BlueCross BlueShield of Tennessee Medical Policy Manual

Subcutaneous Immune Globulins

NDC CODE(S)

44206-0451-XX - Hizentra 20% 100 mg (CSL Behring AG)

 

76125-0900-XX - Gammaked 10% 500 mg (Kedrion Biopharma, Inc.)

 

13533-0800-XX - Gamunex-C 10% 500 mg (Talecris Biotherapeutics)

 

00944-2700-XX - Gammagard Liquid 10% 500 mg (Baxter Healthcare Corporation)

 

00944-2510-XX - HyQvia 10% with Recomb Human Hyaluronidase 160 U/mL 100 mg (Baxter)

 

00944-2511-XX - HyQvia 10% with Recomb Human Hyaluronidase 160 U/mL 100 mg (Baxter)

 

00944-2512-XX - HyQvia 10% with Recomb Human Hyaluronidase 160 U/mL 100 mg (Baxter)

 

00944-2513-XX - HyQvia 10% with Recomb Human Hyaluronidase 160 U/mL 100 mg (Baxter)

 

00944-2514-XX - HyQvia 10% with Recomb Human Hyaluronidase 160 U/mL 100 mg (Baxter)

 

00944-2850-XX - Cuvitru 20% (Baxalta US Inc.)

DESCRIPTION

Immune globulins or immunoglobulins (Ig) are specialized glycoproteins which function in the body as antibodies in the immune system.  Produced by plasma cells, there are generally considered to be five human isotypes of immunoglobulins, IgA, IgD, IgE, IgG and IgM.  Of these, IgG, IgA and IgM are referred to as natural antibodies as they are produced without deliberate immunization or antigen exposure.  IgD and IgE are produced in response to the introduction of specific foreign antigens to which they bind and deactivate.  Together, all immunoglobulin isotypes are vital components of the body’s immune response.

IgG is the most common of the immune globulins.  It has multiple functions including placental antibody transfer, phagocytic cell surface binding and the activation of complement.  Commercial preparations of immune globulins are sterile, highly purified IgG products manufactured from large pools of human plasma, typically from 1000 or more healthy blood donors.  They contain more than 95% unmodified IgG but only trace amounts of IgA and/or IgM. Immune globulins are utilized in the treatment of various conditions.  Various immune globulins are commercially available preparations and labelled information must be specific for administration intravenously (IV), intramuscularly (IM) or subcutaneously (SQ).

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

DOSAGE & ADMINISTRATION

Dosing should be calculated using adjusted body weight if one or more of the following criteria are met:

Use the following dosing formulas to calculate the adjusted body weight (round dose to nearest 5 gram increment in adult patients):

Dosing formulas

BMI = 703 x (weight in pounds/height in inches2)

IBW (kg) for males = 50 + [2.3 (height in inches – 60)]

IBW (kg) for females = 45.5 + [2.3 x (height in inches – 60)]

Adjusted body weight = IBW + 0.5 (actual body weight – IBW)

This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide. Patient-specific variables should be taken into account.

INDICATION(S)

DOSAGE & ADMINISTRATION

 

 

 

 

Primary immune deficiency including Wiskott-Aldrich Syndrome

Hizentra:

  • Weekly dose: 1.37*(previous IVIG dose(g)/number of weeks between IVIG doses)

  • Biweekly dose: twice the weekly dose (using calculation above)

Gamunex-C/Gammaked/Gammagard Liquid:

  • Weekly dose: 1.37*(previous IVIG dose(g)/number of weeks between IVIG doses)

HyQvia:

  • Naïve to IgG or switching from SCIG: 300 to 600 mg/kg at 3 to 4 week intervals after initial ramp-up*

  • Switching from IGIV: use the same dose and frequency as the previous IV treatment after initial ramp-up*

Cuvitru:

  • Switching from IVIG or HyQvia:

  • Weekly dose: 1.30*(previous IVIG or HyQvia dose (g)/number of weeks between IVIG or HyQvia doses)

  • May be administered from daily up to every two weeks (biweekly)

  • Biweekly dose: twice the weekly dose (using calculation above)

  • Frequent dosing (2-7 times per week): divide the calculated weekly dose by the desired number of times per week

  • Switching from SCIG

  • Weekly dose (in grams) should be same as the weekly dose of prior SCIG treatment (in grams)

  • Biweekly dose: multiply the calculated weekly dose by 2

  • Frequent dosing (2-7 times per week): divide the calculated weekly dose by the desired number of times per week

Dosing for immunoglobulin products is highly variable depending on numerous patient specific factors, indication(s), and the specific product selected. For specific dosing regimens refer to current prescribing literature.

