At the February 2020 WG2 Meeting the form was discussed.
Clarification of Billing Unit Standard
New Product/Package Information
QUIC Request:
This QUIC form is being submitted to confirm the correct billing unit for CABENUVA.
The FDA PDUFA date is December 29, 2019 for CABENUVA, a 2-drug co-packaged kit consisting of extended-release injectable suspensions of cabotegravir (CAB ER) and rilpivirine (RPV ER). Each kit will include the two different medications in separate vials. CABENUVA is expected to be indicated as a complete regimen for the treatment of HIV-1 infection. Note that the labeling and packaging for CABENUVA is not yet FDA-approved.
The two injectable medications (CAB ER and RPV ER) will not be FDA-approved for individual use, nor will they be sold individually. The products are not mixed prior to injection and are co-administered as separate gluteal intramuscular injections.
The lowest saleable unit of the product will be a kit – each kit containing 1 vial of CAB ER, 1 vial of RPV ER, 2 syringes, 2 needles, 2 syringe labels, and 2 vial adaptors. See below for a mock-up of the kit.
Two dosing kits will be available to accommodate the patient’s dosing schedule:
CABENUVA 400-mg/600-mg Kit (NDC 49702-253-15) containing:
• One single-dose vial of cabotegravir extended-release injectable suspension containing 400 mg/2 mL (200 mg/mL) of cabotegravir.
• One single-dose vial of rilpivirine extended-release injectable suspension containing 600 mg/2 mL (300 mg/mL) of rilpivirine
CABENUVA 600-mg/900-mg Kit (NDC 49702-240-15) containing:
• One single-dose vial of cabotegravir extended-release injectable suspension containing 600 mg/3 mL (200 mg/mL) of cabotegravir.
• One single-dose vial of rilpivirine extended-release injectable suspension containing 900 mg/3 mL (300 mg/mL) of rilpivirine.
Why Needed:
The request is needed because CABENUVA is one of few drugs co-packaged together as separate vials to be co-administered where the individual medications are not available for sale independently nor FDA-approved for individual use.
Outcome Anticipated:
There are two possible outcomes regarding how CABENUVA can be billed.
1) The billing unit is an EACH, assigned to each of the 2 dosing kits available on the market.
2) The billing unit is mL. However, this could result in claims processing errors, as it is unclear as to whether the quantity would be 2 or 4 for the 2-mL dosing kit (or 3 or 6 for the 3-mL dosing kit). Additionally, the mg/mL value for CAB ER is different than that for RPV ER. The two injectable medications will not be FDA-approved for individual use nor sold separately, and a complete dose requires 2 injections: one injection of CAB ER and one injection of RPV ER.
Task Group Discussion (12/3/19):
The syringe labels are blank labels to be placed on the syringes so a physician can add the drug name and time.
In the mock-up, the prominent 3mL represents the volume for each molecule in the box for the CABENUVA 600-mg/900-mg Kit. It is intended to differentiate the two packages (CABENUVA 400-mg/600-mg vs CABENUVA 600-mg/900-mg).
Concern was expressed that it will be billed as 2mL or 3mL (instead of 4 or 6) because of the prominence of 3mL on the packaging and its presence on the vials.
Although this may be a kit to manufacturers, CMS or the public at large, it is not a kit per 5.5.1 of the Billing Unit Standard. The two vials have the same billing units and the needles, syringes and adapters are ignored per the BUS.
The manufacturer noted they expect the FDA label to call it a dosing kit.
CMS representative on the call confirmed that for rebate purposes it will be considered a kit. There will be a discrepancy between the NCPDP Billing Unit and the CMS rebate unit requiring a crosswalk.
It is anticipated that payers may set up edits to ensure claims are submitted with 4 or 6.
The task group provided recommendations to the manufacturer
Have regulatory department check with FDA on SPL listing of the product; may be a roadblock which could delay the launch
If there is a way to modify the packaging, recommend listing total mL administered.
Add to label that it is non-breakable to prevent splitting of the two vials
Ask the opinion of the Institute for Safe Medication Practice about how to list; they have been vocal about the combining of two products.
May be required to have separate NDCs for the two vials. If so, the outer NDCs in the QUIC form are the ones to report to the drug data compendia and to use for processing claims.
Task Group recommendation: Billing Unit of mL per Section 5.2.2 and 5.2.9 of the Billing Unit Standard. The quantity will be 4 for NDC 49702-253-15 and 6 for NDC 49702-240-15.
WG Discussion (02/06/20):
At this meeting, a motion was made and seconded to classify the BU=mL for a quantity of 4 for NDC 49702-253-15 and 6 for NDC 49702-240-15 per Section 5.2.2 and 5.2.9 of the Billing Unit Standard. The motion carried.