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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NDA Resubmitted for Investigational Dry Eye Therapy, Reproxalap
NDA Resubmitted for Investigational Dry Eye Therapy, Reproxalap
NDA Resubmitted for Investigational Dry Eye Therapy, Reproxalap
June 17, 2025
Aldeyra has resubmitted its new drug application for reproxalap, an investigational dry eye treatment, which contained new data from an additional FDA-requested trial.
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Sandoz Launches Biosimilars of Xgeva/Prolia
Sandoz Launches Biosimilars of Xgeva/Prolia
June 17, 2025
Wyost and Jubbonti are interchangeable with Xgeva/Prolia and are approved for all of the same indications in bone cancer and osteoporosis.
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Sarepta Stops Shipments of Elevidys For Non-Ambulatory DMD Patients
Sarepta Stops Shipments of Elevidys For Non-Ambulatory DMD Patients
June 16, 2025
A second patient with Duchenne muscular dystrophy has died from acute liver failure after receiving the gene therapy Elevidys.
Biosimilar Uptake Has Been Slow but This is Changing
Biosimilar Uptake Has Been Slow but This is Changing
Biosimilar Uptake Has Been Slow but This is Changing
June 13, 2025
In an interview, James D. Chambers, Ph.D., from Tufts Medical Center, talks about the factors that are impacting the biosimilar market.
FDA Accepts NDA for Zoliflodacin, Potentially First Gonorrhea Antibiotic in Decades
FDA Accepts NDA for Zoliflodacin, Potentially First Gonorrhea Antibiotic in Decades
FDA Accepts NDA for Zoliflodacin, Potentially First Gonorrhea Antibiotic in Decades
June 13, 2025
The FDA has accepted a New Drug Application for zoliflodacin, a first-in-class oral antibiotic for treating uncomplicated gonorrhea, offering a potential new option amid rising antibiotic resistance.
FDA Approves Ibtrozi For Adults With ROS1+ NSCLC
FDA Approves Ibtrozi For Adults With ROS1+ NSCLC
FDA Approves Ibtrozi For Adults With ROS1+ NSCLC
June 12, 2025
Ibtrozi had a 90% response rate in treatment naïve adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, according to the results of a news release.
FDA Approves Enflonsia To Protect Infants During Their First RSV Season
FDA Approves Enflonsia To Protect Infants During Their First RSV Season
FDA Approves Enflonsia To Protect Infants During Their First RSV Season
June 12, 2025
Enflonsia is the first FDA-approved respiratory syncytial virus (RSV) preventative for infants, regardless of weight, according to the news release.
Blue Shield of California Breaks Up Pharmacy Benefit; Other Payers Considering the Same Approach
Blue Shield of California Breaks Up Pharmacy Benefit; Other Payers Considering the Same Approach
Blue Shield of California Breaks Up Pharmacy Benefit; Other Payers Considering the Same Approach
June 10, 2025
A survey by PSG has found that the pressure to control drug costs is leading some payers to look into unbundling pharmacy benefits as a way for better control.
Requiring Humira Biosimilars Results in Huge Savings for Navitus Clients
Requiring Humira Biosimilars Results in Huge Savings for Navitus Clients
Requiring Humira Biosimilars Results in Huge Savings for Navitus Clients
June 10, 2025
Switching to Humira biosimilars saved Navitus clients more than $315 million in upfront costs in 2024 and resulted in a 60% reduction in net costs per claim.
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Transparency for PBMs. Can It Become Something More than Just a Buzzword?
Transparency for PBMs. Can It Become Something More than Just a Buzzword?
June 6, 2025
The pharmacy benefit manager (PBM) industry is under pressure to shift to models that avoid conflicts of interest and misaligned incentives.
FDA Approved Bayer’s Nubeqa for Metastatic Castration-Sensitive Prostate Cancer
FDA Approved Bayer’s Nubeqa for Metastatic Castration-Sensitive Prostate Cancer
FDA Approved Bayer’s Nubeqa for Metastatic Castration-Sensitive Prostate Cancer
June 5, 2025
The approval is based on results from the phase 3 ARANOTE trial, which showed Nubeqa, when combined with androgen deprivation therapy (ADT), reduced the risk of radiographic progression or death by 46% compared to ADT with placebo.
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States Become More Aggressive with PBM Reform
States Become More Aggressive with PBM Reform
May 30, 2025
State efforts are aiming to bring more disclosure and transparency to PBM practices, mandating certain pharmacy reimbursement levels, requiring 100% pass-through rebates, and prohibiting spread pricing.
