Formulary Watch

Jaypirca is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor. It has a wholesale acquisition cost of $21,000 per 30 days of therapy.

This approval marks the fifth indication for Keytruda-based regimens in non-small cell lung cancer and the 34th indication in the United States.

AstraZeneca is developing a next-generation long-acting antibody for pre-exposure prophylaxis of COVID-19, which it plans to make available in the second half of 2023.

Three out of four health plans scored a “C” or an “F” because of utilization management restrictions they place on medication for autoimmune conditions.

The Peripheral and Central Nervous System Drugs Advisory Committee meeting is scheduled for March 22, 2023, to review Biogen’s tofersen.

Once-daily, oral SGLT2 inhibitor Brenzavvy has been shown to reduce blood sugar and improve glycemic control.

A phase 3 trial showed that Jardiance reduced the risk of kidney disease progression or cardiovascular death in adults with chronic kidney disease by 28% compared with placebo. An FDA decision is expected in the second half of 2023.

Lilly expects topline results from the confirmatory phase 3 trial in the second quarter of 2023 and plans to submit for full approval.

This is the fourth indication for the Bruton’s tyrosine kinase inhibitor.

Tukysa with trastuzumab is indicated for second-line treatment of HER2-positive metastatic colorectal cancer, the first such therapy for this cancer.

There are currently no medications approved for the treatment of NASH, which can lead to cirrhosis, eventual liver failure, cancer and death. The FDA has assigned a PDUFA target action of June 22, 2023, for the therapy, obeticholic acid.

Rykindo is a bi-weekly long-acting risperidone injection to treat patients with schizophrenia and bipolar 1 in adults.

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

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

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

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.

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

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

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.

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.

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.

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.

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.

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

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

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.

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.

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

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.

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.