DNA showing COVID

Catching up after COVID: Market access strategy, approaches and tools to get access back on track with payers.

COVID-19 has led to unprecedented change.

It has put pressure not only on delivery of care, but also on Health Technology Assessment (HTA) agencies and payers who have had to pivot their work to meet COVID-19 demands, as well as change their priorities towards treatments that can be given at home.

 

For companies, it has already affected clinical trials and brings the prospect of launch delays which will hit the bottom line. 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’ pandemic world of 2021 and beyond with a market access strategy to get back on track.

 

Launch disruptions predicted to hit revenues

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. The global market seems to be holding steady despite the COVID-19 pandemic (Figure 1).

 

Fig. 1 showing an appropriate market access strategy

 Figure 1: Revenue of the worldwide pharmaceutical market from 2010 to 2020

Source: Data from Statista.com

 

Regulators were 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 suggest that the number of new active substances launched in 2020 was in line with historic norms in Germany, France, Italy and the UK. Spain was the only major EU country that showed significant delays to pricing and reimbursement decisions.

 

The Spanish experience could be a marker for the future challenges industry will face, as the full impact of COVID-19 on the industry is yet to be felt. Launch disruptions are predicted to come with a high opportunity cost of around US $19 billion, foregone from worldwide pharmaceutical revenue until 2025.

 

Drivers of launch disruption

 1. Clinical trial delays


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 have had to delay their initiation.

 

Even when trials were running during 2020, recruitment slowed. That will have future spill overs for companies as to when they can file with regulators and when they will be in a position to start the pricing and reimbursement process.

 

2. HTA and payer delays


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 suggest that it was the non-oncology treatments that were most affected.

 

Fig 2 show another example of a market access strategy

 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.

 

Source: Data from IQVIA. (March 2021) Impact of COVID-19 on the pharmaceutical market – EU4 & UK. Available at: https://www.iqvia.com/library/white-papers/monitoring-the-impact-of-covid-19-on-the-pharmaceutical-market-eu5

 

In September 2020, IQVIA estimated that the average duration of HTA delays in Europe was at least five to seven months.

 

3. Lower levels of commercial activity


The pharmaceutical industry has 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. Those interactions have shifted to phone calls or video meetings and away from face-to-face meetings.

 

Health care practitioners are also seeing patients less. Home care is a priority as it can 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 is 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 has 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. Optimising digital working is giving some companies the edge.

 

Market access strategy and prospects post-COVID

Launch disruptions are not the only issue pharma will face as they seek to launch new treatments in the post COVID-19 world. It is only going to get tougher in the marketplace.

 

1. More demand for health care and tighter budgets

COVID-19 has put pressure on health care systems, which will be 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. This will put more pressure on health care systems.

 

In some cases, real cuts are already being made to health care budgets. In the UK the budget released on 5 March 2021 shows 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, and 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 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.

For example, in November 2020, NHS England took the decision that, because of the need to fund COVID-19 activity, there was not enough money left to pay for BioMarin’s Kuvan (sapropterin) for phenylketonuria.

 

At the time of writing, NICE was still appraising the treatment and Kuvan had only had interim funding, which was subsequently withdrawn. Routine funding may come, though, as NICE issued a draft positive recommendation in February 2021.

 

That might be a reprieve for BioMarin, but it is likely it will not be the last funding cut made. Nor is it likely just to be a phenomenon in England, but one that will be seen internationally.

 

2. Digital launches and virtual payer engagement


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, 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.

 

What does pharma need to do?

1. A more systematic approach to launch planning


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.

 

2. Identify and communicate value in the post-COVID-19 world

Value articulation has never been so important as it is now in these COVID-19 times. 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 changes 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 suggest the launch winners in 2020 included those treatments that offer a clinical advantage in terms of reduced visits to hospital.

 

3. Optimise HTA and payer communication in a digital first world


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.

 

In summary, the disruption caused by COVID-19 is likely to affect the pharma industry for many years to come.

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 produces an increased need to cut through the crowd with clear value articulation strategies and messaging.

 

Speak to a member of our team today to find out how we can support you in getting your value messages clearly heard with a market access strategy and more.

 

Contact us now. 

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