Radar on Drug Benefits

✦ 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.

✦ Democrats and Republicans on the House Energy and Commerce Committee sent FDA Commissioner Stephen Hahn a joint letter asking why generic drug approvals are so slow. Members cited EpiPen, noting that the drug took 10 years to approve in the FDA’s expedited track, and mentioned a 2018 Government Accountability Office report that recommended the FDA offer more guidance to pharma. The FDA only issued five of a possible 28 complex generic drug approvals in fiscal year 2017. View the letter at https://bit.ly/2REbyKh.

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.

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.

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.

“We’ve been keeping a keen eye on the new 2020 formulary postings, watching weekly and monitoring all the big payers’ formularies, and it’s been interesting to note that it looks as though Novo is still in negotiations” for Rybelsus, Jeffrey Casberg, M.S., R.Ph., director of clinical pharmacy at IPD Analytics, tells AIS Health. “You would think by now more often than not you’d see more formularies updated, and we haven’t seen that yet.” IPD provides drug intelligence and consulting to stakeholders across the pharmaceutical landscape.

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.

In the Senate, tweaking the Part D benefit is part of a larger piece of bipartisan legislation (S. 2543), championed by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.), which was approved by the Finance Committee in July and was modified in December. From the House, there’s the sweeping legislation (H.R. 3) proffered by Speaker Nancy Pelosi (D-Calif.), which passed in December only to meet a dead end in the Senate. Like the Wyden/Grassley bill, it would implement hard out-of-pocket spending caps for Part D beneficiaries and considerably change how costs are divided up in the catastrophic phase of coverage. In both bills, Medicare would pay less, enrollees would pay nothing, and manufacturers and plan sponsors would pay more in that coverage phase.

✦ Novo Nordisk Inc. on Jan 2 launched three new strategies to make insulin more affordable for patients. The My$99Insulin Program allows eligible patients — with or without insurance — to get up to three vials or two packs of any combination of Novo Nordisk insulin products for $99 by enrolling on NovoCare.com and downloading an online card that can be redeemed at a pharmacy. In addition, authorized generic versions of NovoLog and NovoLog Mix will now be stocked at the wholesaler level, and patients can order them at the pharmacy and pick them up in one to three business days. Finally, Novo Nordisk said that in order to prevent insulin rationing, in some cases it will provide a free, one-time, immediate supply of up to three vials or two packs of pens of Novo Nordisk insulin for individuals with a prescription. Read more at https://prn.to/2QSw0GW.

✦ A machine learning system can do a better job of preventing medication errors than clinical decision support (CDS) tools such as alerts and reminders, according to a new study. The study, published in the January edition of The Joint Commission Journal on Quality and Patient Safety, analyzed outpatient data from Brigham and Women’s Hospital and Massachusetts General Hospital in Boston to determine whether a machine learning system generated clinically valid alerts, then compared the alerts to those generated by an existing CDS system. It found that 68.2% of the alerts produced by the machine learning system would not have been generated by the existing CDS system, 92% of a random sample of the chart-reviewed alerts were accurate, and 80% were clinically valid. The study also estimated that the machine learning system could have saved more than $60 per drug alert by potentially preventing adverse events in an outpatient setting, and $1.3 million when extrapolating the findings to the full patient population. Visit https://bit.ly/2ZXqlU0.