Formulary Watch |

Optum Rx Revenue Grows 9% in 2022

FDA Approves Rybelsus for First-line Treatment of Diabetes

This update removes a previous limitation that it could not be used as the first therapy.

ACS: Cancer Mortality has Decreased 33%

CMS Sets Dates for Drug Negotiation Program

CMS officials plan to engage with the public for feedback and insights as they implement the Medicare Drug Price Negotiation Program.

RxPreferred Benefits Latest to Partner with Mark Cuban Cost Plus Drugs

FDA Approves Rescue Combination Medication for Asthma

Airsupra is the first rescue medication to manage both the symptoms and the inflammation associated with asthma.

Eisai Selects Soleo Health as Specialty Pharmacy Provider for Leqembi

Soleo Health will distribute Leqembi, the newly approved Alzheimer's therapy, to provider offices and infusion centers, as well as administer it across its own ambulatory infusions centers.

FDA Approved 49 New Therapies Last Year

Top 15 Potential Blockbuster Drugs to Watch

Discolored Product Leads to Recall of Epinephrine Ingredient

Epinephrine (L-adrenaline) is a bulk active pharmaceutical ingredient used to manufacture or compound prescription products.

FDA Accepts sNDA for Rexulti for Alzheimer’s Agitation

The agency has assigned a Prescription Drug User Fee Act target action date of May 10, 2023, and plans to hold an advisory Committee

Eisai/Biogen Submit Alzheimer’s Drug Leqembi for Full Approval

The supplemental BLA is based on data from a confirmatory phase 3 trial. The submission was made the same day Eisai/Biogen received accelerated approval.

FDA Approves Alzheimer’s Medication Lecanemab

FDA Grants Priority Review for Glofitamab for Blood Cancer

Genentech’s glofitamab is a bispecific antibody being reviewed to treat adults with large B-cell lymphoma. The FDA is expected to make a decision on approval by July 1, 2023.

FDA Accepts Second UCB Application for Generalized Myasthenia Gravis

Rozanolixizumab is a monoclonal antibody that addresses a different driver of generalized myasthenia gravis. An FDA decision is expected in the second quarter of 2023.

FDA Accepts BLA for RSV Prevention in Infants

Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.

Blue Cross Organizations Launch Drug Contracting Collective

Synergie Medication Collective, which launches this month, is focused on improving affordability and access to gene therapies, infusible cancer drugs and other medications administered in a clinical setting.

Drug Makers Start 2023 With Price Hikes

Celltrion Submits BLA for New Formulation of Infliximab

CT-P13 SC is a subcutaneous formulation of Celltrion’s Inflectra, a biosimilar of Remicade. The BLA seeks approval to treat patients with inflammatory bowel disease.

Wegovy Approved for Teens; Supply May be Delayed

Glass Particles in Vial Lead to Vancomycin Recall

Hospira is calling one lot of vancomycin hydrochloride, an antibiotic to treat patients with serious infections caused by methicillin-resistant staphylococci.

Orasis Submits NDA for Blurry Vision Treatment

If approved, CSF-1 would be the second therapy to treat patients with presbyopia, or age-related blurry vision.

Regence Reduces Annual Drug Spend by $37 Million with Biosimilars

FDA Approves New Therapy for Urea Cycle Disorders

Olpruva is a new formulation of sodium phenylbutyrate to treat patients with urea cycle disorders, a genetic condition that causes ammonia to build up in the blood.

Best Read Healthcare Trend Stories in 2022

Among the best-read healthcare trend and PBM-related stories are ICER’s report on unsupported prices, fake drugs containing meth, an anti-tau drug that shows promise in Alzheimer’s, oncology docs say prior auth hurts patients, and satisfaction with PBMs declines.

FDA Clears Twice a Year Monoclonal Antibody for MS

Best Read Product Recall Stories in 2022

Among the most-read product recall stories are those of amoxicillin, metformin, sodium bicarbonate Omnipod 5, and clopidogrel and atenolol.

FDA Issues Complete Response Letter for Palovarotene

Palovarotene is a therapy for an ultra-rare disease that transforms the body’s soft tissue into bone. The FDA has requested additional information from clinical trials.

Best Read PBM News Stories in 2022

Among the most-read stories about PBMs include Transcarent and Prescryptive Health teaming up for employer pharmacy; Kroger Health ending agreement with Express Scripts; Mark Cuban Cost Plus Drugs teaming up with EmsanaRx and Vivio Health; and Abarca Health takes on a challenging implementation.

FDA Accepts Application for Nonprescription Naloxone

A decision by the FDA is expected by April 28, 2023, and, if approved, Harm Reduction Therapeutics will launch RiVive in early 2024.