*HyQvia initial treatment interval/dosage ramp-up schedule:

Week

Infusion Number

3-week treatment interval

4-week treatment interval

1

1st infusion

Grams X 0.33

Grams X 0.25

2

2nd infusion

Grams X 0.67

Grams X 0.50

4

3rd infusion

Total grams

Grams X 0.75

7

4th infusion

N/A

Total grams

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of subcutaneous immune globulin therapy for the treatment or prevention of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2015). Immune globulin therapy (8.01.05). Retrieved July 6, 2016 from BlueWeb.

Lexi-Comp Online. (2016, March). AHFS DI. Immune globulin. Retrieved July 6, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, July). Immune globulin. Retrieved July 6, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2016, September). Center for Biologics Evaluation and Research. Cuvitru®, immune globulin subcutaneous (human), 20% solution. Retrieved September 16, 2016 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM520587.pdf.

U. S. Food and Drug Administration. (2012, June). Center for Biologics Evaluation and Research. Gammagard® liquid, immune globulin infusion (human), 10% solution, for intravenous and subcutaneous administration. Retrieved July 6, 2016 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM070010.pdf.

U. S. Food and Drug Administration. (2015, December) Center for Biologics Evaluation and Research. Gamunex®-C. [Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified]. Retrieved July 6, 2016 from http://www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm069968.pdf.

U. S. Food and Drug Administration. (2015, January). Center for Biologics Evaluation and Research. HyQvia® [immune globulin infusion 10% (human) with recombinant human hyaluronidase] solution for subcutaneous administration. Retrieved July 6, 2016 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM414440.pdf.

U. S. Food and Drug Administration. (2014, August). Center for Biologics Evaluation and Research.  Hizentra®, immune globulin subcutaneous (human), 20% liquid.  Retrieved July 6, 2016 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM203150.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  2/27/2018

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

Pharmaceutical Decision Support Tree

Subcutaneous Immune Globulins (Cuvitru®, Gammagard® Liquid, Gammaked®, Gamunex®-C, HyQvia®, Hizentra®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #7

  1. Does the request have evidence of baseline values for BUN and serum creatinine that were obtained within 30 days of request?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of primary humoral immunodeficiency (PI) with a further diagnosis that includes, but is not limited to, the humoral defect associated with ANY ONE of the following (not all-inclusive)?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the individual ANY ONE of the following?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have ANY ONE of the following?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for ANY ONE of the following for six months?

INDICATION(S)

BILLABLE UNITS / 28 days

DOSAGE & ADMINISTRATION

 

 

Primary immune deficiency including Wiskott-Aldrich Syndrome

960

Hizentra:

Weekly dose: 1.37*(previous IVIG dose(g)/number of weeks between IVIG doses)

Biweekly dose: twice the weekly dose (using calculation above)

192

Gamunex-C/Gammaked/Gammagard Liquid:

Weekly dose: 1.37*(previous IVIG dose(g)/number of weeks between IVIG doses)

690

HyQvia:

Naïve to IgG or switching from SCIG: 300 to 600 mg/kg at 3 to 4 week intervals after initial ramp-up*

Switching from IGIV: use the same dose and frequency as the previous IV treatment after initial ramp-up*

92g

Cuvitru:

Switching from IVIG or HyQvia:

Weekly dose: 1.30*(previous IVIG or HyQvia dose (g)/number of weeks between IVIG or HyQvia doses)

May be administered from daily up to every two weeks (biweekly)

Biweekly dose: twice the weekly dose (using calculation above)

Frequent dosing (2-7 times per week): divide the calculated weekly dose by the desired number of times per week

Switching from SCIG

Weekly dose (in grams) should be same as the weekly dose of prior SCIG treatment (in grams)

Biweekly dose: multiply the calculated weekly dose by 2

Frequent dosing (2-7 times per week): divide the calculated weekly dose by the desired number of times per week

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 6?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was there absence of unacceptable toxicity from the agent?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Were BUN and serum creatinine results obtained within the last 6 months and the concentration and rate of infusion adjusted accordingly?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was disease response evidenced by ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria for one year renewal

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.