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: [email protected]

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FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1, 2024
Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.

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Biologics License Application Resubmitted for Prademagene Zamikeracel
Biologics License Application Resubmitted for Prademagene Zamikeracel
October 29, 2024
Prademagene zamikeracel (pz-cel) could be a new treatment for rare genetic disease recessive dystrophic epidermolysis bullosa (RDEB).
GoodRx Offers Weight Loss Drug Qsymia for $149 at Retail Pharmacies
GoodRx Offers Weight Loss Drug Qsymia for $149 at Retail Pharmacies
GoodRx Offers Weight Loss Drug Qsymia for $149 at Retail Pharmacies
October 29, 2024
Qsymia’s manufacturer also released postmarketing data showing the oral therapy for weight loss was associated with reductions in 24-hour mean systolic blood pressure.
Rigel Warns Physicians About Fatal Infections from Gavreto
Rigel Warns Physicians About Fatal Infections from Gavreto
Rigel Warns Physicians About Fatal Infections from Gavreto
October 24, 2024
Gavreto used to treat metastatic RET fusion-positive non-small cell lung cancer and RET fusion-positive thyroid cancer.
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FDA Approves IV Form of Stelara Biosimilar Selardsi
FDA Approves IV Form of Stelara Biosimilar Selardsi
October 23, 2024
This week’s approval expands Seldardsi indications to treat adults with Crohn’s disease and ulcerative colitis.
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FDA Approves First-in-Class Drug for Gastric Cancer
FDA Approves First-in-Class Drug for Gastric Cancer
October 18, 2024
Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and gastroesophageal cancers.
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Karen Lynch Steps Down as CEO of CVS Health
Karen Lynch Steps Down as CEO of CVS Health
October 18, 2024
David Joyner has been appointed president and CEO of CVS Health effective immediately.
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FDA Approves Imuldosa, the Fifth Stelara Biosimilar
FDA Approves Imuldosa, the Fifth Stelara Biosimilar
October 14, 2024
Imuldose will be marketed in the United States by Accord BioPharma and is expected to launch in the first half of 2025.
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FDA Approves Hympavzi for Hemophilia A and B
FDA Approves Hympavzi for Hemophilia A and B
October 11, 2024
Hympavzi is the first anti-tissue factor pathway inhibitor approved in the United States for hemophilia.
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FDA Approves Itovebi for Metastatic Breast Cancer
FDA Approves Itovebi for Metastatic Breast Cancer
October 11, 2024
Itovebi is approved to treat patients with PIK3CA-mutated HR-positive, HER2 negative metastatic breast cancer in combination with Ibrance and fulvestrant. It will have a cost of $22,867 for a 28-day cycle.
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Are PBMs Putting GLP-1 Drugs on Their Formularies?
Are PBMs Putting GLP-1 Drugs on Their Formularies?
October 11, 2024
PBMs are putting weight loss drugs, including Wegovy and Zepbound, on their national formularies, but coverage by plans is uneven. What is needed is more data about whether these drugs can lower overall healthcare costs.
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IQVIA: Patients Unlikely to See Savings from Medicare’s Drug Price Negotiation
IQVIA: Patients Unlikely to See Savings from Medicare’s Drug Price Negotiation
October 10, 2024
The IQVIA analysis finds that the impact of drug price negotiation on patients’ out-of-pocket spending could also be smaller than expected.
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FDA Accepts NDA for Menopause Drug, Elinzanetant
FDA Accepts NDA for Menopause Drug, Elinzanetant
October 9, 2024
If approved, elinzanetant would be another non-hormonal option for menopausal women seeking hot flash relief.
Trilliant Report Finds the Money Spent on Healthcare Doesn’t Provide Value
Trilliant Report Finds the Money Spent on Healthcare Doesn’t Provide Value
Trilliant Report Finds the Money Spent on Healthcare Doesn’t Provide Value
October 7, 2024
Sanjula Jain of Trilliant Health talks about how employers are best positioned to demand value for money from the U.S. healthcare system.
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UnitedHealthcare Adds Deductibles to Medicare Part D for 2025
UnitedHealthcare Adds Deductibles to Medicare Part D for 2025
October 3, 2024
UnitedHealthcare is adding deductibles to Part D prescriptions on certain formulary tiers as a result of plan design changes from the Inflation Reduction Act.
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NDA Resubmitted for Dry Eye Treatment Reproxalap
NDA Resubmitted for Dry Eye Treatment Reproxalap
October 3, 2024
Dry eye disease affects up to 15% of the U.S. population and is one of the largest markets in the ophthalmology field.
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Stelara Biosimilar Otulfi Approved by FDA to Treat Multiple Autoimmune Disorders
Stelara Biosimilar Otulfi Approved by FDA to Treat Multiple Autoimmune Disorders
October 1, 2024
Otulfi is the fourth Stelara biosimilar to be approved by the FDA.
Blue Shield of California to Offer Humira Biosimilar Idacio
Blue Shield of California to Offer Humira Biosimilar Idacio
Blue Shield of California to Offer Humira Biosimilar Idacio
October 1, 2024
Blue Shield of California is purchasing Idacio for a net price of $525 per monthly dose, and most plan members will pay $0 out of pocket.
FDA Approves Dupixent for Patients with COPD
FDA Approves Dupixent for Patients with COPD
FDA Approves Dupixent for Patients with COPD
September 27, 2024
This is the sixth indication for Dupixent and the only biologic approved in the United States to treat COPD.
FDA Approves the Oral Medication KarXT for Schizophrenia
FDA Approves the Oral Medication KarXT for Schizophrenia
FDA Approves the Oral Medication KarXT for Schizophrenia
September 27, 2024
KarXT — now with the brand name Cobenfy— is expected to be available in October with a list price of about $22,500 annually. The drug represents a new way to treat adults with schizophrenia.
Survey Finds Payers are Looking for Change in Pharmacy Benefits
Survey Finds Payers are Looking for Change in Pharmacy Benefits
Survey Finds Payers are Looking for Change in Pharmacy Benefits
September 26, 2024
PSG's Morgan Lee talks about how customers of the Big 3 PBMs report lower satisfaction across most measures, and they are less likely to recommend their PBM.
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Pfizer Withdraws Sickle Cell Drug Oxbryta from Market
Pfizer Withdraws Sickle Cell Drug Oxbryta from Market
September 26, 2024
Clinical data suggests an imbalance in vaso-occlusive crises and fatal events that require further assessment, and the company said it will provide updates in the future.
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FDA Approves Second Drug to Treat Rare Neurodegenerative Disease
FDA Approves Second Drug to Treat Rare Neurodegenerative Disease
September 25, 2024
Aqneursa is the second drug approved within a week to treat Niemann-Pick Disease, Type C.
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Takeaways from Senate Hearing on Semaglutide Pricing
Takeaways from Senate Hearing on Semaglutide Pricing
September 25, 2024
Novo Nordisk said it’s open to discussions with PBMs based on their commitments that a lower semgalutide list price would not impact formulary coverage.
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The FTC Insulin Case is About Access — and Rebates
The FTC Insulin Case is About Access — and Rebates
September 25, 2024
The FTC said it is focusing on insulin as the “poster child” of a broken system, where PBMs leverage formulary placement to receive higher rebates from pharmaceutical manufacturers.
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