Nine for 2021: Addressing the pandemic legacy

In this second ‘Nine for 2021‘ article, IQVIA’s Sarah Rickwood looks at four issues which will directly impact pharma in 2021: the permanent changes in customer engagement models, the implications of a geographic re-balancing towards the East, CNS as the new value growth area for the 2020s, and the new biologics environment as biosimilars accelerate.

Focus on customer engagement impact

The customer engagement story of 2020 could be summarised in three themes: trend break, agility and remote interaction. The trend break was the most immediately measurable commercial model impact. For April 2020 almost all face-to-face contact with healthcare professionals (HCPs) ceased. Preventing virus transmission, as well as “getting out of the way” of healthcare professionals pivoting to address the virus was key, and HCPs largely welcomed the way pharma reacted as responsible and necessary.

However, qualitative interviews conducted by IQVIA with HCPs in the top 5 European countries on their experience of engagement with pharma during 2020 show that doctors still valued interaction, including face to face interaction, with pharma and missed it when it was absent.

Pharma moved rapidly to remote interactions, even to the point of all virtual launches of new products. The overall volume of interactions fell, and those remaining became more remote and less interactive. The agility of many organisations effecting this rapid change was impressive, and a more resilient hybrid model seemed to be emerging as face-to-face interactions returned post the first wave.

This has, of course, been more recently challenged in Europe by second wave infections and new lockdowns, but this masks more fundamental and as yet unresolved challenges for 2021’s commercial model, which could be defined by environment divergence and the need to achieve impact.

Environment divergence

The promotional environments of major pharmaceutical markets were already divergent in 2019 – some, like Italy and Spain were very high on traditional face to face interactions, others, like the UK, were the complete opposite, and still others, like Japan and the US, had high volumes of both digital and face to face contacts. The ways in which country promotional environments recovered from the first lockdowns has accentuated that divergence. This has implications for the commercial model companies employ by geography.

Environment divergence has been accelerated by recovery post the first infection wave – IQVIA ChannelDynamics data shows that in Europe, countries have recovered to a different promotional mix.

The UK has diverged most – it was always the country with the lowest volume of face-to-face contacts, and those contacts remain at negligible levels, replaced (but not completely) with remote rep contacts, creating a near 100% remote engagement model.

Other European countries have seen face to face contacts recover, then fall back because of second waves, but the model that emerged towards the end of 2020 was lower in volume and much more hybrid – a greater proportion of interactive contact was remote. The US, Japanese and Chinese promotional environments saw contact volumes recover to close to or greater than 2019 levels, with a channel mix that was more heavily remote.

The divergence of promotional environments is especially stark in the difference in the total interactive time the pharma industry had with healthcare professionals in 2020, compared to 2019. Up to November, the US and Japan actually saw increases in interactive time in 2020. Not so China, and especially not so the lead five European countries – on average European pharmaceutical companies saw a loss of 30% of the interactive time they previously had with healthcare professionals in 2020. Much of this lost time would have ordinarily been spent introducing and establishing new innovations and building growing products.

The need to achieve impact

As interactive time with HCPs is likely to be scarce, companies need to be even more ruthless in prioritising content and in deciding what content to generate in the first instance – for example, in Real World Evidence, as outlined in IQVIA’s white paper, ‘Excellent Launches are winning the Evidence battle’.

CNS (re) emerges

The 2010s were the decade of oncology: the decade started with oncology tipping hypertension off the top spot as the world’s most valuable therapy area, and during the next ten years, via continuous introduction of significant innovation, oncology grew its share of global prescription medicine value from 8% to 13% of sales. Oncology will continue to dominate the world market in the 2020s, albeit with slower growth, but that is not news. Instead, we will focus on therapy areas which will take on new significance in the 2020s. Of these, the most significant in terms of the conditions’ prevalence, and unrealised therapeutic potential, is CNS.

CNS is a “Back to the Future” story – scroll back to the 1990s and 2000s and CNS was one of the largest segments of the Rx market by value, driven by anti-depressants, atypical neuroleptics, anxiolytics and hypnotics. Then, by the 2010s, a wave of genericisations took down the blockbusters across all leading classes, and innovation stalled. Hopes for an effective disease modifying Alzheimer’s treatment, the holy grail of CNS research, were repeatedly dashed by late stage failures. By the end of the 2010s, CNS as a whole was highly genericised, with low innovation and few important launches. From 2021 onwards, this will change. Over the next five years we expect the global CNS market to accelerate ten-fold in list price value from near-flat historical growth of 0.4% CAGR for the past 5 years to 3-5% CAGR for the period of 2020-2025 to reach $100 billion globally by the middle of the decade.

The drivers behind this transformation are two classic elements – perennial unmet need and innovation, but with some very specific 2020s twists. The pandemic and consequent lockdowns have led, in some countries, to an explosion of mental health disorders. The pandemic has accelerated the trend to remote and digital healthcare at a time when the development and use of digital diagnostics and biomarkers has become possible and very relevant to many CNS conditions. Psychiatry has proven one of the areas of clinical practice most amenable virtual delivery.

