Standards QUIC Form Resolutions

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 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.

At the November 2024 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
The product discussed in this QUIC form is a tubeless disposable insulin patch pump.  The device sticks to the patient’s skin.  The device connects via Bluetooth to a CGM (i.e. Dexcom G7/Abbott Libre 3+) as well as the patient’s phone.  The device uses the continuous glucose monitoring data via an algorithm to dose small amounts of insulin about every 5 minutes to the patient when needed.  The device monitors and treats the patient’s diabetes/ diabetes information and transmits the data to the patient’s smart phone.
 
The Beta Bionics patch system will consist of 2 pieces. One piece will last 1-year and contain various components of the system including the drivetrain, etc. (a drive train transfers power from an engine to something, in this case an insulin dosing apparatus). This 1-year piece will attach to the second piece of the system which mostly consists of the insulin bladder. The patient experience will be application of the insulin bladder to the skin and then sliding on the 1-year piece which clicks and locks in place.  After 3 days, the patient will remove the combined “patch”, pull apart the two components, and repeat with the same 1-year component and a new bladder. No where on the patch will the patient be able to see any data. The patch will connect to a patient’s smart phone and the data and manipulation of the patch will occur through the Beta Bionics developed app.
 
Within the Refill Kit, a patient will receive the following:
10x insulin bladders
10x needles
10x syringes
 
Question #1:  please confirm that under this configuration, the quantity would be 30 (thirty). We are trying to avoid this, so see question #2.
 
Question #2: To make this a quantity of 1 (one), if we would also add 10 alcohol swabs to the device, would it be a quantity of 1 (one) or would it then be 40 (forty)?
 
Please compare to Omnipod (Insulet) and Twiist (Sequel).
Outcome Anticipated:
We are seeking the committee’s guidance on what configuration would qualify the Beta Bionics Patch Refill Kit to be a quantity of 1 (one).  Therefore, depending on if a patient changes the patch every 2 or 3 days, the pharmacy would dispense 2 or 3 packs to obtain a 30 day supply.
Task Group Discussion Task Group Discussion (10/15/24):
Configuration/Question #1
10x insulin bladders
10x needles
10x syringes
 
BU Assignment of EA
Package Size = 30
Reasoning: Does not meet the definition of kit per 5.5.1. Consequently, section 5.1.6 (“Non-drug entities, such as test strips, swabs or alcohol wipes, are billed as eaches, and the quantity is the actual number in the container” and FAQ 7.41 (“non-drug” entities are not intended to exhibit a therapeutic effect on their own) apply. The contents of the refill kit are considered non-drug entities and do not have a therapeutic effect independently.
 
Configuration/Question #2
10x insulin bladders
10x needles
10x syringes
10x alcohol swabs
 
BU Assignment of EA
Package Size = 40
Reasoning: Does not meet the definition of kit per 5.5.1. Consequently, section 5.1.6 (“Non-drug entities, such as test strips, swabs or alcohol wipes, are billed as eaches, and the quantity is the actual number in the container”) and FAQ 7.41 (“non-drug” entities are not intended to exhibit a therapeutic effect on their own) apply. The contents of the refill kit are considered non-drug entities and do not have a therapeutic effect independently. Nothing in the refill kit that the alcohol swabs are accompanying has a therapeutic effect. The simple addition of an alcohol swab doesn’t make it a kit if nothing else in the package has a therapeutic effect.
 
Support was expressed for the proposed assignments for the two different configurations. No opposition stated.
 
The BU and package assignment is based upon the information presented in the QUIC form. If any changes are made to the product that do not align with the information in the QUIC form, then the BU and package size assignment may no longer apply.
WG Discussion (11/07/24):
A motion was made and seconded to classify the BU = EA per section 5.1.6 and FAQ 7.41 of the BUS with a package size of 30 EA or 40 EA depending on the configuration of the package. The BU and package assignment is based upon the information presented in the QUIC form. The motion carried.

