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  • December 16, 2013

FDA Approval for GAZVYA
Genentech’s GAZYVA (obinutuzumab) is a new FDA-approved anti-CD20 monoclonal antibody indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). The drug comes in a 1,000mg single-dose vial.

For Day 1 of Cycle 1 (the first time the patient receives the drug) the patient will only receive 100mg out of the 1,000mg SDV. The remaining 900mg is to be administered on Day 2 of Cycle 1. For subsequent administrations, the indicated dosage will be 1,000mg (the entire SDV) as indicated below:

The recommended dose and schedule for the approved regimen is:
Cycle 1: 100 mg intravenously on day 1, 900 mg on day 2, and 1000 mg on days 8 and 15.
Cycles 2-6: 1000 mg administered intravenously every 28 days

0.5 mg/kg orally on days 1 and 15 of each cycle

Because this is a new drug, it will be billed with a Not Otherwise Specified (NOS) drug code until assigned a specific HCPCS code and the claim must contain all the necessary information required when using a NOS code.

Additionally, this drug is only available in a single-dose 1000mg vial and the approved regimen calls for a first dose of only 100mgs. Due to these factors, the following questions will need to be addressed by your payers:

  • Is prior-authorization required for this drug?
  • Should the NOC chemotherapy code J9999 be used for this drug?
  • How many units are to be reported on Day 1 of Cycle 1 (to represent 100mg) when we are expecting to administer the remaining 900mg from the same 1,000mg SDV the following day?
  • If the NOC billing unit for this drug is 100mg, we could bill exactly for the dose given each day. However, if the NOC billing unit is “1” as it often is for NOC codes, how are we to bill for the first 100mg on Day 1 of Cycle 1 and the remaining 900mg on Day 2 of Cycle 1 – keeping in mind that this is a SDV but the package insert instructions tell us to refrigerate the remainder of the vial to be administered on the next day. See the specific instructions are under the How supplied/storage and handling regarding refrigeration (section 16.1) of the Prescribing Information.
  • What other additional information do you need in the notes section to explain the drug/administration?
  • Are payers aware of any state regulations  (like VA) addressing the mixing, diluting or reconstituting of a sterile product use of SDVs which limits the timeframe to use the drug and would require you to discard the remaining 900mgs in the vial on day 1 and open a new vial on day 2?

Here are the instructions that we have received from Noridian Health Care Solutions, but please be aware that these may change pending new information from Noridian:

For Day 1 Cycle 1, hold the bill until the next day when you know what is going to happen.  Submit the claims for Day 1 and Day 2 at the same time.  If the second dose is not administered, then you can either submit the entire contents of the SDV on a single claim line, or you may split the two lines indicating that one is wastage (-JW modifier).  If the second dose is administered, then you would submit two lines for the administrations and two lines for the drugs. For either scenario, the drug would be billed with J9999 with the name of the drug and the amount administered/wasted in the comment field.

Watch your MAC and other payer bulletins, articles and alerts for specific billing/coding information.