CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Abaloparatide (Tymlos) — Clinical prior authorization and coverage criteria

Covers clinical prior authorization and coverage criteria for abaloparatide (Tymlos) for treatment of osteoporosis in postmenopausal women and men at high fracture risk, including documentation and duration limits. Affects prescribers and pharmacists managing member therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbaloparatide (Tymlos) — Clinical prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with supporting documentation (fracture history, pretreatment T-score, and FRAX) and request initial approval for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12initial authorization duration

24lifetime limit (months)

<35renal threshold

highFRAX trigger

Coverage Criteria for Abaloparatide (Tymlos)

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Initial therapy coverage criteria

Covered when ALL of the following are met for initial therapy (postmenopausal women and men):

FDA‑approved indication: Indication is treatment of postmenopausal women or men with osteoporosis at high risk for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Supports covered FDA‑approved uses

Postmenopausal: fracture or T‑score/FRAX: For postmenopausal women: member has a history of fragility (osteoporotic vertebral or hip) fracture OR pretreatment T‑score ≤ -2.5 OR pretreatment T‑score between -2.5 and -1 (osteopenia) with a high pre‑treatment FRAX fracture probability; and when osteopenia is present, the member must also meet at least one of the following: failed or intolerant to prior injectable osteoporosis therapy, indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T‑scores ≤ -3, or increased fall risk), or has had an oral bisphosphonate trial ≥ 1 year or there is a clinical reason to avoid oral bisphosphonates.

From Postmenopausal osteoporosis and TYMLOS sections

Men: fracture or T‑score/FRAX: For men: authorization may be granted when criteria parallel the postmenopausal indications — history of osteoporotic fracture or multiple risk factors for fracture, pretreatment T‑score thresholds, or failure/intolerance to other osteoporosis therapies as described above.

FDA‑approved indications for men

Prior therapy requirement or contraindication: Member has failed prior treatment with or is intolerant to previous injectable osteoporosis therapy OR has had an oral or injectable bisphosphonate trial of at least 1‑year duration OR there is a clinical reason to avoid treatment with an oral bisphosphonate (see Appendix A).

Required for some pathways (see Postmenopausal osteoporosis; TYMLOS)

Continuation therapy

Continuation therapy:

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

Section IV: Continuation of therapy

Duration and lifetime limits

Duration limits:

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

Section V: Other

All indications for abaloparatide (Tymlos) that are beyond the FDA‑approved indications and recognized compendial uses are considered experimental/investigational and are not covered under this policy.

Use of abaloparatide for indications not listed among the FDA‑approved or compendial indications is considered not medically necessary and will not be approved.

Clinical Thresholds and Coding-related Definitions

Pre‑treatment T‑score threshold — osteoporosis and osteopenia definitions, FRAX considerations

Osteoporosis definitionPre-treatment T-score ≤ -2.5 qualifies as osteoporosis for therapy consideration.

Osteopenia with high FRAXPre-treatment T-score > -2.5 and < -1 (osteopenia) plus a high pre-treatment FRAX fracture probability qualifies when other criteria are met.

FRAX tool referenceUse the 10-year FRAX probability (https://www.shef.ac.uk/FRAX) as documented in Appendix A to determine high fracture probability.

FRAX adjustment for glucocorticoidsIf glucocorticoid treatment >7.5 mg/day (prednisone equivalent), multiply the major osteoporotic fracture probability by 1.15 and the hip fracture probability by 1.2.

Renal function threshold — creatinine clearance cutoff

Renal function cutoffCreatinine clearance < 35 mL/min is listed as a clinical reason to avoid oral bisphosphonates.

Context of avoidanceRenal insufficiency is included among clinical reasons to avoid oral bisphosphonate therapy in Appendix A.

Implication for prior therapy requirementPresence of renal insufficiency can be used as the clinical reason to avoid an oral bisphosphonate trial when meeting initial therapy criteria.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required. Initial approvals are generally for 12 months; continuation approvals may be granted for 12-month intervals for members currently receiving the medication through a previously authorized benefit who have not experienced clinically significant adverse events during therapy.

Initial authorization: typically 12 months
Continuation authorization: 12 months when criteria met

Documentation Required

Failure/Intolerance to Prior Therapy or Contraindication

Documented failure or intolerance to prior therapy, or a documented contraindication to bisphosphonate therapy, is required when specified by the clinical criteria. Acceptable documentation includes prior treatment history showing at least a one-year trial of an oral or injectable bisphosphonate, clinical notes describing intolerance or adverse effects, or a listed clinical reason to avoid bisphosphonates (see Appendix A).

Failure/intolerance: e.g., ≥1 year oral or injectable bisphosphonate trial with inadequate response or documented intolerance
Contraindication to bisphosphonates: clinical reasons per Appendix A (e.g., active upper GI disease, malabsorption, inability to sit/stand, renal insufficiency)

Denial Risk

Lifetime Duration Exceedance

Requests that would exceed the cumulative lifetime limit for parathyroid hormone analogs will be subject to denial or require special review. The combined cumulative duration of teriparatide and abaloparatide must not exceed 24 months in a member's lifetime.

Lifetime cumulative limit for teriparatide + abaloparatide = 24 months
Requests exceeding 24 months may be denied or require additional clinical justification

Definitions and Risk Thresholds

High FRAX fracture probability — Appendix A definition and adjustment notes

High FRAX — major osteoporotic fractureDefined as 10‑year major osteoporotic fracture risk ≥ 20% per Appendix A.

High FRAX — hip fractureDefined as 10‑year hip fracture risk ≥ 3% per Appendix A.

Calculation resource10‑year probabilities should be calculated using the FRAX tool (https://www.shef.ac.uk/FRAX) as noted in Appendix A.

Glucocorticoid adjustmentIf glucocorticoid treatment >7.5 mg/day, multiply the major osteoporotic fracture probability by 1.15 and the hip fracture probability by 1.2.

High risk for fracture — examples and indicators

Prior fragility fractureHistory of an osteoporotic vertebral, hip, or other fragility fracture qualifies as high fracture risk.

Very low T‑scoreT‑score ≤ -3 is listed as an indicator of very high fracture risk.

Advanced age and frailtyAdvanced age and frailty are cited as indicators of very high fracture risk.

Glucocorticoid useCurrent glucocorticoid use is an indicator of very high fracture risk and factors into FRAX adjustment calculations.

Increased fall riskIncreased fall risk is included among indicators of very high fracture risk.

OpenPayer

Abaloparatide (Tymlos) — Clinical prior authorization and coverage criteria

Coverage Criteria for Abaloparatide (Tymlos)

Clinical Thresholds and Coding-related Definitions

Prior Authorization, Documentation, and Provider Requirements

Definitions and Risk Thresholds

Background