AUTHORIZATION

Amgen Can Help Support Patients at Every Step of the Access Process

ACTIMMUNE® (Interferon gamma-1b) treatment may require initial action from the HCP and office staff for patients to get access.

Each patient’s access process may be different, but our team will serve as a partner to help navigate your patient’s unique experience.

Benefits Investigation


Amgen By Your Side Can Assist You With the Benefits Investigation (BI) Process

Our team will contact your patient’s insurance company to review coverage and work with the patient to ensure they understand:

  • Whether the medicine is covered by their policy
  • Any estimated out-of-pocket costs and financial assistance that may be available
  • All prior authorization (PA) requirements

Take a deeper look at Amgen By Your Side’s support of patient access

Prior Authorization


Your Patient May Need a Prior Authorization (PA) Before Beginning ACTIMMUNE

Health plans sometimes require a PA before approving coverage of medicine. Also referred to as a preauthorization or precertification, this is a process that your office must complete, describing the reasons your patient should be prescribed ACTIMMUNE and why the health plan should cover the costs. PAs are commonly required for medicines that treat rare diseases.

The requirements for a PA will differ from health plan to health plan. Your office must complete and submit all required forms and provide other information and documents requested.

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Some of the items commonly required for a PA are:

  • A letter of medical necessity (Downloadable sample below)
  • Health plan identification numbers
  • Confirmation of diagnosis, including test results
  • Your patient’s medical history, including previously tried and failed medications and lifestyle modifications
  • Medical articles about the disease and the Amgen medicine being prescribed
  • Plan-specific PA forms (when applicable)

Appeal


If a PA Is Denied, an Appeal Can Be Submitted

An appeal letter may be needed if a PA for ACTIMMUNE is denied. When writing an appeal letter, ensure that you address the specific details of the denial reason(s). Refer to the letter of denial for specific language regarding the reason and address any patient-specific concerns.

Supplemental documentation may include:

  • Relevant clinical notes for your patient
  • Recent test results
  • Supporting scientific publications/journal articles
  • A summary of your recommendation at the end of the letter
  • A letter of medical necessity

Make sure you match the exact language in the denial letter. It is imperative to address the specifics of the denial in the appeal. Before you submit your appeal, make sure to:

  • Check for any incomplete or missing information, a common reason for denial
  • Schedule a peer-to-peer meeting with health plan stated guidelines
  • Contact a Case Manager to learn about additional resources and next steps in the process

Important Safety Information

INDICATIONS AND USAGE

ACTIMMUNE® (Interferon gamma-1b) is indicated:

  • For reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease
  • For delaying time to disease progression in patients with severe, malignant osteopetrosis

Important Safety Information

CONTRAINDICATIONS

  • In patients who develop or have known hypersensitivity to interferon-gamma, E. coli derived products, or any component of the product

WARNINGS AND PRECAUTIONS

  • ACTIMMUNE should be used with caution in patients with:
    • Pre-existing cardiac conditions, including ischemia, congestive heart failure, or arrhythmia
    • Seizure disorders or compromised central nervous system function; reduce dose or discontinue
    • Myelosuppression, or receiving other potentially myelosuppressive agents; consider dose reduction or discontinuation of therapy
    • Severe renal insufficiency
    • Age <1 year
  • Monitoring:
    • Patients begun on ACTIMMUNE before age 1 year should receive monthly assessments of liver function. If severe hepatic enzyme elevations develop, ACTIMMUNE dosage should be modified
    • Monitor renal function regularly when administering ACTIMMUNE in patients with severe renal insufficiency; accumulation of interferon gamma-1b may occur with repeated administration. Renal toxicity has been reported in patients receiving ACTIMMUNE
  • Pregnancy, Lactation, and Fertility:
    • ACTIMMUNE should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus
    • Use of ACTIMMUNE by lactating mothers is not recommended. ACTIMMUNE or nursing should be discontinued dependent on the importance of the drug to the mother
    • Long-term effects of ACTIMMUNE on fertility are not known

