Teprotumumab-trbw (Tepezza)

Section: Injections
Effective Date: April 01, 2020
Last Reviewed: March 16, 2020

Description

Teprotumumab-trbw (Tepezza) binds to IGF-1R and blocks its activation and signaling.

There is a risk of hyperglycemia with teprotumumab-trbw (Tepezza) and, if an individual is diabetic, glycemic control medications may need to be adjusted as appropriate. Compliance with glycemic control should be encouraged.

There is a risk of inflammatory bowel disease (IBD) with teprotumumab-trbw (Tepezza). Individual should be advised to seek medical advice immediately if they experience diarrhea, with or without blood or rectal bleeding, associated with abdominal pain or cramping/colic, urgency, tenesmus or incontinence.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Teprotumumab-trbw (Tepezza) may be considered medically necessary when ALL of the following criteria are met:

  • Individual is 18 years of age or older; and
  • Individual has a diagnosis of moderate to severe Thyroid associated orbitopathy [thyroid eye disease (TED)]; and
  • Onset of TED symptoms within 9-12 months prior; and
  • Clinical activity score (see table below) of greater than or equal to four (4); and
  • Individual does not require immediate surgical ophthalmological intervention; and
  • Individual does not have clinically significant optic neuropathy (Individual has not had a decrease in best corrected visual acuity (BVCA) within the previous six months, i.e., decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement); and
  • Individual does not have corneal decompensation unresponsive to medical management; and
  • Individual is euthyroid, mild hypothyroid, mild hyperthyroid (defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits) or seeking care for dysthyroid state from an endocrinologist or other provider experienced in the treatment of thyroid diseases; and
  • If individual is diabetic, individual is being managed by an endocrinologist or other provider experienced in the treatment and stabilization of diabetes; and
  • Individual is not pregnant.

Teprotumumab-trbw (Tepezza) for any other indication is considered experimental/investigational. Scientific evidence does support its use for any other indication.

Procedure Codes

J3590

Reauthorization Criteria

More than one (1) course of therapy of eight (8) infusions of teprotumumab-trbw (Tepezza) is considered experimental/investigational. Scientific evidence does not support more than one (1) course of therapy of eight (8) infusions.

Procedure Codes

J3590

Outpatient HCPCS (C Codes)

C9399

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

E05.00

Professional Statements and Societal Positions Guidelines

Adapted from Endocrine Society Publication. Diagnosis of Graves’ Orbitopathy (DiaGO). J Clin Endocrinol Metab. 2015;100(3):E458-E462.

Clinical Activity Score for Graves Orbitopathy

For each item present, one (1) point is given. The sum of these points is the clinical activity score

Pain

1

Painful oppressive feeling on or behind the globe, during the last four (4) weeks

 

2

Pain on attempted u, side or down gaze, during the last four (4) weeks

Redness

3

Redness of the eyelid(s)

 

4

Diffuse redness of the conjunctiva, covering at least one (1) quadrant

Swelling

5

Swelling of the eyelid(s)

 

6

Chemosis

 

7

Swollen caruncle

 

8

Increase of proptosis of greater than or equal to 2mm during a period of 1-3 months

Impaired function

9

Decrease of eye movements in any direction greater than or equal to 5o during a period of 1-3 months

 

10

Decrease of visual activity of greater than or equal to one (1) line(s) on the Snellen chart (using a pinhole) during a period of 1-3 months

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