Thalomid - NC Standard

Restricted Product(s)

• Thalomid® (thalidomide)

FDA Approved Use

• For the treatment patients with newly diagnosed multiple myeloma (MM) in combination with dexamethasone.
• For the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).
• As maintenance therapy for prevention and suppression of the cutaneous manifestations of erythema nodosum leprosum (ENL) recurrence.

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 has a diagnosis of erythema nodosum leprosum (ENL); AND
   1. Thalidomide is being prescribed to treat or prevent cutaneous lesions; OR
   2. Thalidomide is being prescribed to treat moderate to severe neuritis in conjunction with a corticosteroid; OR 
3. The patient has a diagnosis of multiple myeloma; AND
   1. The patient will be taking Thalomid in combination with dexamethasone; AND
   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. All other indications (not mentioned above) 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
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year) 

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

March 2024: Criteria change: Updated quantity limit chart to increase the QL on existing strengths (50 mg & 100 mg) to allow for a dose up to the FDA max of 400 mg/day due to discontinuation of 150 mg and 200 mg strength capsules.
July 2023: Criteria change: Criteria review and formatting changes. Updated to separate different indications with OR. Removed Crohn’s disease and aphthous ulcers associated with HIV/AIDS as indications.
March 2020: Criteria change: Reformatted criteria. Allow for approval if currently taking for a cancer diagnosis and utilizing the generic product (if available).
October 2018: Annual review; No change.
April 2017: Quantity limits added.
January 2017: Reviewed for ASO Net Results and Essential formularies.
July 2011: Original utilization management criteria issued.