ModifiedHealth NetPolicy N/A

Clinical Policy: Abaloparatide (Tymlos)

Policy governing medical necessity, prior authorization, and coverage criteria for abaloparatide (Tymlos) for treatment of postmenopausal and male osteoporosis for Health Net lines of business (Commercial, HIM, Medicaid). Applies to providers requesting coverage under the plan.

Policy Summary

PayerHealth Net

PolicyAbaloparatide (Tymlos) — coverage criteria for postmenopausal and male osteoporosis

Policy CodePolicy N/A

Change TypeIndication expansionapproval duration revisionstep therapy clarifications

Effective Date07.17

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating diagnosis, prior bisphosphonate history or applicable exception, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Added newly approved indication of male osteoporosis to criteria.

Revised initial approval duration to 12 months for Medicaid/HIM and added Commercial approval duration of 6 months or to the member's renewal date, whichever is longer.

Clarified failure of generic alendronate is preferred and clarified dosage regimen.

Added option to bypass bisphosphonate trial if member has experienced loss of BMD, lack of BMD increase, or had an osteoporotic/fragility fracture while on bisphosphonate therapy.

80 mcg/daymax daily dose

2 yearslifetime limit

1 pen/30ddispensing limit

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approval (Commercial)

12 monthsapproval (Medicaid/HIM)

male osteoporosisnew indication

Coverage Criteria for Abaloparatide (Tymlos)

Initial Therapy

Covered when ALL of the following are met for diagnosis of postmenopausal osteoporosis (PMO) or male osteoporosis:

Diagnosis and age: Diagnosis of postmenopausal osteoporosis (PMO) or male osteoporosis

Age ≥ 18 years or documentation of closed epiphyses on X‑ray

Evidence of very high fracture risk: Member is at very high risk for fracture as evidenced by ONE of: recent osteoporotic fracture within the past 12 months; BMD T‑score at hip or spine ≤ -3.0; or BMD T‑score ≤ -2.5 plus a major osteoporotic fracture (spine, forearm, wrist, humerus).

See Appendix E for T‑score definitions

Prior bisphosphonate pathway or exceptions: Member has completed a 3‑year trial of bisphosphonate therapy (generic alendronate preferred) at up to maximally indicated doses OR meets one of the exceptions: all bisphosphonates contraindicated; clinically significant adverse effects to both IV and PO formulations; loss of BMD while on bisphosphonate therapy; osteoporotic/fragility fracture while on bisphosphonate therapy; lack of BMD increase after ≥12 months of bisphosphonate therapy.3 years

Appendix B and D provide details on alternatives and contraindications; option to bypass trial added in 1Q 2022 updates

Dose and cumulative exposure limits: Requested dose does not exceed 80 mcg per day; dispensing does not exceed 1 pen every 30 days; member has not received ≥ 2 years cumulative abaloparatide therapy.80 mcg/day; 2 years cumulative

Dose and duration per Dosage and Administration

Continuation Therapy

Continued therapy is covered when the member meets ONE of the following:

Continuation eligibility: Member is currently receiving medication via the Centene benefit and is responding positively to therapy; OR member previously met initial approval criteria; OR member is in continuity of care regulations for state/product.

Member must not have exceeded 2 years cumulative abaloparatide therapy and dose limits remain as specified; dose increases must not exceed 80 mcg/day and 1 pen every 30 days.

Policy updates and coverage-modifying criteria

Policy-level coverage stance and notable criteria updates

Indication expansion: Policy criteria were updated to include male osteoporosis as an approved indication for abaloparatide.

1Q 2023 annual review

Bypass of bisphosphonate trial: Bypass of prior bisphosphonate trial allowed if member has experienced loss of BMD, lack of BMD increase, or an osteoporotic/fragility fracture while on bisphosphonate therapy (in addition to contraindications or adverse effects).

Added in 1Q 2022 update

Approval durations and updates: Initial and continuation approval durations differ by line of business: Medicaid/HIM initial approval revised to 12 months; Commercial continuation approval modified to 6 months or to the member's renewal date, whichever is longer. Policy clarifications include preferred failure of generic alendronate and added Appendix E for T‑score interpretation.

1Q 2024 and 1Q 2025 updates

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the request includes sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid, or other evidence of coverage documentation.

During the 1Q 2022 annual review the policy documentation was updated to note that the osteosarcoma black box warning was removed from Appendix C; no explicit exclusion for osteosarcoma is stated in the excerpt provided.

Use of abaloparatide (or other agents) for non‑FDA approved indications without sufficient documentation of efficacy and safety consistent with the plan’s off‑label use policies is considered not authorized and may be denied.

Within the excerpted content there are no explicit entries listing conditions that are determined to be "not medically necessary." Requests may still be denied for lack of supporting documentation or failure to meet the stated coverage criteria.

Coding, Dose Limits, and Approval Durations

Referenced HCPCS CodesHCPCS

J3490

Unclassified drugs

BMD T-score thresholds

Osteoporosis definitionOsteoporosis is defined as a BMD T-score ≤ -2.5 (AACE/WHO guidance).

Very high fracture risk - T-scoreBMD T-score at the hip or spine ≤ -3.0 qualifies as very high risk.

T-score plus fractureBMD T-score ≤ -2.5 plus a major osteoporotic fracture (spine, forearm, wrist, humerus) qualifies.

Dose limit

Maximum single‑day dose80 mcg subcutaneously once daily.

Dosing routeSubcutaneous (SC) administration.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for this therapy. Approval durations vary by line of business: Medicaid/HIM — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer. Inclusion or exclusion of codes in this clinical policy does not guarantee coverage; providers should reference the most up-to-date professional coding guidance when submitting claims for reimbursement.

