Medical Policy

Effective Date:02/01/2016 Title:Idiopathic Pulmonary Fibrosis Treatment (Ofev & Esbriet)
Revision Date: Document:BI494:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Ofev (Nintedanib) and Esbriet (pirfenidone) require prior authorization.

2)    Ofev and Esbriet are used to treat idiopathic pulmonary fibrosis (IPF).

3)    Ofev and Esbriet are oral specialty drugs and must be obtained through the contracted specialty pharmacy.

Medical Statement

Ofev (Nintedanib) and Esbriet (pirfenidone) are considered medically necessary for initial therapy in patients 18 years of age or older meeting the following criteria. Initial approval will be for 6 months:


1)    Diagnosis of idiopathic pulmonary fibrosis (IPF)  AND

2)    Confirmed by physical exam  AND

3)    %FVC < 80% of predicted

4)    Documented predicted diffusing capacity for carbon monoxide (%DLco)  AND

5)    %TLC < 80% of predicted AND

6)    CT with classic findings of usual interstitial pneumonitis (UIP) AND

7)    NOT to be used concurrently with other medications for idiopathic pulmonary fibrosis  AND

8)    NO known cause of the interstitial lung disease / fibrosis  AND

9)    Drug interaction assessment has been performed by the physician (Ofev and Esbriet are metabolized primarily (70-80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6, and 2E1) AND

10) Prescribed by a pulmonologist


For renewal, Ofev and Esbriet are considered medically necessary if:

1)    Assessment by the healthcare professional that the medication is helping the patient by meeting at least ONE of the following criteria while taking this medication:

a.    Slowed the rate of decline of lung function

b.    Improved (or no decline in ) symptoms of cough or shortness of breath

c.    Improved sense of well-being

2)    NOT to be used concurrently with other medications for IPF

3)    Drug interaction assessment has been performed by the physician


As specialty drugs, both Ofev and Esbriet are limited to no more than a 30 day supply per fill.


1)    Ofev Prescribing Information. Boehringer-Ingelheim. Ridgefield, CT. October 2014.

2)    Esbriet Prescribing Information. Genentech, Inc. San Francisco, CA. September 2015.

3)    Clinical Pharmacology. Accessed online November 13, 2015.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.