Formulary Watch |

FDA Approves Reblozyl as First-Line Treatment in MDS-Related Anemia

In head-to-head study, Reblozyl nearly doubled the percent of patients achieving primary endpoint of concurrent transfusion independence and hemoglobin increase vs. epoetin alfa.

Janssen Seeks Full Approval for Balversa for Urothelial Carcinoma

The FDA granted accelerated approval to Balversa in 2019. Patients who received Balversa in Janssen’s confirmatory study achieved a median overall survival of more than one year. It reduced the risk of death by 36%.

EmpiRx Health to Scale Its Value-Driven Pharmacy Program

AbbVie Submits Skyrizi to FDA, EMA for Ulcerative Colitis Indication

The submissions to both the FDA and the EMA are supported by two phase 3 trials demonstrating Skyrizi achieved the primary endpoint of clinical remission. Skyrizi is already available to treat patients with plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

FDA Approves First Biosimilar of MS Drug Tysabri

Sandoz’s Tyruko, the first biosimilar to Biogen’s Tysabri, is expected to be available as soon as possible. Pricing has not yet been made available.

Switching to Long-Acting Injectable Paliperidone is Not Cost-Effective in Stable Schizophrenia

Humira Biosimilar Hadlima Making Coverage Inroads on Formularies

Specialty Drugs Driving Increase in Hospital Pharmacy Spend

FDA Grants Priority Review to Xtandi for Earlier Treatment in Prostate Cancer

If approved, Xtandi would be the first hormonal therapy for non-metastatic patients with increasing PSA levels. The FDA has assigned an action date in the quarter of 2023.

FDA Sets Review Date for First-in-Class Therapy for MDS

The FDA set an action date of June 16, 2024, for imetelstat to treat transfusion-dependent anemia in myelodysplastic syndromes. Regulators said they plan to hold an advisory committee meeting as part of their review.

FDA Approves Abrysvo to Prevent RSV in Infants

Abrysvo is the first RSV vaccine approved to be given to pregnant women at 32 to 36 weeks to prevent infection in infants.

FDA Approves Ingrezza for Disorder Associated with Huntington’s Disease

In addition to tardive dyskinesia, Ingrezza now also treats chorea associated with Huntington’s disease, which is a movement disorder that effects coordination, gait, swallowing and speech.

FDA Approves Higher Dose Eylea

The higher dose of Eylea allows longer intervals between injections for patients with macular degeneration and diabetic retinopathy. It will have a list price of $2,625 per single-use vial.

FDA Approves Veopoz for Hereditary Immune Disease

Veopoz is the first treatment for CHAPLE disease, which causes damage to blood and lymph vessels along the upper digestive tract. The list price is $34,615.38 per single-use vial.

FDA Sets PDUFA Date for Full Approval of Tarpeyo

The FDA granted accelerated approval to Tarpeyo in December 2021 to treat patients with primary IgA nephropathy, a rare disease that attacks the kidneys. The action date for full approval is Dec. 20, 2023.

Blue Shield of California to Work with Prime Therapeutics to Negotiate Drug Prices

Shifting Health Plan Policies Impact Access to Specialty Drugs

FDA Approves First Drug for Rare Bone Disorder

FDA Grants Priority Review for Tibsovo sNDA for Myelodysplastic Syndromes

Tibsovo is currently approved in the United States as a monotherapy to treat adults with IDH1-mutant relapsed or refractory acute myeloid leukemia.

New PBM Launches to Bring a New Model to Pharmacy Benefits

FDA Sets Review Date for Combination Antibiotic for Complicated UTIs

The FDA has granted priority review for cefepime-taniborbactam to treat patients with complicated urinary tract infections and set an action date of Feb. 22, 2024.

New Illinois Law Promotes PBM Transparency

Illinois Governor JB Pritzker signed into law a bill prohibiting PBM retaliation against pharmacists who disclose information during government proceedings.

FDA Grants Accelerated Approval to Elrexfio for Multiple Myeloma

Elrexfio is a bispecific antibody to treat relapsed or refractory multiple myeloma. It will be available within the next few weeks and have a monthly list price of $41,500.

FDA Approves Long-Acting Botulinum Toxin for Cervical Dystonia

Daxxify is a long-acting botulinum toxin that will launch in 2024. It previously received FDA approval to treat frown lines.

FDA Approves Combination Tablet for Metastatic Prostate Cancer

The combination of niraparib and abiraterone in a single tablet — now with the name Akeega — will be available in mid-September and have a list price of $18,750 for a 30-day supply.

Kaiser Permanente Expects to Save $300 Million Switching to Amjevita

What We’re Reading: Drug Prices May Lead to ACA Premium Increases; Dealing with Problem Doctors; Autism, Obesity and Other Co-Occurring Conditions

Fresenius Kabi Reaches Agreement with J&J over Stelara Biosimilar

Following similar agreements, the settlement allows Fresenius Kabi and Formycon to launch their ustekinumab biosimilar no later than April 15, 2025.

Study: Amjevita May Not Provide Much of a Discount

Tufts Evaluation Finds Health Plans Vary in Step Therapy for Camyzos