PD-1 Inhibitors Gain Ground in Immuno-Oncology

Programmed cell death protein 1 (PD-1) inhibitors are positioned for significant growth as immunotherapy options in oncology treatment, according to a pair of presenters at AMCP Nexus. 

Kirby J. Eng, RPh, executive director, business development, PharMedQuest, and Edward Li, PharmD, MPH, BCOP, associate professor of pharmacy practice, University of New England College of Pharmacy, briefed attendees on the workings, efficacy, and costs associated with the first 2 PD-1 inhibitors available in the United States—nivolumab and pembrolizumab.

Nivolumab and Pembrolizumab 

PD-1 is an immune system checkpoint protein that normally limits autoimmunity during an inflammatory response by dampening T cells in peripheral tissues. PD-1 inhibitors ramp up the immune response to fight cancer cells.

Pembrolizumab and nivolumab first received US Food and Drug Administration approval in 2014. Both are indicated to treat patients with unresectable or metastatic melanoma and metastatic non-small-cell lung cancer.

In more than a dozen studies to date, PD-1 inhibitors have demonstrated statistically and clinically significant improvements in overall survival for both types of cancer after failure of prior therapies, according to the presentation. 

Toxicities associated with nivolumab and pembrolizumab are fewer than the CTLA-4 inhibitor ipilimumab, another immune checkpoint inhibitor approved in 2011.

Plan Coverage

PD-1 inhibitors are most often covered under a health plan’s medical benefit, according to the presentation, although coverage under the pharmacy benefit is a possibility. Coinsurance is the main cost offset for the plan sponsor. The treatment is costly, with PD-1 inhibitor combination regimens already projected at $250,000 per year. Those high costs, along with required IV administration, special handling rules, complex dosing, and other factors, have resulted in many health plans considering PD-1 inhibitors as specialty drugs.

Going forward, expanded indications and combination therapies are likely. 

The Role of Specialty Pharmacy

According to the presenters, the role of specialty pharmacy will include the ability to process CMS-1500 format, manage average wholesale price-based reimbursement and average sales price-based reimbursement, support provider variable fee schedules, provide medical and pharmacy claims integration, and work in conjunction with clinical pathway providers. 

Unmet needs for immun-oncology that managed care organizations will seek from specialty pharmacy in the future will be more frequent and
customizable reporting; claims integration capability; better projection, estimation, and extrapolation of future costs; better ccess to treatment guidelines and drug costs; and identification of health care providers not optimizing evidence-based, cost-effective care. Those needs, the presenters mentioned, stem from a Genentech Oncology Trend Report published earlier this year.

In other words, a paradigm shift will need to occur, with specialty pharmacy offering more than simply drug dispensing or a medical benefit carve-out, the presenters maintained. Specialty pharmacy must be equally adept at medical and pharmacy benefit drug management.—Jolynn Tumolo