Highlights
- Insulin manufacturers decrease prices and cap out-of-pocket costs for patients
- FiercePharma publishes “Top 10 Drugs losing U.S. Exclusivity in 2023” report
- Colorado proposes legislation capping out-of-pocket costs for epinephrine injectors
- Cardinal Health publishes 2023 Biosimilars Report
FDA Approvals and Launches
- Altuviiio (antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl) is approved to treat hemophilia A.
- Syfovre (pegcetacoplan) is approved as the first treatment for geographic atrophy, a cause of blindness for more than one million people in country.
- Zavzpret (zavegepant) nasal spray is approved to treat acute migraines.
News
Insulin manufacturers announce price decreases and caps on out-of-pocket costs
- Eli Lilly cites price reductions of up to 70% for insulin lispro, Humalog, Humulin, and Rezvoglar, biosimilar interchangeable with Lantus.
- Out-of-pocket costs will be capped at $35 at participating retail pharmacies for patients with commercial insurance.
- Novo Nordisk cites price reductions of up to 75% for Levemir, Novolin, NovoLog, and their unbranded counterparts.
- Sanofi reduces the list price of Lantus by 78% and Apidra by 70%.
- Out-of-pocket costs will be capped at $35 for Lantus for patients with commercial insurance.
- The announced price changes and co-pay caps take effect on various dates.
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FiercePharma publishes “Top 10 Drugs losing U.S. Exclusivity in 2023” report
- Drugs detailed in the report include Humira (adalimumab), Stelara (ustekinumab), and ADHD treatment Vyvanse (lisdexamfetamine).
Colorado proposes legislation capping out-of-pocket costs for epinephrine injectors
- The proposed bill requires that pharmacies collect an amount not to exceed $60 for a 2-pack of “all covered prescription epinephrine auto-injectors”.
Cardinal Health publishes 2023 Biosimilars Report
- Landmark developments cited include the first ophthalmologic biosimilars, growth in the numbers of products achieving interchangeability, and the varying formulary coverage of Humira (adalimumab) biosimilars.
- The report also discusses potential indirect and direct impacts that the Inflation Reduction Act might have on the biosimilar market.
CVS outlines obesity epidemiology and coverage considerations for treatment
- CVS projects increasing rates of obesity and that up to 55% of patients seeking treatment will be prescribed weight-loss drugs such as Wegovy.
- Traditionally, GLP-1 agonists have been used to treat diabetes but they have become increasingly popular for use in weight management since Wegovy’s approval in 2021.
- A comprehensive strategy should include appropriate coverage guidelines for patients and education for both prospective patients and health care providers.
White House describes prescription drug benefits of Inflation Reduction Act
- The statement provides high-level data and touts the benefits of Medicare inflation rebates, price negotiations with manufacturers, insulin cost caps, and vaccine policies.
Federal court judge reverses Affordable Care Act (ACA) provision requiring plans to cover preventive treatments
- The ACA provision mandated coverage, at no cost to members, for preventive treatments such as certain cholesterol medications, contraceptives, and supplements,
- The ruling is expected to undergo the appeals process and could be overturned by a higher court.
- A similar ruling was overturned by the Supreme Court in June 2021.
Courts continue legislative battle over abortion drug mifepristone
- A district court in Texas overturned the FDA’s approval of the drug, however, an appeals court reinstated its approval.
- In addition to contesting the drug’s FDA approval, other recent legislation has disputed how and when the drug may be obtained by patients.
FDA Advisory Committee votes in favor of approving Paxlovid (nirmatrelvir/ritonavir) for the treatment of COVID-19
- If approved, the drug would be the first FDA-approved oral treatment for COVID-19. It was authorized for emergency use in December 2021.