CurrentWashington State Health Care AuthorityPolicy 45.55.00-1

Pulmonary Fibrosis Agents

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This policy governs prior authorization and medical-necessity coverage for nintedanib (Ofev) and pirfenidone (Esbriet) used to treat confirmed idiopathic pulmonary fibrosis for Apple Health clients receiving Washington Medicaid fee-for-service or managed care coverage.

Policy Summary

PayerWashington State Health Care Authority

PolicyPulmonary Fibrosis Agents

Policy CodePolicy 45.55.00-1

Change TypeMaterial update

Effective DateOctober 1, 2018

Next Review DateN/A

Key ActionFor non-preferred agents, document inadequate response or documented intolerance to at least two preferred agents, or one if only one preferred agent is available.

SourceLink

POLICY UPDATE CHANGES

The policy added case-by-case approval language for medically necessary or situational circumstances when standard criteria are not met.

The policy added continuation-of-therapy language for clients new to Apple Health or a managed care organization.

The policy updated dosage and quantity limits for nintedanib and pirfenidone.

The policy added a note directing providers to the Apple Health Preferred Drug List and explaining preferred-agent requirements for new-to-market and non-preferred agents.

2Covered pulmonary fibrosis agents

12 monthsInitial authorization duration

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CurrentWashington State Health Care AuthorityPolicy 45.55.00-1

Pulmonary Fibrosis Agents

Customize your policy alerts

Sign up for Washington State Health Care Authority Policy 45.55.00-1 alerts

Get alerted when Policy 45.55.00-1 changes without checking for updates manually.

Monitor payer policy activity

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Policy Summary

PayerWashington State Health Care Authority

PolicyPulmonary Fibrosis Agents

Policy CodePolicy 45.55.00-1

Change TypeMaterial update

Effective DateOctober 1, 2018

Next Review DateN/A

Key ActionFor non-preferred agents, document inadequate response or documented intolerance to at least two preferred agents, or one if only one preferred agent is available.

SourceLink

POLICY UPDATE CHANGES

The policy added case-by-case approval language for medically necessary or situational circumstances when standard criteria are not met.

The policy added continuation-of-therapy language for clients new to Apple Health or a managed care organization.

The policy updated dosage and quantity limits for nintedanib and pirfenidone.

The policy added a note directing providers to the Apple Health Preferred Drug List and explaining preferred-agent requirements for new-to-market and non-preferred agents.

2Covered pulmonary fibrosis agents

12 monthsInitial authorization duration

Reauthorization duration

2Preferred agents required for non-preferred therapy

Not allowedCombination therapy

Coverage Criteria

Initial Therapy

Covered when ALL of the following initial authorization criteria are met:

ALL of the following

ONE of
- Idiopathic pulmonary fibrosis is confirmed by the presence of usual interstitial pneumonia (UIP) on high-resolution computed tomography (HRCT).
- Idiopathic pulmonary fibrosis is confirmed by surgical lung biopsy.
Ofev and Esbriet will not be used in combination.
The medication is prescribed by, or prescribed in consultation with, a specialist in pulmonology.

Continuation Therapy

Covered for reauthorization when the following criterion is met:

Documentation demonstrates positive clinical benefit from therapy.

Approve for 12 months. Clients new to Apple Health or new to an MCO requesting continuation therapy should be reviewed under these reauthorization criteria.

Case-by-Case Medical Necessity

Requests may be approved on a case-by-case basis when standard criteria are not met and the clinical reviewer determines that documented circumstances support medical necessity:

ALL of the following

The standard authorization criteria are not fully met.
Medically necessary or situational circumstances are documented.
The clinical reviewer determines, based on professional judgment, that approval is medically necessary.

Ofev and Esbriet must not be used in combination.

Provider Actions and Documentation

Prior Authorization

Non-Preferred Agent Authorization

New-to-market drugs and other non-preferred agents in this class are subject to prior authorization under the Apple Health Preferred Drug List (AHPDL). Check the current AHPDL to determine preferred status.

Current AHPDL: https://www.hca.wa.gov/assets/billers-and-providers/applehealth-preferred-drug-list.xlsx

Prior Authorization

Initial Authorization Requirements

Initial authorization requires documentation supporting the diagnosis, non-combination use, and required specialist involvement.

Confirmed diagnosis of idiopathic pulmonary fibrosis.
Ofev and Esbriet will not be used in combination.
The drug is prescribed by or in consultation with a pulmonology specialist.

Clinical Background

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrosing interstitial pneumonia of unknown cause that occurs in adults and is limited to the lungs. It is associated with the histopathologic or radiologic pattern of usual interstitial pneumonia. The covered agents, Ofev (nintedanib) and Esbriet (pirfenidone), are used for confirmed IPF when the applicable authorization and specialist-prescribing requirements are met.

Definitions

Idiopathic pulmonary fibrosis

ConditionIdiopathic pulmonary fibrosis (IPF) is a specific form of chronic, progressive, fibrosing interstitial pneumonia of unknown cause.

PopulationOccurs in adults and is limited to the lungs.

Associated patternAssociated with the histopathologic and/or radiologic pattern of usual interstitial pneumonia (UIP).

Usual interstitial pneumonia

FindingUsual interstitial pneumonia (UIP) is the histopathologic and/or radiologic pattern associated with idiopathic pulmonary fibrosis.

