BlueCross BlueShield of Tennessee Medical Policy Manual

Rituximab-abbs

NDC CODE(S)

63459-0103-XX Truxima 100 mg/10ml SOLN (TEVA PHARMACEUTICALS USA)

 

63459-0104-XX Truxima 500 mg/50ml SOLN (TEVA PHARMACEUTICALS USA)

DESCRIPTION

Rituximab-abbs is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen.  It is the first biosimilar to rituximab and has been approved as a biosimilar, not as an interchangeable product.

Rituximab products target the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab products lead to B-cell lysis, possibly through complement dependent cytotoxicity (CDC) and antibody dependent cell mediated cytotoxicity (ADCC).

POLICY

See also: Rituximab

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

CLL/SLL

Initial therapy - 375 mg/m² weekly x 8 doses; OR 375 mg/m² cycle 1, then 500 mg/m² every 28 days cycles 2-6 (6 total doses)

Renewal therapy - 375 mg/m² once weekly for 4 doses per 6 month period; OR 375mg/ m² every 8 weeks

NHL, PTLD, Waldenström’s, Castleman’s or HL  

Initial therapy -  375 mg/m2 once weekly for 4 - 8 doses in a 6 month period

Renewal therapy - 375 mg/m² once weekly for 4 doses per 6 month period; OR 375mg/ m² every 8 weeks

CNS Lymphoma

Intravenous

Initial: 375 mg/m2 once weekly for 4 - 8 doses in a 6 month period

Renewal Therapy:375 mg/m² once weekly for 4 doses per 6 month period; OR

375 mg/ m² every 8 weeks

Intrathecal/Intraventricular

10-40 mg weekly to every 3 weeks

ALL

375 mg/m2 once weekly for 4 - 8 doses in a 6 month period

RA

1,000 mg on days 1 and 15, repeated up to every 16 weeks

Pemphigus Vulgaris

Initiation:

Administer 1,000 mg on days 1 and 15 in combination with tapering doses of glucocorticoids

Used in combination with prednisone (or equivalent):

Moderate disease: 0.5 mg/kg/day tapered over 3 months

Severe disease: 1 mg/kg/day tapered over 6 months

Maintenance:

Administer 500 mg at month 12 and repeat every 6 months thereafter or based on clinical evaluation.

Relapse:

Administer 1000 mg upon relapse, resumption of glucocorticoids may be considered.

*Subsequent infusions (maintenance and relapse) should be no sooner than 16 weeks after the previous infusion.

GPA (WG), MPA

Induction

375 mg/m² weekly x 4 doses, initially

Maintenance

Administer 1,000 mg (as 2 x 500mg doses) for two doses separated by two weeks, then followed by 500mg every 6 months thereafter based on clinical evaluation.

*Initial MAINTENANCE infusions should be no sooner than 16 weeks and no later than 24 weeks after the previous infusion if Rituxan was used for initial induction therapy.

*Initial MAINTENANCE infusions should be initiated within 4 weeks following disease control when initial induction occurred with other standard of care immunosuppressants.

AIHA or Thrombocytopenia

375 mg/m² weekly x 4 doses in a 6 month period

cGVHD

375 mg/m² weekly x 4 doses, then 375 mg/m² monthly x 4 months

 

 

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months (12 months initially for pemphigus vulgaris) and may be renewed unless otherwise specified.

Refer to DOSAGE LIMITS below

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).

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Nononcologic uses of rituximab (5.01.24). Retrieved September 13, 2018 from BlueWeb.

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Uses of monoclonal antibodies for the treatment of non-Hodgkin’s lymphoma and acute myeloid leukemia in the non-stem cell transplant setting (2.03.05). Retrieved September 13, 2018 from BlueWeb.

International Pemphigus & Pemphigoid Foundation. (2017) For Medical Professionals - Diagnostic Testing.  Retrieved September 17, 2018 from http://www.pemphigus.org/research/clinically-speaking/diagnostic-testing/.

Lexi-Comp Online. (2019). AHFS DI. Rituximab. Retrieved January 28, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, January). Rituximab. Retrieved January 28, 2019 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Rituximab. Retrieved January 28, 2019 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018, November). Center for Drug Evaluation and Research. TRUXIMA® (rituximab-abbs) injection, for intravenous use. Retrieved December 12, 2018 from

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761088s000lbl.pdf.

ORIGINAL EFFECTIVE DATE: 4/30/2019

MOST RECENT REVIEW DATE:  5/31/2019

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.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 100 mg 

DIAGNOSIS

MAXIMUM UNITS

CLL/SLL

Initial therapy – Loading dose: 10 units x 1 dose, Subsequent doses: 13 units every 28 days x 5 doses per 6 months

Renewal therapy - 10 units per dose every 8 weeks x 4 doses per 6 months

All other oncology indications

Initial therapy -  10 units per dose weekly x 8 doses per 6 months

Renewal therapy - 10 units per dose every 8 weeks x 4 doses per 6 months

Pemphigus Vulgaris

Initiation - 10 units every 14 days x 2 doses in a 12 month period Maintenance - 5 units every 16 weeks

Rheumatoid Arthritis (RA )

10 units per dose every 14 days x 2 doses in a 16 week period

cGVHD

10 units per dose weekly x 4 doses, then 10 units monthly x 4 months

All other non-oncology indications

10 units per dose weekly x 4 doses in a 6 month period