Highlights
- Apretude (cabotegravir) injectable receives approval as HIV pre-exposure prophylaxis (PrEP) therapy dosed once every two months
- Commercial health plans required to cover the cost of OTC, at-home COVID-19 tests
- Department of Health and Human Services (HHS) releases Prescription Drug and Health Care Spending interim final rule
FDA approvals and launches
- Apretude (cabotegravir) injectable receives approval as HIV pre-exposure prophylaxis (PrEP) therapy dosed once every two months.
- Rinvoq (upadacitinib), a Janus kinase (JAK) inhibitor approved to treat rheumatoid arthritis, receives additional approval to treat psoriatic arthritis.
- Vyvgart (efgartigimod alfa-fcab) receives approval as first in-class therapy to treat myasthenia gravis.
- Caplyta (lumateperone) gains status at the only approved drug to treat depressive episodes associated with bipolar I or II disorder.
- Tezspire (Tezepelumab-ekko) receives approval as first in-class therapy to treat severe asthma.
News
Commercial health plans required to cover the cost of OTC, at-home COVID-19 tests
- Requirements include reimbursement for a maximum of 8 tests per person, per month.
- Reimbursement amounts may vary depending on if a plan meets certain “safe harbor” conditions.
Department of Health and Human Services (HHS) releases Prescription Drug and Health Care Spending interim final rule
- The rule requires health plans in the group and individual markets to submit certain information about prescription drug and health care spending.
- This interim rule follows two interim final rules published in July and October 2021.
- Enforcement of the rule is deferred until December 27, 2022 and will apply to data starting from the 2020 plan year.
Committee on Oversight and Reform releases Drug Pricing Investigation final staff report
- The report discusses factors affecting manufacturer pricing strategies such as the patent system, competition suppression, and patient assistance programs.
FDA issues emergency use authorization for molnupiravir to treat COVID-19
- Molnupiravir is an oral medication indicated for high-risk patients and should be initiated as soon as possible after diagnosis.
JAMA study estimates the cost of insulin among different stakeholders in the pharmacy distribution system
- The study found that between 2014 and 2018, net prices received by manufacturers decreased while pharmacies, PBMs, and wholesalers retained an increasing share of costs.
Kaiser Family Foundation (KFF) publishes Employer Health Benefits Survey
- Since 2011, average family premiums have increased 47%, more than wages or inflation.
- 18% of programs exclude manufacturer coupons from deductibles and out-of-pocket limits.
- 13% of programs delay coverage of high-cost drugs until the new therapy is proven effective.
Avalere Health releases report on utilization management trends
- The authors describe increased use of utilization management in all therapeutic areas, with prior authorizations being used more often for cancer and autoimmune disorders than for other areas.
ICER publishes their latest Unsupported Price Increase report
- The report describes top selling drugs that had substantial price increases in 2020 after accounting for rebates.
- Humira (adalimumab) was responsible for the largest increase in drug spending due to net price change.
Drug Channels discusses 10 trends affecting the retail pharmacy industry
- • Trends include increased utilization of specialty drugs and specialty pharmacies, reduced margins from participation in narrow pharmacy networks, and the growth of online pharmacies.
CVS Health and Microsoft announce strategic partnership
- Goals of the partnership include building technologies to personalize CVS Health’s customer experience through capabilities such as customized health recommendations.