At the November 2024 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
The product discussed in this QUIC form is a tubeless disposable insulin patch pump. The device sticks to the patient’s skin. The device connects via Bluetooth to a CGM (i.e. Dexcom G7/Abbott Libre 3+) as well as the patient’s phone.  The device uses the continuous glucose monitoring data via an algorithm to dose small amounts of insulin about every 5 minutes to the patient when needed.  The device monitors and treats the patient’s diabetes/ diabetes information and transmits the data to the patient’s smart phone.
 
The Beta Bionics patch system will consist of 2 pieces. One piece will last 1-year and contain various components of the system including the drivetrain, etc. (a drivetrain transfers power from an engine to something, in this case an insulin dosing apparatus). This 1-year piece will attach to the second piece of the system which mostly consists of the insulin bladder. The patient experience will be application of the insulin bladder to the skin and then sliding on the 1-year piece which clicks and locks in place.  After 3 days, the patient will remove the combined “patch”, pull apart the two components, and repeat with the same 1-year component and a new bladder. No where on the patch will the patient be able to see any data. The patch will connect to a patient’s smart phone and the data and manipulation of the patch will occur through the Beta Bionics developed app.
 
Within the Intro Kit, a patient will receive the following:
1x 1-year reusable piece
10x insulin bladders
10x needles
10x syringes
Question #1:  please confirm that under this configuration, the quantity would be 1 (one) because the 1-year piece acts as the monitor for the device by monitoring the status and relaying that information to the patient’s smart phone.
 
Question #2: If this is not a quantity of 1 (one) and is instead a quantity of 31 (thirty-one), if we would also add 10 alcohol swabs to the device, would it be a quantity of 1 (one) or would it then be 41 (forty one)?
 
Please compare to Omnipod (Insulet) and Twiist (Sequel).
Outcome Anticipated:
We are seeking the committee’s guidance on what configuration would qualify the Beta Bionics Patch Intro Kit to be a quantity of 1 (one).
Task Group Discussion Task Group Discussion (10/01/24):

• This product is an insulin pump in the form of a patch and there is no long-term durable component to the product
  • There are 2 parts to the product, the bladder where the insulin goes (lasts for 3 to 4 days) and a more durable piece that the bladder clicks into (can last for up to a year)
  • The first time a patient fills the prescription they would get an introduction kit which contains the hardware which has a battery powered drivetrain (there are no buttons or screens), 10 bladders, 10 needles, and 10 syringes. (31 components)
    • The refill kit contains 5 needles, 5 syringes, and 5 bladders. (15 components)
  • If alcohol swabs were added to the packages, would it be considered a kit with a package size of 1?
• There were two new terms introduced and not understood which are causing confusion
  • Drivetrain
    • The drivetrain has an adhesive and sticks to the body (patch insulin pump)
    • The drivetrain is the transmitter that will communicate the information via Bluetooth to the application on the patient’s smartphone
      • There are no screens on the device itself
        • Data is projected to the connected Bluetooth device
      • The patient will need to have a Libre or Dexcom because the device uses the information from the glucose monitor to dose the insulin
      • The drivetrain’s application will provide how much insulin is delivered, what the CGM (Continuous Glucose Monitoring) rating is, and other information to the Bluetooth connected device
      • Everything is done through the application such as a announcing meals, suspending insulin, putting in exercise mode, etc.
      • There is no separate hardware piece that displays information
        • The information is only supplied through the connected device
      • The device is a digital therapeutic that transmits the information to the patient’s phone
  • Bladder (empty)
    • The bladder Is where the medication is stored and the patient fills this with the insulin they are taking
    • Bladders last about three days
• For a product to be considered a kit it must come with a drug or therapeutic device (such as a glucose monitoring device) adding alcohol swabs does not make supplies a kit.
  • Why does the Sequel Twiist™ have a quantity of 1 for the starter kit and refill kits? (QF 202308 Twiist™ Infusion Pump starter and refill kits)
    • The decision was made under the assumption that if the product contained alcohol pads it was automatically a kit
  • Review decision on Omnipod Introduction Kits (Package Size Verification list)
• The task group will need to review the analog products before making a decision
  • The task group will continue the discussion on the next call 10/15/2024.

