1、White Paper Rising to The Challenge: Five key focus areas for Life Sciences during and after the COVID-19 pandemic SARAH RICKWOOD, Vice President, European Marketing and Thought Leadership, IQVIA Table of contents Introduction 3 Five key focus areas 4 Medicines demand and supply 4 Clinical trials an

2、d regulatory engagement 8 Engagement with healthcare professionals 8 Innovation and launch 8 Mapping out the strategic implications for medium and longer term continuity 12 Acknowledgment 13 References 14 About the author 15 | 3 The spread of COVID-19 has created a global healthcare crisis, and has

3、led to an unprecedented response from people, communities and systems. Healthcare workers on the front lines are giving it their all to contain, treat and reduce the impact of this pandemic. The pharmaceutical and life science industry has risen to the challenge by rapidly mobilising to join the fig

4、ht against the virus. Their support extends beyond the development of treatments and vaccines for COVID-19; across countries we have seen offers of people, expertise, and financial support to the healthcare systems they partner with. In any fast moving, uncertain situation such as the COVID-19 pande

5、mic, any article or white paper comes with a practical warning - as the situation changes, so too will insights and perspectives. This paper is therefore based on the evidence in hand as of the end of March 2020. Introduction 4 | Rising to The Challenge This feels like an immediate crisis only. It i

6、snt. The challenge of COVID-19 for pharmaceutical and life sciences industries is that nothing and no country can nor should be viewed in isolation. While it is true that there are acute scenarios at the country level that occupy our immediate attention, the long-term consequences are starting to be

7、come apparent. Fighting COVID-19 is the top priority, but adjusting to a new reality is a close second. In fact, it is entirely possible that in some ways, the pharmaceutical industry will never return to the pre- COVID-19 normal. This is why, in thinking about COVID-19, we need to think both fast a

8、nd slow: clearly theres a huge amount coming at us every day in terms of addressing the immediate crisis. But this “fog of war” must not prevent us from thinking about the longer term implications for healthcare systems and our industry. This white paper will cover five key focus areas for pharmaceu

9、tical companies as they address COVID-19. For now, the focus is on illuminating the immediate levers of pharma market movement, though long term hypotheses are also raised. 1. Supply and demand 2. Pressure on regulators; 3. Change in interactions between pharma and Healthcare Professionals; 4. Globa

10、l interconnectedness of active pharmaceutical ingredient (API) and generics manufacturing; 5. Launch schedules, and other longer term impacts. Focus 1: Medicines demand and supply The COVID-19 pandemic has actual and potential impacts on medicines manufacturing, supply and demand. Decisions pharmace

11、utical companies must make in these early days will be about the manufacturing and sourcing of medicines, addressing demand and managing supply. At the time of writing, European countries are generally not reporting significant or concerning shortages linked to COVID-19, and in the US the FDA has re

12、-emphasised its requirement for manufacturers to communicate on any anticipated supply disruptions. In both administrations, of course, there were shortages reported for products prior and unrelated to COVID-19, but everyone is aware of the possibility caused by exceptional changes in both demand an

13、d supply, and all have initiated plans to monitor and address the situation, including for some countries, export bans, changes in regulations covering distribution, and auditing of the distribution system. MEDICINES AND ACTIVE PHARMACEUTICAL INGREDIENT SUPPLY The global pharmaceutical industry has

14、become far more integrated in terms of Active Pharmaceutical Ingredients (APIs) and finished medicines manufacturing, and supply for the high volume medicines which treat the majority of patients over the past decade. The COVID-19 pandemic has therefore unsurprisingly raised concerns about the resil

15、ience (and vulnerability) of such a highly interdependent network as waves of countries are affected by the virus. China is a significant and growing API supplier, and those APIs make their way into generics which supply the European and US markets, among others. In China, pharma is fortunate that A

16、PI manufacturers tend to be located on the coast, away from the epicentre of the COVID-19 infections, and manufacturing is expected to be resilient. Equally, Indian generics manufacturers, often dependent on | 5 Chinese APIs, do have substantial stockpiles, although India did restrict the export of

