Tagrisso - NC Standard

Restricted Product(s)

• Tagrisso® (osimertinib)

FDA Approved Use

• For the first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptors (EGFR) exon 19 deletions or exon 21 L858R mutations as detected by an FDA-approved test. 
• For the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test when given in combination with pemetrexed and platinum-based chemotherapy. 
• For the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. 
• As adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. 
• For the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

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); 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. The patient has been diagnosed with non-small cell lung cancer (NSCLC) and has ONE of the following:
   1. The patient has a confirmed diagnoses of metastatic non-small cell lung cancer (NSCLC); AND
      1. The patient has epidermal growth factor (EGFR) exon 19 deletions or is exon 21 L858R mutation-positive [medical record documentation required]; AND
         1. The requested medication is being used as first-line treatment; OR 
         2. The patient will receive requested medication in combination with pemetrexed and platinum-based chemotherapy [medical record documentation required]; OR
      2. The patient has a epidermal growth factor (EGFR) T790M mutation [medical record documentation required]; AND
         1. The disease has progressed on or after EGFR TKI therapy; OR
   2. The patient has a confirmed diagnosed of locally advanced non-small cell lung cancer (NSCLC); AND 
      1. The patient has epidermal growth factor (EGFR) exon 19 deletions or is exon 21 L858R mutation-positive [medical record documentation required]; AND 
         1. The patient will receive requested medication in combination with pemetrexed and platinum-based chemotherapy [medical record documentation required]; OR 
   3. The patient has had complete tumor resection; AND 
      1. The patient has epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R mutations [medical record documentation required]; AND 
      2. The requested medication will be used as adjuvant therapy; OR
   4. The patient has a confirmed diagnosis of locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC); AND 
      1. The patient has epidermal growth factor (EGFR) exon 19 deletions or is exon 21 L858R mutation [medical record documentation required]; AND 
         1. The disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy; 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)

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

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

October 2024: Criteria change: Added coverage to allow Tagrisso coverage for adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. Reformatted policy.
March 2024: Criteria change: Added coverage to allow Tagrisso coverage in combination with pemetrexed and platinum-based chemotherapy, as first-line treatment in adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
March 2023: Criteria update: Criteria review and formatting changes. Added duration of approval to quantity limit exception criteria.
December 2020: Criteria update: Addition of new indication for adjuvant treatment of early-stage NSCLC.
Sept 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic (if available).
Apr 2018: Reformatted Policy; Added coverage for first line epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R mutations based on updated FDA indication.
Apr 2017: Quantity limits added
Jan 2017: Reviewed for ASO Net Results and Essential formularies
Dec 2015: Original utilization management criteria issued.