Standards QUIC Form Resolutions

At the May 2016 WG2 meeting the form was discussed. Requested: New Product /Package Information: Package Size Confirmation: Dronabinol Oral Solution 4.25 mg/0.85 ml is supplied in a clear, amber-colored glass bottle containing 30 ML of Liquid. This amber glass bottle comes in a carton that contains a dosing syringe, and one dosing syringe adapter. This adapter allows for the dosing syringe to withdraw the proper amount of medication for the patient. We would like to avoid any confusion or kit status by presenting this information to NCPDP for review. Why Needed: There are multiple components within a single drug carton. We are sending a formal review request to ensure that the product package size (30 ML) is the appropriate package size and Billing Unit, and to avoid any perception of 1 Each, Kit. Dosing syringe is used in the administration of a product is widely understood, but the adapter may cause confusion. Anticipated Outcome: Based on the NCPDP Billing Unit Standard 5.5.1 (Special Considerations Section), we believe that this does not meet the standards of 1 Each - KIT. The Oral Syringe and Adapters are specifically called out in the section of items that should be “ignored” when determining Kit status. Discussion: This form was reviewed by the WG2 Product Review and BU Exceptions TG on their call of March 8, 2016. Alisha Nielsen and Crystal Nielsen of Two Labs Marketing were on the call to answer questions. Alisha reviewed the form and showed pictures of the label (blacked out). There are multiple components in the box but the components are exceptions to a “kit” designation. There is a large rubber adapter that fits into the mouth of the bottle to help with the insertion of the syringe and to minimize spillage as this is a Schedule 3 product. This product should be approved on April 1, 2016. The Billing Unit standard was reviewed and all agreed the BU=mL with a quantity of 30. At this meeting, a motion was made and seconded to classify the BU= mL with a quantity of 30. The motion carried without opposition.

At the February 2016 WG2 meeting the form was discussed. Requested: New Product /Package Information: Request: To clarify the Billing Units and Package Sizes for these intraocular products. These products have been on most compendia’s files with a Billing Unit of “each” for a longtime. However, based on new labeling that specifies the number of “mls” in each container and sections 5.2.2 and 5.2.9 of the BUS, the package size and billing units for these NDCs should be as follows: DISCOVISC DISP SYRINGE NDC 08065-1837-10-per product labeling contains 1ml syringe DUOVISC VISCOELASTIC SYSTEM NDC 08065-1831-35-per product labeling contains 2 syringes – 0.35mL + 0.4mL so BU should be mL with a PS of 0.75. DUOVISC VISCOELASTIC SYSTEM NDC 08065-1831-50-per product labeling contains 2 syringes – 0.5mL + 0.55mL so BU should be mL with a PS of 1.05. Why Needed: To ensure consistency in billing this product with all compendia. To coordinate among compendia the date of the BU and PS change in order to avoid market disruptions. Discussion: This product was reviewed via email by the compendia of the Product Review and BU Exceptions task group prior to the February 2016 Work Group meetings. All compendia had these listed as each based on package inserts since labels were not available. Information on the products was obtained from the information in the product catalogue on page 9. https://www.myalcon.com/products/surgical/docs/MIX12163PG_Catalog_4_18.pdf Since both are intraocular products they would be considered injectable and would be listed as BU = ML and PS = total of both syringes per BUS: 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…… “. 5.2.9 For multi-component products whose components share the same billing unit, the total quantity for the product is the sum of the component sizes. For example, if a multi-component product contains 100 ML and 225 ML, the billing unit for the entire product is ML and the quantity is 325.” All compendia agreed: • 08065-1837-10 Discovisc – BU=mL PS=1 • 08065-1831-35 DuoVisc – per product labeling contains 2 syringes – 0.35mL + 0.4mL so BU should be mL with a PS of 0.75. • 08065-1831-50 DuoVisc – per product labeling contains 2 syringes – 0.5mL + 0.55mL so BU should be mL with a PS of 1.05. At this meeting, a motion was made and seconded to classify per Sections 5.2.2 and 5.2.9 of the BUS: • 08065-1837-10 Discovisc – BU=mL with a PS=1 • 08065-1831-35 DuoVisc – BU=mL with a PS=0.75. • 08065-1831-50 DuoVisc – BU=mL with a PS=1.05. The compendia will make the change of billing units effective on these NDCs April 1, 2016 (compendia to make change to coincide with their end of quarter files). NCPDP will announce this change. The motion carried without opposition.

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.