This week, Directors Brett Gardiner and Rachel Howard attended the ISPOR Europe conference in Copenhagen, Denmark. On November 4th to 6th, Directors Brett Gardiner and Rachel Howard joined 5,500 other healthcare leaders in attending the ISPOR Europe 2019 conference in Copenhagen, Denmark. The conference opened with an announcement that four Nordic countries have pledged to spend 5% of their GDP on preventive healthcare by 2030, a significant investment in the health of these Nations. This was a timely announcement given the three-day program of events centred around the theme of ‘Digital Transformation of Healthcare’.
Monday November 4th
The first plenary session opened with a panel discussion on healthcare digitalisation. Technology is driving a paradigm shift in terms of how healthcare is organised, delivered and accessed – but there remains a long way to go in order to optimise its effectiveness. Inevitable concerns are ensuring data privacy and security, with audience questions reflecting the fears and mistrust of the role major tech companies such as Google, Facebook and Apple might play in this space.
The impact of GDPR – a barrier or a safeguard? – was also considered. Another obstacle limiting true digitalisation of healthcare is lack of interoperability between systems. Here the FHIR (Fast Healthcare Interoperability Resources, pronounced ‘fire’) standards were referenced as a potential solution to be followed in order for the vast potential of digital healthcare to be fully realised.
We spent the rest of the day moving between breakout sessions and symposia. The first of these explored the issue of delayed access due to health technology assessment (HTA) capacity limitations, and considered whether this was a necessary reality or an unacceptable problem. While everyone recognises timely access for patients is important, there is also an understanding that this cannot be granted at any speed or any cost. This is especially relevant in the current context of increasing disconnect between the data needed to meet regulatory requirements for marketing authorisation (efficacy, safety, quality) and the demands of payers for market access (value, cost effectiveness, budget impact). However, there is recognition that the HTA process can be lengthy in many countries. We heard the perspective of Lesley Tilson from Ireland’s National Centre for Pharmacoeconomics (NCPE), who explained that in Ireland, following a four-week rapid review process upon positive CHMP recommendation, only 50% of drugs are prioritised to go through a full HTA review. Further streamlining the HTA process, increasing the capacity of HTA bodies to conduct assessments and promoting cross-border collaboration to reduce duplication of efforts (as we are seeing with EUnetHTA and BeNeLuxA) may also help to minimise access delays – though these take time to set up and are not ‘quick fixes’.
Next, we headed to a “standing-room only” session that debated the controversial topic of whether the time has come for the pharma industry to accept modest prices. A Bain & Company study showed that 50% of all drug launches fail to meet company expectations, with payer pushback on price increasingly having a significant impact on biopharma companies’ bottom lines. The fundamental, unresolved conundrum is how to balance the needs of all stakeholders: satisfying the demands of investors while also ensuring affordability for healthcare systems. It was argued that one of the challenges is the appropriate implementation of value-based pricing (VBP), because cost effectiveness thresholds are disconnected from budget impact and affordability. Innovative strategies to achieve more modest prices without reducing incentives for innovation were a hot topic throughout the conference.
A third breakout session questioned the feasibility and desirability of indication-based pricing (IBP) – another key issue, particularly in the context of the latest waves of oncology launches where product value often varies from one indication to another. The panel presented both sides of the argument: on the one hand, it is claimed a single price can stifle innovation as it disconnects value from price, while setting indication-based prices can potentially represent a means of overcoming access restrictions to ensure more patients can benefit from the therapy. However, we heard both philosophical and practical objections to this position – there is an opportunity cost to expanding access through IBP that needs to be considered, and it is problematic to enforce. As evidenced by the example of Avastin being used in place of Lucentis for eye disease in the UK – use by indication needs to be carefully policed.
We rounded out Monday with an evening educational symposium that appealed to our interest in emerging markets: exploring how value assessment principles can be applied to support access to innovation in the Middle East and North Africa (MENA) region. Current HTA in the region is limited, and pricing is governed by external reference pricing (ERP) principles and tendering. Countries have expressed interest in moving towards more collaborative, transparent systems, with KSA and the UAE releasing their healthcare visions for 2030, and Egypt implementing a series of healthcare reforms. However, a shift from ERP to VBP would require considerable capacity building, and formal HTA may need to be a longer-term goal. Abdulaziz Al-Saggabi from the Ministry of National Guard Health Affairs in Saudi Arabia shared the latest updates on his country’s efforts to implement HTA, with a framework having been put in place earlier this year based on a Multi-Criteria Decision Analysis (MCDA) approach to priority setting.
