Claudia Rubin, Director at Decideum, questions what will Health Technology Assessment look like post-COVID?
As England and the devolved nations emerge from COVID-19 lockdown at varying rates, so too their respective health technology assessment (HTA) bodies are taking a similarly varied approach to returning to business as usual.
While some normal business is resuming across the medicines landscape, many are now looking at how we can create a new normal – being more ambitious than before in how we make HTA work better for patients and for the system.
The Scottish Medicines Consortium (SMC) has, for example, already acknowledged that a business-as-usual approach will not satisfy their intention of reducing their backlog as quickly as possible.
“The most clear and present challenge HTA bodies will face following the resumption of operations is a backlog in appraisals”
Prior to the emergence of the pandemic, there were already challenges facing the UK’s HTA bodies. The SMC was struggling with capacity issues, leading to a backlog in dealing with submissions. The National Institute of Health and Care Excellence (NICE), which was due to take on all new indications by April 2020, (including those that would have been covered by NHS England), needed to boost capacity in an already overstretched programme.
As the pandemic unfolded, NICE, SMC and the All Wales Medicines Strategy Group (AWMSG) set out their programmes of suspended operations due to COVID-19.
NICE prioritised its activities to focus on therapeutically critical topics (including ‘appraisals involving a cancer medicine’) and guidance addressing COVID-19 diagnostic or therapeutic interventions. The SMC ‘suspended all meetings with immediate effect’ and AWMSG, meanwhile, opted to ‘suspend normal business’.
Meanwhile, NHS England Specialised Commissioning Clinical Priorities Advisory Group (CPAG) delayed its May 2020 round until late July, in further evidence that NICE is not yet ready to absorb CPAG’s activities as planned, by April 2020.
As of 1 June, of the 89 NICE technology appraisals with a final scope produced since October 2018, 66% were still in progress, 28% had been suspended due to COVID-19 and 6% were suspended for other reasons. Cancer medicines, as promised, have been nominally unaffected by the restrictions (excluding those under Cancer Drugs Fund review) though the actual impact of say remote committee hearings, is yet to be borne out.
Very little information was made public on the prioritisation process of topics, making it difficult to establish accountability for these decisions. While NICE has now started publishing guidance not related to COVID-19, moving closer towards ‘business as usual’, recent NICE Board papers suggest that prioritisation of some sort will have to continue. It is crucial that justification for prioritised topic selection is made transparent.
The most clear and present challenge HTA bodies will face following the resumption of operations is a backlog in appraisals – this may lead to decision outcome delays, further hindering patient access to latest treatments.
Increasing internal capacity could allow HTA bodies to ramp up operations while maintaining gold-standard appraisals. This would require more financial backing though and whether there is the appetite for this additional investment from budget-holders remains to be seen.
Perhaps more likely, this autumn NICE will review the fee charged to companies for technology appraisals, barely a year after it was first introduced. Should this cost be increased to cover the burden of additional capacity, for example, this could have a range of implications for industry and patients. These include concerns over affordability for SMEs and reducing the attractiveness of the UK as a market for investment (of particular importance in the context of the UK exiting the EU), ultimately further limiting or delaying patient access.
Despite NHS England repeatedly stating intentions to disband CPAG’s operations, the backlog in NICE appraisals may instead require CPAG to continue to serve as an important silo for reviewing a small group of medicines. The relatively fast turnaround of CPAG funding decisions, could also mean that more ‘interim’ funding decisions are sought, filling the gap while the backlog at NICE is addressed.
Will companies look to the AWMSG as a quicker route to market in Wales if they perceive NICE and SMC to be overloaded by their respective backlogs? This could lead to the AWMSG, which has limited capacity, seeing a rise in their usually low number of submissions, deepening the backlog and creating further unexpected inequality of access across the four nations of the UK.
The introduction of RAPID-C19 (Research to Access Pathway to Investigational Drugs – COVID 19), a new collaboration between NICE, National Institute for Health Research, Medicines and Healthcare products Regulatory Agency and NHS England to triage, coordinate, and fast-track potential COVID-19 therapies, demonstrates that when there is a drive to speed up access to treatments, it can be achieved.
It will be hoped that the progress made by RAPID-C19, which appears to mimic the structure of the Accelerated Access Collaborative, will be built upon and repurposed for other areas of medicine. It would be a missed opportunity not to learn lessons through collaborations of this sort to improve access to medicines in future.
COVID-19 has brought some uncertainty about the direction of the HTA space in the UK, as it has with the majority of sectors. Will an overburdened NICE lead to more innovative commercial deals being carved out at NHS England? Might this lay a precedent for a novel twist in the relationship between pharma and payers?
Furthermore, if NICE maintains a level of prioritisation in its topic selection post-COVID, to what extent will the impact on treatments for ‘deprioritised’ conditions be acceptable?
Claudia Rubin is Director at Decideum. Go to www.decideum.com