The House of Representatives on Nov. 19 passed Democrats’ hard-fought, $1.7 trillion social spending bill, bringing it significantly closer to becoming law and ushering some of the most ambitious drug pricing reforms ever attempted.
With the fate of the Build Back Better Act now in the hands of the Senate, the debate over how its drug pricing provisions will impact innovation in the life sciences industry has never been hotter — especially now that the Congressional Budget Office (CBO) has weighed in.
To some industry observers, the bill’s most controversial attempts to rein in drug prices — including allowing Medicare to negotiate the price of drugs with manufacturers and penalizing drugmakers if their list prices rise faster than inflation — are tantamount to sabotage of the pharmaceutical sector.
The three largest PBMs — Cigna Corp.’s Express Scripts, UnitedHealth Group’s OptumRx, and CVS Health Corp.’s Caremark — each posted strong results in the third quarter of 2021. Indeed, those PBMs were essential — in the eyes of Wall Street — to making up for the impact of COVID-19 on the profitability of their parent companies’ health insurance subsidiaries.
SCAN Health Plan, a California-based Medicare Advantage insurer, is pushing further into the world of virtual drug management with an investment in Arine, a software vendor with a focus on artificial intelligence-backed medical management solutions.
On Oct. 19, SCAN Group, the carrier’s parent company, announced it had taken a minority stake in the vendor, with whom it had a previously established client relationship. The investment in Arine, whose software platform relies on predictive analytics to drive medication adherence, gives SCAN the ability to target specific populations and tailor messages individually to members, including to traditionally underserved populations, according to Binoy Bhansali, corporate vice president of corporate development for SCAN Group.
President Joe Biden recently nominated former FDA Commissioner Robert Califf, M.D., to run the agency once more, ending nearly a year of temporary leadership under Acting Commissioner Janet Woodcock, M.D. One insider says that Califf might look to reform and improve the accelerated approval pathway following the controversial Aduhelm (aducanumab) approval earlier this year.
Califf previously led the FDA during the Obama administration, running the agency for roughly the last two years of Obama’s term. Califf advocates for using “real-world evidence” in addition to clinical trial data in medical approvals. Aduhelm, an Alzheimer’s drug, was approved without such data, though studies of the drug relying on real-world evidence — which takes into account electronic medical record and insurance claims data — are underway. During Califf’s initial tenure, Sarepta Therapeutics’ eteplirsen, a muscular dystrophy drug, also earned accelerated approval despite a large outcry from medical researchers.
Plan sponsors’ overall satisfaction with their PBMs increased from 8.0 on a 1-10 scale in 2020 to 8.2 in 2021, according to Pharmaceutical Strategies Group’s 2021 Pharmacy Benefit Manager Customer Satisfaction Report. Based on surveys completed by 291 plan sponsors who provide pharmacy benefits to their employees, the report found that PBMs with 20 million or fewer members tend to have higher satisfaction ratings than larger PBMs. Average satisfaction was highest for PBMs’ opioid management programs, while gene therapy financial protection programs rated the lowest and only 13% of the respondents used such programs. Among PBMs with more than 20 million members, MedImpact scored the highest overall satisfaction rate (8.5).
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