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Parathyroid Hormone Analog for Osteoporosis Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1065
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
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 |
*generic available |
1 |
Teriparatide |
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 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
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-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)
|
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 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 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)
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) |
REFERENCES
Number |
Reference |
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/ |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
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 |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
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 |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
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 |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
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 |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
FORTEO - brand non-preferred, generic preferred |
FORTEO will be approved when ALL of the following are met:
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:
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:
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 CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 2 years |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ CSReg _ Parathyroid_Hormone_Analog_for_Osteoporosis_PAQL _ProgSum_ 10-01-2024