Abaloparatide (Tymlos) coverage
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Defines medical necessity and prior authorization criteria for abaloparatide (Tymlos) for treatment of osteoporosis in postmenopausal women and men at high fracture risk, and continuation criteria for members under QualChoice lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met:
Initial Osteoporosis Criteria
- a. Very high fracture risk: Member is at very high risk for fracture as evidenced by (i) recent osteoporotic fracture within the past 12 months OR (ii) BMD T-score at hip or spine ≤ -3.0 OR (iii) BMD T-score at hip or spine ≤ -2.5 AND major osteoporotic fracture (hip, spine, forearm, wrist, humerus).
b. Prior bisphosphonate therapy
- Exceptions to bisphosphonate requirement: (i) All bisphosphonates contraindicated; (ii) Clinically significant adverse effects to both IV and PO formulations; (iii) Loss of BMD while receiving bisphosphonate therapy; (iv) Lack of BMD increase after ≥ 12 months of bisphosphonate therapy; (v) Osteoporotic or fragility fracture while receiving bisphosphonate therapy.
Continuation Therapy
Continued therapy is covered when ALL of the following are met:
Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace) or an approved evidence of coverage document.
For members covered by Medicaid, any state Medicaid coverage provisions that conflict with the terms of this clinical policy take precedence. Providers should refer to the applicable state Medicaid manual for specific coverage rules that supersede this policy.
Use of abaloparatide (Tymlos) for diagnoses or indications that are not FDA‑approved and are not addressed within this policy is not authorized unless appropriate supporting documentation is provided per the applicable off‑label use policy or evidence of coverage.
Product Coding & Limits
| NDC not listed | Product availability: single-patient-use prefilled pen: 3, 120 mcg/1.56 mL (30 daily doses of 80 mcg) |
| J3490 | Unclassified drugs |
Provider Actions & Authorization
Obtain prior authorization; note approval durations and lifetime limit
Prior authorization is required for abaloparatide (Tymlos). Approval durations: HIM — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer. A cumulative lifetime limit of 2 years of abaloparatide use applies.
- Approval durations: HIM 12 months; Commercial 6 months or to renewal date
- Cumulative lifetime abaloparatide use limit: 2 years
Document prior authorization for drug billing (e.g., J3490)
If billing under an unclassified drug code, obtain and document any required prior authorization per Health Plan procedures. J3490 is referenced in this policy as an example HCPCS code for unclassified drugs.
- Example code referenced: J3490 (Unclassified drugs)
- Document prior authorization for drug billing as required by the plan
Provide documentation that member meets high‑risk or prior bisphosphonate trial requirement
For initial approval, document that the member either is at very high risk for fracture OR has completed a 3‑year trial of bisphosphonate therapy (generic alendronate preferred) at maximally indicated doses unless an exception applies. Include evidence cited in the criteria (e.g., recent osteoporotic fracture, BMD T-score thresholds, or reasons bisphosphonate therapy is contraindicated or ineffective).
- Very high fracture risk evidence: recent osteoporotic fracture within 12 months; BMD T‑score ≤ -3.0 at hip or spine; or BMD T‑score ≤ -2.5 plus a major osteoporotic fracture
- OR: completed a 3‑year trial of bisphosphonate therapy (generic alendronate preferred) unless one of listed exceptions applies
No explicit step therapy beyond listed initial requirements
No additional step therapy protocols are specified in this policy; the document does not impose a separate step‑therapy sequence beyond the initial criteria requiring either very high fracture risk or prior bisphosphonate therapy.
- Policy does not define extra step therapy requirements beyond the initial criteria
Submit clinical documentation to support that approval criteria are met
Providers must submit supporting documentation such as office chart notes, laboratory results, and other clinical information to show the member has met all approval criteria.
- Examples of acceptable documentation: office chart notes, lab results, other clinical information
Align documentation and claims with the clinical policy and member coverage terms
Use this clinical policy as a guide to medical necessity, and ensure claims and coverage decisions follow all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable law.
- Verify member's coverage documents (e.g., evidence of coverage, certificate of coverage) and applicable law when submitting claims
Non‑FDA use may be denied without off‑label or evidence support
Requests for non‑FDA approved indications that are not addressed in this policy may be denied unless there is sufficient documentation of efficacy and safety per the applicable off‑label use policies (CP.CPA.09, HIM.PA.154) or evidence of coverage.
- Non‑FDA indications require supporting documentation per Off‑Label Use policies: CP.CPA.09 (Commercial) or HIM.PA.154 (Health Insurance Marketplace)
Coding listed in policy does not guarantee coverage or payment
Inclusion or exclusion of codes in this policy does not guarantee payment. Providers should reference the most up‑to‑date professional coding guidance prior to claim submission.
- Codes listed are informational only; verify current coding guidance before billing
- Coding presence in policy does not ensure coverage or payment
Background
Abaloparatide (Tymlos) is a parathyroid hormone‑related peptide analog indicated for the treatment of osteoporosis in postmenopausal women and in men at high risk for fracture. It acts as an anabolic agent to increase bone mineral density and reduce the risk of vertebral and nonvertebral fractures. Product availability is provided as a single‑patient use prefilled pen containing 120 mcg/1.56 mL (30 daily doses of 80 mcg); clinical guidance and guideline references supporting its use are cited in the policy references.
Definitions & Thresholds
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