Sanofi S.A. is cutting its losses on its PCSK9 inhibitor, exiting the U.S. market for the drug completely after various tactics, including slashing prices and promoting value-based contracts to payers, failed to spark sales for the high cholesterol treatment. But at the same time, Novartis International AG is betting big on the PCSK9 market by acquiring the manufacturer of an investigational PCSK9 that has strong Phase 3 results, AIS Health reported.

Sanofi, which had partnered with Regeneron Pharmaceuticals on Praluent (alirocumab), will turn the U.S. marketing of Praluent over to Regeneron beginning in the first quarter of 2020, and availability of the drug is not expected to be affected.

The Supreme Court has agreed to hear a case that observers say ultimately could upend state-based efforts to regulate PBMs and potentially even lead to legislation on the federal level to rein them in, AIS Health reported. The lawsuit, which was brought by the Pharmaceutical Care Management Association, challenges a 2015 Arkansas law that requires PBMs to reimburse pharmacies at or above their wholesale cost for generic drugs.

The case boils down to whether PBMs are acting as agents under the Employee Retirement Income Security Act of 1974 (ERISA) and therefore are exempt from state-level regulation, or whether they are a "non-interested party and therefore subject to regulation," says Jeff Myers, founder of health care consulting firm OptDis. He says that he believes it's likely the high court justices will side with PCMA and the PBM industry, agreeing that ERISA bars state laws like the one at issue in Arkansas.

State lawmakers will continue to focus on the cost of prescription drugs as the 2020 legislative season gets underway, potentially advancing measures to require the disclosure of manufacturer drug pricing information and bills to limit or eliminate the role PBMs play in state Medicaid programs, AIS Health reported.

However, the abbreviated length of the election-year legislative sessions, plus some unexpected hiccups in states that already have passed bills on those issues, could limit how much actually gets done at the state level in 2020, legislative observers say.

The pace of health care mergers and acquisitions likely will cool slightly in 2020, some industry experts tell AIS Health. Still, insurers are likely to seek out companies with assets such as care management or information technology solutions, while provider consolidation will continue in certain markets, AIS Health reported.

"We expect that payer M&A will continue into 2020, with a bias toward vertical rather than horizontal deals," says Michael Abrams, managing partner of Numerof & Associates, Inc. "Payers will use such deals to expand into adjacent market spaces to differentiate their offerings as integrated platforms that can deliver superior value, customer experience and innovation."

The business arm of the Navajo Nation plans to contract with Molina Healthcare, Inc., to offer Medicaid managed care as part of a partnership between New Mexico, tribal officials and the insurer, AIS Health reported.

The program would be the first-ever Medicaid managed care program dedicated solely to the health care, cultural needs and geographic needs of native populations living in the Navajo Nation, according to Molina.

New oral medications for acute migraine — one pending launch and two more that could be approved in the coming months — likely won't shake up formulary coverage for a condition that's largely treated by generic triptan medications, pharmacy benefit experts tell AIS Health.

Eli Lilly and Co. on Oct. 11 received FDA approval for its drug Reyvow (lasmiditan), an oral medication that's the first serotonin (5-HT)1F receptor agonist to be approved for migraine. Meanwhile, Allergan on Nov. 19 said it's on track for December FDA consideration of ubrogepant, an oral CGRP receptor antagonist for acute migraine. Biohaven Pharmaceuticals also has applied for FDA approval on its oral CGRP antagonist rimegepant.

Although three new drugs for Parkinson's disease have been approved over the last year, plans generally are sticking with the drugs they've included on formularies for several years, most of which are generic, experts tell AIS Health.

That may change in the long term as new gene therapies that currently are in development are approved and come online. But none of those potential new treatments are close to market right now, says Mesfin Tegenu, R.Ph., president of PerformRx.