17、certain molecules on the 3rd March, a restriction the authorities emphasised was intended to be temporary1. South Korea, a major centre for biosimilar manufacturing and a country that was affected early by the pandemic, has not, according to our research, seen factory closures. List of India restric

18、ted export 26 products (14 molecules), now includes Hydroxychloroquine prohibition as of 25/03 https:/dgft.gov.in/sites/ default/files/Noti%2050_0.pdf Figure 1: Generic/API supply chain across countries Global interdependency has grown significantly; and this increases fragility in COVID-19 crisis A

19、PIsAPIs APIs China Pharmaceutical, chemical and electronics industries have recovered to 70% of original capacity Biosimilars Korea No impact so far on biosimilars India 14 molecules restricted export * 12 weeks stocks held India lockdown has potential to impact Generics Biosimilars not flagged as b

20、eing impacted. Major Korean producers operating at full capacity Chinese API manufacturers based in less affected provinces Reportedly 70% of Chinese API for Indian manufacturers sourced from China Asia most exposed to Chinese products EU sees “limited immediate risk” due to stockpiling* US manufact

21、ures some APIs in the US. In August 2019 13% of API facilities supplying the US were based in China The potential for impact exists, but could be mitigated 6 | Rising to The Challenge MEDICINES DEMAND The refocus of healthcare systems to managing the immediate COVID-19 crisis, combined with lockdown

22、s and social distancing, fundamentally means a reduction in routine healthcare system contacts. In the US, this has already resulted in longer prescriptions in retail pharmacies, according to IQVIA daily prescription data, in terms of number of days of prescription so renewals need to be more infreq

23、uent and this trend is also seen in other countries. However, in the medium term of the next 3 months, treatments for chronic illness, especially chronic asymptomatic illnesses, could see falls in treatment initiation and switch because these require healthcare professional intervention, which most

24、commonly would have happened face to face. Ironically, this may be concurrent with a rise in repeat prescriptions as patients stock up in anticipation of isolation. In either scenario, changes in how medicines are prescribed and dispensed may need to be taken. In the US we already see a switch to lo

25、nger term repeat Rxs, for example. The result will be a drop in the share of major chronic medication markets that is dynamic ( i.e. new or switched prescriptions). Pharmaceutical companies will need to monitor if this happens and find ways to re-ignite the dynamic market should it contract. Demand

26、challenges fall into three main groups: Primary demand: products managing infection control (e.g. face masks, hand hygiene, disinfectant, and other disposable paper items and surgical devices). These items have already seen hundred fold increases in demand over the previous period in 2019, for examp

27、le, in Italy in February. There is also primary demand for treatments for fever such as paracetamol and other anti-pyretics. In the UK, paracetamol has seen volume changes in the week commencing 9th March of +91% versus the 2020 average. Adjacent to primary demand: treatments associated with respira

28、tory infections such as antibiotics (even though the main culprit is a virus), and asthma and other respiratory medications. Beclometasone and salbutamol, both asthma treatments, each saw UK increases in volume in the week commencing the 9th March of 27% and 23% respectively. These movements could w

29、ell be driven by asthmatics, aware they are more at risk from getting very sick from COVID-19, stocking up on vital medicines so they do not have to visit health facilities. Other stocking up effects are possible, where patients are on chronic medications for long term conditions, such as diabetes o

30、r cardiovascular patients anticipating isolation or reluctant to visit healthcare facilities. So far, global supply chains seem to be resilient, but the threat remains, and close attention must be paid to supply and demand in the coming weeks and throughout 2020, as knock-on downstream effects are p

31、ossible. Potential treatments (separate from vaccines), all currently unlicensed for use in the treatment of COVID-19, could also see movement. There are multiple molecules, all currently unlicensed for this indication, which have been discussed as possible treatments for COVID-19. Some of these are

32、 on the market across multiple countries, some only in a few and some are developmental and have not been authorised for any purpose. Potential candidates for treatment will undoubtedly change, and rapidly, with some under consideration already failing in trials, and new ones being considered. The W

