Standards QUIC Form Resolutions

At the November 2025 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard^©
New Product/Package Information
Product Identification Code Questions/Issues
Request: 
If approved by the FDA, ZOLGENSMA INTRATHECAL™ will be the only, one-time gene therapy administered intrathecally in patients with SMA over the age of 2. Administration is a fixed dose of 1.2 × 10¹⁴ vector genomes (vg).
 
There is a currently marketed weight-based formulation of ZOLGENSMA^® for intravenous infusion in patients with SMA under the age of 2. The recommended dosage of ZOLGENSMA^® is 1.1 × 10¹⁴ vector genomes (vg) per kg of body weight.
 
Novartis would like to confirm the billing unit as we prepare to list ZOLGENSMA INTRATHECAL™ in compendia and ensure clarity to avoid billing issues and patient delays upon launch.
Why Needed:
Novartis seeks to establish a billing unit for ZOLGENSMA INTRATHECAL™ that takes into consideration that it is a fixed-dose, packaged as a single vial in a carton with 2 separate NDCs (71894-200-01 and 71894-200-02). Also, Novartis is requesting clarity upon launch to avoid billing issues and patient delays that takes into consideration that there is a currently marketed weight-based dose for intravenous administration with 36 separate NDCs (71894-120 through 71894-144).
Outcome Anticipated:
Defined billing unit of 1 each (vial) as each single dose vial contains 1.2 × 10¹⁴ vg of onasemnogene abeparvovec (ZOLGENSMA INTRATHECAL™) in 3 mL of solution vial with an extractable volume of not less than 3 mL.
Task Group Discussion (10/14/25):

• This product will be provided in a single-use vial in a single carton
  • No more than two NDCs will be associated with this product
• Effective June 2025, the FDA is requiring single vials and single cartons to provide the same product code with a different package size identifier
• The package size (volume of the liquid) will be constant across all lots, and all of the product should be extracted and administered with no wastage.
  • The formulation is a fixed-dose versus weight-based variable
  • The genome factor will be the recommended dosage per FDA label and not variable.
• If the language in section 16 of the package insert states that there is a variable volume such as “not less than 3 mL” Zolgensma^® will be an assignment of BU = EA with a package size of 1 EA per section 5.1.7 of the BUS.
  • If there are any changes in the language in the package insert or label explicitly stating 3 mL and not less than 3 mL, there will be a change in the billing unit assignment.
• Agreement on the assignment of BU = EA per Section 5.1.7 of the BUS, with a package size of 1 EA for both the inner and outer NDC numbers.

WG Discussion (11/07/25):

• If something changes between now and when the packaging is approved by the FDA, how will that be handled? The QUIC form will be re-reviewed and re-issued if the task group feels that something needs to change. If after the product is launched and there needs to be a quantity change, there will be an e-Blast sent out.
• If the packaging does change, how will the NCPDP members be notified? Each of these manufacturers will be notified that the QUIC forms were reviewed/approved. When this product is approved by the FDA, the task group will still need to see the updated package information/artwork. The manufacturer will need to send NCPDP any updated information. Additionally, after the compendia begins entering the product into their databases, any discrepancies will be noted in the monthly billing unit discrepancy report.
• What if the outer carton quantity changes? The manufacturers would not be able to launch any package size variation that was not approved by the FDA. Since this is a gene-therapy product, there may be variable volumes from batch to batch (which is why the package size should be 1 each), the task group would need to confirm that the FDA did not remove any language regarding variable volume that would switch it from “each” to “mL.” 
• Can NCPDP issue a “conditional approval” while this product is in review with the FDA and then a “final approval” once the FDA clears this product? This should also be addressed in task group call prior to next meeting and include Margaret in the discussion.

• A motion was made and seconded to classify the BU = EA per Section 5.1.7 of the Billing Unit Standard^© with a package size of 1 EA for both the inner and outer NDC numbers. The motion carried.

The product name was updated based on a notification from the manufacturer on 11/13/2025.
 

At the November 2025 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard^©
New Product/Package Information
Request: 
Beta Bionics is commercializing an insulin dosing patch pump.  The product has a 1-year durable component (mint controller) and a disposable component (mint(s)) that will be used for 3 days and then disposed of. 
 
Mint controller – a hard plastic piece which contains the motherboard, memory, Bluetooth radio, motor, and drive train for the purpose of receiving CGM values, computing algorithmic values, dosing insulin, and relaying the CGM value as well as other information to a patient’s phone or alternate display device.
 
Mint – a 200-unit (of u-100 insulin) reservoir which also includes the battery, needle, and adhesive backed cloth patch material.
 
For the refill kit, the components of the kit will be as follows: 5 mints.  Each of the mints will be in a sterile tray that will also include a syringe and needle for the purpose of filling the 200-unit mint reservoir.
 
