Subject: pirfenidone-Esbriet 1881-A SGM P2023
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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
Esbriet/pirfenidone is 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:
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, alternative
diagnosis) 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
All members (including new members) requesting authorization
for continuation of therapy for an indication listed in Section III
may be granted an authorization of 12 months when the
member is currently receiving treatment with the requested
medication.
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; February 2022.
- Raghu G, Remy-Jardin M, Richeldi L, et al. Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline. Am J Respir Crit Care Med. 2022;205(9):e18-e47. doi:10.1164/rccm.202202-0399ST
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.
June 11, 2023