 
After the task group meeting on 10/1/24, the submitter provided an updated QUIC form and provided further changes via email. The modifications from the updated QUIC form have been incorporated by staff into the original QUIC form and shown with tracked changes.
 
10/15/2024 Notes
Configuration Option/Question #1
1x 1-year reusable piece
10x insulin bladders
10x needles
10x syringes
 
BU Assignment of EA
Package Size = 1
Reasoning: Qualifies as kit and 1 EA per BUS 5.5.1 #3 (meters packaged with test trips); the reusable piece considered to be the meter.
 
Configuration Option/Question #2
1x 1-year reusable piece
10x insulin bladders
10x needles
10x syringes
10 alcohol swabs
 
BU Assignment of EA
Package Size = 1
Reasoning: Qualifies as kit and 1 EA per BUS 5.5.1 #3 (meters packaged with test trips); the reusable piece considered to be the meter.
 
Support was expressed for the proposed assignments for the two different configurations. No opposition stated.
 
The BU and package assignment is based upon the information presented in the QUIC form. If any changes are made to the product that do not align with the information in the QUIC form, then the BU and package size assignment may no longer apply.
WG Discussion (11/07/24):
A motion was made and seconded to classify the BU = EA per section 5.5.1 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:
UGN-102 is supplied as a carton (kit) containing two inner NDCs that are mixed together prior to administration: -Two 40 mg (each) single-dose vials of mitomycin supplied as a sterile, lyophilized cake or powder. (NDC 72493-104-40) -One 60 mL single-dose vial of sterile hydrogel supplied as a sterile, clear, colorless gel to be used as a vehicle for reconstitution. (NDC 72493-105-60). As there are multiple items in the UGN-102 package, this is considered a kit, and the outer (NDC 72493-106-03). UGN-102 is the only commercially available product. UGN-102 is intended to be dispensed as a complete carton as described in the Instructions for Pharmacy (IFP) and Prescribing Information (PI).
Why Needed:
Determine NCPDP’s definition of a unit.  UGN-102 will be packaged and sold as a kit. The internal contents cannot be broken out and sold separately from the kit carton.  This is very similar to Jelmyto where NCPDP defined a unit as a kit.
Avoid payer and compendia confusion regarding product units as we experienced during the launch of Jelmyto.
Outcome Anticipated:
The expected outcome is to have a unit of UGN-102 defined as a unit of 1, (kit).
Task Group Discussion Task Group Discussion (09/17/24):

• This product is similar to Jelmyto which was adjudicated in 2020 with a BU = EA and a package size of 1 per 5.5.1 of the BUS.
  • Are there any notable differences from the Jelmyto other than the size of hydrogel vial?
    • The reverse thermal gel is 60mL for the UGN-102 and is 20mL for the Jelmyto, there are no other differences.
• This product cannot be diluted with anything other than the reverse thermal gel.
  • The gel becomes liquid when it is chilled and becomes semi-solid when injected and warms up to body temperature at the tumor site.
• The hydrogel vehicle is used for the installation and release of the mitomycin and was considered as an inactive component of the dilution process.
  • This process allows for longer absorption and greater clinical benefit. This would not occur without the hydrogel.
• From QF 202005 Jelmyto
  • What was perceived to be diluent (hydrogel) and discounted is actually a clinical component as the product won’t work without it.
• Agreement of an assignment of BU = EA per section 5.5.1 and FAQ 7.49 with a package size of 1 for NDC 72493-106-03.

WG Discussion (11/07/24):

• A motion was made and seconded to classify the BU = EA per section 5.5.1 and FAQ 7.49 with a package size of 1 EA. The motion carried.