At the most common prescribed frequency of change, every 3 days, the patient will receive 2 boxes which contain a total of 10 mints and last 30 days.  For patients with large insulin requirements, they will receive 3 boxes which contain a total of 15 mints. 
Why Needed:
New to market product.
Outcome Anticipated:
Unit = eaches; Qty = 5
 
The box will contain 5 mints each of which are configured within a sterile tray also containing a syringe and needle for the purpose of filling the reservoir with insulin.  Because of the tray configuration, the quantity counted are the trays making the quantity = 5.
 
This follows the logic of Insulet’s Omnipod refill kits.
Task Group Discussion (09/02/25):

• Each refill kit contains 5 sterile trays (5 Mints)
  • Each sterile tray contains:
    • A Mint reservoir, a syringe and needle for the purpose of filling the 200-unit Mint reservoir.
      • All items supplied in each tray are sterile products intended to be used together
  • Outer and inner packages (trays) have the same NDC number
• Because the contents of the sterile tray are intended to be used together and not separately, the task group agrees each tray should be counted as one unit. Section 5.5.1 of the BUS will be reviewed and updated to reflect this billing unit assignment and package size.
• Agreement of an assignment of BU = EA per section 5.5.1 of the BUS with a package size of 5 for each refill kit.

WG Discussion (11/07/25):
A motion was made and seconded to classify the BU = EA with a package size of 5 per section 5.5.1 of the Billing Unit Standard^©. The motion carried.

At the November 2025 WG2 Meeting the form was discussed.
New Product/Package Information
Request: 
Beta Bionics is commercializing an insulin dosing patch pump.  The product has a 1-year durable component (mint controller) and a disposable component (mint(s)) that will be used for 3 days and then disposed of. 
 
Mint controller – a hard plastic piece which contains the motherboard, memory, Bluetooth radio, motor, and drive train for the purpose of receiving CGM values, computing algorithmic values, dosing insulin, and relaying the CGM value as well as other information to a patient’s phone or alternate display device.
 
Mint – a 200-unit (of u-100 insulin) reservoir which also includes the battery, needle, and adhesive backed cloth patch material.
 
For the starter kit, the components of the kit will be as follows: 1 mint controller and 10 mints.  Each of the mints will be in a sterile tray that will also include a syringe and needle for the purpose of filling the 200-unit mint reservoir.
 
At the most common prescribed frequency of change, every 3 days, the starter kit will last a patient 30 days. 
Why Needed:
New to market product.
Outcome Anticipated:
Unit = eaches; Qty = 1
 
Because the starter kit has a durable component that is involved with processing and displaying a CGM value, the kit is considered a quantity of 1.
 
This follows the logic of Beta Bionics currently commercialized iLet Starter Kits, Sequel’s twist starter kit, and Insulet’s Omnipod starter kit.
Task Group Discussion (09/02/25):

• Mint controllers are supplied once a year in the starter kit
  • Kit contains:
    • 1 mint controller with 10 Mint trays
      • Each of the sterile Mint trays includes a syringe and needle for the purpose of filling the 200-unit Mint reservoir.
• Agreement of an assignment of BU = EA per section 5.5.1 of the BUS with a package size of 1

WG Discussion (11/07/25):
A motion was made and seconded to classify the BU = EA with a package size of 1 per section 5.5.1 of the Billing Unit Standard^©. The motion carried.
 
 

At the August 2025 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
TAR-200  (JNJ-17000139) is an investigational intravesical system that is designed to provide local release of gemcitabine in the bladder. TAR-200 contains gemcitabine and urea mini tablets within a dual-lumen silicone tube for gradual release of gemcitabine by an osmotic delivery mechanism throughout the prescribed indwelling period. TAR-200 is inserted intravesically via a specifically developed urinary placement catheter, after which it self-coils into a bi-oval shape (see figure). Removal of TAR-200 can be achieved using grasping forceps and cystoscopy.
 
TAR-200 is co-packaged with the Urinary Placement Catheter (UPC). The UPC is a sterile, single-use, unit which has been specifically developed for the transurethral insertion of TAR-200 into the bladder.
Why Needed:
TAR-200 (JNJ-17000139) includes both the intravesical system and the urinary placement catheter. Catheters, while they may be considered “non-drug items” are not specifically described in the NCPDP Billing Unit Standard Implementation Guide Version 5.0 and we want to ensure that it is easy for the compendia and their downstream customers to understand the package size and billing unit of this product consistently.
Outcome Anticipated:
While the urinary placement catheter is not explicitly referenced in Billing Unit Standard Section 5.5.1, it should be classified similarly to items such as syringes, needles, and tubing, which are essential for administration.
 
TAR-200, an intravesical system, includes a predetermined dose (manufactured with a fixed amount of drug and not subject to alteration). The intravesical system and the UPC are intended to be used together by a healthcare professional for product administration.
 
