Indication and Limitations of Use


IMLYGIC® (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Limitations of use: IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases. Close Read More
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Access & Reimbursement

Amgen believes in the importance of access to treatment and may be able to help patients who have concerns about affording IMLYGIC® (talimogene laherparepvec). In this section, you’ll find information about Amgen's access and reimbursement resources, including IMLYGIC® coding and billing information, Amgen Assist 360™, the IMLYGIC FIRST STEP™ Program, and Amgen's charitable Safety Net Foundation. In addition, this section includes information about charitable independent co-pay foundations* that may help patients afford their prescribed melanoma medicine.

*Provided through independent charitable patient assistance programs; program eligibility is based on the charity's criteria. Amgen has no control over independent, third-party programs and provides referrals as a courtesy only.

IMLYGIC® Coding and Billing Information

Amgen Assist 360™

Visit amgenassist360.com for information on reimbursement, billing and coding, and Amgen Assist 360™ Nurse Ambassadors.

Patients prescribed certain Amgen products and their caregivers can receive one-on-one phone assistance from our Nurse Ambassadors who provide guidance in such matter as co-pay and reimbursement assistance. Nurse Ambassadors also connect your eligible patients to independent, third-party organizations* for support, including:

  • Help Finding Transportation and Lodging Assistance*
  • Referrals to Resources for Day-to-Day Living

*Provided through independent third-party foundations (501(c)(3), tax-exempt nonprofit organizations). Amgen Assist 360™ has no control over independent, third-party programs and provides connections as a courtesy only.

Based on program eligibility.

IMLYGIC® Patient Brochure

Print a downloadable booklet designed to help patients understand how IMLYGIC® works and what to expect during treatment that also provides information on co-pay assistance and support organizations.

IMLYGIC FIRST STEP™ for Eligible Commercially Insured Patients

The IMLYGIC FIRST STEP™ Program can help eligible commercially insured patients meet their deductible, co-insurance, and co-payment.

  • No out-of-pocket cost for the first dose.
  • No income eligibility requirement.
  • For subsequent doses, Amgen will pay the out-of-pocket amount in excess of $25 per dose, up to $10,000 in assistance per patient per calendar year.

Here’s what patients need to qualify:

  • Must be prescribed IMLYGIC®.
  • Must have private commercial health insurance that covers medication costs for IMLYGIC®.
  • Must not be a participant in any federal-, state-, or government-funded healthcare program such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD), or TRICARE.
  • May not seek reimbursement for value received from the Amgen FIRST STEP™ Program from any third-party payers, including flexible spending accounts or healthcare savings accounts. If at any time patients begin receiving coverage under any federal-, state-, or government-funded healthcare program, patients will no longer be eligible to participate in the Amgen FIRST STEP™ Program and must call 1-888-65-STEP1 (1-888-657-8371) Monday through Friday, 9:00 am–8:00 pm ET, to stop participation. Restrictions may apply.
    This is not health insurance. Program invalid where otherwise prohibited by law.

Other restrictions apply. Not valid where prohibited by law. Amgen reserves the right to revise or terminate this program, in whole or in part, without notice at any time.

Coverage limits:

  • Program covers out-of-pocket medication costs for IMLYGIC® only. Program does not cover any other costs related to office visit or administration of IMLYGIC®.
  • No out-of-pocket cost for first dose or cycle; $25 out-of-pocket cost for subsequent dose or cycle; maximum benefit of $10,000 per patient per calendar year. Patient is responsible for costs above these amounts.
  • Ongoing activation of the Amgen FIRST STEP™ card is contingent on the submission of the required Explanation of Benefits (EOB) form by the healthcare provider’s office within 45 days of use of the Amgen FIRST STEP™ card. Patients will be responsible for reimbursing the program for all amounts paid out if the EOB for the date of service is not received within 45 days.

For additional program details please visit www.AmgenFIRSTSTEP.com or call 1-888-65-STEP1 (1-888-657-8371).


For Eligible Uninsured Patients

The Safety Net Foundation

The Safety Net Foundation is a nonprofit patient assistance program that helps qualifying uninsured patients access Amgen medicines, including IMLYGIC®, at no cost. For more information, visit www.safetynetfoundation.com, or call 1-888-SN-AMGEN (1-888-762-6436).


Other Co-pay Resources

Independent Co-pay Foundations§

Patients who need assistance with out-of-pocket costs for melanoma medication may be eligible for assistance from an Independent Nonprofit Co-pay Foundation. For contact information or to be referred to an independent co-pay foundation, visit www.amgenassist360.com, or call 1-888-4ASSIST (1-888-427-7478).

§Provided through independent charitable patient assistance programs that set their own eligibility criteria. Amgen has no control over third party programs and provides referrals as a courtesy only.

