In May 2021, NICE indicated its intention to review and update existing guidance for TA379; Nintedanib for treating idiopathic pulmonary fibrosis and TA504; Pirfenidone for treating idiopathic pulmonary fibrosis to consider the patient population not currently recommended to receive treatment in the existing guidance. We recently wrote to inform you that we are preparing to undertake a partial review of NICE TA379, Nintedanib for treating idiopathic pulmonary fibrosis, which will start shortly. NICE will review the population for those which nintedanib currently isn’t recommended (those with FVC > 80%).
With regards to Pirfenidone for treating idiopathic pulmonary fibrosis; following conversations with the company (Roche), we are unable to progress with an update of the guidance for pirfenidone at this time. As noted in the review decision documentation from May 2021, there is no new clinical evidence or a change in the price for pirfenidone that would facilitate a change in the current recommendations.
However, we are aware of the potential introduction of generic versions of pirfenidone. In the new manual for developing guidance, published in January 2021, we established a new process to conduct rapid updates to guidance after loss of market exclusivity (see section 5.10). Roche have signalled that they are willing to support utilisation of this process to explore opportunities for generic pirfenidone. We will progress consideration of the generic pirfenidone internally and will be in contact with more information in due course.