Subject: Tymlos 1826-A SGM P2021
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
Tymlos is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, 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
Postmenopausal osteoporosis
Authorization of an initial total of 12 months may be granted to postmenopausal members with osteoporosis when ANY of the following criteria are met:
A. Member has a history of fragility fractures
B. 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:
1. 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)
2. Member has failed prior treatment with or is intolerant to previous injectable osteoporosis therapy
(e.g., zoledronic acid [Reclast], denosumab [Prolia])
3. 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)
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 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.
B. Member has experienced clinical benefit (e.g. no new fracture seen on radiography) and has 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.
Special Notes:
VI. 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://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]. Waltham, MA: Radius Health, Inc. September 2021.
- Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; March 21, 2019. Accessed October 7, 2020.
- 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 and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis 2020. Endocr Pract. 2016;22 (Suppl 1):1-46.
- FRAX® Fracture Risk Assessment Tool. © Centre for Metabolic Bone Diseases, University of Sheffield, UK. Available at: https://shef.ac.uk/FRAX. Accessed October 13,2021
- Ensrud KE, Crandall CJ. Osteoporosis. Ann Intern Med 2017;167(03):ITC17–ITC32.
- Eastell R, Rosen CJ, Black DM, et al. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2019;104:1595-1622.
- Carey, John. What is failure of bisphosphonate therapy for osteoporosis. Cleve Clinic J Med. 2005; 72:1033-1039.
- 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.
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
