Forteo® Package Size Update – Compendia Adjustment Expected April 1, 2025

As previously reported by PAAS National® in our December 2024 Newsline article, the FDA revised the product labeling for Forteo® (teriparatide injection) and its generics to accurately reflect the amount of drug delivered to the patient and not the overfill existing in the pen injector delivery device (from a 600 mcg/2.4 mL pen to a 560 mcg/2.24 mL pen). Despite this adjustment, the NCPDP billing quantity and unit still reflected the previous 2.4 mL measure.

Because this change was due to a label correction, the FDA is not requiring the manufacturers to change the NDC number or recall the boxes labeled as 600 mcg/2.4 mL. The manufacturers will simply relabel the products to reflect 560 mcg/2.24 mL instead. While the newly labeled products were expected to enter the marketplace in February 2025, the metric quantity is not expected to be updated in the drug data compendia until April, giving the compendia time to accurately prepare for this change.

This may cause some pharmacies confusion if they have already received the 2.24 mL labeled products but can only bill one pen as 2.4 mL. What should pharmacies do if this happens? PAAS still recommends …

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you verify how your software currently bills Forteo® and its generics. Make sure that when submitting a claim, the metric quantity aligns with what is displayed in your software system’s compendia and that the correct cost for one pen is included in your transmission. Once the compendia updates the metric quantity to 2.24 mL, ensure your drug file is updated to accurately reflect your cost for one pen accordingly.

PAAS Tips:

  • Plans may reject claims based on package size, so know how to access and edit your drug file if needed
  • Know which package size is assigned in your pharmacy system drug file to avoid possible over- or underpayments when 2.4 mL or 2.24 mL are billed
  • Wholesaler ordering websites may not list products in the same NCPDP billing unit or package size
    • Check to see if the item numbers associated with Forteo® and its generics have changed
  • Questions about billing quantity or unit of measure? Send us a question through the Ask a PAAS Expert on the Member Portal

Jenevra Azzopardi, CPhT
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