33、HO publishes a regularly updated landscape of pharmacotherapies under consideration2. These include generics; corticosteroids (which were also used to treat SARS and MERS); chloroquine, indicated for malaria; antivirals, mostly currently used for HIV but also broad spectrum antivirals; immunological

34、 treatments, including MAbs for RA; JAK kinase inhibitors and Avastin; interferons alpha and beta; and others, including Gilenya, a multiple sclerosis medication. Some of the immunological and interferon treatments are also available in biosimilar form. | 7 PREVENTION ChannelDynamics 29/03/2020; F2F

35、 includes detailing and meetings, Remote includes phone detailing, e-detailing (live+automated), postal all aspects of launch plans will need to be reviewed and potentially modified. It is likely to take a long time, even into 2021, for healthcare systems to recover, and some dimensions may be perma

36、nently changed. CASE STUDY: In Italy, equipment first; information second. Between the 14th and the 16th of March 2020, IQVIA Italy was privileged to be able to interview over 1,000 Italian physicians, both specialists and general practitioners, to ask them whether they still wanted engagement and s

37、upport from pharmaceutical companies during the COVID-19 crisis and if so, what type of support and information they required. The results were clear over 80% of doctors still wanted engagement and interaction with pharmaceutical companies during the COVID-19 crisis, stating that maintaining an onli

38、ne/remote interaction was “important”. The nature of the remote engagement healthcare professionals are seeking, and the content and support they require, is important. Healthcare professionals are requesting practical support that will help them to do their job safely and effectively in the immedia

39、te crisis: first, protective equipment, second, information (scientific updates and information in real time, on symptoms, diagnosis and drugs, centers for treatment, management of complex cases, and communications on the healthcare situation). They want information in a rapid, time efficient format

40、: email and WhatsApp messaging is preferred. What was striking about HCP response was the expression of appreciation for pharmaceutical companies who were engaged and present for them during the crisis. In the medium-long term, healthcare professionals are looking for pharmaceutical company support

41、in remote patient management, something which could be a feature of the post COVID-19 healthcare environment for some time. This includes exploring medicines delivery, and tele- and e-health solutions. Over 80% of doctors still wanted engagement and interaction with pharmaceutical companies during t

42、he COVID-19 crisis | 11 The most obvious change is likely to be the continuation of remote engagement with healthcare professionals in both promotional and non promotional situations. For promotions, including launch promotions, the importance of remote engagement was already established and growing

43、. Already in 2018, the most commercially successful launches in the seven major country markets (which account for almost 90% of the first five years of launch sales) were also the most digital, as defined by the makeup of the first years promotional activity8. Post COVID-19 launch planning should a

44、nticipate further changes in engagement with healthcare professionals, likely with not only more use of digital channels, but also changed expectations of which channels and types of content. Asking healthcare professionals about their changed engagement preference and responding to their feedback w

45、ith adjustments will be important. Planning for non promotional medical affairs engagement, which in a highly specialised world is increasingly important, will also need to be a priority. Outside of promotions, other launch activities will certainly see shifts. Market access discussions for post- CO

46、VID launches will be conducted in the new context of healthcare systems which have seen huge calls on resource and budget. Even with substantial emergency funding specific to COVID-19, other areas of funding may be weakened. The value healthcare systems place on the benefits of new launches may chan

47、ge; for example, greater value will likely be placed on products with the potential to keep patients away from visiting hospitals (i.e. sub-cut as opposed to iv, or applications that reduce the number of face to face interactions, such as smart delivery devices). Figure 4: COVID-19 is impacting the

48、ongoing and planned clinical trials of both major and smaller pharma companies Number of other pharma companies (n=24) Number of top 20 pharma companies 0 10 20 30 10 0 1 7 4 9 6 77 0 2 4 6 8 10 Ongoing trials impactedNew trials impacted YesNoUnknown Number of other pharma companies (n=24) Number of

49、 top 20 pharma companies 0 10 20 30 10 0 1 36 40 Ongoing trials impactedNew trials impacted 0 2 4 6 8 10 Ongoing trials impactedNew trials impacted YesNoYesNo Top 20 pharma companies are focusing on delaying the start of new trials rather than interrupting ongoing trials. Companies are often citing the welfare of trial p