Formulary Watch |

Medicare’s Spending on Ozempic and Other GLP-1s Rises Steeply

AllianceRx Walgreens Pharmacy Selected to Distribute Vivjoa

Vivjoa is an azole antifungal to reduce the incidence of chronic vaginal yeast infection in postmenopausal women.

FDA Approves Merck’s Drug for Pulmonary Arterial Hypertension

CMS Estimates Savings for Patients from Medicare Inflation Rebates

FDA Approves Combination Therapy for PAH

J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with pulmonary arterial hypertension.

FDA Issues CRL for Odronextamab for Lymphoma Indications

FDA officials indicated that the confirmatory trial for odronextamab for patients with follicular lymphoma and diffuse large B-cell lymphoma should be under way before resubmission.

FDA Grants Full Approval to Elahere

The full approval was based on the confirmatory phase 3 MIRASOL trial, which showed that Elahere resulted in a 33% reduction in risk of death and a 35% reduction in the risk of cancer progression.

Medicaid, Medicare Part D to Provide Coverage of Wegovy, But Not for Weight Loss

FDA Approves Nonsteroidal Drug for Duchenne

Duvyzat is an oral nonsteroidal drug that works to reduce the inflammation and loss of muscle experienced by patients with Duchenne muscular dystrophy. It will be available in the third quarter of 2024.

GSK Caps Respiratory Medications at $35 a Month

FDA Approves Drug that Treats Hypertension in a New Way

New Gene Therapy for Rare MDL to Cost $4.25 Million

Celltrion Launches Zymfentra, a Subcutaneous Form of Infliximab

FDA Approves Iclusig for New Patients with Aggressive Leukemia

Payers Question CMS’ Ability to Get Discounts Though Drug Price Negotiation

FDA Approves Gene Therapy for Rare Disease MDL

Lenmeldy (atidarsagene autotemcel) is the first gene therapy to treat children with juvenile metachromatic leukodystrophy (MLD).

FDA Sets Action Date for Resubmitted Lymphir in Rare Skin Cancer

The FDA has assigned a goal date of Aug.13, 2024, for Lymphir to treat patients with relapsed or refractory cutaneous T-cell lymphoma.

AstraZeneca to Cap Asthma and COPD Meds at $35 a Month

AstraZeneca also said it had reduced the list price of Symbicort beginning Jan. 1, 2024.

FDA Approves Tevimbra for Esophageal Cancer

Tevimbra will be available in the second half of this year and is indicated as a second-line treatment of patients with esophageal squamous cell carcinoma, which is an aggressive cancer.

FDA Approves Breyanzi for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Breyanzi is the first CAR-T therapy to treat adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

FDA Approves Rezdiffra, First Drug for NASH

FDA Approves Livmarli for Second Liver Disease Indication

Silicone Particles in Product Leads to Recall of Treprostinil

One lot of treprostinil injection is being recalled. Tresprostinil is a prostacyclin vasodilator used to treat patients with pulmonary arterial hypertension.

Prime Therapeutics and Capital Rx Create Technology Alliance

Spending on Children’s Mental Health Conditions Increases, Study Finds

In 2021, pediatric mental health conditions were associated with $31 billion in child spending and $59 billion in household spending, which made up 46.6% of all pediatric medical spending that year.

FDA Approves Praluent for Children with Genetic Form of High Cholesterol

The additional indication is for chhildren as young as 8 years of age with heterozygous familial hypercholesterolemia.

FDA Issues CRL for Monthly MS Drug

GA Depot is a once-monthly injection to treat patients with relapsing forms of multiple sclerosis. No information was provided for why the FDA issued a complete response letter.

Celltrion Submits Application for Interchangeable Xolair Biosimilar

The submission is for the same indications, including Xolair’s recently approved indication IgE-mediated food allergy.

Michigan is First Medicaid Program to Offer Lyfgenia for Sickle Cell

FDA Approves Additional Indication for Wegovy

It can now be used to reduce the risk of cardiovascular death, heart attack and stroke in overweight patients with heart disease.