Subject: Ofev 1882-A SGM P2023
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 Indications
A. Idiopathic Pulmonary Fibrosis
Ofev is indicated for the treatment of adults with idiopathic
pulmonary fibrosis (IPF).
B. Chronic Fibrosing Interstitial Lung Diseases with a
Progressive Phenotype
Ofev is indicated for the treatment of adults with chronic
fibrosing interstitial lung diseases (ILDs) with a progressive
phenotype.
C. Systemic Sclerosis-Associated Interstitial Lung Disease
Ofev is indicated to slow the rate of decline in pulmonary
function in adult patients with systemic sclerosis-associated
interstitial lung disease (SSc-ILD).
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
A. 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:
1. Other known causes of interstitial lung disease (e.g.,
domestic and occupational environmental exposures,
connective tissue disease, drug toxicity) have been
excluded AND
2. 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.
B. Chronic Fibrosing Interstitial Lung Diseases with a
Progressive Phenotype
Authorization of 12 months may be granted for treatment of
chronic fibrosing interstitial lung diseases with a progressive
phenotype when the member meets both of the following
criteria:
1. The member has completed a high-resolution computed
tomography (HRCT) study of the chest that shows fibrosis
affecting at least 10 percent of the lungs.
2. The member has progressive disease (e.g., forced vital
capacity [FVC] decline greater than or equal to 10% of
the predicted value, worsening respiratory symptoms,
increased extent of fibrosis on HRCT).
C. Systemic Sclerosis-Associated Interstitial Lung Disease
(SSc-ILD)
Authorization of 12 months may be granted for treatment of
systemic sclerosis-associated interstitial lung disease when
the member’s diagnosis was confirmed by a high-resolution
computed tomography (HRCT) study of the chest.
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 Ofev.
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:
- Ofev [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. October 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
- Distler O, Highland KB, Gahlemann M, et al. Nintedanib for systemic sclerosis-associated interstitial lung disease. N Engl J Med. 2019;380(26):2518-2528. doi:10.1056/NEJMoa1903076
- van den Hoogen F, Khanna D, Fransen J, et al. 2013 Classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative. Arthritis Rheum. 2013;65(11):2737-47. doi:10.1002/art.38098
- Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in progressive fibrosing interstitial lung diseases. N Engl J Med. 2019;381(18):1718-1727. doi:10.1056/NEJMoa1908681
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
