ModifiedmhnPolicy CP.PHAR.188

Teriparatide (Forteo, Bonsity)

Defines medical necessity and prior authorization criteria for teriparatide (Forteo, Bonsity) for osteoporosis indications across commercial, HIM, and Medicaid lines of business; applies to providers requesting coverage for members in the payer's jurisdictions.

Policy Summary

Payermhn

PolicyTeriparatide (Forteo, Bonsity)

Policy CodePolicy CP.PHAR.188

Change TypeMaterial revisions and additions

Effective DateNov 15, 2017

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing diagnosis (PMO, GIO, or male osteoporosis), required prior therapy or bypass justification, and dose limits (≤20 mcg/day; 1 pen/28 days).

SourceLink

POLICY UPDATE CHANGES

Added Bonsity and revised FDA Approved Indication(s) section to align with current labeling for both Forteo and Bonsity; added generic Forteo and generic Bonsity formulations; added redirection to generic Forteo for all brand requests; added HCPC codes C9399 and J3490.

Removed osteosarcoma black box warning per package insert update.

Removed prior criteria that limited therapy to 2 years cumulative PTH analog therapy; added requirement for provider attestation if continuing beyond 2 years that member remains or has returned to high fracture risk and that risks vs benefits were reviewed.

Added step therapy bypass for Illinois HIM per IL HB 5395 and revised initial approval duration to 12 months for Medicaid/HIM.

20 mcg/daymaximum daily dose allowed

1 pen/28 daysmaximum supply/interval

Medicaid/HIM: 12 moapproval duration

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Commercial: 6 moapproval duration

up to 2 yrsprevious cumulative limit

J3110, J3490, C9399HCPCS / billing codes

Coverage Criteria for Teriparatide (Forteo, Bonsity)

Initial Approval — Osteoporosis

Covered when ALL of the following are met:

Initial approval for osteoporosis

(a) Very high risk criteria: Member is at very high risk for fracture as evidenced by one of: (i) recent osteoporotic fracture within the past 12 months; (ii) BMD T-score at hip or spine ≤ -3.0; OR (iii) BMD T-score at hip or spine ≤ -2.5 AND a major osteoporotic fracture (hip, spine, forearm, wrist, humerus).
(b) Prior bisphosphonate therapy or exceptions: Member has completed a 3-year trial of bisphosphonate therapy (alendronate preferred) at up to maximally indicated doses, UNLESS one of the following applies: (i) all bisphosphonates are contraindicated; (ii) clinically significant adverse effects to both IV and PO formulations; (iii) loss of BMD while on bisphosphonate therapy; (iv) lack of BMD increase after ≥ 12 months of bisphosphonate therapy; OR (v) osteoporotic/fragility fracture while receiving bisphosphonate therapy.

Additional initial requirements: 2. Age ≥ 18 years or documentation of closed epiphyses on x-ray; 3. If request is for brand Forteo or Bonsity, member must use generic teriparatide (generic Forteo) unless contraindicated or clinically significant adverse effects are experienced; 4. One of the following: (a) for PMO, failure of Prolia or Tymlos at up to maximally indicated doses unless contraindicated or intolerant; OR (b) if request is for continuation of cumulative PTH analog therapy beyond 2 years, provider attestation that member remains at or has returned to high fracture risk and that risk versus benefit of continued therapy has been reviewed with the member; 5. Dose limits — does not exceed both: (a) 20 mcg per day; and (b) 1 pen every 28 days.

Continued Therapy — Osteoporosis

Covered when ALL of the following are met for continuation:

Continuation requirements: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) member is currently receiving medication and continuity of care regulations apply per state/product; 2. Member is responding positively to therapy; 3. If request is for continuation of cumulative PTH analog therapy beyond 2 years, provider attestation that member remains at or has returned to high fracture risk and that risk versus benefit has been reviewed with the member; 4. If request is for brand Forteo or Bonsity, member must use generic teriparatide (generic Forteo) unless contraindicated or clinically significant adverse effects are experienced; 5. If request is for a dose increase, new dose must not exceed both: (a) 20 mcg per day; and (b) 1 pen every 28 days.

Coverage and administrative criteria (extracted elements)

Coverage includes teriparatide when product labeling and clinical policy criteria are met; the following administrative and product-specific conditions apply:

Product options: Forteo, Bonsity, and generic teriparatide formulations are included; redirection to generic Forteo for brand requests may be applied per policy updates.

