CurrentCignaPolicy IP0329

Bone Modifiers - Tymlos

Defines prior authorization and medical necessity criteria for coverage of Tymlos (abaloparatide) for treatment of osteoporosis in postmenopausal women and men at high risk for fracture under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyBone Modifiers - Tymlos

Policy CodePolicy IP0329

Change TypeMaterial revisions and clarifications

Effective Date

Next Review Date

Key ActionObtain prior authorization; approvals are for up to 2 years total during a patient's lifetime when all clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

Examples for inadequate efficacy and intolerance to oral bisphosphonates were added.

Criterion added allowing approval of teriparatide where patients cannot take oral bisphosphonates (employer plans note: trial of teriparatide may be required).

Criterion added allowing approval of Tymlos for patients with severe renal impairment (example: CrCl < 35 mL/min).

Binosto (alendronate effervescent tablets for oral solution) was added as an example of an oral bisphosphonate.

Policy title updated from 'Abaloparatide' to 'Bone Modifiers - Tymlos'.

Note clarifying that calcium and/or vitamin D supplements may be used in combination with Tymlos.

2 yearsmaximum lifetime approval duration

CrCl < 35 mL/minrenal impairment example

Postmenopausal women; Men

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Tymlos (abaloparatide) Coverage Criteria

Initial therapy — Postmenopausal women

Approve for up to 2 years (total) during a patient's lifetime if the patient meets ALL of the following (A, B, and C):

Overall: All of A, B, and C must be met

Postmenopausal women pathway (FDA‑approved)

A - Diagnostic criteria: Patient meets ONE of: i) T‑score ≤ -2.5 at lumbar spine, femoral neck, total hip, and/or 33% (one‑third) radius (wrist); OR ii) prior osteoporotic/fragility fracture; OR iii) BOTH: (a) low bone mass (example: T‑score between -1.0 and -2.5 at lumbar spine, femoral neck, total hip, and/or 33% radius) AND (b) prescriber states patient is at high risk for fracture.T‑score values as specified

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B - Prior therapy or clinical circumstances: Patient meets ONE of: i) tried ibandronate IV (Boniva) or zoledronic acid IV (Reclast); OR ii) tried ≥1 oral bisphosphonate or oral bisphosphonate‑containing product and meets ONE of: (a) inadequate efficacy after 12 months (examples include ongoing significant BMD loss, lack of BMD increase, or osteoporotic/fragility fracture) OR (b) significant intolerance (examples include severe GI or severe musculoskeletal adverse effects); OR iii) cannot take oral bisphosphonates for reasons such as inability to swallow, inability to remain upright after dosing, or pre‑existing GI conditions (e.g., esophageal lesions/ulcers, strictures, achalasia); OR iv) patient has severe renal impairment (example threshold: CrCl < 35 mL/min) OR has had an osteoporotic/fragility fracture.12 months trial for oral bisphosphonate when applicable

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C - Formulary/Preferred product: Preferred product criteria is met for the product(s) as listed in the policy's tables.

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Initial therapy — Men

Approve for up to 2 years (total) during a patient's lifetime if the patient meets ALL of the following (A, B, and C):

Overall: All of A, B, and C must be met

Men pathway (FDA‑approved)

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B - Prior therapy or clinical circumstances: Patient meets ONE of: i) tried zoledronic acid IV (Reclast); OR ii) tried ≥1 oral bisphosphonate or oral bisphosphonate‑containing product and meets ONE of: (a) inadequate efficacy after 12 months or (b) significant intolerance; OR iii) cannot take oral bisphosphonates for listed reasons (e.g., inability to swallow, inability to remain upright after dosing, pre‑existing GI conditions); OR iv) patient has severe renal impairment (example threshold: CrCl < 35 mL/min) OR prior osteoporotic/fragility fracture.

