The FDA in 2018 approved Epidiolex (cannabidiol) oral solution — the first FDA-approved drug that contains a purified drug substance derived from marijuana — for the treatment of seizures associated with two rare and severe forms of epilepsy in patients 2 years or older. Over the past two years, more treatments for epilepsy entered the market. Most recently, the FDA in August 2020 gave another indication to Epidiolex to treat seizures associated with tuberous sclerosis complex in people at least 1 year old. For most epilepsy medications on the market, the majority of insured people have plans that put them under the preferred/preferred (prior authorization and/or step therapy) tiers and covered/covered (PA/ST) tiers, as of December 2020.
Centene Corp. is the fourth-largest health insurer in the U.S., serving more than 20 million lives nationwide. About 70% of Centene's members are enrolled in public-sector health insurance products. Nationally, the company is No. 1 in managed Medicaid, holding contracts with 26 states (see map below). The insurer also dominates the Affordable Care Act exchanges, leading the national market with 2.2 million members in 20 states. In Sept. 2020, Centene unveiled plans to expand its exchange products to two new states, Michigan and New Mexico, plus 400 new counties in its existing markets for the 2021 plan year.
As we look back over the past year, the COVID-19 pandemic has been top of mind for many involved in pharma commercialization and coverage. Less than a year after scientists sequenced the COVID genome, the FDA granted emergency use authorization to vaccines from Pfizer Inc./BioNTech SE and Moderna, Inc. in December — an unprecedented time frame for vaccine development, testing and rollout. Shortly thereafter, vaccinations started to be administered. But that wasn’t the only pharma industry story of 2020. AIS Health spoke with a variety of industry experts on various trends over the past year.
Pharmaceutical manufacturers historically have spearheaded most outcomes research into their products. But specialty pharmacies, faced with complex patient paths and stiffening competition for limited-distribution drugs, increasingly are conducting their own outcomes studies.
The goal, stakeholders say, is for specialty pharmacies — particularly those that are owned by health systems and integrated delivery networks (IDNs) — to show how their services improve patient care and are cost-effective overall.
With its third FDA approval in less than two-and-a-half years, Alnylam Pharmaceuticals, Inc. is bringing another orphan drug for a rare condition to the U.S. market. And similar to the first two, Oxlumo (lumasiran) comes with a costly price tag. To help provide payers with some predictability around costs, the company is extending a new value-based agreement, as well as offering another VBA that the company introduced with its previous approval.
The year 2020 has been filled with unpredictability amid all the changes ushered in by the COVID-19 pandemic. Because of the pandemic-driven economic crisis and ballooning unemployment, member enrollment has seen significant shifts from commercial health coverage toward managed Medicaid plans, according to AIS’s Directory of Health Plans. Though insurers are required to cover coronavirus testing and many chose to waive out-of-pocket costs for coronavirus treatment, their gross margins soared compared to 2019 as a result of significant drops in elective and routine care utilization.