2015 saw the arrival of some truly innovative new medicines with the promise of totally transforming some disease areas.
In October, the interim report of the Accelerated Access Review laid out plans for speeding-up access to innovative drugs in the UK. The five key propositions were then used to frame the next phase of engagement, which will help to form the Review’s final recommendations and report due to be published in Spring 2016.
“The ultimate test of this review will be whether the final recommendations can be implemented rapidly, leading to improved delivery,” commented Rob Webster, chief executive of the NHS Confederation.
Innovation is key to patient access
2015 saw the arrival of some truly innovative new medicines
with the promise of totally transforming some disease areas. Yet, most new
oncology medicines are increasingly struggling to make it as far as the
doctor’s clinic as they stumble at the NICE hurdle. With the NHS under
increasing financial pressure, we need to look at new ways to get these
medicines to the patients who need them – being innovative, coming up with new
solutions and doing things differently.
At Janssen, we introduced the first-ever patient access
scheme, where the NHS pays for our medicine based on the outcome for patients,
the Velcade Response Scheme, and recently introduced a similar scheme for our
hepatitis C medicine. Yet, such risk-sharing arrangements are increasingly not
welcomed by the Department of Health or NICE, who see them as burdensome to
Along with other colleagues in the industry, we have been
contributing to the Accelerated Access Review and hope that 2016 will bring the
reform to NICE that is needed in order for the UK to realise its ambition to be
a world leader for the development and adoption of new scientific and medical
Jennifer Lee, director
of health economics and market access, Janssen UK
Aligning regulators and payers is essential for patient access
In the past two years, both the European Medicines Agency
and the US Food and Drug Administration granted their highest number of
marketing authorisations in almost 20 years, and the pace shows no signs
In the interests of patients, the EMA and FDA efforts to
reduce authorisation times have resulted in approval of life-saving treatments
in a much shorter time frame. However, as an industry, we know all too well
that marketing authorisation does not always equate to treatment access. The
real challenge comes when payers assess these innovative treatments.
One example, in oncology, is payer demand for overall
survival data as a clinical trial endpoint, which, by definition, means
enrolled patients have to die in order for this to be accurately measured. In
many tumour types, overall survival data can take years to collect, ultimately
resulting in unacceptable delays in patients getting access to a potentially
The licensing agencies understand this issue and have
adapted their systems when new drugs are truly innovative. Unfortunately, payer
systems do not match this flexibility and innovative drugs are often not funded
for the patients they were designed to treat. Now is the time to drive a change
and increase alignment between the licensing agencies and payers.
McGrath, chairman and director of oncology,
Succinct Medical Communications and OPEN Health