How a new drugs approval scheme could save lives
Haematology A disconnected system for accessing cancer drugs mean that patients do not always get the best treatment and NHS money is wasted. Now action is being taken to change that.
In the last 18 months five new drugs have been licensed to treat myeloma, a bone marrow cancer that affects 17,500 people in the UK. Yet people with myeloma who live in the UK may have to wait years to get these drugs, or they may not be licensed at all.
So what is wrong with the system that delivers cancer drugs?
“The current system doesn’t work as well as it should and as a result, patients are losing out,” says Eric Low, chief executive of Myeloma UK, and advisor to the Accelerated Access Review, which aims to cut the time it takes for drugs to be made available to patients.
Low says that part of the problem is that pharmaceutical companies generate and supply the information about how treatments work to the UK Health Technology Assessment (HTA) bodies that decide which treatments can be made available to patients. In England the HTA is The National Institute for Health and Care Excellence (NICE), and its decision-making system is slightly different to those used by the bodies in Scotland, Wales and Northern Ireland.
“In order to decide which treatments the NHS should fund, the HTA bodies often require different data than that generated by drug companies to get approval from international and European drug marketing authorisation agencies. Because drug companies work in global markets they are unlikely to spend extra to generate data for local HTAs,” says Low.
Why is the approval process so complex?
As each devolved nation of the UK has its own systems for approving new drugs, the UK environment is particularly complex.
“As a result patients are often subject to a postcode lottery in terms of which drugs are approved in their area,” says Low.
What's more, drug company data is sometimes out of step with prescribing practice, which has moved on since the data was gathered.
“This means that the HTA's guidance may not reflect the best way to use a new treatment and gives doctors very little scope to prescribe treatments that suit disease variations and patient preferences. It is very much a one-size-fits-all system and as a result the NHS is much more likely to buy according to cost and not patient outcomes,” says Low.
The problem is being addressed by patient organisations and Myeloma UK is encouraging pharmaceutical companies, HTA bodies, patient organisations, academics and clinicians to work together to deliver studies aimed at providing the specific data that the HTAs require, and complementing the development programmes of drug companies.
“This will make the drugs approval process more uniform, easier and faster, and allows the NHS to see which drugs are the most cost effective. It could increase personalised medicine and give doctors more freedom to prescribe the most appropriate drugs for patients sooner,” adds Low.