Employer plan criteria

Employer plan variant:

Employer plan requirement: Approve for up to 2 years if the patient meets the following: patient has tried one of teriparatide pen (Forteo, generic), brand teriparatide, or Bonsity; AND patient has not received more than 2 years of cumulative therapy with Tymlos.2 years cumulative maximum

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Tymlos (abaloparatide) for any use other than the specified FDA‑approved indications is considered not medically necessary. Specifically, concurrent use with other medications for osteoporosis is not allowed and is listed as not medically necessary. Examples of medications that should not be given concurrently with Tymlos include Prolia (denosumab), oral bisphosphonates (alendronate, risedronate, ibandronate), IV bisphosphonates (zoledronic acid, IV ibandronate), calcitonin nasal spray, teriparatide (Forteo), and Evenity (romosozumab). Calcium and/or vitamin D supplements may be used concomitantly.

Use of Tymlos for osteoporosis prevention or other non‑specified indications is considered not medically necessary. The policy notes that Tymlos has not been studied in patients for prevention of osteoporosis and that the benefits and risks of using Tymlos when substantial bone loss has not occurred have not been investigated.

Coding and Diagnostic Criteria

Covered NDC/ProductNDCCovered

NDC	Tymlos (abaloparatide subcutaneous injection) – product specific NDC(s) referenced in prescribing information (document cites NDC namespace)

Conditions Not Covered / Concurrent therapymixedNot Covered

none	Concurrent use with other osteoporosis medications (e.g., Prolia [denosumab], oral bisphosphonates [alendronate, risedronate, ibandronate], IV bisphosphonates [zoledronic acid, ibandronate], teriparatide [Forteo], romosozumab [Evenity], calcitonin nasal spray) is listed as not covered.

T-score thresholds

T-score qualifying thresholdT-score ≤ -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% (one-third) radius (wrist)

Low bone mass definitionT-score between -1.0 and -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% (one-third) radius (wrist)

Use of prior or historical T-scoresCurrent or any past T-score may be used to determine eligibility (T-score at or below -2.5 qualifies)

Renal function example threshold

Severe renal impairment exampleCreatinine clearance < 35 mL/min is cited as an example of severe renal impairment

Renal impairment as pathway criterion

Provider Actions and Authorization Requirements

Denial Risk

Denial Triggers

Claims submitted for services that are not accompanied by covered diagnosis or procedure code(s) under this Coverage Policy will be denied as not covered. Tymlos is not covered for concurrent use with other osteoporosis medications; examples of medications that must NOT be used concurrently with Tymlos include Prolia (denosumab), oral bisphosphonates (alendronate, risedronate, ibandronate), intravenous bisphosphonates (zoledronic acid [Reclast], ibandronate IV), calcitonin nasal spray (Miacalcin/Fortical), teriparatide (Forteo), and Evenity (romosozumab). Receipt of sample product does not satisfy criteria requirements for coverage.

Claims without covered diagnosis/procedure codes will be denied.
Concurrent use of Tymlos with other osteoporosis medications will be denied.
Sample product receipt does not meet coverage criteria.

Prior Authorization

Therapy Trial and Prior Authorization Requirements

Definitions and High-Risk Criteria

High risk for fracture — definition

History of osteoporotic/fragility fracturePrior osteoporotic or fragility fracture qualifies a patient as high risk for fracture

Multiple risk factorsPatients with multiple clinical risk factors for fracture meet the high‑risk definition

Failed or intolerant to other osteoporosis therapyPatients who have failed or are intolerant to other osteoporosis therapies are considered at high risk for fracture

Background

Tymlos (abaloparatide) is a parathyroid hormone‑related protein (PTHrP) analog indicated to treat osteoporosis in postmenopausal women and to increase bone density in men at high risk for fracture. High risk is defined as a history of osteoporotic/fragility fracture, multiple risk factors for fracture, or failure/intolerance of other osteoporosis therapies. The prescribing information notes that safety and efficacy have not been evaluated beyond 2 years of therapy and that Tymlos should be avoided in patients at increased baseline risk of osteosarcoma.

Policy Revision History

2026-02-01annual_revisionLatest

Annual revision updated policy title to 'Bone Modifiers - Tymlos'; added Binosto as an example bisphosphonate; added examples for inadequate efficacy and intolerance; added criteria allowing approval of teriparatide where patients cannot take oral bisphosphonates (employer plan note); added criterion allowing approval for patients with severe renal impairment (example CrCl < 35 mL/min); clarified that calcium and/or vitamin D supplements may be used concomitantly.

2025-01-15annual_revision

Annual revision with no criteria changes recorded on this date (administrative).