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SUPPORT FOR YOUR PRACTICE AND YOUR PATIENTS

Enroll in ELAHERE Support Services

Here to help you navigate access for your patients

ELAHERE Support Services is committed to helping appropriate patients start on ELAHERE by offering access and reimbursement support as well as affordability assistance.

ELAHERE Support Services
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Access & reimbursement support

  • Benefits investigation
  • Prior authorization (PA) assistance
  • Appeals assistance
Copay icon

Co-pay assistance program*

To support commercially eligible patients with out-of-pocket costs

Patients could pay as little as $0 for their medication

Patient assistance icon

Patient Assistance Program (PAP)

To help uninsured or underinsured patients who meet eligibility requirements access medication at no charge

Questions? Connect with an ELAHERE Support Services Program Specialist

Phone:
1-833-ELAHERE (1-833-352-4373)1-833-ELAHERE (1-833-352-4373)

Monday to Friday, 8 AM to 8 PM ET

Email:
ELAHERESupport@cardinalhealth.com

Download ELAHERE Support Services Patient Enrollment Form

Order ELAHERE

To order ELAHERE, contact your participating specialty distributor or specialty pharmacy listed in the ELAHERE Ordering Information Sheet.

Download the ELAHERE Ordering Information Sheet

J-Code for ELAHERE

Effective July 1, 2023, the permanent J-Code for ELAHERE is J9063 - Injection, mirvetuximab soravtansine-gynx, 1 mg.

The Centers for Medicare & Medicaid Services (CMS) released the April 2023 Quarterly Healthcare Common Procedural Coding System (HCPCS) file, which includes the designation of J9063 for injection, mirvetuximab soravtansine-gynx, 100 mg/20 mL.

Test for FRα

More than a dozen central labs do FOLR1 IHC testing, including (but not limited to):

Caris Life Sciences

Labcorp

Myriad

NeoGenomics

PathAI Diagnostics

Additional labs continue to receive validation for FOLR1 IHC. Please check with your preferred lab directly for availability.

FR-assist

The ImmunoGen FR-ASSIST program was developed to reduce barriers to IHC testing for FRα expression and to help oncologists make informed treatment decisions for their patients with ovarian cancer.

Currently, Caris Life Sciences,§ Labcorp, Myriad, NeoGenomics, and PathAI Diagnostics are offering FRα expression testing at no charge to individuals being treated in the United States who meet the eligibility criteria.||

Contact your ELAHERE representative for updated information about testing for FRα

Resources for your practice

ELAHERE HCP Brochure

Healthcare Professionals Brochure

Clinical information about ELAHERE and the results of the SORAYA trial

ELAHERE Dosing and Administration Flashcard

Dosing and Administration Booklet

Information about how ELAHERE infusions are dosed and administered

Spanish ELAHERE Dosing and Administration Flashcard

Spanish Dosing and Administration Booklet

Information about how ELAHERE infusions are dosed and administered - Spanish Version

ELAHERE Ocular Events Checklist

Ocular Assessment Form

Offer your patients a checklist to track any ocular events they may experience

FPO

ELAHERE Ordering Information Sheet

Information on how to order ELAHERE through specialty distributors or specialty pharmacy partners

ELAHERE Support Services Enrollment Form

ELAHERE Support Services Patient Enrollment Form

Enroll your patients in the ELAHERE Support Services program to receive access, reimbursement, and affordability support

Spanish ELAHERE Support Services Enrollment Form

Spanish ELAHERE Support Services Patient Enrollment Form

Enroll your patients in the ELAHERE Support Services program to receive access, reimbursement, and affordability support - Spanish Version

Letter of Medical Necessity Template

Letter of Medical Necessity Template

Sample letter of medical necessity to help patients access ELAHERE treatment and receive reimbursement from their insurance provider

Letter of Appeals Template

Letter of Appeals Template

Sample letter of appeals to petition a patient's insurance provider in the event of denial of claim for coverage

ELAHERE Billing and Coding Guide

ELAHERE Billing and Coding Guide

Physician office and hospital/outpatient coding information to reference when billing and submitting claims for ELAHERE

