FORTEO (teriparatide)

FORTEO (teriparatide)

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, teriparatide reduces the risk of vertebral and nonvertebral fractures. 
• Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture: Indicated to increase bone mass in men with primary or hypogonadal 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. 
• Men and women with glucocorticoid-induced osteoporosis at high risk for fracture: Indicated for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) 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.

Coverage Criteria:

For diagnosis of postmenopausal osteoporosis or osteopenia:

• Diagnosis of postmenopausal 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 
• For Forteo only: Trial and failure or intolerance to both of the following: 
  • Brand Teriparatide 
  • Tymlos (abaloparatide); AND
• One of the following:
  • Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime 
  • Patient remains at or has returned to having a high risk for fracture despite a total of 24 months of use of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) 

For diagnosis of primary or hypogonadal osteoporosis or osteopenia: 

• Diagnosis of postmenopausal 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 
• For Forteo only: Trial and failure or intolerance to Brand Teriparatide; AND 
• One of the following:
  • Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime 
  • Patient remains at or has returned to having a high risk for fracture despite a total of 24 months of use of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) 

For diagnosis of glucocorticoid-induced osteoporosis:

• Diagnosis of glucocorticoid-induced osteoporosis; AND
• Patient is 18 years of age or older; AND
• History of prednisone or its equivalent at a dose greater than or equal to 5 mg/day for greater than or equal to 3 months; AND
• One of the following:
  • BMD T-score less than or equal to -2.5 based on BMD measurements from lumbar spine, femoral neck, total hip, or radius (one-third radius site) 
  • 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 
  • History of one of the following fractures resulting from minimal trauma: vertebral compression fracture, fracture of the hip, fracture of the distal radius, fracture of the pelvis, or fracture of the proximal humerus 
  • One of the following: 
    • Glucocorticoid dosing of at least 30 mg per day 
    • Cumulative glucocorticoid dosing of at least 5 grams per year; AND 
• Trial and failure, contraindication, or intolerance to one bisphosphonate (e.g., alendronate); AND
• Forteo only: Trial and failure or intolerance to Brand Teriparatide; AND 
• One of the following:
  • Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime 
  • Patient remains at or has returned to having a high risk for fracture despite a total of 24 months of use of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide])

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
• One of the following:
  • Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime 
  • Patient remains at or has returned to having a high risk for fracture (e.g. patient has a fracture while on osteoporosis therapy or long-term glucocorticoids, a history of multiple fractures, T-score ≤ -3.0, etc.) despite a total of 24 months of use of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide])

Dosing:

• The recommended dosage is 20 mcg given subcutaneously once a day. 
• Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate.
• Use of FORTEO for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture.

Coverage Duration: 

• Initial: 1 year to assess patient’s response to therapy
• Reauthorization: 1 year

Authorization is not covered for the following:

• Combination therapy with other osteoporotic agents (e.g. abaloparatide [Tymlos], bisphosphonate, calcitonin nasal spray, denosumab [Prolia], raloxifene)
• 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: 

• According to the American College of Rheumatology (ACR) guidelines for the prevention and treatment of glucocorticoid-induced osteoporosis, patients considered at high risk of fractures are as follows: (a) prior osteoporotic fracture, (b) a hip or spine BMD T-score less than or equal to -2.5,(c) FRAX 10-year risk of hip or major osteoporotic fracture at 3 percent or more and 20 percent or more, respectively, or (d) glucocorticoid use of at least 30mg per day or cumulative glucocorticoid doses of at least 5 grams per year. 
• Use for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture. 
• Most of the evidence supporting the efficacy of Forteo is based on studies evaluating its use in the treatment of glucocorticoid-induced osteoporosis (GIOP). To identify high risk patients, the GIOP studies (Saag et al, 2009) included patients with a history of prednisone or its equivalent at a dose greater than or equal to 5 mg/day for greater than or equal to 3 months. 
• According to AACE, alendronate, risedronate, zoledronic acid, or denosumab have evidence for broad spectrum anti-fracture efficacy (spine, hip, nonvertebral fracture risk reduction) and are appropriate as initial therapy for most patients at high risk of fracture. Raloxifene or ibandronate may be appropriate initial therapy in some cases where patients requiring drugs with spine-specific efficacy. Teriparatide has been shown to reduce the risk of vertebral and nonvertebral fractures. It is recommended for patients with very high fracture risk or those in whom bisphosphonate therapy has been ineffective. 
• According to ACR, oral bisphosphonates are considered first-line for patients with glucocorticoid-induced osteoporosis at high risk for fractures. For patients in whom oral bisphosphonates are not appropriate, IV bisphosphonates should be considered. If bisphosphonate therapy is not appropriate, teriparatide should be considered. 
• 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:

• 12/02/2013 – New policy approved by P&T. 
• 12/01/2023 – Updated criteria based on revised guidelines and prescribing information. Added Brand Teriparatide into criteria. (P&T, 11/14/2023) 

References:

1. Forteo prescribing information. Eli Lilly and Company. Indianapolis, IN. April 2021. 
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. North American Menopause Society. Management of postmenopausal osteoporosis in postmenopausal women: 2010 position statement of the North American Menopause Society. Menopause 2010;17(1):25-54. 
5. Per clinical consult with bone disease specialist, September 26, 2011. 
6. Saag KG, Zanchetta JR, Devogelaer JP, et al. Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: thirty-six-month results of a randomized, double-blind, controlled trial. Arthritis Rheum. 2009;60(11):3346-55. 
7. Tymlos prescribing information. Radius Health, Inc. Waltham, MA. April 2021. 
8. Per clinical consultation with endocrinologists. January 23 & 30, 2018. 
9. American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis: 2022 edition. Available at: https://rheumatology.org/glucocorticoid-induced-osteoporosis-guideline. Accessed May 2023. 
10. 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. 
11. Teriparatide prescribing information. Alvogen, Inc. Morristown, NJ. November 2019.