Subject: Ofev 1882-A SGM P2022
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 idiopathic pulmonary fibrosis (IPF).
B. Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype
Ofev is indicated for the treatment of 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 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:2
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
Authorization of 12 months may be granted for treatment of systemic sclerosis-associated interstitial lung
disease when 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.
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, excluding when Ofev 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:
- Ofev [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. October 2020.
- 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].
- 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.
- 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.
- Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in progressive fibrosing interstitial lung diseases. N Engl J Med. 2019;381:1718-27.
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 26, 2022
