For Healthcare Professionals For Patients and Caregivers Important Safety Information TEPEZZAhcp.com
AUTHORIZATION

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

TEPEZZA® (teprotumumab-trbw) treatment may require initial action from the HCP and office staff for patients to get access.

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 PA requirements

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

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Prior Authorization

Your Patient May Need a Prior Authorization (PA) Before Beginning Treatment With TEPEZZA

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 TEPEZZA 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 between health plans. Your office must complete and submit all required forms and provide other information and documents requested.

keyboard

Some of the items commonly required for a PA are:

  • A letter of medical necessity (Downloadable sample below)
  • Your patient’s Clinical Activity Score (CAS)
  • 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)

thyroid-eye-disease-clinical-documentation-guidethyroid-eye-disease-clinical-documentation-guide

Use the following form to generate your patient’s CAS, a common requirement for PA
request-insurance-coveragerequest-insurance-coverage

Complete this Word document to request insurance coverage for patients on TEPEZZA

Appeal

If a PA Is Denied, an Appeal Can Be Submitted

An appeal letter may be needed if a PA for TEPEZZA 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:

  • A letter of medical necessity
  • Relevant clinical notes for your patient
  • Recent test results
  • Your patient’s medical history, including previously tried and failed medications and lifestyle modifications
  • Supporting scientific publications/journal articles
  • A summary of your recommendation at the end of the letter

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, be sure to:

  • Check for any incomplete or missing information, a common reason for denial
  • Schedule a peer-to-peer meeting with health plan
  • Contact a Patient Access Liaison (PAL) to learn about additional resources and next steps in the process
appeal-template-actimmune

Use this Word document featuring a customizable appeals template for patient cases that were denied PA

See how Amgen By Your Side can help with billing and coding

Familiarize yourself with important forms and downloadable resources that explain the process

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache, and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with TEPEZZA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving TEPEZZA.

Hearing Impairment Including Hearing Loss: TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, dry skin, weight decreased, nail disorders, and menstrual disorders.

Please see Full Prescribing Information or visit TEPEZZAhcp.com for more information.

P-TEP-US-01234 07/23

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache, and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with TEPEZZA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving TEPEZZA.

Hearing Impairment Including Hearing Loss: TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, dry skin, weight decreased, nail disorders, and menstrual disorders.

Please see Full Prescribing Information or visit TEPEZZAhcp.com for more information.

P-TEP-US-01234 07/23