Pomalyst (pomalidomide)

Restricted Product(s):

• Pomalyst (pomalidomide)

FDA Approved Use:

• Indicated, in combination with dexamethasone, for adults with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
• For the treatment of Kaposi sarcoma (KS) in adults with AIDS-related KS after failure of highly active antiretroviral therapy (HAART) and in adults with KS who are HIV-negative.

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 has a confirmed diagnosis of multiple myeloma (MM); AND
   1. The patient has received at least TWO prior therapies for multiple myeloma including lenalidomide and a proteasome inhibitor (e.g., bortezomib or carfilzomib); AND
   2. The patient has demonstrated disease progression on or within 60 days of completion of the last therapy for multiple myeloma; OR
5. The patient has a confirmed diagnosed of Kaposi sarcoma (KS); AND
   1. For patients whose Kaposi sarcoma is AIDS-related:
      1. The patient has achieved an HIV viral load < 10,000 copies/mL; AND
      2. The patient has failed highly active antiretroviral therapy (HAART); AND
      3. The patient will continue to receive and be adherent to a highly active antiretroviral therapy (HAART) regimen consistent with current clinical guidelines; 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.

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:

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

May 2020: Criteria update: Added new indication for Kaposi sarcoma (KS).

October 2019: Criteria update: Reformatted criteria.

October 2018: Annual review; No change.

April 2017: Quantity limits added

January 2017: Reviewed for ASO Net Results and Essential formularies January 2017: Reviewed for ASO Net Results and Essential formularies

October 2016: Annual review; No change.

May 2015: Historical update