Radar on Specialty Pharmacy

Pharma manufacturers depend on contracts with PBMs — and, increasingly, their group purchasing organizations (GPOs) — to ensure favorable formulary positioning with PBMs’ health plan and employer clients. But as those contracts have grown more complex and less transparent, drugmakers may be at risk of losing significant amounts of money, according to some industry experts.

Revenue leakage — unintended revenue loss because of process inefficiencies — can be a huge financial drain on pharma manufacturers. It also may potentially result in compliance risks with the Anti-Kickback Statute and its discount safe harbor protections, “so it always has to be clearly defined as to what the rebate or any monies between pharma and the PBM being exchanged; there has to be a reason,” explains Stephanie Seadler, vice president of Trade Relations at EmsanaRx.

A new prostate cancer drug is sparking interest among payers and oncologists alike, according to a survey by Zitter Insights. While the product offers a new mechanism of action for the indication, the manufacturer recently halted production of the therapy temporarily in two of its three global sites “out of an abundance of caution” due to “potential quality issues” that could pose a glitch in initial uptake of the therapy.

On March 23, the FDA approved Novartis Pharmaceuticals Corp.’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as ¹⁷⁷Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in people who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The product from Novartis unit Advanced Accelerator Applications USA, Inc. is the first FDA-approved targeted radioligand therapy for eligible people with mCRPC that combines a targeting compound with a therapeutic radioisotope.

A recent study of a new drug to treat primary biliary cholangitis (PBC) found that common symptoms experienced by real-world patients were similar to those experienced by people in clinical trials for the agent.

PBC is a chronic disease that causes the liver’s small bile ducts to be destroyed, resulting in permanent liver damage and putting people at risk for liver failure and death. There is no cure for PBC, and the goal of treatment is to slow progression of the condition and manage its symptoms, which most commonly are itching, also known as pruritis, and fatigue.