Dosing and product presentation: Standard dosing regimen: 20 mcg subcutaneously once daily; product pens contain 28 daily doses. Maximum documented dose 20 mcg/day.20 mcg SC QD

See product labeling for pen presentations and Appendix B for dosing details

Prior bisphosphonate trial bypass: Bisphosphonate trial may be bypassed if member experienced loss of BMD, lack of BMD increase, or had an osteoporotic/fragility fracture while receiving bisphosphonate therapy (in addition to standard contraindication/adverse effect exceptions).

Requests for uses that are not FDA‑approved and that are not specifically addressed in this policy are not authorized unless the provider submits sufficient supporting documentation in accordance with the applicable off‑label use and non‑formulary policies. Refer to the off‑label use policies CP.CPA.09 (commercial), HIM.PA.154 or HIM.PA.33 (health insurance marketplace as applicable), and CP.PMN.53 (Medicaid) or to the relevant no coverage/formulary policies when the requested indication or recent labeling change is not reflected in this policy.

Contraindications and clinically significant adverse effects for bisphosphonates are described in Appendix E and include examples such as hypocalcemia and hypersensitivity to product components for both oral and IV formulations. Product‑specific contraindications and adverse effects that may preclude use (examples) include pregnancy, esophageal abnormalities for oral agents, acute renal failure/creatinine clearance thresholds for IV agents, osteonecrosis of the jaw, and atypical femoral fractures; these conditions should be considered when evaluating eligibility for teriparatide.

Uses that are not listed under the authorized diagnoses/indications in section III are considered not medically necessary and will not be approved unless supported by the applicable off‑label use policy or a formulary exception. When a requested use is not specifically listed and a recent label change does not apply, follow the specified off‑label or non‑formulary review pathways (see CP.CPA.09, HIM.PA.154/HIM.PA.33, or CP.PMN.53 as appropriate).

Prior policy language that strictly limited cumulative PTH analog therapy to 2 years has been removed. Continuation of therapy beyond a cumulative 2‑year duration now requires a documented provider attestation that the member remains at or has returned to high fracture risk and that the risks versus benefits of additional therapy have been reviewed with the member; absence of this attestation may render continuation requests not approvable.

Product and Billing Codes; Clinical Thresholds

Drug products referencedmixed

Forteo	Brand name teriparatide
Bonsity	Brand name teriparatide

Referenced HCPCS codesHCPCS

J3110	Injection, teriparatide, 10 mcg.
J3490	Unclassified drugs.
C9399	Unclassified drugs or biologicals

BMD T-score thresholds — key diagnostic thresholds used for eligibility

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

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

WHO operational definition referenceT-score is standard deviation from young normal mean; normal considered −1.0 or above (WHO definition).

Age / epiphyses — age requirement or closed epiphyses documentation

Age requirementAge ≥ 18 years is required for approval.

Closed epiphyses documentation

Prior Authorization, Documentation, and Prescribing Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for teriparatide (including brand and generic formulations). Providers must obtain authorization prior to dispensing/administering the drug.

Prior authorization may be required for related agents (bisphosphonates, Prolia, Tymlos) per policy notes.
HCPCS/CPT/other codes referenced for informational billing purposes: J3110 (Injection, teriparatide, 10 mcg), J3490 (Unclassified drugs), C9399 (Unclassified drugs or biologicals). Inclusion/exclusion of codes does not guarantee coverage — verify current coding guidance prior to claim submission.

Documentation Required

Providers must submit supporting clinical documentation to demonstrate that the member meets all approval criteria. Failure to submit required documentation may result in denial of the request.

Acceptable documentation includes office chart notes, BMD results, laboratory values, radiology reports (e.g., x-ray showing closed epiphyses if member <18), and documentation of prior therapy trials or contraindications.

Background on Teriparatide

Teriparatide is a recombinant human parathyroid hormone analog indicated to increase bone mass and reduce fracture risk in adults with osteoporosis, including postmenopausal women, men with osteoporosis, and patients with glucocorticoid‑induced osteoporosis who are at high fracture risk or who have failed or are intolerant to other therapies. Its mechanism of action is anabolic on bone, stimulating new bone formation when given as the standard dosing regimen of 20 mcg subcutaneously once daily; product presentations are multi‑dose prefilled pens containing 28 daily doses.

Key Definitions and Dosing

High risk of fracture — definition and FRAX thresholds

Definition: high risk of fractureHistory of osteoporotic fracture or multiple clinical risk factors (per Appendix D) defines high risk of fracture.

FRAX numeric thresholdsFRAX-defined high risk = 10‑year major osteoporotic fracture probability ≥ 20% or hip fracture probability ≥ 3%.

