Effective Date

Date of Origin 

7/1/2023

Forteo®
(teriparatide [recombinant])

Injection solution

Treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy

Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy

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 or patients who have failed or are intolerant to other available osteoporosis therapy

1

Teriparatide

Injection solution

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

Increase of 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

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

3

Tymlos®
(abaloparatide)

Injection solution

Treatment of postmenopausal women 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

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.

2

Diagnosis of Osteoporosis

The National Osteoporosis Foundation states that the diagnosis of osteoporosis (OP) can be established by either measurement of bone mineral density (BMD) or by the occurrence of adulthood hip or vertebral fracture in the absence of major trauma (such as a motor vehicle accident or multiple story fall).  For evaluation, BMD measurement should be taken by central dual-energy X-ray absorptiometry at the lumbar spine and femoral neck (hip).  A BMD taken at the one-third (33%) radius site can be used for diagnosing osteoporosis when the hip and lumbar spine cannot be measured or are unusable or uninterpretable.  In postmenopausal women and men age 50 and older, the World Health Organization (WHO) diagnostic T-score criteria is applied to the BMD measurement.  For those patients that are not postmenopausal women and not men age 50 and older, WHO BMD classification should not be applied, and the diagnosis of osteoporosis should not be made on densitometric criteria alone.(5)  

                                         WHO Definitions of bone density(5)

The WHO absolute fracture risk model (Fracture Risk Algorithm, FRAX) was developed to calculate the 10-year probability of a hip fracture and the 10-year probability of a major osteoporotic fracture, taking into account femoral neck BMD and clinical risk factors.   

Treatment

According to the National Osteoporosis Foundation, postmenopausal women and men age 50 and older presenting with the following should be considered for treatment:

• A hip or vertebral fracture
• T-score of -2.5 or lower at the femoral neck, total hip, or lumbar spine (or at the 33% radius site if necessary)
• Low bone mass (T-score between -1 and -2.5) and a 10-year probability of a hip fracture greater than or equal to 3% or a 10-year probability of a major osteoporosis-related fracture greater than or equal to 20% based on the US-adapted WHO algorithm(5)

The American Association of Clinical Endocrinologists (AACE)(6), the Endocrine Society(7), and the North American Menopause Society (NAMS)(8) all agree with these treatment thresholds for postmenopausal women.  The Endocrine Society also agrees with these treatment thresholds for men with increased fracture risk.(9)

Treatment

According to the National Osteoporosis Foundation, postmenopausal women and men age 50 and older presenting with the following should be considered for treatment:

• A hip or vertebral fracture
• T-score of -2.5 or lower at the femoral neck, total hip, or lumbar spine (or at the 33% radius site if necessary)
• Low bone mass (T-score between -1 and -2.5) and a 10-year probability of a hip fracture greater than or equal to 3% or a 10-year probability of a major osteoporosis-related fracture greater than or equal to 20% based on the US-adapted WHO algorithm(5)

The Endocrine Society also agrees with these treatment thresholds for men with increased fracture risk.(9)

Postmenopausal women

The 2020 AACE Guidelines created a ‘very high’ risk category for post-menopausal women with osteoporosis. The following patients are considered to be a very high fracture risk:

• Patients with a recent fracture (within the past 12 months), fractures while on approved osteoporosis therapy multiple fractures, or fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids),
• Patients with a very low T-score (less than -3.0),
• Patients with a high risk for falls or history of injurious falls,
• Patients with very high fracture probability by FRAX (e.g., major osteoporosis fracture greater than 30%, hip fracture greater than 4.5%) or other validated fracture risk algorithm.

