Effective Date

Date of Origin 

10-01-2024            

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

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 of fracture.

*generic available

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

Use of Teriparatide 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 of fracture.

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

Postmenopausal Osteoporosis

The American Association of Clinical Endocrinologists/American College of Endocrinology joint guidelines for postmenopausal osteoporosis state that there are several pathways to diagnose osteoporosis:(5)

• T-score -2.5 or below in the lumbar spine, femoral neck, total proximal femur or distal 1/3 of the radius 
• Low-trauma spine or hip fracture (regardless of bone mineral density)
• T-score between -1.0 and -2.5 and a fragility fracture of proximal humerus, pelvis, or distal forearm
• T-score between -1.0 and -2.5 and high FRAX (Fracture Risk Assessment Tool) (or if available, TBS [trabecular bone score]-adjusted FRAX) fracture based on country-specific thresholds

T-scores represent the number of standard deviations from the normal young-adult mean values, and are used for diagnostic classification in postmenopausal women. However, bone mineral density (BMD) testing is not intended as a treatment threshold. BMD should be combined with other clinical risk factors for fractures for accurate assessment of fracture risk and to guide treatment decisions.  The World Health Organization (WHO) has defined T-score criteria as follows:(5)

• Normal: -1.0 or above
• Osteopenia: T-score between -1.0 and -2.5
• Osteoporosis: T-score at or below -2.5
• Severe or established osteoporosis: -2.5 or below with fragility fracture

Very High-Risk Postmenopausal Women

The 2020 American Association of Clinical Endocrinology (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:(6)

• 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.  

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.

Men over the age of 50

The Endocrine Society recommends pharmacological treatment for men aged 50 or older at high risk of fracture including, but not limited to:(10)

• 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 of the 2012 Endocrine Society clinical practice guideline for Osteoporosis in Men, alendronate, risedronate, zoledronic acid, and teriparatide were recommended.  Denosumab can also be used for men receiving androgen deprivation therapy (ADT) 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)

Treatment

According to the National Osteoporosis Foundation, postmenopausal women and men age 50 and older presenting with the following should be considered for treatment:(3)

• 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

The Endocrine Society also agrees with these treatment thresholds for men with increased fracture risk.(10) In their 2020 Postmenopausal Osteoporosis Guidelines, the AACE stated that osteoporosis can be diagnosed if there is a fragility fracture in the absence of other metabolic bone disease, independent of the T-score.  Thus, patients with a T-score indicating osteopenia, but who have had a fragility fracture of the spine, hip, proximal humerus, pelvis, or distal forearm should be diagnosed with osteoporosis and considered for pharmacologic therapy.(6)  

Glucocorticoid-Induced Osteoporosis

Oral bisphosphonates are currently regarded as the first line option for adults 40 years of age or over receiving long-term glucocorticoids that are at high risk for fracture, based on available population fracture data.  Other options include IV bisphosphonates, parathyroid hormone/parathyroid hormone-related peptide, and denosumab.  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).(8)

Until the effect of concomitant use of osteoporosis agents is better understood, the AACE does not recommend concomitant use of agents for osteoporosis.(4)

Safety

FORTEO and Teriparatide is contraindicated in patients with a hypersensitivity to teriparatide or to any of its excipients.(1,3)

1

FORTEO prescribing Information. Eli Lilly & Co. April 2021.

2

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

3

Teriparatide Prescribing Information. Alvogen, Inc. November 2023.

4

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. https://www.sciencedirect.com/science/article/pii/S1530891X20428277

7

Reference no longer used.

8

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. https://jamanetwork.com/journals/jama/fullarticle/2544640  

10

Endocrine Society Guideline: Osteoporosis in Men: An Endocrine Society Clinical Practice Guideline 2012. 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. https://onlinelibrary.wiley.com/doi/full/10.1002/art.40137

13

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

Tymlos

abaloparatide subcutaneous soln pen-injector

3120 MCG/1.56ML

M ; N ; O ; Y

N

Forteo

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

600 MCG/2.4ML

M ; N ; O ; Y

O ; Y

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

620 MCG/2.48ML

M ; N ; O ; Y

N

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

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

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

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 - brand non-preferred, generic preferred

FORTEO will be approved when ALL of the following are met:

