Standards QUIC Form Resolutions

At the February 2016 WG2 meeting the form was discussed. Requested: New Product /Package Information: Request: We are requesting a label review to ensure we are in alignment to NCPDP BUS. NAZQUE ™ is a Single Use Nasal Spray that will be found in both emergency and retail settings. Each NAZQUE ™ Sprayer contains 0.9 MG of Naloxone (less than 1 ML). 1 Dose equals 2 Inhalers. Each Carton contains x 4 inhalers (2 Doses). Why Needed: There are several ways in which this product can be interpreted for quantity and billing. A.) 1 Dose = 2 Inhalers B.) 1 Carton contains = 4 Inhalers (2 Doses) C.) 1 Each Inhaler contains Liquid (Less than 1 ML) Anticipated Outcome: Based upon the following section, we believe that Nazque ™ will have a quantity of 4 with a unit of EACH. Per 4.2.1 (Billing Unit of EACH) – Unit Of Use Packages, or self-contained single dose packages with a quantity less than 1 milliliter or gram should be billed as “one each”. For example: ointment packets of less than 1 Gram or eye drops in dropperettes that are less than 1 ML. This rule does not apply to injectable products. Discussion: This form was reviewed by the WG2 Product Review and BU Exceptions TG on their call of November 17, 2015. Alisha Nielsen of Two Labs Marketing reviewed the form and showed pictures of the container and packaging. Inhalers cannot be reused and cannot be self-administered. All agreed the BU=EACH with a quantity of 4 per Section 4.2.1 of the BUS. At this meeting, a motion was made and seconded to classify the BU=EACH with a total quantity of 4 per section 4.2.1 of the BUS. The motion carried without opposition.

At the November 2015 WG2 meeting the form was discussed. Requested: New Product /Package Information: Request: Jazz Pharmaceuticals is requesting confirmation from the NCPDP Billing Unit Standard that this product’s unit of measurement (UOM) would be milliliter AND to allow the NCPDP workgroup #2 attendees/members to comment on the package labeling attached. Why Needed: This request is needed to confirm the billing unit standard and allow the NCPDP workgroup to review the package labeling BEFORE the product has been FDA approved and will be commercially launched in 2016 Outcome Anticipated: Jazz Pharmaceuticals anticipates the billing unit as a milliliter and that there are no concerns with the package labeling. Jazz Pharmaceuticals will be attending the workgroup 2 meeting in St. Louis, MO on 11/4/2015. Discussion: This product was reviewed via email and on the Product Review and BU Exceptions task group call of October 20, 2015. Chad Pulliam and Mike Sargent of Jazz Pharmaceuticals were on the call to assist. This product is predicted to be approved in the early spring of 2016. There are two NDCs but the carton of 10 is the only one commercially available. Each vial contains 2.5 mLs. The group agreed the BU=mL with a quantity of 2.5 mL per vial and 25 mL for the case of ten per Section 5.2.2 of the BUS. At this meeting, Mike Sargent of Jazz Pharmaceuticals was present to answer questions. A motion was made and seconded to classify the BU=mL with a quantity of 2.5 mL per vial and 25 mL for the case of ten per Section 5.2.2 of the BUS. The motion carried without opposition.

At the November 2015 WG2 meeting the form was discussed. Requested: New Product /Package Information: Request: OTO-201 is a sustained-exposure formulation of ciprofloxacin in development for the treatment of middle ear effusion in pediatric patients with otitis media undergoing tympanostomy tube placement (TTP) surgery. A single intratympanic dose provides a full course of treatment, administered by the physician during TTP. FDA action date is 12/25/15. OTO-201 will be the only FDA-approved product indicated for this setting and the first product FDA-approved for intratympanic administration, thereby setting a precedence. Why Needed: Confirmation of Labeling, Billing Unit and Route of Administration. 1.) Label: 1 (ML) of Susp. in a 2 ML Single Use Vial. (No overfill issue) 2.) Per section 4.2.2 ML will be the designated billing unit and the billing quantity will be 1 ML regardless of administered dose. 3.) OTO-201 will be the only FDA approved product Indicated for full course treatment (Single dose administration) for patients who undergo TTP, and the first product approved for Intratympanic administration. Therefore, a new Route of “intratympanic” is needed. Outcome Anticipated: We anticipate the Billing Unit to be listed as (ML) per section 4.2.2 of the BUS. We do not anticipate any “Overfill” situations as the product has 1 ML of solution, in a 2 ML Single Use Vial. (A single dose in one or both ears may be administered intratympanically as part of a procedure, regardless of quantity used, the billing should be 1 “ML”). A new route of administration of Intratympanic exists on the FDA’s/SPL. Compendia may need to create one. Discussion: This product was reviewed via email and on the Product Review and BU Exceptions task group call of October 20, 2015. Iris Tam of Otonomy was on the call to discuss the product. Iris provided an overview of the product and the product packaging was reviewed. It was stressed this is designed for a single patient use. There is no overfill consideration and syringes and needles are not part of this product. A presentation will provided at the WG2 November meeting that will provide labeling and administration information. The concern regarding the Route of Administration should be addressed by the manufacturer with each compendium. The task group agreed the BU=mL with a quantity of one per Section 5.2.2 of the BUS. At this meeting, Iris provided a presentation on the new product. A motion was made and seconded to classify the BU=mL with a quantity of one per Section 5.2.2 of the BUS. The motion carried without opposition.