Patients who have been diagnosed with osteoporosis but do not meet the above definition of very high fracture risk are to be considered to be at high risk.(6)  

The AACE recommends alendronate, denosumab, risedronate, and zoledronate as appropriate initial therapy for most osteoporotic patients with high fracture risk.  Abaloparatide, denosumab, romosozumab, teriparatide, and zoledronate should be considered for patients unable to use oral therapy and as initial therapy for patients at very high fracture risk.(6)  

Men

The Endocrine Society recommends pharmacological therapy for men at high risk of fracture including, but not limited to:

• Men who have had a hip or vertebral fracture without major trauma
• Men who have not experienced a spine or hip fracture, but whose BMD of the spine, femoral neck, and/or total hip is 2.5 standard deviations below the mean of normal young white males
• In the US, men who have a T-score between -1.0 and -2.5 in the spine, femoral neck, or total hip plus a 10-year risk of hip fracture greater than or equal to 3% using FRAX.  For men outside the US, region-specific guidelines should be considered
• Men who are receiving long-term glucocorticoid therapy in pharmacological doses

Men at high risk of fracture can be treated with medication approved by regulatory agencies such as the U.S. FDA or the European Medicines Agency (EMA) (at the time of this writing, alendronate, risedronate, zoledronic acid, and teriparatide.  Denosumab can also be used for men receiving ADT [androgen deprivation therapy] for prostate cancer).  The selection of therapeutic agent should be individualized based on factors including fracture history, severity of osteoporosis (T-scores), the risk for hip fracture, patterns of BMD, comorbid conditions, cost, and other factors.(10)

The American College of Physicians (ACP) recommends bisphosphonates to reduce the risk for vertebral fracture in men who have clinically recognized osteoporosis.(11)

Glucocorticoid-Induced Osteoporosis

Oral bisphosphonates are currently regarded as first line options on the grounds of their low cost.  However, teriparatide has shown its effects on BMD and vertebral fracture risk in glucocorticoid-treated individuals with osteoporosis and should be considered as an alternative first line option in patients at high risk of vertebral fracture.(12)   The American College of Rheumatology defines high risk of fracture as: adults aged greater than or equal to 40 years, previous osteoporotic fracture, hip or spine BMD T-score less than or equal to -2.5, or 10 year fracture risk of greater than or equal to 20% (major osteoporotic fracture or greater than or equal to 3% (hip fracture).(12)  

Due to the lack of evidence on the effect on fracture risk, concomitant use of osteoporosis agents is not recommended.  There are no head-to-head trials with a preplanned endpoint of reduced fractures comparing one drug with another for osteoporosis.(6)

Safety

Teriparatide carries the following black box warnings:(3)

• In rats, teriparatide caused an increase in the incidence of osteosarcoma, a malignant bone tumor.
• Because of the uncertain relevance of the rat osteosarcoma finding to humans, prescribe teriparatide only for patients for whom potential benefits outweigh potential risk. 
• Teriparatide should not be prescribed for patients at increased baseline risk for osteosarcoma (e.g., those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, pediatric and young adult patients with open epiphyses, or prior external beam or implant radiation therapy involving the skeleton).

In 2020, Forteo received a labeling update regarding length of therapy.  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.  The boxed warning for osteosarcoma was also removed at that time.  Of note, these changes were in the Forteo brand label only, and did not occur in Teriparatide.(1,3)

1

Forteo Prescribing Information. Eli Lilly & Co. Indianapolis, IN. April 2021.

2

Tymlos Prescribing Information.  Radius Health, Inc.  December 2022.

3

Teriparatide Prescribing Information.  Alvogen, Inc.  November 2019  

4

Bonsity Prescribing Information.  Pfenex, Inc.  October 2019.Reference no longer used

5

Cosman F, de Beur SJ, LeBoff MS, et. al. Clinician’s Guide to Prevention and Treatment of Osteoporosis.  National Osteoporosis Foundation, Osteoporosis Int 25:2359-2381, 2014.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176573/pdf/198_2014_Article_2794.pdf  

6

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 Update. Available at https://www.endocrinepractice.org/action/showPdf?pii=S1530-891X%2820%2942827-7 

7

Eastell R, Rosen CL, Black DM, et. al.  Pharmacological Management of Osteoporosis in Postmenopausal Women:  An Endocrine Society Clinical Practice Guideline.  J ClinEndocrinol Metab 104: 1595-1622, 2019. Reference no longer used

8

North American Menopause Society. Management of osteoporosis in postmenopausal women: 2010 position statement of the North American Menopause Society. Menopause. 2010;17(1):25-54.  Available at http://www.menopause.org/docs/default-document-library/psosteo10.pdf  Accessed 6/23/2021.Reference no longer used

