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.

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.

A federal appeals court on Feb. 11 rejected Amgen Inc.’s bid to resuscitate antibody patents for its PCSK9 inhibitor Repatha, a victory for Regeneron Pharmaceuticals, Inc. and Sanofi S.A., the manufacturers of Repatha’s only rival, Praluent. (Praluent was developed by both companies, but following a 2020 restructuring of their arrangement, Regeneron is now solely responsible for the drug in the U.S.). The judge in the case agreed with a lower court ruling that Amgen could not make patent claims over monoclonal antibodies without more thoroughly describing their molecular structure, a decision that could have wider implications for the pharmaceutical industry.

Anthem, Inc. is the second-largest health insurer in the U.S., serving more than 33 million lives nationwide. It is also the largest Blue Cross and Blue Shield affiliate, acting as a Blues licensee in 14 states. Anthem's in-house PBM unit, IngenioRx, manages most of its pharmacy benefits, though CVS Specialty Pharmacy serves as its specialty PBM vendor. Anthem also operates Anthem Behavioral Health, and completed an acquisition of Beacon Health Options, one of the largest independent providers of behavioral health services in the U.S., in May 2020.

California and other states that are carving out drug benefits and implementing one single formulary within their state Medicaid programs likely will pose both a challenge and an opportunity for drug manufacturers seeking Medicaid market share for their products, stakeholders say.

As of this year, five states have generally carved out their pharmacy benefits from their Medicaid managed care organization (MCO) contracts: Missouri, North Dakota, Tennessee, West Virginia and Wisconsin. That means the states themselves, rather than the Medicaid MCOs and their affiliated PBMs, now are managing their pharmacy benefits. New York’s and California’s carve-outs are scheduled to take effect this spring.

Therapeutic interventions have evolved from people taking a pill every day to treat a condition to the one-time cell and gene therapies aimed at halting disease progression or even curing a disease. The rise of these innovative new products means that payers need more information than ever in order to properly assess treatments, as well as compare them with existing methods of care. They also can benefit from collaborations with manufacturers, including on innovative pricing models.

People being treated for advanced prostate cancer now have a new oral option, offering patients the ability to not have to visit a provider for administration — an especially welcome alternative during the COVID-19 pandemic. Industry experts point to an array of reasons as to why the new drug should expect to get a lot of use. And a recent Zitter Insights survey indicates that the majority of oncologist respondents likely will prescribe it, with many saying they expect to favor it over the current standard of care.

Beginning in April, California and New York will join a growing list of states that have opted to carve out prescription drug benefits from their Medicaid contracts with insurers, wagering that the state can do a better job at negotiating drug prices with manufacturers than managed care organizations and their contracted PBMs.

NOTES: Nevada plans to carve out the prescription drug benefit effective in FY 2023, when MCO contracts are renewed. California and New York plan to carve out pharmacy benefits starting in April 2021. Utah did n...

Although the fourth quarter of 2020 brought financial challenges for some health insurers due to surging coronavirus infections, the pharmacy-focused divisions of those publicly traded firms seemed to provide a universal bright spot.