While many killer diseases of the past, such as childhood infections, have been contained through medical advances, adult chronic diseases are a huge burden on society and there is a real unmet need in many therapeutic areas, according to Michael Rawlins, Chairman of NICE, speaking recently at the Economist pharmaceuticals conference.
Particular areas of unmet need include stroke, COPD, diabetes, cancer, substance abuse and neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease. Mental illness, particularly schizophrenia, bipolar disorder and depression are also poorly managed and account for 4 per cent of GDP in lost productivity in the UK each year, said Rawlins.
However, while the prize is great for a pharma company that proves successful, the actual drug discovery process is only be the first hurdle to overcome, and there are several problems firms need to be aware of when taking on the chronic disease challenge, Rawlins warned.
First of all, the clinical trials needed to demonstrate new chronic disease drugs as beneficial are both extremely timely and costly due to the very nature of chronic illness.
In addition, most patients with a chronic disease also have other comorbidities and are therefore unsuitable for participation clinical trials, which require "clean patients," causing a problem with patient recruitment.
"By the age of 75, most people have at least three comorbidities," said Rawlins.
Because of this, many clinicians are also reluctant to prescribe new medications for chronic illnesses unless they have also been tested in further clinical trials in patients with comorbidities, so as to avoid unknown side-effects.
The challenges do not stop there. It is notoriously difficult to get drugs reimbursed for chronic illnesses by government regulatory bodies, said Rawlins.
"The pharma industry now not only has to demonstrate innovation, but also increased benefit in relation to costs incurred by the drug," said Rawlins.
If the debate can instead be shifted to focus on the the cost of treatment versus the cost of the chronic illness, more drug companies will succeed in this lucrative sector.