9

Miller PD, Hattersley G, Juel Riis B, et al. Effect of abaloparatide vs. placebo on new vertebral fractures in postmenopausal women with osteoporosis. JAMA. 2016;316(7):722-733.  Available at: https://jamanetwork.com/journals/jama/fullarticle/2544640  

10

Endocrine Society Guideline: Osteoporosis in Men: An Endocrine Society Clinical Practice Guideline 2012. Available at: https://academic.oup.com/jcem/article/97/6/1802/2536476  

11

Qaseem A, Forciea MA, McLean RM, et. al.  Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update from the American College of Physicians.  Ann Intern Med. 2017;166:818-839.  https://annals.org/aim/fullarticle/2625385/treatment-low-bone-density-osteoporosis-prevent-fractures-men-women-clinical 

12

Buckley L, Guyatt G, Fink HA, et al. 2017 American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis.  Arthritis and Rheumatology Vol. 69, No. 8, August 2017, pp 1521–1537.  Available at: https://onlinelibrary.wiley.com/doi/full/10.1002/art.40137

13

Compston, J. Glucocorticoid-induced osteoporosis: an update.  Endocrine 2018; 61(1):7-16. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5997116/  

Through Preferred

Tymlos

abaloparatide subcutaneous soln pen-injector

3120 MCG/1.56ML

M ; N ; O ; Y

N

1. Preferred

Forteo

Teriparatide (Recombinant) Soln Pen-inj 600 MCG/2.4ML

600 MCG/2.4ML

M ; N ; O ; Y

N

1. Preferred

Teriparatide (Recombinant) Soln Pen-inj 620 MCG/2.48ML

620 MCG/2.48ML

M ; N ; O ; Y

N

2. Non-Preferred

Forteo

teriparatide (recombinant) soln pen-inj

600 MCG/2.4ML ; 620 MCG/2.48ML

1

PEN

28

DAYS

Tymlos

abaloparatide subcutaneous soln pen-injector

3120 MCG/1.56ML

1

PEN

30

DAYS

Forteo

Teriparatide (Recombinant) Soln Pen-inj 600 MCG/2.4ML

600 MCG/2.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tymlos

abaloparatide subcutaneous soln pen-injector

3120 MCG/1.56ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Teriparatide (Recombinant) Soln Pen-inj 620 MCG/2.48ML

620 MCG/2.48ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Forteo

teriparatide (recombinant) soln pen-inj

600 MCG/2.4ML ; 620 MCG/2.48ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tymlos

abaloparatide subcutaneous soln pen-injector

3120 MCG/1.56ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Forteo preferred

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Preferred Agent (Forteo) will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient is currently being treated with the requested agent within the past 90 days OR
   2. The prescriber states that the patient is currently being treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR
   3. The patient has a diagnosis of osteoporosis and ALL of the following:
      1. ONE of the following:
         1. The patient’s sex is male and the patient’s age is over 50 years OR
         2. The patient is postmenopausal OR
         3. The prescriber has provided information that the requested agent is medically appropriate for the patient’s sex AND
      2. The patient’s diagnosis was confirmed by ONE of the following:
         1. A fragility fracture in the hip or spine OR
         2. A T-score of -2.5 or lower OR
         3. A T-score of -1.0 to -2.5 and ONE of the following:
            1. A fragility fracture of a proximal humerus, pelvis, or distal forearm OR
            2. A FRAX 10-year probability for major osteoporotic fracture of greater than or equal to 20% OR
            3. A FRAX 10-year probability of hip fracture of greater than or equal to 3% AND
      3. ONE of the following:
         1. The patient is at a very high fracture risk as defined by ONE of the following:
            1. Patient had a recent fracture (within the past 12 months) OR
            2. Patient had fractures while on FDA approved osteoporosis therapy OR
            3. Patient has had multiple fractures OR
            4. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids) OR
            5. Patient has a very low T-score (less than -3.0) OR
