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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FDA Approves Amvuttra for ATTR-CM in Extended Label
FDA Approves Amvuttra for ATTR-CM in Extended Label
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21, 2025
This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
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FDA Approves Tremyfa to Treat Active Crohn’s Disease
FDA Approves Tremyfa to Treat Active Crohn’s Disease
March 21, 2025
Tremfya is also approved to treat patients with plaque psoriasis, active psoriatic arthritis and ulcerative colitis and is available as both a subcutaneous and intravenous induction option.
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Optum Rx Changes How Pharmacies Are Reimbursed
Optum Rx Changes How Pharmacies Are Reimbursed
March 20, 2025
Optum Rx's new cost-based program uses an internal algorithm that leverages multiple available industry data sources, such as NADAC and PAC, to inform reimbursement.
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Optum Rx Ends Reauthorization for Many Chronic Disease Drugs
Optum Rx Ends Reauthorization for Many Chronic Disease Drugs
March 19, 2025
Optum Rx has eliminated reauthorization for almost 70 drugs for chronic diseases, about 10% of its overall pharmacy prior authorizations.
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FDA Grants Priority Review to Kerendia in Heart Failure
FDA Grants Priority Review to Kerendia in Heart Failure
March 17, 2025
Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with a left ventricular ejection fraction (LVEF) of ≥40%.
Stelara Biosimilar Steqeyma Launches at 85% Discount
Stelara Biosimilar Steqeyma Launches at 85% Discount
Stelara Biosimilar Steqeyma Launches at 85% Discount
March 13, 2025
Steqeyma is one of seven Stelara biosimilars that have been approved by the FDA.
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13, 2025
Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
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New PBM Reform Bill Would End Spread Pricing at Medicaid Pharmacies
New PBM Reform Bill Would End Spread Pricing at Medicaid Pharmacies
March 12, 2025
The new bill would also require state Medicaid programs to report National Average Drug Acquisition Costs (NADAC) as a way to increase transparency in drug pricing.
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FDA Approves First Generics of Xarelto
FDA Approves First Generics of Xarelto
March 12, 2025
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce the risk of stroke and deep vein thrombosis.
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FDA Approves First Biosimilar of Xolair
FDA Approves First Biosimilar of Xolair
March 10, 2025
Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy and chronic spontaneous urticaria.
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6, 2025
Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
Novo Nordisk Lowers Wegovy Price for Cash-Paying Patients
Novo Nordisk Lowers Wegovy Price for Cash-Paying Patients
Novo Nordisk Lowers Wegovy Price for Cash-Paying Patients
March 5, 2025
NovoCare Pharmacy will provide all dose strengths of Wegovy at a reduced cost of $499 per month for cash-paying patients without insurance.
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FDA Accepts Amneal’s BLA for Two Denosumab Biosimilars
FDA Accepts Amneal’s BLA for Two Denosumab Biosimilars
March 4, 2025
The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.
Fresenius Kabi Launches Otulfi, the 4th Biosimilar of Stelara to Become Available
Fresenius Kabi Launches Otulfi, the 4th Biosimilar of Stelara to Become Available
Fresenius Kabi Launches Otulfi, the 4th Biosimilar of Stelara to Become Available
March 4, 2025
The FDA had approved Otulfi in September 2024 to treat Crohn’s disease, ulcerative colitis, psoriasis and active psoriatic arthritis. Information on pricing is not yet available.
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.
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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.
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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.
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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.
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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.
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