Standards QUIC Form Resolutions

At the February 2023 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Etranacogene dezaparvovec is a variable volume, variable vial, patient specific Kit. ETRANACOGENE is a single-outpatient infused dose (FIX-PADUA), adeno-associated virus (AAV) gene therapy for Factor IX deficient patients. Once the dose is prescribed, the outer carton/artwork will be printed with the patient specific variable vial dosing, patient information and NDC number that would be associated with that patient specific dosing information. There will be at least 38 different OUTER NDC strength range dosing options. 
Why Needed:
The final package size will not be easily determined due to the variable vial volumes, variable dosing options and at least 38 different NDC configurations. Additionally, the artwork files (outer carton) will be patient specific printed and filled with the final prescribed dose.
Outcome Anticipated:
We are anticipating a 1 (Each) designation for each OUTER NDC carton that contains the variable volume vials and the patient specific single outpatient infused variable doses (vials) per Section 5.1.7 of the BUS. Products derived from biologic sources where the strength or the volume is variable from lot to lot shall be billed as “1” each. In the case where strength varies from lot-to-lot, the number of strength units shall be the package size. In the case where volume varies from lot-to-lot and the strength remains constant, the billing unit shall be “1” each per packaged product.
Task Group Discussion (11/29/22):

• The artwork appears generic this is because once the physician has identified the patients factor IX deficiencies the amount of HEMGENIX® the patient needs are determined then that prescription goes to the specialty pharmacy and they will print the NDC, patient name and dose on the carton
  • Each carton is printed patient specific that is why the label looks like it is in draft or not complete
• The PI says there will be 38 NDC versions for clarification is this based on the number of vials that get dispensed?
  • This is determined by the number of vials that get dispensed and the strength and ranges
    • The minimum dispensed will be 10 vials and the maximum will be 48 vials dispensed
    • In the future there may be additional NDC numbers added
• The emphasis appears to be on the outer NDC will there be inner NDCs?
  • There is an inner NDC number per FDA requirements the NDC will not be loaded separately because the inner NDC volume is variable from lot to lot and the kits may contain different drug product lot numbers
• Each vial contains an extractable volume of no less than 10 mL is the additional volume considered overfill?
  • There cannot be less than 10 mL extracted, more can be extracted depending on the lot and quantity within it
  • Because of the number of vials in the variable strength there will be occurrences where you will have multiple lot numbers in any outer NDC number configuration therefore the appearance of some of the vials may look greater than others
• There is only one specialty pharmacy that will be dispensing this treatment
  • This product is intended to be a single infusion with no additional doses
• Agreement of each NDC as a kit with a BU assignment of 1 EA per section 5.1.7 of the BUS

WG Discussion (02/02/23):
A motion was made and seconded to classify the BU=EA per section 5.1.7 of the BUS with a package quantity of 1 due to the variable strength per single-dose unit.
 

At the February 2023 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Eli Lilly and Company (Lilly) requests NCPDP’s assistance to determine consistent and accurate billing for a forthcoming refill kit containing various diabetes supplies. Lilly would like to confirm that NCPDP’s “kit” definition would be applied to their soon-to-launch product. Lilly also requests insight on the billing quantity that would be assigned. 
The Refill Kit is expected to contain the following:
100 blood glucose test strips
100 pen needles
100 lancets
2 gauze pads
Lilly’s refill kit is not meant to be broken; the pharmacy is to dispense the package as is. The refill kit does not contain a blood glucose meter.
Why Needed:
The request is needed to ensure that a consistent and accurate billing unit and quantity are submitted to the drug pricing compendia providers at the time of product launch. Lilly wishes to avoid pharmacy and payer confusion as it relates to the dispense quantity for the refill kit.
Outcome Anticipated:
The Billing Unit Standard 5.5.1 states that “Kits are defined as products that contain one of the following:
1) at least two distinct items with different billing units
2) one product packaged with medicated or unmedicated swabs, wipes and/or cotton swabs/balls
3) meters packaged with test strips”
Lilly anticipates that the Refill Kit meets NCPDP’s definition of a kit and that NCPDP will confirm that a quantity and billing unit of “1 each” is appropriate.
Task Group Discussion (11/29/22):