            6. Patient is at high risk for falls or has a history of injurious falls OR
            7. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture greater than 30%, hip fracture greater than 4.5%) or by other validated fracture risk algorithm OR  
         2. ONE of the following:
            1. The patient has tried and had an inadequate response to a bisphosphonate (medical records required) OR
            2. The patient has an intolerance or hypersensitivity to a bisphosphonate (medical records required) OR
            3. The patient has an FDA labeled contraindication to ALL bisphosphonates (medical records required) OR
   4. The patient has a diagnosis of glucocorticoid-induced osteoporosis and ALL of the following:
      1. The patient is either initiating or currently taking glucocorticoids in a daily dosage equivalent to 5 mg or higher of prednisone AND
      2. The patient’s expected current course of therapy of glucocorticoids is for a period of at least 3 months AND
      3. The patient’s diagnosis was confirmed by ONE of the following:
         1. A fragility fracture in the hip or spine OR
         2. A T-score of -2.5 or lower OR
         3. A T-score of -1.0 to -2.5 and ONE of the following:
            1. A fragility fracture of a proximal humerus, pelvis, or distal forearm OR
            2. A FRAX 10-year probability for major osteoporotic fracture of greater than or equal to 20% OR
            3. A FRAX 10-year probability of hip fracture of greater than or equal to 3% AND
      4. ONE of the following:
         1. The patient is at a very high fracture risk as defined by ONE of the following:
            1. Patient had a recent fracture (within the past 12 months) OR
            2. Patient had fractures while on FDA approved osteoporosis therapy OR
            3. Patient has had multiple fractures OR
            4. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids) OR
            5. Patient has a very low T-score (less than -3.0) OR
            6. Patient is at high risk for falls or has a history of injurious falls OR
            7. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture greater than 30%, hip fracture greater than 4.5%) or by other validated fracture risk algorithm OR  
         2. ONE of the following:
            1. The patient has tried and had an inadequate response to a bisphosphonate (medical records required) OR
            2. The patient has an intolerance or hypersensitivity to a bisphosphonate (medical records required) OR
            3. The patient has an FDA labeled contraindication to ALL bisphosphonates (medical records required) AND
2. The patient will NOT be using the requested agent in combination with a bisphosphonate, denosumab (e.g., Prolia, Xgeva), romosozumab-aqqg or another parathyroid hormone analog (e.g., abaloparatide) AND
3. The patient does NOT have any FDA labeled contraindications to the requested agent AND
4. ONE of the following:
   1. The patient has never received treatment with a parathyroid hormone analog (Teriparatide, Forteo, and Tymlos) OR
   2. The patient has been previously treated with parathyroid hormone analog(s) and ONE of the following:
      1. The total duration of treatment with Forteo (teriparatide), Teriparatide, and Tymlos (abaloparatide) has NOT exceeded 24 months in lifetime OR
      2. BOTH of the following:
         1. The patient has received 24 months or more of parathyroid hormone analog treatment in their lifetime, and is at high risk for fracture (e.g., shown by T-score, FRAX score, continued use of glucocorticoids at a daily equivalent of 5 mg of prednisone or higher) AND
         2. The patient was previously treated with Forteo

Length of approval:  Approve for up to 2 years for new Forteo starts or patients new to the plan’s Prior Authorization process.  Approve for 1 year if patient has already had 2 years of Forteo in lifetime and is at high risk.  Only one parathyroid hormone analog will be approved for use at a time.

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Teriparatide - through preferred

