Viva Health Elahere Prior Auth Coverage

Coverage criteria for Elahere (mirvetuximab soravtansine-gynx)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial criteria: Patient is at least 18 years of age; AND therapy will be used in combination with artificial tears and ophthalmic topical steroids; AND baseline ophthalmological testing (visual acuity and slit lamp exam) obtained prior to initiation and periodic follow-up ophthalmological examinations thereafter (e.g., every other cycle for the first 8 cycles and as clinically indicated); AND no moderate to severe hepatic impairment (total bilirubin >1.5 x ULN); AND absence of the following: Grade 3–4 non-infectious interstitial lung disease/pneumonitis, peripheral neuropathy greater than Grade 1, active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring (e.g., uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision); AND patient has folate receptor alpha (FRα) expression–positive disease as determined by an FDA-approved or CLIA-compliant test; AND patient has persistent, recurrent, progressive, or relapsed disease; AND indication-specific histology and platinum-sensitivity/resistance criteria are met as follows (see children).

Indication-specific histology and platinum status

Low-grade serous carcinoma: Patient has low-grade serous carcinoma AND patient has platinum-resistant disease AND therapy is used as a single agent or in combination with bevacizumab.
Epithelial and other listed histologies: Patient has epithelial ovarian, fallopian tube, or primary peritoneal cancer OR carcinosarcoma (malignant mixed Müllerian tumor) OR clear cell carcinoma of the ovary OR mucinous neoplasm of the ovary OR grade 1 endometrioid carcinoma; AND patient is not experiencing an immediate biochemical relapse (rising CA-125 without radiographic evidence of disease); AND either (a) patient has platinum-resistant disease and therapy is used as a single agent or in combination with bevacizumab OR (b) patient has platinum-sensitive disease treated with two prior lines of platinum-based therapy and therapy is used as a single agent.

Continuation Therapy / Renewal — Renewal approval when ALL of the following are met

Renewal approval when ALL of the following are met:

Renewal: Patient continues to meet the universal and indication-specific criteria (including concomitant therapy requirements and monitoring) identified in the initial approval criteria; AND there is disease response defined as stabilization of disease or decrease in tumor size or tumor spread; AND there is absence of unacceptable toxicity from the drug (examples include persistent or recurrent pneumonitis/interstitial lung disease, severe peripheral neuropathy, or severe ocular toxicities such as visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis).

Prior authorization may be renewed every 6 months.

Patients must not have active or chronic corneal disorders, a history of corneal transplantation, or any active ocular condition that requires ongoing treatment or monitoring (examples include uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, or monocular vision). Additionally, baseline and ongoing ophthalmologic monitoring are required: obtain a baseline visual acuity and slit-lamp exam prior to initiation and continue follow-up eye exams periodically (e.g., every other cycle for the first 8 cycles, then as clinically indicated). These ocular precautions are required because therapy must be administered in combination with supportive ocular care (artificial tears and topical ophthalmic steroids) and because significant ocular toxicity is a contraindication to initiation or continuation of therapy.

Do not initiate therapy in patients with moderate to severe hepatic impairment defined as total bilirubin > 1.5 × ULN. Patients with Grade 3–4 non-infectious interstitial lung disease or pneumonitis or peripheral neuropathy > Grade 1 are not appropriate candidates for approval. These conditions are triggers for denial or non-renewal, and ongoing or recurrent severe pulmonary or neurologic toxicities should preclude continuation of therapy.

Regimen	Indication / Notes
Elahere 6 mg/kg AIBW IV every 21 days	For FRα‑positive ovarian, fallopian tube, or primary peritoneal cancers (including specified histologies such as carcinosarcoma, clear cell, mucinous, and grade 1 endometrioid) meeting the policy's histology and platinum‑sensitivity/resistance criteria; dosing is 6 mg/kg adjusted ideal body weight (AIBW) intravenously every 3 weeks until disease progression or unacceptable toxicity.
Elahere 6 mg/kg AIBW IV every 21 days + bevacizumab (when indicated)	Used in patients with low‑grade serous carcinoma with platinum‑resistant disease or other eligible histologies with platinum‑resistant disease where combination with bevacizumab is specified by the criteria; same dosing schedule (6 mg/kg AIBW IV q21 days).

