Physician Views: The idiopathic pulmonary fibrosis (IPF) market – let battle commence
The battle for market share in the US idiopathic pulmonary fibrosis (IPF) market is one that will be watched with much interest in 2015, with recent events setting the scene nicely.
The FDA recently simultaneously approved Roche's Esbriet and Boehringer Ingelheim's Ofev, and with both products set to launch within days, IPF patients (approximately 100 000 in the US) and pulmonologists will have access to recognised therapies for the first time.
Additional factors of note shaping this narrative include Roche's very recent acquisition of Esbriet (via its acquisition of InterMune in September) and the similar price tags, of around $95 000 per patient per year, set by the two companies for their respective products. There has already been some debate as to whether the price of these therapies will prompt payers to limit usage among less severe IPF patients.
At the crux of the commercial rivalry between Roche and Boehringer Ingelheim appears to be the perception that Esbriet is the better understood product (it had been submitted once before to the FDA on the basis of earlier study data), which has also demonstrated some superiority over Ofev in terms of mortality benefit. That said, the FDA has not included a statistically significant mortality benefit claim on Esbriet's label, which stems from a pooled analysis across two studies that has been published in the NEJM.
Poll Questions
To provide further insight into the pending launches of Esbriet and Ofev, FirstWord is polling US-based pulmonologists with the following questions...
The FDA recently simultaneously approved Roche's Esbriet and Boehringer Ingelheim's Ofev, and with both products set to launch within days, IPF patients (approximately 100 000 in the US) and pulmonologists will have access to recognised therapies for the first time.
Additional factors of note shaping this narrative include Roche's very recent acquisition of Esbriet (via its acquisition of InterMune in September) and the similar price tags, of around $95 000 per patient per year, set by the two companies for their respective products. There has already been some debate as to whether the price of these therapies will prompt payers to limit usage among less severe IPF patients.
At the crux of the commercial rivalry between Roche and Boehringer Ingelheim appears to be the perception that Esbriet is the better understood product (it had been submitted once before to the FDA on the basis of earlier study data), which has also demonstrated some superiority over Ofev in terms of mortality benefit. That said, the FDA has not included a statistically significant mortality benefit claim on Esbriet's label, which stems from a pooled analysis across two studies that has been published in the NEJM.
Poll Questions
To provide further insight into the pending launches of Esbriet and Ofev, FirstWord is polling US-based pulmonologists with the following questions...
- Which of the two recently approved IPF products - Esbriet (pirfenidone) and Ofev (nintedanib)- do you expect to prescribe most frequently?
- To what percentage of eligible IPF patients would you expect to prescribe this product?
- Can you select the factor(s) that will primarily dictate your choice of one product over the other from the below list?
- Efficacy – primary endpoints
- Efficacy – secondary endpoints
- Mortality benefit
- Safety
- Cost
- Previous experience with compound
- Previous experience with marketing company (Esbriet-Roche | Ofev – Boehringer Ingelheim)
- Other (please state)
- Esbriet has been shown to provide a statistically significant mortality benefit as per a pre-defined analysis of pooled data (results published in the NEJM), but FDA labelling for the drug does not include this (the FDA requested a different statistical analysis compared to that published in the NEJM).Based on your current knowledge of both products (Esbriet and Ofev), what is your perception of any mortality benefit superiority for Esbriet?
- Extremely significant benefit
- Very significant benefit
- Moderately significant benefit
- Marginally significant benefit
- No benefit
- What percentage of US IPF patients do you anticipate will have been treated with either Esbriet or Ofev in 12 months time (i.e. a year-post launch)?
