Clinical Policy: Abaloparatide (Tymlos)
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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.
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.
Coverage Criteria for Abaloparatide (Tymlos)
Initial Therapy
Covered when ALL of the following are met for diagnosis of postmenopausal osteoporosis (PMO) or male osteoporosis:
Age ≥ 18 years or documentation of closed epiphyses on X‑ray
See Appendix E for T‑score definitions
Appendix B and D provide details on alternatives and contraindications; option to bypass trial added in 1Q 2022 updates
Dose and duration per Dosage and Administration
Continuation Therapy
Continued therapy is covered when the member meets ONE of the following:
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
1Q 2023 annual review
Added in 1Q 2022 update
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
| J3490 | Unclassified drugs |
Provider Actions, Prior Authorization, and Documentation
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
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.
- 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
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)
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
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
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