UK Report Calls for Streamlining to Accelerate Access to Drugs by Four Years
The UK government on Monday released a new report on accelerated access, claiming the UK's National Health Service (NHS) could speed access to new drugs and devices by streamlining regulatory, health technology assessment (HTA) and reimbursement mechanisms.
Specifically, the report proposes the development of an "accelerated access pathway" that would help speed up new technologies, including drugs, devices and diagnostics with the potential to provide significant benefits to patients or cost savings to the UK.
In order to identify such products, the report suggests the creation of a "transformative designation" that would combine elements of other accelerated access programs such as the European Medicines Agency's (EMA) PRIorityMEdicines (PRIME) scheme or the Medicines and Healthcare products Regulatory Agency's early access to medicines scheme (EAMS), while factoring in costs and other national priorities.
Criteria for the transformative designation could include:
- "Magnitude of health gain;
- Impact on unmet need;
- Alignment with NHS England's clinical priorities and other national priorities;
- Impact on system efficiency;
- Potential cost impact, from cost saving to significantly cost increasing;
- Opportunity for clinical pathway transformation;
- Innovative nature of the technology."
"We expect that only around five to ten innovations per year would receive the transformative designation and not all of these will travel down the entire Accelerated Access Pathway," the report states.
Figure 1. Accelerated Access Pathway
"Our analysis shows that patient access can be brought forward by up to four years where an EAMS scientific opinion is used (saving 12-18 months), and where there are no delays in the technology appraisal (which can take up to two years) or in NHS commissioning and adoption (which can take two years or even longer)," the report says.
Much of these gains rely on boosting efficiency and alignment across the National Institute for Health and Care Excellence (NICE) and NHS.
"Medicines regulators have already responded by adapting their processes to increase the speed of approval; but these opportunities will be lost and patients will be disadvantaged if the rest of the healthcare system is not equally agile," the report says.
NICE CEO Simon Stevens says his agency supports the recommendations in the report.
Dealing With Brexit
One issue the report did not anticipate when it was commissioned in 2014 was the potential for the UK to leave the EU.
However, the review finds Brexit to be a source of both challenge and opportunity:
"Since the UK voted to leave the European Union, the importance of these principles have, if anything, been amplified. Given the uncertainty for the financial sector and heavy manufacturing in a future potentially outside the single market, it seems clear that the life sciences industry will provide a crucial pillar for future economic growth. This will, of course, require a targeted industry strategy and may benefit from a future regulatory regime," writes Professor Sir John Bell, who chaired the report's external advisory group.