CurrentCignaPolicy N/A

Bone Modifiers - Tymlos Prior Authorization Policy

Defines Cigna's prior authorization criteria, coverage limits, and not-covered uses for Tymlos (abaloparatide) for treatment of osteoporosis in postmenopausal women and men at high risk for fracture.

Policy Summary

PayerCigna

PolicyBone Modifiers - Tymlos Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria revised (material) with wording standardization and examples added

Effective Date

Next Review DateOct 8, 2025

Key ActionObtain prior authorization — approvals allowed up to 2 years lifetime when documentation shows qualifying T‑score/history and required bisphosphonate trial or documented exception.

SourceLink

POLICY UPDATE CHANGES

Exception for patients who sustained an osteoporotic or fragility fracture while on oral bisphosphonate therapy was removed and incorporated into notes describing inadequate efficacy or intolerance.

The requirement language was standardized by replacing 'as determined by the prescriber' with 'according to the prescriber.'

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

Conditions Not Covered note clarified that calcium and/or vitamin D supplements may be used in combination with Tymlos.

2 yearsMaximum lifetime Tymlos therapy duration approved

Postmenopausal women, MenPopulations with FDA‑approved coverage criteria

≥12 months

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Coverage Criteria for Tymlos (abaloparatide)

inv-01: Osteoporosis Treatment for a Postmenopausal Patient (Initial or FDA‑approved use)

Approve for up to 2 years (total) during a patient's lifetime when ALL of the following are met:

Postmenopausal approval

A - diagnostic criteria: Patient meets ONE of the following: (i) T-score ≤ -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% (one-third) radius (wrist) (current or at any time in the past); OR (ii) history of an osteoporotic fracture or fragility fracture; OR (iii) BOTH: low bone mass (example: T-score between -1.0 and -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% radius) AND, according to the prescriber, patient is at high risk for fracture.
T-score can be current or at any time in the past
B - prior therapy or exception: Patient meets ONE of the following: (i) tried IV ibandronate (Boniva) or zoledronic acid (Reclast); OR (ii) tried at least one oral bisphosphonate or oral bisphosphonate-containing product and meets ONE of: (a) inadequate efficacy after a trial duration of 12 months (examples include ongoing/significant loss of BMD, lack of BMD increase, and/or an osteoporotic/fragility fracture) OR (b) significant intolerance to an oral bisphosphonate (examples include severe gastrointestinal or severe musculoskeletal adverse events); OR (iii) cannot take an oral bisphosphonate due to inability to swallow, inability to remain upright after administration, or a pre-existing gastrointestinal medical condition (examples: esophageal lesions, esophageal ulcers, or esophageal emptying abnormalities); OR (iv) according to the prescriber, the patient has severe renal impairment (example: creatinine clearance < 35 mL/min) OR the patient has had an osteoporotic or fragility fracture.
Examples of oral products are listed in policy (e.g., alendronate, risedronate, ibandronate, Binosto)

Duration: Approve for up to a total of 2 years of Tymlos therapy during the patient’s lifetime2 years

If patient has already received partial treatment (e.g., 3 months), approve remaining months up to a 2-year lifetime total

inv-02: Osteoporosis Treatment for Men (Initial or FDA‑approved use)

Approve for up to 2 years (total) during a patient's lifetime when ALL of the following are met:

Men approval

A - diagnostic criteria: Patient meets ONE of the following: (i) T-score ≤ -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% (one-third) radius (wrist) (current or at any time in the past); OR (ii) history of an osteoporotic fracture or fragility fracture; OR (iii) BOTH: low bone mass (example: T-score between -1.0 and -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% radius) AND, according to the prescriber, patient is at high risk for fracture.
T-score can be current or at any time in the past
B - prior therapy or exception: Patient meets ONE of the following: (i) tried zoledronic acid intravenous infusion (Reclast); OR (ii) tried at least one oral bisphosphonate or oral bisphosphonate-containing product and meets ONE of: (a) inadequate efficacy after a trial duration of 12 months (examples include ongoing/significant loss of BMD, lack of BMD increase, and/or an osteoporotic/fragility fracture) OR (b) significant intolerance to an oral bisphosphonate; OR (iii) cannot take an oral bisphosphonate due to inability to swallow, inability to remain upright after administration, or a pre-existing gastrointestinal medical condition (examples: esophageal lesions, esophageal ulcers, or esophageal emptying abnormalities); OR (iv) according to the prescriber, the patient has severe renal impairment (example: creatinine clearance < 35 mL/min) OR the patient has had an osteoporotic or fragility fracture.

