Diabetes and Endocrinology

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.

The Inflation Reduction Act’s cap on out-of-pocket costs for insulin is likely to improve outcomes for almost half of Medicare’s insulin users.

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

Lilly’s first-in-class medicine that activates both the GLP-1 and GIP receptors, Mounjaro, is the latest to be included on the FDA’s drug shortages list because of high demand.

Prescryptive will offer a subscription-based program for employers that aims to provide a more predictable benefit for companies and their employees.

Lilly’s Rezvoglar is a long-acting human insulin analog. It follows Semglee as a biosimilar that can be substituted for Lantus for both adults and children with diabetes.

Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It will be available by the end of the year with a wholesale acquisition cost of $13,850 per vial.

Omnipod DASH PDMs are at increased risk of malfunction if overcharged beyond the maximum battery voltage.

A new formulary design will be offered on the Value Script and Value Plus plans; it will contain medications used to treat diabetes and will cost only $11 per 30-day supply.

Omnipod 5 is now available through retail pharmacies, as well as specialty and mail-order pharmacies.

Abiraterone is used together with prednisone to treat patients with metastatic prostate cancer.

The Inflation Reduction Act also allows Medicare to negotiate prices on some drugs and caps out-of-pocket costs for Medicare beneficiaries.

Optum has teamed up with Sanofi to provide savings cards for six insulins through the Optum Store.

The new PDUFA date is Nov. 17, 2022. If approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes.

Sanofi has lowered the out-of-pocket cost for those without insurance of its insulins to $35 for a 30-day supply through the company’s savings program.

Byetta is used to control blood sugar in patients with diabetes. A new warning includes the risk of gallstones and gallbladder inflammation.

If insulin copays were capped at $35, Part D enrollees would save 29% on average, according to new analysis from Kaiser Family Foundation.

Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control.

Ozempic is now available in three doses to improve blood sugar in people with type 2 diabetes.

Allan Coukell, Civica’s senior vice president of public policy, discusses how the generic manufacturer is disrupting the market for insulins.

Once approved, the insulins will be available to patients for no more than $30 per vial.

Patients who are part of the Walgreen’s Prescription Savings Club can receive Semglee at up to 80% off the cash price.

OptumRx will favor the reference product Lantus on the Premium Formulary. The organization also released coverage information about other newly approved therapies.

Branded and unbranded versions of the interchangeable biosimilar to treat patients with diabetes are now available.

Prime’s formularies will include the insulin biosimilar over the reference product Lantus beginning in January 2022.

Express Scripts will put the first interchangeable biosimilar insulin on its National Preferred Formulary and exclude Lantus, the reference product.

Effective Jan. 1 2022, the move brings the price to 2008 levels.

The approval allows for substitution at the pharmacy counter for Lantus, its reference product.

Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.

FDA staff raised safety concerns ahead of the advisory panel hearing.