CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tagrisso (osimertinib) — Coverage Criteria

Defines accepted indications, authorization, and exclusions for Tagrisso (osimertinib) for members covered by the plan; applies to utilization management reviews of medication requests processed by Evolent/UM.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTagrisso (osimertinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNovember 29, 2024.

Next Review DateN/A

Key ActionSubmit prior authorization to Evolent/UM demonstrating the member meets an accepted indication and provide documentation confirming EGFR mutation status by a standard test.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 yearsmaximum adjuvant duration for resected stage IB-IIIA EGFR+ NSCLC

80 mgsingle dose maximum

30monthly maximum (80 mg or 40 mg tablets)

Exon 19, Exon 21primary activating mutations listed for coverage

T790Mlisted as subsequent-therapy indication after progression on earlier EGFR TKIs

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Coverage Criteria for Tagrisso (osimertinib)

Covered Indications

Covered when any one of the following indication-specific conditions is met:

NSCLC first-line: Recurrent or metastatic EGFR‑positive NSCLC with Exon 19 deletion or Exon 21 L858R mutation when used as first‑line therapy with or without platinum‑based chemotherapy.

T790M subsequent therapy: Subsequent therapy for EGFR T790M mutation‑positive disease following progression on erlotinib (Tarceva), afatinib (Gilotrif), gefitinib (Iressa), or dacomitinib (Vizimpro).

Adjuvant resected disease: Adjuvant therapy for EGFR‑positive (Exon 19 deletion or Exon 21 L858R) stage IB–IIIA NSCLC after complete resection; maximum duration up to 3 years.duration <= 3 years

Unresectable stage III: Adult members with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or after concurrent or sequential platinum‑based chemoradiation and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.

Initial Therapy

Initial therapy indications per policy

Initial or first-line use: Recurrent or metastatic EGFR‑positive NSCLC with Exon 19 deletion or Exon 21 L858R when used as first‑line therapy, with or without platinum‑based chemotherapy.

Coverage excludes concurrent use with other anti-cancer therapy, with one important exception: adjuvant chemotherapy when given with adjuvant osimertinib for completely resected, EGFR‑positive stage IB‑IIIA NSCLC is allowed. Additionally, dosing that exceeds a single dose of 80 mg or treatment that would surpass the policy's monthly maximum of 30 tablets (whether 80 mg or 40 mg tablets) is excluded. Requests lacking documentation confirming EGFR mutation status by a standard test are also excluded.

The policy designates uncommon EGFR Exon 20 insertion mutations as an exclusion; use of osimertinib for these mutations is considered not approved under this policy. Investigational or off‑label uses of Tagrisso that lack sufficient supporting evidence or are not generally accepted by the medical community are also excluded. The policy defines insufficient evidence as absence of adequate patient or regimen representation in published studies, lack of clinically meaningful outcomes per ASCO benchmarks, poor experimental design, reliance on uncontrolled case reports or abstracts without full peer‑reviewed publication, or other limitations listed in the policy's evidentiary criteria.

Initial and Continuation Therapy Rules

Continuation exemption

Continuation exemption rules for not-approvable medications when previously used:

Continuation exemption: The requested medication was used within the last year.

Continuation exemption: The member has not experienced disease progression and/or has not had intolerance to the requested medication.

Continuation exemption: No additional medication(s) are being added to the continuation request.

Continuation Therapy

Continuation requests for medications previously used may be approved when ALL are met:

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. All requests for Tagrisso (osimertinib) must be submitted to and processed by Evolent/UM and must document that the member meets an accepted indication per policy (FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature).

Requests processed by Evolent/UM
Authorization required prior to dispensing

Step Therapy

Step Therapy Note

Tagrisso may be used as subsequent therapy for EGFR T790M mutation‑positive NSCLC after progression on earlier EGFR TKIs (erlotinib, afatinib, gefitinib, dacomitinib). No other explicit step therapy algorithm is specified; use as subsequent therapy for T790M after progression is the intended sequencing.

Subsequent therapy for documented EGFR T790M after progression on erlotinib, afatinib, gefitinib, or dacomitinib

Step Therapy and Prior Exposure Considerations

Step	Requirement
1	Prior exposure to an earlier EGFR tyrosine kinase inhibitor (erlotinib, afatinib, gefitinib, or dacomitinib) with documented disease progression on that agent supports use of osimertinib for EGFR T790M mutation-positive disease.

Quantity Limits and Dosing Constraints

Tagrisso (osimertinib) — quantity limit value summary (30)

Quantity limit (monthly)30 tablets per month

Allowed tablet strengths80 mg tablets or 40 mg tablets

Single-dose maximum80 mg per dose

Policy referenceSee EXCLUSION CRITERIA: treatment exceeds monthly maximum of 30 (80 mg) tablets or 30 (40 mg) tablets; dosing exceeds single dose limit of 80 mg.

Definitions

Adjuvant therapy — definition and policy limit for adjuvant osimertinib duration

DefinitionAdjuvant therapy: treatment given after complete surgical resection to reduce risk of recurrence.

Covered adjuvant indicationEGFR positive (Exon 19 deletion or Exon 21 L858R) stage IB-IIIA NSCLC after complete resection.

Maximum durationUp to 3 years

Concurrent chemotherapyUse with adjuvant chemotherapy is allowed per policy (adjuvant osimertinib may be given with or without adjuvant chemotherapy).

EGFR Exon 20 insertion — definition and exclusion

DefinitionEGFR Exon 20 insertion mutation: an uncommon EGFR alteration.

Site-of-Care Notes

Note

No specific site-of-care limits; follow FDA label

The policy does not impose site-of-care restrictions; providers should follow the FDA label/package insert for administration details when using an infusion center or other settings.

Refer to the FDA label/package insert for specific administration and medication management details.

Background

Osimertinib (Tagrisso) is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor used for EGFR‑mutated non‑small cell lung cancer. The policy context emphasizes approved, mutation‑directed indications and documents exclusions and quantity/dosing limits (for example, the 80 mg single‑dose maximum and monthly tablet limits) to guide utilization management reviews.