Underlying this all, long term innovative investment is finally yielding fruit in a range of CNS therapy areas, for example new therapies for treatment-resistant depression (e.g. Janssens’s Spravato), the novel CGRP inhibitors for migraine, or dual orexin receptor antagonists (DORAs) developed for insomnia. Two of the three largest selling products launches in 2020 by 2020 sales were CNS products: the oral migraine treatments Ubrelvy and Nurtec. Progress on the holy grail of an effective disease modifying Alzheimer’s treatment is also possible in 2021, but not a foregone conclusion.

CNS will end 2021 with a renewed relevance and powered by new innovation, both molecular and digital, placing the therapy class in a strong position to re-ascend the rankings as one of the  most valuable therapy areas for the remainder of the 2020s.

Biosimilars accelerate

Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. 2021 marks the start of the era when these healthcare systems really need biosimilars to come good on their promise to realise cost savings. As economic crisis leads to healthcare spend constraints, the proportion of product value that will lose exclusivity in the next five years that is biologic has never been higher, at 44% of the $200m of the 2019 pharmaceutical market which will lose exclusivity in the next five years.

Counting from infliximab, the first of the monoclonal antibodies to face biosimilar competition, uptake of the biosimilar into the originator molecule has improved significantly, with the last volley of biosimilar launches reaching 40% of all treatment days within 12 months of in Europe, compared to nearly three years for infliximab to reach that level. Bevacizumab (Avastin) is on track to achieve 40% average European biosimilar treatment day penetration in six months, the first to do so. However, biosimilar uptake is not evenly distributed, and savings are still not always realised where they are most needed. Given the very powerful incentives that especially European countries will have to realise savings on medicines budgets where they can, we expect further measures to be implemented to promote the use of biosimilars in 2021.

Pharma pivots East

Increasingly, pharmaceutical companies add China to their launch priority countries group, typically the US, EU, and Japan, and from 2021, this trend is likely to accelerate. Europe, still in the throes of lockdowns and second waves will be living with healthcare system disruption for much of 2021, as well as economic austerity. Fragmentation of the European top 5 as the UK pursues its own regulatory regime post Brexit may also impact Europe’s attractiveness. The US, also still to effectively manage the infections crisis, will enter a new phase with the Biden presidency, and that could mean changes to healthcare system and pharmaceutical pricing reform.

China entered the first wave of the pandemic crisis earliest and emerged earliest, and (as at January 2021) has so far managed to avoid the debilitating second waves which have precipitated further lockdowns and healthcare system disruption in Europe and the US. Whilst the details of China’s economic recovery have been disputed, one forecaster, the Centre for Economics and Business Research, has predicted that China will now overtake the US as the world’s leading economy in 2028, five years earlier than was previously forecast.

China has been the world’s second most valuable pharmaceutical market since 2013, but it has not been an important market in terms of contribution to the sales of the newer innovative pharmaceutical products – in fact, whilst China ranked second on total Rx market sales, it ranked below 30 in terms of sales of newly launched innovative products. This is now changing and will be accelerated in 2021 by how China exits the pandemic crisis.

Pre-pandemic, China had already worked hard to reform its regulatory systems, reducing the backlog of medicines applications under or awaiting review by 80% by the end of 2019. New Active Substances, as monitored by IQVIA audits, entered the Chinese market in 2020 at historically high rates – by August 2020, 27 new active substances were in the Chinese market, as opposed to a five-year historic average of 15 by that point in the year for China.

Approval is not everything, and there remain significant market access and pricing challenges for innovative launches in China, but China’s domestic appetite for innovation is growing fast – the innovative branded products segment of the market grew by 12% in value between 2015 and mid-2020, while the remainder of the market grew by 3%. In addition to China, Japan, already one of the key country contributors to early innovative launch sales, has also accelerated the introduction and uptake of innovation in recent years. Japan has also emerged from the pandemic relatively unscathed, in terms of healthcare system, although economic recovery might be slow.

Because of these trends, from 2021, the importance of China and Japan to innovative product value is likely to progressively increase, driven both by increases in attractiveness of these two markets, and challenges in the European (and possibly US) environment. This will tip the geographic balance of the global pharmaceutical industry east, which will not just influence where pharmaceutical companies get their value from, but also usher a new collection of Chinese innovators into the global market.

