Romosozumab-aqqg (Evenity™)

Restricted Product(s)

• romosozumab-aqqg (Evenity™) subcutaneous injection for administration by a healthcare professional

FDA Approved Use

• Romosozumab-aqqg (Evenity™) 
  • Treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary when the following criteria are met:

1. The patient has a confirmed diagnosis of osteoporosis; AND 
2. The patient is at high risk for fracture as defined by one of the following: 
   1. A history of previous osteoporosis related fracture; OR 
   2. A pre-treatment bone mineral density (BMD) T-score of ≤ -3 at the total hip or femoral neck; OR 
   3. A pre-treatment bone mineral density (BMD) T-score of ≤ -2.5 at the total hip or femoral neck, AND one of the following: 
      1. The patient has tried and failed or has an intolerance or contraindication to bisphosphonates; OR 
      2. The patient has tried and failed other injectable osteoporosis therapies (i.e., denosumab, abaloparatide, teriparatide) as defined by fracture with loss of BMD despite compliance with osteoporosis therapy; AND 
3. The requested agent will not be used in combination with other pharmacological agents used to treat osteoporosis; AND 
4. The patient does not have hypocalcemia or hypocalcemia has been corrected prior to initiating therapy with the requested agent; AND 
5. The patient has not had a myocardial infarction or stroke within the preceding year; AND 
6. The total duration of romosozumab (Evenity) therapy will not exceed 12 months; AND 
7. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
8. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*
   
   Duration of Approval: 12 months total duration

*Site of Care Medical Necessity Criteria

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
   4. Re-initiation of therapy, defined as ONE of the following: 
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR 
   5. Requirement of a change in the requested restricted product formulation; AND 
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References

All information referenced is from FDA package insert unless otherwise noted below.

1. Barrionuevo P, Kapoor E, Asi N, et al. Efficacy of pharmacological therapies for the prevention of fractures in postmenopausal women: a network meta-analysis. J Clin Endocrinol Metab. 2019;104(5):1623-30. 
2. Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016;375(16):1532-43. 
3. Cosman F, de Beur SJ, LeBoff MS, et al. National Osteoporosis Foundation (NOF). Clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014;25(10):2359-81. 
4. Saag KG, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med. 2017;377(15):1417-27.

Policy Implementation/Update Information

October 2021: Criteria change: Added Site of Care medical necessity criteria. Policy notification given 8/2/2021 for effective date 10/1/2021.
June 2021: Criteria change: Added maximum units; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.
*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy.