TYMLOS (abaloparatide)

TYMLOS (abaloparatide)

Self-Administration - subcutaneous injection

Diagnosis considered for coverage:

• Postmenopausal women with osteoporosis at high risk of fracture: Indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Tymlos reduces the risk of vertebral fractures and nonvertebral fractures. 
• Increase bone density in men with osteoporosis at high risk for fracture: Indicated 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.

Coverage Criteria:

For diagnosis of postmenopausal osteoporosis or osteopenia and primary/hypogonadal osteoporosis or osteopenia:

• Diagnosis of one of the following
  • Postmenopausal osteoporosis or osteopenia
  • Primary or hypogonadal osteoporosis or osteopenia; AND
• Patient is 18 years of age or older; AND
• One of the following:  
  • For diagnosis of osteoporosis, both of the following: 
    • Bone mineral density (BMD) T-score of -2.5 or lower in the lumbar spine, femoral neck, total hip, or radius (one-third radius site)
    • One of the following: 
      • History of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm
      • Trial and failure, contraindication, or intolerance to one osteoporosis treatment (e.g., alendronate, risedronate, zoledronic acid, Prolia [denosumab]); OR
  • For diagnosis of osteopenia, both of the following: 
    • BMD T-score between -1.0 and -2.5 in the lumbar spine, femoral neck, total hip, or radius (one-third radius site)
    • One of the following: 
      • History of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm, or
      • Both of the following:
        • Trial and failure, contraindication, or intolerance to one osteoporosis treatment (e.g., alendronate, risedronate, zoledronic acid, Prolia [denosumab])
        • One of the following FRAX (Fracture Risk Assessment Tool) 10-year probabilities: 
          • Major osteoporotic fracture at 20% or more in the U.S., or the country-specific threshold in other countries or regions 
          • Hip fracture at 3% or more in the U.S., or the country-specific threshold in other countries or regions; AND 
• Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime 

*Tymlos will not be approved if the patient has already received 24 months of therapy of parathyroid hormones; if the patient has not yet received 24 months of therapy, approval may be granted for the balance of the time remaining.

Reauthorization Criteria:

• Documentation of positive clinical response to therapy (e.g., stable, or improved bone mineral density (BMD), reduction in or no new fractures, reduction in fracture risk); AND
• Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime 

Dosing:

• The recommended dosage is 80 mcg given subcutaneously once a day. 
• Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate.
• The safety and efficacy of TYMLOS have not been evaluated beyond 2 years of treatment. Use of the drug for more than 2 years during a patient’s lifetime is not recommended.

Coverage Duration: 

• Initial: 1 year to assess patient’s response to therapy
• Reauthorization: 1 year
• Approve treatment of all parathyroid hormone analogs to a combined maximum of 2 years.

Authorization is not covered for the following:

• Combination therapy with other osteoporotic agents (e.g. bisphosphonate, calcitonin nasal spray, denosumab [Prolia], raloxifene, teriparatide [Forteo])
• Glucocorticoid-induced osteoporosis 
• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
 

• The WHO FRAX tool is available at www.shef.ac.uk/FRAX and incorporates multiple clinical factors that predict fracture risk, largely independent of BMD. 

Policy Updates:

• 07/25/2017: New policy approved by P&T. 
• 12/01/2023 – Updated criteria based on revised guidelines and prescribing information. (P&T, 11/14/2023)

References:

1. Tymlos prescribing information. Radius Health, Inc. Waltham, MA. December 2022. 
2. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2020 update. Available at: https://pro.aace.com/disease-state-resources/bone-and-parathyroid/clinical-practice-guidelines/clinical-practice. Accessed May 6, 2021. 
3. National Osteoporosis Foundation. Clinician's guide to prevention and treatment of osteoporosis. Washington (DC): National Osteoporosis Foundation; 2013. 
4. Per clinical consultation with endocrinologists. January 23 & 30, 2018. 
5. Eastell R, Rosen CJ, Black DM, et al. Pharmacological management of osteoporosis in postmenopausal women: An endocrine society clinical practice guideline. J Clin Endocrin Metab. 2019; 104(5):1595-1622. 
6. Watts NB, Adler RA, Bilezikian JP, et al. Endocrine Society. Osteoporosis in men: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(6):1802-22.