CurrentUnitedHealthcarePolicy 2025 P 1222-11

UnitedHealthcare Pharmacy Clinical Pharmacy Programs - Tymlos (abaloparatide)

UnitedHealthcare prior authorization policy for Tymlos (abaloparatide) covering indications, clinical criteria for approval, lifetime treatment duration limits, and program rules applicable to commercial pharmacy benefit members.

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs - Tymlos (abaloparatide)

Policy CodePolicy 2025 P 1222-11

Change TypeAnnual review; indication added for men (2/2023)

Effective DateDec 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Tymlos; approvals issued for up to 24 months and limited to cumulative 24 months lifetime of parathyroid hormone analog therapy.

POLICY UPDATE CHANGES

Annual review with no changes to coverage criteria; updated references.

Added new indication for use in men with osteoporosis to background and coverage criteria.

1Covered Drug (Tymlos)

24 monthsMaximum cumulative treatment duration

2Indications (postmenopausal women, men)

Coverage Summary

UnitedHealthcare’s prior authorization policy covers Tymlos (abaloparatide) as a covered_with_criteria therapy for treatment of osteoporosis in postmenopausal women and in men with osteoporosis, when clinical criteria are met. Approvals are contingent on meeting the program’s clinical requirements (sex and diagnosis, evidence of high fracture risk or history of failure/intolerance/contraindication to other osteoporosis therapies) and program rules applicable to commercial pharmacy benefit members. The policy specifies that prior authorization/notification is required and that authorizations will be issued for up to 24 months, with applicability to automated approval processes varying by program.

Initial and Continuation Therapy Criteria

Osteoporosis - Initial and Continuation Approval Criteria

Tymlos will be approved based on ALL of the following criteria:

Top-level criteria

Patient sex and diagnosis
- Female patient with postmenopausal osteoporosis
  - Patient is female
  - Diagnosis of postmenopausal osteoporosis
- Male patient with osteoporosis
  - Patient is male
  - Diagnosis of osteoporosis
High fracture risk OR prior therapy failure/intolerance/contraindication
- Patient is at high risk of fracture
  Examples: recent fracture within past 12 months; fractures while on approved osteoporosis therapy; multiple fractures; fractures while on drugs causing skeletal harm (e.g., long-term glucocorticoids); very low T-score (e.g., less than -3.0); high risk for falls or history of injurious falls; very high fracture probability by FRAX (e.g., major osteoporosis fracture >30%, hip fracture >4.5%)
- Patient has history of failure, intolerance, or contraindication to other available osteoporosis therapy
  Examples: alendronate, denosumab, risedronate, zoledronate
Treatment duration limit: Treatment duration has not exceeded a total of 24 months of cumulative use of parathyroid hormone analogs during the patient's lifetime<= 24 months
Includes Teriparatide Injection, Forteo, Tymlos. Authorization will be issued for up to 24 months; duration limited to 24 months cumulative lifetime.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Tymlos (abaloparatide). Authorizations will be issued for up to 24 months, and duration of coverage is limited to a cumulative 24 months lifetime of parathyroid hormone analog therapy (e.g., Teriparatide, Forteo, Tymlos).

Authorization duration: up to 24 months
Lifetime cumulative limit for parathyroid hormone analogs: 24 months

Documentation Required

Clinical documentation for high fracture risk or therapy failure

Document evidence that the patient is at high risk for fracture or has a history of failure, intolerance, or contraindication to other available osteoporosis therapies. Examples of acceptable evidence include recent fracture (e.g., within the past 12 months), fractures while on approved osteoporosis therapy, multiple fractures, very low T-score (e.g., < -3.0), high FRAX probability (e.g., major >30% or hip >4.5%), high fall risk or history of injurious falls, or prior trial of other osteoporosis agents. Note that state mandates and the member’s specific benefit plan may require additional documentation.

Recent fracture (e.g., within past 12 months)
T-score (e.g., < -3.0) or FRAX score (e.g., major >30%, hip >4.5%)
Prior therapy names: alendronate, denosumab, risedronate, zoledronate

Billing Rule

Automated approval possibility

UnitedHealthcare may approve initial and re‑authorization requests based solely on previous claim or medication history, diagnosis codes (ICD-10), and/or claim logic. Use of automated approval and re‑approval processes varies by program and/or therapeutic class.

Clinical Evidence & Guidelines

Label treatment duration evidence: Safety and efficacy have not been evaluated beyond 2 years; cumulative use of Tymlos and other parathyroid hormone analogs should be limited to 24 months lifetime.

Guideline support: The AACE/ACE and the Endocrine Society recommend limiting abaloparatide treatment to 2 years and endorse use in patients at very high fracture risk (examples: recent fracture within 12 months; fractures on therapy; multiple fractures; very low T-score < -3.0; high fall risk or very high FRAX probability such as major osteoporotic fracture > 30% or hip fracture > 4.5% ).

Background

Tymlos (abaloparatide) is a parathyroid hormone analog indicated to increase bone density and treat osteoporosis in postmenopausal women and in men at high risk for fracture or who have failed or are intolerant to other osteoporosis therapies. Treatment is recommended to be limited to 2 years, and cumulative lifetime use of parathyroid hormone analogs beyond 24 months is not recommended. Definitions used in the policy include examples of "high risk of fracture" (e.g., recent fracture within the past 12 months, fractures while on therapy, multiple fractures, very low T-score < -3.0, high fall risk, or very high FRAX probabilities).