Clinical risk factor examplesRisk factors include age, prior fracture, glucocorticoid use, rheumatoid arthritis, smoking, alcohol, low BMI, parental hip fracture, and secondary osteoporosis.

BMD T-score thresholds — very high risk thresholds and qualifying criteria

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

BMD plus fracture qualifier

Policy Summary

Payermhn

PolicyTeriparatide (Forteo, Bonsity)

Policy CodePolicy CP.PHAR.188

Change TypeMaterial revisions and additions

Effective DateNov 15, 2017

Next Review Date

SourceLink

On This Page

Continuation beyond 2 years administrative requirement: If request is for continuation of cumulative PTH analog therapy beyond 2 years, provider must attest that the member remains at or has returned to high fracture risk and that risks versus benefits of continued therapy have been reviewed with the member.>2 years cumulative PTH analog therapy

Provider attestation required

Documentation of closed epiphyses on x‑ray may be accepted in lieu of age criterion.

Product presentation relevanceProduct pens are multi‑dose prefilled pens containing 28 daily doses (used to support supply/interval calculations).

FRAX high risk — FRAX probability thresholds for high risk

FRAX major osteoporotic fracture threshold10‑year major osteoporotic fracture probability ≥ 20% defines high risk.

FRAX hip fracture threshold10‑year hip fracture probability ≥ 3% also defines high risk.

FRAX risk factors includedFRAX incorporates age, sex, BMI, smoking, alcohol, prior fracture, parental hip fracture, glucocorticoid use, rheumatoid arthritis, secondary osteoporosis, and femoral neck BMD when available.

Maximum documented prior regimen note — dosing max and prior policy reference to 2-year cumulative PTH analog use

Maximum daily doseMaximum documented dose: 20 mcg per day.

Maximum cumulative prior regimen note (historical)Prior policy referenced up to 2 years cumulative PTH analog use as a lifetime guidance; revisions removed the strict 2‑year limit but retained attestation requirements for continuation beyond 2 years.

Supply limit supporting regimenMaximum supply/interval: 1 pen every 28 days (pen contains 28 daily doses).

Provider should include documentation of diagnosis (PMO, GIO, or male osteoporosis), fracture history, BMD T-scores, dates and doses of prior bisphosphonate or other therapies, and any adverse events or contraindications.

Denial Risk

Attestations, Contraindications, and Therapy Bypass

Providers must attest to specific conditions when applicable, and note clinically relevant contraindications or adverse effects that may impact coverage decisions.

Provider attestation required when cumulative PTH analog therapy beyond 2 years is requested: attest that the member remains at or has returned to high risk for fracture and that risks vs benefits of continued therapy were reviewed with the member.
Bisphosphonate trial bypass is allowed if member has: loss of BMD while on bisphosphonate therapy, lack of BMD increase after ≥12 months of bisphosphonate therapy, or experienced an osteoporotic/fragility fracture while receiving bisphosphonate therapy.
Examples of contraindications/adverse effects that may lead to denial include hypocalcemia, pregnancy, severe hypersensitivity to product components, osteonecrosis of the jaw, atypical femoral fractures, severe renal impairment as specified in product labeling, and other clinically significant adverse effects (see Appendix E).

Note

State and Program Exceptions / Brand-to-Generic Redirection

State-specific operational notes and step-therapy exceptions apply. Illinois (IL) HIM requests: step therapy requirements do not apply per IL HB 5395 (effective 1/1/2026).

When request is for a brand product (Forteo or Bonsity), redirect to the generic teriparatide (generic Forteo/Bonsity) unless contraindicated or clinically significant adverse effects are documented.
Medicaid/Health Insurance Marketplace (HIM) programs may have specific initial approval durations and step-therapy bypass rules; verify program-specific requirements (e.g., initial approval duration revised to 12 months for Medicaid/HIM).

BMD T-score ≤ -2.5 plus a major osteoporotic fracture also qualifies as very high/qualifying criteria.

WHO T-score contextT-score interpretation uses WHO definitions; normal is −1.0 or above and osteoporosis is ≤ −2.5 in context of fragility fracture.

Dosing regimen — standard dosing 20 mcg SC QD; pen presentation and supply limits

Standard dosing regimen20 mcg subcutaneously once daily (20 mcg SC QD) is the recommended regimen for PMO, GIO, and male osteoporosis.

Product presentationTeriparatide (Forteo and Bonsity) available as multi‑dose prefilled pens containing 28 daily doses of 20 mcg.

Supply limitMaximum supply: 1 pen every 28 days (pen contains 28 daily doses).