Radar on Specialty Pharmacy

Prime Therapeutics LLC and Magellan Rx Management, a Prime company as of the end of last year, recently presented findings from a series of studies that used integrated medical and pharmacy claims to assess real-world drug use. Their findings show that different strategies can help identify potential member issues that could impact payer costs.

The studies were presented at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting, held in San Antonio, Texas, March 21 to 24.

Biomarker testing is an important tool in cancer care, but a recent survey found payer coverage issues are creating access barriers. According to CancerCare, researchers found that biomarkers helped providers offer personalized care for various cancers for nearly all — 93% — respondents. Twenty percent of surveyed patients were able to forgo unneeded chemotherapy and/or radiation, while 10% found that they were eligible for a clinical trial.

However, the survey also found that 29% of people who had biomarker testing had insurance that did not cover it, prompting them to undergo appeals, obtain financial assistance or pay out of pocket for the service. In addition, 25% of patients said that their insurer required prior authorization (PA) for the process, a tactic that can delay access to treatment.

In late 2022, the FDA approved the first gene therapy for bladder cancer, Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg). Almost three-quarters of oncologists surveyed by Zitter Insights expressed at least moderate interest in the agent, and payers said they expect to manage the drug to label. While the drug gives another treatment alternative to a much-needed area, it likely will continue to put financial pressure on payers, industry experts tell AIS Health, a division of MMIT.

On Dec. 16, the FDA approved Adstiladrin for the treatment of adults with high-risk, Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The agency gave the novel adenovirus vector-based gene therapy priority review, breakthrough therapy and fast track designations. Dosing is once every three months into the bladder via a urinary catheter. The company said it expects the therapy to be available in the second half of 2023.

The FDA will withdraw Makena (hydroxyprogesterone caproate) from the U.S. market, the agency said April 6. The move follows manufacturer Covis Pharma Group saying on March 7 that it had requested an “orderly wind-down” of the drug from the market. However, “effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” said the agency in its statement. “Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved.”

The decision brings to a close a long-running saga that started more than a decade ago, as well as shines a spotlight on the FDA’s often-criticized accelerated approval pathway.

A judge recently struck down certain preventive services coverage mandated by the Affordable Care Act (ACA). If upheld, the decision could upend access to potentially life-saving services that have been provided for free for more than a decade.

Judge Reed O’Connor from the U.S. District Court for the Northern District of Texas issued the ruling in Braidwood Management v. Becerra (No. 4:20-cv-00283-O) on March 30. The following day, the Justice Department said it was appealing the decision, sending the case to the U.S. Court of Appeals for the Fifth Circuit, potentially reaching the Supreme Court.