CurrentUnitedHealthcarePolicy N/A

Tymlos (abaloparatide) prior authorization — coverage criteria

Prior authorization criteria and utilization management for Tymlos (abaloparatide) for treatment of osteoporosis in adults, describing who is eligible and limits on duration of therapy for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyTymlos (abaloparatide) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2025

Next Review DateOct 1, 2025

Key ActionObtain prior authorization; approvals issued for up to 24 months with documentation of diagnosis and fracture risk or prior therapy failure.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

24 monthsmaximum cumulative parathyroid hormone analog therapy duration

postmenopausal women & menindicated patient populations

12/1/2025policy effective date

P&T through 10/2025policy review history

Coverage Criteria for Tymlos (abaloparatide)

Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Primary eligibility

Sex/Diagnosis: (female AND diagnosis of postmenopausal osteoporosis) OR (male AND diagnosis of osteoporosis)

Risk or prior therapy: Patient is at high risk of fracture (examples: recent fracture within the past 12 months; fractures while on approved osteoporosis therapy; multiple fractures; fractures while on drugs causing skeletal harm such as long-term glucocorticoids; very low T-score e.g., < -3.0; high fall risk or history of injurious falls; very high fracture probability by FRAX e.g., major fracture >30% or hip >4.5%) OR patient has history of failure, intolerance, or contraindication to other available osteoporosis therapy (e.g., alendronate, denosumab, risedronate, zoledronate).

Examples and guidance per AACE/ACE and Endocrine Society and policy.

Continuation Therapy / Duration Limit — Coverage limited by cumulative lifetime exposure:

Policy Summary

PayerUnitedHealthcare

PolicyTymlos (abaloparatide) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2025

Next Review DateOct 1, 2025

Key ActionObtain prior authorization; approvals issued for up to 24 months with documentation of diagnosis and fracture risk or prior therapy failure.

SourceLink

On This Page

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Coverage limited by cumulative lifetime exposure:

Duration limit: Treatment duration has not exceeded a total of 24 months cumulative use of parathyroid hormone analogs (e.g., Teriparatide/Forteo, Tymlos) during the patient's lifetime.<= 24 months cumulative

Authorization will be issued for up to 24 months.

Coverage for Tymlos (abaloparatide) is provided when the member meets the defined clinical eligibility and risk criteria and when total cumulative exposure to parathyroid hormone analogs has not exceeded the lifetime limit. Prior authorization is required; when approved, authorization will be issued for up to 24 months. Documentation supporting sex and diagnosis (postmenopausal osteoporosis for females or osteoporosis for males) and evidence that the patient either is at high/very high fracture risk or has a history of failure, intolerance, or contraindication to other osteoporosis therapies should be submitted to support approval.

Requests may be approved based on submitted clinical documentation or on prior claim/medication history and claim logic. Historical bone mineral density (BMD) results, prior medication trials, ICD-10 diagnosis codes, and prior claims can be used to determine eligibility and to support initial approvals or re‑authorizations. Absent adequate documentation of the required diagnosis, fracture risk or alternative-therapy failure/intolerance, or cumulative therapy within limits, requests may be denied.

Use of Tymlos or other parathyroid hormone analogs beyond a cumulative 24 months in a patient’s lifetime is not covered. This limit reflects clinical guidance and available evidence: the safety and efficacy of abaloparatide have not been evaluated beyond 2 years, and major guideline bodies recommend limiting treatment to 2 years.

Because longer-term safety and benefit are unsupported by the evidence, cumulative parathyroid hormone analog therapy exceeding 24 months is considered not medically necessary and will not be authorized.

Initial Therapy Requirements

Initial Therapy — Initial approval requires all listed eligibility elements.

Initial approval requires all listed eligibility elements.

Initial approval: Patient meets sex/diagnosis requirement AND meets either high fracture risk OR history of failure/intolerance/contraindication to other osteoporosis therapies.

Other therapies include examples such as alendronate, denosumab, risedronate, zoledronate.

Continuation and Renewal Criteria

Continuation Therapy — Continuation/renewal allowed only if cumulative lifetime use does not exceed 24 months.

Continuation/renewal is allowed only if cumulative lifetime use does not exceed 24 months.

Continuation criteria: Cumulative parathyroid hormone analog therapy ≤ 24 months total in patient's lifetime.<= 24 months

Authorization issued for up to 24 months; use beyond 24 months is not recommended due to lack of safety/efficacy data.