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Non-Preferred Agent(s) Teriparatide will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient is currently being treated with the requested agent within the past 90 days OR
   2. The prescriber states that the patient is currently being treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR
   3. The patient has a diagnosis of osteoporosis AND ALL of the following:
      1. ONE of the following:
         1. The patient’s sex is male AND the patient’s age is over 50 years, AND ONE of the following:
            1. The patient has tried and had an inadequate response to a preferred agent (Forteo) OR
            2. The patient has an intolerance or hypersensitivity to the preferred agents (Forteo) that is not expected to occur with the requested agent OR
            3. The patient has an FDA labeled contraindication to the preferred agent (Forteo) that is not expected to occur with the requested agent OR
         2. The patient is postmenopausal AND ONE of the following:
            1. The patient has tried and had an inadequate response to BOTH of the preferred agents (Forteo AND Tymlos) OR
            2. The patient has an intolerance or hypersensitivity to both of the preferred agents (Forteo AND Tymlos) that is not expected to occur with the requested agent OR
            3. The patient has an FDA labeled contraindication to both of the preferred agents (Forteo AND Tymlos) OR
         3. The prescriber has provided information that the requested agent is medically appropriate for the patient’s sex AND
      2. The patient’s diagnosis was confirmed by ONE of the following:
         1. A fragility fracture in the hip or spine OR
         2. A T-score of -2.5 or lower OR
         3. A T-score of -1.0 to -2.5 and ONE of the following:
            1. A fragility fracture of a proximal humerus, pelvis, or distal forearm OR
            2. A FRAX 10-year probability for major osteoporotic fracture of greater than or equal to 20% OR
            3. A FRAX 10-year probability of hip fracture of greater than or equal to 3% AND
      3. ONE of the following:
         1. The patient is at a very high fracture risk as defined by ONE of the following:
            1. Patient had a recent fracture (within the past 12 months) OR
            2. Patient had fractures while on FDA approved osteoporosis therapy OR
            3. Patient has had multiple fractures OR
            4. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids) OR
            5. Patient has a very low T-score (less than -3.0) OR
            6. Patient is at high risk for falls or has a history of injurious falls OR
            7. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture greater than 30%, hip fracture greater than 4.5%) or by other validated fracture risk algorithm OR  
         2. ONE of the following:
            1. The patient has tried and had an inadequate response to a bisphosphonate (medical records required) OR
            2. The patient has an intolerance or hypersensitivity to a bisphosphonate (medical records required) OR
            3. The patient has an FDA labeled contraindication to ALL bisphosphonates (medical records required) OR
   4. The patient has a diagnosis of glucocorticoid-induced osteoporosis AND ALL of the following:
      1. ONE of the following:
         1. The patient has tried and had an inadequate response to a preferred agent (Forteo) OR
         2. The patient has an intolerance or hypersensitivity to the preferred agent (Forteo) that is not expected to occur with the requested agent OR
         3. The patient has an FDA labeled contraindication to the preferred agent (Forteo) that is not expected to occur with the requested agent AND
      2. The patient is either initiating or currently taking glucocorticoids in a daily dosage equivalent to 5 mg or higher of prednisone AND
      3. The patient’s expected current course of therapy of glucocorticoids is for a period of at least 3 months AND
      4. The patient’s diagnosis was confirmed by ONE of the following:
         1. A fragility fracture in the hip or spine OR
         2. A T-score of -2.5 or lower OR
         3. A T-score of -1.0 to -2.5 and ONE of the following:
            1. A fragility fracture of a proximal humerus, pelvis, or distal forearm OR
            2. A FRAX 10-year probability for major osteoporotic fracture of greater than or equal to 20% OR
            3. A FRAX 10-year probability of hip fracture of greater than or equal to 3% AND
      5. ONE of the following:
         1. The patient is at a very high fracture risk as defined by ONE of the following:
            1. Patient had a recent fracture (within the past 12 months) OR
            2. Patient had fractures while on FDA approved osteoporosis therapy OR
            3. Patient has had multiple fractures OR
            4. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids) OR
            5. Patient has a very low T-score (less than -3.0) OR
            6. Patient is at high risk for falls or has a history of injurious falls OR
            7. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture greater than 30%, hip fracture greater than 4.5%) or by other validated fracture risk algorithm OR
         2. ONE of the following:
            1. The patient has tried and had an inadequate response to a bisphosphonate (medical records required) OR
            2. The patient has an intolerance or hypersensitivity to a bisphosphonate (medical records required) OR
            3. The patient has an FDA labeled contraindication to ALL bisphosphonates (medical records required) AND
2. The patient will NOT be using the requested agent in combination with a bisphosphonate, denosumab (e.g., Prolia, Xgeva), romosozumab-aqqg or another parathyroid hormone analog (e.g., abaloparatide) AND
3. The patient does NOT have any FDA labeled contraindications to the requested agent AND
4. ONE of the following:
   1. The patient has never received treatment with a parathyroid hormone analog (Teriparatide, Forteo, and Tymlos) OR
   2. The patient has been previously treated with parathyroid hormone analog(s) AND the total duration of treatment with Forteo (teriparatide), Teriparatide, and Tymlos (abaloparatide) has NOT exceeded 24 months in lifetime

Length of approval:  up to a total of 2 years of treatment in lifetime between Teriparatide and Tymlos (abaloparatide).  Only one parathyroid hormone analog will be approved for use at a time.

