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Date Printed: October 23, 2017: 07:25 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-32

Original Effective Date: 05/01/11

Reviewed: 11/12/14

Revised: 11/15/16

Next Review: 10/11/17

Subject: Tesamorelin (Egrifta®) Injection

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           

Dosage/ Administration

Position Statement

Billing/Coding

Reimbursement

Program Exceptions

Definitions

           

Related Guidelines

Other

References

Updates

 

Previous Information

       

   

DESCRIPTION:

Lipodystrophy is a disorder of fat metabolism involving a loss of subcutaneous adipose tissue (SAT) from the face, extremities and buttocks as well as an accumulation of fat around the liver, stomach, and other abdominal organs. Although lipodystrophy may result due to a genetic disorder, it has been linked to antiretroviral therapy, specifically protease inhibitors.

Tesamorelin (Egrifta) was approved by the U.S. Food and Drug Administration (FDA) in November 2010 as a daily subcutaneous therapy to reduce abdominal lipodystrophy in HIV-infected individuals. Two multicenter, randomized, double-blind, placebo-controlled studies were conducted in individuals with HIV-associated lipodystrophy and excess abdominal fat. Study 1 randomized 412 participants and Study 2 included 404 randomized participants. Both studies consisted of a 26-week Main Phase and a 26-week Extension Phase. Inclusion criteria were age 18-65 years, a waist circumference ≥ 95 cm (37.4 inches) and a waist-to-hip ratio ≥ 0.94 for men, ≥ 94 cm (37.0 inches) and ≥ 0.88 for women, respectively, and FBG < 150 mg/dL (8.33 mmol/L). Exclusion criteria included BMI ≤ 20 kg/m2, type 1 diabetes, and type 2 diabetes if previously treated with insulin.

At week 26, treatment with tesamorelin resulted in a reduction from baseline in mean abdominal fat of 1.0 kg in Study 1 and 0.8 kg in Study 2, respectively (compared with an increase of 0.4 kg in Study 1 and of 0.2 kg in Study 2, respectively, in individuals receiving placebo). Treatment with tesamorelin resulted in an increase from baseline in mean lean body mass of 1.3 kg in Study 1 and of 1.2 kg in Study 2, respectively (compared with a decrease of 0.2 kg in Study 1 and of 0.03 kg in Study 2, respectively, in individuals receiving placebo). Tesamorelin did not adversely alter antiretroviral effectiveness as measured by mean circulating levels of CD4 counts or HIV-1 RNA (viral load).

In Study 2, the reduction of VAT was approximately 18% (p<0.001) and continued for 12 months. Those participants who switched from treatment with tesamorelin to placebo lost the initial improvements in VAT. The decrease in VAT was statistically significant for the treatment group (-10.9%) compared to -0.6% in the placebo group at 6 months (p<0.0001). There was no change in abdominal or limb subcutaneous fat. Secondary endpoints were significantly improved for self-rating of belly appearance distress (p=0.02) and physician rating of belly profile (p=0.02) in the treatment groups compared to the placebo groups. Levels of triglyceride changes from baseline (-51 ± 169 mg/dl, p<0.001 compared to baseline) and total cholesterol (-7 ± 36 mg/dl, p=0.009 compared to baseline) were maintained in the treatment group. However, there were no significant changes observed in the ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol in the treatment group.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

Initiation of tesamorelin (Egrifta®) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is diagnosed with HIV-associated lipodystrophy that is symptomatic (e.g., abdominal pain, shortness of breath) – documentation from the medical record must be provided

2. Member has been assessed by CT scan to establish a baseline measurement of visceral adipose tissue (VAT) – documentation must be provided

