At the August 2019 WG2 meeting the form was discussed.
Requested: New Product/Package Information
Request:
Xeris is hoping for FDA Approval of two drug candidates that are under review with a PDUFA date of June 10th. The drug candidates are both Glucagon for treatment of severe hypoglycemia – a rescue drug. One is Glucagon HypoPen for single use Injection via an auto-injector and the other is Glucagon Pre-Filled Syringe for single use Injection via prefilled syringe. All current Glucagon for Injection products that are currently on the market carry a billing unit of EA and we’d like the same for our product once approved.
|
Why Needed:
Glucagon is a rescue drug for treatment of severe hypoglycemia. To avoid industry confusion and billing errors across payers and to achieve prescriber parity, we request that Xeris drug candidates, when approved, carry the same billing unit of EA like all other Glucagon for Injection products.
|
Anticipated Outcome:
Xeris Glucagon billing units expressed in EA which is uniform with all current Glucagon for single use Injection products marketed by Novo Nordisk, Eli Lilly, and Fresenius Kabi. Also, the Glucagon for Injection via Auto-Injector administration device is comparable to the EpiPen which carries a billing unit of EA. There are no other components in the package to constitute a kit and it cannot be broken apart by a pharmacist.
|
TG Discussion (6/11/19):
* 0
.5mg is for pediatric (0.1mL); 1mg is for adults (0.2mL)
* Per section 5.2.2; Injectables that are liquid-filled vials, including multi-chamber products, ampoules, and syringes must be billed as the total number of milliliters (ML) dispensed. If multi-chambered vials with both components are liquid, the billing unit is the sum of the milliliters of the product. If a manufacturer has labeled a product for the quantity to dispense (i.e. excluding the overfill), the reported quantity for dispensing should be total number of milliliters. See section ‘Frequently Asked Questions”, question 7.28 and 7.34. NOTE: if the product is derived from a biologic source and has
a variable volume, see section 5.1.7.
* Other glucagon products are listed as one each because they are comprise of lyophilic powders, whereas this product is not.
* Manufacturer believes that there may be confusion since this is the first glucagon product listed as mL. Compendia and payers can work together to communicate this information to the industry so the pharmacies know to submit the correct billing unit.
* TG agrees that in order to ensure consistency, the NCPDP Billing Unit for this product should be listed as mL per section 5.2.2. (0.1mL for 0.5mg and 0.2mL for 1mg)
WG Discussion (8/8/19):
At this meeting, a motion was made and seconded to classify this product with a BU=mL per section 5.2.2. (0.1mL for 0.5mg and 0.2mL for 1mg respectively).