Line of therapy — second-line | third-line (varies by subgroup)

Line of therapy rules encoded in indication: Used for patients with persistent, recurrent, progressive, or relapsed disease. Specific line (second-line versus third-line) varies by subgroup per the initial criteria: includes platinum-resistant disease (typically second-line) and platinum-sensitive disease after two prior platinum-based lines (third-line), as specified by histology subgroup in the initial criteria.

Billing, codes, and dosing limits

Covered HCPCS CodesHCPCSCovered

J9063

Injection, mirvetuximab soravtansine-gynx, 1 mg

NDCNDC

72903-0853-xx

Elahere 100 mg/20 mL (5 mg/mL) single-dose vial

Covered ICD-10 Diagnosis CodesICD-10Covered

C48.1	Malignant neoplasm of specified parts of peritoneum
C48.2	Malignant neoplasm of peritoneum, unspecified
C48.8	Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C56.1	Malignant neoplasm of right ovary
C56.2	Malignant neoplasm of left ovary
C56.3	Malignant neoplasm of bilateral ovaries
C56.9	Malignant neoplasm of unspecified ovary
C57.00	Malignant neoplasm of unspecified fallopian tube
C57.01	Malignant neoplasm of right fallopian tube
C57.02	Malignant neoplasm of left fallopian tube

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inv-08: Maximum units and dosing interval

Maximum billable units700 billable units every 21 days (HCPCS units)

Recommended dosing regimen6 mg/kg AIBW administered IV every 21 days (every 3 weeks)

Dose calculation noteTotal dose calculated using AIBW (see AIBW definition) and administered until disease progression or unacceptable toxicity

Prior authorization, documentation, and renewal actions required

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval is valid for 6 months and may be renewed every 6 months thereafter. Coverage requires the patient be ≥ 18 years of age and have documented FRα-positive disease by an FDA‑approved or CLIA‑compliant test.

Prior authorization initial validity: 6 months; renewals: every 6 months
Age requirement: ≥ 18 years
FRα expression: documented positive result from FDA-approved or CLIA-compliant test

Note

Renewal Requirements

Renewal of prior authorization requires documentation that the patient continues to meet the universal and indication-specific criteria and demonstrates clinical benefit without unacceptable toxicity.

Patient continues to meet universal and indication-specific criteria (including concomitant therapy requirements and performance status)
Documented disease response: stabilization of disease or decrease in tumor size or spread

FRα testing requirement

inv-17: FRα (folate receptor alpha)

Biomarker requiredFolate receptor alpha (FRα) expression positive disease is required for coverage

Test typeFRα status must be determined by an FDA‑approved or CLIA‑compliant test

Companion diagnostic referenceIf confirmed using an immunotherapy assay, see FDA companion diagnostics guidance

Key definitions used in this policy

inv-14: FRα-positive definition

FRα‑positive definitionTumor demonstrates folate receptor alpha expression as determined by an FDA‑approved or CLIA‑compliant assay

Documentation requiredSubmit results of the FDA‑approved or CLIA‑compliant test confirming FRα positivity with prior authorization

Reference for assay confirmationFDA companion diagnostics information referenced in product labeling

inv-15: AIBW

AIBW formulaAIBW = IBW + 0.4 × (Actual weight − IBW)

Female IBW example (kg)Female IBW (kg) = 0.9 × height (cm) − 92

Use of AIBW

Background on Elahere

Elahere (mirvetuximab soravtansine-gynx) is an antibody–drug conjugate that requires coadministration of ocular supportive measures due to a known risk of corneal and other ocular toxicities. Prior to initiation, a baseline ophthalmologic assessment (visual acuity and slit lamp exam) must be documented and ongoing periodic eye exams performed. Patients with significant preexisting ocular disease or with specific hepatic, pulmonary, or neurologic toxicities are not candidates for treatment per the policy criteria.

OpenPayer

Elahere (mirvetuximab soravtansine-gynx) prior authorization and coverage for ovarian/fallopian tube/primary peritoneal cancers