3. Member meets all of the following:

a. Body mass index (BMI) greater than 20 kg/m2

b. Waist circumference greater than or equal to 95 cm (37.5 in) – documentation from the medical record must be provided

c. Waist-to-hip ratio greater than or equal to 0.94 – documentation from the medical record must be provided

d. HIV postive – laboroatory documentation must be provided

e. Fasting blood glucose (FBG) is less than 150 mg/dL (8.33 mmol/L) – laboroatory documentation must be provided

f. No history of type 1 diabetes or insulin-treated type 2 diabetes

g. No active malignancy (e.g. a potential cancer which is being evaluated or a diagnosed cancer which is being treated)

h. No concomitant use of growth hormone

4. Member is 18 years of age or older

5. Dose does not exceed 2 mg daily

Duration of approval: 6 months

Continuation of tesamorelin (Egrifta®) meets the definition of medical necessity for members meeting the following criteria:

1. Authorization/reauthorization for tesamorelin has been previously approved by Florida Blue or another health plan in the past two years for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy OR the member currently meets all indication-specific initiation criteria criteria (NOTE: BMI, waist circumference, and waist-to-hip ratio may be evaluated using pre-treatment measurements)

2. Member meets one of the following:

a. Member has had a reduction of 20% in VAT measured by CT scan – documentation of baseline and on-treatment imaging must be provided

b. Member currently demonstrates a beneficial response to treatment with tesamorelin AND has been receiving treatment for a minimum of 12 months

3. Member meets all of the following:

a. Fasting blood glucose (FBG) is less than 150 mg/dL (8.33 mmol/L) – laboroatory documentation must be provided

b. No history of type 1 diabetes or insulin-treated type 2 diabetes

c. No active malignancy (e.g. a potential cancer which is being evaluated or a diagnosed cancer which is being treated)

d. No concomitant use of growth hormone

4. Dose does not exceed 2 mg daily

Duration of approval: 6 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

• Lipodystrophy in HIV-infected patients: 2 mg subcutaneously once a day.

Drug Availability

• 2 mg vial for reconstitution with sterile water

PRECAUTIONS:

Boxed Warning

None

Contraindications

• Active malignancy

• Known hypersensitivity to tesamorelin and/or mannitol

• Pregnancy

• Disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or primary tumor/surgery, head irradiation or head trauma

Precautions/Warnings

Neoplasms: preexisting malignancy should be inactive and its treatment complete prior to initiation.

Elevated IGF-1: IGF-1 should be monitored regularly; consider discontinuation if elevated levels persist.

Fluid retention: may include edema, arthralgia, and carpal tunnel syndrome

Glucose intolerance: may develop secondary to therapy; evaluate glucose status prior to and during therapy.

Hypersensitivity: seek immediate medical attention if suspected.

Injection site reactions: rotate sites to avoid.

Acute critical illness: consider discontinuation.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

C9399

Unclassified drugs or biologicals (This code should only be used for drugs and biologicals that are approved by the FDA on or after January 1, 2004) (Hospital Outpatient Use ONLY)

J3490

Unclassified drug

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

E88.1

Lipodystrophy, not elsewhere classified

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Growth Hormone Therapy, 09-J0000-27
Mecasermin (Increlex®), 09-J0000-57

OTHER:

None.

REFERENCES:

  1. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016 Oct 2]. Available from: http://www.clinicalpharmacology.com/.
  2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2016 Oct 2]. Available from: http://clinicaltrials.gov/.
  3. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016 Oct 2]. Available from: http://www.thomsonhc.com/.
  4. EMD Serono, Inc. Egrifta (tesamorelin) kit. 2010 [cited 2016 Oct 2]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3de31cec-31dc-4ac4-9717-367a687d22f2/.
  5. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2016 Oct 2]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/12/16.

GUIDELINE UPDATE INFORMATION:

05/01/11

New Medical Coverage Guideline.

05/15/12

Review and revision to guideline; consisting of updating references.

03/15/13

Review and revision to guideline; consisting of revising description section and precautions section; updating references.

12/15/13

Review and revision to guideline; consisting of revising dosage/administration, precautions, program exceptions, references.

12/15/14

Review and revision to guideline; consisting of references.

11/15/16

Revision to guideline; consisting of description, position statement, coding, references

Date Printed: October 23, 2017: 07:25 AM