CurrentViva Health PlanPolicy IC-0686

Elahere (mirvetuximab soravtansine-gynx) for ovarian, fallopian tube, and primary peritoneal cancer

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This policy governs prior authorization, dosing, initial approval, renewal, administration, and billing requirements for intravenous Elahere in adult members with specified folate receptor alpha-positive ovarian, fallopian tube, or primary peritoneal cancers. It applies to providers seeking coverage under Viva Health Plan's pharmacy and specialty drug benefit.

Policy Summary

PayerViva Health Plan

PolicyElahere (mirvetuximab soravtansine-gynx) for ovarian, fallopian tube, and primary peritoneal cancer

Policy CodePolicy IC-0686

Change TypeNo material change

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation and obtain approval before administering Elahere; initial authorization is valid for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

6 monthsRenewal interval

700Maximum units / 21 days

18 years

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CurrentViva Health PlanPolicy IC-0686

Elahere (mirvetuximab soravtansine-gynx) for ovarian, fallopian tube, and primary peritoneal cancer

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0686 alerts

Get alerted when Policy IC-0686 changes without checking for updates manually.

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Policy Summary

PayerViva Health Plan

PolicyElahere (mirvetuximab soravtansine-gynx) for ovarian, fallopian tube, and primary peritoneal cancer

Policy CodePolicy IC-0686

Change TypeNo material change

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation and obtain approval before administering Elahere; initial authorization is valid for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

6 monthsRenewal interval

700Maximum units / 21 days

18 years

Coverage Criteria

Universal Initial Approval Criteria

Covered when ALL of the following initial approval requirements are met:

ALL of the following

Member is at least 18 years of age.
Therapy will be used in combination with artificial tears and ophthalmic topical steroids.
Member has a baseline ophthalmological test, including visual acuity and slit lamp examination, obtained before initiation of therapy, and will continue periodic follow-up ophthalmological examinations thereafter (every other cycle for the first 8 cycles, then as clinically indicated).

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Covered when ALL applicable requirements are met:

ALL of the following

Member has folate receptor alpha (FRα) expression-positive disease, as determined by an FDA-approved or Clinical Laboratory Improvement Amendments (CLIA)-compliant test.
If confirmed using an immunotherapy assay, see the FDA companion diagnostics resource: http://www.fda.gov/companiondiagnostics
Member has persistent, recurrent, progressive, or relapsed disease.
ONE of the following disease-specific pathways
- Low-grade serous carcinoma
  - ANY of the following
    Platinum-resistant disease
    Therapy is used as a single agent or in combination with bevacizumab.
    Platinum-sensitive disease

Continuation or Renewal Therapy

Renewal may be approved when ALL of the following are met:

ALL of the following

Member continues to meet the universal and other applicable indication-specific criteria identified in the initial approval criteria, including concomitant therapy requirements (excluding prerequisite therapy), performance status, and other relevant requirements.
Disease response is demonstrated, defined as stabilization of disease or a decrease in the size of the tumor or tumor spread.
Member has no unacceptable toxicity from the drug.
Examples of unacceptable toxicity include persistent or recurrent pneumonitis/interstitial lung disease (ILD), severe peripheral neuropathy, and severe ocular toxicities such as visual impairment, keratopathy, dry eye, photophobia, eye pain, or uveitis.

Coverage is not available for members with moderate to severe hepatic impairment, defined as total bilirubin greater than 1.5 times the upper limit of normal (ULN).

Therapy is not appropriate for members with any of the following: non-infectious interstitial lung disease or Grade 3 or 4 pneumonitis; peripheral neuropathy greater than Grade 1; active or chronic corneal disorders; history of corneal transplantation; or active ocular conditions requiring ongoing treatment or monitoring, including uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, papilledema, or monocular vision.

For the epithelial ovarian, fallopian tube, primary peritoneal, carcinosarcoma, clear cell, mucinous, or grade 1 endometrioid disease pathway, Elahere will not be used for immediate treatment of a biochemical relapse, defined as rising CA-125 without radiographic evidence of disease.

Initial Approval

Initial approval requires all universal criteria and at least one applicable disease-specific pathway:

Initial Elahere approval: The member is at least 18 years of age; all universal safety, concomitant therapy, and ophthalmologic monitoring criteria are met; disease is FRα-positive as confirmed by an FDA-approved or CLIA-compliant test; disease is persistent, recurrent, progressive, or relapsed; and at least one applicable ovarian, fallopian tube, or primary peritoneal cancer indication pathway is satisfied.Age ≥18; FRα-positive disease

Apply the disease-specific pathways for histology, platinum sensitivity or resistance, prior platinum-based therapy, and permitted combination therapy.

