Spotlight on Market Access

Brand Products Offer More Options for Heart Failure Treatment

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.

With Switching Down, MAOs Seek ‘Untapped’ Markets

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.

Medicare Advantage Enrollment Soars Past 26 Million in Latest AEP

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.

Current Market Access to Chronic Heart Failure Medications

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.

Oncologists Expect to Prescribe New Renal Cell Carcinoma Drug

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

Development of COVID-19 Vaccines, Tests, Therapeutics Could Have Broader Impact

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.

FDA Approval Makes Breyanzi Third CAR-T Therapy in Non-Hodgkin’s Lymphoma

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.

As Authorized Generics Proliferate the Market, Their True Benefits Are Unclear

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.

Pass-Through Rebate Models Must Demonstrate Value to Catch On

With the Trump administration’s rebate rule delayed and possibly slated for repeal by Democrats in Congress, major changes in how the PBM industry distributes rebate revenue will have to come from the private sector. While a notable minority of PBMs has adopted alternative rebate models, experts say that plan sponsors’ demand for such models is muted, as they still must demonstrate that they generate more value than traditional models.

Lives Changes Driven by COVID-19 as of January 2021

When the COVID-19 pandemic began in the U.S. in March 2020, the closures and disruptions that the virus brought to nearly every facet of life sparked concern about the impact on market access. Would there be major shifts in medical and pharmacy coverage, with millions of lives moving from commercial coverage to the ranks of uninsured? The actual effects on health insurance enrollment, however, were relatively muted. Wide swaths of the workforce transitioned more easily to remote work than was initially predicted. And even in some industries that did see significant economic impact, employers were able to furlough employees rather than laying them off, allowing workers to maintain coverage, while other enrollees opted to use COBRA to keep their insurance.