Ocular Billing and Coding Guide

Ocular Billing and Coding Guide

Ophthalmic exam codes for eye care providers to reference when billing and submitting claims

Resources for your patients

ELAHERE Patient Brochure

Patient Brochure

Overview of treatment with ELAHERE for patients

ELAHERE Ocular Events Brochure

Ocular Brochure

Help your patients prepare for their eye care management while on ELAHERE

Spanish Language Patient Resources

Spanish ELAHERE Patient Brochure

Spanish ELAHERE Patient Brochure

Overview of treatment with ELAHERE for patients

ELAHERE Ocular Events Brochure

Spanish ELAHERE Ocular Brochure

Help your patients prepare for their eye care management while on ELAHERE

ELAHERE Patient Brochure

Spanish Medication Guide

Important information about ELAHERE treatment

Speak to an ELAHERE Rep

For questions about the clinical trial, ordering ELAHERE, obtaining a patient starter kit, or accessing financial support, please be in touch with an ELAHERE representative.

Request a Rep

*Terms and conditions apply. Patients are eligible for co-pay assistance if enrolled in private commercial health insurance and are not covered by state or federal healthcare programs, and who meet the eligibility criteria. Patients will be enrolled for 12 months. There are no income requirements to participate in the program.
Criteria include: patients who are uninsured or have insurance that excludes coverage for ELAHERE (including patients on Medicare and Medicaid), residents of the United States or Puerto Rico, or patients who meet the financial eligibility requirements. Terms and conditions apply.
Providers are responsible for determining the appropriate coding and submission of accurate claims. ImmunoGen does not guarantee reimbursement or payment of claims.
§Medicare and Medicaid beneficiaries, including those enrolled in Medicare Advantage and managed Medicaid plans, are not eligible for sponsored testing at Caris. These patients may be eligible for this program through Labcorp, Myriad, or NeoGenomics.
||See Labcorp, Myriad, and NeoGenomics websites for terms and conditions, or speak with a representative from any of the participating labs.

FOLR1=folate receptor 1; FRα=folate receptor alpha; IHC=immunohistochemistry.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: OCULAR TOXICITY

  • ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
  • Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated.
  • Administer prophylactic artificial tears and ophthalmic topical steroids.
  • Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose.
  • Discontinue ELAHERE for Grade 4 ocular toxicities.

WARNINGS and PRECAUTIONS

Ocular Disorders

ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.

Ocular adverse reactions occurred in 61% of patients with ovarian cancer treated with ELAHERE. Nine percent (9%) of patients experienced Grade 3 ocular adverse reactions, including visual impairment, keratopathy/keratitis (corneal disorders), dry eye, photophobia, and eye pain; and one patient (0.2%) experienced Grade 4 keratopathy. The most common (≥5%) ocular adverse reactions were visual impairment (49%), keratopathy (36%), dry eye (26%), cataract (15%), photophobia (13%), and eye pain (12%).

The median time to onset for first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9). Of the patients who experienced ocular events, 49% had complete resolution and 39% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade) at last follow up. Ocular adverse reactions led to permanent discontinuation of ELAHERE in 0.6% of patients.

Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.

Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions.

Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE. Pneumonitis occurred in 10% of patients treated with ELAHERE, including 0.8% with Grade 3 events, and 1 patient (0.2%) with a Grade 4 event. One patient (0.2%) died due to respiratory failure in the setting of pneumonitis and lung metastases.

Monitor patients for pulmonary signs and symptoms of pneumonitis. Infectious, neoplastic, and other causes for symptoms should be excluded through appropriate investigations.

Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)

PN occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 2% of patients experienced Grade 3 PN. PN adverse reactions included peripheral neuropathy (19%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (2%), peripheral motor neuropathy (1%), neuralgia (0.4%), polyneuropathy (0.2%) and oral hypoesthesia (0.2%).

Monitor patients for signs and symptoms of neuropathy. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

Embryo-Fetal Toxicity

Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).

Permanent discontinuation of ELAHERE due to adverse reactions occurred in 11% of patients. The most common (≥2%) adverse reactions leading to permanent discontinuation were intestinal obstruction (2%) and thrombocytopenia (2%). One patient (0.9%) permanently discontinued ELAHERE due to visual impairment (unilateral decrease to BCVA ≤20/200 that resolved to baseline after discontinuation).