Continuation and Renewal

Elahere Renewal

Renewal is available for each six-month authorization interval when all continuation criteria are met:

Elahere continuation criteria: The member continues to meet applicable universal and disease-specific criteria, including relevant concomitant therapy requirements; treatment has resulted in disease stabilization or a decrease in tumor size or tumor spread; and there is no unacceptable toxicity from Elahere.Stable disease or decreased tumor size or spread

Unacceptable toxicity includes persistent or recurrent pneumonitis or interstitial lung disease, severe peripheral neuropathy, and severe ocular toxicity, including visual impairment, keratopathy, dry eye, photophobia, eye pain, or uveitis.

Coding, Dosing, and Quantity Limits

Covered HCPCS CodesHCPCSCovered

J9063

Injection, mirvetuximab soravtansine-gynx, 1 mg; 1 billable unit = 1 mg

Covered NDCsNDCCovered

72903-0853-xx

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

Covered 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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Maximum HCPCS Units

Maximum billable amount700 billable HCPCS units

Billing intervalEvery 21 days

Limit applies toMaximum units per dose and over time

Minimum Age

Minimum ageAt least 18 years

Approval applicationRequired for initial approval

Universal criteria

Quantity Limits

Elahere Quantity Limit

ProductElahere (mirvetuximab soravtansine-gynx)

Maximum billable units700 billable units

PeriodEvery 21 days

Provider Requirements and Coverage Risks

Prior Authorization

Six-Month Prior Authorization

Prior authorization is required. Initial authorization is valid for 6 months (180 days) and may be renewed every 6 months (180 days) thereafter.

Initial validity: 6 months (180 days).
Renewal interval: every 6 months (180 days).

Documentation Required

Initial Clinical Documentation

Before initial approval, submit documentation showing that the member meets the universal and indication-specific clinical criteria for Elahere therapy.

Member is at least 18 years of age.
Therapy will be used with artificial tears and ophthalmic topical steroids.
Baseline ophthalmological testing, including visual acuity and slit-lamp examination, was completed before treatment.

Administration Site and Schedule

Note

Administer at an infusion center

Administer Elahere in an infusion center as an intravenous infusion every 3 weeks (21-day cycle), using 6 mg/kg adjusted ideal body weight. Continue treatment until disease progression or unacceptable toxicity.

Clinical Background

Elahere (mirvetuximab soravtansine-gynx) is an intravenous folate receptor alpha-targeting antibody-drug conjugate. It is used for selected folate receptor alpha-positive ovarian, fallopian tube, and primary peritoneal cancers in adults with persistent, recurrent, progressive, or relapsed disease. Depending on the applicable disease pathway, treatment may be administered as a single agent or in combination with bevacizumab, with coverage subject to the required platinum-sensitivity or platinum-resistance criteria.

Key Definitions

FRα-Positive Disease

Required statusFolate receptor alpha (FRα) expression-positive disease

Acceptable testingExpression must be confirmed by an FDA-approved or Clinical Laboratory Improvement Amendments (CLIA)-compliant test

Immunotherapy assayAn immunotherapy assay may be used for confirmation

Adjusted Ideal Body Weight

AIBW formulaIdeal body weight (IBW) plus 0.4 times the difference between actual weight and IBW

Female IBW formula0.9 × height in centimeters − 92 kilograms

Dosing application

Policy Summary

PayerViva Health Plan

PolicyElahere (mirvetuximab soravtansine-gynx) for ovarian, fallopian tube, and primary peritoneal cancer

Policy CodePolicy IC-0686

Change TypeNo material change

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation and obtain approval before administering Elahere; initial authorization is valid for 6 months.

SourceLink

On This Page

Therapy is used as a single agent.

Specified epithelial, carcinosarcoma, clear cell, mucinous, or grade 1 endometrioid disease

Member has epithelial ovarian, fallopian tube, or primary peritoneal cancer; carcinosarcoma (malignant mixed Müllerian tumor); clear cell carcinoma of the ovary; mucinous neoplasm of the ovary; or grade 1 endometrioid carcinoma.
ANY of the following
- Platinum-resistant disease
  - Therapy is used as a single agent or in combination with bevacizumab.
- Platinum-sensitive disease
  - Disease has been treated with two prior lines of platinum-based therapy.
  - Therapy is used as a single agent.

