Subject: Tymlos 1826-A SGM P2023
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 of postmenopausal women with osteoporosis at high risk for fracture (defined as
history of osteoporotic fracture or multiple risk factors for fracture), or patients who have
failed or are intolerant to other available osteoporosis therapy.
B. Treatment to increase bone density 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.
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 Section III.
III. CRITERIA FOR INITIAL APPROVAL
A. Postmenopausal osteoporosis
Authorization of an initial total of 12 months may be granted to postmenopausal members
with osteoporosis when EITHER of the following criteria is met:
1. Member has a history of fragility fractures
2. 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:
i. 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)
ii. Member has failed prior treatment with or is intolerant to previous injectable
osteoporosis therapy (e.g., zoledronic acid [Reclast], denosumab [Prolia],
teriparatide [Forteo, Bonsity])
iii. 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 an initial total of 12 months may be granted to male members with
osteoporosis when EITHER of the following criteria is met:
1. Member has a history of an osteoporotic vertebral or hip fracture
2. Member meets BOTH of the following criteria:
i. 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)
ii. 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)
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 have not experienced clinically significant adverse events during therapy.
V. OTHER
The cumulative duration of parathyroid hormone analogs (teriparatide and abaloparatide) will
not exceed a total of 24 months in the member’s lifetime.
VI. APPENDICES
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. FRAX Fracture Risk Assessment Tool
• 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://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:
- Tymlos [package insert]. Boston, MA: Radius Health, Inc.; June 2023.
- Miller PD, Hattersley G, Riis BJ, et al. Effect of Abalaoparatide Vs Placebo on New Vertebral Fractures in Postmenopausal Women with Osteoporosis: A Randomized Clinical Trial. JAMA. 2016; 316 (7): 722:733.
- 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.
- FRAX® Fracture Risk Assessment Tool. © Centre for Metabolic Bone Diseases, University of Sheffield, UK. Available at: https://www.shef.ac.uk/FRAX. Accessed October 5, 2023.
- Ensrud KE, Crandall CJ. Osteoporosis. Ann Intern Med. 2017;167(03): ITC17–ITC32.
- 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.
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 14, 2024