At the November 2024 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request:
Beta Bionics is commercializing starter kits for the iLet Bionic Pancreas product line.  These starter kits will augment our stand-alone products currently commercialized.  Within this request I will only discuss one of the 3 kits as the other two will follow the same quantity logic.
Why Needed:
Background which is germane to the current discussion.  In ~ June 2023, I presented to this work group about what was then Beta Bionic’s newly cleared insulin delivery device.  The automated insulin delivery system (AID) which I will call a pump for short, was straight forward as a quantity of 1.  This product is on the market under 11-digit billing number (NDC like) 50050-0001-01.  Conversely, the monthly supplies were not as straight forward.  Where our discussion landed was that since the monthly supply “kit” had 10 units each of 5 items (cartridge, adapter, needle, syringe, infusion set), the quantity was 10 x 5 = 50.  Hence, if you look at 50050-0100-10, you will see a quantity of 50.
 
To update our product line congruent with requests from several of our payers, we are commercializing starter kits which combine the pump with the 1st month of supplies.  Specifically, there will a total of 51 items in the “kit”:   1x pump, 10x cartridges, 10x adapters, 10x needles, 10x syringes, 10x infusion sets
 
Our question is:  Do we have to continue the logic and have the quantity for the starter kit be 51? Or can we call this starter kit 1?  We prefer to use the quantity = 1 as we will be more straight forward to providers and patients.
 
Two similar situations in the industry are as follows:
 
1)  Insulet’s Omnipod® system.  For the Omnipod® 5 G6 Pods, the quantity per box = 5, however the
 Omnipod® 5 G6 Intro Kit, which contains a handheld PDM + the 5 pods = quantity 1
 
2) Sequel’s Twiist™ system.  The Twiist™ refill kit = quantity 1.  Likewise, the Twiist™ Starter Kit, which contains their durable insulin pump + their consumable components = quantity 1.
Outcome Anticipated:
We are seeking the committee’s guidance on whether our Inset start kit is a quantity of 1 or 51.  We would like the quantity to be 1 as that is in alignment with Insulet/Sequel products and, we believe, more understandable for providers and patients.
Task Group Discussion Task Group Discussion (09/03/24):

• Mark Hopman was on the call to review the QUIC Form and discussed the various products that will be available in the future that will follow suit with today’s decision.
• In July for 2023 the task group reviewed QF 202307 iLet Infusion kits which contained only supplies (the insulin pump was not included in these kits).
  • Agreement of a BU = EA with the package size being the total number of ConvaTec Inset, cartridges, needles, syringes, and adaptors contained in each package.
    • At the November 2023 Work Group there was agreement with the decision to count every item in the package.
• Payers, specifically Medicaid, have asked Beta Bionics to follow suit with what Insulet has done in the market with the Omnipod® product line which includes an insulin pump and the first month of supplies.
  • In this iLet Starter kit there is an insulin pump which is a quantity of 1 and the supplies which are a quantity of 50.
    • Due to the inclusion of the insulin pump is this package considered a kit with a package size of 1 or are the monthly supplies counted along with the insulin pump to create a package size of 51 without a kit designation?
• For the Omnipod® systems insulin pump (hardware) was added to the supplies, and it was considered a kit with a package size of 1 by the listing compendia.
  • It would be a little confusing if the iLet packages did not follow the same direction
• Sequel’s Twiist™ system which contains the refill kit, and their durable insulin pump is also listed as 1 EA.
• There was not a QUIC Form submitted for Omnipod® 5 however there was a QUIC Form submitted for the Sequel Twiist™ System (QF 202308).
  • For the Twiist™ Systems the package size of 1 was agreed on for both the starter kits and refill kits.
    • The refill kits were given a package size of 1 because they were supplied with alcohol pads
  • The Omnipod® contains a controller (referred to as a meter or Personal Diabetes Manager (PDM)), so it was assigned a package size of 1
    • This package doesn’t contain alcohol swabs.
• The Billing Unit Standard does not address any products which contain insulin pumps
  • BUS 5.5.1 defines a kit as meters packaged with test strips. Would this apply to an insulin pump packaged with supplies?
    • Is an insulin pump a delivery device which is an exception and should be ignored for purposes of billing or is an insulin pump more like a meter?
      • If it is considered a delivery device all items in the package should be counted.
      • The task group is leaning towards a package size of 51 per BUS 5.1.18 supported by FAQ 7.41 counting all the supplies and the insulin pump.
      • Per FAQ 7.41 all entities such as test strips, swabs, wipes etc., are billed as EA and the quantity is the actual number in the container/package.
      • Since there is no product in this package per BUS 5.5.1 all the items should be counted.
        • The task group will need to review the BUS to more clearly define what a product is in section 5.5.1 number 2.
• If a decision is made to change the Omnipod® products it would be a massive change because this product line is widely used.
  • These products are becoming very popular and evolving quickly, the task group needs to review and add these types of devices/products to the BUS for consistency among the compendia.
• The task group voted on the package size for the iLet Starter Kit Inset™ and 10 of the 20 participants voted for a package size of 51. The others did not vote.
  •  Agreement of an assignment of BU = EA per section 5.1.18 and FAQ 7.41 with a package size of 51 for each iLet starter kit.