At the November 2015 WG2 meeting the form was discussed. Requested: New Product /Package Information: Request: 1.) Carton Label Review - Package Size and Billing Unit confirmation needed for exhaler drug/device. Carton Contains 8 Pouches/Doses. (X 2 nosepieces in each pouch) + 2 Units for administration. 2.) Device is not an inhaler or nasal spray. It is a breath powdered Exhaler. The device will not function with the action of inhalation but rather blowing out (exhalation). Why Needed: 1.) Package Size and Billing Unit are not detailed on the Carton Labeling. We need clarification on the package size and Billing Unit. 2.) Product identification will require explanation as it does not currently exist. Inhaler (inhalation) is not a proper product identifier as the device will only deliver medications via breath powered exhalation (Exhaler). Anticipated Outcome: 1.) Billing Unit = EACH Package Size = #16. (Per BUS Section: 4.2.1: Each is used when product is dispensed in discreet units.) #16 Disposable Powder Filled Nose Pieces. + 2 Devices are only used in the administration of the drug and therefore not considered in the package size. 2.) Metered Dose Exhaler (exhalation device) will be acknowledged and understood by the NCPDP Working group prior to submission. Discussion: This form was reviewed by the WG2 Product Review and BU Exceptions TG on their call of October 20, 2015. Alisha Nielsen of Two Labs Marketing, the submitter of the form and Khody Farahmand of Avanir were on the call to assist. Alisha provided an overview of the product to be released next month. Each administration requires two nose pieces. The product package was reviewed and noted that there is 11 milligrams per dose for a total dose of 22 milligrams. The task group agreed the BU=EACH with a total quantity of 16 per section 5.1.3 of the BUS. They also noted this is not a kit since the devices are for delivery and are excluded for purposes of billing per Section 5.5.1 of the BUS. At this meeting, a motion was made and seconded to classify the BU= EACH with a total quantity of 16 per section 5.1.3 of the BUS. The motion carried without opposition.

At the August 2015 WG2 meeting the form was discussed.
See QUIC #201516 Clindesse

At the August 2015 WG2 meeting the form was discussed.
Requested: Clarification of the BUS:
Request: Clindesse is a vaginal cream with an applicator. Product labeling shows that each applicator delivers 5gm of vaginal cream. Product labeling also shows that the new weight is 5.8gm. NDC 21695085805 may have inactive since 2011. 
Why Needed: Looking for compendia to agree on primary package size.
Outcome Anticipated: Per BUS FAQ 7.34: For non-injectable products, the package size will be based on the total amount of the product delivered (amount that can be extracted from the container, i.e. dispensed). Any overfill will not be considered part of the reported quantity. Based on this the PS for Clindesse should be 5gm not 5.8gm.
Discussion: Via email discussion prior to the TG call:
For this product, I want to confirm the BU=gm and the PS=5. PS is not 5.8 b/c we do not count the overfill; only the volume delivered.
Agree that it should be 5 grams per the standard. We used 5.8 as well as that is what we had on the previous NDC. My suggestion is if we agree that it should be 5 grams. We change not only this NDC but the previous NDC 64011-0124-08 so there is consistency in the product. Otherwise, we will be explaining why one is 5.8 and the other 5. The label for 64011-0124-08 matches the label on the new NDC.
It sounds like we’re all in agreement that for NDC 45802004201 and NDC 64011-0124-08, the PS should be 5.
Following is a list of all the Gynazole and Clindesse products with obsolete dates. If we’re all in agreement that these products should be 5gm not 5.8gm, we need to coordinate a change.

