AstraZeneca Letters re: Farxiga® Data Discrepancies

Similar to the LifeScan letters highlighted in the April 2025 article, Diabetic Test Strip Authorized Distributors – LifeScan Audits Continue!, there are two different versions of the AstraZeneca letter. The gentle version requests that pharmacies review wholesaler invoices and pharmacy dispensing records to ensure that claims are dispensed/billed properly, while the stronger version requests cooperation by providing data to AstraZeneca to include total tablets purchased and dispensed in 2024. Both versions point out that 2023 data show no such discrepancies.

The unsupported assertions of an invoice shortage should prompt pharmacies to perform an internal review of their own purchase and dispensing data to see if the claim has any merit. If shortages are uncovered, then pharmacies should attempt to determine the root cause(s) and implement appropriate corrective actions to prevent a recurrence.

A few possible reasons that should be considered include:

1. Excess supply on-hand from 2023
2. Return to Stock Errors
3. Claims with overbilled quantities
4. Purchases from other pharmacies that may not be visible to the manufacturer
5. Incorrect NDCs billed
6. Counterfeit product in the supply chain
7. Fraudulent billing of claims where no inventory was purchased
8. Failure to reverse claims that were not picked up

While not stated directly, the tone and wording of the letters imply that AstraZeneca suspects that pharmacies purchased/dispensed the Authorized Generic NDC and billed claims under the Brand NDC. This type of error causes manufacturers to pay inappropriate rebates and is considered fraudulent, if done intentionally.

The Authorized Generic version of Farxiga^® (dapagliflozin), labeled by Prasco Laboratories, entered the market January 3, 2024, and has the identical appearance (color, shape, size, imprint) as the branded product indicating that it is the exact same tablets in the bottles – with different labeling, NDCs, and most importantly, prices.

As of this publication it is unclear how AstraZeneca will proceed. If you have a letter, be sure to send it into PAAS right away so that we may guide you through next steps.

PAAS Tips:

• AstraZeneca has a list of Authorized Distributors of Record on its website. The contractual requirements are unclear as to whether pharmacies are obligated to purchase Farxiga only from an Authorized Distributor; however, one way to ensure you are not purchasing counterfeit product would be to order only from one of these authorized distributors.
• Make sure that inventory purchased from another pharmacy or via a third-party marketplace is performed in accordance with DSCSA and that these transactions are thoroughly documented
  • See March 2025 Newsline article, The NEW Inventory Transfer Log and Why It Could Save You Big!
  • Document pharmacy to pharmacy (P2P) purchases on the Pharmacy Inventory Transfer Log
• Ensure that claims are billed with the exact NDC that is purchased/dispensed – this is a contractual requirement of every payor, for every claim
  • Pharmacist visual verification of Farxiga® tablets alone is insufficient to prevent this error type – make sure you check the NDC of the stock bottle against the claim to confirm accuracy
  • Consider staff education on this possible error type and implementing barcode scanners to prevent mistakes