CurrentAgency for Health Care AdministrationPolicy N/A

Bonsity (teriparatide)/Forteo (teriparatide) Injection Prior Authorization Criteria

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This policy governs prior authorization for Bonsity (teriparatide) and Forteo (teriparatide) injection for adults with osteoporosis at high risk for fracture. It applies to providers requesting initiation or continuation of therapy under the Agency for Health Care Administration pharmacy policy.

Policy Summary

PayerAgency for Health Care Administration

PolicyBonsity/Forteo (teriparatide) Injection Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of applicable initiation or continuation criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearMaximum authorization length

≥18Minimum patient age

12 monthsZoledronate trial

T-score ≤ -2.5DXA threshold

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CurrentAgency for Health Care AdministrationPolicy N/A

Bonsity (teriparatide)/Forteo (teriparatide) Injection Prior Authorization Criteria

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Sign up for all Agency for Health Care Administration policy alerts

Know when Agency for Health Care Administration releases new policies or updates existing guidance.

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Policy Summary

PayerAgency for Health Care Administration

PolicyBonsity/Forteo (teriparatide) Injection Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of applicable initiation or continuation criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearMaximum authorization length

≥18Minimum patient age

12 monthsZoledronate trial

T-score ≤ -2.5DXA threshold

Extended therapy threshold

20% / 3%FRAX thresholds

Coverage Criteria

Initial Therapy Criteria

Covered when all initiation requirements are met, including at least one qualifying osteoporosis or high-fracture-risk condition.

All initial therapy requirements

Age: Patient is at least 18 years old.≥18 years
Specialist involvement: Therapy is prescribed by or in consultation with an endocrinologist, rheumatologist, or obstetrician/gynecologist.
Calcium and vitamin D: Patient is taking calcium and vitamin D.
Confirm in medical records or pharmacy claims.
Qualifying osteoporosis or high-fracture-risk condition
- DXA-confirmed osteoporosis: DXA documents a hip (femoral neck) or spine T-score of ≤ -2.5, dated within the past 2 years.T-score ≤ -2.5; within the past 2 years
  Confirm in medical records.
- Prior spine or hip fracture: Patient has a history of a spine or hip fracture.
  Confirm in medical records.
- Elevated FRAX risk: Patient has a T-score between -1.0 and -2.5 and a FRAX major osteoporotic fracture probability of ≥20% or hip fracture probability of 3%.T-score -1.0 to -2.5; FRAX ≥20% major osteoporotic or 3% hip fracture probability
  Confirm in medical records.
Zoledronate trial and failure: Patient completed a minimum 12-month trial of zoledronate and demonstrated failure.≥12 months
Failure may include intolerance or contraindication to other bisphosphonates, no increase from baseline BMD based on T-score history, or recurring fractures without major trauma after at least one year of therapy.

Continuation Therapy Criteria

Covered for continuation when all continuation requirements are met.

All continuation therapy requirements

Calcium and vitamin D: Patient is taking calcium and vitamin D.
Confirm in medical records or pharmacy claims.
BMD response: Medical records demonstrate stable BMD within interventional goals or increasing BMD after a minimum of one year of therapy.At least 1 year of therapy
Records should demonstrate sequential BMD progression or stability. T-score results may date back as far as five years; depending on BMD progression, retesting may occur every one to five years.
Continued high fracture risk after two years: For a request to continue cumulative therapy beyond two years, the provider attests that the member remains at or has returned to high risk for fracture.

Clinical Thresholds

DXA osteoporosis threshold

Measurement siteHip (femoral neck) or spine

Qualifying thresholdT-score ≤ -2.5

DXA recencyDated within the past 2 years

FRAX major osteoporotic fracture probability

Risk measureFRAX major osteoporotic fracture probability

Minimum probability≥ 20%

DocumentationFRAX results must be confirmed in medical records

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Bonsity or Forteo (teriparatide) injection. Authorizations may be approved for up to one year when the applicable review criteria are met.

Applicable use includes postmenopausal women with osteoporosis at high risk for fracture; men with primary or hypogonadal osteoporosis at high risk for fracture; or men and women with osteoporosis associated with sustained systemic glucocorticoid therapy who are at high risk for fracture.

Step Therapy

Zoledronate Trial and Failure Required

Before initiating teriparatide, documentation must show a minimum 12-month trial of zoledronate and failure of therapy.

Acceptable failure includes intolerance to other bisphosphonates, such as an adverse reaction or contraindication; no increase from baseline BMD as indicated by T-score history; or recurring fractures without major trauma after at least one year of therapy.
Documentation of the zoledronate trial and failure is required.

Policy Background

This policy addresses prior authorization for Bonsity or Forteo (teriparatide) injection in adults with osteoporosis who are at high risk for fracture. Covered uses include treatment of postmenopausal women with osteoporosis, increasing bone mass in men with primary or hypogonadal osteoporosis, and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women. Qualification may be established through DXA-confirmed osteoporosis, a history of spine or hip fracture, or osteopenia-range T-scores accompanied by elevated FRAX fracture risk.

Definitions

FRAX

Full nameWHO Fracture Risk Assessment Tool

PurposeEstimates major osteoporotic fracture probability

Additional estimateEstimates hip fracture probability

DXA

Full nameDual-energy X-ray absorptiometry

Clinical measureMeasures bone mineral density

Policy useDocuments osteoporosis or assesses change from baseline using hip (femoral neck) or spine T-scores

Initial Therapy Criteria

Initial Therapy

Initial therapy requires all listed criteria, including at least one qualifying osteoporosis or high-fracture-risk condition.