1. ONE of the following:
   1. The requested agent is FORTEO generic equivalent AND ONE of the following:
      1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
      2. The prescriber states the patient has been treated with requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
   2. ALL of the following:
      1. ONE of the following:
         1. The patient has a diagnosis of osteoporosis and BOTH of the following:
            1. ONE of the following:
               1. The patient’s sex is male and ONE of the following:
                  1. The patient’s age is 50 years or over OR
                  2. The requested agent is medically appropriate for the patient’s age and sex OR
               2. The patient's sex is female and ONE of the following:
                  1. The patient is postmenopausal OR
                  2. The requested agent is medically appropriate for the patient’s sex and menopause status AND
            2. ONE of the following:
               1. The requested agent is FORTEO generic equivalent OR
               2. The requested agent is brand FORTEO AND BOTH of the following:
                  1. The patient has an intolerance, hypersensitivity, or has an FDA labeled contraindication to FORTEO generic equivalent that is not expected to occur with the requested agent AND
                  2. The patient has tried and had an inadequate response, has an intolerance, hypersensitivity, or has an FDA labeled contraindication to Tymlos (abaloparatide) OR​​​​​​
         2. 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. ONE of the following:
               1. The requested agent is FORTEO generic equivalent OR
               2. The requested agent is brand FORTEO and t​he patient has an intolerance, hypersensitivity, or has an FDA labeled contraindication to FORTEO generic equivalent that is not expected to occur with the requested agent 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 labeled 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 for osteoporosis (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 total duration of treatment with parathyroid hormone analog(s) for osteoporosis has NOT exceeded 2 years in lifetime OR
   2. The total duration of treatment with parathyroid hormone analog(s) for osteoporosis has exceeded 2 years in lifetime AND the patient is at high risk of fracture (e.g., shown by T-score, FRAX score, continued use of glucocorticoids at a daily equivalent of 5 mg of prednisone or higher)

Length of approval: 

For those who have not yet received a total of 2 years of treatment in their lifetime between FORTEO (teriparatide), Teriparatide, and Tymlos (abaloparatide), approve for up to the remainder of that 2 year therapy which has not yet been received.

For those who have already received a total of 2 years of treatment in their lifetime between FORTEO (teriparatide) or Teriparatide AND is at high risk of fracture, approve for up to 1 year.

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

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Teriparatide - non-preferred

Teriparatide will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of osteoporosis and BOTH of the following:
      1. ONE of the following:
         1. The patient’s sex is male and ONE of the following:
            1. The patient’s age is 50 years or over OR
            2. The requested agent is medically appropriate for the patient’s age and sex OR
         2. The patient's sex is female and ONE of the following:
            1. The patient is postmenopausal OR
            2. The requested agent is medically appropriate for the patient’s sex and menopause status AND
      2. BOTH of the following:
         1. The patient has tried and had an inadequate response, has an intolerance, hypersensitivity, or has an FDA labeled contraindication to FORTEO generic equivalent that is not expected to occur with the requested agent AND
         2. The patient has tried and had an inadequate response, has an intolerance, hypersensitivity, or has an FDA labeled contraindication to Tymlos (abaloparatide) OR​​​​​​
   2. 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 has tried and had an inadequate response, has an intolerance, hypersensitivity, or has an FDA labeled contraindication to FORTEO generic equivalent that is not expected to occur with the requested agent 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 labeled 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
4. 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 for osteoporosis (e.g., abaloparatide) AND
5. The patient does NOT have any FDA labeled contraindications to the requested agent AND
6. ONE of the following:
   1. The total duration of treatment with parathyroid hormone analog(s) for osteoporosis has NOT exceeded 2 years in lifetime OR
   2. The total duration of treatment with parathyroid hormone analog(s) for osteoporosis has exceeded 2 years in lifetime AND the patient is at high risk of fracture (e.g., shown by T-score, FRAX score, continued use of glucocorticoids at a daily equivalent of 5 mg of prednisone or higher)

Length of approval: 

For those who have not yet received a total of 2 years of treatment in their lifetime between FORTEO (teriparatide), Teriparatide, and Tymlos (abaloparatide), approve for up to the remainder of that 2 year therapy which has not yet been received.

For those who have already received a total of 2 years of treatment in their lifetime between FORTEO (teriparatide) or Teriparatide AND is at high risk of fracture, approve for up to 1 year.

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

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Tymlos - preferred

Tymlos will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
   2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) 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 ONE of the following:
            1. The patient’s age is 50 years or over OR
            2. The requested agent is medically appropriate for the patient’s age and sex OR
         2. The patient's sex is female and ONE of the following:
            1. The patient is postmenopausal OR
            2. The requested agent is medically appropriate for the patient’s sex and menopause status 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 labeled 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:  up to the remainder of a total of 2 years of treatment in lifetime between FORTEO (teriparatide), Teriparatide, and Tymlos (abaloparatide). 

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

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. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
   1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
   2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why 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 2 years