Based on the details provided, we respectfully request that the billing unit for TAR-200 be designated as “each,” with a corresponding quantity of “1.”
Task Group Discussion (08/05/25):

• TAR-200 is a fixed-dose drug-device combination product designed for the treatment of bladder cancer.
  • It consists of gemcitabine and urea mini tablets embedded within a silicone tube, which is inserted into the bladder via catheter.
  • Once implanted, the device remains in the bladder for three weeks, during which time gemcitabine elutes into the urine, providing localized treatment.
• Should the package size be determined based on the total number of tablets contained within each unit?
  • Each TAR-200 system contains the same total amount of drug, the exact number of mini-tablets is not specified and, according to Johnson & Johnson representatives, will not be included on the label or package insert.
• After review and discussion, it was determined that TAR-200 does not meet the definition of a kit as outlined in Section 5.5.1 of the Billing Unit Standard (BUS).
• TAR-200 is more appropriately aligned with the definitions provided in Sections 5.1.14 and 5.1.16 of the BUS.
• BUS Section 5.1.14

Implants or implanted dosage forms, which are solid or gel products (i.e., Ocusert®, Ozurdex®), are measured as “each.”

• BUS section 5.1.16

When counting the number of eaches for a product that contains adapters, delivery devices or any of the items listed as exclusions in the Section 5.5.1 kit definition, do not include adapters, delivery devices or kit definition exclusions in the count of the number of eaches for the product.

• This product is not diluted and is not supplied with a separate diluent.
  • The mini tablets are embedded within a silicone tube, which is implanted into the bladder, where the tablets dissolve during the treatment.
• Agreement of an assignment of BU = EA per section 5.1.14 and 5.1.16 of the BUS with a package size of 1 for each TAR-200 system.
  • It was noted by a task group member during the call that if the quantity of tablets is ever included on the label or package insert, the product would be subject to re-review for appropriate billing unit and quantity designation.

WG Discussion (08/13/25):
A motion was made and seconded to classify the BU = EA with a package size of 1 per section 5.1.14 and 5.1.16 of the Billing Unit Standard. The motion carried.
 

At the May 2025 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Miudella® is a next-generation, hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years.  We would like to confirm the billing unit as we prepare to list it in the compendia.
Why Needed:
This is a new product launch and we would like to confirm the billing unit.
Outcome Anticipated:
Billing unit of 1 each.
Task Group Discussion (04/15/25):

• Miudella® is a hormone-free, low-dose copper intrauterine device or IUD (referred to as a drug device by the manufacturer).
  • An intrauterine system (IUS) is the same as an intrauterine device (IUD) which is billed as one each per section 5.1.14 of the BUS.
• Agreement of an assignment of BU = EA per section 5.1.14 of the BUS with a package size of 1.

WG Discussion (11/07/24):
A motion was made and seconded to classify the BU = EA per 5.1.14 of the BUS with a package size of 1 EA. The motion carried.
 

At the May 2025 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
SRP-9003 is a gene therapy candidate and proposed commercial product that will feature multiple SKUs that will be manufactured and prepared based on a given patient’s weight. The gene therapy will not be inventoried in the channel but rather, will be manufactured and prepared for a specific patient and sent to the requesting hospital for just-in-time administration via intravenous infusion. The goal is to have each SKU considered as an each with the NDC based on vector genome volume.
Why Needed:
Sarepta seeks to establish a billing unit and quantity for SRP-9003 that takes into consideration that SRP-9003 is a gene therapy that is prepared specifically for the patient when ordered based on the patient’s weight. Each stock keeping unit (SKU) will be supplied with a number of vials per 2 kg of patient body weight, as well as one (1) alcohol wipe per vial of gene therapy within each weight-based kit.
Outcome Anticipated:
A billing unit of each (kit) with a billing quantity of 1 will be assigned for SRP-9003.

Task Group Discussion (03/04/25):

• There is a total of 46 NDC numbers for SRP-9003
  • These NDC numbers represent the 46 distinct weight-based kits
  • Each package will contain one vial for two kilograms of body weight and an alcohol swab for each vial
    • There will be separate NDC numbers for each vial, however these vials are not intended to be individually available for sale
      • Each inner vial has the same NDC number on it which differs from the outer package NDC number
      • Each inner vial is believed to have a set volume
        • The only difference in each of the 46 NDC numbers will be the number of vials that are included in each package
• This product will be packaged and shipped similar to the way Elevidys was supplied
  • Product is shipped frozen directly to the facility where it will be administered to the patient
• Are the alcohol swabs included in sections 16 and 17 of the package insert?
  • Sarepta will refer to the Elevidys package insert as a model for how they plan on packaging SRP-9003
  • Confirmed that sections 16 (how supplied) and 17 (instructions for use) of the Elevidys include the alcohol swabs
• Agreement of an assignment of BU = EA per 5.1.7 and 5.5.1 of the BUS with a package size of 1.

