Formulary Watch |

FDA Approves Enzyme Replacement Therapy for Rare Clotting Disorder

Adzynma is a recombinant protein designed to replace the deficient ADAMTS13 enzyme.

Cigna Makes Changes to Drugs Lists for 2024

Drug Spend for IBD Drugs Could Shift to Pharmacy Benefit

Lilly’s Weight Loss Drug Approved by the FDA

Postpartum Depression Therapy to Launch with $15,900 Price

How Magellan’s Behavior Health Program Saved up to $4,300 PMPY

Optum Rx Announces Formulary Exclusions for 2024

ICER: Greater Transparency of Coverage Policies Needed

FDA Approves Novel Therapy for Gastroesophageal Reflux

Voquezna is a potassium-competitive acid blocker, which has a mechanism similar to proton pump inhibitors but with a more rapid action. It will be available in December and has a list price of $650 for a 30-count bottle.

Express Scripts Includes Inpefa on Commercial Formularies

Express Scripts has also included the heart failure drug Inpefa on its Medicare formularies.

FDA Approves First Interchangeable Stelara Biosimilar

Amgen’s Wezlana is approved to treat multiple inflammatory diseases. It is expected to launch no later than Jan. 1, 2025

FDA Assigns Goal Date for Mavorixafor for Rare Immunodeficiency Disease

If approved, mavorixafor would be the first therapy for WHIM syndrome, an ultra-rare disease that can cause recurrent lung infections, papillomavirus-related warts, and an increased risk of developing certain types of cancer. The PDUFA date is April 30, 2024.

Payer Coverage of Biosimilars Varies by Preference

CarePartners Adds Yuflyma to its Cost Savings Program

FDA Approves First Treatment for Nasopharyngeal Carcinoma

Loqtorzi is indicated in combination with chemotherapy for first-line treatment and as monotherapy for patients with disease progression on or after platinum containing chemotherapy.

FDA Approves New Duchenne Muscular Dystrophy Drug

Agamree is a novel corticosteroid that will be available in the first quarter of 2024.

J&J Warns of Risk of Respiratory Depression with Spravato

Lilly’s First-in-Class Therapy for Ulcerative Colitis Get FDA Approval

Mirikizumab — now with the brand name — Omvoh has a list price of $9,593 per month for the IV formulation and $10,360 per subcutaneous administration.

Study Reveals Inconsistent Wait Times for Decisions on Cancer Drug Coverage

Recall Impacts Exela and Civica Brands

In total, 11 lots of three different products have been recalled because of silicone found in retained samples.

FDA Sets New Review Date for Bladder Cancer Immunotherapy

N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine is being reviewed by the FDA to treat non-muscle-invasive bladder cancer. The goal date is April 23, 2023.

Subcutaneous Leqembi Clears More Amyloid than IV Formulation

FDA Assigns Review Date for Resubmission of Kidney Disease Treatment

Akebia has resubmitted its NDA for vadadustat with postmarketing safety data from Japan, where it has been on the market for more than three years. The new review date is March 27, 2024.

FDA Approves Tibsovo for IDH1 Mutated Myelodysplastic Syndromes

Tibsovo is also approved to treat patients with IDH1-mutant acute myeloid leukemia and bile duct cancer.

FDA Approves Byooviz as Interchangeable Lucentis Biosimilar

Byooviz was approved as the first biosimilar to Lucentis and launched with a list price of $1,130 per single-use vial.

Dupixent Gets Complete Response Letter for Inflammatory Skin Disorder

The FDA is requesting additional efficacy data to support an approval for patients with chronic spontaneous urticaria; results of an ongoing study are expected late next year.

FDA Approves First Subcutaneous Infliximab for IBD

FDA Expands Indication of Voxzogo for Young Children with Dwarfism

Voxzogo is now approved for all ages in children with achondroplasia, the most common form of dwarfism.

Phase 3 Trial Shows Significant Weight Loss with Mounjaro

KFF: Premiums for Employer-Sponsored Insurance Increased 7% in 2023