For companies, it affected clinical trials and resulted in launch delays which hit the bottom line. So, 2.5 years on from the start of the pandemic, how can companies looking to launch non-COVID treatments get access back on track?
At Insocius, our expert pharma value communications and change management teams can help with value articulation and support leaders to engage with HTA agencies and payers in the ‘digital-first’ post-pandemic world of 2022 and beyond with a market access strategy to get back on track.
Revenue for the worldwide pharmaceutical market hit US$1,265 billion in 2020, rising from US$1,250 billion in 2019 according to data from Statista.com.
Figure 1: Revenue of the worldwide pharmaceutical market from 2010 to 2020
Source: Data from Statista.com
Regulators were also able to keep up the pace of approvals in 2020, despite COVID-19. In fact, the EU and the US saw a record-breaking number of 133 new therapeutic drugs approved in 2020.
IQVIA data also suggested that the number of new active substances launched in 2020 was in line with historic norms in Germany, France, Italy and the UK. In fact, in the early days of the pandemic, Spain was the only major EU country that showed significant delays to pricing and reimbursement decisions.
However, nearly two years on and it is predicted that launch disruptions came with a cost of around US $19 billion, foregone from worldwide pharmaceutical revenue until 2025.
Respondents to a survey of industry by GlobalData conducted from 17th November to 9th December 2020 put clinical trials as the most frequently cited area in the pharmaceutical value chain affected by COVID-19. At worst, companies were not able to start trials or had to delay their initiation.
Even when trials were running during 2020, recruitment slowed. This, in turn, had future spill overs for companies as to when they could file with regulators and when they were in a position to start the pricing and reimbursement process.
Many HTA agencies had to re-prioritise their usual work due to COVID-19. Workload increased for most HTA agencies according to Health Technology Assessment International (HTAi), a member-driven organisation bringing together those who have an interest in HTA.
HTAi surveyed their members in 2020 and a third of 52 respondents said they had seen an increase in their workload overall.
NICE put their efforts into working on treatments they saw as therapeutically critical, for example, and paused their work on others. NICE was not alone in being affected by COVID-19.
IQVIA data suggests that the number of HTAs published were lower in 2020 across Europe, although the picture varies by country with Germany bucking that trend (Figure 2). IQVIA also suggests that it was the non-oncology treatments that were most affected.
Figure 2: HTA productivity in EU4 and UK, average 2015-2019 to 2020
Note: Productivity refers to number of HTA reports. The chart compares the number of HTA reports in 2020 versus the average number produced between 2015 to 2019.
In September 2020, IQVIA estimated that the average duration of HTA delays in Europe was at least five to seven months.
The pharmaceutical industry had to make a significant shift in the way it interacts with health care practitioners as a result of COVID-19.
Pharma had 30% less interactive time with health care practitioners in Europe in 2020 compared with 2019, according to IQVIA survey results, and those interactions shifted to phone calls or video meetings and away from face-to-face meetings.
Health care practitioners also saw patients less. Home care became a priority as it could be delivered more easily than treatments in the hospital setting.
NHS England for example, had proactively sought to move patients with cancer onto what they describe as ‘COVID friendly’ treatments from home from August 2020.
That trend was also seen in Europe: IQVIA data released on 21 March 2021 and based on oncologist surveys in France, Germany, Italy, Spain and the UK found that, in Wave 2 of the pandemic (June 2020), 39 per cent reported a change in treatment protocol to introduce oral cancer medications where possible.
By Wave 3 (October 2020), this rose to 46 per cent, and it stayed there for Wave 4 (February 2021).
Perhaps companies have also become less effective as they too have had to adjust to working away from the office and have shifted to commercial teams working remotely.
Some may have missed an opportunity: IQVIA suggest that companies that rapidly shifted to digital strategies did well with their 2020 launches and that optimising digital working gave some companies the edge.
Launch disruptions are not the only issue pharma will face as they continue to seek to launch new treatments in the post COVID-19 world. It is only going to get tougher in the marketplace.
COVID-19 put pressure on health care systems, which has been exacerbated by the unmet needs of patients with other conditions who have had to wait for care or are not seeking care early.
Deloitte has highlighted that in the beginning of the pandemic in France, general practitioner consultations fell by 40%, and those with specialists by 50%, even allowing for teleconsultations.
The fall-out from COVID-19 may also include an impact on mental health and physical health, which will also put more pressure on health care systems.
In some cases, real cuts had to be made to health care budgets. In the UK, the budget released on 5 March 2021 showed a 15% cut for the NHS, from £199.2bn in 2020/21 spent by the Department of Health and Social Care to £169.1bn planned for 2021/22.
Spending had been temporarily boosted in 2020/21 to help with meeting COVID-19 needs, however, much of the extra COVID-19 funding will not be maintained post pandemic. That is a concern: funding is not keeping up with demand, and cost-consciousness will continue to intensify.
It will become harder to secure premium prices for new medicines against this backdrop of rising demand and funding cuts. It may even be harder to maintain reimbursement.
HTA agencies may still, to a degree, be playing catch up and the time they take to conduct their assessments may well return to pre-pandemic levels soon, but permanent change in working practices has already happened.
NICE, for example, have adopted a virtual approach permanently. According to their consultation on the review of the health technology evaluation processes that closed on the 15 April 2021, there will only be virtual scoping workshops in future.
Technology Appraisal committee meetings will be virtual too as the default, although in-person committee meetings may be an option ‘where appropriate.’
For regional payers and local purchasers, Insocius’ expert team anticipates that interaction will move back to face-to-face for important meetings, but remote meetings will continue.
The challenge for pharma is how to be effective in conveying value and negotiating on market access when they are not in the room with payers and – beyond that – when they have to launch digitally and engagement with health care practitioners is virtual.
Launch disruptions may mean more time to plan but that also means companies have to be ready to execute a digital-first payer and market access strategy when the time is right.
Companies need a comprehensive and structured approach to bringing together the cross-functional input to develop and, crucially, to implement a digital-first launch strategy. No longer can companies rely on water cooler conversations and ad hoc meetings.
Value articulation has never been so important as it is now. Less money will translate into more scrutiny and greater price pressure on new treatments. Articulating value needs investment right from the outset, and outside support can bring a valuable focus to identifying and communicating value.
COVID-19 also changed how health services operate. Companies need to show how their new treatment will help the health system and the health care practitioner to meet their post-COVID 19 goals.
It is no surprise that IQVIA data suggests the launch winners in 2020 included those treatments that offer a clinical advantage in terms of reduced visits to hospital.
Face-to-face meetings do not look to be coming back, at least not at scale. Companies need to be conscious of the context-poor setting of electronic communication.
When there is less opportunity to provide nuance or flexibility to add content during a Zoom call, the value communication tools need to be even more persuasive, with the asset’s value proposition and value messages even clearer than before.
This will see delays throughout the course of the product life cycle, from clinical development, through regulatory and market access approval, and on to commercialisation.
Companies can choose how they react: weather the storm or respond proactively by leveraging the expertise of market access and value articulation professionals.
At Insocius, we believe in the need for market access teams to take the initiative and adjust course towards a post-COVID pharma access world.
An increased pressure on healthcare systems’ resources and an increasingly ‘virtual’ or ‘digital-first’ environment for engaging with payers produce an increased need to cut through the crowd with clear value articulation strategies and messaging.