July 2021 AI Alert

Metformin: Stay Informed on High Generic Costs and FDA Recalls

Metformin: Background

When we talk about prescription Fraud, Waste, and Abuse (FWA), we think of emerging schemes such as topical pain/scar creams, compounds, ingredients for foot baths, high-cost wellness vitamins, or combo drugs. Health plans and Special Investigation Units (SIU) should also add Metformin HCL ER to the list of drugs to keep on their radar.

Metformin is an inexpensive medication prescribed by doctors to improve blood glucose control in adults with type 2 diabetes mellitus. Metformin is often found to be within the top 50 drugs billed by pharmacies by volume count in terms of prescription utilization. According to the America’s Health Rankings analysis of CDC, diabetes is the nation’s seventh leading cause of death. Given this statistic, one could fathom Metformin being the top drug billed by volume, but why would this line item also show up in your “Top 50” most expensive drugs?

Metformin: Variations

Metformin is manufactured in three (3) different forms; immediate-release (IR) tablets, Osmotic Release (OSM), and extended-release (ER). These products provide similar clinical efficacy but vary greatly in cost, so it’s imperative for health plans and SIUs to know the differences between the different types. Health plans should practice their due diligence and make sound clinical judgments to determine appropriateness of these variations.

The table below lists the different formulations of Metformin and its cost per unit:

In the table above, you can see the big differences in cost per unit between the different variations of Metformin.

Why should health plans monitor high-cost generics like Metformin?

It’s vital for health plans and SIUs to review claims data to identify inappropriate costs and utilization continuously. Maintenance drugs such as those that treat diabetes are often overlooked by SIUs. Due to the emerging prescription fraud schemes impacting health plans, investigators and analysts are giving those schemes precedence over these outrageously priced generic drugs.

Codoxo has identified the following National Drug Code(s) (NDC) that are tied to these high costs:

• NDC- 16714-0938-01
• NDC- 16714-0939-01
• NDC- 47335-0305-88
• NDC- 68180-0336-07
• NDC- 68180-0337-07
• NDC- 68180-0338-01
• NDC- 68180-0339-09
• NDC- 68462-0520-01
• NDC- 68462-0521-90
• NDC- 68682-0018-90
• NDC- 68682-0021-50
• NDC- 70010-0496-01

Note: It’s difficult to imagine why any plan would cover brand versions of Metformin ER without strict letters of medical necessity or any other edits. Health plans should consider blocking these high-cost generic and brand versions, which will likely save considerable sums if they do.

Metformin Food Drug Administration (FDA) Recall

As per a released statement by the FDA, many drug manufacturers have voluntarily recalled Metformin ER due to the presence of impurities. Of the listed NDCs above, Codoxo has identified NDCs manufactured by Lupin Pharmaceuticals and Granules Pharmaceuticals that were recalled. These NDCs start with NDC labeler ‘68180’ and ‘70010’.

It is encouraged for health plans and SIUs to calculate their plan’s exposure and search the FDA recall list to take the appropriate next steps regarding their utilization. To cross-reference the NDCs, see https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-metformin-products.

How can the Codoxo Forensic AI Platform assist your health plan with identifying emerging risks, trends, and other outlier claims for Metformin?

• The AI engine and detectors identify patterns, volume, and frequency across all peer groups and claims allowing customers to identify, analyze, and respond to potential FWA and efficacy issues
• The Query tool allows users to build custom queries tailored to their organizational needs

If you are an existing customer, please contact your Customer Success representative or support@codoxo.com for assistance with this topic.  If you would like more information or to set up a demonstration of the Codoxo Forensic Platform, please contact sales@codoxo.com.

References:

1.  America’s Health Rankings: https://www.americashealthrankings.org/explore/annual/measure/Diabetes/state/ALL
2.  U.S. Food & Drug Administration List of Recalled Metformin Products: https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-metformin-products
3.  U.S. Food & Drug Administration Lupin Pharmaceuticals Voluntary Recall: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-metformin-hydrochloride-extended
4.  Centers for Disease Control and Prevention (CDC) Diabetes Report:  https:www.cdc.gov/media/releases/2017/p0718-diabetes-report.html