Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Prolia and Biosimilars SGM 2026-A P2024b
Drug
Prolia and Biosimilars
PROLIA(denosumab)
CONEXXENCE(denosumab-bnht)
JUBBONTOI(denosumab-bbdz)
OSPOMYV(denosumab-dssb)
STOBOCLO(denosumab-bmwo)
Policy:
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 Indications1-5
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.
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.
Treatment of glucocorticoid-induced osteoporosis in men and women at high risk of 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.
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer.
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Compendial Uses6
For treatment-related bone loss in patients with prostate cancer receiving androgen deprivation therapy (ADT).
Treatment in postmenopausal (natural or induced) patients with breast cancer receiving adjuvant aromatase inhibition therapy to maintain or improve bone mineral density and reduce risk of fractures.
All other indications are considered experimental/investigational and not medically necessary.
Documentation
Postmenopausal Osteoporosis, Osteoporosis in Men, Glucocorticoid-Induced Osteoporosis
Chart notes or medical record documentation indicating a history of fractures, T-score, and Fracture Risk Assessment Tool (FRAX) fracture probability (if applicable).
Prostate Cancer
Chart notes, medical record documentation, or claims history supporting use of androgen deprivation therapy (ADT).
Breast Cancer
Chart notes, medical record documentation, or claims history supporting use of aromatase inhibition therapy.
Coverage Criteria
Postmenopausal Osteoporosis1-5,7-9
Authorization of 12 months may be granted to postmenopausal members with osteoporosis when EITHER of the following criteria is met:
Member has a history of fragility fractures (e.g., low trauma fracture from force similar to a fall from standing position).
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) and meets ANY of the following criteria:
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)
Member has failed prior treatment with or is intolerant to previous injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], teriparatide [Forteo], abaloparatide [Tymlos])
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)
Osteoporosis in Men1-5,7,10,11
Authorization of 12 months may be granted to male members with osteoporosis when EITHER of the following criteria is met:
Member has a history of an osteoporotic vertebral or hip fracture
Member meets BOTH of the following criteria:
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)
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)
Glucocorticoid-Induced Osteoporosis1-5,10,14
Authorization of 12 months may be granted for members with glucocorticoid-induced osteoporosis when ALL of the following criteria are met:
Member is currently receiving or will be initiating glucocorticoid therapy at an equivalent prednisone dose of ≥ 2.5 mg/day for ≥ 3 months.
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)
Member meets ANY of the following criteria:
Member has a history of a fragility fracture (e.g., low trauma fracture from force similar to a fall from standing position).
Member has a pre-treatment T-score less than or equal to -2.5
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)
Prostate Cancer1-6,12
Authorization of 12 months may be granted to members who are receiving androgen deprivation therapy (ADT) for prostate cancer.
Breast Cancer1-6,12
Authorization of 12 months may be granted to members who are receiving adjuvant aromatase inhibition therapy for breast cancer.
Continuation of Therapy1-5
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 either of the following:
Member has received less than 24 months of therapy and has not experienced clinically significant adverse events during therapy
Member has received 24 months of therapy or more and meets both of the following:
Member has experienced clinical benefit (i.e., improvement or stabilization in T-score since the previous bone mass measurement)
Member has not experienced any adverse effects
Appendix
Appendix A: Clinical Reasons to Avoid Oral Bisphosphonate Therapy9,15
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)
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
High FRAX fracture probability: 10-year major osteoporosis-related fracture risk ≥ 20% or hip fracture risk ≥ 3%
10-year probability; calculation tool available at: https://frax.shef.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:
Conexxence [package insert]. Lake Zurich, IL: Fresenius Kabi USA, LLC; March 2025
Jubbonti [package insert]. Princeton, NJ: Sandoz Inc.; March 2024.
Ospomyv [package insert]. Incheon, South Korea: Samsung Bioepis; February 2025.
Stoboclo [package insert. Incheon, South Korea: Celltrion Inc.; February 2025.
The NCCN Drugs & Biologics Compendium® 2025 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed April 8, 2025.
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.
Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis-2020 update. Endocr Pract. 2020;26 (Suppl 1):1-46.
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. 2020;105(3):587-594.
Carey JJ. What is a ‘failure’ of bisphosphonate therapy for osteoporosis? Cleve Clin J of Med. 2005;72(11):1033-1039.
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.
Gralow JR, Biermann JS, Farooki A, et al. NCCN Task Force Report: Bone Health in Cancer Care. J Natl Compr Canc New. 2013;11(Suppl 3):S1-50.
Humphrey MB, Russell L, Danila MI, et al. 2022 American College of Rheumatology Guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis. Arthritis Rheumatol. 2023;75(12):2088-2012.
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.
