Given the substantial discrepancy, cash-strapped healthcare payers must assess whether the new generation of medicines represents value for money. As a result, drug developers are increasingly aware that surmounting the regulatory hurdle is no longer enough; they must also satisfy the payer, who in effect has become a second gatekeeper to patients’ access to new medicines.
A related issue is the advent of what is known as personalized medicine. Increasing knowledge of genetics is producing a new generation of medicines specifically tailored for individual patients, posing yet another new challenge to the industry, regulators and payers.
In short, innovations in medical research demand an updated drug-development process in which the patient is paramount. By relying on benefit-risk analysis, rather than on a more rigid, phased approval process, potentially life-saving medications can better reach the patients who need them.
Alasdair Breckenridge, former professor of clinical pharmacology at the University of Liverpool and chair of the Committee on Safety of Medicines, is chair of the United Kingdom Medicines and Healthcare Products Regulatory Agency.
Copyright: Project Syndicate