CurrentBlue Cross Blue Shield - IowaPolicy 05.20.62

Tymlos (abaloparatide) prior authorization and coverage criteria

Defines medical necessity and prior authorization requirements for Tymlos (abaloparatide) for treatment of osteoporosis in postmenopausal women and men, including preferred-product step requirements and continuation/ lifetime limits for Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTymlos (abaloparatide) prior authorization and coverage criteria

Policy CodePolicy 05.20.62

Change TypeNo material changes

Effective DateMar 10, 2026

Next Review DateJan 1, 2026

Key ActionObtain prior authorization with required documentation and document trial of preferred products (Teriparatide or Bonsity) or exception.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial authorization duration

24 monthsmaximum cumulative lifetime duration

>=20% / >=3%FRAX thresholds (major/hip)

Teriparatide/Bonsitypreferred step

Coverage Criteria for Tymlos (abaloparatide)

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Initial Therapy — Postmenopausal osteoporosis

Covered when ALL of the following are met for postmenopausal women:

Postmenopausal initial approval

Preferred-product exception: Member has had a documented inadequate response OR documented intolerable adverse event OR contraindication to a preferred product (Teriparatide or Bonsity), or is currently receiving treatment with a targeted product (excluding samples or manufacturer patient assistance).
Disease severity: Member has a history of fragility fractures.
OR low bone density with high risk: Pre-treatment T-score ≤ -2.5 OR pre-treatment T-score between -2.5 and -1.0 with a high pre-treatment FRAX fracture probability, AND at least one of the following: indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, or increased fall risk); failed or intolerant to prior injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], denosumab [Prolia]); OR oral bisphosphonate trial of ≥ 1 year duration or clinical reason to avoid oral bisphosphonate.

Initial Therapy — Osteoporosis in men

Covered when ALL of the following are met for men with osteoporosis:

Male initial approval

Preferred-product exception: Member has had a documented inadequate response OR documented intolerable adverse event OR contraindication to a preferred product (Teriparatide or Bonsity), or is currently receiving treatment with a targeted product (excluding samples or manufacturer patient assistance).
Fracture history: Member has a history of osteoporotic vertebral or hip fracture.
OR low bone density with high risk: Pre-treatment T-score ≤ -2.5 OR pre-treatment T-score between -2.5 and -1.0 with a high pre-treatment FRAX fracture probability, AND at least one of the following: indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, or increased fall risk); failed or intolerant to prior injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], denosumab [Prolia]); OR oral bisphosphonate trial of ≥ 1 year duration or clinical reason to avoid oral bisphosphonate.

Continuation Therapy

Continuation authorization may be granted for up to 12 months when ANY of the following are met:

Continuation criteria: A) Evidence of clinical benefit by bone mass measurement showing improvement or stabilization in T-score compared with the previous measurement and no adverse effects; OR B) Clinical benefit such as no new fractures on radiography and no clinically significant adverse events during therapy.

Cumulative Duration Limit

Cumulative duration limit: Cumulative lifetime duration of parathyroid hormone analogs (teriparatide and abaloparatide) must not exceed 24 months.

Non‑formulary use of Tymlos (abaloparatide) may be considered when the member meets the policyspecific criteria for approval and ALL of the following non‑formulary exception requirements are documented: (1) the requested indication is an FDA‑approved use or is supported by recognized compendia (e.g., AHFS, Micromedex, accepted guidelines) with any required diagnostic testing or lab results provided; (2) the prescribed dose and quantity fall within FDA labeling or compendial dosing guidelines; and (3) all covered formulary alternative drugs have been tried and were ineffective, intolerable, contraindicated, or otherwise unsuitable — with chart notes or other documentation showing prior treatment failure, the severity of adverse events (if applicable), and the dosage and duration of prior therapy.

Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Tymlos (abaloparatide). Initial approvals may be granted for up to 12 months when documentation and clinical criteria are met.

Initial authorizations up to 12 months when criteria met
Applies to postmenopausal osteoporosis and osteoporosis in men

Step Therapy

Preferred-Product Step Requirement

Policy requires use of a preferred product (Teriparatide or Bonsity) before coverage of Tymlos unless a documented exception applies (inadequate response, intolerable adverse event, or current treatment with a targeted product). The preferred-product step applies to both postmenopausal women and men.

Preferred products: Teriparatide (Recombinant, Alvogen) or Bonsity
Exceptions: documented inadequate response, documented intolerable adverse event, or currently receiving a targeted product (excluding samples or manufacturer patient assistance program supplies)

Documentation Required

Required Documentation for Prior Authorization

Submit supporting chart notes or relevant medical record documentation to initiate prior authorization review. Documentation should include history of fragility or osteoporotic fractures, pre-treatment T-score, and FRAX fracture probability when applicable.

Include chart notes or medical records showing history of fractures (fragility or vertebral/hip as applicable)
Provide pre-treatment T-score
Provide FRAX fracture probability when applicable (see policy Appendix B)

Denial Risk

Documentation and Step Therapy Omissions May Lead to Denial

Prior authorization may be denied if required supporting documentation or step-therapy information is missing. Missing items that risk denial include absence of fracture history documentation, missing pre-treatment T-score or FRAX calculation, or lack of documentation supporting an exception to the preferred-product requirement.

Denial risk if documentation of fractures, T-score, or FRAX is not provided
Denial risk if documentation does not support inadequate response or intolerance to preferred products when request is for Tymlos without preferred-product trial

Background

Abaloparatide (Tymlos) is an anabolic parathyroid hormone‑related peptide analog indicated to increase bone mineral density and reduce the risk of vertebral and nonvertebral fractures in patients with osteoporosis. The policy applies Tymlos in accordance with product labeling and clinical guidance, requiring selection of patients at high fracture risk (for example, those with prior fragility fractures, very low pre‑treatment T‑scores, or high FRAX probability) and steering to preferred biologic alternatives when appropriate.

Initial authorizations for Tymlos are limited to up to 12 months for eligible postmenopausal women or men with osteoporosis who meet the clinical criteria, and treatment with parathyroid hormone analogs (including abaloparatide and teriparatide) is subject to a cumulative lifetime limit of 24 months.

OpenPayer

Tymlos (abaloparatide) prior authorization and coverage criteria

Coverage Criteria for Tymlos (abaloparatide)

Procedures, Codes, and Risk Thresholds

Authorization, Documentation, and Step Therapy Requirements

Background

Definitions