If 2020 was the crisis year, 2021 is the year of transformation. Some of our nine 2021 trends were set pre-crisis, for example the re-emergence of CNS, but may see some acceleration or change because of the crisis. Others, for example the transformation of the commercial model and the renewed focus on impact, have been dramatically shaped by the events of 2020, leading the industry into a much-accelerated change and possibly taking commercial environments in directions they would not have moved without the pandemic. Others, and especially the pandemic-accelerated tilt towards the East in terms of innovative market, have ramifications that will be decades long in realisation. 2020 was a year in which, by rising to the challenge of the pandemic, the pharmaceutical industry demonstrated it can accomplish that which would previously have been labelled impossible. Whatever the challenges, the pharmaceutical industry enters 2021 with a new sense of purpose.

About the author

Sarah RickwoodSarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.

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Are face-to-face medical meetings a thing of the past?

Everything, from exercise classes to pub quizzes, went online last year – and medical education was no exception. In their droves, congresses, conferences, and masterclasses went virtual in a bid to ensure healthcare professionals were supported, up to date, and socially distanced.

But is this change here to stay? Are the days of queuing for coffee, rushing to symposiums, and the glitzy conference dinner a thing of the past? We asked those in the know.

International reach

Online learning makes medical education more accessible but presents challenges in terms of networking opportunities and sponsor exposure.

That is according to Jamie McGregor, head of policy, intelligence and operations at the Neurology Academy, which provides education programmes and masterclasses across a range of neurological specialisms.

“We have gone worldwide,” he says. “We have had people from Indonesia, West Africa – places where people usually find it very hard to access medical education. A recent international masterclass in MS had 53 delegates from 11 countries.”

Geography is not the only accessibility consideration, as healthcare professionals have less time than ever. For most, study leave is a distant memory, and many are juggling long working hours with childcare and other family commitments.

“People can dip in and out of online content, rather than block three days out of their calendar to attend a course. They also avoid all the travel time and the expense.

“But in terms of disadvantages, we are always at the mercy of the IT gods, and from a delivery standpoint, there’s a lot more to organise. You’ve got potentially hundreds of people you need to make sure can log on and take part.”

Online can also be more difficult for speakers because they are unable to gauge their audience’s reaction, and the loss of networking opportunities has also been noted.

“We have really tried to drive engagement and give delegates the opportunity to get involved – we have had question and answer functions, Twitter feeds and dedicated inboxes. For the smaller events, we have set up WhatsApp groups so they can talk amongst themselves,” says McGregor.

“We want to try to make them feel as though they are in the room.”

Sponsor engagement was also a concern for the academy, and McGregor admits this is something they are still working on.

“We want to give sponsors as much exposure as possible, and make sure delegates understand that without the sponsorship, the events either would not be happening at all, or would certainly not be free.

“So far, we have tried virtual networking cafes, where pharma reps can sit and chat to people, and we are doing online sponsored symposiums. There is more that we want to do, and we will work with our sponsors on that, but it’s definitely a learning curve.”

Re-creating face-to-face

The pivot from “in real life” to virtual wasn’t an easy one for the team at the British Society of Echocardiography, but they were determined that the “vital educational event” would go ahead.

“A virtual conference is a completely different beast to a face-to-face event – the project plan needs turning on its head,” says Jo Sopala, executive director at the society, adding that she was “immensely grateful” to work with a trusted platform supplier who could provide expertise and support.

“I think digital will always have a part to play. I suspect for the next year we will remain predominantly virtual, but once we can socialise again, there will be a call for face-to-face events. People, and particularly the medical fraternity, will need the personal connection”

“There was a huge amount of work to do. We had a full programme and had already invited speakers. To facilitate a virtual event, we had to go right back to the drawing board: revising the programme, the structure and pretty much everything.”

The hard work paid off, and the virtual conference was deemed a success with a 50% increase in audience and wider international reach when compared to the previous year.

“We received overwhelmingly positive feedback about the content, platform, engagement and accessibility, and were very proud of the result,” Sopala says.

They worked hard to recreate the social element of conference, opting for a platform with inbuilt networking abilities and even throwing a virtual “conference disco”.

“You cannot underestimate the value of networking and informal clinical supervision/support that people get at conferences – something which is probably needed now more than ever,” Sopala says, adding that this had been difficult to recreate in the digital setting.

“The other slight downside was that our sponsors did not receive the level of engagement they would usually expect, but we will work with them and providers to improve on that.”

Asked if virtual medical meetings were the future, Sopala says she envisions a hybrid model, post-2021.

“I think digital will always have a part to play. I suspect for the next year we will remain predominantly virtual, but once we can socialise again, there will be a call for face-to-face events.

“People, and particularly the medical fraternity, will need the personal connection,” she says.

Industry adaptations

While educational content lends itself to the virtual model, translating sponsor exposure into the online space has posed something of a challenge.

Fiona Robinson, director of exhibition design company Discovery Events, says: “We have looked into various virtual platforms for clients for exhibition stands, including virtual tours, downloaded videos, brochures and information.

“But it is a really different way of disseminating information.”

Many clients have diverted spend from conferences to online content generation and are “taking the opportunity to profile themselves in different ways”.

