Subject: pirfenidone-Esbriet 1881-A SGM P2022a
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ESBRIET
(pirfenidone)
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pirfenidone
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Policy:
I. INDICATIONS
The indications below including FDA-approved
indications and compendial uses are considered a
covered benefit provided that all the approval criteria
are met and the member has no exclusions to the
prescribed therapy.
FDA-Approved Indication
Indicated for the treatment of idiopathic pulmonary
fibrosis (IPF).
All other indications are considered
experimental/investigational and not medically
necessary.
II. DOCUMENTATION
Submission of the following information is necessary
to initiate the prior authorization review (where
applicable):
A. Result of a chest high-resolution computed
tomography (HRCT) study.
B. If a lung biopsy is conducted, submit the
associated pathology report.
III. CRITERIA FOR INITIAL APPROVAL
Idiopathic Pulmonary Fibrosis (IPF)
Authorization of 12 months may be granted for
treatment of idiopathic pulmonary fibrosis when the
member has undergone a diagnostic work-up which
includes the following:2
A. Other known causes of interstitial lung disease
(e.g., domestic and occupational environmental
exposures, connective tissue disease, drug
toxicity) have been excluded AND
B. The member has completed a high-resolution
computed tomography (HRCT) study of the chest
or a lung biopsy which reveals a result consistent
with the usual interstitial pneumonia (UIP)
pattern, OR has completed an HRCT study of the
chest which reveals a result other than the UIP
pattern (e.g., probable UIP, indeterminate for UIP)
and the diagnosis is supported by a lung biopsy. If
a lung biopsy has not been previously conducted,
the diagnosis is supported by a multidisciplinary
discussion between a radiologist and
pulmonologist who are experienced in IPF.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for
members with an indication listed in Section III who
are currently receiving treatment with the requested
medication, excluding when the requested medication
is obtained as samples or via manufacturer's patient
assistance programs.
V. OTHER
Note: If the member is a current smoker, they should
be counseled on the harmful effects of smoking on
pulmonary conditions and available smoking
cessation options.
Place of Service:
Outpatient
The above policy is based on the following references:
- Esbriet [package insert]. South San Francisco, CA: Genentech USA, Inc.; February 2022.
- Pirfenidone [package insert.] Berkeley Heights, NJ: Laurus Labs Limited; July 2022
- Raghu G, Remy-Jardin M, Myers JL, et al. Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2018 Sep 1;198(5):e44-e68.
- Vancheri C, Kreuter M, Richeldi L, et al. Nintedanib with add-on pirfenidone in idiopathic pulmonary fibrosis: results of the Injourney trial. Am J Respir Crit Care Med. 2017 Sept 10. doi: 10.1164/rccm.201706-1301OC. [Epub ahead of print].
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
October 12, 2022