Tuesday November 5th
We returned to the theme of digital transformation with a second plenary session that went into more depth into shaping the digital healthcare system. We were introduced to the ‘5 Es’ that digital healthcare has the potential to achieve: Engage, Empower, Educate, Evaluate & Evolve. The panel themselves managed to do all of these things, with an impassioned discussion about the possibility of extracting meaningful information from the ‘quantified self’ data many of us collect on our smart devices every day outside of a healthcare context – tracking sleep and steps, for example. The digitalisation of society is impossible to resist, and it has the potential to generate data ‘tsunamis’, but should we start with a research question before interrogating the data, or interrogate and explore what’s there in the hope it will unearth early signals. There was a comment that for every 300 health apps out there, only 1 has robust evidence behind it, so there is a need to be discerning when it comes to digital technologies – not swayed by solutions looking for problems, but focusing on demand-driven solutions based around patients’ needs. At the same time, we need to beware of an Orwellian future in which healthcare systems use our data as a weapon (e.g. denying you obesity medication if you haven’t provided evidence of daily work outs) – especially given much of this health data lies in the hands of big corporations where society has little access to it.
An individual’s data and its potential to be weaponised also became very apparent in the session on ‘Genomics in the future of health – the road to better outcomes.’ The focus of the session was to understand how personalised health is built on genomics and a future paradigm shift is on the horizon, however there are several questions that need to be addressed. Dr. Terry Vrijenhoek, Staff and Faculty Advisor from University Medical Centre, Utrecht, Netherlands, mentioned that that one of his interns identified who an individual was in less than two weeks, using only the de-identified genomics data of a patient. Issues like this carry the potential to generate significant risks (e.g. being denied insurance coverage, workplace/job discrimination, etc). Ultimately, the challenge will be to strike the right balance between open access to data and ensuring it is well stewarded.
Next on our agenda was a tour around the poster and exhibition hall, and we attended a selection of therapy area specific presentations before heading into a couple of sessions focused on Cell & Gene Therapy / Advanced Therapy Medicinal Products (ATMP). Set to be a $43.7 billion dollar market by 2024, the undoubted hot topic of 2019 is how healthcare systems will be able to afford these potentially curative therapies. We heard perspectives from the US, Italy, France, Germany and the UK about the special market access pathways that these technologies can potentially follow; the next session then challenged whether gene therapies should be exempt from HTA scrutiny. In a lively session, the interactive audience poll was roughly divided between ‘yes’, ‘no’ and ‘partly’. The already-discussed issue of HTA delays is a particular problem in the case of these therapies, where patients urgently need access and don’t have time to wait for payers to decide how to pay for them – so anything that can expedite review would be welcomed. HTA was compared to the video assistant referee (VAR) in football, in that it is intended to support objective decision-making, but it is heavily criticised and has some way to go to be perfect – especially in the case of these specialised therapies, which it was not designed to appraise. Where ATMPs are concerned, the question remains as to whether the extra layer of cost effectiveness analysis is worth the time in that it leads to improved decision making – or should it be skipped and go straight to managed entry agreements.
Our day concluded with a networking reception in the exhibit hall; a well-earned time to unwind and take in all that we had heard.
Wednesday November 6th
The final day of the conference got off to an early start with a number of breakout sessions, including an eagerly anticipated discussion on whether subscription-based models for drug reimbursement represent a fad or the future. While the panel argued the use of ‘Netflix model’ to refer to these agreements may indeed be a fad, the principle of subscription services is well established in economics, and can represent an innovative way to re-engineer the demand curve by decoupling price and quantity. Potentially everybody can win with this model – more patients are able to access therapy without restrictions or gatekeeping, payers can leverage economies of scale to negotiate a bigger, better deal, and pharma companies can be assured of guaranteed revenues. But there are risks, too – will payers find themselves locked in to contracts with drugs that are subsequently outclassed by newer entrants, for example. Accurate epidemiological data is essential for both the industry and payers when devising these agreements, as there is a need for both sides to ensure they will be commercially viable. While we heard a detailed case study of where this model was successfully used to purchase direct acting antivirals (DAAs) for hepatitis C in Australia, examples of these subscription-based models remain few and far between. Other notable examples include the subscription to hepatitis C treatments for Medicaid patients and prisoners agreed by the US state of Louisiana earlier this year, and the recent “portfolio-based” deal implemented in England for Vertex’s cystic fibrosis treatments. Despite their potential and an apparent appetite on the part of payers to explore such agreements, there are practical issues associated with their implementation that have yet to be easily overcome.
With the exhibition hall quietening down, we took the opportunity to browse the poster hall and chat to some of the authors about their research, before heading in to the third plenary session focused on the endless opportunities of big healthcare data. Real world evidence (RWE) is increasingly relevant for market access, especially in the context of the impracticalities of running double-blinded randomised controlled trials (RCTs) for many of the upcoming ATMPs and ultra orphan drugs. We heard examples of how RWE has been used to augment RCTs, by providing an external control arm for single arm studies. We then learnt about the concept of diff-in-diff studies, and how these can be used (and misused) to draw conclusions from real world data and harnessed to drive learning at the healthcare system level. And finally, we heard about the potential for artificial intelligence and deep machine learning in mining this data to have meaningful implications for healthcare. A fitting close to illustrate how, as healthcare undergoes its digital transformation, roles are changing and responsibilities need to be shared.
Contact us if you would like to discuss any of the themes or issues outlined here in more detail.
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