Spotlight on Market Access

As the use of patient-paid prescriptions continues to grow, it is posing a challenge to the pharmacy benefit market, contended longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. And with some industry developments such as the Inflation Reduction Act likely to impact the uptake of high-price/high-rebate drugs, patient-paid prescriptions could become an even bigger disruption within the market than they already are.

The issue of patient-paid prescriptions — which include both cash-pay claims and discount-card claims — is “potentially something that’s going to actually be genuinely disruptive, actually something that could change the structure of both the PBM industry and how plan sponsors” think about benefit design, Fein asserted. Both approaches, he explained, remove the third-party payer, allowing patients to make a transaction directly with a pharmacy.

In 2028, the federal government will likely negotiate the prices of 38 drugs covered under Medicare Part D and two under Medicare Part B, according to an analysis published this month in the Journal of Managed Care & Specialty Pharmacy. Inmaculada Hernandez, Pharm.D., Ph.D., one of the study’s authors, tells AIS Health the evaluation “is going to be very helpful for health plans and PBMs to know which drugs are going to be negotiated” as they evaluate the impact of the Inflation Reduction Act (IRA).

The IRA, which passed last year, includes a provision that requires the government to negotiate for the first time with pharmaceutical manufacturers the prices of some high-cost medications that are not subject to generic or biosimilar competition. It will begin with 10 Part D drugs in 2026, an additional 15 Part D drugs for 2027, another 15 Part D and Part B drugs in 2028 and an additional 20 Part D and Part B medications each year starting in 2029. Part D covers retail prescription drugs, while Part B covers provider-administered medications.

Independence Health Group is the parent company of Independence Blue Cross, the second-largest Blues insurer in Pennsylvania (behind Highmark Health), and AmeriHealth Caritas, a managed Medicaid payer serving more than 2.3 million beneficiaries in seven states and the District of Columbia. It also operates the AmeriHealth Insurance Company of New Jersey, a commercial payer serving about 209,000 members. Founded in 1938 as the Associated Hospital Service of Philadelphia, Independence now counts more than 4.5 million members across the spectrum of health insurance products. Still based in Philadelphia, it leads its home state’s individual, self-funded (administrative services only, or ASO) and managed Medicaid insurance markets. Optum’s FutureScripts serves as the primary pharmacy benefits manager for Independence Blue Cross. AmeriHealth Caritas, meanwhile, operates its own in-house PBM, PerformRx.

The FDA recently 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 likely will manage the drug to label.

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.

More than six years after the FDA approved it, the first biosimilar of AbbVie Inc.’s Humira (adalimumab) has finally launched in the U.S. On Jan. 31, Amgen Inc.’s Amjevita (adalimumab-atto) became available at two different wholesale acquisition costs — one 55% below Humira’s WAC and one 5% below it — a strategy that acknowledges the lure of rebates within the U.S. market. It remains to be seen whether additional adalimumab biosimilars launching this year will follow suit or explore a different strategy to differentiate themselves.

Initially approved Sept. 23, 2016, Amjevita was the first of eight Humira biosimilars that the FDA had OK’d as of early February. The tumor necrosis factor (TNF) inhibitor is approved for seven of Humira’s nine indications, including rheumatoid arthritis, plaque psoriasis and Crohn’s disease, although the biosimilar is indicated for ulcerative colitis in adults, while Humira is approved for UC in people at least 5 years old. The two Humira indications not on Amjevita’s label are hidradenitis suppurativa and uveitis.