Newsletter

Pharmacy Briefing | May 2023

27 June 2023

Highlights

FDA Advisory Committee votes against approval of obeticholic acid in the treatment of nonalcoholic steatohepatitis (NASH)
Eli Lilly launches head-to-head trial comparing Mounjaro (tirzepatide) to Novo Nordisks’s Wegovy (semaglutide)
ICER publishes White Bagging, Brown Bagging, and Site of Service Policies: Best Practices in Addressing Provider Markup in the Commercial Insurance Market
Navitus releases 2022 Drug Trend Report

Qulipta (atogepant) receives additional indication as a preventive treatment for chronic migraines.
Arexvy and Abrysvo are approved as the first vaccines used to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV).
Vowst (fecal microbiota spores, live-brpk) is approved to prevent recurrence of Clostridioides difficile (C.diff) infection.
Narcan OTC (naloxone) is approved as first over-the-counter (OTC) option to treat opioid overdoses.
Inpefa (sotagliflozin) is approved to reduce the risk of cardiovascular death In patients with heart failure, type 2 diabetes, chronic kidney disease, and other risk factors.

White bagging and brown bagging represent two alternative ways to dispense certain specialty drugs to patients at a lower cost than traditional “buy and bill” pricing
The report discusses how these practices affect patient safety, equitable access to care, and overall costs.

Wegovy was approved in June 2021 and is a highly utilized treatment for for weight management.
Mounjaro (tirzepatide) achieved up to 15.7% weight loss in recent results from the SURMOUNT-2 phase III clinical trial.

Obeticholic acid, currently available to treat a liver disorder known as primary biliary cholangitis, is under FDA review as potentially the first approved treatment for NASH.

Opill is under FDA review as potentially the first over-the-counter (OTC) birth control tablet on the market.

Navitus cites a 2.6% average net total cost trend for its commercial clients from 2021 to 2022 and a $89.73 net total cost per member per month.
- The net costs cited in the report account for manufacturer rebates.

The House Committee investigation will require CVS Caremark, Express Scripts, and OptumRx to provide the committee with documents and information related to their business practices.
The Federal Trade Commission (FTC) inquiry previously issued “compulsory orders” to the six largest PBMs and, additionally, is extending these orders to Zinc Health Services and Ascent Health Services, two manufacturer rebate (group purchasing organizations) GPOs.

The initiative will create an Independent Pharmacy Advisory Committee and will involve increasing reimbursements to certain independent pharmacies, with a stated goal of expanding health care access to patients in rural communities.
- The independent pharmacies referenced are those that are “unaffiliated with a drug wholesaler in areas with only one pharmacy within 10 or more miles from an Express Scripts customer.”

The manufacturer reported that its net prices declined for the 6th year in a row but claims that patients are not benefitting from these price decreases.

Group purchasing organizations (GPOs) are used by PBMs to leverage a larger number of covered lives in rebate negotiations with drug manufacturers.