• The kit contains 100 test strips, 100 pen needles, 100 lancets and 2 gauze pads it is not intended to be broken and the pharmacy is to dispense it as is
  • A glucose meter is not included in this package
  • Eli Lilly has included gauze pads in the packaging therefore per section 5.5.1 of the BUS this makes the product a kit
• This is a refill kit that will be used with the Tempo system
  • A Tempo kit was released without the gauze pads and that package is billed as 300 each
    • The new kit will be revised with a new NDC number
  • Eli Lilly recently submitted an NDC with lancets, pen needles and test strip and no gauze pads are included this package is billed as 300 EA, is this product related?
    • Eli Lilly confirmed that this is a refill kit intended to be used with Tempo smart system which includes insulin
      • This is a revised kit that will be listed as a new product with a new NDC on the kit
      • The package currently marketed with a BU of 300 EA will be revised with a new NDC to avoid confusion
• Agreement of a kit with a BU assignment of 1 EA per section 5.5.1 of the BUS.

WG Discussion (02/02/23):
A motion was made and seconded to classify the BU=EA per section 5.5.1 of the BUS with a package quantity of 1 due to the gauze pads included in the package for the Tempo™ Refill Kit.
 

At the November 2022 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
Request: 
According to the NCPDP Billing Unit Standard, Section 7.11, Antihemophilic Products are to be billed as an Each based on the number of micrograms or units dispensed.  The packaging for Sevenfact includes a vial with powder to be reconstituted, a syringe with Sterile Water for Injection as the diluent and a vial adapter.
Why Needed:
Clarification is needed to determine if Sevenfact is to be billed based on the number of micrograms dispensed or as 1 EA for each NDC dispensed..
Outcome Anticipated:
Determine the quantity dispensed for a prescription for Sevenfact and determine if a Frequently Asked Question (FAQ) is needed for this product for the WG2 Billing Unit Standard Document.
Task Group Discussion (08/23/22):

• Clarification of the Billing Unit Standard was needed to determine if Sevenfact is to be billed based on the number of micrograms dispensed or as 1 each (EA) for each NDC dispensed.
• The task group reviewed sections 5.1.7 and 4.2.1 of the billing unit standard and FAQ 7.11 and agreed that Sevenfact be billed as 1 each per section 4.2.1 of the BUS.
  • Sevenfact is a lyophilized powder for reconstitution in a single use vial
• The task group recommendation is to continue to list Sevenfact as 1 each per section 4.2.1 of the BUS.
• No changes or updates needed to the BUS.

Task Group Discussion (10/04/22):

• Sevenfact is to be billed as the number of micrograms (mcg) dispensed where 1 mcg = 1 each per section 5.1.7. This is similar to “Alpha-1 proteinase inhibitors (such as Prolastin) are billed as an each using the number of MILLIGRAMS dispensed (each; 1 MG = 1 EA)”. The same will be true for the antihemophilic products using micrograms (each; 1 MCG = 1 EA). Section 5.1.7 will be updated to include an example of antihemophilic products.
• Additionally, BUS FAQ 7.11 was reviewed “To ensure correct reimbursement and consistency among antihemophilic products, the price per unit has been identified per unit, international unit, or mcg. The billing unit for antihemophilic products is “EA,” as in the number of micrograms or units not as in the number of “kits.”  The billing unit is each (EA). The package size is “1” and the quantity dispensed/billed is the number of units or mcg dispensed”.
• The task group recommendation is to list the SevenFact as 1 microgram equals 1 each per BUS section 5.1.7 and FAQ 7.11.

WG Discussion (11/03/22):
A motion was made and seconded to classify the BU = EA and the quantity of 1 x the number micrograms dispensed per 5.1.7 and FAQ 7.11 of the Billing Unit Standard.
 