 
September 17, 2024, Notes:

• On 04/05/2022 Omnipod 5 and Omnipod Dash Intro Kits were reviewed by the task group, and the decision was made to classify each kit with a BU = EA and a package size 1 EA.
  • This decision was made due to Omnipod’s controller which monitors glucose levels.
• Initially the task group thought the iLet Starter Kit Inset™ was only an insulin pump, after further review it was determined that this product also contains a continuing glucose monitoring device, which was not apparent during the original discussion.
  • iLet Starter Kit Inset™ monitors glucose levels automatically with an integrated continues glucose monitor transmitter when online, if offline information is stored.
• After further review the task group determined an assignment of BU = EA per section 5.5.1 of the BUS with a package size of 1 for each iLet Starter Kit Inset™.

WG Discussion (11/07/24):

• A motion was made and seconded to classify the BU = EA per section 5.5.1 of the BUS with a package size of 1 for each iLet Starter Kit Inset™. The motion carried.

At the August 2024 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard and New Product/Package Information
Request: 
Galderma is seeking FDA approval for a single dose dual-chamber auto-injector. This dual-chamber is comprised of 1 chamber being liquid filled diluent and the other powder filled (medicine). After the two chambers are mixed/dissolved, the product will have a strength of 30mg/0.49mL
Why Needed:
Anticipating confusion with the billing unit and package size. 1, EACH vs. 0.49mL. In an effort to ensure accuracy of addition to all Compendia databases upon approval and ensuring that the promotional materials are accurately depicting the package size and dosage form we are seeking NPCPD review.
Outcome Anticipated:
Package Size 1, Billing Unit EACH per 5.1.2 Injectable powder-filled vials and multi-component containers (i.e. mix-o-vial with solution and powder within the vial) are billed as a unit of “each” regardless of size or content of vial in metric decimal units.
Task Group Discussion Task Group Discussion (07/23/24):

• The task group reviewed 5.1.2 and 5.2.2 of the BUS.
  • The task group feels that 5.2.2 applies to only liquid products in multi-chambers
  • 5.1.2 references multi-component vials billed as a unit of "each" regardless of size or content of vial in metric decimal units.
    • Solu-Cortef Sterile NDC 0009-0016-12 is a similar product in a vial and is listed as 1 each.
    • Caverject Impulse is a single-dose, dual chamber syringe system. The system includes a cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile water for reconstitution in the rear chamber. This product is similar to the Galderma product and is listed as 1 EA.
• Agreement of an assignment of BU = EA per section 5.1.2 of the BUS with a package size of 1 EA.

WG Discussion (08/08/24):

• A motion was made and seconded to classify the BU = EA per section 5.1.2 of the BUS with a package size of 1 EA. The motion carried.