Age requirement applies along with safety, concomitant therapy, and ophthalmologic monitoring criteria

Hepatic Impairment Exclusion

Moderate to severe hepatic impairmentTotal bilirubin greater than 1.5 times the upper limit of normal (ULN)

Coverage requirementMember must not have moderate to severe hepatic impairment

Eligible bilirubin thresholdTotal bilirubin must be 1.5 times ULN or less

Dose and Cycle

Dose6 mg/kg based on adjusted ideal body weight (AIBW)

AdministrationIntravenous infusion

Treatment intervalEvery 3 weeks (21-day cycle)

Treatment durationContinue until disease progression or unacceptable toxicity

Member has FRα-positive disease confirmed by an FDA-approved or CLIA-compliant test.

Disease is persistent, recurrent, progressive, or relapsed and meets the applicable ovarian, fallopian tube, or primary peritoneal cancer indication, including required platinum sensitivity/resistance, prior platinum-based therapy, and treatment combination restrictions.

Documentation Required

Monitoring and Renewal Documentation

For renewal, document continued eligibility, required supportive care, ophthalmologic monitoring, disease response, and absence of unacceptable toxicity.

Continue artificial tears and ophthalmic topical steroids.
Document follow-up ophthalmological examinations periodically, including every other cycle for the first 8 cycles and thereafter as clinically indicated.
Document disease stabilization or a decrease in tumor size or tumor spread.
Document absence of unacceptable toxicity, including severe ocular toxicity, recurrent pneumonitis or interstitial lung disease, and severe peripheral neuropathy.

Billing Rule

Product and Administration Documentation

Administer Elahere using adjusted ideal body weight and submit claims with the correct product and HCPCS unit documentation.

Elahere (mirvetuximab soravtansine-gynx) is administered by intravenous infusion at 6 mg/kg adjusted ideal body weight every 21 days until disease progression or unacceptable toxicity.
Calculate AIBW as IBW + 0.4 × (actual weight − IBW); female IBW = 0.9 × height in centimeters − 92.
Bill HCPCS J9063: injection, mirvetuximab soravtansine-gynx, 1 mg; 1 billable unit equals 1 mg.
Product: Elahere 100 mg/20 mL (5 mg/mL) single-dose vial; NDC 72903-0853-xx.

Denial Risk

Failure to Meet Initial Clinical Criteria

Initial approval may be denied when the member does not satisfy all required age, universal, disease, testing, or treatment-use criteria.

Member is younger than 18 years of age.
FRα-positive disease is not documented with an FDA-approved or CLIA-compliant test.
Disease is not persistent, recurrent, progressive, or relapsed, or the applicable cancer subtype and platinum-status requirements are not met.
Treatment does not follow the required single-agent or bevacizumab combination rules, including the requirement for two prior lines of platinum-based therapy for the specified platinum-sensitive indication.
Therapy is intended for immediate treatment of biochemical relapse without radiographic evidence of disease.
Any universal criterion is not met, including required artificial tears/topical steroids, baseline ophthalmologic testing, or the absence of specified hepatic, pulmonary, neurologic, or ocular contraindications.

Denial Risk

Safety, Monitoring, or Response Failure

Renewal may be denied or not continued when required monitoring or supportive care is not documented, disease is not responding, or toxicity is unacceptable.

Member no longer meets universal or indication-specific criteria, including concomitant therapy requirements.
Required baseline or follow-up ophthalmologic examinations are not completed or documented.
Artificial tears and ophthalmic topical steroids are not used as required.
Disease does not stabilize or decrease in tumor size or tumor spread.
Unacceptable toxicity is present, including persistent or recurrent pneumonitis/ILD, severe peripheral neuropathy, or severe ocular toxicity such as visual impairment, keratopathy, dry eye, photophobia, eye pain, or uveitis.

Billing Rule

Dose or Billing Limit Exceeded

Claims are at risk when dosing, product identification, or billed units do not match the policy limits and administration requirements.

Do not exceed 700 billable HCPCS units every 21 days.
Dose is 6 mg/kg based on adjusted ideal body weight, administered every 21 days; document the AIBW calculation.
For J9063, report 1 billable unit per 1 mg administered.
Use the Elahere 100 mg/20 mL (5 mg/mL) single-dose vial and corresponding NDC 72903-0853-xx documentation.

Use AIBW to calculate the total intravenous dose of 6 mg/kg