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QUIC FORM 201313 Adrenaclick auto-injector, NDC 59630-0803-02 and 59630-0804-02 Resolution

At the May 2013 Work Group 2 meeting this form was pended.

Christopher Worrell of Amedra presented this form and gave a brief presentation of the product and comparison.

Request Type: Product Identification Code Questions/Issues

Request: Amedra Pharmaceuticals LLC (“Amedra”) is making this request concerning the product Adrenaclick®. Amedra acquired the ownership of the product and the drug application (NDA 020-800) from Shionogi Pharmaceuticals in March 2012 and plans to reintroduce the product in the Amedra label in the near future.

Currently there are four products that are defined as "epinephrine auto-injectors" approved and marketed in the US. These products include EpiPen® (Mylan Specialty), Twinject® (Amedra Pharmaceuticals), Adrenaclick® (Amedra Pharmaceuticals) and Auvi-Q® (Sanofi-Aventis). Three of these products are considered single use auto injectors (EpiPen, Adrenaclick, and Auvi-Q) and the fourth (Twinject) is considered a two use auto injector. The focus of this request is limited to the three auto injectors (EpiPen, Adrenaclick, and Auvi-Q) which all deliver a single dose of epinephrine via the injector device. All three products have labeling which provides for the use in treatment of allergic reactions and anaphylaxis and each product delivers identical amounts of epinephrine (either 0.15mg or 0.3mg) to the patient via a prefilled auto injector type device.

While the labeling of each product is identical in treatment of allergic reactions and anaphylaxis, each product delivers the epinephrine via their unique auto injector design. However all products deliver, through their respective auto injector, the same active epinephrine dose of either 0.15mg or 0.3mg to the patient. The products are pharmaceutically equivalent as they are all the same dosage form, route of administration, and are identical in strength or concentration (strength as defined by the dose of epinephrine delivered to the patient).

Because these are products in which the drug is delivered via an auto injector and the patient cannot modify, manipulate or otherwise adjust this dose the strength of the active epinephrine drug product delivered is the defining measurement as opposed to the concentration or volume of the drug product contained within the auto injector. For example the EpiPen Jr (0.15mg) product contains epinephrine in a 1:2,000 concentration in the drug syringe and through the specific design of the EpiPen Jr auto injector delivers 0.15mg of active epinephrine drug to the patient. Whereas the Adrenaclick 0.15mg product drug syringe contains a 1:1,000 concentration of epinephrine yet also delivers 0.15mg active epinephrine drug to the patient, again through the specific design of the auto injector.

The various products (EpiPen, Adrenaclick, and Auvi-Q) appear to be listed in the compendia with the concentration in addition to the amount of epinephrine delivered.

Why Needed: The request is to list these products with the strength and not concentration to minimize confusion. Listing by strength will ensure that pharmacists (and other constituents) properly understand that each auto injector is delivering the same active dose of epinephrine (again either 0.15mg or 0.3mg) to the patient.

Anticipated Outcome: Amedra would request modification so that the products are listed by strength and not concentration consistent with the most prominent label display for these products.

May 2013 Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of April 9th.

The request is not for a billing unit but is in regards to strength. Do we list this by the amount of epinephrine per ml or should it just be the amount of epinephrine? We should wait to discuss this at work group since this request could concern other areas within the compendia and each has their own policy. The compendia will discuss within their organization and bring the information they obtain to the work group meeting.

This is a sealed device that is not designed to be taken apart. 7.2.1 of the BUS should apply to the billing unit. Part of the charge to this group is how the product is identified as well as the proper billing unit. The compendia need more time to discuss internally because this has wide-sweeping ramifications. This impacts many areas. A motion was made and seconded to pend the form until there is more time for the compendia to review. Compendia will review and provide discussion at the June 4th task group call. All others need to look and see what this change will do and the downstream implications. FDA is .3 ml per injection for all three of these products. Syringe is only holding the active drug and the unit delivers the drug. The motion carried without opposition.

August 2013 Discussion: The Product Review and Billing Unit Exception Task Group discussed this product on their call of June 4th: Request from manufacturer does not take into account the various fields that could be impacted within each compendium. This would also affect some proprietary fields. Quantity and NDC are submitted on a claim and the strength does not affect the billing unit. Uniformity of identification of the strength of this product is sought by the submitter. The compendia unanimously stated that this discussion is not part of the Billing Unit Standard and therefore out of NCPDP scope. The task group recommends the submitter contact each individual compendium to discuss editorial policies for the population of these types of fields. This decision was shared with Chris Worrell via email on June 26, 2013.

A motion was made and seconded to deny this request for listing of these products by strength and that they remain as they are (not list these strengths as mg and they remain mg per ml). The BU of these products would be by ml. The motion carried without opposition.

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