At the February 2015 WG2 meeting the form was discussed.
Alan Ryan of Sandoz and David Gulick of Novartis were present to assist with questions
Requested: New Product/Package Information and Clarification of the BUS
Request: Novartis Pharmaceuticals Corporation is requesting that NCPDP designate both the package size and the unit size as “each” for Cosentyx 300mg packages. This encompasses both the Sensoready
® pen (autoinjector) form and the prefilled syringe form. The 300mg package consists of 2x150mg injections, with each 150mg injection having the same NDC as the 150mg package. The 300mg package is NOT a multi-dose package. The approved dosing is expected to include both 300mg and 150mg, and both 300mg and 150mg packages will be marketed.
Why Needed: Because the 300mg package consists of 2 x 150mg injections and is not a multi-pack, unless both the package and unit size is classified as “each”, there is a high potential for one or more of the following to occur:
1. Payers may overpay pharmacists who split the 300mg package to dispense 1 autoinjector or syringe to a patient prescribed 150mg, and bill payers at the 150mg package price, unless the product has linear pricing (in linear pricing, 300mg price equals 2x150mg price).
2. Pharmacies may be underpaid in any pricing scenario other than linear pricing, in the event that payers require 300mg package splitting and pharmacies dispense the 150mg package.
3. Payers may restrict patient access to the recommended 300mg dose due to higher cost, in any pricing scenario other than flat pricing.
4. Higher patient out-of-pocket costs may be borne by those patients with percentage coinsurance; this would be the case under any pricing scenario. This represents a significant and growing number of patients.
Outcome Anticipated: Novartis requests that NCPDP designate
both the package size and the unit size as “each” for Cosentyx 300mg packages, including both the Sensoready
® (autoinjector) and prefilled syringe dosage forms. Additionally, Novartis requests that each of the pricing databases list both the 300mg package and unit size as “each” in their respective proprietary databases. This designation will reduce the potential for barriers to patient access and payer overpayment or underpayment.
Discussion: This product was discussed by the Product Review and Billing Unit Exception Task Group on their call of January 27
th. David Gulick of Novartis Pharmaceuticals Corp. and 10 other Novartis and Sandoz folks were on the call to assist with questions. Anne informed all that this task group does not discuss pricing but rather factors that assist in the assignment of the appropriate billing unit in accordance with the BUS. Is this a prefilled syringe that has a delivery device, a cartridge that goes into a delivery device or something that requires reconstitution? The prefilled is ready to use as is the autoinjector. Is this150 mg per ml? Yes for the autoinjector and each prefilled syringe. So 300mg would be for 2 ml? Yes. Is there a syringe of 300mg? No, there is only the 150mg. Do the individual syringe in the 150 and the individual syringe packaged in the 300 have the same NDC? Syringe in the 300mg package has the same NDC as the 150mg package. Is the number of mLs shown on the package? Yes. One can find the labels on DailyMed.
It was determined the
BU=mL per Section 5.2.2 (Dosage forms filled as mL) because they are prefilled and liquid and nothing else in the box to make it an each. The 150mg box would be a dispensing quantity of one mL and the box of two syringes would be a dispensing quantity of two mLs.
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.
Concerns were expressed regarding the patients getting the right dose if the BU is mL. Novartis asked if there was any more information that could be provided before a final decision is made by WG2. Yes, the current copy of packaging and package inserts would be helpful to have during the review. That information will be forwarded to Patsy.
At this meeting, David Gulick reviewed the request and explained the unique nature of this product. The manufacturer is asking for an exception since this is packaged as a single dose package not to be dispensed individually. Packages state not to be sold independently. There has been some billing confusion since the product hit the market. The core nine is the same. The inner syringes have the same NDC but that NDC is different than the outer package. There is no protocol for granting exceptions in the past but we have always documented the reason for the exception via an FAQ in order to avoid future products from requesting exceptions as well. For the sake of billing it is 2 ml, for dispensing it is 2 syringes and for the sake of prescribing it is 300 mgs. If NDCs on the syringes are the same, why can’t they be sold separately? They can but the FDA approved the language on the packaging that they are not to be dispensed or sold separately. There are a lot of products like this where the labeling does not express the way it should be billed and these would also require granting of exceptions. Exceptions are granted only in the case where there is no other applicable area of the standard that may be applied. Cannot see how this would be granted as an exception. Alisha brought up an example of a similar product recently adjudicated by this WG in the same manner as this product. Another attendee supported the task group’s decision to apply the BUS.
There was a motion for the BU to be each. There was no second and it was asked what the each represents. The each is one for each box, one for the single syringe and two for the two packages? Are you counting the prefilled syringe or the box? This is a perfect example as to what will happen if you make it an each. There will be more confusion. A motion was made and seconded to approve as submitted. The motion was amended and seconded to adjudicate the form as BU=mL as adjudicated by the task group,
BU=mL per Section 5.2.2 with a quantity of one for the single package syringe and two for the package containing two syringes. This should be reported as mL to CMS. The motion carried with one in opposition.