Formulary Watch |

Harm Reduction Launches Naloxone Nasal Spray

Nonprescription RiVive was approved in July 2023 to reverse opioid overdose. Harm Reduction is donating 200 doses to Remedy Alliance for distribution.

New Study Planned for Bevacizumab to Treat AMD

Outlook Therapeutics plans to begin a study in the first quarter of 2024 to address the issues identified in a FDA complete response letter. If approved, Lytenava would be the only bevacizumab product to specifically treat age-related macular degeneration.

FDA Approves Topical for Rare Skin Disorder

Filsuvez treats children and adults with epidermolysis bullosa, a condition that causes the skin to blister, and junctional epidermolysis bullosa, which causes lesions in the mouth.

Lupin Gets Approval for Chantix Generic

In other generic news, the FDA has approved generics of the osteoporosis drug Forteo and Amneal is developing a generic version of Vascepa.

FDA Approves Zoryve Foam for Seborrheic Dermatitis

Zoryve foam will have the same wholesale acquisition cost as the cream version: $858 per tube.

FDA Issues Complete Response Letter for Cosibelimab in Cutaneous Squamous Cell Carcinoma

The FDA cited issues related to an inspection of Checkpoint Therapeutics’ third-party contract manufacturing organization.

PBM Ventegra Includes Avastin Biosimilar on Formulary

FDA Approves Adbry for Atopic Dermatitis in 12 to 17 Year Olds

The price for of Adbry is $1,810.87 for a two pack of syringes.

FDA Approves Welireg for Advanced Kidney Cancer

Welireg is now also indicated for patients whose renal cell carcinoma has progressed after treatment with PD-1 or PD-L1 inhibitor and a TKI therapy.

Oral Postpartum Depression Drug Zurzuvae Launches

FDA Sets Review Date for Bispecific Antibody for Solid Tumor

The FDA has set a target date of June 12, 2024, for tarlatamab to treat adult patients with advanced small cell lung cancer. If approved, it would be the first bispecific antibody for a solid tumor.

Survey Finds More than Half of Employers Not Confident in PBM Practices

Drug prices and the practices of PBMs are among the concerns expressed by employers who responded to the Pulse of the Purchaser survey by National Alliance of Healthcare Purchaser Coalitions.

MAPS Submits NDA for Psychedelic Therapy for PTSD

Optum Rx to Provide Weight Loss Management Program

Optum Rx standard formularies currently include the weight loss drugs Wegovy and Saxenda, and the PBM is evaluating Zepbound.

FDA Sets Review Date for Marstacimab to Treat Hemophilia

Marstacimab is being reviewed to prevent or reduce the frequency of bleeding episodes in people with hemophilia A or B. The FDA has set an action date in the first quarter of 2024.

ICER: Humira Among Drugs that had Unsupported Price Increases in 2022

Improper Seal Leads Cipla to Recall Vigabratrin

Cipla is recalling one lot of vigabatrin, which is used to treat seizures.

FDA Approves Two Gene Therapies for Sickle Cell Disease

FDA Sets Review Date for Elafibranor for Rare Liver Disease

If approved, elafibranor would be a second-line treatment for patients with primary biliary cholangitis. The Prescription Drug User Fee Act action date is June 10, 2024.

Drug Costs, Regulation are Top of Mind of Mind for Employers

What We’re Reading: Sickle Cell Disease and Exa-cel Gene Therapy

New Lung Cancer Drug Augtyro is Now Available

Augtyro, approved last month, launched with a month wholesale acquisition $29,000 for patients with ROS1-positive non-small cell lung cancer.

Study Questions Whether the High Price of Ocrevus is Warranted

FDA Approves Fabhalta, an Oral Treatment for Rare Blood Disorder

Fabhalta was approved to treat patients with paroxysmal nocturnal hemoglobinuria and will have a wholesale acquisition cost of $550,000 per year.

CarelonRx Will Launch Digital Pharmacy in 2024

CarelonRx says it will be able provide optimal support for members because, as a PBM, it as able to communicate directly with members’ providers.

Express Scripts and Cigna Add Zepbound to Formularies

IQVIA: Drug Shortages are Growing

FDA Approves Jaypirca for Leukemia/Lymphoma Indication

Jaypirca is also approved to treat mantle cell lymphoma. It has a list price of $21,000 for a 30-day supply.

Pfizer Stops GLP-1 Obesity Trial Because of High Discontinuation Rates

Twice-daily danuglipron was being studied in a phase 2 study in adults with obesity. Pfizer is now conducting a pharmacokinetic study for a once-daily formulation.

Younger People Are Looking to GLP-1 Drugs for Weight Loss