Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.
14% of the US adult population has Diabetes, typically the highest drug spend category
The National Center for Health Statistics (NCHS) released diabetes prevalence data for 2013-2016. This report doesn’t speak to increasing prevalence but rather a snapshot of where things are during this timeframe. The key takeaway message from this report is 14.0% of the United States adult population has diabetes.1 The population who has the diagnosis of diabetes is 9.7% while 4.3% is undiagnosed.1 The potential costs associated with the undiagnosed diabetes population are concerning. Generally, diabetes is usually the highest or second highest drug spend category. With an extra 30% of the patient population not currently on therapy, costs associated with diabetes is only going to continue to grow at alarming rates.
Newest Category for Migraine Management Gets Another Approval
The preventative migraine category of Calcitonin Gene-Related Peptide (CGRP) has another option which was approved by the FDA in September. Ajovy (Fremanezumab-vfrm injection) is indicated for the preventative treatment of migraines in adults. 2 This product is administered either monthly or quarterly as a subcutaneous injection. Ajovy joins Aimovig (Erenumab-aooe injection) as the first two products available. The currently available products are both injections however oral formulations are in the pipeline with potential availability in 2019.
Fish Oil Drug, Vascepa, Shows Reduction in Cardiovascular Events
Early results for a major cardiovascular study were released on September 24 showing a 25% reduction in risk of cardiovascular events. Vascepa (Omega Three Fatty Acids) was shown to reduce the risk of cardiovascular events in patients with elevated cardiovascular risk, high triglyceride levels and currently taking a statin.3 This is the first clinical study to demonstrate the value of fish oil. Vascepa is currently indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.3 How this new clinical data will impact the way triglycerides are managed and how Vascepa is positioned within treatment guidelines is still too be determined. The full results of this study are to be presented in November and may provide additional insight.
Generic Versions of Popular Hepatitis C Medications to Become Available at a Reported 60-70% Discount
Gilead, manufacturer of hepatitis C products Harvoni (ledipasvir/sofosbuvir) and Epclusa (sofosbuvir/velpatasvir), announced it will be selling authorized generic versions of these products.4 It has been reported these generics will be available at discounts of 60%-70% when compared to the brand name versions.4 This could have a significant impact on the specialty pharmacy market. Over the most recent few years, there has been several hepatitis C therapies approved. These approvals have increased the competition in this marketplace. With this increased competition, the value of rebates in this category has drastically increased. What will this market change do to the minimum specialty rebate guarantees? How are authorized generics or single source generics categorized in your current pharmacy benefit contract? These are considerations to review in the very near future to ensure your pharmacy benefit remains competitive.