CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tymlos (abaloparatide) for osteoporosis

Defines prior authorization criteria and coverage rules for abaloparatide (Tymlos) for treatment of osteoporosis in postmenopausal women and men at high risk for fracture, documentation required, continuation criteria, lifetime cumulative duration limits, and clinical exceptions for avoiding bisphosphonates.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTymlos (abaloparatide) for osteoporosis

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or authorization criteria.

12 monthsInitial authorization duration

24 monthsMax cumulative PTH analog

>=20% / >=3%FRAX high-risk thresholds

Coverage Summary & Scope

Abaloparatide (Tymlos) is an FDA-approved parathyroid hormone-related protein analog indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture and to increase bone density in men with osteoporosis at high risk for fracture. Coverage stance: covered_with_criteria. Coverage is limited to FDA‑approved indications; all other uses are considered investigational/not medically necessary. The policy defines prior authorization criteria, documentation requirements, continuation rules, and lifetime cumulative duration limits consistent with the FDA‑approved indications.

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Initial Therapy Criteria (Postmenopausal Women)

FDA-Approved Indications (covered when ALL criteria met)

The following FDA-approved indications are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

Indication: Postmenopausal women or Men with osteoporosis
- Postmenopausal women with osteoporosis: Treatment of postmenopausal women with osteoporosis at high risk for fracture (history of osteoporotic fracture or multiple risk factors), 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), or patients who have failed or are intolerant to other available osteoporosis therapy
Required documentation and no exclusions
- No exclusions to prescribed therapy: Member has no exclusions to the prescribed therapy
- Submit supporting documentation: Supporting chart notes or medical record indicating history of fractures, T-score, and FRAX fracture probability as applicable are submitted

A. Postmenopausal osteoporosis — Initial authorization (12 months)

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

History of fragility fractures: Member has a history of fragility fractures
No fragility fracture: pre-treatment T-score/osteopenia plus one of following
- Pre-treatment T-score criteria: 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 meets ANY of the following
  - Indicators of very high fracture risk: Member has indicators of very high fracture risk (examples: advanced age, frailty, glucocorticoid use, very low T-scores <= -3, or increased fall risk)

Initial Therapy Criteria (Men)

B. Osteoporosis in men — Initial authorization (12 months)

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

History of fragility fractures: Member has a history of fragility fractures
Pre-treatment T-score or osteopenia with FRAX AND bisphosphonate trial/avoidance: 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)

TYMLOS (abaloparatide) specific criteria

Osteoporotic vertebral or hip fracture: Member has a history of an osteoporotic vertebral or hip fracture
Pre-treatment T-score and bisphosphonate trial/avoidance: 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)

Continuation Therapy Criteria

IV. Continuation of therapy

Authorization of 12 months may be granted for continuation

Currently receiving via previously authorized benefit: Member is currently receiving the requested medication through a previously authorized pharmacy or medical benefit
No clinically significant adverse events: Member has not experienced clinically significant adverse events during therapy

V. Cumulative duration limit

V. Cumulative duration limit: Cumulative duration of parathyroid hormone analogs (teriparatide and abaloparatide) will not exceed a total of 24 months in the member's lifetime24 months lifetime

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required with documentation

Submit supporting chart notes or medical record indicating history of fractures, pre-treatment T-score, and FRAX fracture probability as applicable to initiate prior authorization review.

Documentation Required

Document bisphosphonate trial or clinical reason to avoid

Provide documentation of at least a 1-year trial of an oral or injectable bisphosphonate OR documentation of a clinical reason to avoid bisphosphonate therapy as described in Appendix A.

Denial Risk

Lifetime cumulative limit enforcement

Claims may be denied or not authorized if the cumulative lifetime duration of parathyroid hormone analog therapy (teriparatide plus abaloparatide) exceeds 24 months.

Prior Authorization

Continuation authorization criteria

For continuation requests, verify the member is currently receiving the medication through a previously authorized pharmacy or medical benefit and has not experienced clinically significant adverse events during therapy; submit supporting documentation (medical record/chart notes) to support continuation.

Clinical Evidence & References

Primary evidence sources referenced for this policy are the Tymlos (abaloparatide) package insert (Tymlos [package insert], Radius Health, Inc.; June 2023) and a key randomized controlled trial: Miller PD et al., JAMA 2016;316(7):722-733. The policy framework and criteria draw from the package insert and the cited RCT as primary evidence.

Evidence quick facts

Key RCT citationMiller PD et al. JAMA 2016;316(7):722-733

Package insert dateTymlos [package insert], June 2023

Definitions & Appendices Reference

Fragility fracture: defined as a history of osteoporotic fracture such as vertebral or hip fracture documented in the chart; presence of fragility fracture satisfies criteria for treatment authorization.

High FRAX fracture probability: defined as a 10-year major osteoporosis-related fracture risk of ≥ 20% or hip fracture risk of ≥ 3% (see Appendix B for the FRAX tool and adjustment factors for glucocorticoid use).

Clinical reasons to avoid oral bisphosphonate (see Appendix A): includes anatomic or functional esophageal abnormalities, active upper GI problems, documented or potential gastrointestinal malabsorption, inability to remain upright 30–60 minutes, inability to take oral bisphosphonate before first food/drink/medication, creatinine clearance < 35 mL/min, or history of intolerance to oral bisphosphonates. Appendices A and B are referenced in the approval criteria and should be consulted for specific thresholds and examples.