“Websites are playing an even more important role than ever before, certainly as a sales tool. It is every company’s shop window to the world, and promoting expertise has never been more critical,” says Robinson.

The pandemic-driven shift to digital communications has demonstrated it is possible to maintain contacts while working from home, and people have adapted quickly. But, Robinson says, that will not spell the end of face-to-face conferences in the future.

“What I’m continually hearing is that people are sick of Zoom meetings and that it’s just not the same as in-person comms,” she says.

“Many a deal has been made in a bar after congress and this kind of social interaction plays a huge part of the business world. People like a good conference giveaway, and even the most seasoned travellers do still get a buzz from visiting a foreign country.

“Can we really imagine a world without face-to-face congresses? Without that personal networking touch? I, for one, hope they will not be lost to a virtual world.”

About the author

Amanda Barrell is a health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.

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2021 – The healthcare changes here to stay

2020 was the year that changed everything, and as the new year begins many are wondering what awaits the world in 2021. Impetus Digital co-founder and CEO Natalie Yeadon reflects on the last 12 months and shares her views on the healthcare, research and digital changes that could be here to stay.

I think it is fair to say that 2020 will not be particularly missed by anyone. Many started the year with big plans, whether for overseas trips, weddings, or industry events, and then the unthinkable happened. While the world first heard of the novel coronavirus in late 2019, it was not until 11 March 2020 that it was declared a global pandemic and it finally sank in just how serious of a threat it was. But how will the world continue to change in 2021?

Major global events

COVID-19 has amplified many of the issues that society was already facing. Although the pandemic has largely taken the media’s focus away from the climate crisis, it has given us a preview of what is to come if we do not stop exploiting the planet and our wildlife. Indeed, 2020 brought new record forest fires and extreme weather events.

In addition, 2020 was the year where social justice (not least in the form of Black Lives Matter protests) was brought into focus. Racial discrimination and bias were also uncovered in healthcare, with stark differences in COVID-19 rates and mortality between different ethnicities in many countries.

COVID-19 has widened the already large class divides seen between white-collar and service workers, with the former typically having the option of working from home and taking the recommended social distancing precautions. Conversely, the latter group is largely being forced to carry on with their work with little protection and low compensation, if they even have a job to go to after many smaller businesses closed their doors.

Public health has been politicised

Somehow, in 2020, wearing a mask to prevent the spread of a highly contagious disease became a controversial and political issue. People were asked to stay home, watch Netflix, and bake sourdough bread to protect those who are vulnerable, yet photos of packed bars and sports stadiums soon emerged and anti-masking protests were held across the world.

Epidemiologists, researchers, and clinicians are now household names, with people like Dr Anthony Fauci and Sweden’s Anders Tegnell drawing their fair share of both praise and criticism domestically and internationally. Countries’ strategies to contain the spread of the virus have been debated and criticised, and it will likely be years before we will be able to say which approaches were “right” and “wrong”.

“On the upside, the pandemic has brought enhanced focus to mental health issues and innovative approaches on how to best address these. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma around mental health can be lifted and better treatment strategies can emerge”

Mental health focus

The secondary effects on mental health during the pandemic are vast. We are already seeing increased rates of depression and anxiety because of the pandemic, and there are no signs of this slowing down. Women are especially impacted, disproportionately having to take on childcare or home-schooling compared to their male counterparts.

On the upside, the pandemic has brought enhanced focus to these issues and innovative approaches on how to best address mental health. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma can be lifted and better treatment strategies can emerge.

United global research

Another positive note is that the pandemic has accelerated laboratory and clinical trial collaboration far beyond what has ever been seen before. From the onset of the pandemic, scientists have been openly sharing their data with investigators from other centres or countries. It has also shown that the time it takes to get a drug to market can be substantially reduced when there is enough funding and political will. How this will affect clinical trials and regulatory approvals in the future remains to be seen, but there is reason to be optimistic.

Healthcare goes virtual

Before 2020, telehealth appointments were few and far between, with many clinics not set up for these services. Since then, the growth of telemedicine has been exponential. Another aspect of healthcare that has had to adapt is the way we monitor chronic conditions. Older patients or those with co-morbidities are at higher risk of severe COVID-19, so frequent clinic visits for routine blood pressure measurements are not always feasible. As a result, we have seen a dramatic increase in the interest and uptake of remote monitoring devices such as wearables and mobile health apps. I predict that this is just the beginning of healthcare’s virtualisation and am excited to see what the new year has in store.

Remote work is the future

Another major change in 2020 was of course the sudden move to remote work. For many, it was a 180-degree shift from business as usual. Interestingly, in a Canadian survey, the majority of respondents (55%) expected at least some of the workforce to remain remote in a substantial way after the pandemic is over, while only 17% expected all staff to be onsite five days a week. Further, major companies like Twitter have announced that employees will be able to work from home permanently, signalling a clear change in the way that we do work. While not without challenges, I see remote work becoming a mainstay due to its greater flexibility and convenience for workers.

