A diagnosis of osteoporosis

(defined as a bone mineral density (BMD) T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to a young-adult reference population OR a clinical diagnosis based on history of a low trauma fracture (fragility fracture) at high risk for fracture;

AND

1. The individual meets one of the following:

A. Individual is at very high risk for fracture as defined by one or more of the following (AACE/ACE 2020):

• Recent fracture (within the past 12 months)
• Fractures while on approved osteoporosis therapy
• Multiple fractures
• Fractures while on drugs causing skeletal harm (e.g. long-term glucocorticoids)
• Very low T-score (less than -3.0)
• High risk for falls or history of injurious falls
• Very high fracture probability by FRAX (fracture risk assessment tool) (e.g. major osteoporosis fracture >30%, hip fracture >4.5%) or other validated fracture risk algorithm;

OR

B. Individual has been refractory to a prior trial of a bisphosphonate; OR

C. Individual is intolerant to or has a contraindication to a bisphosphonate as defined by:

1. Hypersensitivity to TWO bisphosphonates (one of which must be alendronate); OR
2. Pre-existing gastrointestinal disorders (Barrett's esophagus, hypersecretory disorders, delayed esophageal emptying, atrophic gastritis, etc.); OR
3. Inability to stand or sit upright for at least 30 minutes; OR
4. Severe renal insufficiency as defined by creatinine clearance less than 35 mL/min for alendronate agents and zoledronic acid or creatinine clearance less than 30 mL/min for risedronate and ibandronate;

AND

III.

Individual has been refractory to, is intolerant of, or has a contraindication to one of the following:

• Prolia (denosumab); OR
• Forteo or Bonsity (teriparatide); OR
• Tymlos (abaloparatide);

IV.

Individual is not using Evenity (romosozumab-aqqg) in combination with any of the following:

• Prolia (denosumab);
• Bisphosphonates;
• Evista (raloxifene);
• Miacalcin/Fortical (calcitonin nasal spray);
• Reclast (zoledronic acid);
• Forteo or Bonsity (teriparatide);
• Tymlos (abaloparatide);

V.

Individual has utilized Evenity (romosozumab-aqqg) for a total duration of less than 12 months in their lifetime. Requests for Evenity (romosozumab-aqqg) may not be approved when the above criteria are not met and for all other indications.

Quantity Limits

Evenity (romosozumab-aqqg) Quantity Limits

Evenity (romosozumab-aqqg) 105 mg/1.17mL prefilled syringe
2 prefilled syringes per month

Drug Limit Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS
J3111
Injection, romosozumab-aqqg, 1 mg Evenity]

ICD-10 Diagnosis

M80.00XA-M80.88XS Osteoporosis with current pathological fracture
M81.0-M81.8
Osteoporosis without current pathological fracture

Document History

Reviewed: 08/18/2023