January

2020 Outlook: Experts Predict Part D Reform, Minimal Pressure on PBMs

January 23, 2020

If Congress or the Trump administration are able to enact any type of drug-pricing reform during 2020 — a year sure to be dominated by the upcoming elections — it’s likely to be a redesign of Medicare Part D, industry experts tell AIS Health. That would put some additional financial responsibility on health insurers’ shoulders, but for PBMs, the regulatory overhang appears to have largely abated, experts say.

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Express Scripts Coverage, FDA Label Update Boost Rybelsus

With Chart: Current Market Access to GLP-1 Medications

January 23, 2020

Access to Novo Nordisk’s Rybelsus (semaglutide) — the first oral glucagon-like peptide-1 receptor agonist (GLP-1) to treat adults with type 2 diabetes — got a major boost Jan. 17 when Novo said Express Scripts, part of Cigna Corp., will cover the agent. Rybelsus was approved in September 2019 and is available as a once-daily tablet version of the drugmaker’s Ozempic (semaglutide), a weekly injection launched in 2018.

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Firms Shake Up PCSK9 Market, With Sanofi Out, Novartis In

January 23, 2020

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.

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News Briefs

January 23, 2020

✦ The Supreme Court has agreed to hear a case that ultimately could upend state-based efforts to regulate PBMs. The lawsuit, which was brought by the Pharmaceutical Care Management Association (PCMA), 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 tells AIS Health that he believes it’s likely the high court will side with PCMA and the PBM industry, agreeing that ERISA bars state laws like the one at issue in Arkansas. View court documents related to the case at https://bit.ly/3aCjOmw.

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‘Hotspotting’ Study Stirs Debate About Social Determinants

with Chart: Health Care ‘Hotspotting’ Program Shows Little Effect on Medically Complex Patients

January 20, 2020

In the health care industry, it’s become almost dogma that a small number of “superutilizers” — typically patients with complex medical and social challenges — are driving a disproportionate share of costs in the system. But a newly published study suggests that efforts to improve care and lower costs associated with those individuals aren’t always as effective as they’re heralded to be. And some think that should serve as a gut check for how organizations like health insurers think about social determinants of health.

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Supreme Court Agrees to Decide if PBMs Fall Under ERISA

January 20, 2020

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. The lawsuit, which was brought by the Pharmaceutical Care Management Association (PCMA), challenges a 2015 Arkansas law.

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 tells AIS Health 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.

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