At the August 2022 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Verrica requests NCPDP’s assistance to determine consistent and accurate billing for the single use applicator that is applied to Molluscum Contagiosum lesions. Cantharidin is a Blistering Agent that is applied to the Molluscum Contagiosum lesions and contains a dye marker to aid in physician application. This pre-filled, single use applicator contains less than 1 mL but parts of the labeling are identified as 0.45 mL. We believe that the Compendia may identify this as a package size of 1 and billing unit of EACH but would like to confirm. 
Why Needed:
The artwork files identify the quantity as 0.47 ml, but the Billing Unit Standard (BUS) identifies products that contain less than one ML as each. This request is needed because the labeling would conflict with the anticipated outcome of the NCPDP BUS.
Outcome Anticipated:
The Billing Unit Standard identifies products that contain less than one ML as each, and a package size of 1. (5.2.1) + (5.1.12) Unit-Of-Use package/self-contained single dose packages that contain less than 1 mL or GRAM should be billed as “One EACH”.
Task Group Discussion (05/17/22):

• Agreement of a BU assignment of 1 EA x the number of single dose applicators supplied in the package per 5.2.1 and 5.1.12 of the BUS
  • Quantity will be 1 each on the single dose/unit-of-use applicator NDC 71349-070-01
  • Each applicator contains approximately 0.45mL cantharidin solution
  • Quantity for package 71349-070-06 will be 6 each
  • The package contains 6 single dose applicators and 2 break tools
  • Quantity for package 71349-070-12 will be 12 each
  • The package contains 12 single dose applicators and 2 break tools
  • The break tools will be ignored and not counted in the package count for billing purposes
  • The break tool is a proprietary tool for this product and is not useful for anything other than the administration of cantharidin solution
  • Verrica is correct in saying products that contain less than one mL and are unit-of-use self-contained single dose packages should be billed as 1 each per sections 5.2.1 and 5.1.12 of the billing unit standard 

WG Discussion (08/04/22):
A motion was made and seconded to classify the BU 1 EA x the number of single dose applicators supplied in the package per 5.2.1 and 5.1.12 of the BUS

At the February 2022 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Eli Lilly and Company (Lilly) requests NCPDP’s assistance to determine consistent and accurate billing for a forthcoming Refill Kit for diabetes supplies. Lilly would like to confirm that NCPDP’s kit definition would be applied to their Refill Kit and also requests insight on the billing quantity that would be assigned. The Refill Kit is expected to contain 100 test strips, 100 pen needles and 100 lancets.  Lilly’s Refill Kit is not meant to be broken; the pharmacy is to dispense the package as is.
Of note, Lilly also plans to simultaneously launch a diabetes supply Starter Kit. The Starter Kit will contain a blood glucose meter, digital device product, test strips, lancets, pen needles, a lancing device, and a welcome letter. 
Why Needed:
The request is needed to ensure that a consistent and accurate billing unit and quantity are submitted to the drug pricing compendia providers at the time of product launch. Lilly wishes to avoid pharmacy, provider and payer confusion as it relates to the dispense quantity for the Refill Kit and wants to be assured that the Starter Kit and Refill kit can be prescribed in a consistent manner, i.e., both as “1 each”.  Because this combination of diabetes testing supplies has rarely been packaged together into a single kit for listing in the drug pricing compendia, Lilly found few product analogues to use as comparators. Lilly also seeks any recommendations that will help prevent confusion for NCPDP members, industry stakeholders, and patients.
Outcome Anticipated:
Lilly anticipates that each Refill Kit will be billed as “1 each”.  
It is anticipated that NCPDP can also confirm that the Starter Kit will be billed as a “1 each”, meeting NCPDP’s definition of a kit.
Task Group Discussion (11/30/21):

• Agreement of a BU assignment of 300 each on the “refill kit” per 5.1.6 and 5.1.18 of the BUS
  • Individually each of these products are billed as each.
  • Needles and lancets are the product and not to be ignored in the package count.
  • Lilly is correct in saying that the “starter kit” is 1 each as per 5.5.1 of the BUS.

WG Discussion (02/02/22):
A motion was made and seconded to classify the BU = EA per 5.1.6 and 5.1.18 of the BUS with a package size of 300.
 

