Formulary Watch covers formularies, pharmacy benefit management companies, drug approvals, and other matters related to medications, their prices and insurance coverage.
Ocaliva, approved for primary biliary cholangitis, faced FDA warnings and restrictions after postmarket data showed higher risks of liver transplant and death among treated patients.
In separate announcements, Form Health and 9amHealth said they would provide patients seeking support for obesity care with nutrition and lifestyle support, as well as prescriptions for medications.
Orforglipron will be submitted to global regulatory authorities for the treatment of obesity or for weight loss by the end of 2025, with diabetes submissions to follow in 2026.
A new Business Group on Health survey finds that nearly a quarter of all employer healthcare spending (24%) went to pharmacy expenses in 2024, and employers forecast an 11% to 12% increase in pharmacy costs heading into 2026.
The FDA has granted priority review of the sNDA and assigned a goal date of Dec. 20, 2025, for Imcivree to treat patients with acquired hypothalamic obesity, which is caused by an abnormality of the hypothalamus.
A new study finds Medicare beneficiaries are facing higher deductibles and cost-sharing requirements following changes implemented by health plans as a result of the Inflation Reduction Act.
Tonmya is the first new fibromyalgia treatment approved by the FDA in more than 15 years, providing symptom relief for at least 30% of patients when compared to placebo, according to clinical trial results.
Wegovy is the first GLP-1 drug approved to treat adults with metabolic dysfunction-associated steatohepatitis (MASH). An ongoing study aims to confirm the benefits.
Papzimeos is the first and only FDA-approved treatment for adults with recurrent respiratory papillomatosis (RRP), with ongoing clinical studies showing symptom relief for up to two years.
To help Medicare plans better manage members with high drug expenses, Prime Therapeutics has launched an AI-driven tool to help plans identify members likely to experience increases in pharmacy costs.
Managing specialty and cancer drugs, as well as the GLP-1 therapies, tops the list of priorities this year and next, according to a survey by the International Foundation of Employee Benefit Plans.
Pharmacists and prescribers express ongoing concern about medication prior authorization struggles, but most are willing to adopt new technologies to ease the burden, according to a recent Surescripts survey.
Ixchiq now has a warning about its use among elderly people with multiple underlying health conditions after postmarketing reports indicated there is a risk of neurologic and cardiac events in people over the age of 60.
Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.
Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Icotrokinra is a first-in-class targeted oral peptide that blocks interleukin (IL) 23 and its receptor, which plays a key role in the inflammatory response in plaque psoriasis.