Obsolete Dates	NDC	Name
	*64011024601	GYNAZOLE 1 2% CREAM
6/30/2008	54868483800	GYNAZOLE-1 CREAM
10/16/2012	64011000108	GYNAZOLE-1 CREAM
7/1/2008	54569545200	GYNAZOLE-1 CREAM
	*45802004201	CLINDESSE 2% VAGINAL CREAM
1/24/2011	21695085805	CLINDESSE 2% VAGINAL CREAM
7/1/2015	64011012408	CLINDESSE 2% VAGINAL CREAM

This will cause significant billing issues if the changes are not well coordinated. I’m not sure if you’ll be able to accomplish this by end of quarter. We need some type of indication of Rx volume/month.
Discussion by Product Review and BU Exceptions TG call of July 28, 2015: This product is being reviewed because when adding the new NDC 45802004201 as 5 gm per the Billing Unit Standard, existing product was reviewed and the billing unit did no match. While all agreed the correct BU on these products is 5 gm, changing the billing unit of existing product posed a concern as to industry impact. Preliminary claim data on NDC 64011012408 showed some but not significant usage. The task group agreed the BU=5 gm on the active NDCs 64011024601 (Gynazole) and 45802004201 (Clindesse) and any new products released in the future per FAQ 7.34 of the BUS. Coordination of the effective date will be made amongst all compendia. The effective date will be determined at the WG2 meeting should WG2 agree with the recommendation by the task group. To minimize disruption in the market place, the older products for Gynazole and Clindesse with obsolete dates will not change billing units and will remain with a BU=5.8 gm. This recommendation applies to QUIC form #201516 for Clindesse and QUIC form #201517 for Gynazole. As in the past, the final determination made by WG2 will be distributed via an NCPDP NOW article(s) to inform the industry of the proper billing unit and effective date.
(Note to the Application of the BU TG: Considerations to change existing billing units should include the impact to the market place and usage volume as were applied in this review.)
At this meeting, a motion for QUIC forms #201516 Clindesse and #201517 Gynazole was made and seconded to classify the BU=5 gm on the active NDCs 64011024601 (Gynazole) and 45802004201 (Clindesse) and any new products released in the future per FAQ 7.34 of the BUS. To minimize disruption in the market place, the older products for Clindesse (NDCs 21695085805 and 64011012408) and Gynazole (NDCs 54868483800, 64011000108 and 54569545200) with obsolete dates will not change billing units and will remain with a BU=5.8 gm. The motion carried with no opposition. The compendia will make the change based on their monthly cutoff date. Compendia will send an email to all the compendia giving their date and a final effective date will be determined.
Post Meeting Note: All compendia will make this change on August 20, 2015.

