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Novo Nordisk set to release Ozempic

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Signs value-based pact with Prime Therapeutics for Victoza

PLAINSBORO, N.J. — Novo Nordisk this week gained Food and Drug Administration approval for Ozempic (semaglutide injection), a medication for type 2 diabetes.

Also this week, Novo Nordisk and pharmacy benefit manager Prime Therapeutics said they signed a value-based contract for Victoza (liraglutide injection), another type 2 diabetes medication.

A glucagon-like peptide (GLP-1) receptor agonist, Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The injection is administered once weekly, on the same day each week, and it can be taken any time of the day with or without meals, Novo Nordisk said.

Novo NordiskOzempic is approved for use in 0.5-mg and 1-mg doses and will come in the Ozempic prefilled pen.

Plans call for a first-quarter 2018 release in the U.S. market, according to Novo Nordisk. The company said that, to ensure broad insurance coverage and patient access, Ozempic will be priced at parity to current market-leading weekly GLP-1 receptor agonists and be offered with a savings card program to reduce co-payments for commercially -insured patients. Also under the access strategy, Novo Nordisk is working with health insurance providers to create innovative contracting solutions.

“The Ozempic approval builds on Novo Nordisk’s commitment to offering health care professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients’ lifestyles,” stated Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “We are grateful to the many adults with type 2 diabetes who participated in the studies, as well as the clinical trial investigators. Thanks to their collective contributions, Novo Nordisk is able to bring once-weekly Ozempic to the type 2 diabetes community.”

Novo Nordisk said the Ozempic approval is based on the results from a Phase 3a clinical trial program. In people with type 2 diabetes, the drug showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release. As a secondary endpoint in the trials, treatment with Ozempic led to reductions in body weight.

“Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals,” according to Helena Rodbard, medical director for Endocrine and Metabolic Consultants in Rockville, Md., and past president of the American Association of Clinical Endocrinologists. “The approval of semaglutide offers health care professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals.”

Announced on Friday, the Prime Therapeutics pact with Novo Nordisk is aimed at controlling overall costs for the PBM’s plan members. Prime said that, along with Novo Nordisk, it will assess the effectiveness of Victoza and reimburse commercial clients if certain measures aren’t achieved.

“We appreciate Novo Nordisk’s collaboration to address diabetes treatment in a way that will allow us to use data and analytics to improve patients’ health and promote affordability,” commented Jonathan Gavras, chief medical officer at Prime Therapeutics.

The Victoza agreement is part of Prime’s CareCentered Contract program, an outcomes-based initiative to help rein in costs for the PBM’s clients, employers and members.

“Through this contract, we saw an opportunity to bring together our depth of diabetes knowledge with Prime’s strong analytics capabilities to help people with diabetes,” Hobbs added. “Improving patient care is a key focus for both organizations, and we’re hopeful that over time our learnings lead to helping all of our customers better understand what works and what doesn’t.”


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