CurrentOklahoma Health Care AuthorityPolicy N/A

Forteo (teriparatide) Coverage Criteria

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This policy governs SoonerCare prior authorization and coverage of Forteo (teriparatide) for osteoporosis, including initial and continuation therapy requirements, safety restrictions, approval duration, and total lifetime coverage limits.

Policy Summary

PayerOklahoma Health Care Authority

PolicyForteo (teriparatide) Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded to Tier 3 prior authorization category

Effective DateApril 2010

Next Review DateN/A

Key ActionSubmit prior authorization for new starts and document the required diagnosis, clinical criteria, prior-agent trial, and recent BMD results.

SourceLink

POLICY UPDATE CHANGES

Forteo was added to the Osteoporosis Product Based Prior Authorization Category as a Tier 3 medication during fiscal year 2010.

1 yearPrior authorization approval period

2 yearsMaximum total coverage period

30Members receiving Forteo, Jul 2008–Jun 2009

71FY09 petitions submitted

35/10/26

Policy Summary

PayerOklahoma Health Care Authority

PolicyForteo (teriparatide) Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded to Tier 3 prior authorization category

Effective DateApril 2010

Next Review DateN/A

Key ActionSubmit prior authorization for new starts and document the required diagnosis, clinical criteria, prior-agent trial, and recent BMD results.

SourceLink

On This Page

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CurrentOklahoma Health Care AuthorityPolicy N/A

Forteo (teriparatide) Coverage Criteria

Customize your policy alerts

Sign up for all Oklahoma Health Care Authority policy alerts

Know when Oklahoma Health Care Authority releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerOklahoma Health Care Authority

PolicyForteo (teriparatide) Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded to Tier 3 prior authorization category

Effective DateApril 2010

Next Review DateN/A

Key ActionSubmit prior authorization for new starts and document the required diagnosis, clinical criteria, prior-agent trial, and recent BMD results.

SourceLink

POLICY UPDATE CHANGES

Forteo was added to the Osteoporosis Product Based Prior Authorization Category as a Tier 3 medication during fiscal year 2010.

1 yearPrior authorization approval period

2 yearsMaximum total coverage period

30Members receiving Forteo, Jul 2008–Jun 2009

71FY09 petitions submitted

35/10/26

Policy Summary

PayerOklahoma Health Care Authority

PolicyForteo (teriparatide) Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded to Tier 3 prior authorization category

Effective DateApril 2010

Next Review DateN/A

Key ActionSubmit prior authorization for new starts and document the required diagnosis, clinical criteria, prior-agent trial, and recent BMD results.

SourceLink

On This Page

FY09 petition outcomes

Coverage Criteria

Continuation Therapy

Continued coverage is available for members already stabilized on Forteo.

Stabilized continuation: Member is already stabilized on Forteo.

The member should be approved for continued coverage without being required to stop Forteo and try another agent.

Initial Therapy

New-start members must meet all applicable prior authorization requirements.

New-start requirements

Qualifying patient pathway
- Postmenopausal woman pathway: Member is a postmenopausal woman at high risk for fracture or cannot tolerate, is allergic to, or has failed to improve while using other agents.BMD T-score at or below -2.5 for high risk for fracture
- Male osteoporosis pathway: Member is a man with primary or hypogonadal osteoporosis at high risk for fracture or cannot tolerate, is allergic to, or has failed to improve while using other agents.BMD T-score at or below -2.5 for high risk for fracture
Required diagnosis: Member has an appropriate ICD-9 code or diagnosis of osteoporosis.
Prior osteoporosis-agent trial: Member has completed a trial with any one other osteoporosis agent.At least 12 months
The trial is not required when the other agent was contraindicated, or the member was intolerant or allergic.
Recent BMD documentation: A BMD test result is documented on the petition.T-score at or below -2.5; test performed within the last month

Coverage Limitations

Coverage is limited by the following treatment-safety and combination-therapy restrictions.

Treatment limitations

No concurrent osteoporosis therapy: Concurrent use of Forteo with other osteoporosis agents is not covered.
Maximum total coverage: Total Forteo coverage does not exceed 2 years.2 years
Forteo has not been proven to be safe and efficacious for longer than 2 years.

Concurrent use of Forteo with other osteoporosis agents is not covered.

Forteo coverage is limited to a maximum total period of 2 years. Use beyond 2 years is excluded because longer-term safety and efficacy have not been established; animal studies also identified a potential osteosarcoma risk.

Coding and Clinical Thresholds

Required diagnosisICD-9

ICD-9 osteoporosis diagnosis code

An appropriate ICD-9 code/diagnosis of osteoporosis is required; the specific code is not listed.

BMD T-score

ThresholdAt or below -2.5

Applies toHigh risk for fracture

DocumentationThe BMD T-score must be indicated on the prior authorization petition

Recent BMD test

Required timingWithin the last month

Required resultBMD T-score at or below -2.5

DocumentationTest results should be indicated on the prior authorization petition

Provider Actions and Authorization Rules

Prior Authorization

Continuation Therapy for Stabilized Members

Members already stabilized on Forteo should receive continued coverage without being required to stop Forteo and try another osteoporosis agent.

Prior Authorization

New-Start Prior Authorization Required

New-start members require prior authorization and must satisfy all applicable clinical requirements before Forteo coverage is approved.

