Radar on Specialty Pharmacy

✦ Pfizer Inc. unveiled its launch strategy for three biosimilars. Zirabev (bevacizumab-bvzr) launched Dec. 31 at a wholesale acquisition cost (WAC) of $61.343 per 10 mg, a 23% discount to that of reference drug Avastin (bevacizumab), from Genentech USA, Inc., a member of the Roche Group. Ruxience (rituximab-pvvr) launched Jan. 23 at a WAC of $71.68 per 10 mg, a 24% discount to the WAC of reference drug Rituxan (rituximab) from Genentech and Biogen. And Trazimera (trastuzumab-qyyp) will launch Feb. 15 with a WAC of $80.74 per 10 mg, a 22% discount to that of Genentech’s Herceptin (trastuzumab). View the press release at https://bit.ly/2RV1vll.

✦ Infused oncology drug payments are almost two times more in hospital outpatient departments (HOPDs) than they are in physician offices (POs), according to an issue brief from the Employee Benefit Research Institute (EBRI) Center for Research on Health Benefits Innovation. The analysis looked at 18,195 users of the top 37 infused cancer therapies for employment-based and commercially insured patients in 2016. Researchers found that those drugs cost 86.2% more on average per unit in the HOPD setting vs. PO, with HOPDs being reimbursed an average of $8,753 more per patient. The reimbursement difference, researchers found, was “primarily due to differences in prices rather than differences in treatment modality.” For more information, download the issue brief at https://bit.ly/2umwmyf.

✦ Jan. 8: The FDA expanded the label of Keytruda (pembrolizumab) to include the treatment of people with bacillus Calmette-Guérin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have decided not to undergo cystectomy. The agency initially approved the programmed death receptor-1 (PD-1) inhibitor from Merck & Co., Inc. in 2014 (RSP 9/14, p. 4), and it is approved for more than 20 cancer indications. The recommended dose for the newest indication is 200 mg infused intravenously over 30 minutes every three weeks. GoodRx lists the price of one 100 mg/4 mL vial as more than $9,600. For more information, visit www.keytruda.com.

✦ Jan. 9: The FDA approved Blueprint Medicines Corp.’s Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor harboring a platelet-derived growth factor receptor alpha exon 18 mutation, including PDGFRA D842V mutation, the most common exon 18 mutation. The agency gave the kinase inhibitor breakthrough therapy, fast track and orphan drug designations. Tablets are available in 100 mg, 200 mg and 300 mg strengths, and dosing is 300 mg once daily. The company priced all three strengths at $32,000 per 30 days. Visit https://ayvakit.com.

Step therapy has long been a go-to utilization management strategy for payers, as it is often applied to specialty drugs.

But as more and more costly medications come onto the market, the practice has become nearly ubiquitous, prompting some pushback from various stakeholders, including providers, patients and manufacturers.

In December, the FDA gave another indication to Pfizer Inc. and Astellas Pharma Inc.’s Xtandi (enzalutamide) for the treatment of men with metastatic castration-sensitive prostate cancer. Many commercial payers have indicated that they may parity prefer Xtandi with chemotherapy for this indication, which is also known as metastatic hormone-sensitive prostate cancer (mHSPC), according to Zitter Insights research.

Drug Is Used in Other Prostate Cancers

The Dec. 16 approval, which had priority review, is Xtandi’s third in prostate cancer (RSP 1/20, p. 8). The FDA initially approved the drug in August 2012 for metastatic castration-resistant prostate cancer (RSP 9/12, p. 9); approval for use in nonmetastatic castration-resistant prostate cancer came in July 2018 (RSP 7/18, p. 10).

Among the different forms of leukemia, chronic lymphocytic leukemia (CLL) is one of the most common in adults. The FDA has approved multiple treatments for the condition, making it a potential target of value-based contracts — assuming manufacturers would be amenable to such deals.

According to the American Cancer Society, about one-quarter of new leukemia cases are CLL, which is one of the more than 60 subtypes of non-Hodgkin lymphoma.