House Passes Insulin Bill

The U.S. House of Representatives has passed the Affordable Insulin Now Act seen here. According to the bill’s summary this bill does the following: 

• Limits cost-sharing for insulin under private health insurance and the Medicare prescription drug benefit.

• Caps cost-sharing under private health insurance for a month's supply of selected insulin products at $35 or 25% of a plan's negotiated price (after any price concessions), whichever is less, beginning in 2023.

• Caps cost-sharing under the Medicare prescription drug benefit for a month's supply of covered insulin products at $35 beginning in 2023.

• Currently, the Centers for Medicare & Medicaid Services is testing a voluntary model under the Medicare prescription drug benefit (the Part D Senior Savings Model) in which the copayment for a month's supply of insulin is capped at $35 through participating plans. The model is set to expire on December 31, 2025.

• The bill also (1) further delays implementation of regulations relating to the treatment of certain Medicare prescription drug benefit rebates from drug manufacturers for purposes of federal anti-kickback laws, and (2) increases funding for the Medicare Improvement Fund.

The bill now goes to the Senate where 60 votes are needed to send it to the President. 

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FDA Approves First Interchangeable Biosimilar

The U.S. Food and Drug Administration (FDA) has “approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.

Biological products include medications for treating many serious illnesses and chronic health conditions, including diabetes. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means you can expect the same safety and effectiveness from the biosimilar as you would the reference product.

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.”

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If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.