Member is a postmenopausal woman at high risk for fracture, defined as a T-score at or below -2.5, or cannot tolerate, is allergic to, or has failed to improve with other agents.
Member is a man with primary or hypogonadal osteoporosis at high risk for fracture, defined as a T-score at or below -2.5, or cannot tolerate, is allergic to, or has failed to improve with other agents.
An appropriate osteoporosis diagnosis and ICD-9 code must be documented.

Policy Background

Forteo (teriparatide) is used for osteoporosis in selected patients at high risk for fracture or who cannot tolerate, are allergic to, or have not improved with other osteoporosis agents. The policy identifies a BMD T-score of at or below -2.5 as the high-risk threshold.

Key Definitions

High risk for fracture

DefinitionA BMD T-score at or below -2.5

Clinical significanceQualifies as high risk for fracture

Applicable pathwaysUsed for qualifying postmenopausal women and men with primary or hypogonadal osteoporosis

Already stabilized

DefinitionThe member is already receiving Forteo and has been stabilized on therapy

Coverage statusEligible for continued coverage

Treatment transitionThe member should not be required to stop Forteo and try another agent

Initial Therapy

New-start members must meet all specified prior authorization criteria.

Initial Forteo therapy

Qualifying patient pathway
- Postmenopausal woman pathway: Member is a postmenopausal woman at high risk for fracture or cannot tolerate, is allergic to, or has failed to improve while using other agents.BMD T-score at or below -2.5 for high risk for fracture
- Male osteoporosis pathway: Member is a man with primary or hypogonadal osteoporosis at high risk for fracture or cannot tolerate, is allergic to, or has failed to improve while using other agents.BMD T-score at or below -2.5 for high risk for fracture

Continuation Therapy

Members already stabilized on Forteo qualify for continued coverage.

Stabilized continuation: Member is already stabilized on Forteo.

The member should be approved for continued coverage without being required to stop Forteo and try another agent.

Step Therapy Requirement

Step	Requirement	Duration	Exception
1	Trial of any one other osteoporosis agent before a new Forteo start	At least 12 months	Trial may be waived if the agent was contraindicated or the member was intolerant or allergic

Coverage Duration Limit

Quantity limit

MedicationForteo (teriparatide)

Maximum total coverage2 years

Safety basisUse beyond 2 years is excluded because longer-term safety and efficacy have not been established

Prior osteoporosis-agent trial

Minimum durationAt least 12 months

Required therapyA trial of any one other osteoporosis agent

ExceptionsThe trial is not required when the other agent was contraindicated, or the member was intolerant or allergic

Maximum total Forteo coverage

Maximum total coverage2 years

Authorization periodPrior authorization should be approved for 1 year

Reason for limitForteo has not been proven safe and efficacious for longer than 2 years

Authorization Duration

Prior authorization approval should be issued for 1 year, subject to the maximum total Forteo coverage period of 2 years.

Approval period: 1 year.
Total lifetime coverage limit: 2 years.

Step Therapy

Prior Osteoporosis-Agent Trial Required

Before a new Forteo start, the member must have completed at least a 12-month trial with another osteoporosis agent, unless that agent was contraindicated, not tolerated, or caused an allergic reaction. A BMD test with a T-score at or below -2.5 must also have been performed within the last month.

Document the prior 12-month trial with at least one other agent, or the applicable contraindication, intolerance, or allergy exception.
Include BMD results from within the last month in the prior authorization petition.

Documentation Required

New-Start Clinical Documentation

The prior authorization petition for a new Forteo start must document the applicable osteoporosis diagnosis, fracture-risk criteria, prior-agent history or exception, and recent BMD results.

Appropriate ICD-9 code/diagnosis of osteoporosis.
Postmenopausal woman or man with primary or hypogonadal osteoporosis, as applicable.
T-score at or below -2.5 and BMD test within the last month.
Prior 12-month osteoporosis-agent trial, unless contraindicated, not tolerated, or allergic.

Denial Risk

Failure to Meet Initial-Therapy Criteria

A new Forteo start should be denied when the member does not meet the required clinical criteria or the prior authorization petition does not establish medical necessity.

No qualifying osteoporosis diagnosis or ICD-9 code.
No qualifying high-fracture-risk status or documented inability to tolerate, allergy to, or failure to improve with other agents.
No qualifying 12-month prior-agent trial or stated exception.
No BMD test within the last month showing a T-score at or below -2.5.

Denial Risk

Concurrent Osteoporosis Therapy Not Covered

Concurrent use of Forteo with other osteoporosis agents is not covered unless additional clinical research becomes available supporting the safety and efficacy of combination use.

Do not approve concurrent Forteo therapy with another osteoporosis agent under the current criteria.

Denial Risk

Do Not Exceed Lifetime Coverage Limit

Forteo coverage is limited to a maximum total period of 2 years because longer-term safety and efficacy have not been established. Animal studies indicate potential osteosarcoma risk, and the medication guide advises against use beyond 2 years.

Maximum total coverage: 2 years.
Forteo is contraindicated in the presence of osteosarcoma risk conditions, including Paget's disease, radiation therapy of bone, bone metastases, or hypercalcemia.
Treatment may cause leg cramps and dizziness.

Required diagnosis: Member has an appropriate ICD-9 code or diagnosis of osteoporosis.

Prior osteoporosis-agent trial: Member has completed a trial with any one other osteoporosis agent.At least 12 months

The trial is not required when the other agent was contraindicated, or the member was intolerant or allergic.

Recent BMD documentation: A BMD test result is documented on the petition.T-score at or below -2.5; test performed within the last month

No concurrent osteoporosis therapy: Forteo is not used concurrently with other osteoporosis agents.