CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tymlos 1826 A Sgm P2022B

Defines prior authorization criteria for Tymlos (abaloparatide) for treatment of postmenopausal women and men with osteoporosis, required documentation, initial and continuation authorization durations, lifetime cumulative duration limit for parathyroid hormone analogs, and clinical exceptions (Appendices).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTymlos 1826 A Sgm P2022B

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit supporting chart notes or medical records indicating history of fractures, T-score, and FRAX fracture probability as applicable to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material change to policy: there are no material clinical/coverage changes in this brief.

2Covered patient populations (postmenopausal women, men)

12 monthsTypical initial authorization duration

24 monthsLifetime limit for parathyroid hormone analogs

≥1 yearRequired bisphosphonate trial duration (if applicable)

Coverage Summary

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Coverage stance: covered with criteria for FDA-approved indications and compendial uses when approval criteria are met and no exclusions exist. Scope: prior authorization criteria define use of Tymlos (abaloparatide) for postmenopausal women and men with osteoporosis at high risk for fracture, require submission of supporting documentation (history of fractures, pre-treatment T-score, and FRAX fracture probability as applicable), and specify initial/continuation authorizations and lifetime limits. Alignment to FDA: policy coverage is limited to the FDA-approved indications — treatment of postmenopausal women and treatment to increase bone density in men at high risk for fracture — and requires meeting the stated clinical thresholds. All other indications are considered experimental/investigational and may be denied.

Key thresholds

Pre-treatment T-score≤ -2.5 OR > -2.5 and < -1 (osteopenia)

High FRAX fracture probability10-year major osteoporotic fracture risk ≥ 20% OR hip fracture risk ≥ 3%; adjust risk ×1.15 for major fracture and ×1.2 for hip fracture if glucocorticoids >7.5 mg/day prednisone-equivalent

Oral bisphosphonate trial durationAt least 1 year (or documented clinical reason to avoid oral bisphosphonate per Appendix A)

Renal insufficiency cutoffCreatinine clearance < 35 mL/min (clinical reason to avoid oral bisphosphonate)

Lifetime parathyroid hormone analogs limitCumulative parathyroid hormone analog therapy ≤ 24 months lifetime

Indications (Covered When All Apply)

Indications (covered when ALL of the following apply)

FDA-approved indications and compendial uses are covered provided approval criteria are met and no exclusions to therapy exist.

Covered FDA Indications

Postmenopausal women with osteoporosis: Treatment of postmenopausal women with osteoporosis at high risk for fracture (history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy
Men with osteoporosis: Treatment to increase bone density in men with osteoporosis at high risk for fracture (history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy

General requirement

No exclusions to therapy: Member has no exclusions to the prescribed therapy
Documentation: Supporting documentation (chart notes/medical record) indicating history of fractures, T-score, and FRAX fracture probability as applicable is submitted
Refer to submission requirements for prior authorization

Postmenopausal Osteoporosis — Initial Authorization (up to 12 months)

Postmenopausal Osteoporosis - Initial Authorization (up to 12 months)

Authorization of an initial total of 12 months may be granted when ANY of the following criteria are met:

Postmenopausal Osteoporosis - Initial Authorization

Low T-score OR osteopenia with high FRAX plus one of the following
- T-score or osteopenia with high FRAX: Pre-treatment T-score ≤ -2.5 OR pre-treatment T-score > -2.5 and < -1 (osteopenia) with high pre-treatment FRAX fracture probability (See Appendix B)T-score ≤ -2.5 OR (>-2.5 and < -1) with high FRAX
  High FRAX defined as 10-year major osteoporotic fracture risk ≥20% or hip fracture risk ≥3% (apply glucocorticoid multipliers as applicable)
- Additional qualifiers
  - Very high fracture risk indicators: Member has indicators of very high fracture risk (examples: advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, or increased fall risk)
  - Prior injectable therapy failure or intolerance: Member has failed prior treatment with or is intolerant to previous injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], denosumab [Prolia])
  - Oral bisphosphonate trial or avoidance: Member has had an oral bisphosphonate trial of at least 1-year duration OR there is a clinical reason to avoid treatment with an oral bisphosphonate (See Appendix A)oral bisphosphonate trial ≥ 1 year or documented reason to avoid
    Clinical reasons to avoid include GI disorders, inability to sit upright, malabsorption, renal insufficiency (CrCl <35 mL/min), prior intolerance

Examples and thresholds: High FRAX: 10-year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%; adjust risk by ×1.15 for major fracture and ×1.2 for hip fracture if glucocorticoid treatment >7.5 mg prednisone-equivalent/daySee Appendix B

Osteoporosis in Men — Initial Authorization (up to 12 months)

Osteoporosis in Men - Initial Authorization (up to 12 months)

Authorization of an initial total of 12 months may be granted to male members with osteoporosis when ANY of the following criteria are met:

Osteoporosis in Men - Initial Authorization

Fracture history or T-score plus bisphosphonate trial/avoidance
- Fracture history: Member has a history of an osteoporotic vertebral or hip fracture
- T-score/FRAX and bisphosphonate requirement: Member has a pre-treatment T-score ≤ -2.5 OR pre-treatment T-score > -2.5 and < -1 (osteopenia) with a high pre-treatment FRAX fracture probability (See Appendix B); AND member has had an oral OR injectable bisphosphonate trial of at least 1-year duration OR there is a clinical reason to avoid treatment with a bisphosphonate (See Appendix A)T-score ≤ -2.5 OR (>-2.5 and < -1) with high FRAX; bisphosphonate trial ≥ 1 year or documented reason to avoid

FRAX threshold note: High FRAX defined as 10-year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%See Appendix B

Continuation Therapy Criteria

Continuation of Therapy

Criteria for renewal / continuation

Continuation of Therapy: Authorization of 12 months may be granted for members currently receiving the requested medication through a previously authorized pharmacy or medical benefit and who have not experienced clinically significant adverse events during therapy12 months

Includes new members receiving an ongoing authorized benefit

Operational rule: initial authorizations and continuation authorizations may each be granted for up to 12 months. Additionally, the cumulative lifetime duration of parathyroid hormone analogs (teriparatide and abaloparatide) will not exceed 24 months.

Limits and Exclusions

Lifetime cumulative limit

Lifetime cumulative limit: Cumulative duration of parathyroid hormone analogs (teriparatide and abaloparatide) will not exceed a total of 24 months in the member's lifetime≤ 24 months lifetime

All other indications beyond FDA-approved and compendial uses listed are considered experimental/investigational and may be denied

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required with documentation

Submit supporting chart notes or medical records indicating history of fractures, pre-treatment T-score, and FRAX fracture probability as applicable to initiate prior authorization review. Include objective measures (fracture history, T-score, FRAX) when requesting coverage for Tymlos.

History of fractures (chart notes / imaging reports)
Pre-treatment T-score (DXA report)
FRAX 10-year fracture probability (when applicable)

Documentation Required

Document prior bisphosphonate trials or reasons to avoid

For members without a history of fracture, document the pre-treatment T-score and the FRAX 10-year fracture probability. If approval is being requested based on avoidance of bisphosphonates, provide the clinical reason to avoid per Appendix A, or document an oral or injectable bisphosphonate trial of at least 1 year.

Pre-treatment T-score and FRAX risk for members without fractures
Document oral OR injectable bisphosphonate trial of ≥1 year if applicable
If avoiding oral bisphosphonates, supply a clinical reason consistent with Appendix A (examples: esophageal abnormalities, active upper GI disease, malabsorption, inability to sit/stand, renal insufficiency CrCl <35 mL/min, prior intolerance)

Billing Rule

Authorization durations

Initial authorizations may be granted for up to 12 months. Continuation (renewal) authorizations may be granted for 12 months for members currently receiving therapy who have not experienced clinically significant adverse events. The cumulative lifetime duration of parathyroid hormone analogs (teriparatide and abaloparatide) must not exceed 24 months.

Initial authorization: up to 12 months
Continuation/renewal authorization: 12 months
Cumulative lifetime limit for parathyroid hormone analogs (teriparatide + abaloparatide): 24 months

Denial Risk

Not covered if indication not listed

Indications that are not FDA-approved or compendial uses listed in the policy are considered experimental/investigational and not medically necessary and may be denied. Requests for uses beyond the covered indications may be denied if documentation does not support an approved indication.

Coverage is aligned to FDA-approved indications and compendial uses only
All other indications may be denied as experimental/investigational

Background & Definitions

Background summary: Tymlos (abaloparatide) is a parathyroid hormone receptor agonist indicated to reduce fracture risk and increase bone density in patients with osteoporosis at high risk for fracture. Policy aligns coverage to FDA-approved indications for postmenopausal women and men at high risk for fracture and requires objective measures to support use — including a pre-treatment T-score (≤ -2.5 or > -2.5 and < -1) and, when applicable, a high pre-treatment FRAX probability (10-year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%, with specified adjustments for glucocorticoid use). The policy also requires documentation of prior therapy trials or valid clinical reasons to avoid bisphosphonates (e.g., ≥ 1 year oral bisphosphonate trial or Appendix A contraindications such as esophageal abnormalities, active upper GI disease, malabsorption, inability to remain upright, renal insufficiency with creatinine clearance < 35 mL/min, or prior intolerance).

Term	Definition
High FRAX fracture probability
10-year major osteoporotic fracture risk ≥ 20% or hip fracture risk ≥ 3%; multiply estimated risk by 1.15 for major fracture and by 1.2 for hip fracture if glucocorticoid treatment > 7.5 mg prednisone-equivalent/day
Osteopenia
Pre-treatment T-score > -2.5 and < -1
Fragility fracture
Clinical history of fracture consistent with osteoporosis (e.g., vertebral or hip fracture)