Spotlight on Market Access

Cigna Healthcare, the insurance arm of The Cigna Group, is the fifth-largest health insurer in the U.S., serving nearly 17 million lives nationwide. More than 90% of its members are enrolled in employer-based health plans, though it also ranks ninth in Affordable Care Act exchange enrollment nationwide. While Cigna currently has a robust Medicare Advantage (MA) presence, ranking eighth nationally, the insurer will soon exit the government health insurance business entirely, with plans to sell its MA line to Health Care Service Corp. This deal fueled persistent rumors that Cigna was plotting a merger with MA powerhouse Humana Inc., but the company has consistently quashed any "Cigmana" speculation.

More than two-and-a-half years after it first brought a lawsuit against SaveOnSP, Johnson & Johnson has added two additional divisions of The Cigna Group to the case challenging its copay maximizer program. In a recently unsealed motion, J&J added Express Scripts and Accredo as defendants “to stop a scheme to pilfer tens of millions of dollars from the financial support that JJHCS [Johnson & Johnson Health Care Systems Inc.] provides for patients.”

Traditionally, when a manufacturer provides copay assistance for one of its drugs, that dollar amount would count toward the patient’s deductible and out-of-pocket maximum. But copay maximizer programs will distribute 100% of available manufacturer copay offset funds over 12 months, as opposed to copay accumulators, which apply the maximum manufacturer assistance up front and deplete that contribution before the end of the year. Payments in both approaches do not count toward members’ deductibles and out-of-pocket maximums.

The number of prior authorization (PA) determinations made by Medicare Advantage insurers has risen steadily in recent years as enrollment in MA has grown, according to a new KFF analysis.

In 2021, there were 37 million PA determinations, followed by 46 million in 2022 and nearly 50 million in 2023. The increase corresponds to the growing enrollment in MA plans, from 22 million in 2019 to 31 million in 2023.

The continuing rise of weight-loss medications and manufacturers entering the direct-to-consumer (DTC) health care arena were among some of the top pharma industry trends in 2024. Oncology remained a leading area of drug development, as did gene therapies, which in turn spurred the use of nontraditional payment models for payers as they grappled with covering the multimillion-dollar therapies. AIS Health spoke with Julia Scanlan, associate consultant in advisory services for MMIT, about those and other noteworthy occurrences within the pharma industry over the past year. (Editor’s note: These comments have been edited for length and clarity. AIS Health and MMIT are both Norstella companies.) 

Since the first chimeric antigen receptor T cell (CAR-T) therapy was approved on Aug. 30, 2017, several similar cellular agents have followed, and 2024 was a particularly noteworthy year. Accomplishments included the first cell therapy for treating a solid tumor, the first new CAR-T since 2022 and two approvals of existing therapies in earlier lines of treatment.

On Feb. 16, 2024, the FDA gave accelerated approval to Iovance Biotherapeutics, Inc.’s Amtagvi (lifileucel) for the treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. The tumor infiltrating lymphocyte (TIL) therapy — which is created from patients’ unique T cells from their tumor as opposed to the T cells in a patient’s blood that the CAR-Ts use — is the first and only one-time individualized T cell therapy with FDA approval for a solid tumor cancer.