Help for locating centers and clinics that may provide IMLYGIC® (talimogene laherparepvec) treatment to appropriate patients.

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IMLYGIC® (talimogene laherparepvec) Suspension for Injection

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IMPORTANT SAFETY INFORMATION

Contraindications
  • Do not administer IMLYGIC® to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.
  • Do not administer IMLYGIC® to pregnant patients.
Warnings and Precautions
  • Accidental exposure to IMLYGIC® may lead to transmission of IMLYGIC® and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.
  • Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
  • To prevent possible inadvertent transfer of IMLYGIC® to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.
  • Herpetic infections: Herpetic infections (including cold sores and herpetic keratitis) have been reported in IMLYGIC®-treated patients. Disseminated herpetic infection may also occur in immunocompromised patients. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
  • Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the option of follow-up testing for further characterization of the infection.
  • IMLYGIC® is sensitive to acyclovir. Acyclovir or other antiviral agents may interfere with the effectiveness of IMLYGIC®. Consider the risks and benefits of IMLYGIC® treatment before administering antiviral agents to manage herpetic infection.
  • Injection Site Complications: Necrosis or ulceration of tumor tissue may occur during IMLYGIC® treatment. Cellulitis and systemic bacterial infection have been reported in clinical studies. Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
  • Impaired healing at the injection site has been reported. IMLYGIC® may increase the risk of impaired healing in patients with underlying risk factors (eg, previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.
  • Immune-Mediated events including glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with IMLYGIC®. Consider the risks and benefits of IMLYGIC® before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events.
  • Plasmacytoma at Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC® administration in a clinical study. Consider the risks and benefits of IMLYGIC® in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
Adverse Reactions
  • The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC®-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC® treatment, but were more frequent during the first 3 months of treatment.
  • The most common Grade 3 or higher adverse reaction was cellulitis.

Please see full Prescribing Information and Medication Guide for IMLYGIC®.

INDICATION AND LIMITATIONS OF USE

IMLYGIC® (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Limitations of use: IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases.

IMPORTANT SAFETY INFORMATION

Contraindications
  • Do not administer IMLYGIC® to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy, due to the risk of life-threatening disseminated herpetic infection.
  • Do not administer IMLYGIC® to pregnant patients.
Warnings and Precautions
  • Accidental exposure to IMLYGIC® may lead to transmission of IMLYGIC® and herpetic infection, including during preparation and administration. Health care providers, close contacts, pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. The affected area in exposed individuals should be cleaned thoroughly with soap and water and/or a disinfectant.
  • Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials. Exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
  • To prevent possible inadvertent transfer of IMLYGIC® to other areas of the body, patients should be advised to avoid touching or scratching injection sites or occlusive dressings.
  • Herpetic infections: Herpetic infections (including cold sores and herpetic keratitis) have been reported in IMLYGIC®-treated patients. Disseminated herpetic infection may also occur in immunocompromised patients. Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
  • Patients or close contacts with suspected signs or symptoms of a herpetic infection should contact their health care provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442). Patients or close contacts have the option of follow-up testing for further characterization of the infection.
  • IMLYGIC® is sensitive to acyclovir. Acyclovir or other antiviral agents may interfere with the effectiveness of IMLYGIC®. Consider the risks and benefits of IMLYGIC® treatment before administering antiviral agents to manage herpetic infection.
  • Injection Site Complications: Necrosis or ulceration of tumor tissue may occur during IMLYGIC® treatment. Cellulitis and systemic bacterial infection have been reported in clinical studies. Careful wound care and infection precautions are recommended, particularly if tissue necrosis results in open wounds.
  • Impaired healing at the injection site has been reported. IMLYGIC® may increase the risk of impaired healing in patients with underlying risk factors (eg, previous radiation at the injection site or lesions in poorly vascularized areas). If there is persistent infection or delayed healing of the injection site, consider the risks and benefits of continuing treatment.
  • Immune-Mediated events including glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, and vitiligo have been reported in patients treated with IMLYGIC®. Consider the risks and benefits of IMLYGIC® before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events.
  • Plasmacytoma at Injection Site: Plasmacytoma in proximity to the injection site has been reported in a patient with smoldering multiple myeloma after IMLYGIC® administration in a clinical study. Consider the risks and benefits of IMLYGIC® in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
Adverse Reactions
  • The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC®-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. Pyrexia, chills, and influenza-like illness can occur at any time during IMLYGIC® treatment, but were more frequent during the first 3 months of treatment.
  • The most common Grade 3 or higher adverse reaction was cellulitis.

Please see full Prescribing Information and Medication Guide for IMLYGIC®.

INDICATION AND LIMITATIONS OF USE

IMLYGIC® (talimogene laherparepvec) is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Limitations of use: IMLYGIC® has not been shown to improve overall survival or have an effect on visceral metastases.