Treatment guidelines
OFEV® (nintedanib) in IPF:
Treatment guidelines summary
The American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Asociación Latinoamericana de Torax (ALAT) guidelines recommend nintedanib (OFEV®) as a treatment option for patients with idopathic pulmonary fibrosis (IPF).1
This recommendation puts a high value on the potential benefit of nintedanib (OFEV®) on patient-important outcomes such as disease progression as measured by rate of a forced vital capacity (FVC) decline and mortality.1
OFEV® (nintedanib) in PPF:
Treatment guidelines summary
The 2022 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Asociación Latinoamericana de Torax (ALAT) Clinical Practice Guideline update define progressive pulmonary fibrosis (PPF) as at least two of three criteria (worsening symptoms, radiological progression, and physiological progression) occurring within the past year with no alternative explanation in a patient with an interstitial lung disease (ILD) other than IPF.2
They conditionally recommended nintedanib (OFEV®) for the treatment of PPF in patients who have failed standard management for fibrotic ILD, other than IPF.2
Reimbursement guidelines
OFEV® (nintedanib) in IPF:
National Institute for Health and Care Excellence (NICE):
TA379:3
1. Recommendations
1.1. Nintedanib (OFEV®) is recommended as an option for treating idiopathic pulmonary fibrosis (IPF), only if:
- the person has a forced vital capacity (FVC) between 50% and 80% of predicted
- the company provides nintedanib with the discount agreed in the patient access scheme and
- treatment is stopped if disease progresses (a confirmed decline in percent predicted FVC of 10% or more) in any 12-month period.
TA864:4
1. Recommendations
1.1. Nintedanib (OFEV®) is recommended as an option for treating IPF in adults, only if:
- they have a forced vital capacity of above 80% predicted
- the company provides it according to the commercial arrangement.
Scottish Medicines Consortium (SMC) SMC2513:5
Advice: following a full submission considered under the orphan equivalent process:
Nintedanib (OFEV®) is accepted for restricted use within NHS Scotland.
Indication under review: in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
SMC restriction: For use in patients with a predicted forced vital capacity (FVC) > 80%.
Nintedanib (OFEV®) has previously been accepted for restricted use in adults with IPF with a predicted FVC ≤ 80%; this advice remains valid.
The Health Service Executive (HSE):6
Reimbursement for nintedanib (OFEV®) in idiopathic pulmonary fibrosis (IPF) has been approved by the HSE in June 2017.
OFEV® (nintedanib) in PPF:
National Institute for Health and Care Excellence (NICE) TA747:7
1. Recommendations
1.1. Nintedanib (OFEV®) is recommended within its marketing authorisation, as an option for treating chronic progressive fibrosing interstitial lung diseases (PF-ILD) in adults.
Scottish Medicines Consortium (SMC) SMC2331:8
Advice: following a full submission considered under the orphan equivalent process:
Nintedanib (OFEV®) is accepted for use within NHS Scotland.
Indication under review: in adults for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive fibrosing phenotype other than idiopathic pulmonary fibrosis (IPF).
To access further information and resources for managing IPF and PPF patients, click here
- Raghu G, et al. Am J Respir Crit Care Med 2015;192:e3–e19.
- Raghu et al. Am J Respir Crit Care 2022;205(9):e18–47.
- National Institute for Health and Care Excellence (NICE). Technology appraisal guidance TA379. Available at: https://www.nice.org.uk/guidance/ta379 (Accessed July 2023).
- National Institute for Health and Care Excellence (NICE). Technology appraisal guidance TA864. Available at: https://www.nice.org.uk/guidance/ta864 (Accessed July 2023).
- Scottish Medicines Consortium (SMC). Advise 2513. Available at https://www.scottishmedicines.org.uk/media/7449/nintedanib-ofev-resub-final-feb-2023-for-website.pdf (Accessed July 2023).
- National Centre for Pharmacoeconomics, Ireland: Nintedanib (Ofev®). Avilable at: https://www.ncpe.ie/nintedanib-ofev/ (Accessed July 2023).
- National Institute for Health and Care Excellence (NICE). Nintedanib for treating progressive fibrosing interstitial lung diseases. Technology appraisal guidance TA747: November 2021. Available at: https://www.nice.org.uk/guidance/ta747 (Accessed July 2023).
- Scottish Medicines Consortium (SMC). Treatment in adults of other chronic fibrosing interstitial lung diseases with a progressive phenotype. SMC2331. Published 7 June 2021. Available at: https://www.scottishmedicines.org.uk/medicinesadvice/nintedanib-ofev-full-smc2331/ (Accessed July 2023).
- OFEV® 100 mg and 150 mg soft capsules Summary of Product Characteristics. Boehringer Ingelheim.
Adverse events should be reported.
UK: Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone) or by email to PV_local_uk_ireland@boehringer-ingelheim.com.
IE: Reporting forms and information can be found at www.hpra.ie/homepage/about-us/report-an-issue. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 01 291 3960 or by email to PV_local_uk_ireland@boehringer-ingelheim.com.
OFEV® is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. The recommended dose is one 150 mg capsule taken twice daily.9
