Teriparatide Products - PA, NF
Indications for Prior Authorization
Forteo (teriparatide injection), Teriparatide (teriparatide injection)
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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, teriparatide reduces the risk of vertebral and nonvertebral fractures. -
For diagnosis of 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. -
For diagnosis of 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.
Criteria
Brand Forteo, Brand Teriparatide, generic teriparatide
Prior Authorization (Initial Authorization)
Length of Approval: 24 Month(s)
For diagnosis of Postmenopausal osteoporosis or osteopenia at high risk for fracture, Primary or hypogonadal osteoporosis or osteopenia at high risk for fracture
- Diagnosis of one of the following:
- Postmenopausal osteoporosis or osteopenia
- Primary or hypogonadal osteoporosis or osteopenia
- One of the following: [2,4,8,10,D]
- 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])
- 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: [F]
- 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
- For Brand Forteo, trial and failure or intolerance to all of the following:
- Brand Teriparatide
- Generic teriparatide
- Tymlos (abaloparatide)
- One of the following: [7,B]
- Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime OR
- 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])
Brand Forteo, Brand Teriparatide, generic teriparatide
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Postmenopausal osteoporosis or osteopenia at high risk for fracture, Primary or hypogonadal osteoporosis or osteopenia at high risk for fracture
- One of the following: [7,B]
- Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime OR
- 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 Brand Forteo, trial and failure or intolerance to all of the following:
- Brand Teriparatide
- Generic teriparatide
- Tymlos (abaloparatide)
Brand Forteo
Non Formulary
Length of Approval: 24 Month(s)
For diagnosis of Postmenopausal osteoporosis or osteopenia at high risk for fracture, Primary or hypogonadal osteoporosis or osteopenia at high risk for fracture
- Diagnosis of one of the following:
- Postmenopausal osteoporosis or osteopenia
- Primary or hypogonadal osteoporosis or osteopenia
- One of the following: [2,4,8,10,D]
- 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
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to one osteoporosis treatment (e.g., alendronate, risedronate, zoledronic acid, Prolia [denosumab])
- 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:
- Paid claims or submission of medical records (e.g., chart notes) confirming 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: [F]
- 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
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to all of the following:
- Brand Teriparatide
- Generic teriparatide
- Tymlos (abaloparatide)
- One of the following: [7,B]
- Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime OR
- 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])
Brand Forteo, Brand Teriparatide, generic teriparatide
Prior Authorization (Initial Authorization)
Length of Approval: 24 Month(s)
For diagnosis of Glucocorticoid-induced osteoporosis at high risk for fracture
- Diagnosis of glucocorticoid-induced osteoporosis 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 [C] AND
- One of the following: [8,A]
- 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) OR
- 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
- 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
- Trial and failure, contraindication, or intolerance to one bisphosphonate (e.g., alendronate) [E] AND
- For Brand Forteo, trial and failure or intolerance to both of the following:
- Brand Teriparatide
- Generic teriparatide
- One of the following: [7,B]
- Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime OR
- 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])
Brand Forteo, Brand Teriparatide, generic teriparatide
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Glucocorticoid-induced osteoporosis at high risk for fracture
- One of the following: [7,B]
- Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime OR
- 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 Brand Forteo, trial and failure or intolerance to both of the following:
- Brand Teriparatide
- Generic teriparatide
Brand Forteo
Non Formulary
Length of Approval: 24 Month(s)
For diagnosis of Glucocorticoid-induced osteoporosis at high risk for fracture
- Diagnosis of glucocorticoid-induced osteoporosis 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 [C] AND
- One of the following: [8,A]
- 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) OR
- 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
- 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
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to one bisphosphonate (e.g., alendronate) [E] AND
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or intolerance to both of the following:
- Brand Teriparatide
- Generic teriparatide
- One of the following: [7,B]
- Treatment duration of parathyroid hormones (e.g., teriparatide, Tymlos [abaloparatide]) has not exceeded a total of 24 months during the patient's lifetime OR
- 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])
P & T Revisions
1970-01-01, 2024-05-23, 2024-01-18, 2024-01-03, 2023-05-12, 2022-04-19, 2021-11-30, 2021-06-25, 2021-04-08, 2021-01-07, 2020-05-25, 2020-04-18
References
- Forteo prescribing information. Eli Lilly and Company. Indianapolis, IN. April 2021.
- 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.
- 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
- 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.
- Per clinical consult with bone disease specialist, September 26, 2011.
- 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.
- Tymlos prescribing information. Radius Health, Inc. Waltham, MA. April 2021.
- Per clinical consultation with endocrinologists. January 23 & 30, 2018.
- 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.
- 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.
- Teriparatide prescribing information. Alvogen, Inc. Morristown, NJ. November 2019.
Revision History
- 2024-05-23: 2024 UM Annual Review. Consolidated criteria for Brand Forteo, Brand Teriparatide and generic teriparatide for diagnoses of postmenopausal osteoporosis and hypogonadal osteoporosis into one criteria bucket without any changes to clinical intent. Added in t/f of Tymlos to Brand Forteo for diagnosis of hypogonadal osteoporosis. Background updates.
- 2024-01-18: Removed OptumRx SP formulary and updated to OptumRx formulary
- 2024-01-03: Addition of generic teriparatide to mirror Brand Forteo PA criteria
- 2023-05-12: 2023 UM Annual Review. Added in "For diagnosis of osteoporosis" and "For diagnosis of osteopenia" to align with Tymlos. No change to clinical intent. Updated criteria for GIC to align with 2022 update from ACR to include GC dosing of at least 30 mg or cumulative GC dose of at least 5 grams per year for high risk stratification of patients.
- 2022-04-19: GPI Reclassification
- 2021-11-30: Updated guideline name, added NF section to Forteo.
- 2021-06-25: Updated references section.
- 2021-04-08: Formulary strategy update for Forteo to require an embedded step through Brand Teriparatide and Tymlos, where appropriate.
- 2021-01-07: Updated criteria to account for Forteo label update allowing longer duration of treatment in patients who remain at or return to having a high risk for fracture.
- 2020-05-25: Added new brand Teriparatide to existing guideline; Removed reference to "Forteo" specifically and changed to "teriparatide" to account for both brand Forteo and Teriparatide products, where applicable; Background updates.
- 2020-04-18: GPI replication update for Forteo (added GPI 3004407000D220, removed GPI 30044070002020).
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