers with 100 or more employees require employees to get vaccinated or produce negative COVID-19 test results on a weekly basis.
- The rule is not active as of October 2021 and is still in development.
Department of Health and Human Services (HHS) publishes “Comprehensive Plan for Addressing High Drug Prices”
- The report proposes potential legislation that includes drug pricing negotiation, Medicare Part D reform, policies that accelerate the use of biosimilar and generic drugs, and other possible policies.
FDA authorizes booster doses of COVID-19 vaccine for certain populations
- Appropriate populations include those 65 years of age or older and those with higher risk of severe disease or higher risk of exposure.
FiercePharma previews potential 2021 FDA approvals
- Potential approvals include efgartigimod, a first in-class treatment for autoimmune disorder myasthenia gravis.
ARS Pharmaceuticals takes steps to prepare for the launch of Neffy (epinephrine nasal spray)
- The manufacturer received Fast Track Designation for the drug in 2019, which is still pending FDA approval.
Bausch Health settles for $300 million in Glumetza (metformin ER) lawsuit
- The settlement is the result of an antitrust lawsuit, alleging that the manufacturer paid a competitor to delay the launch of a generic version of the product.
Eli Lilly reduces list price of generic insulins
- The pricing change will apply to all generic insulins produced by the manufacturer and will take effect on January 1, 2022, reducing the price 40%.
Clinical Trials
Pfizer begins phase 3 clinical trial for investigational vaccine against respiratory syncytial virus (RSV)
- The RENOIR trial will test the safety and efficacy of the vaccine in adults ages 60 years or older.