Subject: Tymlos 1826-A SGM P2022b
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 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 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])
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 ANY 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:
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. 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. December 2022.
- Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; September 1, 2022. Accessed October 10, 2022.
- 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. 2020 ;26 (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 10, 2022.
- 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.
- 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.
September 03, 2023