Diagnostic methodUIP identified on high-resolution computed tomography (HRCT) is a qualifying method for confirming idiopathic pulmonary fibrosis.

Initial Authorization Criteria

Initial Authorization

Initial authorization requires all listed clinical criteria.

Initial authorization

Diagnostic confirmation
- HRCT: Usual interstitial pneumonia is present on high-resolution computed tomography.
- Surgical biopsy: Diagnosis is confirmed by surgical lung biopsy.
No combination therapy: Ofev and Esbriet will not be used in combination.

Reauthorization Criteria

Reauthorization

Reauthorization is available when positive clinical benefit is documented.

Positive clinical benefit: Documentation of positive clinical benefit is provided.

Approve for 12 months.

Preferred-Agent Step Therapy

Step	Requirement	Documentation for failure or intolerance
1	Try at least two preferred agents. If only one preferred agent is available in the class, try that one preferred agent.	Document inadequate response or intolerance due to a severe adverse reaction or contraindication.

Drug Quantity and Dose Limits

Quantity limit

DrugNintedanib (Ofev)

Strength100 mg capsule

Quantity limit60 capsules per 30-day supply

Quantity limit

DrugNintedanib (Ofev)

Strength150 mg capsule

Quantity limit60 capsules per 30-day supply

Policy Summary

PayerWashington State Health Care Authority

PolicyPulmonary Fibrosis Agents

Policy CodePolicy 45.55.00-1

Change TypeMaterial update

Effective DateOctober 1, 2018

Next Review DateN/A

Key ActionFor non-preferred agents, document inadequate response or documented intolerance to at least two preferred agents, or one if only one preferred agent is available.

SourceLink

On This Page

Documentation Required

Reauthorization Requirements

Reauthorization requires documentation of positive clinical benefit. When criteria are met, approval is issued for 12 months.

Submit documentation demonstrating positive clinical benefit for continued therapy.
Approval duration: 12 months.

Step Therapy

Preferred-Agent Step Requirement

Before coverage of a non-preferred agent, document an inadequate response or intolerance to the required preferred agents identified on the current AHPDL.

If at least two preferred agents are available in the class, document an inadequate response or intolerance to at least two.
If only one preferred agent is available, document an inadequate response or intolerance to that one agent.

Documentation Required

Diagnostic Confirmation

Document confirmed idiopathic pulmonary fibrosis using at least one qualifying diagnostic method.

Usual interstitial pneumonia (UIP) shown on high-resolution computed tomography (HRCT).
Surgical lung biopsy.

Documentation Required

Specialist Involvement

The medication must be prescribed by a pulmonology specialist or prescribed in consultation with a pulmonology specialist.

Submit documentation of the pulmonology prescriber or pulmonology consultation, as applicable.

Documentation Required

Continuation Documentation

For reauthorization, submit documentation demonstrating that the patient has received positive clinical benefit from therapy.

Positive clinical benefit documentation is required for continued approval.
Reauthorization approval duration is 12 months when criteria are met.

Step Therapy

Preferred-Agent History

For a non-preferred agent, document the required preferred-agent history before requesting coverage.

Document inadequate response to the required preferred agents; or
Document intolerance due to a severe adverse reaction or contraindication to the required preferred agents.
The required number is at least two preferred agents when two or more are available, or one preferred agent when only one is available.

Denial Risk

Failure to Meet Initial Clinical Criteria

Initial authorization may be denied when the required clinical criteria are not established.

The diagnosis of idiopathic pulmonary fibrosis is not confirmed by HRCT showing UIP or by surgical lung biopsy.
The requested drug would be used in combination with Ofev or Esbriet.
The required pulmonology prescriber or consultation is not documented.

Denial Risk

No Documented Clinical Benefit

Reauthorization may be denied when documentation does not demonstrate positive clinical benefit from treatment.

Submit positive clinical benefit documentation with the reauthorization request.
Approval, when supported, is limited to a 12-month duration.

Denial Risk

Preferred-Agent Requirement Not Met

Coverage of a non-preferred agent may be denied when the required preferred-agent step is not met.

No documentation of inadequate response or intolerance to at least two preferred agents when two or more are available.
No documentation of inadequate response or intolerance to the single preferred agent when only one is available.
Intolerance must be due to a severe adverse reaction or contraindication.

Confirmation requirementInitial authorization requires confirmation by at least one qualifying method, including UIP on HRCT or surgical lung biopsy.

Specialist prescribing: The drug is prescribed by or in consultation with a specialist in pulmonology.

DrugPirfenidone (Esbriet)

Strength150 mg capsule

Quantity limit60 capsules per 30-day supply

Quantity limit

DrugPirfenidone (Esbriet)

Limit typeMaximum daily dose

Daily dose limit2,403 mg per day

Quantity limit

DrugPirfenidone (Esbriet)

Strength267 mg capsule/tablet

Quantity limit270 capsules or tablets per 30-day supply

Quantity limit

DrugPirfenidone (Esbriet)

Strength534 mg tablet

Quantity limit90 tablets per 30-day supply

Quantity limit

DrugPirfenidone (Esbriet)

Strength801 mg tablet

Quantity limit90 tablets per 30-day supply