Relacorilant (Lifyorli) coverage for platinum‑resistant ovarian, fallopian tube, or primary peritoneal cancer
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This policy defines medical necessity and prior authorization criteria for relacorilant (Lifyorli) when used in combination with nab‑paclitaxel for adults with platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, and provides continuation, dosing, contraindication, and related guidance affecting commercial, HIM/ICHRA, and Medicaid lines of business.
Criteria added for the new FDA‑approved indication of relacorilant (Lifyorli) for platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with nab‑paclitaxel.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial therapy:
Initial approval duration = 12 months.
Continuation Therapy
Covered when ALL of the following are met for continued therapy:
Continued approval duration = 12 months.
Coverage is not authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the request is supported by sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, or CP.PMN.53 for Medicaid, or other evidence of coverage documents.
Coverage and administration of benefits for relacorilant (Lifyorli) are subject to the specific terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). These contractual provisions, together with applicable state and federal requirements and Health Plan administrative policies, govern eligibility for coverage and payment and may limit or exclude coverage when they apply.
Concurrent systemic glucocorticoid therapy used for a lifesaving indication (for example, immunosuppression after organ transplantation) is a contraindication to relacorilant and is not medically necessary for coverage when present. Requests that indicate concurrent systemic glucocorticoids for lifesaving purposes should be denied per this contraindication check.
Coding & Definitions
Provider Actions & Prior Authorization
Prior authorization required for Lifyorli (relacorilant)
Prior authorization is required. The request must document the diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer; that the prescriber is an oncologist or consulted an oncologist; the member is ≥18 years; disease is platinum‑resistant (progression <6 months from completion of a platinum‑containing therapy); the member has received 1–3 prior systemic regimens with at least one including bevacizumab; Lifyorli will be given in combination with nab‑paclitaxel; dosing limits (150 mg on the day before, day of, and day after each nab‑paclitaxel infusion; maximum 3 capsules per dose; maximum 9 doses per 28 days; minimum dose 125 mg) are met; and contraindication checks (e.g., not given concurrently with systemic glucocorticoids for a lifesaving indication) are addressed.
- Must show member received 1–3 prior systemic regimens, at least one including bevacizumab
- Must confirm combination administration with nab‑paclitaxel and adherence to dosing limits
- Prescriber is an oncologist or in consultation with oncology
Policy guides prior authorization/coverage decisions
This clinical policy is intended to guide medical necessity determinations and may be used by the Health Plan to make prior authorization and coverage decisions for relacorilant (Lifyorli).
Therapeutic alternatives per Appendix B
Preferred and alternative systemic chemotherapy regimens are listed in Appendix B and may be considered or required per formulary and line‑of‑business policies; examples include carboplatin/paclitaxel ± bevacizumab, paclitaxel/cisplatin, carboplatin/doxorubicin, docetaxel/carboplatin ± bevacizumab, fluorouracil/oxaliplatin/leucovorin ± bevacizumab, capecitabine/oxaliplatin ± bevacizumab, single‑agent options (docetaxel, etoposide, gemcitabine, topotecan, capecitabine, pemetrexed, vinorelbine, ifosfamide), and combinations with bevacizumab as listed.
- Therapeutic alternatives may not be formulary agents for all lines of business and may require prior authorization
- Use may be constrained by formulary/line‑of‑business step policies
Provider must follow policy requirements when requesting coverage
Providers must ensure requests adhere to all policy requirements and supply clinical justification consistent with the approval criteria when seeking coverage for Lifyorli.
Required documentation to support authorization
Submit supporting clinical documentation with the authorization request — for example, office chart notes, lab results, prior treatment records, and other clinical information that demonstrate the member meets all approval criteria (diagnosis, platinum‑resistant status, prior regimens including bevacizumab, prescriber specialty, dosing plan, and response for continuation requests).
- Include documentation of prior systemic regimens and at least one bevacizumab‑containing regimen
- Document platinum‑resistant status (progression <6 months after platinum therapy) and current response for continuation requests
Follow member coverage terms, conditions, exclusions, and limitations
Coverage and administration of benefits are subject to the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy or contract); providers must follow those terms, conditions, exclusions, and limitations when submitting claims or requests.
Denial triggers for unsupported or undocumented requests
Requests for non‑FDA approved indications that are not supported by sufficient evidence per applicable off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or lack required documentation that the member meets approval criteria will be denied.
- Non‑FDA indications require sufficient off‑label documentation per plan policies
- Missing required clinical documentation may trigger denial
Coverage administration subject to member coverage documents
All coverage decisions and the administration of benefits for Lifyorli remain subject to the specific terms, conditions, exclusions, and limitations of the member's coverage documents and applicable plan policies and procedures.
Background
Relacorilant (Lifyorli) is a glucocorticoid receptor antagonist recently approved by the FDA in combination with nab‑paclitaxel for adults with platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic regimens, at least one of which included bevacizumab. The pivotal approval and policy criteria reference key trial evidence (including the phase 3 ROSELLA trial) and align dosing with the product regimen: 150 mg orally on the day before, the day of, and the day after each nab‑paclitaxel infusion, with allowance to reduce to 125 mg for adverse reactions; dosing limits include a maximum of 3 capsules per dose and 9 doses per 28 days.
Definitions
Initial Therapy — Dosing & Requirements
Initial Therapy Dosing
Continuation Therapy Criteria
Continuation Therapy
Continued approval duration = 12 months.
Step Therapy & Therapeutic Alternatives
| Therapeutic alternative | Examples / regimen notes |
|---|---|
| carboplatin + paclitaxel ± bevacizumab | Listed as a systemic therapy option; dosing varies (see regimen references). |
| paclitaxel + cisplatin | Listed as a systemic therapy option; dosing varies. |
| carboplatin + doxorubicin | Listed as a systemic therapy option; dosing varies. |
| docetaxel + carboplatin ± bevacizumab | Listed as a systemic therapy option; dosing varies. |
| FOLFOX (fluorouracil + oxaliplatin + leucovorin) ± bevacizumab | Listed as a systemic therapy option; dosing varies. |
| capecitabine + oxaliplatin ± bevacizumab | Listed as a systemic therapy option; dosing varies. |
| cyclophosphamide + bevacizumab | Listed as a systemic therapy option; dosing varies. |
| docetaxel (single agent) | Listed as a systemic therapy option; dosing varies. |
| etoposide | Listed as a systemic therapy option; dosing varies. |
| gemcitabine | Listed as a systemic therapy option; dosing varies. |
| doxorubicin ± bevacizumab | Listed as a systemic therapy option; dosing varies. |
| topotecan | Listed as a systemic therapy option; dosing varies. |
| capecitabine (single agent) | Listed as a systemic therapy option; dosing varies. |
| pemetrexed | Listed as a systemic therapy option; dosing varies. |
| vinorelbine | Listed as a systemic therapy option; dosing varies. |
| ifosfamide | Listed as a systemic therapy option; dosing varies. |
Quantity Limits & Dosing
Site of Care
Site of care & administration schedule — oral with nab‑paclitaxel
Lifyorli is administered orally per the dosing schedule in combination with nab‑paclitaxel; nab‑paclitaxel is recommended on days 1, 8, and 15 of each 28‑day cycle, and Lifyorli is given the day before, the day of, and the day after each infusion.
- Setting: office or infusion center
- Nab‑paclitaxel schedule: days 1, 8, and 15 of a 28‑day cycle
- Lifyorli dosing days: day before, day of, and day after each nab‑paclitaxel infusion
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