Virtual events are rapidly improving

Finally, the ways that pharmaceutical and scientific communities attend meetings and events completely changed in 2020. Virtual meetings such as advisory boards and steering committees were already popular before this year but were often accompanied by in-person meetings. We have now seen without a doubt that it is possible to meet the same objectives virtually, often more effectively and at a lower cost.

The biggest change, however, is the way we now attend larger events such as conferences, congresses, and medical education events. There is no shortage of online conference solutions available, but there is still much to improve on. For example, some aspects of in-person events are not always there or are poor substitutes for the real thing.

Ideally, virtual event platforms should be comprehensive so that everything you need is in the same place. The layout, branding, and inclusions should be completely customisable to your needs, and it should come with all aspects of in-person events such as networking, breakout workshops, exhibitor booths, and poster sessions. The good news is that these types of platforms are getting better by the day, and so are the virtual events that they host.

What have we learned from the last year?

The past 12 months have shown that firstly, we live in a highly polarised world where science and public health are up for debate. Secondly, crisis leads to innovation and finally digital health technologies are the future with remote work and virtual meetings here to stay.

Wishing you all a safe, happy, and healthy 2021.

About the author

Natalie YeadonNatalie Yeadon is the CEO and co-founder of Impetus Digital, where she helps life science clients virtualise their meetings and events and create authentic relationships with their customers.

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Nine for 2021: The COVID-19 legacy

In the first of a two part series, IQVIA’s Sarah Rickwood covers nine key trends and events that will affect the global healthcare and pharmaceutical industries in 2021.

One bright spot in an otherwise dreadful year: the pharmaceutical industry has discovered it can do things it never dreamed possible. Anyone who proposed that a novel, deadly virus would spread, with a vaccine developed demonstrating 95% efficacy, and approved for patients in less than a year would have been scoffed at.

If they had also predicted that the second person to receive the vaccine out of trial would be a gentleman named William Shakespeare, they would certainly have been dismissed as a fantasist. Yet these things have happened. The pharmaceutical industry has been through extraordinary times, and responded magnificently.

2021 will of course be a year of aftermath as the world resolves the COVID-19 infection crisis. It will also be a year of challenge, because the healthcare system crisis and the economic crisis triggered by the COVID-19 infection crisis will last longer than the infection crisis which caused them. It will also be a year of opportunity: trends which existed pre-COVID-19 have been accelerated by the changes wrought by the pandemic, and events and trends unaffected by COVID-19 will come to fruition in 2021.

“This may mean a change in patient journeys to pharmacotherapy becoming longer and more complex, but also occurring in different settings”

With the roll out of vaccination across population tiers, starting with the most vulnerable, there will be a progressive reduction in social distancing and pandemic imposed restrictions, but since vaccination will necessarily take time and different countries will move at different rates, it is unrealistic to expect that the restrictions of 2020 will rapidly disappear.

The crises that the pandemic has triggered will also become much more apparent in 2021 as the infection crisis recedes. These are the crisis of healthcare system capacity and non COVID-19 patient backlog, and the economic crisis, still largely to come in impact, which will constrain healthcare spend, both public and private, across countries and have knock-on impacts for medicines spend. These crises will provide the backdrop to both 2021 and the years beyond, and the nine trends that we will discuss must, of course, be viewed in their context, but we will focus on trends of opportunity and positive change for healthcare and the pharmaceutical industry.

Healthcare systems reconfigure

Around the world, the infection crisis put healthcare systems into shock. The prospect of overwhelming hospital ICU capacity was the primary driver of lockdowns, as governments sought to “flatten the curve” and manage infections. Certain countries were also forced to respond by building new capacity-dedicated facilities for severe COVID-19 patients, like the largely unused “Nightingale” hospitals in the UK.

All countries also created capacity within the existing hospital provision by cancelling elective surgeries and non-urgent hospital treatment. Where treatment continued, such as in cancer cases, it was where possible, shifted to a homecare setting, creating a rapid and substantial shift of care from hospital and into primary care and homecare. Primary care itself saw significant reconfiguration- for many patients, routine consultations became virtual- although not necessarily all digital or telemedicine as might be conceived by innovators.

Healthcare systems ended 2020 in a very different place to where they were in 2019, with hospital capacity (and hospital finances) challenges. These changes are likely to reduce only slowly in the Vaccine+ environment, and will not be entirely reversed.

For pharmaceutical companies there are a number of implications. As face to face visits with healthcare professionals declined, so did new diagnoses and new treatment starts, and also evaluations of current patients and switching of treatments. This has built a backlog of non COVID-19 patients in the system, patients who have either not seen treatment, or whose treatment has been delayed or sub-optimal. It varies by country and by therapy area, but is pervasively present, and its consequences play out both now and long into the future. In the near term, launch products, which rely for establishment on new and switch patient opportunities, have, with a few notable exceptions, had a dreadful year.

