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.
- AbbVie’s next generation treatment for rheumatoid arthritis, Rinvoq (upadicitinib), is approved for the treatment of moderate to severe rheumatoid arthritis.
- AveXis notifies FDA of Zolgensma (onasemnogene abeparvovec-xioi) data manipulation.
- 2019 Milliman Medical Index (MMI) is released, reports relatively modest prescription drug cost growth.
- Oklahoma court holds Johnson and Johnson liable for $572 million in damages in opioid lawsuit.
FDA Approvals and Launches
- Rinvoq (upadicitinib), an orally administered drug, is approved to treat moderate to severe rheumatoid arthritis.
- Taltz (ixekizumab) receives third indication, can be used to treat ankylosing spondylitis in addition to plaque psoriasis and psoriatic arthritis.
- Wakix (pitolisant) is approved to treat excessive daytime sleepiness in adults with narcolepsy.
- Nourianz (istadefylline) is approved as an add-on treatment in Parkinson’s disease.
- Inrebic (fedratinib) is approved to treat certain forms of myelofibrosis, a rare bone marrow cancer.
AveXis notifies FDA of Zolgensma (onasemnogene abeparvovec-xioi) data manipulation
- AveXis may face penalties because the company was aware of the data manipulation issue before FDA approval and failed to report it.
- FDA still considers the drug to have a favorable benefit-risk profile and remains confident the treatment should remain on the market.
2019 Milliman Medical Index (MMI) is released, reports relatively modest prescription drug cost growth
- Drug costs for a hypothetical family of four are estimated to have increased by 4.5% from 2017 to 2018 and then by 2.1% from 2018 to 2019.
Oklahoma court holds Johnson and Johnson liable for $572 million in damages in opioid lawsuit
- Judge’s ruling found that the company’s “misleading marketing and promotion of opioids created a nuisance.”
CVS Health formularies target drugs that have hyperinflated prices and cheap alternatives
- The CVS hyperinflation strategy is projected to save clients $0.38 per member per month by removing targeted drugs from template formularies.
- The five drugs spotlighted in the report are chlorzoxazone, metformin ER, fenoprofen, lidocaine/tetracaine, and Ortho DF.
Annals of Internal Medicine publishes finding that Medicare and its beneficiaries could have saved $17.7 billion between 2011 and 2017 through substitution with certain generic drugs
- The study focuses on drugs with similarly effective, in-class counterparts such as Nexium (esomeprazole) and omeprazole.
Associated Press analysis shows brand-name drug prices are growing at a slower pace than in previous years
- Analysis found a median list price increase of 5% in the first seven months of 2019, which is “down about 9% or 10% over those months the prior four years.”
Kaiser Health News describes the damaging impact of authorized generics on market pricing
- The report highlights the recent authorized generic launches of Tekturna (aliskiren), EpiPen (epinephrine), and Humalog (insulin lispro).
FDA advisory panel votes in favor of approving Descovy (emtracitabine/tenofovir alafenamide) for use in HIV pre-exposure prophylaxis (PrEP)
- Currently, Truvada (emtracitabine/tenofovir disoproxil) is the only HIV drug approved for use in PrEP.
- Truvada is expected to face generic competition in September 2020.
Express Scripts announces changes to National Preferred Formulary
- Changes include 32 new product exclusions and 19 products moving from preferred to non-preferred status.
Clinical Trials and Research
Taltz (ixekizumab) bests Tremfya (guselkumab) in phase 4 head-to-head clinical trial
- Taltz achieved primary and all major secondary endpoints in the study population of patients with moderate-to-severe plaque psoriasis.
Skyrizi (risankizumab) achieves statistically significant improvements over Humira (adalimumab) in treating patients with moderate to severe plaque psoriasis
- In addition to increased efficacy, no additional safety concerns were associated with Skyrizi treatment.
ATLAS-2M study achieves primary endpoint of HIV suppression using injectable drug given once every two months
- Eight-week administration shown to be non-inferior to four-week administration. FDA approval decision on a once-monthly regimen for the drug is expected by the end of 2019.
U.S. Preventive Services Task Force (USPSTF) issues a draft recommendation statement widening scope of hepatitis C screening
- New proposal updates the guidance of screening adults born between 1945 and 1965 to screening all adults 18 to 79 years old.