Highlights
- FDA approves changes to COVID-19 vaccine administration
- Amgen publishes 2021 Biosimilar Trends Report
- Pfizer unveils warranty program for cancer drug Xalkori (crizotinib)
- Express Scripts to favor Semglee (insulin glargine-yfgn), the first interchangeable biosimilar insulin, on National Preferred Formulary
FDA approvals and launches
- Tavneos (avacopan) receives approval to treat a systemic autoimmune disease that affects the body’s blood vessels.
- Seglentis (celecoxib/tramadol) is approved to treat severe, acute pain.
- Cyltezo (adalimumab-adbm) is approved as an interchangeable biosimilar to Humira (adalimumab).
- Due to patent protections, the drug likely will not be available until at least 2023.
- Vuity (pilocarpine) ophthalmic solution is approved to treat presbyopia, otherwise known as age-related near sightedness.
News
FDA approves changes to COVID-19 vaccine administration
- The agency is approving booster doses in certain circumstances, mixed dosing regimens of vaccines from different manufacturers, and emergency use authorization in the pediatric population.
Amgen publishes 2021 Biosimilar Trends Report
- The average sales prices (ASP) for both reference products and biosimilars have been decreasing over time, at a compound annual growth rate (CAGR) between 4% - 19%.
- Regulatory pathways supporting the continued approval of interchangeable biosimilars are expected to contribute to this trend.
Pfizer unveils warranty program for cancer drug Xalkori (crizotinib)
- The warranty serves as a form of value-based pricing, offering a refund on out of pocket and payer costs if the drug is discontinued by a member due to clinical reasons before the fourth bottle is dispensed.
Express Scripts to favor Semglee (insulin glargine-yfgn) on National Preferred Formulary
- Semglee is a form of long-acting insulin and competes with reference product Lantus (insulin glargine).
Express Scripts announces “Right Price” discount card solution
- “Right Price” applies discount card pricing to a member’s out-of-pocket cost if the pricing is lower than pricing under a member’s pharmacy benefits plan.
- The PBM has integrated with Amazon to provide members with access to the Amazon prescription discount card and the option to purchase medications through Amazon Pharmacy.
OptumRx offers Gene Therapy Risk Protection program effective January 2022
- The program will cover Zolgensma (onasemnogene abeparvovec) and Luxturna (voretigene neparvovec) as well as two additional drugs expected to launch in 2022.
- In return for a flat PMPM fee, OptumRx will provide coverage for these therapies as well as utilization management that ensures their clinical appropriateness for members.
IQVIA report details drug spending dynamics on an international level
- Oncology, diabetes, and immunology are the therapeutic classes driving current spending trends.
- Drug spending as a percent of healthcare costs has been fairly stable over the last two decades, averaging about 15% for the 11 countries studied.
CMS guidance confirms that group health plans can offer premium discounts to COVID-19 vaccinated members
- Conversely, plans are not permitted to deny or limit coverage for members that are not vaccinated.
Drug Channels discusses the increasing trend of “white bagging”
- “White bagging” refers to the practice of a specialty pharmacy filling a patient’s prescription and delivering it to a physician’s office or clinic for administration at a later date.