Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Romosozumab-aqqg (Evenity) may be considered medically necessary when the following criteria are met:
-
The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
-
ONE of the following:
-
The individual must have a current BMD T-score less than or equal to -2.5;
or
-
The individual has a new fracture (as evidenced by submitted documentation) after a 6-month trial of teriparatide, as evidenced by paid claims or printouts;
and
-
The individual must be at high risk of fracture, confirmed by documentation of at least one of the following:
-
A history of hip or vertebral fracture;
or
-
A T-score of −2.5 or lower at the femoral neck or spine;
or
-
A T-score of between −1.0 and −2.5 at the femoral neck or spine and a ten-year hip fracture risk of greater than or equal to 3% as assessed with the FRAX;
or
- A10-year risk of a major osteoporosis-related fracture of greater than or equal to 20% as assessed with the FRAX.
NOTE:
Romosozumab (Evenity) is limited to a one year approval per lifetime.
The use of romosozumab-aqqg (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
