Radar on Drug Benefits

In OptumRx’s latest Drug Pipeline Report, the UnitedHealth Group-owned PBM highlights a pair of drugs that offer long-sought treatments for two forms of liver disease. Because those diseases are so uncommon, the price of those drugs is likely to be quite high.

The drugs in question are Bylvay (odevixibat), which the FDA approved on July 20, and maralixibat, which the agency is expected to approve in late September. Bylvay, which is manufactured by Albireo Pharma, Inc., is the first drug approved for treating pruritus — or persistent itchiness — in all subtypes of progressive familial intrahepatic cholestasis (PFIC), a group of three related genetic disorders. Mirum Pharmaceuticals, Inc.’s maralixibat, if approved, would be the first treatment for patients ages 1 year and older with Alagille Syndrome (ALGS), a rare genetic disorder in which bile ducts are abnormally narrow, malformed and reduced in number.

Prime Therapeutics LLC saw telemedicine schemes contribute to a 60% year-over-year increase in reported false claims from 2020 to 2021. The Blue Cross Blue Shield affiliate-owned PBM, which is in its second full year of an artificial intelligence-powered fraud, waste and abuse (FWA) reduction program, reported that the program saved its health plan clients $285 million in 2020, in part because it detected telemedicine-driven schemes.

Elan Rubinstein, Pharm.D., head of pharmacy benefits consulting firm EB Rubinstein Associates, says it’s unsurprising that increased telemedicine led to a spike in prescription fraud.

Colorado, Louisiana, New Hampshire and Minnesota have joined New Jersey in requiring PBMs to participate in a reverse auction bidding process to administer the pharmacy benefit for their state employee health plans (SEHPs). Experts say the laws are a useful tool in the larger trend of states trying to control health care costs, though they add that it can’t be the only solution used to tackle to the problem of high drug prices.

Traditionally, when states are looking for a PBM to manage pharmacy benefits for their public employees, they field complex requests for proposals (RFPs) that can be difficult to compare to one another. A reverse auction, on the other hand, requires bidding PBMs to offer the same contract terms — set forth in a drug benefit plan proposed by the state — and to compete solely on price. In 2016, New Jersey was the first state to pass a reverse auction model for its SEHP, and the program launched in 2017.

Mere days after the top PBM trade group filed suit against a regulation requiring PBMs to report historical net prices of prescription drugs, the Biden administration issued guidance that effectively says that provision won’t be enforced anytime soon.

Still, it’s not yet certain what the Pharmaceutical Care Management Association (PCMA) or the U.S. Chamber of Commerce — which filed a similar suit against the so-called “transparency in coverage” rule — plan to do regarding their litigation. And one health plan trade group wants the administration to do more to address its concerns about the price transparency regulation.