At the May 2024 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
Request:
Pfizer seeks clarification of the appropriate billing unit quantity associated with the two-count pen configuration of Abrilada™ (adalimumab-afzb), a recently-launched biosimilar of Humira® (adalimumab), which is represented by NDCs 0069-0325-02 and 025-0325-02 (identical Abrilada™ product configurations under a different labeler codes).
The relevant Abrilada™ configurations at issue here involve the following:
(1) Abrilada™ Prefilled Syringe Carton (Two Count) – Carton containing 2 single-dose prefilled glass syringes, each packaged in a dose tray, and 2 alcohol preps.
(2) Abrilada™ Pen Carton (Two Count) - Carton containing 2 single-dose pens and 2 alcohol preps. The pens are not included in dose trays as they are not necessary for the safe packaging of the pens. This is the configuration in question, represented by NDCs 0069-0325-02 and 025-0325-02.
Because these configurations include an NDC-assigned, prefilled syringe or pen packaged with an NDC-assigned alcohol prep, Abrilada™ is appropriately classified as a “kit” with a billing unit of “each” under NCPDP guidelines.
From our discussions with representatives of the compendia, Pfizer understands that based on the number of dose trays involved in the kit configuration per NCPDP guidelines, the compendia list the two-count syringe configuration as having a quantity of “2” but list the two-count pen configuration as having a quantity of “1.” However, as described in detail in the section that follows, Pfizer believes both patient safety and the consistent and accurate billing of the product across private and public payors support a quantity of 2 for both configurations.. In this case, drawing distinctions in drug quantity across the two configurations based on the presence of a dose tray misrepresents the clinical features and purpose of the products and as described below, introduces needless risk to patient safety and complication into billing and rebating processes.
Why Needed:
Pfizer believes both the two-count prefilled syringe and pen configurations should be associated with a quantity of 2. Both configurations contain two unit doses, as demonstrated by the labeling on the outside carton specifying that the carton contains “2 Prefilled Pens” and “2 Prefilled Syringes.” (Please see the attachment accompanying this request for images of the packaging.) A quantity of 2 thus accurately reflects the contents of the cartons and is consistent with NCPDP Billing Unit Standard “General Rules” guidance § 2.2.B that “[t]he billing unit and quantity are taken from the product labeling that is affixed to the product and is readily available to the dispensing pharmacist.” Similarly, as shown in the screenshot below, the packaging insert of the pen configuration identifies these units as containing “Two Counts.”
This characterization also is consistent with FDA’s understanding of the two-count pen configuration. As shown in the screenshot below, the National Drug Code Directory describes the units as “2 KIT in 1 CARTON.”
Importantly, Pfizer believes it is critical for the pen two-count configuration to be affiliated with a quantity of 2 to promote patient safety. Both the syringe and pen two-count configurations contain the same amount of medication and are intended to supply a patient with two unit doses. The only difference across the products is the particular applicator (i.e., syringe vs. pen), which is to account for patient preferences in drug delivery and does not represent any difference in the amount of drug product or therapeutic purpose across the two presentations. Because a quantity of 2 is generally understood to align with two patient doses, Pfizer is concerned that associating the two-count pen configuration with a quantity of 1 could confuse patients, pharmacists, and prescribers. For example, a patient that previously relied on the two-count syringe configuration and opts to switch to the two-count pen configuration would receive a product labeled by the pharmacist as including a single dose. The patient -- or perhaps a pharmacist advising a patient -- might be under the misconception that both pre-filled pens should be administered as a single dose to receive a corresponding amount of medication.
Additionally, associating the two-count pen configuration with a quantity of 2 also is necessary for consistent billing of the product with commercial payors as well as under the Medicaid Drug Rebate Program and 340B programs. Because the two-count pen configuration in fact contains 2 units, the package is twice as expensive as one-count Abrilada™ pen configurations that Pfizer also markets. Representing both the two-count and one-count products as a quantity of 1 will disrupt rebating practices, likely leading to the underpayment of rebates to payors who reimburse for the two-count package. Similar issues emerge under the MDRP and 340B programs. Were Pfizer to report the two-count pen configuration as a UPPS of 1 under the MDRP, the unit rebate amount for the one-count of the product would likely be inflated, and states seeking rebates for the two-count pen configuration would likely receive an underpayment.
Finally, associating the two-count pen configuration with a quantity of 2 also would promote consistency across the marketplace for injectable TNF inhibitors. Specifically, the two-count pen configuration of Abrilada™ is meant to correspond to the two-count pen configuration of Humira, NDC 0074-4339-02, which is reported by the compendia as maintaining a quantity of 2. Applying this same quantity to the two-count pen configuration of Abrilada™ would ensure alignment across TNF-inhibitor biologicals and their corresponding biosimilars.
Outcome Anticipated:
To the extent NCPDP guidelines require a quantity of 1 for the two-count pen configuration of Abrilada™, Pfizer respectfully requests an exception that the product instead be associated with a quantity of 2.
Task Group Discussion Task Group Discussion (03/19/24)
- Trays are used as a separation of a product and components has nothing to do with the protection of the product.
- Per section 5.5.1 the packages containing trays are classified as a kit because of the alcohol swabs and the quantity is determined by the number of trays if a kit contains separate, distinct trays within the kit, the billing unit is an “each,” but the quantity is the number of trays rather than “1.”
- Per section 7.4 products that meet the NCPDP definition of a kit are billed as “1 each” kit.
- Per section 7.5 Kits with multiple, distinct trays are subject to be dispensed by the tray. Thus, kits with trays would be billed as “each” with a quantity of the number of trays.
- The concern is that if an exception was created for this product it would not only open the door to exceptions for every manufacturer who has a similarly packaged product but would add more confusion to pharmacies, PBMs rules/coding and NCPDPs Billing Unit Standard.
- The task group agrees that the packages without dose trays should remain as 1 EA to avoid any confusion.
- The configuration is not unique, exceptions are only granted in extremely rare circumstances due to the impact on invoicing, reimbursement, rebate adjudication and clinical evaluation per section 5.6 of the BUS.
- Agreement of an assignment of BU = EA per section 5.5.1, 5.6, 7.4 and 7.5 of the BUS with a package size of 1 EA (kit) for NDCs 0069-0325-02 and 0025-0325-02.
WG Discussion (05/06/24):
A motion was made and seconded to classify the BU = EA per section 5.5.1, 5.6, 7.4 and 7.5 of the BUS with a package size of 1 EA (kit) for NDCs 0069-0325-02 and 0025-0325-02. The motion carried.