Following the NICE 2017 conference, Cathy Wright, Managing Director, OPEN Access Consulting shares her insights on the road ahead for access to medicines.
Considerable time at
this year’s NICE annual conference was
given to ensuring the audience knew about and understood the recent changes for
technology appraisals and how these changes will affect all stakeholders
including manufacturers, health-care professionals, commissioners and
importantly, patients. Meindert Boysen, Programme Director, Health
Technology Appraisals, NICE, led discussions focused on the new ‘fast track’
appraisal process, the introduction of a ‘budget impact test’, highly
specialised technology appraisals and how to engage with NICE for early advice.
The new ‘fast track’ appraisal
process is aimed at those technologies where there is no uncertainty the QALY
will be less that £10K and incorporates the previously suggested abbreviated
technology appraisal. The process entails a shorter manufacturer submission,
with no requirement for a cost effectiveness model, removing around 11 weeks
from the single technology appraisal route. It’s likely the majority of
technologies to qualify for this route will be in the primary care setting and
with 30-days for implementation (as opposed to the regular 90 days) it will be
important to engage with Clinical Commissioning Group commissioners to ensure
optimal adoption. Ten technologies have already been identified as potential
candidates for appraisal via this route in 2017.
The ‘budget impact test’ has
been designed to encourage early dialogue between manufacturers, NICE and NHS
England, help the NHS introduce products that will have significant budget
impact and encourage flexible commercial deals. Helen Jones, Strategy and
Policy Lead Specialised Commissioning, NHS England, emphasised that £20 million
isn’t a capped amount the NHS will pay or change the decision NICE has made but
it will act as a trigger to open a conversation on how introduction is managed.
Suggested methods for introduction may include a commercial agreement to reduce
the net budget impact below £20 million or a managed access agreement to phase
the introduction. The finer details of how this ‘test’ will all work in
practice are yet to be clarified. One size won’t fit all and NICE are still
waiting for the first technology to trigger those discussions.
The highly specialised technology appraisal
process is the most challenging, allowing for fair appraisal. Only four pieces
of guidance have been published to date. Many require managed access agreements
and/or collection of real-world data to allow positive recommendation and
introduction. A £100,000 QALY has been retained from the consultation document
and activates automatic funding. For technologies with a higher cost per QALY,
an incremental health weighting system has been introduced. Only 3 technologies
can go through the highly specialised appraisal route per year, so one key
concern from the audience was what happens to those products that fall in the
gap between the highly specialised and single technology appraisal routes.
For further details about OPEN Access Consulting (an
OPEN Health Company) please get in touch with Cathy Wright,
Managing Director, OPEN Access Consulting at email@example.com