Tymlos should not be used concurrently with other agents for osteoporosis. Examples explicitly listed in the policy include denosumab (Prolia), oral bisphosphonates (alendronate, risedronate, ibandronate), IV bisphosphonates (zoledronic acid/ Reclast, IV ibandronate), teriparatide (Forteo), romosozumab (Evenity), and calcitonin nasal spray. This concurrent use is considered a condition not covered and may result in denial of the request.

The policy allows concurrent use of calcium and/or vitamin D supplements with Tymlos; these supplements are not considered part of the prohibition on concomitant osteoporosis medications.

Use of Tymlos for osteoporosis prevention—that is, in patients who do not have substantial bone loss— is not covered. The policy states Tymlos has not been studied in this population and the benefits and risks of building bone in patients without substantial bone loss have not been investigated, therefore requests for prevention are considered not covered.

Tymlos is considered not medically necessary for any indication not explicitly listed in the Recommended Authorization Criteria. The policy specifically calls out concurrent use with other osteoporosis medications as an example of uses that are not medically necessary and not covered.

Safety guidance in the prescribing information—namely limited evaluation of safety beyond 2 years of therapy and increased osteosarcoma risk in certain populations—supports restricting use to the listed criteria and not approving off‑label or unlisted uses.

Coding and Test Thresholds

Covered/affected product codesmixed

NDC/HCPCS not specified

Tymlos (abaloparatide) specific product codes not listed in policy document

Oral bisphosphonate trial duration — typical requirement

Required oral bisphosphonate trial durationTrial of oral bisphosphonate for 12 months (inadequate efficacy defined as ongoing significant BMD loss, lack of BMD increase, and/or an osteoporotic/fragility fracture)

Alternate prior therapyIV bisphosphonate (e.g., zoledronic acid or IV ibandronate) may satisfy prior therapy requirement

Exception documentationPrescriber may document significant intolerance to oral bisphosphonates (e.g., severe GI or musculoskeletal adverse events) instead of a 12‑month trial

Inability to take oral bisphosphonatesCannot swallow, cannot remain upright after dosing, or has pre‑existing GI condition (examples: esophageal lesions, ulcers, strictures, achalasia)

Note on timingT‑score evidence may be current or from any time in the past when assessing need for therapy

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required — Tymlos

Prior authorization is required for Tymlos. Approvals are issued for up to a maximum of 2 years total lifetime when the specified clinical criteria are met. For patients who have already received a portion of therapy, the remaining approval duration will allow completion of a cumulative maximum of 2 years.

Prior Authorization

Bisphosphonate trial or documented exception

Approval generally requires prior trial of bisphosphonate therapy (oral or IV) unless the prescriber documents inadequate efficacy or intolerance, or documents a clinical reason the patient cannot use oral bisphosphonates (e.g., inability to swallow, inability to remain upright after dosing, pre-existing gastrointestinal condition). Examples of oral bisphosphonates include alendronate (Fosamax, Binosto), risedronate (Actonel, Atelvia), and ibandronate (Boniva). Examples of IV bisphosphonates include zoledronic acid (Reclast) and IV ibandronate.

Required trial examples: oral bisphosphonate for 12 months or IV bisphosphonate (e.g., zoledronic acid).
Acceptable exceptions: documented significant intolerance (severe GI or musculoskeletal adverse events), documented inadequate efficacy after appropriate trial, or inability to take oral bisphosphonates (swallowing difficulty, cannot remain upright, or pre-existing GI condition).

Background

Tymlos (abaloparatide) is a parathyroid hormone–related peptide analog indicated for the treatment of osteoporosis in postmenopausal women and in men at high risk for fracture. The medication stimulates bone formation and is intended for patients meeting the policy’s diagnostic and prior‑therapy criteria.

The prescribing information notes that the safety and efficacy of Tymlos have not been evaluated beyond 2 years of therapy and that use for more than 2 years during a patient’s lifetime is not recommended; avoid use in patients at increased baseline risk of osteosarcoma (for example, those with open epiphyses, metabolic bone disease, bone metastases, or prior skeletal malignancy).

Definitions

High risk for fracture — definition

Definition of high risk for fracturePatients with a history of osteoporotic or fragility fracture, multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapy

Diagnostic criteria that indicate high riskT‑score ≤ -2.5 at lumbar spine, femoral neck, total hip, or 33% radius; OR history of osteoporotic/fragility fracture; OR low bone mass (T‑score -1.0 to -2.5) plus prescriber judgment of high risk

Clinical examples of risk factorsMultiple clinical risk factors (per prescriber) such as prior fractures, poor bone density, or intolerance/failure of prior therapies may establish high risk