WG Discussion (11/07/24):
A motion was made and seconded to classify the BU = EA per 5.1.7 and 5.5.1 of the BUS with a package size of 1 EA. The motion carried.
 

At the February 2025 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Confirmation of Package Size+ Billing Unit needed: Tabelecleucel is an allogeneic (EBV) Epstein Barr Virus-specific T-Cell Immunotherapy agent harvested from human donors. Each lot is tested for specificity of lysis of EBV+ targets, T-cell restriction of specific lysis, and verification of low alloreactivity. Each lot is selected for an individual patient from the existing product inventory based on an appropriate HLA restriction. An individual patient may receive 1-9 Vials (1 OUTER Carton NDC will be used regardless of the amount of vials required).
Why Needed:
Anticipating confusion with the billing unit and package size. 1, EACH While this product is not autologous, the allogeneic component is harvested from human donors. Each lot is different, and individual patients will be matched against existing donor inventory. The inner vials will NOT have NDC’s. They will have APIN#’s per FDA because they are donor product and would have thousands of continuously changing NDC’s.
Outcome Anticipated:
Package Size 1, Billing Unit EACH
Task Group Discussion (12/17/24):
Agreement of an assignment of BU = EA per section 5.1.7 of the BUS with a package size of 1 EA.
WG Discussion (11/07/24):
A motion was made and seconded to classify the BU = EA per section 5.1.7 of the BUS with a package size of 1 EA. The motion carried.
 

At the November 2024 WG2 Meeting the form was discussed.
New Product/Package Information
Request:
(obecabtagene autoleucel) is a CD19-directed genetically modified autologous anti-CD19 (CAT) CAR-positive T cell immunotherapy. It is prepared from the patient’s own peripheral blood mononuclear cells, which are collected via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells, activated and transduced with a replication-incompetent lentiviral vector containing the CD19 CAR transgene. The transduced T cells are expanded in cell culture, washed, formulated into a suspension, and then cryopreserved. It is frozen in patient-specific infusion bag(s) and thawed prior to infusion.
Why Needed:
Unlike some other Autologus products, patients will receive a minimum of 3 bags.
Outcome Anticipated:
Package Size 1 = Billing Unit, EACH d/t patients own peripheral blood mononuclear cells (autologous).
Task Group Discussion (10/29/24):

• This product is an autologous product that uses the patient’s own cells which are harvested and prepared in multiple bags
  • The patient will receive a minimum of 3 bags, but can range up to 5 bags per NDC number
    • There is only one billable NDC number however there maybe multiple NDC numbers associated with each product based on the type of cells harvested
• Why would there be more than one NDC number associated with the product?
  • There could be multiple NDC numbers depending on the type of genes that are being extracted from the patient and other components such as a cassette
    • This product is a cryotherapy and must be frozen
    • This product is shipped in a dewar (metal container, packed with dry ice) which contains the cassettes in which the bags are held in
      • In some cases, the FDA may require inner NDC number for the handling of the types of cells being delineated
    • Patients receiving therapy have the same diagnosis and need the same type of therapy, so the FDA has assigned one outer NDC number regardless of the number of bags contained in the package
• What would be scanned when dispensing this therapy?
  • The inner bag cannot be scanned because of the way these types of products are packaged, the NDC code on the dewar will encompass all the information
    • The outer NDC number will be for the entire product regardless of the number of bags contained in the package.
• How will the pharmacy know which NDC number to bill?
  • This product is not shipped to the pharmacy it is delivered directly to the physician’s office or hospital so there should not be a pharmacy claim
    • This will be billed under the patient’s medical benefits
    • The physician’s office will harvest the patient’s viable cells and send them to a lab for processing
      • Once the cells are processed, they will be frozen in the bags and shipped directly to the physician’s office/hospital for administration to the patient by the physician
• Will the number of cells be on the package, and will this be submitted similar to anti-hemophilic products?
  • The details on the outer carton would identify how many bags are frozen and packaged within the dewar
  • This product is not like the anti-hemophilic factors where it is dependent on the number of cells/units packaged
    • Other products like this are referred to as a single therapy or single treatment and can consist of multiple bags
• The following update has been made to version 5 of the BUS expanding section 5.1.7 to include gene-therapy products:

Gene-therapy agents (i.e., HEMGENIX) are billed as 1 EA per package when the total volume and/or number of vials varies from lot-to-lot within the assigned identifier

• Agreement of an assignment of BU = EA per section 5.1.7 of the BUS with a package size of 1 for the outer NDC number

WG Discussion (11/07/24):

• A motion was made and seconded to classify the BU = EA per section 5.1.7 of the BUS with a package size of 1 EA for the outer package NDC number. The motion carried.