Formulary Watch |

Formulary Watch covers formularies, pharmacy benefit management companies, drug approvals, and other matters related to medications, their prices and insurance coverage.

Editorial Contact: Denise Myshko: dmyshko@mjhlifesciences.com

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Trelegy and Breo Offer Incremental Improvement Over Generics
Trelegy and Breo Offer Incremental Improvement Over Generics
Trelegy and Breo Offer Incremental Improvement Over Generics
March 3, 2025
The Institute for Clinical and Economic Review has prepared a special report on Trelegy and Breo, two therapies that treat patients with chronic obstructive pulmonary disease that are part of CMS's drug price negotiation program.
MedImpact Adds the Biosimilars Selarsdi and Yesintek to Formulary
MedImpact Adds the Biosimilars Selarsdi and Yesintek to Formulary
MedImpact Adds the Biosimilars Selarsdi and Yesintek to Formulary
February 27, 2025
Selarsdi and Yesintek have launched this month at prices that are 85% and 90% off the cost of Stelara.
BC of Michigan Adds — and Drops — Step Edits for Darzalex Faspro
BC of Michigan Adds — and Drops — Step Edits for Darzalex Faspro
BC of Michigan Adds — and Drops — Step Edits for Darzalex Faspro
February 27, 2025
Blue Cross Blue Shield of Michigan said it is evaluating any potential updates to the coverage process for Darzalex Faspro and there are no changes at this time.
FDA Accepts sNDA for Zoryve Cream for Atopic Dermatitis Treatment in Young Children
FDA Accepts sNDA for Zoryve Cream for Atopic Dermatitis Treatment in Young Children
FDA Accepts sNDA for Zoryve Cream for Atopic Dermatitis Treatment in Young Children
February 26, 2025
This once-daily topical treatment is the latest phosphodiesterase-4 (PDE4) inhibitor designed for mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years. The PDUFA target action date of October 13, 2025, is set for its decision on the application.
lymphoma  © airdone - stock.adobe.com
FDA Accepts BLA Resubmission for Follicular Lymphoma Drug, Odronextamab
FDA Accepts BLA Resubmission for Follicular Lymphoma Drug, Odronextamab
February 26, 2025
The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
doganmesut-stock.adobe.com
Congress Turns Attention to PBM Reform, Sort of
Congress Turns Attention to PBM Reform, Sort of
February 26, 2025
At what was supposed to be a hearing to discuss PBM reform, some in Congress veered off into discussions about Medicaid and maternal health, and even Elon Musk.
MichaelVi-stock.adobe.com
Lilly Lowers Prices of Some Zepbound Doses for Self-Pay Patients
Lilly Lowers Prices of Some Zepbound Doses for Self-Pay Patients
February 25, 2025
The new lower prices apply to some doses of Zepbound provided in vials but not the autoinjector pens.
luchschenF-stock.adobe.com
Updated: Two More Stelara Biosimilars Launch, Including One that is 90% Off Stelara
Updated: Two More Stelara Biosimilars Launch, Including One that is 90% Off Stelara
February 24, 2025
There are four biosimilars of Stelara available to treat chronic autoimmune diseases — Wezlana, Selarsdi and now Pychiva and Yesintek.
Second Biosimilar of Stelara Launches
Second Biosimilar of Stelara Launches
Second Biosimilar of Stelara Launches
February 21, 2025
Teva and Alvotech are introducing Selarsdi at an 85% discount off the reference product Stelara. Selarsdi is available as a subcutaneous injection and for intravenous infusion.
Aquir-stock.adobe.com
FDA Approves First Biosimilar of Novolog
FDA Approves First Biosimilar of Novolog
February 19, 2025
Merilog is expected to be available in July 2025, and Sanofi will provide Merilog to patients for $35 or less for a 30-day supply.
Orawan-stock.adobe.com
FDA Accepts Alvotech/Teva’s Application for Eylea Biosimilar
FDA Accepts Alvotech/Teva’s Application for Eylea Biosimilar
February 18, 2025
So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.
FDA Approves Second Biosimilars for Prolia/Xgeva
FDA Approves Second Biosimilars for Prolia/Xgeva
FDA Approves Second Biosimilars for Prolia/Xgeva
February 17, 2025
Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis and multiple myeloma/bone metastases from solid tumors.
© The 2R Artificiality - stock.adobe.com
FDA Approves Gomekli, First and Only NF1-PN Treatment for Both Children and Adults
FDA Approves Gomekli, First and Only NF1-PN Treatment for Both Children and Adults
February 14, 2025
Gomekli is the second ever FDA-approved treatment for rare tumor disease, NF1-PN and the first to be approved for both adult and pediatric patients.
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
February 13, 2025
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic atrophy secondary to age-related macular degeneration.
 Игорь Головнёв-stock.adobe.com
David Joyner: CVS Health is on a Pharmacy Transformation Journey
David Joyner: CVS Health is on a Pharmacy Transformation Journey
February 12, 2025
Just as Andrew Witty of UnitedHealth Group did in a call with investors last month, CVS Health’s CEO David Joyner defended the role of PBMs in healthcare.
 LELISAT-stock.adobe.com
FDA Sets Review Date for Linvoseltamab for Multiple Myeloma
FDA Sets Review Date for Linvoseltamab for Multiple Myeloma
February 11, 2025
The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma is July 10, 2025.
AGPhotography-stock.adobe.com
FDA Approves Combination Antibiotic for Complicated Infections
FDA Approves Combination Antibiotic for Complicated Infections
February 10, 2025
Emblaveo will be available in the third quarter of 2025 to treat patients with intra-abdominal infections, a common cause of sepsis in the intensive care unit.
 yodiyim-stock.adobe.com
FDA Sets Review Date for Chronic Lung Disease Therapy
FDA Sets Review Date for Chronic Lung Disease Therapy
February 7, 2025
Regulators have set a goal of Aug. 12, 2025, for brensocatib to treat patients with non-cystic fibrosis bronchiectasis, a chronic lung disease.
 RFBSIP-stoc
FDA Approves Susvimo for Diabetic Macular Edema
FDA Approves Susvimo for Diabetic Macular Edema
February 4, 2025
Susvimo is also approved to treat age-related macular degeneration, and the medication, ranibizumab, is delivered though a refillable ocular implant.
FDA Approves Third Biosimilar of Actemra
FDA Approves Third Biosimilar of Actemra
FDA Approves Third Biosimilar of Actemra
February 3, 2025
The new biosimilar, Celltrion’s Avtozma, was approved in both IV and subcutaneous forms to treat inflammatory conditions such as arthritis.
 mbruxelle-stock.adobe.com
FDA Approves Ozempic to Reduce Kidney Disease in Type 2 Diabetes
FDA Approves Ozempic to Reduce Kidney Disease in Type 2 Diabetes
January 28, 2025
Chronic kidney disease affects about 37 million adults in the United States and is expected to rise. It is a common complication of type 2 diabetes.
Alzheimer's puzzle © Orawan - stock.adobe.com
FDA Approves New IV Maintenance Dose of Leqembi
FDA Approves New IV Maintenance Dose of Leqembi
January 27, 2025
A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research shows.
© Framestock - stock.adobe.com
FDA and EMA Accepts Applications for New Nusinersen Regimen
FDA and EMA Accepts Applications for New Nusinersen Regimen
January 23, 2025
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
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