At the November 2021 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Enzyvant Therapeutics, Inc. is requesting clarification to ensure accuracy in billing amongst all Compendia, we are seeking NCPDP review Allogeneic Processed Thymus Tissue-AGDC is a biological source and the strengths are variable (5.1.7 – Billed as Each).
Why Needed:
Not all Thymic tissues may be used, and they are provided with sponges and filter screens we have a kit type scenario (5.5.1 – Billed as Each).
Outcome Anticipated:
Because both segments of the Billing Unit Standard equal EACH, we anticipate the outcome to reflect the billing unit of each and a package size of 1.
Task Group Discussion (10/19/21):

• Agreement of the assignment of BU = EA per section 5.1.7 of the BUS with a package quantity of 1 due to the variable strength, single-dose unit (72359-001-01).
  • RETHYMIC® is the first of its kind; one of the first regenerative therapies in that division.
  • Product is only available from one source (a surgery center) and is not available to wholesale, retail or specialty channels and is sent directly to the surgery center.
  • RETHYMIC® is single patient use.
  • Patient type is pediatric who are born without a thymus and is indicated for immune reconstitution of patients with congenital athymia.
  • This product is processed thymus tissue from healthy infants that have a cardiac surgery. Portions of the thymus gland is processed, and the tissue is stretched on filters and placed on sponges which are an inactive ingredient but are needed to process the tissue.
  • Each package contains a single NDC number that will encompass multiple slices per polystyrene dish which contains the filters and the sponges in a single-dose unit.
  • The sponges contain fetal bovine serum that helps in processing of the allogeneic tissue
  • The components are only for the processing of the product and are not used for the administration.
  • The product is already available and converting from clinical trial to approval.

WG Discussion (11/05/21):
A motion was made and seconded to classify the BU = EA per 5.1.7 of the BUS with a package size of 1 (72359-001-01).
 

At the August 2021 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
JAZZ Pharmaceuticals is requesting confirmation from the NCPDP Billing Unit Standard that this product’s unit of measure (UOM) would be units per mL and to allow the NCPDP members to comment on the packaging label attached. Also attached is the RYLAZE™ package insert.

Why Needed:
This request is needed to confirm the billing unit standard. RYLAZE™’s has one carton containing 3 single dose vials. Each single dose vial contains 10 mg/0.5 mL asparaginase erwinia chrysanthemi (recombinant)-rywn. When replacing a long-acting asparaginase product, the recommended dosage of RYLAZE™ is 25 mg/m² administered intramuscularly every 48 hours.
Outcome Anticipated:
Jazz anticipates a BU= mL. This anticipated outcome is based on Section 5.2.2 (Dosage Forms Billed as “Milliliters) of the Billing Unit Standard.
Task Group Discussion (07/13/21):
Agreement of an assignment of BU = ML per 5.2.2 of BUS with a package size of .5 x number of vials dispensed. 1.5 mL for 3 vials (68727-900-03).
WG Discussion (08/04/21):
A motion was made and seconded to classify the BU = ML per 5.2.2 of BUS with a package size of .5 x number of vials dispensed. 1.5 mL for 3 vials (68727-900-03).

At the May 2021 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
Request: 
Takeda Pharmaceuticals is requesting confirmation from the NCPDP Billing Unit Standard on this product’s unit of measure would be ml. In addition, Takeda would welcome any additional considerations that should be taken for this packaging format.

• 1 Carton (64764-105-60) contains #60 Single-dose stick packs (64764-105-10)
• Artwork of the Carton and Single-dose stick packs have been included with submission

Why Needed:
Takeda anticipates a PDUFA sometime in April with product launch taking place shortly thereafter. Takeda would like to confirm the proper billing unit for this product and be advised of any recommended action that will help prevent confusion for NCPDP members, industry partners, and patients.
Outcome Anticipated:
Takeda anticipates a BU = ml which would mean one Carton has a billing unit quantity of 600 ml and one Single-dose stick pack has a billing unit quantity of 10 ml
Task Group Discussion (03/09/21):
Agreement of an assignment of BU = ML per 4.2.2 and 5.2.1 of the BUS with a package size of 10ml (64764-105-10) or 600ml (64764-105-60).
WG Discussion (05/03/21):
A motion was made and seconded to classify the BU = ML per 4.2.2 and 5.2.1 of the BUS with a package size of 10ml (64764-105-10) or 600ml (64764-105-60).