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Tymlos

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

Preferred Agent (Tymlos) will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient is currently being treated with the requested agent within the past 90 days OR
   2. The prescriber states that the patient is currently being treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR
   3. The patient has a diagnosis of osteoporosis AND ALL of the following:
      1. ONE of the following:
         1. The patient’s sex is male and the patient’s age is over 50 years OR
         2. The patient is postmenopausal OR
         3. The prescriber has provided information that the requested agent is medically appropriate for the patient’s sex AND
      2. The patient’s diagnosis was confirmed by ONE of the following:
         1. A fragility fracture in the hip or spine OR
         2. A T-score of -2.5 or lower OR
         3. A T-score of -1.0 to -2.5 and ONE of the following:
            1. A fragility fracture of a proximal humerus, pelvis, or distal forearm OR
            2. A FRAX 10-year probability for major osteoporotic fracture of greater than or equal to 20% OR
            3. A FRAX 10-year probability of hip fracture of greater than or equal to 3% AND
      3. ONE of the following:
         1. The patient is at a very high fracture risk as defined by ONE of the following:
            1. Patient had a recent fracture (within the past 12 months) OR
            2. Patient had fractures while on FDA approved osteoporosis therapy OR
            3. Patient has had multiple fractures OR
            4. Patient had fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids) OR
            5. Patient has a very low T-score (less than -3.0) OR
            6. Patient is at high risk for falls or has a history of injurious falls OR
            7. Patient has a very high fracture probability by FRAX (e.g., major osteoporosis fracture greater than 30%, hip fracture greater than 4.5%) or by other validated fracture risk algorithm OR
         2. ONE of the following:
            1. The patient has tried and had an inadequate response to a bisphosphonate (medical records required) OR
            2. The patient has an intolerance or hypersensitivity to a bisphosphonate (medical records required) OR
            3. The patient has an FDA labeled contraindication to ALL bisphosphonates (medical records required) AND
2. The patient will NOT be using the requested agent in combination with a bisphosphonate, denosumab (e.g., Prolia, Xgeva), romosozumab-aqqg, or another parathyroid hormone analog (e.g., teriparatide) therapy AND
3. The patient does NOT have any FDA labeled contraindications to the requested agent AND
4. The total duration of treatment with Forteo (teriparatide), Teriparatide, and Tymlos (abaloparatide) has NOT exceeded 2 years in lifetime

Length of approval:  For those who have had less than 2 years of treatment in lifetime between Teriparatide, and Tymlos (abaloparatide), approve for the remainder of the 2 years of therapy remaining. Only one parathyroid hormone analog will be approved for use at a time.

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Forteo preferred

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. ALL of the following:
   1. The requested quantity (dose) is greater than the program quantity limit AND
   2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
   3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

Length of approval:  Approve for up to 2 years for new Forteo starts or patients new to the plan’s Prior Authorization process.  Approve for 1 year if patient has already had 2 years of Forteo in lifetime and is at high risk.  Only one parathyroid hormone analog will be approved for use at a time.

Teriparatide - through preferred

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. ALL of the following:
   1. The requested quantity (dose) is greater than the program quantity limit AND
   2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
   3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

Length of approval:  up to a total of 2 years of treatment in lifetime between Teriparatide and Tymlos (abaloparatide).  Only one parathyroid hormone analog will be approved for use at a time.

Tymlos

Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. ALL of the following:
   1. The requested quantity (dose) is greater than the program quantity limit AND 
   2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication OR
   3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

Length of approval:  For those who have had less than 2 years of treatment in lifetime between Teriparatide and Tymlos (abaloparatide), approve for the remainder of the 2 years of therapy remaining.  Only one parathyroid hormone analog will be approved for use at a time.