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NICE eschews Value-Based Assessment for now: Are we ready for consensus?
Sometimes standing still is the best way to move forward. Just ask the UK's National Institute for Health and Care Excellence (NICE), which this month decided against adopting its mooted value-based assessment (VBA) model in favour of a more comprehensive look at how new treatments access the NHS. The VBA model (discussed by my colleague Kavita), itself a response to the lapsed concept of value-based pricing (VBP), was put forward by NICE earlier this year. However, what NICE referred to as a lack of consensus among the responses received during the proposal's consultation period has in part spurred the Institute to call for this broader reflection.
Patience is a virtue
Pausing to take stock of the bigger picture is probably wise. The pricing and reimbursement sphere, and the healthcare world at large, are currently grappling with no small number of challenges to the current operating model. From the questions increasingly being asked over sustainability (think of the uproar over super-premium pricing and the proliferation of orphan and ultra-orphan disease assets), to the inroads being made toward increasingly experimental and cross-institutional ways of working (think of the EMA's adaptive licensing pilot), we have grown accustomed to a system in state of flux. Everyone is questioning what we mean by "value," and how it can and should best be recognised and rewarded over time.
No small task then for a payer to go about reassessing the fundamentals, given the very way that industry conducts R&D and interfaces with its external stakeholders are no longer a given. At the same time, how liberating, as flux and an appetite for innovation mean we are less bound by the status quo, more able to redesign a pricing and reimbursement system fit for purpose.
And yet, as the stakes are raised, does the consensus to which NICE referred in its latest decision become less or more elusive? As we eschew what may be a band-aid approach for a more deep-rooted solution, are we moving more head-on towards the underlying points of contention? And if so, are we equipped to address them?
Potential sticking points
Given the questions being asked in today's world of pricing and reimbursement, when conducting a broader reflection on how new medicines are accessed, what are likely to be the sticking points, those items which challenge consensus?
Over the years, we have seen a narrative of "give and take" emerge between payers and industry. As the era of the mass-marketed, primary-care blockbuster has given way to the premium-priced, niche therapeutic, we have seen the advent of risk sharing, enabling the latter to gain reimbursement in exchange for various concessions to the healthcare system. In turn, when questions were raised over whether risk was being shared equitably, and whether these arrangements actually imposed unintended costs on the system, we saw a movement toward the simplification of these schemes.
But this issue has not gone away. Still, some therapies are rejected for reimbursement. Still, other assets with even higher price tags have emerged from the pipeline. The idea of risk sharing, and how it ought to be shouldered between industry and the healthcare system, remains an open question. This is larger than the patient access scheme, that lever which has formalised risk sharing in the UK policy space. Under the fundamental concept of risk sharing, we might include other policy measures, such as flexible pricing, whereby NICE looks to assess price rises or decreases in line with real-world usage.
In issuing its recent statement on the consultation outcome, the Institute has already called for "more productive sharing of risk," including a framework that would "progressively reflect the value of new treatments as our knowledge of what they can offer to patients increases." I wrote before about industry's apparent lack of interest in taking up the current flexible-pricing option as a question of incentives. But, in a broader overhaul, NICE may put forward plans to make this model something of a new status quo - something which would be a game-changer for industry.
Consensus, take two
While the decision to refrain from immediate implementation of a VBA model may make sense (up against a system in flux with plenty of deep-seated issues to address), and may come as a relief to those in industry with specific concerns over the nature of the latest proposal, there is the realisation that we have prolonged the period of uncertainty. Perhaps we need to begin thinking now about how we will reach consensus next time - as consensus at that stage may prove equally, if not more, elusive.
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