Radar on Specialty Pharmacy

✦ The FDA’s Oncologic Drugs Advisory Committee voted to keep most indications for a handful of immune checkpoint inhibitors that target programmed death-1/programmed death ligand-1 (PD-1/PD-L1) and received accelerated approval pending further clinical trial data (RSP 4/21, p. 1). Receiving “yes” votes were Tecentriq (atezolizumab) from Roche subsidiary Genentech USA, Inc. for certain triple-negative breast cancers and urothelial carcinomas and Merck & Co., Inc.’s Keytruda (pembrolizumab) for certain urothelial carcinomas and hepatocellular carcinomas. Keytruda received a negative vote for certain gastric cancers and Bristol Myers Squibb’s Opdivo (nivolumab) did also for certain hepatocellular carcinomas. View the meeting materials at https://bit.ly/3uj4XqJ.

✦ Amber Specialty Pharmacy is partnering with MarkeTouch Media to enhance communication with patients via automated, targeted and responsive outbound notifications across services through the TouchPoint Management solution. The move frees up staff from performing routine tasks, allowing them to focus on patients, says the company. Visit www.amberpharmacy.com.

✦ April 6: The FDA approved a new dosing regimen for Eli Lilly and Co.’s Erbitux (cetuximab) of 500 mg/m2 as a 120-minute infusion every two weeks as a single agent or in combination with chemotherapy for people with K-ras wild-type epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The previously approved 250 mg/m2 per-week regimen remains an option. The drug’s monthly list price is $13,596.20. Visit www.erbitux.com.

✦ April 7: The FDA gave full approval to Gilead Sciences, Inc.’s Trodelvy (sacituzumab govitecan- hziy) for adults with unresectable locally advanced or metastatic triple- negative breast cancer who have received at least two systemic therapies, including at least one for metastatic disease. The agency gave the antibody-drug conjugate accelerated approval on April 22, 2020 (RSP 5/20, p. 8). The recommended dose of the intravenous infusion is 10 mg/kg once weekly on days one and eight of a continuous 21-day treatment cycle. Dosing for the first infusion is over three hours, which can be reduced to one to two hours if that dosing is tolerated. Website Drugs.com lists the price of one single-dose vial of 180 mg lyophilized powder as more than $2,173. Visit https://trodelvy.com.

Some companies that analyze specialty drug spend do so with a focus solely on the pharmacy benefit. This approach, however, may fail to take into account a significant amount of medical benefit spending within certain conditions, including inflammatory diseases. A recent study by Prime Therapeutics LLC revealed trends across both benefits for the conditions, which account for almost 20% of all pharmacy and medical benefit drug expenditures among Prime’s commercially insured book of business. It also demonstrated that the class may benefit from indication-based pricing.

The study was presented at the Academy of Managed Care Pharmacy’s AMCP 2021 virtual conference in April.

The multiple sclerosis (MS) therapeutic class boasts more than 20 disease modifying therapies (DMTs) that have various routes of administration. A recent study of oral therapies to treat relapsing-remitting MS (RRMS) found that they are well tolerated, have high adherence rates and have low rates of adverse events.

AllianceRx Walgreens Prime conducted the research in conjunction with Duquesne University School of Pharmacy. The study was presented at the Academy of Managed Care Pharmacy’s AMCP 2021 virtual conference in April.

Based on invoice price levels, the IQVIA Institute for Human Data Science anticipates that the global medicine market will experience a 3% to 6% compound annual growth rate (CAGR) through 2025. Oncology and immunology are the top two therapy areas globally, and they are expected to grow 9% to 12% CAGR during the same time period, according to the company’s recently released report titled Global Spending and Usage of Medicines: Outlook to 2025.

“Despite the pandemic causing significant disruption to health care systems and the use of medicines in the early part of 2020, the overall impact on medicine use was relatively modest during the year,” says Murray Aitken, IQVIA senior vice president and executive director of the IQVIA Institute for Human Data Science. “This was in part because of significant stockpiling of chronic medicines in advance of movement restrictions and higher demand for some drugs used in the treatment of COVID-19 patients, which offset fewer new therapy starts and delays in treatment. The pandemic reinforced the resilience of the pharmaceutical sector and its adaptability, even in the most challenging of times.”