Radar on Specialty Pharmacy

✦ Ontruzant (trastuzumab-dttb) launched on April 15. Merck & Co., Inc. will commercialize the Herceptin (trastuzumab) biosimilar in the U.S. per a deal with Samsung Bioepis Co., Ltd. Ontruzant is available in 150 mg single-dose vials and 420 mg multiple-dose vials. The wholesale acquisition cost for the 150 mg vial is $1,325, and the WAC for the 420 mg vial is $3,709. Both are discounts of 15% off Herceptin’s list price. Merck will market and distribute it in the U.S. until the drugmaker spins off Ontruzant and other products to a new yet-to-be named, independent, publicly traded company, which is expected to occur in the first half of 2021. Visit www.merckconnect.com/ontruzant.

✦ Teva Pharmaceuticals USA, Inc. and its parent company Teva Pharmaceutical Industries Ltd. filed a lawsuit (No. 1:20-cv-00808) against the FDA and HHS over the decision not to transition Copaxone (glatiramer acetate) from the Public Health Service Act to the Federal Food, Drug, and Cosmetic Act (RSP 3/20, p. 4). On March 23, 100 products made the transition as mandated by the Biologics Price Competition and Innovation Act. Teva is claiming that the FDA’s decision is “arbitrary, capricious, and contrary to law, and it thus should be set aside under the Administrative Procedure Act.” View the lawsuit at https://bit.ly/3b8Porb.

✦ April 8: The FDA granted an additional approval to Pfizer Inc. subsidiary Array BioPharma Inc.’s Braftovi (encorafenib) in combination with Lilly USA, LLC’s Erbitux (cetuximab) for the treatment of adults with metastatic colorectal cancer with the BRAFV600E mutation, as detected by an FDA-approved test (see brief below), after prior therapy. The agency initially approved the capsule in June 2018 (RSP 7/18, p. 10). The recommended dose for the new use is 300 mg once daily in combination with Erbitux. Website GoodRx lists the price of two bottles, each with 90 75 mg capsules, as more than $12,400. Visit www.braftovi.com.

✦ April 13: The FDA approved AstraZeneca and Merck & Co., Inc.’s Koselugo (selumetinib) for people at least 2 years old with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. The agency gave the kinase inhibitor breakthrough therapy, rare pediatric disease and orphan drug designations. AstraZeneca received a priority review voucher under the rare pediatric disease designation program. Recommended dosage of the capsule is 25 mg/m2 twice daily. Multiple news outlets report that the drug’s monthly list price for an average patient will be $12,500. Visit www.koselugo.com.

High cost is only one characteristic of specialty drugs that makes managing them so important. They fall under both the pharmacy and medical benefits, they have complicated treatment regimens, and they have fraud, waste and abuse (FWA) potential. Recent research from Prime Therapeutics LLC shows that a specialty drug managed care (SDMC) pharmacist working with a health plan resulted in substantial savings. The study also reveals the importance of having integrated pharmacy and medical benefit data, as well as prior authorization data.

SDMC Pharmacist Is Specialized Position

An SDMC pharmacist is a specialized position that “requires advanced clinical knowledge of drug therapies, as well as deep understanding of pharmacy and medical drug claim interpretation (e.g., dose, waste and frequency),” explains Patrick Gleason, Pharm.D., assistant vice president of health outcomes at Prime.

Prime Therapeutics LLC recently released the results of two studies focused on two classes of high-cost biologics, asthma and hereditary angioedema (HAE). Both conditions have seen new therapies recently and may be candidates for value-based contracts.

While more than 25 million people in the United States suffer from asthma, about 5% to 10% of those suffer from severe allergic or eosinophilic asthma. While asthma overall has a societal cost of around $56 billion, those patients account for almost 50% of that cost. Global Initiative for Asthma 2019 guidelines recommend an asthma biologic for this subset of patients, and the first Prime study examined the use of five biologics: Cinqair (reslizumab), Dupixent (dupilumab), Fasenra (benralizumab), Nucala (mepolizumab) and Xolair (omalizumab).

On April 15, the FDA approved the first drug for patients with low-grade upper tract urothelial cancer, UroGen Pharma Ltd.’s Jelmyto (mitomycin). It offers patients a nonsurgical option for a condition that often requires numerous surgeries (see brief, p. 8). While most commercial payers surveyed about its management said they will manage it per its FDA label, a handful said they are likely to manage it less restrictively.

The cancer is rare and develops in the lining of the upper urinary tract, ureters and kidneys. Because of the complexity of the anatomy of the urinary tract system, the condition can be challenging to treat. According to UroGen, “The current standard of care includes multiple surgeries and most patients require a radical nephroureterectomy, which includes the removal of the renal pelvis, kidney, ureter and bladder cuff.” That most diagnoses are made in people at least 70 years old complicates their treatment as well, as many of them have compromised kidney functionality, and major surgery may result in additional complications.