Initial therapy

Age: Patient is at least 18 years old.≥18 years
Specialist prescriber or consultation: Therapy is prescribed by or in consultation with an endocrinologist, rheumatologist, or obstetrician/gynecologist.
Calcium and vitamin D: Patient is taking calcium and vitamin D.
Confirm in medical records or pharmacy claims.
Qualifying osteoporosis or high-fracture-risk condition

Continuation Criteria

Continuation Therapy

Continuation requires all listed continuation criteria.

Continuation therapy

Calcium and vitamin D: Patient is taking calcium and vitamin D.
Confirm in medical records or pharmacy claims.
BMD response: Medical records demonstrate stable BMD within interventional goals or increasing BMD after a minimum of one year of therapy.At least 1 year of therapy
Medical records should reference sequential progression or stability of BMD. T-score results may be up to five years old; depending on BMD progression, retesting may occur every one to five years.
High fracture risk beyond two years:

Step Therapy Requirements

Step	Requirement	Minimum duration	Failure criteria
1	Trial and failure of zoledronate before initiating teriparatide.	12 months	Intolerance or contraindication to other bisphosphonates; no increase from baseline bone mineral density as indicated by T-score history; or recurring fractures in the absence of major trauma following at least one year of therapy.

Quantity and Authorization Limits

Maximum authorization period

MedicationBonsity/Forteo (teriparatide) injection

Maximum authorizationUp to one year

Authorization durationOne year per authorization period

Policy Summary

PayerAgency for Health Care Administration

PolicyBonsity/Forteo (teriparatide) Injection Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of applicable initiation or continuation criteria.

SourceLink

On This Page

>2 years of cumulative therapy

This requirement applies only to requests beyond two years.

FRAX hip fracture probability

Risk measureFRAX hip fracture probability

Minimum probability3%

Qualifying contextMay qualify when the T-score is between -1.0 and -2.5

Osteopenia-range T-score

T-score rangeBetween -1.0 and -2.5

Associated assessmentFRAX major osteoporotic fracture probability ≥ 20% or hip fracture probability of 3%

DocumentationThe T-score and FRAX results must be confirmed in medical records

Documentation Required

Initiation Documentation Required

For initiation, the provider must submit medical records or pharmacy-claim support confirming calcium and vitamin D use and documentation supporting osteoporosis and high fracture risk.

Patient must be at least 18 years old.
Prescription must be from or in consultation with an endocrinologist, rheumatologist, or obstetrician/gynecologist.
Documented osteoporosis must include a DXA hip (femoral neck) or spine T-score of ≤ -2.5 dated within the past 2 years; alternatively, records may document a spine or hip fracture, or a T-score between -1.0 and -2.5 with FRAX major osteoporotic fracture probability ≥ 20% or hip fracture probability of 3%.
Calcium and vitamin D use must be confirmed in medical records or pharmacy claims; the osteoporosis or fracture-risk evidence must be confirmed in medical records.

Documentation Required

Continuation Documentation Required

Continuation requests require documentation that the member remains clinically appropriate for therapy and that bone mineral density is stable within interventional goals or increasing after at least one year of therapy.

Calcium and vitamin D use must be confirmed in medical records or pharmacy claims.
For cumulative therapy beyond 2 years, the provider must attest that the member remains at or has returned to a high risk for fracture.
T-score results may be up to 5 years old. Depending on BMD progression, retesting may occur every 1 to 5 years.
Records should reference sequential BMD results demonstrating improvement or stability.

Denial Risk

Failure to Meet Clinical Criteria

Requests may be denied when the clinical criteria are not met or the required supporting documentation is absent.

Patient is younger than 18 years old.
The prescription is not from or in consultation with an endocrinologist, rheumatologist, or obstetrician/gynecologist.
Calcium and vitamin D use is not confirmed in medical records or pharmacy claims.
The records do not establish osteoporosis or qualifying high fracture risk through the required DXA result, spine or hip fracture history, or qualifying FRAX result.
The required minimum 12-month zoledronate trial and documented failure are not demonstrated.
For continuation, records do not demonstrate stable or increasing BMD, or the required high-fracture-risk attestation is absent for cumulative therapy beyond 2 years.

BMD

Full nameBone mineral density

Reported asA T-score

Policy usesEstablishes osteoporosis, assesses fracture risk, and evaluates response to therapy

DXA-confirmed osteoporosis: Documented osteoporosis with a hip (femoral neck) or spine T-score of ≤ -2.5, dated within the past 2 years.T-score ≤ -2.5; within the past 2 years
Confirm in medical records.
Prior fracture: History of a spine or hip fracture.
Confirm in medical records.
Elevated FRAX fracture risk: History of a T-score between -1.0 and -2.5 with a FRAX major osteoporotic fracture probability of ≥20% or hip fracture probability of 3%.T-score -1.0 to -2.5; FRAX ≥20% major osteoporotic or 3% hip fracture probability
Confirm in medical records.

Zoledronate trial and failure: Patient completed a minimum 12-month trial of zoledronate and demonstrated failure.≥12 months

Failure may be defined as intolerance or contraindication to other bisphosphonates, no increase from baseline BMD as indicated by T-score history, or recurring fractures without major trauma following at least one year of therapy.

If the request is for continuation of cumulative therapy beyond two years, the provider attests that the member remains at or has returned to high risk for fracture.

>2 years of cumulative therapy

Applies to requests beyond two years.