In the long term, the health impact of delayed or absent treatment for patients could play out as more severe or advanced disease presentation, higher co-morbidities and even earlier deaths. It will take a decade to fully evaluate the true impact.

For pharmaceutical companies, this may mean a change in patient journeys to pharmacotherapy becoming longer and more complex, but also occurring in different settings. Products which allowed patients to self-administer had a differential advantage which was quite variable before- in some cases it was an obvious advantage, in others the institutional inertia which promoted administration in facilities was slow to change. Now, the playing field is very clearly slanted toward self-administration as a consistently attractive advantage, with oral treatments (such as the oral migraine agents) clear winners.

Expect to see self-administration and oral presentations become a bigger factor in health technology assessment in the future.

The non COVID-19 patient backlog

The non COVID-19 patient backlog which has built across conditions and countries is something addressed in another in-depth article for pharmaphorum.

Throughout 2020, IQVIA data, both secondary and primary research pointed to often substantial share of non-COVID-19 patients receiving no, or suboptimal treatment. An IQVIA survey to Neurology, Cardiology, Rheumatology, Dermatology and Ophthalmologists in June 2020 across the lead five European countries showed an average of 30% of patients either “no shows” or still waiting for treatment that was delayed. IQVIA’s survey of oncologists and haematologists in the top 5 European countries on their experience of treating their cancer patients before and during the pandemic showed specialists reported their patient caseload fell to 41 patients a week (from 77/week pre-pandemic) at the height of the first wave of the pandemic. The June period, which coincided with lows of infection numbers in these countries, was little improved, at 50 patients/week, and as countries faced the second wave of infection in October, the number of patients reported seen per week had fallen back again, to 45.

“The real impact on submissions and approvals will be in 2021 and beyond, when the pandemic’s true impact on clinical trials becomes apparent”

In 2021, and beyond, addressing the patient backlog (and the consequences of failing to do so) will be an increasingly prominent healthcare topic, as the health impact for untreated, disengaged and sub-optimally treated patients becomes apparent. This will become especially acute with the COVID-19 vaccination roll-out, as this will engage health systems in a vaccination roll-out of unprecedented scale, whilst progressively removing the obstacles to re-engaging with care. We expect there will be a need for public information campaigns to encourage people to come forward for diagnosis and treatment of non-acute conditions which may simply have been tolerated during the pandemic.

The focus is likely to be on people who may have chronic, primary care treatable conditions, such as hypertension, dyslipidaemia, or early type II diabetes. There are also clear concerns, and some hard evidence, that mental health conditions have risen in number and existing conditions been exacerbated during the lockdown, most worryingly, among the healthcare professionals who are so vital to post-pandemic recovery.

In 2021, the pharmaceutical industry must play its role in supporting post-pandemic healthcare system recovery, creating specific plans against this issue, tailored to country and therapy area.

The post pandemic launch

A key commercial concern in the early days of the pandemic was the impact that it might have on innovative launch. Bringing the newest pharmacotherapies to market could be affected at multiple  levels – the approvals of new products by regulators, the availability of products in the commercial supply chain, access to new medicines evaluated and granted by payers, and then finally, the uptake and use of the product to its full potential.

New product approvals do not seem to have been adversely affected by the pandemic – as at the time of writing, the FDA has approved 48 novel drugs in 2020, matching the 48 medicines defined in the same way in 2019. The latest 2020 approval was Orladeyo for hereditary angioedema on 4 December, so there is potential for 2020’s approvals to exceed those of 2019. The EMA’s new medicines evaluation process seems similarly unaffected in 2020. This is encouraging but not unexpected; products approved in 2020 completed their trials and submitted their marketing authorisation applications prior to the pandemic. The real impact on submissions and approvals will be in 2021 and beyond, when the pandemic’s true impact on clinical trials becomes apparent.

Actual availability of approved medicines, as measured by IQVIA’s MIDAS data, is similarly unaffected in the US. In Europe the picture is more mixed- despite the single source of approvals from the EMA (including for the UK as 2020 is a transitional year). Actual availability of new medicines varies by country and falls below historical averages to August in Spain, and to a lesser extent the UK.

In Europe, health technology assessment (HTA) and payers granting access to products pose an additional barrier to launch uptake – so far IQVIA analysis of HTA concludes that whilst the pandemic had some impact on the volume of HTA activity, it has not yet changed the proportion of assessments that are positive or negative.

Ultimately, the real question is whether pandemic and post pandemic launches will fulfil their clinical and commercial potential. Global data on 2020 launch sales so far shows a challenging picture: a small number of launches have done well, solely because of their US sales. These strong launches include three with MIDAS sales of over $100m to August 2020, Ubrelvy and Nurtec, oral migraine agents both launched in February 2020 so prior to the first infection wave in the US, and Tepezza, the first and only approved treatment for the serious and rare condition, Thyroid Eye Disease (TED). The only other launch with significant global sales (again, from US sales) is a triple negative breast cancer treatment, Trodelvy. This and the remainder of the top 10 products by sales to August 2020 have made an average of $15m in global sales, as opposed to $33m for products of the same ranking in 2019.

