Formulary Watch |

FDA Expands Indication for Biktarvy for Those with Resistant HIV

CarelonRx to Launch Digital Weight Management Program

FDA Approves Simlandi, Third Interchangeable Humira Biosimilar

FDA Withdraws Approval of Pepaxto in Multiple Myeloma

KFF: Healthcare Affordability is an Election Issue

The economy and healthcare costs are the issues voters want to hear about going into the 2024 presidential election, finds a survey by KFF.

FDA Grants Priority Review to Dupixent in COPD

If approved, this would be the sixth indication for Dupixent and the only biologic therapy for COPD. The target action date is June 27, 2024.

Questions Remain about CMS’s Plan for Gene Therapy Access in Medicaid

FDA Approves Biweekly Dosing of Tecvayli for Multiple Myeloma

Patients with multiple myeloma who switched from weekly to biweekly dosing of Tecvayli were able to maintain their response with fewer infections.

FDA Sets Review Date for Linvoseltamab for Advanced Multiple Myeloma

Linvoseltamab is bispecific antibody designed to treat relapsed/refractory multiple myeloma. The FDA’s target action date is Aug. 22, 2024

The VA Replaces Humira with Hadlima on National Formulary

FDA Sets Date for First-in-Class Lung Cancer Therapy

If approved, datopotamab deruxtecan would be the first TROP2-directed antibody drug conjugate to treat patients with non-small cell lung cancer. The FDA’s action date is in the fourth quarter of 2024.

FDA Approves Amtagvi, the First TIL Therapy for a Solid Tumor

Amtagvi was approved to treat patients with advanced melanoma. It is a one-time cell therapy that will be administered at authorized treatment centers and have a wholesale acquisition cost of $515,000.

FDA Sets Date for Full Approval, Broader Indication for Elevidys

IQVIA: Rebates put Biosimilar Manufacturers at a Disadvantage

Rebates, falling prices, and rebate walls, where drug manufacturers agree to a certain price in exchange for an exclusive contract with payers, limit competition and create a dynamic of misaligned incentives.

FDA Sets Goal Date for Augtyro for Solid Tumors with NTRK Gene Fusions

Regulators have a set a date of June 15, 2024, to review new indication for Augtyro, which is already available to treat lung cancer with ROS1-positive lung and has a list price of $29,000 for a 30-day supply.

FDA Approves Onivyde for First-line Metastatic Pancreatic Cancer

Onivyde is also approved to treat patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.

FDA Extends Review of Gene Therapy for Rare Immune Disorder

Rocket’s application for Kresladi is being extended by three months for regulators to review additional information submitted at the request of the FDA. The new Prescription Drug User Fee Act (PDUFA) date is now June 30, 2024.

Newly Approved Vaccines Face a Fragmented Policy Landscape

Express Scripts Adds Voquezna to Formulary for Gastroesophageal Reflux

FDA Approves Eohilia as an Oral Treatment for Eosinophilic Esophagitis

Eohilia is a liquid formulation of budesonide that will be available by the end of February. It will have a wholesale acquisition cost of $1,875 per month.

FDA Grants Priority Review to Seladelpar as Second-line Treatment for Rare Liver Disease

The FDA has set a Prescription Drug User Fee Act target action date of Aug. 14, 2024, for seladelpar to treat adults with primary biliary cholangitis.

FDA Grants Priority Review to Engineered Tissue for Vascular Replacement

The FDA has set a Prescription Drug User Fee Act date of Aug. 10, 2024, for Human Acellular Vessel to repair arteries in patients with extremity vascular trauma.

Amneal Resubmits Application for Novel Parkinson’s Therapy

The FDA had issued a complete response letter (CRL) in July 2023 for IPX203 and asked for additional pharmacokinetic data of carbidopa, one of the drugs the oral, extended release therapy.

The IRA’s Out-of-Pocket Cap to Benefit more than 1 Million People

In three states — California, Florida, and Texas — more than 100,000 Part D enrollees exceeded $2,000 in spending on prescription drugs in 2021, finds a new analysis from KFF.

CVS’s Health Services Revenue Grew to $186.8 Billion

HHS: Patients Should Not Face High Copays for Paxlovid

Survey: Many Support Medicare Coverage of Weight Loss Drugs

FDA Assigns Action Date for Arexvy to Prevent RSV in 50 to 59 Population

The Prescription Drug User Fee Act date is June 7, 2024, for the additional indication of preventing respiratory syncytial virus (RSV) in adults aged 50 to 59 who are at increased risk. It is already approved for those over the age of 60.

FDA Sets PDUFA Date for Acoramidis in Heart Failure Indication

The FDA has set an action date of Nov. 29, 2024, to review acoramidis to treat patients with transthyretin amyloid cardiomyopathy.

FDA Sets Advisory Meeting for Abecma in Supplemental Multiple Myeloma Indication

The Oncologic Drugs Advisory Committee will meet on March 15, 2024, to review overall survival data for Abecma in earlier lines of treatment in relapsed or refractory multiple myeloma.