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 to Hold Ad Comm Meeting for Rexulti in PTSD
FDA to Hold Ad Comm Meeting for Rexulti in PTSD
FDA to Hold Ad Comm Meeting for Rexulti in PTSD
January 10, 2025
The target action date for Rexulti in combination with sertraline to treat patients with post-traumatic stress disorder, originally planned for Feb. 8, 2025, will be delayed.
Bayer Submits Supplemental NDA for Kerendia in Heart Failure
Bayer Submits Supplemental NDA for Kerendia in Heart Failure
Bayer Submits Supplemental NDA for Kerendia in Heart Failure
January 10, 2025
Kerenida is currently approved to slow the progression of chronic kidney disease associated with type 2 diabetes.
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FDA Requires Guillain-Barré Warning for Abrysvo and Arexvy
FDA Requires Guillain-Barré Warning for Abrysvo and Arexvy
January 9, 2025
Regulators say, however, the benefits of vaccination with Abrysvo and Arexvy in preventing respiratory syncytial virus continue to outweigh their risks.
IBX Excludes Coverage of Drugs with Accelerated Approvals for 18 Months
IBX Excludes Coverage of Drugs with Accelerated Approvals for 18 Months
IBX Excludes Coverage of Drugs with Accelerated Approvals for 18 Months
January 7, 2025
Effective Jan. 1, 2025, Independence Blue Cross has begun excluding coverage for 18 months for therapies — but not cancer drugs — that have an accelerated approval based on a surrogate endpoint.
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Capricor Completes BLA for Deramiocel for Duchenne Cardiomyopathy
Capricor Completes BLA for Deramiocel for Duchenne Cardiomyopathy
January 3, 2025
Deramiocel is a cell therapy that has healing effects in muscle cells. If approved, deramiocel would be a once-quarterly therapy and the first specifically approved for cardiomyopathy in patients with Duchenne muscular dystrophy.
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FDA Sets Goal Date for Ovarian Cancer Combination
FDA Sets Goal Date for Ovarian Cancer Combination
January 2, 2025
FDA officials have set a review date of June 30, 2025, to review avutometinib in combination with defactinib to treat patients with recurrent low-grade serous ovarian cancer.
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FDA Issues Complete Response for Zynquista in Type 1 Diabetes
FDA Issues Complete Response for Zynquista in Type 1 Diabetes
January 1, 2025
In November 2024, a regulatory advisory board said the benefits of Zynquista does not outweigh the risks in adults with type 1 diabetes and chronic kidney disease.
FDA Approves Subcutaneous Opdivo to Treat Solid Tumors
FDA Approves Subcutaneous Opdivo to Treat Solid Tumors
FDA Approves Subcutaneous Opdivo to Treat Solid Tumors
December 28, 2024
Opdivo Qvantig is the first subcutaneously administered PD-1 inhibitor approved by the FDA. It is expected to be available in early January 2025 and will be priced at parity to the IV version of Opdivo.
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FDA Approves First Once-Daily Generic of Victoza for Type 2 Diabetes
FDA Approves First Once-Daily Generic of Victoza for Type 2 Diabetes
December 24, 2024
Liraglutide injection is now approved for adult and pediatric patients ages 10 and up, proving another option amid the GLP-1 shortage.
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FDA Approves Zepbound for Obese Adults with Sleep Apnea
FDA Approves Zepbound for Obese Adults with Sleep Apnea
December 23, 2024
Up to half of obstructive sleep apnea patients taking Zepbound had no symptoms after one year of treatment, averaging 25 fewer breathing interruptions per hour.
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Savara Begins Rolling BLA for Molbreevi for Rare Lung Disease
Savara Begins Rolling BLA for Molbreevi for Rare Lung Disease
December 20, 2024
If approved, Molbreevi could be the first FDA-approved treatment for patients with autoimmune pulmonary alveolar proteinosis, a rare lung disease.