Coding and Duration Limits

inv-05: Treatment duration limit

Treatment duration limitCumulative parathyroid hormone analog therapy ≤ 24 months total during the patient’s lifetime (i.e., not to exceed 2 years), authorization issued for up to 24 months

Policy rationaleSafety and efficacy of Tymlos have not been evaluated beyond 2 years of treatment; cumulative use >2 years is not recommended

Applies toAll parathyroid hormone analogs (examples: abaloparatide/Tymlos, teriparatide/Forteo) counted toward the lifetime 24-month limit

Effect on coverageUse beyond 24 months cumulative lifetime exposure is considered not covered/not medically necessary

Authorization practicePrior authorization will be issued for up to 24 months and re-authorization requires documentation that cumulative use remains ≤ 24 months

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for this therapy. Authorization will be issued for up to 24 months and may be approved based on submitted clinical documentation. Coverage duration is limited to a cumulative total of 24 months of parathyroid hormone analog therapy (e.g., Teriparatide, Forteo, Tymlos) during the member's lifetime. State mandates, federal requirements, and the member's specific benefit plan may affect coverage.

Authorization duration: up to 24 months (lifetime cumulative limit = 24 months for parathyroid hormone analogs)

Step Therapy

Step / Alternative Therapy Requirement

Coverage requires documentation of either high fracture risk OR a history of failure, intolerance, or contraindication to other available osteoporosis therapies (for example, alendronate, denosumab, risedronate, zoledronate). High fracture risk examples include recent fracture (e.g., within 12 months), fractures while on approved osteoporosis therapy, multiple fractures, very low T-score (e.g., < -3.0), high FRAX probability (e.g., major osteoporotic fracture >30% or hip fracture >4.5%), or history of injurious falls.

Documentation Required

Documentation and Automated Approval Note

UnitedHealthcare may approve initial requests and re-authorizations based solely on previous claim/medication history, diagnosis codes (ICD-10), and claim logic. Use of automated approval and re-approval processes varies by program and therapeutic class. Historical bone mineral density (BMD) results may be referenced when available.

Approval sources may include prior claims, medication history, and ICD-10 diagnosis codes
Automated approval processes vary by program; historical BMD may be used

Denial Risk

Documentation Triggers for Denial

Requests that do not document required patient sex, specific diagnosis (e.g., postmenopausal osteoporosis for females or osteoporosis for males), fracture risk assessment, or prior therapy information (failure/intolerance/contraindication when applicable) may be denied. Lack of documentation demonstrating cumulative lifetime parathyroid hormone analog use (to enforce the 24-month lifetime limit) may also result in denial.

Missing patient sex or diagnosis may trigger denial
Absent fracture risk documentation or prior therapy trial/contraindication documentation may trigger denial
Failure to document prior cumulative parathyroid hormone analog use may result in denial

Step Therapy / Alternative Therapy Conditions

Step	Requirement
1	Patient must have either high risk of fracture (examples: recent fracture within 12 months; fractures while on approved osteoporosis therapy; multiple fractures; fractures while on drugs causing skeletal harm such as long-term glucocorticoids; very low T-score e.g., < -3.0; high fall risk or history of injurious falls; very high fracture probability by FRAX® e.g., major fracture >30% or hip >4.5%) OR history of failure, intolerance, or contraindication to other available osteoporosis therapy (e.g., alendronate, denosumab, risedronate, zoledronate).

Step

Requirement

Patient must have either high risk of fracture (examples: recent fracture within 12 months; fractures while on approved osteoporosis therapy; multiple fractures; fractures while on drugs causing skeletal harm such as long-term glucocorticoids; very low T-score e.g., < -3.0; high fall risk or history of injurious falls; very high fracture probability by FRAX® e.g., major fracture >30% or hip >4.5%) OR history of failure, intolerance, or contraindication to other available osteoporosis therapy (e.g., alendronate, denosumab, risedronate, zoledronate).

Key Definitions

inv-11: Very high fracture risk

Definition (examples)Very high fracture risk includes: recent fracture within the past 12 months; fracture(s) while on approved osteoporosis therapy; multiple fractures; fracture(s) while on drugs causing skeletal harm (e.g., long-term glucocorticoids); very low T-score (e.g., < -3.0); high fall risk or history of injurious falls; very high FRAX probability (e.g., major osteoporotic fracture >30% or hip fracture >4.5%).

Guideline sourceDefinition and examples derived from AACE/ACE and Endocrine Society recommendations for identifying very high fracture risk

Clinical implicationsPatients meeting any of these examples may be considered for anabolic therapy (e.g., abaloparatide) as initial therapy

Examples of drug-related riskFractures occurring while on approved osteoporosis therapy or while taking drugs that cause skeletal harm (such as long-term glucocorticoids) qualify as indicators of very high fracture risk.

Risk threshold metricsNumeric thresholds cited include T-score < -3.0, FRAX major fracture probability >30%, FRAX hip fracture probability >4.5%

Background and Drug Information

Abaloparatide (Tymlos) is a human parathyroid hormone analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture and to increase bone density in men with osteoporosis at high risk for fracture. Guideline groups (AACE/ACE and the Endocrine Society) recommend abaloparatide for patients unable to use oral therapy and for those at very high fracture risk, and they advise restricting treatment duration to 2 years because long‑term safety and efficacy beyond that period have not been established.