2021 will therefore be a crunch year for post pandemic launch potential – focus will be on whether 2020 launches can accelerate sales and reach their expected pre-pandemic potential, and whether 2021 launches will experience the same challenges as those in 2020, given the environment will not be “pre pandemic” normal.

Price and value battleground

One key factor affecting innovative launch performance in 2021 will be the economic environment and healthcare system funding. Country GDPs fell an unprecedented amount in 2020, and whilst bounce back is inevitable in 2021 as lockdowns ease, the sums spent on managing the pandemic are huge, and economies are being re-shaped with unemployment sharply on the rise.

Healthcare and pharmaceutical industries generally weather economic downturns well, but there are features of this downturn which suggest particular challenge. The first is the combination of economic challenge with direct healthcare system challenge- stretched resources and the backlog of non COVID-19 patients. The second is the significantly reduced ability of healthcare systems to realise savings from existing pharmaceutical products going off patent. In 2009, $183m of global market value was due to go off patent in the next five years, in 2019, it was $200m. Similar gross figures, but the 2009 figure accounted for 30% of global market value, and 89% of the patent loss was small molecules. In 2019, the share of the market about to lose exclusivity has dropped to 19%, of which 44% is biologics.

From 2021 onwards, healthcare systems are going to be under considerably enhanced pressure to realise greater savings from biosimilars than ever before. Even if they do, however, their savings will be lower. They will need to control medicines spend elsewhere, and that means raising the bar for market access for innovation. We have already seen that the small number of pharmaceutical launches that did well in 2020 did so in the US market and represented either greater convenience and patient self-administration, or because they were unequivocally major steps forward for high unmet need patients.

Is it likely that in the price and value battleground, the distinction between winners and losers becomes much sharper in 2021, with evidence of clear, distinctive benefit more important than ever before. It is also possible that 2021 will see Europe start to fall back as the second market block for early launch return for innovative products, after the US.

Although separate to COVID-19, the UK’s departure from the EU takes it out of the EMA approval regime to become a clearly separate entity to the EU block. The market access lever is more heavily applied in Europe than the US. China and Japan, on the other hand, have come through the pandemic less heavily affected, and China is now approving innovative agents at historically unprecedented levels. Whilst the US will remain paramount for innovative launch, the East is on the rise.

Home healthcare and digital patients

While the technologies (and indeed the logic for) more home healthcare delivery and greater digital engagement existing prior to the pandemic, adoption has most certainly been accelerated vastly by it. 2021 will be the year where we understand where the new equilibrium will establish.

For example, in the US, weekly telehealth medical claims were up +800%, pre-pandemic vs Nov 2020, and building on its Mar 2020 capacity-increasing responses to COVID-19, in November the US CMS introduced the “Acute Hospital Care at Home” programme. However, on the other hand, some US private insurers have begun to roll back exemptions from out-of-pocket costs for non-COVID-19 related telehealth in response to high demand.

Self-administration & novel dosing regimes which free patient from clinic visits were definitely in the news in 2020. Merck, Sharpe and Dohme gained approval to halve its cancer immunotherapy (Keytruda) regimen to once per six weeks, reducing clinical visits by half with novel dosing, for example. Again, 2020 may have represented an acceleration of a pre-pandemic trend; IQVIA MIDAS data suggests spending CAGR 2015-20 for therapies suitable for self-administration was 13%, vs 7% for therapies which require hospital administration.

It’s not, of course, just self-administered pharmaceuticals which enable home healthcare – digital technologies enable home healthcare by allowing diagnosis, monitoring and patient engagement to happen at home. For example, UCB-Medisafe’s epilepsy portfolio digital companion will support patient engagement, and another US innovation, FDA approved platform including biosensor wearables and AI analytics powers Biofourmis’ [email protected] platform which has been rolled out nationally to help facilitate CMS’ “Acute Hospital Care at Home” program.

In the second article of “nine for 2021” we will look at the issues in 2021 which will directly impact pharma, including the permanent changes in pharma’s customer engagement model, the implications of a geographic re-balancing towards the East, CNS as the new value growth area for the 2020s, and the new biologics environment as biosimilars accelerate.

About the author

Sarah RickwoodSarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.

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How Big Data will accelerate the future of digital medicine in 2021

The pandemic has shed light on inefficiencies in healthcare systems, and provided an opportunity to adjust how we manage care in the future. Jennifer Haas, executive vice president of Noteworth, shares her 2021 predictions surrounding the future of telehealth and big data. 

