CurrentmhnPolicy CP.PHAR.294

Osimertinib (Tagrisso) coverage policy

Defines medical necessity, prior authorization and coverage criteria for osimertinib (Tagrisso) for treatment of non-small cell lung cancer (NSCLC) across Commercial, HIM and Medicaid lines of business.

Policy Summary

Payermhn

PolicyOsimertinib (Tagrisso) coverage policy

Policy CodePolicy CP.PHAR.294

Change TypeNo material change

Effective DateDec 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria and documented tumor EGFR mutation status when required; prior authorization may be required.

SourceLink

80 mgStandard daily dose (NSCLC)

160 mgMax dose with strong CYP3A4 inducer

12Typical commercial approval duration

6Medicaid/HIM initial approval duration (months)

Medical Necessity Criteria for Osimertinib (Tagrisso)

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Dosing constraints (one of)

Standard dosing
- Dose does not exceed 80 mg per day
- Dose does not exceed 1 tablet per day
If co-administered with a strong CYP3A4 inducer
- Dose does not exceed 160 mg per day
- Dose does not exceed 2 tablets per day
Or alternative dosing support
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
- Prescribed regimen must be FDA-approved or recommended by NCCN

For Tagrisso requests, member must use generic osimertinib, if available, unless contraindicated or clinically significant adverse effects are experienced

Provider must submit documentation (office notes, labs or other clinical information) supporting that the member has met all approval criteria

Continued Therapy — Non-Small Cell Lung Cancer

Continuation of coverage for Tagrisso is authorized when ALL of the following are met:

ALL of the following

Member is currently receiving the medication via Centene benefit, or documentation supports member has been receiving Tagrisso for at least 30 days
Member is responding positively to therapy
For Tagrisso requests, member must use generic osimertinib, if available, unless contraindicated or clinically significant adverse effects are experienced
If request is for dose increase, new dose must meet one of
- Standard max
  - New dose does not exceed 80 mg per day
  - New dose does not exceed 1 tablet per day
- If co-administered with strong CYP3A4 inducer
  - New dose does not exceed 160 mg per day
  - New dose does not exceed 2 tablets per day
- ANY of the following
  - New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Other diagnoses/indications

For uses not covered in the primary criteria:

ANY of the following

If drug label recently changed (within last 6 months) and policy not updated, refer to applicable no coverage or non-formulary policy depending on formulary status
If requested use is not specifically listed and label-change rule does not apply, refer to the off-label use policy for the relevant line of business

Not Authorized Indications

Coverage is NOT authorized for:

ANY of the following

Non–FDA approved indications that are not addressed in this policy, unless sufficient documentation of efficacy and safety is provided per the off-label use policies

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior authorization and documentation

Provider must submit documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria; prior authorization may be required for prior EGFR TKI therapies.

Include evidence of diagnosis, age, treatment history, and mutation status as applicable
Prior authorization may be required for prior EGFR TKI therapies (e.g., erlotinib, afatinib, gefitinib, dacomitinib)

Documentation Required

Mutation testing requirement

Tumor EGFR mutation status (sensitizing EGFR mutations or T790M) must be documented as detected by an FDA‑approved test when required by the FDA indication or by the policy criteria.

Document the specific mutation (examples: exon 19 deletion/insertion; exon 21 L858R, L861Q; exon 18 G719X; exon 20 S768I; or T790M)
Cite the FDA‑approved test result in submitted records

Step Therapy

Therapeutic alternatives

Therapeutic alternatives (afatinib, gefitinib, erlotinib, dacomitinib) are listed in Appendix B and may require prior authorization; providers should consider formulary alternatives appropriate to the member’s line of business.

See Appendix B for dosing and alternative agent details
These alternatives may not be formulary for all lines of business and may require prior authorization

Denial Risk

Dosing noncompliance

Requests that exceed the policy’s dose limits or that seek treatment for non‑FDA indications without supporting off‑label evidence are at risk for denial.

Standard maximum: 80 mg per day (1 tablet/day); 160 mg/day (2 tablets/day) if co‑administered with a strong CYP3A4 inducer
Off‑label uses require supporting practice‑guideline or peer‑reviewed literature evidence per off‑label policies

Clinical Background

Osimertinib (Tagrisso) is an oral, third‑generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor approved for multiple EGFR‑mutated non‑small cell lung cancer (NSCLC) indications. The FDA approval includes use as adjuvant therapy after complete tumor resection in adult patients whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA‑approved test (adjuvant and certain unresectable stage III settings).

Osimertinib is also approved for the first‑line treatment of metastatic NSCLC when tumors have EGFR exon 19 deletions or exon 21 L858R mutations, and specifically may be used in combination with pemetrexed and platinum‑based chemotherapy for the first‑line treatment of locally advanced or metastatic disease when those mutations are present.

In addition, osimertinib is indicated for patients with metastatic EGFR T790M mutation‑positive NSCLC when disease has progressed on or after prior EGFR TKI therapy. These indications apply to adult patients with mutation status confirmed by an FDA‑approved test and align with the policy requirement to document EGFR mutation status when relevant.

Policy Summary

Payermhn

PolicyOsimertinib (Tagrisso) coverage policy

Policy CodePolicy CP.PHAR.294

Change TypeNo material change

Effective DateDec 1, 2016

Next Review Date

SourceLink

On This Page

OpenPayer

Osimertinib (Tagrisso) coverage policy

Medical Necessity Criteria for Osimertinib (Tagrisso)

Dose Limits and Clinical Thresholds

Prior Authorization, Documentation, and Step Therapy

Policy Identifier and Codes

Clinical Background

Defined Terms

Osimertinib (Tagrisso) coverage policy

Medical Necessity Criteria for Osimertinib (Tagrisso)

Dose Limits and Clinical Thresholds

Prior Authorization, Documentation, and Step Therapy

Policy Identifier and Codes

Clinical Background

Defined Terms

Cross-Reference Policies