Lysodren - NC Standard

Restricted Product(s):

• Lysodren® (mitotane)

FDA Approved Use:

• For the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.

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 adrenal cortical carcinoma; AND
5. 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
6. 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 when patient is currently taking for a cancer diagnosis and utilizing the generic (if available).

February 2020: Criteria change: Reformatted criteria. Allow for approval when patient currently taking medication for cancer diagnosis.

October 2018: Annual review; No change.

April 2017: Original utilization management criteria issued.