Thanks to recent regulatory moves as well as the increasing prevalence of copay accumulator/maximizer programs, the tactics that payers use to counter drug manufacturer copay assistance continue to be a controversial topic in the health care sector. However, it remains unclear how the Biden administration will approach the issue, industry experts say, so stakeholders on both sides of the debate should prepare for more uncertainty.

At least two-thirds of health insurance plans offered in the Affordable Care Act marketplaces in 32 states include a copay accumulator adjustment policy (CAAP), which prevents drug manufacturer coupons from counting toward patients’ annual deductibles or out-of-pocket cost limits, according to a recent study by The AIDS Institute. Meanwhile, the Business Group on Health’s 2021 Large Employers’ Health Care Strategy and Plan Design Survey showed that large companies are increasingly adopting copay accumulator programs to reduce prescription drug costs, as 49% of employers said they either had such a program in place in 2020 or were adding one in 2021, and another 14% planned one for 2022-2023.

Treatment for heart failure still relies significantly on tried-and-true generic drugs, but new brand-name entrants — including Novartis’ Entresto (sacubitril/valsartan) and Amgen’s Corlanor (ivabradine) — are important additions to prescribers’ clinical arsenals against the high-mortality condition, industry insiders say.

Recent data from the 2021 Medicare Annual Election Period (AEP) reflects the anticipated increase in Medicare Advantage enrollment, which is up almost 10% from a year ago (see infographic, below) and indicates penetration exceeding 43%, according to industry estimates. But multiple factors are making it harder for MA organizations to attract new members, and while plans are enhancing their benefit offerings to stay competitive, they must do so in a way that aligns with their star ratings and other financial goals.

Approximately 2.4 million people enrolled in a Medicare Advantage plan from February 2020 to February 2021, bringing the total MA population to 26.3 million medical lives. That’s a 9.9% year-over-year increase, according to AIS Health’s analysis of data from the 2021 Medicare Annual Election Period (AEP). While the AEP was strong overall, the top 10 MA insurers continue to dominate the market, with 62.7% of all new enrollees selecting a plan from UnitedHealthcare, Humana Inc. or CVS Health Corp.’s Aetna. Meanwhile, Centene Corp.’s completed acquisition of WellCare Health Plans, Inc. allowed it to jump from No. 10 to No. 6, more than doubling its 2020 headcount.

The FDA recently expanded the label of Novartis’ Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. It became the first and only FDA-approved drug for both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) in patients whose left ventricular ejection fraction (LVEF) is below normal levels.

A Zitter Insights survey shows that the majority of oncologists are likely to prescribe a newly approved agent for advanced renal cell carcinoma.

The effort to develop therapeutics and vaccines to defend against COVID-19 has progressed at warp speed, if you will. As of March 8, 2021 — just over 13 months since then-HHS Secretary Alex Azar declared a public health emergency for the U.S. — the FDA already had given three vaccines, almost 10 drugs and biologics and 345 in vitro diagnostic tests Emergency Use Authorization (EUA). Industry experts suggest there are some lessons to be learned from the pandemic that the agency may leverage in the approval process overall.

With the FDA’s approval of Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) last month, there are now three chimeric antigen receptor T cell (CAR-T) therapies to treat a certain type of non-Hodgkin’s lymphoma (NHL). A Zitter Insights poll shows that payers do not anticipate its approval as having much of an impact on their management of the space. However, with more of these therapies in the pipeline, payers should take a closer look at these products and their strategies to manage them, say industry experts.

Pharmaceutical manufacturers likely will continue to turn to authorized generics — drugs produced by brand-name drugmakers without the brand label — as they face increased pushback against high drug prices, but payers and patients probably won’t see much benefit as a result, according to industry experts.