Healthcare providers are grappling with the task of scaling digital care delivery operations for ambulatory patients in response to the cost dynamics of effectively treating large populations with limited resources, especially in a post-COVID-19 world. At the heart of this challenge is how to secure, aggregate, analyse, and action the data necessary to make proactive patient care decisions and diagnoses.

In the coming year, there will be a renewed focus on healthcare providers needing to shift their business models to highlight the new need to make healthcare accessible and effective, regardless of geography, location, and mobility.

This will need to be done while also engaging and empowering patients in their own wellness. A recent report highlighted that over 40% of US adults had delayed seeing a doctor during the pandemic. Powering digital medicine platforms with big data and IoT devices ensures clinicians receive access to the entire scope of a patient’s health information while reducing the need for in-person visits and improving patient outcomes.

The ability to use big data in healthcare through digital medicine will prove to be invaluable for healthcare organisations as they work through the pandemic and the new world it has created. Having access to relevant data through digital medicine is helpful because it provides more opportunities for proactive intervention and a more accurate view of the patients’ health with consolidated real-time information.

“Another key benefit to big data incorporated into digital medicine platforms is the healthcare providers’ ability to connect with healthcare apps to track and monitor patient health”

When it comes to digital medicine, big data can improve communication and strengthen relationships between patients and their various healthcare providers.  This is largely because the use of digital medicine platforms feel much more comfortable and personalised for many patients. It not only allows them to take a more active approach in their own healthcare, but gives them access to their clinicians more freely and frequently.  It also allows the care team to be much more connected to the patients’ day to day progress and highlights potential intervention needs before they become critical.  Risk modeling and stratification will continue to evolve, allowing clinicians to collaborate with AI and Big Data to make more accurate predictions of where a patient’s health is trending.

One of the focuses of digital medicine is remote patient monitoring. This technology is especially helpful during the current pandemic as it gives providers the information needed in order to track the patient’s health statuses and react quickly when a patient has an urgent need for proactive care. Remote patient monitoring can alert patients and their healthcare teams when intervention, including seeking in-person medical attention on a scheduled or emergency basis, is needed. Having this data is vital to the future of how patients and their healthcare providers work together. By combining the power of big data within healthcare, digital medicine platforms can help reduce the number of unnecessary visits patients take to the doctor or hospital and alert providers, caregivers, and patients when their status requires in-person care.

Another key benefit to big data incorporated into digital medicine platforms is the healthcare providers’ ability to connect with healthcare apps to track and monitor patient health. As we see within numerous apps or smartphones, they allow users to track health factors such as physical activity, heart rate, breathing rate, and diet. These data points can be transmitted directly to a doctor and be factored into any treatment decisions. Being able to bring this data together creates more insight into a patient’s preventive and personalised care.

The benefits of big data analytics range across the board in healthcare. Most, if not all, healthcare sectors stand to benefit from the implementation of big data analytics within digital medicine. The providers (hospitals or private practices) will be able to provide better care to their patients to make more accurate data-driven decisions more efficiently.  The biggest winner will be the patients themselves who can utilise telemedicine and remote patient monitoring to their advantage in order to enjoy more flexible and convenient access to care which in turn helps them to live healthier lives.

The COVID-19 pandemic has pushed the once-niche telemedicine industry into the mainstream, creating a lasting shift in care delivery. In 2021 and beyond, we will see the healthcare industry shift even more towards digital medicine, specifically AI and risk stratification modeling.

If 2020 has taught the healthcare industry anything, it is that patients want choices and control over their own healthcare.  Healthcare providers and insurers need to listen. Leveraging digital medicine platforms allows providers the ability to draw on the desire for personalized, proactive care by utilising actionable data to proactively monitor a patient’s health status between visits while driving down care costs and improving patient outcomes.

About the author 

Jennifer Haas is executive vice president of sales for Noteworth, where she leads sales, channel partnerships, business development, marketing and social media including profit and loss management.

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PharmaShots Wishes you a Merry Christmas and a Happy New Year

Shots:

  • Thank you for your overwhelming affection and support throughout the year. This year we achieved a massive increase in subscribers
  • PharmaShots mobile app is ready and we planned to launch our PharmaShots mobile app in January 2021
  • May this holiday season fills your life with happiness and wealth. Wish you a Merry Christmas and a Happy New Year 2021!

Ref: PharmaShots | Image: Canva

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AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Shots:

  • AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution throughout the region
  • The price for the vaccine is not final but it is expected not to exceed $4/ dose. The vaccine will initially supply to all Latin American countries except Brazil
  • The clinical trial conducted in the US, South Africa, England, and Brazil is expected to be completed in Nov or Dec’2020, after which the company would seek approvals. If approved, AstraZeneca will transfer technology to Argentina’s INSUD Group and Mexico’s Laboratorios Liomont at the end of the year and begin manufacturing in Q1’21

Click here ­to­ read full press release/ article | Ref: Reuters | Image: Bloomberg

Related News: AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19