DRUG INTERACTIONS

  • Concomitant use of drugs with neurotoxic, hematotoxic, or cardiotoxic effects may increase the toxicity of interferons
  • Avoid simultaneous administration of ACTIMMUNE with other heterologous serum protein or immunological preparations (eg, vaccines)

ADVERSE REACTIONS

  • The most common adverse experiences occurring with ACTIMMUNE therapy are “flu-like” symptoms such as fever, headache, chills, myalgia, or fatigue, which may decrease in severity as treatment continues, and may be minimized by bedtime administration of ACTIMMUNE. Acetaminophen may be used to prevent or partially alleviate the fever and headache
  • Isolated cases of acute serious hypersensitivity reactions have been observed in patients receiving ACTIMMUNE
  • Reversible neutropenia, thrombocytopenia, and elevations of AST and/or ALT have been observed during ACTIMMUNE therapy
  • At doses 10 times greater than the weekly recommended dose, ACTIMMUNE may exacerbate pre-existing cardiac conditions, or may cause reversible neurological effects such as decreased mental status, gait disturbance, and dizziness

Approved Uses and Important Safety Information

INDICATIONS AND USAGE

ACTIMMUNE® (Interferon gamma-1b) is indicated:

  • For reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease
  • For delaying time to disease progression in patients with severe, malignant osteopetrosis

Important Safety Information

CONTRAINDICATIONS

  • In patients who develop or have known hypersensitivity to interferon-gamma, E. coli derived products, or any component of the product

WARNINGS AND PRECAUTIONS

  • ACTIMMUNE should be used with caution in patients with:
    • Pre-existing cardiac conditions, including ischemia, congestive heart failure, or arrhythmia
    • Seizure disorders or compromised central nervous system function; reduce dose or discontinue
    • Myelosuppression, or receiving other potentially myelosuppressive agents; consider dose reduction or discontinuation of therapy
    • Severe renal insufficiency
    • Age <1 year
  • Monitoring:
    • Patients begun on ACTIMMUNE before age 1 year should receive monthly assessments of liver function. If severe hepatic enzyme elevations develop, ACTIMMUNE dosage should be modified
    • Monitor renal function regularly when administering ACTIMMUNE in patients with severe renal insufficiency; accumulation of interferon gamma-1b may occur with repeated administration. Renal toxicity has been reported in patients receiving ACTIMMUNE
  • Pregnancy, Lactation, and Fertility:
    • ACTIMMUNE should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus
    • Use of ACTIMMUNE by lactating mothers is not recommended. ACTIMMUNE or nursing should be discontinued dependent on the importance of the drug to the mother
    • Long-term effects of ACTIMMUNE on fertility are not known

DRUG INTERACTIONS

  • Concomitant use of drugs with neurotoxic, hematotoxic, or cardiotoxic effects may increase the toxicity of interferons
  • Avoid simultaneous administration of ACTIMMUNE with other heterologous serum protein or immunological preparations (eg, vaccines)

ADVERSE REACTIONS

  • The most common adverse experiences occurring with ACTIMMUNE therapy are “flu-like” symptoms such as fever, headache, chills, myalgia, or fatigue, which may decrease in severity as treatment continues, and may be minimized by bedtime administration of ACTIMMUNE. Acetaminophen may be used to prevent or partially alleviate the fever and headache
  • Isolated cases of acute serious hypersensitivity reactions have been observed in patients receiving ACTIMMUNE
  • Reversible neutropenia, thrombocytopenia, and elevations of AST and/or ALT have been observed during ACTIMMUNE therapy
  • At doses 10 times greater than the weekly recommended dose, ACTIMMUNE may exacerbate pre-existing cardiac conditions, or may cause reversible neurological effects such as decreased mental status, gait disturbance, and dizziness