At the August 2015 WG2 meeting the form was discussed.
Requested: Clarification of the BUS:
Request: Definity (Perflutren Lipid Spheres) injectable suspension is an ultrasound contrast agent. Definity is supplied as a single use 2ml clear glass vial containing clear liquid in packages of 4 and 16. Before administration, Definity must be activated by shaking the vial for 45 minutes using a Vialmix apparatus. The PI does not indicate how much volume is yielded after activation of Definity. Labeling indicates that the product is supplied in 2ml vials. The outer package shows a 1.5ml volume before activation. The SPL portion of DailyMed shows that the product comes in 1.5ml vhttp://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ab9c79c-1b5c-4e86-899c-cc74686f070a#S11. 
Why Needed: Looking for compendia to agree on primary package size: 1.5 or 2ml?
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ab9c79c-1b5c-4e86-899c-cc74686f070a#S11
Outcome Anticipated: Per BUS section 5.2.2: Injectables that are liquid filled vials, must be billed as the total number of ML dispensed. If a manufacturer has labeled a product for the quantity to dispense (i.e. excluding theoverfill), the reported quantity for dispensing should be total number of milliliters. FAQ 7.28 indicates that Lucentis PS was based on the dispensed volume and not the total volume (with overfill). However, in the case of Definity it is not clear what the activated volume is.
Discussion: Via email discussion prior to the TG call:
I would like to confirm the BU=ml and PS=8 for 11994001104 DEFINITY 1.1 MG/ML VIAL
And BU=ml and PS=32 for 11994-0011-16 DEFINITY 1.1 MG/ML VIAL
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ab9c79c-1b5c-4e86-899c-cc74686f070a
Some compendia had as 1.5ml and some as 2ml. One had listed as 1.5 based on what DailyMed has on Ingredients and Appearance section under packaging.
Prescribing Insert: http://www.definityimaging.com/pdf/DEFINITY%20Prescribing%20Information%20515987-
0413.pdf 
However the prescribing information does not mention the 1.5 mL
QUIC: Definity (Perflutren Lipid Spheres) injectable suspension is an ultrasound contrast agent. Definity is supplied as a single use 2ml clear glass vial containing clear liquid in packages of 4 and 16. Before administration, Definity must be activated by shaking the vial for 45 minutes using a Vialmix apparatus.The PI does not indicate how much volume is yielded after activation of Definity. Labeling indicates that the product is supplied in 2ml vials. The outer package shows a 1.5ml volume before activation. The SPL portion of DailyMed shows that the product comes in 1.5ml vhttp://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ab9c79c-1b5c-4e86-899c-cc74686f070a#S11
Per BUS section 5.2.2: Injectables that are liquid filled vials, must be billed as the total number of ML dispensed. If a manufacturer has labeled a product for the quantity to dispense (i.e. excluding theoverfill), the reported quantity for dispensing should be total number of milliliters. FAQ 7.28 indicates that Lucentis PS was based on the dispensed volume and not the total volume (with overfill). However, in the case of Definity it is not clear what the activated volume is.
Discussion by Product Review and BU Exceptions TG call of July 28, 2015:
This came from a customer inquiry. It is not a widely used pharmacy product—more of a diagnostic agent. Since 2 mL is predominately shown and not the 1.5 mL, a motion was made and seconded that this is a BU=mL with a vial quantity of 2 mLs per section 5.2.2 of the BUS. The motion carried. The task group recommends a new FAQ be added to the BUS to clarify.
NDC (11994-011-01), vial (2mL x 1 = 2 mL)
NDC (11994-011-04), 4 vial kit (2mL x 4 = 8 mL)
NDC (11994-011-16), 16 vial kit (2mL x 16 = 32mL)
(Note to the Application of the BU TG: This decision was primarily based on what was predominately displayed on the label. The pharmacist would see 2mL and not 1.5 mL.)
At this meeting, a motion was made and seconded to classify the BU=mL with a vial quantity of 2 mL per Section 5.2.2 of the BUS.
NDC (11994-011-01), vial (2mL x 1 = 2 mL)
NDC (11994-011-04), 4 vial kit (2mL x 4 = 8 mL)
NDC (11994-011-16), 16 vial kit (2mL x 16 = 32mL)
The motion carried without opposition.

At the August 2015 WG2 meeting the form was discussed.
Requested: New Product /Package Information:
Request: Request confirmation of billing unit for new product, Kanuma, a single use vial administered via intravenous infusion.
A drug specific J-code will be requested. At product launch and until a drug specific code is issued, the vial will be billed as followed:  NOC J-code 13590 on CMS 1500 and C9399 on UB04
Why Needed: To facilitate billing process for new product commercialization.
Outcome Anticipated: Billing unit of 1 per mL, vial would be 1 0 drug units.
Discussion: This product was reviewed via email and on the Product Review and BU Exceptions task group call of June 2nd. Diane Bernstein and Bill Richardson of Synageva BioPharm were on the call to assist with questions.
This is infusible. Is it reconstituted and added to an infusion bag? No, it comes in liquid form. It is a single dose vial that contains 10 mLs. Is that delivered volume or contained volume? The dosing is by patient weight. The concentration is 20 mg for 10 mLs or 2 mgs per mL. All agreed the BU=mL with a quantity of 10 per Section 5.2.2 of the BUS.
The J Code has not been given and it was warned that it might be different than the billing unit of mL. J codes are used for Medical Benefits and more specific to dose or treatment. J Codes are used if dispensed by the physician. The NCPDP Billing Unit is used for Pharmacy Benefits and to bill an electronic claim when the pharmacy dispenses. Medicare Part D and Medicaids follow and use the NCPDP billing unit.
At this meeting, a motion was made and seconded to classify the BU=mL with a quantity of 10 mL per Section 5.2.2 of the BUS. The motion carried without opposition.