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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 |
7/1/2023 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Forteo® 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® 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
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:
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:
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 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 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 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) |
REFERENCES
Number |
Reference |
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 |
|
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 |
|
8 |
|
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/ |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
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 |
|
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 |
Effective Date |
|
||||||||||
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 |
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 |
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 preferred |
PRIOR AUTHORIZATION CRITERIA FOR APPROVAL Preferred Agent (Forteo) will be approved when ALL of the following are met:
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:
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:
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. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
Forteo preferred |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
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:
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:
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. |
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 _ PS _ Parathyroid Hormone Analog for Osteoporosis Prior Authorization with Quantity Limit _ProgSum_ 7/1/2023