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Matulane - NC Standard

Commercial Policy
Version Date: February 2023

Restricted Product(s):

  • Matulane® (procarbazine hydrochloride)

FDA Approved Use:

  • Indicated, in combination with other anticancer drugs, for the treatment of Stage III and IV Hodgkin’s disease. Matulane is used as part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) regimen.

Criteria for Approval of Restricted Product(s):

  1. The patient is currently taking the requested medication for a cancer diagnosis; AND
    1. The patient will utilize the generic formulation of this product (if available); OR
  2. The patient is 18 years of age of older; AND
  3. The patient is being managed by or in consultation with an oncologist; AND
  4. The patient has been diagnosed with Stage III or IV Hodgkin’s disease; AND
  5. Matulane will be used concurrently as part of a chemotherapeutic regimen including nitrogen mustard, vincristine, procarbazine, and prednisone; AND
  6. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. [Medical records and references / evidence must be provided]; AND
  7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

February 2023: Criteria update: Criteria review and formatting changes.

August 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic (if available).

October 2019: Criteria update: Reformatted criteria.

October 2018: Annual review; No change

April 2017: Original utilization management criteria issued.