Temodar - NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Temodar® (temozolomide)

FDA Approved Use

• For the treatment of adult patients with newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment.
• For the treatment of adult patients with refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.

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 dose requested is according to FDA approved labeling; AND
4. The patient is being managed by or in consultation with an oncologist; AND 
5. If the request is for brand Temodar,
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic temozolomide (medical record documentation required); AND
6. One of the following
   1. The patient has been newly diagnosed with glioblastoma multiforme (GBM) (medical record documentation required); AND
      1. Temodar will be used concomitantly with radiotherapy or as maintenance treatment following radiotherapy OR 
   2. The patient has been diagnosed with refractory anaplastic astrocytoma (medical record documentation required); AND
      1. The patient has experienced disease progression while on a therapy regimen containing nitrosourea and procarbazine; AND
7. 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 
8. 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

July 2022: Criteria change: Require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication. Added medical record documentation required for diagnosis.
March 2020: Criteria change: Reformatted criteria. Allow for approval if currently taking for a cancer diagnosis.
October 2018: Annual review; No change.
January 2017: Original utilization management criteria issued.