CurrentNeighborhood Health Plan of Rhode IslandPolicy 1826-A

Abaloparatide (Tymlos) prior authorization and coverage

Determines medical necessity, documentation, and authorization criteria for abaloparatide (Tymlos) for treatment of osteoporosis in postmenopausal women and men at high fracture risk. Applies to members whose benefits include prescription coverage under this payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbaloparatide (Tymlos) prior authorization and coverage

Policy CodePolicy 1826-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit chart notes or medical record documentation showing history of fractures, pre-treatment T-score, and FRAX fracture probability to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12initial authorization duration

24lifetime cumulative limit (months)

>=20%/>=3%FRAX thresholds

<=-2.5T-score threshold

Coverage Criteria for Abaloparatide (Tymlos)

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Postmenopausal Osteoporosis — Initial Therapy

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

Postmenopausal criteria: Member has a history of fragility fractures (e.g., low trauma fracture from force similar to a fall from standing position).

T-score or osteopenia with high FRAX

High-risk subcriteria: Member has indicators of very high fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T-scores ≤ -3, or increased fall risk) OR has failed prior injectable osteoporosis therapy or is intolerant OR has had an oral bisphosphonate trial of at least 1 year or has a clinical reason to avoid oral bisphosphonate (see Appendix A).

Osteoporosis in Men — Initial Therapy

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

Fracture history in men: Member has a history of an osteoporotic vertebral or hip fracture.

T-score/osteopenia plus prior bisphosphonate: Member has a pre-treatment T-score ≤ -2.5 OR osteopenia (pre-treatment T-score > -2.5 and < -1) 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 of Therapy

Authorization of 12 months may be granted for continuation

Continuation: Member is currently receiving the requested medication through a previously authorized pharmacy or medical benefit and has not experienced clinically significant adverse events during therapy.

Applies to new members currently on therapy as well.

All indications not explicitly listed as FDA-approved or compendial uses in this policy are considered experimental/investigational and therefore not medically necessary. This includes any use outside the treatment of postmenopausal women with osteoporosis at high risk for fracture and the treatment to increase bone density in men with osteoporosis at high risk for fracture, or uses in patients who have failed or are intolerant to other available osteoporosis therapies.

Product and Coding Information

Covered drug productNDC | mixedCovered

Tymlos

abaloparatide (brand/generic and all dosage forms and strengths unless otherwise stated)

FRAX high risk thresholds

FRAX high-risk thresholds10-year major osteoporosis-related fracture risk ≥ 20% OR hip fracture risk ≥ 3%

FRAX calculation reference10-year probability; calculation tool available at: https://frax.shef.ac.uk/FRAX

Glucocorticoid adjustmentMultiply FRAX major osteoporotic fracture score by 1.15 and hip fracture score by 1.2 when glucocorticoid dose > 7.5 mg prednisone equivalent/day

T-score thresholds

Osteoporosis (T-score)Pre-treatment T-score ≤ -2.5

Osteopenia (T-score range)Pre-treatment T-score > -2.5 and < -1

Use in criteriaT-score values are used with FRAX to determine eligibility for initial therapy per coverage criteria

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations are for 12 months; continuation authorizations for 12 months may be granted if current criteria are met and the member has not experienced clinically significant adverse events during therapy. The cumulative duration of parathyroid hormone analogs (teriparatide and abaloparatide) will not exceed a total of 24 months in the member's lifetime.

Initial authorization: 12 months
Continuation authorization: 12 months (if criteria met and no clinically significant adverse events)
Lifetime cumulative limit for parathyroid hormone analogs: 24 months

Denial Risk

Non‑covered / Experimental Indications

Requests for indications other than the FDA‑approved or compendial uses listed in the policy (e.g., treatment of postmenopausal women or men with osteoporosis at high risk for fracture, or patients who have failed or are intolerant to other osteoporosis therapy) will be considered experimental/investigational and are not medically necessary.

Documentation Required

Documentation Required for Prior Authorization

Submit chart notes or medical record documentation indicating history of fractures, pre‑treatment T‑score, and FRAX fracture probability as applicable to the coverage criteria to initiate prior authorization review.

Required documentation: history of fractures
Required documentation: pre‑treatment T‑score
Required documentation: FRAX fracture probability (when applicable)

Step Therapy

Prior Therapy / Contraindication Requirements

Many approvals require prior therapy or evidence of contraindication/intolerance: for postmenopausal women this may include failure of or intolerance to other injectable osteoporosis therapy (e.g., zoledronic acid, denosumab products, teriparatide) or an oral bisphosphonate trial of at least 1 year unless there is a clinical reason to avoid oral bisphosphonates. For men, authorization often requires either a qualifying fracture or both a T‑score ≤ -2.5 (or osteopenia with high FRAX) and prior trial of an oral or injectable bisphosphonate of at least 1 year or a documented reason to avoid bisphosphonates.

Prior injectable therapy failure/intolerance example agents: zoledronic acid (Reclast), denosumab products (Prolia, others), teriparatide (Forteo)
Oral bisphosphonate trial: ≥ 1 year, unless clinical reason to avoid (see Appendix A)
Clinical reasons to avoid oral bisphosphonates include: esophageal abnormalities, active upper GI disease, malabsorption, inability to remain upright 30–60 minutes, inability to take fasting dosing, renal insufficiency (CrCl <35 mL/min), or prior intolerance

Key Definitions

High FRAX fracture probability

High FRAX fracture probability10-year major osteoporosis-related fracture risk ≥ 20% OR hip fracture risk ≥ 3%

Glucocorticoid adjustment detailMultiply estimated FRAX major osteoporotic fracture score by 1.15 and hip fracture score by 1.2 if glucocorticoid treatment > 7.5 mg prednisone equivalent/day

FRAX tool linkFRAX calculation tool: https://frax.shef.ac.uk/FRAX

Osteopenia

Osteopenia definitionPre-treatment T-score greater than -2.5 and less than -1

Context of useOsteopenia plus a high pre-treatment FRAX may satisfy criteria for initial therapy when combined with other qualifying factors

Contrast with osteoporosisOsteopenia range is distinct from osteoporosis (T-score ≤ -2.5) used elsewhere in coverage criteria

Background

Abaloparatide (Tymlos) is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture (for example, those with a history of osteoporotic fracture or multiple fracture risk factors) and to increase bone density in men with osteoporosis at high risk for fracture. The FDA labeling also specifies use in patients who have failed or are intolerant to other available osteoporosis therapies. Uses beyond these indications are considered experimental/investigational and not medically necessary.