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Inqovi – NC Standard

Commercial Policy
Version Date: February 2023

Restricted Product(s):

  • Inqovi® (decitabine and cedazuridine) tablets

FDA Approved Use:

  • For the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

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 or older; AND
  3. The patient is being managed by or in consultation with an oncologist; AND
  4. The patient is being treated for a myelodysplastic syndrome (MDS), including previously treated and untreated, de novo and secondary MDS with the following French American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups; AND
  5. The patient is not taking Inqovi (decitabine and cedazuridine) concomitantly with IV decitabine; 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)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

MedicationQuantity per Day (unless specified)
Inqovi (decitabine and cedazuridine) 35-100 mg5 tablets per 28 days

Quantity Limit Exception Criteria:

  1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
  2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
  3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
  4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

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: Original utilization management criteria issued.

Blue Cross and Blue Shield of North Carolina does not discriminate on the basis of race, color, national origin, sex, age or disability in its health programs and activities. Learn more about our non-discrimination policy and no-cost services available to you.

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