At the August 2024 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
Request: 
This is a 2ml final volume injection, so the question of whether we should be submitting a quantity of 2ml rather than 1 kit has arisen. Seeking clarification on the matter.
Why Needed:
To clarify if we are billing this product accurately.
Outcome Anticipated:
These are classified as kits so I would think the unit to be used is EA. Quantity 1 kit for a 14 day supply, 2 for a 28 day supply etc.
Task Group Discussion Task Group Discussion (05/28/24):

• Risperidone ER Injection doesn’t fit the NCPDP definition of a “kit” although kit is referenced in the labels.
• The product is a powder for suspension so according to 5.1.2 of the BUS this product would be classified as each and not the final volume once reconstituted (which is not stated on any the labels).
  • Since the final volume cannot be determined per section 5.1.17 of the BUS it would be billed as “one each”.
• Per 5.5.1 of the BUS diluents are not used in determining the kit designation.
• Agreement of an assignment of BU = EA per 5.1.2, 5.1.17 and 5.5.1 of the BUS with a package size of 1 for NDC 00480-1232-08.

WG Discussion (08/08/24):

• A motion was made and seconded to classify the BU = EA per 5.1.2, 5.1.17 and 5.5.1 of the BUS with a package size of 1 for NDC 00480-1232-08. The motion carried.

At the May 2024 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
This request is for the Arformoterol Tartrate Inhalation Solution and LC PLUS Nebulizer be considered as a “per mL” billing unit. NCPDP committee advisement is sought to align with submissions to Compendia, CMS, etc.
We believe the co-package of Arformoterol Tartrate Inhalation Solution and LC PLUS Nebulizer does not meet the NCPDP definition of a kit per the Billing Unit Standards (BUS) and should be billed per mL. In part this is based on prior evaluation of similar circumstances (Reference QUIC Form 200909 – TYVASO, and 201306 QUIC_Form KITABIS PAK) which are commercially available and billed per mL. Attached please find a photo of all Arformoterol Tartrate Inhalation Solution and LC PLUS components. The outer carton is designed with a tamper resistant seal to prevent unauthorized access or tampering, including breaking apart the components for resale.
Arformoterol Tartrate Inhalation Solution and LC PLUS Nebulizer is marked under 2 (two) NDCs: (30 units)- 70644-210-30; NDC (60 units)- 70644-210-60, not intended to be broken for resale.. 
Why Needed:
The patient specific label printed by Pfizer states ‘QTY: 1’ to represent the single dose included in the ‘outer carton’ being shipped (See attached Outer Carton Label Example). This product is variable dosing, variable volume and variable lot packaged in a patient-specific outer carton, there will be no readily available standardized quantity or package size on the exterior packaging or in the Package Insert for pharmacy to reference (BUS 2.2B). 
 
The inner carton contains the single dose for a specific patient. It is not an ‘inner-pack’ intended to be broken for multi-use nor should the individual vials be viewed as a component NDC to be billed separately. (See, BUS 7.42)
 
Similar to Hemgenix, this is also a gene therapy product derived from biologic sources where there will be variable vials and variable doses for each patient.  This product request would align with the precedence set by the NCPDP workgroup on 2/2/23 who agreed that each Hemgenix NDC would be viewed as a ‘kit’ with a BU assignment of ‘1 EACH’ and cited BUS 5.1.7 to support that decision.
Outcome Anticipated:
All currently marketed Arformoterol Tartrate inhalation solution products 15 mcg/2mL (brand- Brovana®®, generics from Alembic, Glenmark, Lifestar, Lupin, Slate Run, Sun Pharma, Teva,) and are billed per mL. The billing of Arformoterol Tartrate Inhalation Solution and LC PLUS Nebulizer per mL would be consistent with branded and generic Arformoterol Tartrate inhalation solution products currently in the market.
Task Group Discussion Task Group Discussion (04/16/24):

• This product is similar to Kitabis™ (QF201503) which was classified with a BU = ML per BUS 5.2.1 and 5.5.1 with a package size of 280mL.
  • The same approach was agreed to by the task group.
• Agreement of an assignment of BU = ML per section 5.2.1 and 5.5.1 of the BUS with a package size of 60mL for NDC 70644-210-30 and a package size of 120mL for NDC 70644-210-60.

WG Discussion (05/06/24):
A motion was made and seconded to classify the BU = ML per section 5.2.1 and 5.5.1 of the BUS with a package size of 60mL for NDC 70644-210-30 and a package size of 120mL for NDC 70644-210-60. The motion carried.