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Milliman: Healthcare Costs for Americans Have Almost Tripled in 20 Years
Milliman: Healthcare Costs for Americans Have Almost Tripled in 20 Years
May 29, 2025
Pharmacy costs and outpatient facility care generate 69% of the cost increase for 2025, according to Milliman’s recent Medical Index.
Chief Pharmacy Officer Jason R. Smith on the Challenges Health Systems Face
Chief Pharmacy Officer Jason R. Smith on the Challenges Health Systems Face
Chief Pharmacy Officer Jason R. Smith on the Challenges Health Systems Face
May 28, 2025
Jason R. Smith, Pharm.D., appointed as chief pharmacy officer in February 2025 for the University of Rochester Medical Center, talks about building a stronger workforce, managing drug shortages and keeping up with changes in regulations because of the new administration.
FDA Approves Nucala as Maintenance Therapy for COPD
FDA Approves Nucala as Maintenance Therapy for COPD
FDA Approves Nucala as Maintenance Therapy for COPD
May 23, 2025
Nucula’s new indication is as an add-on therapy for patients with COPD who also have an elevated blood eosinophil count.
FDA Expands Approval of Susvimo to Treat Diabetic Retinopathy
FDA Expands Approval of Susvimo to Treat Diabetic Retinopathy
FDA Expands Approval of Susvimo to Treat Diabetic Retinopathy
May 22, 2025
Susvimo is also approved to treat diabetic macular edema and age-related macular degeneration, and the medication, ranibizumab, is delivered through an ocular implant that is refilled every nine months.
Evernorth to Cap Out-of-Pocket Cost for Wegovy and Zepbound at $200
Evernorth to Cap Out-of-Pocket Cost for Wegovy and Zepbound at $200
Evernorth to Cap Out-of-Pocket Cost for Wegovy and Zepbound at $200
May 22, 2025
Health plan sponsors are also expected to see a reduction in the net cost per prescription of GLP-1 medications to treat obesity.
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FDA Extends Approval of Jivi to Younger Hemophilia A Patients
FDA Extends Approval of Jivi to Younger Hemophilia A Patients
May 20, 2025
Bayer’s Jivi is a factor VIII replacement therapy that has been engineered with a compound that allows for less frequent dosing. It is now indicated for patients 7 years of age and older.
FDA Approves First Advanced Anal Cancer Drug as First-Line Treatment
FDA Approves First Advanced Anal Cancer Drug as First-Line Treatment
FDA Approves First Advanced Anal Cancer Drug as First-Line Treatment
May 16, 2025
Zynyz is now FDA-approved as the first and only approved first line treatment for advanced squamous cell carcinoma of the anal canal.
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Iowa Expands PBM Legislation to Address Concerns of Independent Pharmacies
Iowa Expands PBM Legislation to Address Concerns of Independent Pharmacies
May 16, 2025
A new law in Iowa, if signed by the governor, will mandate 100% pass-through of rebates, increased financial transparency, and a minimal payment for pharmacies. Critics say it will be the most costly mandate in the state’s history.
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Is Arkansas’ New PBM Law the Right Path Forward for Reform? No One Knows Yet
Is Arkansas’ New PBM Law the Right Path Forward for Reform? No One Knows Yet
May 9, 2025
It could improve access to community pharmacies and lower prices. Or it will limit access to critical drugs and impact payers’ ability to contract for a broad range of services. Industry leaders are unsure about the impact of Arkansas’ law banning PBMs from owning pharmacies.
FDA Sets Goal Date for Antipsychotic Drug Bysanti
FDA Sets Goal Date for Antipsychotic Drug Bysanti
FDA Sets Goal Date for Antipsychotic Drug Bysanti
May 6, 2025
The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.
Stelara Biosimilar Yesintek Gains Coverage on Leading Formularies
Stelara Biosimilar Yesintek Gains Coverage on Leading Formularies
Stelara Biosimilar Yesintek Gains Coverage on Leading Formularies
May 6, 2025
Express Scripts, Cigna, UnitedHealthcare, CVS Caremark and Optum Rx are among the payers that have added Yesintek to their formularies.
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FDA Sets Action Date for Oral Wegovy for Weight Loss
FDA Sets Action Date for Oral Wegovy for Weight Loss
May 2, 2025
If approved, Wegovy would be the first oral GLP-1 drug to treat obesity.
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