Romosozumab-aqqg (Evenity) (ARCHIVED)

Policy ID: I-216-008

Section: Injections

Effective Date: July 15, 2019

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-216-008

Section: Injections

Effective Date: July 15, 2019

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Romosozumab-aqqg (Evenity) is a humanized IgG2 monoclonal antibody and sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Romosozumab (Evenity) has a dual effect of increasing bone formation and, to a lesser extent, decreasing bone resorption.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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.

The use of romosozumab (Evenity) may be considered medically necessary for use in post-menopausal women when all of the following criteria are met:

Diagnosis of osteoporosis; and
Individual is determined to be at high risk for fracture as defined by ONE of the following:
- Individual has a bone mineral density (BMD) T-score of less than or equal to -2.5; or
- Individual has a history of previous hip or vertebral fractures; or
- Individual is 40 years of age and older, has BMD T-score between -1 and -2.5, and has a history of glucocorticoid use for at least three (3) months at a dose of 5mg per day or more of prednisone (or equivalent); or
- Individual has ALL of the following:
  - Individual has BMD T-score between -1 and -2.5; and
  - ONE of the following utilizing the Fracture Risk Algorithm (FRAX) calculator:
    - FRAX 10-year risk of major osteoporotic fracture at 20% or more; or
    - FRAX 10-year risk of hip fracture at 3percent or more; and
Individual has experienced therapeutic failure, contraindication, or intolerance to at least one bisphosphonate; and
Individual is not receiving romosozumab (Evenity) in combination with ANY of the following:
- Parathyroid hormone analogs (e.g., Forteo, Tymlos); or
- RANKL inhibitors (e.g., Prolia, Xgeva); and
Romosozumab (Evenity) is limited to 12 injections per lifetime.

The use of romosozumab (Evenity) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J3111

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

M80.00XA

M80.00XD

M80.00XG

M80.00XK

M80.00XP

M80.00XS

M80.011A

M80.011D

M80.011G

M80.011K

M80.011P

M80.011S

M80.012A

M80.012D

M80.012G

M80.012K

M80.012P

M80.012S

M80.019A

M80.019D

M80.019G

M80.019K

M80.019P

M80.019S

M80.021A

M80.021D

M80.021G

M80.021K

M80.021P

M80.021S

M80.022A

M80.022D

M80.022G

M80.022K

M80.022P

M80.022S

M80.029A

M80.029D

M80.029G

M80.029K

M80.029P

M80.029S

M80.031A

M80.031D

M80.031G

M80.031K

M80.031P

M80.031S

M80.032A

M80.032D

M80.032G

M80.032K

M80.032P

M80.032S

M80.039A

M80.039D

M80.039G

M80.039K

M80.039P

M80.039S

M80.041A

M80.041D

M80.041G

M80.041K

M80.041P

M80.041S

M80.042A

M80.042D

M80.042G

M80.042K

M80.042P

M80.042S

M80.049A

M80.049D

M80.049G

M80.049K

M80.049P

M80.049S

M80.051A

M80.051D

M80.051G

M80.051K

M80.051P

M80.051S

M80.052A

M80.052D

M80.052G

M80.052K

M80.052P

M80.052S

M80.059A

M80.059D

M80.059G

M80.059K

M80.059P

M80.059S

M80.061A

M80.061D

M80.061G

M80.061K

M80.061P

M80.061S

M80.062A

M80.062D

M80.062G

M80.062K

M80.062P

M80.062S

M80.069A

M80.069D

M80.069G

M80.069K

M80.069P

M80.069S

M80.071A

M80.071D

M80.071G

M80.071K

M80.071P

M80.071S

M80.072A

M80.072D

M80.072G

M80.072K

M80.072P

M80.072S

M80.079A

M80.079D

M80.079G

M80.079K

M80.079P

M80.079S

M80.08XA

M80.08XD

M80.08XG

M80.08XK

M80.08XP

M80.08XS

M80.0AXA

M80.0AXD

M80.0AXG

M80.0AXK

M80.0AXP

M80.0AXS

M80.811A

M80.811D

M80.811G

M80.811K

M80.811P

M80.811S

M80.812A

M80.812D

M80.812G

M80.812K

M80.812P

M80.812S

M80.819A

M80.819D

M80.819G

M80.819K

M80.819P

M80.819S

M80.821A

M80.821D

M80.821G

M80.821K

M80.821P

M80.821S

M80.822A

M80.822D

M80.822G

M80.822K

M80.822P

M80.822S

M80.829A

M80.829D

M80.829G

M80.829K

M80.829P

M80.829S

M80.831A

M80.831D

M80.831G

M80.831K

M80.831P

M80.831S

M80.832A

M80.832D

M80.832G

M80.832K

M80.832P

M80.832S

M80.839A

M80.839D

M80.839G

M80.839K

M80.839P

M80.839S

M80.841A

M80.841D

M80.841G

M80.841K

M80.841P

M80.841S

M80.842A

M80.842D

M80.842G

M80.842K

M80.842P

M80.842S

M80.849A

M80.849D

M80.849G

M80.849K

M80.849P

M80.849S

M80.851A

M80.851D

M80.851G

M80.851K

M80.851P

M80.851S

M80.852A

M80.852D

M80.852G

M80.852K

M80.852P

M80.852S

M80.859A

M80.859D

M80.859G

M80.859K

M80.859P

M80.859S

M80.861A

M80.861D

M80.861G

M80.861K

M80.861P

M80.861S

M80.862A

M80.862D

M80.862G

M80.862K

M80.862P

M80.862S

M80.869A

M80.869D

M80.869G

M80.869K

M80.869P

M80.869S

M80.871A

M80.871D

M80.871G

M80.871K

M80.871P

M80.871S

M80.872A

M80.872D

M80.872G

M80.872K

M80.872P

M80.872S

M80.879A

M80.879D

M80.879G

M80.879K

M80.879P

M80.879S

M80.88XA

M80.88XD

M80.88XG

M80.88XK

M80.88XP

M80.88XS

M80.8AXA

M80.8AXD

M80.8AXG

M80.8AXK

M80.8AXP

M80.8AXS

M81.0

M81.8

Z78.310

Professional Statements and Societal Positions Guidelines

No Applicable

ND Committee Review

Internal Medical Policy Committee 7-16-2019 Adopted policy Effective July15,2020

Internal Medical Policy Committee 9-26-2019

Added new code J3111

Internal Medical Policy Committee 9-21-2020

Added additional diagnosis codes

Internal Medical Policy Committee 1-19-2021

Added one additional 'or' criteria 'Individual is 40 years of age and older, has BMD T-score between -1 and -2.5, and has a history of glucocorticoid use for at least three (3) months at a dose of 5mg per day or more of prednisone (or equivalent)'

Internal Medical Policy Committee 3-23-2022 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

Updated experimental/investigational statement

Internal Medical Policy Committee 3-19-2024 Effective May 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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