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Romosozumab-aqqg (Evenity)

Section: Injections
Effective Date: October 01, 2019
Revised Date: September 30, 2019

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.

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 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 3% 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 any other indication is considered experimental/investigational, and therefore non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes

J3111

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

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 M80.811A 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 M81.0 M81.8 Z78.310

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