Highlights
- Express Scripts introduces 23 additional exclusions to national formularies
- Optum Rx introduces 17 additional exclusions to premium formulary
- Cardinal Health publishes 2022 Biosimilars Report
- FiercePharma summarizes top 10 drugs facing patent loss in 2022
FDA approvals and launches
- Symbicort (budesonide/formoterol) generic alternative is approved to treat asthma and COPD.
- Revlimid (lenalidomide) faces competition as Teva launches a generic version of the oncology drug.
- Adlarity (donepezil transdermal system) is approved as a once weekly treatment for Alzheimer’s disease.
- Rinvoq (upadacitinib) receives additional approval to treat ulcerative colitis.
News
Express Scripts introduces 23 additional exclusions to national formularies
- The exclusions are the result of their midyear formulary review.
- 99.93% of members are expected to experience no changes as a result of these additional exclusions.
Optum Rx introduces 17 additional exclusions to premium formulary
- Examples of new exclusions include Emgality (galcanezumab), Dexilant (dexlansoprazole), and generic fluticasone/salmeterol inhalers.
Cardinal Health publishes 2022 Biosimilars Report
- Trends discussed in the report include:
- Insulin biosimilars may be a predictive signal for how the market will respond to the increased development of interchangeable biosimilars.
- Manufacturers of reference biologics will protect their market share by introducing authorized biosimilars, new formulations and delivery mechanisms, and by increasing list prices so that deeper rebates can also be offered.
FiercePharma summarizes top 10 drugs facing patent loss in 2022
- The list includes blockbusters Revlimid (lenalidomide) and Restasis (cyclosporine).
- Teva has already launched a generic version of Revlimid (lenalidomide) as of March 2022.
Drug Channels provides annual update on “gross-to-net bubble”
- The “gross-to-net bubble” refers to the difference between drug list prices and net prices after rebates.
- Drug Channels has observed year-over-year increases over the past four years.
Non-profit drug manufacturer Civica Rx unveils plans to distribute more affordable insulin
- The group has quoted a price of $30 per vial and no more than $55 for a box of five pen cartridges.
- The anticipated market availability date for the first product, insulin glargine, is sometime in 2024.
Several Blue Cross and Blue Shield affiliates sue Walgreens for misrepresenting generic drug prices
- The plans allege that Walgreens overcharged them by mispresenting usual and customary (U&C) prices.
Manufacturer Mallinckrodt reaches $260 million settlement resolving allegations of rebate underpayment and kickbacks
- The manufacturer allegedly improperly calculated and underpaid rebates to state Medicaid programs for its drug H.P. Acthar Gel and provided illegal copay subsidies that encouraged patients to purchase its drugs.
Non-profit group estimates the theoretical cost of Build Back Better Act price inflation penalties on manufacturers for Part D
- Council for Informed Drug Spending Analysis (CIDSA) estimated that $150 million in Medicare Part D-related penalties would have been assessed in Q1 2022 based on the previous year’s inflation rate and manufacturer price increases.
- The estimate does not include penalties related to commercial sales which would also be applied.
- The inflation penalties would take effect starting in Q1 2023.
Clinical trials
Subcutaneous form of Vyvgart (efgartigimod) reaches primary endpoints in phase 3 study
- The drug, used to treat autoimmune disease myasthenia gravis, is currently only available as an IV drug.