Formulary Watch |

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

HHS: Opportunities to Reduce Medicare Part B Spending with Biosimilars Remain

Enzyme Replacement Therapy Adzynma Launches with $245,000 Annual Price

Adzynma is a recombinant protein designed to replace the deficient ADAMTS13 enzyme to treat patients with the rare hereditary blood clotting disorder congenital thrombotic thrombocytopenic purpura

FDA Sets Review Date for Zoryve in Atopic Dermatitis

The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.

FDA Issues Warning about Seizure Medications

Regulators have found that medications containing levetiracetam and clobazam have led to drug reaction with eosinophilia and systemic symptoms (DRESS), a rare and severe drug allergy.

FDA Issues Complete Response for Novel Dry Eye Therapy

Regulators indicated that an additional trial would be needed to assess the efficacy of reproxalap to treat patients with dry eye. Aldeyra has submitted to the FDA a Special Protocol Assessment for the new trial.

FDA Sets Review for Nasal Opioid Rescue Drug

The product, OX124, uses a powder-based technology that provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA review date is July 15, 2024.

FDA Approves First Treatment for Rare Noncancerous Tumors

Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. It will launch with a price of $29,000 for a 30-day supply.

FDA Sets Review Date for Therapy for Rare Connective Tissue Disorder

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 25, 2024, for prademagene zamikeracel to treat patients with recessive dystrophic epidermolysis bullosa.

Novartis Recalls Two Additional Lots of Sandimune

This is the second recall of Sandimmune related to the formulation of crystals in some bottles.

Report: Part D Premiums Could Rise Because of IRA Cap on Drug Costs

A recent report predicts there could be an increase in premiums for Medicare Part D prescription drug plans in California, Florida, New York, Pennsylvania and Texas.