Pharmacy Prior Authorization Criteria

Tymlos (abaloparatide injection)

Indications for Prior Authorization

Tymlos (abaloparatide injection)

• For diagnosis of 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.

• For diagnosis of 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.

Criteria

Tymlos

Parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) not to exceed the FDA-recommended treatment duration of 2 years. *Tymlos will not be approved if the patient has already received 24 months of therapy; if the patient has not yet received 24 months of therapy, approval may be granted for the balance of the time remaining.

Prior Authorization

Length of Approval: 24 month(s)*

• One of the following diagnoses:
• Postmenopausal osteoporosis or osteopenia
OR
• Primary or hypogonadal osteoporosis or osteopenia
AND
• One of the following: [2,4,5]
• 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)
AND
• One of the following:
• History of low-trauma fracture of the hip, spine, proximal humerus, pelvis, or distal forearm
OR
• 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)
AND
• 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])
AND
• One of the following FRAX (Fracture Risk Assessment Tool) 10-year probabilities: [A]
• 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 [1,2]

P & T Revisions

2024-05-13, 2023-05-08, 2023-02-17, 2021-12-30, 2021-06-23, 2020-05-29

References

1. Tymlos prescribing information. Radius Health, Inc. Waltham, MA. December 2023.
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. The Bone Health and Osteoporosis Foundation (BHOF). Clinician's guide to prevention and treatment of osteoporosis. Washington (DC): The Bone Health and Osteoporosis Foundation (BHOF); 2022
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.

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Revision History

• 2024-05-13: 2024 UM Annual Review. No criteria changes. Background updates
• 2023-05-08: 2023 UM Annual Review. No criteria changes
• 2023-02-17: Added new indication for Tymlos to increase bone density in men with osteoporosis at high risk for fracture
• 2021-12-30: Added operational note per PA team request.
• 2021-06-23: Updated references section.
• 2020-05-29: Removed reference to "Forteo" as an example of a parathyroid hormone and changed to "teriparatide" where applicable to account for both brand Forteo and Teriparatide products; Background updates.

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