Approval duration: Medicaid/HIM = 12 months; Commercial = 6 months or to member's renewal date, whichever is longer
Coding inclusion disclaimer: Codes shown are informational only and do not ensure coverage; verify current coding guidance prior to claim submission

Documentation Required

Required Supporting Documentation

Provider must submit supporting clinical documentation to demonstrate that the member meets all approval criteria. Acceptable documentation includes office chart notes, relevant laboratory results, bone mineral density (BMD) reports (including T-scores), imaging reports documenting fractures, and prior therapy records documenting bisphosphonate use, adverse effects, or contraindications.

Background on Abaloparatide

Abaloparatide (Tymlos) is a parathyroid hormone‑related peptide analog indicated for the treatment of osteoporosis in postmenopausal women and in men who are at high risk for fracture or who have failed or are intolerant to other therapies. The agent increases bone mineral density and has been shown to reduce vertebral and non‑vertebral fracture risk in postmenopausal women; high fracture risk is defined by history of osteoporotic fracture or multiple risk factors with BMD thresholds per guideline definitions.

Definitions and Risk Criteria

High risk of fracture definition

High risk of fracture - clinical definitionHistory of an osteoporotic fracture or multiple risk factors for fracture defines high risk.

Use of BMD T‑score per guidelinesAACE/WHO guidance uses BMD T‑score; osteoporosis is T‑score ≤ -2.5.

Very high risk criteriaVery high risk includes recent osteoporotic fracture within 12 months, BMD T‑score ≤ -3.0, or T‑score ≤ -2.5 with a major osteoporotic fracture.

Bypass of bisphosphonate trial

Bisphosphonate trial bypass - allowanceBypass of a bisphosphonate trial is allowed if the member experienced loss of BMD, lack of BMD increase after ≥12 months, or sustained an osteoporotic/fragility fracture while on bisphosphonate therapy.

Standard bisphosphonate requirement

Policy Summary

PayerHealth Net

PolicyAbaloparatide (Tymlos) — coverage criteria for postmenopausal and male osteoporosis

Policy CodePolicy N/A

Change TypeIndication expansionapproval duration revisionstep therapy clarifications

Effective Date07.17

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating diagnosis, prior bisphosphonate history or applicable exception, and dosing within limits.

SourceLink

On This Page

Cumulative PTH analog exposure

Lifetime cumulative PTH analog exposureUp to 2 years cumulative abaloparatide (PTH analog) lifetime.

Policy clarificationUse is limited to < 2 years cumulative abaloparatide therapy as noted in 1Q 2022 updates.

Dose relationshipCumulative exposure counted toward the 2‑year limit includes prior abaloparatide therapy; Forteo distinctions noted in update.

Approval duration (Commercial)

Commercial approval duration6 months or to the member's renewal date, whichever is longer.

Context of changeModified for Commercial continuation of therapy in 1Q 2025 annual review.

Typical dispensing intervalDispensing limits referenced as 1 pen every 30 days in dosage guidance.

Approval duration (Medicaid/HIM)

Medicaid/HIM approval duration12 months.

Policy revisionInitial approval duration revised to 12 months for Medicaid/HIM (noted in 1Q 2025 annual review).

Reference noteSee Coding Implications entries describing the 1Q 2025 revisions.

Office chart notes documenting diagnosis and clinical rationale
BMD reports showing T-scores and dates of testing (see Appendix E for T-score interpretation)
Documentation of prior bisphosphonate therapy: dates, agent (generic alendronate preferred), dose, duration (3 years preferred), and reason for discontinuation if applicable
Records of fractures or imaging confirming recent osteoporotic/fragility fractures
Laboratory results or other tests supporting contraindications or adverse events

Documentation Required

Required Clinical Context

Clinical context that affects authorization decisions includes documented classification of 'very high risk' for fracture per updated guideline definitions, evidence of prior bisphosphonate therapy (including whether failure, intolerance, or contraindication exists), and documentation of any BMD loss or lack of BMD increase while on therapy. Requests for non‑FDA indications require sufficient off‑label justification per applicable off‑label use policies.

Very high risk for fracture definitions updated per 2020 guideline revisions (see policy references and Appendix E)
If requesting coverage based on prior bisphosphonate trial bypass, provide objective evidence (loss of BMD, lack of BMD increase after ≥12 months, or fracture while on therapy)
Non‑FDA indications require documentation per off‑label use policies (CP.CPA.09 for commercial; HIM.PA.154 for marketplace; CP.PMN.53 for Medicaid)

Step Therapy

Bisphosphonate Trial Preference and Bypass

Step-therapy preference: a trial and failure of a generic alendronate (bisphosphonate) is generally preferred prior to coverage. Bypass of the bisphosphonate trial is allowed when there is documentation of contraindication, clinically significant adverse effects to both oral and IV bisphosphonates, loss of BMD while on bisphosphonate therapy, lack of BMD increase after ≥12 months of therapy, or occurrence of an osteoporotic/fragility fracture while receiving bisphosphonate therapy.

Preferred step: failure of generic alendronate prior to approval (unless contraindicated or bypass criteria met)
Bypass criteria: contraindication to all bisphosphonates; significant adverse effects to both IV and PO formulations; documented loss of BMD on therapy; lack of BMD increase after ≥12 months; fracture while on bisphosphonate therapy
Document bisphosphonate trial details: agent, dose, duration (3 years preferred), and reason for discontinuation

Members generally must complete a 3‑year trial of bisphosphonate therapy (generic alendronate preferred) unless contraindicated or exceptions apply.

Policy historyOption to bypass was added in the 1Q 2022 update to criteria.