RADAR on Drug Benefits

Will ‘Build Back Better’ Spell Disaster for Pharma Innovation?

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.

Big Three PBMs’ 3Q Results Make Up for Insurer Disappointments

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.

Cigna Corp.’s Evernorth, the parent company of Express Scripts, took in $31.9 billion in pharmacy revenue for the first three quarters of 2021, up from $28.7 billion in the same period during 2020. Wall Street analysts were bullish on Evernorth and Express Scripts despite skepticism of Cigna’s overall performance.

SCAN Health Opts to Invest in Medication Adherence Tool

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.

New FDA Appointee Is Likely to Emphasize Real-World Data

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.

Smaller PBMs Beat Big Firms in Customer Satisfaction

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).

News Briefs: Express Scripts Rolls Out COVID Test Coverage Option | Nov. 23,2021

Cigna Corp.’s Express Scripts is offering its health plan and employer clients a “first-of-its-kind” option to cover over-the-counter COVID-19 tests. Starting Jan. 1, 2022, members of participating plans will be able to choose an applicable COVID-19 test kit at a participating in-network pharmacy and show their Express Scripts member ID card at checkout to process the kit through their pharmacy benefit. Plans that opt into the new solution can set a copay for the COVID tests either at a discounted rate or $0. “Our new COVID-19 test kit solution creates more affordable and easily accessible testing options, ultimately contributing to safer communities and less disruption in our daily lives,” said Amy Bricker, president of Express Scripts.

Will Two New PBM Startups Deliver Savings, Transparency?

Two new PBMs entered the game in recent weeks: EmsanaRx, a not-for-profit venture owned by the Purchaser Business Group on Health (PBGH), and CostPlus PBM, a startup funded by venture capitalist and Dallas Mavericks owner Mark Cuban as part of his larger foray into the pharmaceutical business. Like other recent PBM startups, both ventures claim they will be more transparent and client-focused than the Big Three PBMs (Cigna Corp.’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s OptumRx) — but health care insiders say those promises are hard to keep.

Savings From Interchangeable Biosimilars May Be Muted

The month of October brought two important developments for interchangeable biosimilars, which industry observers have long hoped will help increase uptake of lower-cost versions of complex biologic drugs.

On Oct. 15, the FDA approved Cyltezo, the first interchangeable biosimilar version of blockbuster autoimmune condition treatment Humira. And on Oct. 20, Cigna Corp.-owned Express Scripts revealed that it will now prefer Semglee — the first FDA-approved interchangeable biosimilar on the U.S. market — over the branded long-acting insulin Lantus on the PBM’s largest formulary.

Eli Lilly Pounces on Flailing Aduhelm With Competing Drug

Eli Lilly & Co. has announced plans to run a head-to-head clinical trial of its Alzheimer’s drug, donanemab, against Aduhelm (aducanumab), the controversial Biogen Inc. Alzheimer’s drug. Meanwhile, Aduhelm has continued to have what one expert calls “the worst drug launch ever,” after state Medicaid leaders told CMS they want no part of paying for the drug.

Medication Abortion Regulations, at a Glance

Medication abortion — which involves using two drugs, mifepristone and misoprostol — accounts for 54% of all pregnancy terminations before nine weeks of gestation in the U.S., according to a recent Kaiser Family Foundation analysis. The FDA’s Center for Drug Evaluation and Research exercised “enforcement discretion” of the Risk Evaluation and Mitigation Strategy requirement that asks prescribers to dispense mifepristone to patients in-person during the pandemic.