Denosumab (Prolia®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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.
A. FDA-Approved Indications
1. Treatment of postmenopausal women with osteoporosis 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
2. Treatment to increase bone mass in men with osteoporosis 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
3. Treatment of glucocorticoid-induced osteoporosis at high risk for fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months
4. Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for non-metastatic prostate cancer
5. Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
B. Compendial Uses
1. Prevention or treatment of osteoporosis during androgen deprivation therapy for prostate cancer in patients with high fracture risk
2. Consider in postmenopausal (natural or induced) patients receiving adjuvant aromatase inhibition therapy along with calcium and vitamin D supplementation to maintain or improve bone mineral density and reduce risk of fractures
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: Supporting chart notes or medical record indicating a history of fractures, T-score, and FRAX fracture probability as applicable to Sections III.A, III.B, and III.C.
III. CRITERIA FOR INITIAL APPROVAL
A. Postmenopausal osteoporosis
Authorization of 12 months may be granted to postmenopausal members with osteoporosis when EITHER 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 -2.5OR 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) and meets ANY of the following criteria:
a. Member has indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores [less than or equal to -3], or increased fall risk)
b. Member has failed prior treatment with or is intolerant to previous injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], teriparatide [Forteo, Bonsity], abaloparatide [Tymlos])
c. Member has had an oral bisphosphonate trial of at least 1-year duration or there is a clinical reason to avoid treatment with an oral bisphosphonate (See Appendix A)
B. Osteoporosis in men
Authorization of 12 months may be granted to male members with osteoporosis when EITHER of the following criteria are met:
1. Member has a history of an osteoporotic vertebral or hip fracture
2. Member meets BOTH of the following criteria:
a. Member has a pre-treatment T-score less than or equal to -2.5 OR 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)
b. Member has had an oral OR injectable bisphosphonate trial of at least 1-year duration OR there is a clinical reason to avoid treatment with a bisphosphonate (See Appendix A)
C. Glucocorticoid-induced osteoporosis
Authorization of 12 months may be granted to members with glucocorticoid-induced osteoporosis when ALL of the following criteria are met:
1. Member is currently receiving or will be initiating glucocorticoid therapy at an equivalent prednisone dose of ≥ 2.5 mg/day for ≥ 3 months.
2. Member has had an oral OR injectable bisphosphonate trial of at least 1-year duration OR there is a clinical reason to avoid treatment with a bisphosphonate (See Appendix A)
3. Member meets ANY of the following criteria:
a. Member has a history of a fragility fracture
b. Member has a pre-treatment T-score 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. Breast cancer
Authorization of 12 months may be granted to members who are receiving adjuvant aromatase inhibition therapy for breast cancer.
E. Prostate cancer
Authorization of 12 months may be granted to members who are receiving androgen deprivation therapy for prostate cancer.
IV. CONTINUATION OF THERAPY
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:
A. Member has received less than 24 months of therapy and has not experienced clinically significant adverse events during therapy
B. Member has received 24 months of therapy or more and meets both of the following:
1. Member has experienced clinical benefit (i.e., improvement or stabilization in T-score since the previous bone mass measurement)
2. Member has not experienced any adverse effects
V. 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 oral bisphosphonate 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.
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Prolia (Denosumab) |
Breast Cancer, Osteoporosis (Post-menopausal, in men, or glucocorticoid-induced), Prostate Cancer |
Route of Administration: Subcutaneous 60mg every 6 months |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Prolia [package insert]. Thousand Oaks, CA: Amgen Inc.; May 2022. Accessed January 2023
2. The NCCN Drugs & Biologics Compendium™ © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed October 5, 2023.
3. LeBoff MS, Greenspan SL, Insogna KL, et al. The clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int. 2022;33(10):2049-2102.
4. 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. May 26, 2020;26 (Suppl 1):1-46.
5. Shoback D, Rosen CJ, Black DM, et al. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. May 2020;105(3):587-594.
6. Carey JJ. What is a ‘failure’ of bisphosphonate therapy for osteoporosis? Cleve Clin J of Med. 2005;72(11):1033-1039.
7. 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.
8. Gralow JR, Biermann S, Farooki A, et al NCCN Task Force Report: Bone Health in Cancer Care. JNCCN. August 2013; 11(Suppl 3):S1-50.
9. FRAX® Fracture Risk Assessment Tool. © Centre for Metabolic Bone Diseases, University of Sheffield, UK. Available at: https://www.shef.ac.uk/FRAX. Accessed October 6,2023.
10. 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. August 2017;69(8):1521-1537.
11. Ensrud KE, Crandall CJ. Osteoporosis. Ann Intern Med. August 2017;167(03):ITC17–ITC32.
ORIGINAL EFFECTIVE DATE: 11/13/2010
MOST RECENT REVIEW DATE: 6/11/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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