Imlunestrant (Inluriyo) coverage for ER+/HER2- ESR1-mutated advanced/metastatic breast cancer
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Defines medical necessity and prior authorization requirements for Inluriyo (imlunestrant) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after progression on endocrine therapy; applies to commercial, HIM, and Medicaid lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met
Approval duration: 12 months
Continuation Therapy
Continued therapy covered when ALL of the following are met
Approval duration: 12 months
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents. Requests for non‑FDA uses should include supporting clinical evidence per those off‑label policies to be considered for authorization.
Initial Therapy
Initial Therapy
Continuation / Renewal Criteria
Continuation Therapy
Criteria for continued coverage
Provider Actions & Requirements
Prior Authorization Required
Prior authorization is required for Inluriyo (imlunestrant) for all lines of business. Providers must submit clinical documentation demonstrating the member meets the applicable initial or continuation therapy criteria in this policy. Approval duration is 12 months when criteria are met.
- Applies to all requests for Inluriyo (generic imlunestrant requests subject to brand-consideration rules)
- Submit via the normal prior authorization process
Therapeutic Alternatives / Brand Consideration
Generic imlunestrant must be used when available for both initial and continued therapy. A brand (Inluriyo) request will only be considered when the prescriber documents that the generic is contraindicated or the member experienced clinically significant adverse effects with the generic. Step-therapy alternatives (see Appendix B) should be considered prior to approval when clinically appropriate.
- Brand exception requires clinical rationale documenting contraindication or intolerable adverse reaction to generic imlunestrant
- See Appendix B for endocrine therapy alternatives (e.g., anastrozole, exemestane, fulvestrant, letrozole, tamoxifen, toremifene)
Required Documentation
Provide supporting clinical documentation with the PA request. Acceptable documentation includes office chart notes, relevant laboratory or molecular testing results (e.g., ESR1 mutation testing), imaging reports, treatment history, and progress notes documenting response to therapy.
- Office chart notes documenting diagnosis of breast cancer and treating oncologist involvement
- Pathology / molecular testing demonstrating ESR1 mutation and ER-positive, HER2-negative status
- Records showing prior endocrine therapy and progression (at least one line)
- For premenopausal/perimenopausal biological females: documentation of ovarian ablation or ongoing ovarian suppression
- For biological males: documentation of agent suppressing testicular steroidogenesis
- Documentation of current dosing and rationale if dose exceeds standard limits (see policy limits)
- If brand requested: documentation of contraindication or significant adverse effects to generic imlunestrant
Denial Triggers
Requests lacking required documentation or not meeting the clinical criteria will be denied. Common denial reasons include missing mutation testing, no evidence of prior endocrine therapy failure, insufficient documentation of ovarian suppression when required, requests for non‑specified off‑label uses without supporting peer‑reviewed evidence, or failure to try/use generic imlunestrant when available without documented contraindication.
- No documentation of ESR1 mutation or ER+/HER2- status
- No evidence of prior endocrine therapy and documented progression
- Missing documentation of ovarian suppression/ablation for premenopausal or perimenopausal females
- Brand Inluriyo requested without documentation showing contraindication or intolerance to generic imlunestrant
- Dose requests exceeding policy limits without supporting guideline or peer‑reviewed literature
Coding & Dose Minimums
Step Therapy / Brand Exceptions
| Step | Requirement |
|---|---|
| 1 | |
| For brand Inluriyo (imlunestrant) requests, member must use generic imlunestrant if available unless contraindicated or clinically significant adverse effects are experienced. |
Quantity Limits & Dosing
Site of Care
No site‑of‑care restriction specified
No specific site‑of‑care restrictions are stated in this policy; home administration is permitted where clinically appropriate.
Definitions
Background
Imlunestrant (Inluriyo) is an estrogen receptor antagonist indicated for adults with ER‑positive, HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer whose disease has progressed following at least one line of endocrine therapy. The policy applies to adults aged ≥18 years and follows the pivotal trial design and NCCN guidance requiring ovarian or testicular suppression for premenopausal/perimenopausal females and males, respectively, where applicable.
Coverage under this policy requires prior authorization demonstrating the clinical criteria are met (diagnosis, ESR1 mutation, prior endocrine therapy, oncologist involvement, and appropriate suppression when indicated). Standard dosing is 400 mg once daily (tablet formulation available as 200 mg tablets), with a maximum of 600 mg once daily if the member is receiving a concomitant strong CYP3A inducer. Approval durations for initial and continued therapy are generally 12 months when criteria are satisfied.
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