Requested clarification for the billing unit quantity. At the May 2011 WG2 meeting the form was discussed. Issue: Clarification is requested regarding the billing quantity for AndroGel 1.62% metered-dose pump. The outer packaging and product label state “Total contents: 88g.” The labels also state “Multi-dose pump capable of dispensing 60 metered pump actuations” and “each actuation delivers 1.25g of gel.” Based upon the latter statements, the pump is capable of delivering 75g of gel. Is the billing quantity 88 or 75?
Discussion: There was discussion on Androgel. There is a new strength of Androgel at 1.62 %. The label shows 88 grams but it only delivers 75 grams. The compendia have it listed differently and they need to be consistent. This product came out May 4th. It is anticipated that the compendia will coordinate the change to 75 grams at the end of the quarter. (note, subsequent to the meeting it was noted that all compendia changed the package size to 75 grams before the end of the quarter as the product was just launched).
Post WG Meeting Note: The Product Review and Billing Unit Exceptions Task Group discussed on their call of May 24th and it was agreed that 75 grams should be the package size