The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.
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Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.
The recent study also found that Jardiance for patients with heart failure with preserved ejection fraction could be cost-effective if discounted by 29%.
Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.
Exxua is approved to treat adults with major depressive disorder, but its labeling does not contain warnings about sexual function or weight gain.
Sotatercept is a first-in-class therapy to treat the rare disease pulmonary arterial hypertension. The FDA has assigned a target action date of March 26, 2024.
The class action lawsuit against CVS Health, Caremark, and Aetna was announced earlier today.
Ryzumi is expected to be available in the first half of 2024. Pricing will be available around the time of launch.
Svetlana Mojsov, Ph.D., was a key part of the team that discovered the function of the hormone glucagon-like peptide 1 (GLP-1) and its role in diabetes and weight loss.
Iyuzeh can be stored at room temperature. It has a list price of $299 for a month’s supply.
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The FDA has assigned a target action date of Jan. 31, 2024, for Dupixent to treat children 1 to 11 years of age with the inflammatory condition eosinophilic esophagitis.
In patients who are immunocompromised, Bacillus cereus can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections.
ICER adds a more formal process to evaluate the diversity of clinical trials and an assessment of a product’s impact on patient and caregiver productivity. ICER also plans to evaluate how newer methods — which would consider the change of a drug’s price over time and disease severity — can be applied to its value assessment.
The FDA is conducting an ongoing inspection of a third-party filler.
Jardiance is currently available to treat patients with type 2 diabetes, end stage renal disease and heart failure. It has a list price of $570.48 for a month supply.
Developing novel drugs to treat cancer remains a strong focus for drug developers. Several first-in-class therapies have become available over the last few months.
Non-White patients who used copay cards were significantly more likely to encounter copay adjustment programs, such copay accumulators and maximizers, compared with their White counterparts.
Laurie Sobel, associate director for women’s health policy at KFF, moderated a panel discussion about the challenges associated with providing insurance coverage for the first FDA-approved oral contraceptive, Opill.
An analysis from 3 Axis has found that PBMs control how much pharmacies are reimbursed. This can vary significantly depending on the PBM contracts with insurers, creating a system with large inconsistencies in the prices that consumers pay for both generics and branded products.
The FDA has requested an additional study. ARS Pharmaceuticals plans to appeal the decision.
Atidarsagene autotemcel is a one-time gene therapy to treat patients with the rare and fatal disease metachromatic leukodystrophy (MLD). The agency has set a review date of March 18, 2024.
Earlier this year, RedHill Biopharma began a warranty program for patients taking Talicia, with a commitment to reimburse patient out-of-pocket costs if Talicia does not work.
Momelotinib — now with the brand name Ojjaara — is the first treatment for myelofibrosis patients with anemia. It has a list price of $26,900 for a bottle of 30 tablets.
Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.
The date has been extended by three months to Feb. 24, 2024, because of resource constraints at the regulatory agency.
CMS has included an additional 34 drugs on the list on products subject to rebates if their price increases are higher than inflation.
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