Dosage delays of ELAHERE due to an adverse reaction occurred in 39% of patients. Adverse reactions which required dosage delays in ≥3% of patients included visual impairment (15%), keratopathy (11%), neutropenia (6%), dry eye (5%), cataracts (3%) and increased gamma-glutamyltransferase (3%).

Dose reductions of ELAHERE due to an adverse reaction occurred in 20% of patients. Adverse reactions which required dose reductions in ≥3% of patients included visual impairment (9%) and keratopathy (7%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors

DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure, which may increase the risk of ELAHERE adverse reactions. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation

Advise women not to breastfeed during treatment with ELAHERE and for at least 1 month after the last dose.

Pediatric Use

Safety and effectiveness of ELAHERE have not been established in pediatric patients.

Hepatic Impairment

Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

IMPORTANT SAFETY INFORMATION

BOXED WARNING: OCULAR TOXICITY

  • ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
  • Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated.
  • Administer prophylactic artificial tears and ophthalmic topical steroids.
  • Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose.
  • Discontinue ELAHERE for Grade 4 ocular toxicities.

WARNINGS and PRECAUTIONS

Ocular Disorders

ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.

Ocular adverse reactions occurred in 61% of patients with ovarian cancer treated with ELAHERE. Nine percent (9%) of patients experienced Grade 3 ocular adverse reactions, including visual impairment, keratopathy/keratitis (corneal disorders), dry eye, photophobia, and eye pain; and one patient (0.2%) experienced Grade 4 keratopathy. The most common (≥5%) ocular adverse reactions were visual impairment (49%), keratopathy (36%), dry eye (26%), cataract (15%), photophobia (13%), and eye pain (12%).

The median time to onset for first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9). Of the patients who experienced ocular events, 49% had complete resolution and 39% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade) at last follow up. Ocular adverse reactions led to permanent discontinuation of ELAHERE in 0.6% of patients.

Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.

Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions.

Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE. Pneumonitis occurred in 10% of patients treated with ELAHERE, including 0.8% with Grade 3 events, and 1 patient (0.2%) with a Grade 4 event. One patient (0.2%) died due to respiratory failure in the setting of pneumonitis and lung metastases.

Monitor patients for pulmonary signs and symptoms of pneumonitis. Infectious, neoplastic, and other causes for symptoms should be excluded through appropriate investigations.

Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)

PN occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 2% of patients experienced Grade 3 PN. PN adverse reactions included peripheral neuropathy (19%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (2%), peripheral motor neuropathy (1%), neuralgia (0.4%), polyneuropathy (0.2%) and oral hypoesthesia (0.2%).

Monitor patients for signs and symptoms of neuropathy. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

Embryo-Fetal Toxicity

Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).

Permanent discontinuation of ELAHERE due to adverse reactions occurred in 11% of patients. The most common (≥2%) adverse reactions leading to permanent discontinuation were intestinal obstruction (2%) and thrombocytopenia (2%). One patient (0.9%) permanently discontinued ELAHERE due to visual impairment (unilateral decrease to BCVA ≤20/200 that resolved to baseline after discontinuation).

Dosage delays of ELAHERE due to an adverse reaction occurred in 39% of patients. Adverse reactions which required dosage delays in ≥3% of patients included visual impairment (15%), keratopathy (11%), neutropenia (6%), dry eye (5%), cataracts (3%) and increased gamma-glutamyltransferase (3%).

Dose reductions of ELAHERE due to an adverse reaction occurred in 20% of patients. Adverse reactions which required dose reductions in ≥3% of patients included visual impairment (9%) and keratopathy (7%).

The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors

DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure, which may increase the risk of ELAHERE adverse reactions. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation

Advise women not to breastfeed during treatment with ELAHERE and for at least 1 month after the last dose.

Pediatric Use

Safety and effectiveness of ELAHERE have not been established in pediatric patients.

Hepatic Impairment

Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

INDICATIONS AND USAGE

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Please see full Prescribing Information including BOXED WARNING.