Esbriet® (Pirfenidone) Receives Positive Final Appraisal Determination From NICE For Idiopathic Pulmonary Fibrosis (IPF)Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Mar 2013
InterMune, Inc. today reported that the National Institute for Health and Clinical Excellence (NICE), the health technology appraisal body in England and Wales, has issued its Final Appraisal Determination (FAD) recommending Esbriet® (pirfenidone) for the treatment of mild-to-moderate Idiopathic Pulmonary Fibrosis (IPF).
IPF is a rare and poorly understood lung condition that causes scarring of the lungs, making it increasingly difficult to breathe. It worsens over time and is often fatal[i]. There are approximately 6,100-9,500 people living with mild-to-moderate IPF in the UK (data on file).
The FAD forms the basis of the final guidance to the NHS in England and Wales and is expected to be published in April 2013.
"The positive FAD recommendation by NICE is a major breakthrough and means that patients living with mild-to-moderate IPF and their families in England and Wales will now have access to the only licensed medicine for this very serious lung condition" said Rory Cameron, General Manager for InterMune UK and Ireland. "We believe that pirfenidone meets a genuine unmet need in the treatment of IPF and reinforces InterMune's commitment to improving the lives of IPF patients. This is a great first step for patients, clinicians and the IPF community in England and Wales, and we now look forward to working with the NHS and other partners to ensure that, where clinically appropriate, patients are rapidly provided with access to pirfenidone".
Mike Bray from Pulmonary Fibrosis UK said: "IPF is a progressive and fatal lung disease with a very poor outcome. We see the outcome from NICE to approve the use of pirfenidone for IPF as a huge step forward for patients with this debilitating lung disease."
Dr Gisli Jenkins from the University of Nottingham said: "IPF is a progressive and fatal disease. Pirfenidone is the only drug that has shown any efficacy in this disease. It is excellent news that NICE has approved its use in IPF and this offers hope to patients with IPF. I believe this is a very positive first step on a journey that may ultimately lead to huge improvements in the treatment for patients with this devastating condition."
The NICE Appraisal Committee recommended pirfenidone for the treatment of IPF patients whose forced vital capacity (FVC) is between 50% and 80% predicted at the start of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The FAD also recommended that treatment with pirfenidone for these patients should be discontinued if there is evidence of disease progression (a decline in percent predicted FVC of 10 percent or more within any 12-month period). Patients currently receiving pirfenidone whose FVC does not fall within the recommended guidelines should have the option to continue treatment until they and their clinician consider it appropriate to stop. The FAD recommendations are based on InterMune making pirfenidone available in accordance with the Patient Access Scheme (PAS). The PAS is a confidential pricing and access agreement with the Department of Health.
Pirfenidone is an orally active drug that exhibits anti-inflammatory and anti-fibrotic properties. It inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.
On 28 February 2011, the European Commission granted marketing authorisation for pirfenidone in adults for the treatment of mild-to-moderate IPF. The approval authorises marketing of pirfenidone in all 27 EU member states. Pirfenidone has since been approved for marketing in Norway and Iceland. Pirfenidone is commercially available in Austria, Belgium, Denmark, France, Germany, Iceland, Luxembourg, Norway, Sweden and Canada.
Pirfenidone is priced at £26,100 per full year of treatment or £7.97 per capsule in the UK. InterMune plans to commercially launch pirfenidone by the end of June 2013.
Full safety and efficacy information can be found in the Summary of Product Characteristics here.
About Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF) is a rare and poorly understood lung condition that causes scarring of the lungs, making it increasingly difficult to breathe. It gets worse over time and is often fatali.
IPF can be hard to diagnose because its main symptoms are similar to those of other lung diseases[ii]. It is common for patients to have repeated doctor visits, dismissal of symptoms and misdiagnoses before a correct diagnosis of IPF is made[iii].
More than 5,000 new IPF cases are diagnosed and around 5,000 patients will die of IPF each year in the UK. Although rare, numbers of people with IPF are increasing by 5% each year[iv].
Five year survival rates for IPF are worse than that of several types of cancers[v] [vi]and 50% of sufferers will die within three years of diagnosis.[iv]
Original article posted on Medical News Today.
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