Subject: zoledronic acid-Reclast 2380-A SGM P2021

Drug

RECLAST  (zoledronic acid)

zoledronic acid

Policy:

I.    INDICATIONS 

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications
A.   Treatment and prevention of osteoporosis in postmenopausal women
B.   Treatment to increase bone mass in men with osteoporosis
C.   Treatment and prevention of glucocorticoid-induced osteoporosis in patients expected to be on glucocorticoids
      for at least 12 months
D.   Treatment of Paget’s disease of bone in men and women

All other indications are considered experimental/investigational and not medically necessary.

II.  CRITERIA FOR INITIAL APPROVAL 

A.   Postmenopausal osteoporosis, treatment and prevention
      Authorization of 12 months may be granted to postmenopausal members for treatment or prevention of
      osteoporosis when ANY of the following criteria are met:
      1.   Member has a history of fragility fractures
      2.   Member has a pre-treatment T-score less than or equal to -2.5
      3.   Member has osteopenia (i.e., pre-treatment T-score greater than -2.5 and less than -1)

B.   Osteoporosis in men
       Authorization of 12 months may be granted to male members with osteoporosis when ANY of the following
       criteria are met:
       1.   Member has a history of an osteoporotic vertebral or hip fracture
       2.   Member has a pre-treatment T-score less than or equal to -2.5
       3.   Member has osteopenia (i.e., pre-treatment T-score greater than -2.5 and less than -1) with a high
             pre-treatment FRAX fracture probability (See Appendix B)

C.   Glucocorticoid-induced osteoporosis
      Authorization of 12 months may be granted for members with glucocorticoid-induced osteoporosis when
      BOTH of the following criteria are met:
      1.   Member is currently receiving or will be initiating glucocorticoid therapy at an equivalent prednisone dose
            of greater than or equal to 2.5 mg/day for at least 3 months
      2.   Member meets ANY of the following criteria:
            a.   Member has a history of a fragility fracture
            b.   Member has a pre-treatment T-score of less than or equal to -2.5
            c.   Member has osteopenia (i.e., pre-treatment T-score greater than -2.5 and less than -1) with a
                  high pre-treatment FRAX fracture probability (See Appendix B)

D.   Paget’s disease of bone
      Authorization of one dose (5 mg) may be granted for treatment of Paget’s disease of bone.

III. CONTINUATION OF THERAPY 

A.   Paget’s disease of bone
      All members (including new members) requesting authorization for continuation of therapy must meet
      all initial authorization criteria. 

B.   All other indications
      Authorization of 12 months may be granted for all members (including new members) who are currently
      receiving the requested medication through a previously authorized pharmacy or medical benefit, who
      meet one of the following:
      1.   Member has experienced clinical benefit as evidenced by a bone mass measurement showing an
            improvement or stabilization in T-score compared with the previous bone mass measurement and
            member has not experienced any adverse effects.
      2.   Member has received less than 24 months of therapy and has experienced clinical benefit
            (e.g. no new fracture seen on radiography) and has not experienced clinically significant adverse
            events during therapy.

Special Notes:

IV. APPENDIX
      Appendix A. Clinical reasons to avoid oral bisphosphonate therapy
      •   Presence of anatomic or functional esophageal abnormalities that might delay transit of the
           tablet (e.g. achalasia, stricture, or dysmotility
      •   Active upper gastrointestinal problem (e.g., dysphagia, gastritis, duodenitis, erosive esophagitis, ulcers)
      •   Presence of documented or potential gastrointestinal malabsorption (e.g. gastric bypass procedures, celiac
          disease, Crohn’s disease, infiltrative disorders, etc.)
      •   Inability to stand or sit upright for at least 30 to 60 minutes
      •   Inability to take at least 30 to 60 minutes before first food, drink, or medication of the day
      •   Renal insufficiency (creatinine clearance <35 mL/min)
      •   History of intolerance to an oral bisphosphonate

      Appendix B. WHO Fracture Risk Assessment Tool
      •   High FRAX fracture probability: 10 year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%
      •   10-year probability; calculation tool available at: https://www.sheffield.ac.uk/FRAX/
      •   The estimated risk score generated with FRAX should be multiplied by 1.15 for major osteoporotic fracture
           (including fractures of the spine (clinical), hip, wrist, or humerus) and 1.2 for hip fracture if glucocorticoid
           treatment is greater than 7.5 mg (prednisone equivalent) per day.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Reclast [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2020.
2. Zoledronic acid injection [package insert]. Schaumburg, IL: Sagent Pharmaceuticals, Inc.; August 2021
3. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO:  Wolters Kluwer Health Inc; March 21, 2019. Accessed October 13, 2021.
4. Cosman F, de Beur SJ, LeBoff MS, et al. National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014;25(10): 2359-2381.
5. Jeremiah MP, Unwin BK, Greenwald MH, et al. Diagnosis and management of osteoporosis. Am Fam Physician. 2015;92(4):261-268.
6. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis 2020. Endocr Pract. 2020;26 (Suppl 1):1-46.
7. ACOG Practice Bulletin Number 129: Osteoporosis. Obstet Gynecol. 2012;120(3):718-734.
8. National Institute for Health and Care Excellence. Osteoporosis Overview. Last updated October 13, 2021. Available at: http://pathways.nice.org.uk/pathways/osteoporosis. Accessed October 13, 2021.
9. Treatment to prevent osteoporotic fractures: an update. Department of Health and Human Services, Agency for Healthcare Research and Quality. 2012; Publication No. 12-EHC023-EF. Available at effectivehealthcare.ahrq.gov/lbd.cfm.
10. Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men : an Endocrine Society clinical practice guideline. J Clin Endocr Metab. 2012;97(6):1802-1822.
11. Fink HA, Gordon G, Buckley L, et al. 2017 American College of Rheumatology Guidelines for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis. Arthritis Care Res. 2017;69:1521-1537.
12. Singer FR, Bone HG, Hosking DJ, et al. Paget’s Disease of Bone: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2014; 99(12): 4408-22.
13. FRAX^® Fracture Risk Assessment Tool. © Centre for Metabolic Bone Diseases, University of Sheffield, UK. Available at: https://www.shef.ac.uk/FRAX. Accessed October 13,2021
14. Ensrud KE, Crandall CJ. Osteoporosis. Ann Intern Med 2017;167(03):ITC17–ITC32.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

April 17, 2022