Anticipating a Breakthrough Therapy for Type 1 Diabetes

July 21, 2022
Vice President and Head of PBM & Specialty Product Innovation
Specialty Report PDF cover image, click to download

Specialty Pharmacy Pipeline:
Drugs to Watch Report

Anticipated Launches | Q3 – Q4 2022

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The Specialty Pharmacy Pipeline Drugs to Watch Report for Q3-Q4 2022 highlights a new drug, teplizumab (Provention Bio), to delay onset of clinical type 1 diabetes (T1D) in at-risk individuals ages 8 to 45 years. In a Phase II trial, after an outpatient intravenous course of teplizumab over two weeks, the median time to clinical diagnosis of T1D in high-risk patients was five years compared to two years for the placebo group. The drug is pending FDA approval in November 2022.

Type 1 diabetes is an autoimmune disorder that results from the loss of beta cells. The absence of these cells means the pancreas does not make insulin or produces an insufficient amount of insulin. Insulin is a hormone that helps blood glucose (sugar) enter the cells of the body where it can be used for energy. Without insulin, blood sugar can’t enter the cells and builds up in the bloodstream. High blood sugar is damaging to the body and causes many of the symptoms and complications of diabetes.Centers for Disease Control (CDC) – What is Type 1 Diabetes? Available at Accessed May 24, 2022.

Type 1 diabetes affects approximately 1.9 million people in the United States.American Diabetes Association – Statistics about Diabetes. Available at https://www. Accessed May 24, 2022. Additionally, an estimated 300,000 are in the early states of the disease and show no symptoms.JDRF White Paper – Modeling the Total Economic Value of Novel Type 1 Diabetes (T1D) Therapeutic Concepts – January 2020. Available at Accessed May 24, 2022. These patients are said to have presymptomatic T1D, and approximately 100,000 to 150,000 of them are considered to be at high risk for progressing to symptomatic (insulin dependent) T1D.Informa Pharma Intelligence – KOL estimate on ratio of stage 1 vs stage 2 Type 1 diabetes. Provided January 15, 2021.

Type 1 diabetes is one of only two major autoimmune diseases without any approved disease-modifying therapy.JDRF White Paper. Teplizumab delays the onset of T1D by slowing the destruction of beta calls. It was granted Breakthrough Therapy designation and would be the first approved therapy to delay T1D.

The report details anticipated impact on spend for this therapy. Teplizumab may result in some medical cost avoidance due to being a preventive therapy and thus delaying cost of active disease treatment (e.g., insulin therapy).

The report also includes planned updates to CVS Health’s Specialty Guideline Management.

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July 21, 2022
Vice President and Head of PBM & Specialty Product Innovation

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