 FDA Approves Tryngolza for Rare Triglyceride Disease
 FDA Approves Tryngolza for Rare Triglyceride Disease
FDA Approves Tryngolza for Rare Triglyceride Disease
December 20, 2024
Tryngolza is once-monthly, subcutaneous RNA-targeted therapy and is expected to be available by the end of the year with a price of $595,000.
ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs
ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs
ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs
December 19, 2024
The Institute for Clinical and Economic Review assessed the formularies of 11 payers, covering 57 million people, to determine access for drugs that the organization had reviewed in 2022 for cost-effectiveness.
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FDA Approves Seventh Stelara Biosimilar, Steqeyma
FDA Approves Seventh Stelara Biosimilar, Steqeyma
December 18, 2024
Originally approved in 2009, Stelara patents began expiring in 2023, leading to an influx of recent biosimilars.
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FDA Adds Boxed Warning to Veozah Label
FDA Adds Boxed Warning to Veozah Label
December 18, 2024
The boxed warning follows a safety warning the FDA issued in September about the risk of liver injury from the use of Veozah to treat hot flashes.
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PBM Reform is Part of Congress’ End of Year Bill
PBM Reform is Part of Congress’ End of Year Bill
December 17, 2024
A new bill in Congress would require pass-through prices in both Medicare, and Medicaid and require transparency of PBM practices in the commercial space.
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FDA Accepts Biologics License Application for Infant RSV Antibody
FDA Accepts Biologics License Application for Infant RSV Antibody
December 17, 2024
If approved, clesrovimab would be the first and only FDA approved single dose immunization for infants approved in time for next year's RSV season, which lasts from October to April.
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FDA Approves Nemluvio for Atopic Dermatitis
FDA Approves Nemluvio for Atopic Dermatitis
December 16, 2024
This latest approval is the second indication of the monoclonal antibody, Nemluvio. It was first approved in Aug. 2024 to treat patients with prurigo nodularis.
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Introduction of Biosimilars Led to More Rebates on Humira
Introduction of Biosimilars Led to More Rebates on Humira
December 13, 2024
In 2023, there was lower net spending and prices on adalimumab, which was likely because of rebates from AbbVie, Humira’s manufacturer, a new analysis finds.
ICER Identifies 5 Drugs with Unsupported Price Increases
ICER Identifies 5 Drugs with Unsupported Price Increases
ICER Identifies 5 Drugs with Unsupported Price Increases
December 12, 2024
The Institute for Clinical and Economic Review has identified five drugs — Biktarvy, Darzalex, Entresto, Cabometyx, and Xeljanz — with prices increases that are not supported by new clinical evidence, with a total of $815 million in added costs to U.S. payers in 2023.
Optum Rx Switches Up Humira Biosimilar Coverage for 2025
Optum Rx Switches Up Humira Biosimilar Coverage for 2025
Optum Rx Switches Up Humira Biosimilar Coverage for 2025
December 9, 2024
Beginning in January 2025, Optum Rx will remove from several Humira biosimilars from its formulary, including Hyrimoz (adalimumab-adaz), the unbranded Hyrimoz and Cyltezo (adalimumab-adbm).
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ICER: Potential New Pain Medication Offers Small Savings
ICER: Potential New Pain Medication Offers Small Savings
December 9, 2024
The biggest advantage of suzetrigine would be that it helps patients avoid the use of opioids for acute pain. The FDA’s goal date for suzetrigine is Jan. 30, 2025.
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FDA Sets Goal Date for Lymphoma Drug Columvi
FDA Sets Goal Date for Lymphoma Drug Columvi
December 5, 2024
The combination of Columvi, gemcitabine and oxaliplatin is the first CD20xCD3 bispecific antibody to show positive results in a randomized diffuse large B-cell lymphoma phase 3 trial. The FDA’s decision is expected by July 20, 2025.
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FDA Sets Goal Date for Cardiomyopathy Drug, Aficamten
FDA Sets Goal Date for Cardiomyopathy Drug, Aficamten
December 3, 2024
The FDA has accepted a new drug application for aficamten, a new obstructive hypertrophic cardiomyopathy drug. A goal date has been set for Sept. 26, 2025.
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