THE IMPACT OF COVID-19 ON PATIENT ACCESS TO CANCER CARE IN EUROPE - ADDENDUM - MAY 2021 - EFPIA
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A message of thanks to all healthcare professionals It is important to recognise that the negative The publication has impact of COVID-19 on cancer patients and their explicit endorsement access to care as described in this report could from the following have been much worse. The fact we were able organisations: to mitigate this impact is due to the hard work and sacrifices of healthcare professionals across Europe. We would like to express our gratitude to all the people who worked so tirelessly to ensure access to healthcare to all patients, including cancer patients, during the pandemic. Colophon Copyright © 2021 Vintura. Authors: Christel Jansen and Bas Amesz, Vintura Design and illustrations: Juliette Moulen, Rippel Original design: Hague Corporate Affairs. Text editor: Justin Steed Citation: Vintura, 2021. Every day counts – The impact of COVID-19 on patient access to cancer care in Europe. This report was commissioned and financed by EFPIA. 2 Colophon 3
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe About this report This report is a follow-up to the report “Every Every Day Counts was published when European The aim of this publication is to offer a technology assessment (HTA) bodies, healthcare Day Counts - Improving Time to Patient countries had passed the first peak of the comprehensive overview of the detrimental professional associations, patient organisations, Access to Innovative Oncology Therapies pandemic and restriction measures were being impact of COVID-19 on cancer patients and their policy makers, payers and biopharmaceutical in Europe”. Following a multi-stakeholder eased. But in the meantime, all stakeholders access to care, and to generate key learnings companies. collaboration during 2019 and early 2020, the had experienced the impact of COVID-19 on which can make cancer care delivery more report established a collective understanding access to cancer care during the first wave of resilient to disruptions and more sustainable in The project was initiated and financed by the of causes of delays in patient access to new the pandemic. With the second wave underway, the post-pandemic world. EFPIA Oncology Platform (EOP). The EOP is cancer treatments across Europe. It also many of the participating organisations involved a collaboration between 18 companies from suggested solution areas with the potential to in the development of the initial report proposed This publication is the result of a review of the research-based pharmaceutical industry reduce time to patient access. It was produced this addendum “Every Day Counts - The impact grey and academic literature. Findings were in Europe. It was launched in 2016 and aims by the European Federation of Pharmaceutical of COVID-19 on patient access to oncology care complemented, reviewed, and validated by the to combine forces to improve cancer patient Industries and Associations (EFPIA). in Europe”. European Multi-Stakeholder Sounding Board outcomes across the region. group, comprising representatives from health Just as the report was being readied for Though the COVID-19 pandemic has been publication, the World Health Organisation an extremely challenging time for healthcare began to consider Europe as the active centre systems and patient access to oncology care, it of the COVID-19 pandemic. By mid-March 2020, has forced healthcare practitioners to examine more than 250 million people in Europe were in how they can best deliver care in a changed “The fact a disease can be managed collaboratively, lockdown. environment, and many of the learnings will be useful even after the pandemic has passed. rationally, and systematically is something we have never experienced.” - Member of the EOP European Multi-Stakeholder Sounding Board 4 About this report About this report 5
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe with an increase in the risk of death of between 6 and 13%, depending on the type of cancer. Delays of up to twelve weeks, unsurprisingly, further increase the risk (Hanna et al., 2020). In breast cancer, an eight- It is likely there will be further disruptions to week delay in surgery health service delivery, whether in the form of future short-term shocks due to new COVID increases the risk of death by mutations or pandemics, or less obvious 17%, while a 12-week delay sustainability issues such as the alarming (and increasing) shortage of health personnel increases the risk by 26%. available to care for Europe’s ageing population. Executive summary (Hanna et al., 2020) The true challenge is to look beyond the current crisis and use learning opportunities from the COVID-19 pandemic to make healthcare systems fit for the future. “The COVID-19 pandemic has severely impacted cancer care by disrupting prevention and treatment, delaying Figure 1 diagnosis and vaccination, and affecting access to The journey of any new treatment goes through four main stages: R&D, Marketing Authorisation, Market Access and Patient Access. All these stages have been impacted by COVID-19. medicines. The number of cancer diagnoses has decreased since the onset of the pandemic, suggesting a future increase in cases.” Global European National Local Research and Marketing Market Patient - Europe’s Beating Cancer Plan (European Commission, 2021) development Authorisation Access Access COVID-19 has had a significant impact on For cancer patients this has meant additional patient access to cancer care. A surge of COVID hurdles to accessing cancer care, on top of patients has overloaded healthcare systems factors that were already delaying patient A new treatment goes A European Marketing Market Access Once reimbursed, worldwide, disrupting routine treatment of access in oncology prior to the pandemic through a process of Authorisation is granted is granted after innovations must cancer patients (Saini et al., 2020). Disruptions (Vintura, 2020). ten years of research when the European healthcare be prescribed at and development Medicine Agency (EMA) authorities make a the right time to the have also occurred in several patient access (R&D) on average, positively evaluated positive decision patients for whom milestones including Research & Development The seriousness of this threat was made clear including pre-clinical quality, safety, and regarding the they are intended, and (R&D), Marketing Authorisation, Market Access in November 2020, when researchers quantified development and clinical efficacy. reimbursement of oncology services clinical trials. a new oncology should be accessible and Patient Access to innovative cancer the effect of COVID-19-related delays in cancer therapy and agree to these patients. therapies (see Figure 1). These disruptions are treatment on the risk of death. They found that upon a price. discussed in this report. a treatment delay of four weeks is associated 6 Executive summary 7
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe This multi-stakeholder report captures learnings negative impact of the pandemic for the key from researchers, government agencies, patient access milestones that formed the basis pharmaceutical companies, professional of the report “Every Day Counts - Improving societies, and patient organisations regarding Time to Patient Access to Innovative Oncology the impact of COVID-19 on the accessibility Therapies in Europe” (see Figure 2). of cancer care in Europe. It focuses on the Figure 2 As described in this report, COVID-19 has had a detrimental impact on every access milestone. Screening & Diagnosis • Screening programmes for early detection of cancer have been suspended • Patients experiencing symptoms have visited primary care services less often • Doctors have referred fewer patients for Market further examination Research and Access • Hospital diagnostic capacity has been development (R&D) reduced • The health technology assessment (HTA) process has slowed • Clinical trials have been delayed or • Assessment and reimbursement put on hold of non-COVID therapies have been • Clinical trial outcomes have been deprioritised compromised • Downward pressure on budgets for • Charitable research funds have been innovative therapies is expected to reduced and private equity funds are increase Treatment & Follow-up expected to decrease • Patients are less likely to visit the hospital • The scientific evaluation for their cancer care and marketing authorisation • Doctors have had to make new trade-offs process has slowed between the risks and benefits of cancer treatment Marketing • Availability of healthcare personnel has Authorisation been limited Patient • Resources for blood transfusion and Access surgical care have been in short supply 8 9
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe As well as outlining the negative impacts of into recommendations as to how European Some of these recommendations are not new. necessary momentum to rethink best practices COVID-19 on European cancer care, this report healthcare systems can better recover and Many of the changes required to make European and implement learnings generated during the also captures positive developments which adapt to minimise both access delays for today’s health systems more sustainable have been pandemic. Now is the time to prioritise these should be maintained rather than going back cancer patients, and the impact of future crises known for years. Making them happen, recommendations, in order to make lasting to the old normal. These have been translated on tomorrow’s cancer patients (see Figure 3). however, is both a difficult and lengthy process changes which can strengthen patient access (Braithwaite, 2018). COVID-19 has provided the to cancer care throughout Europe. Figure 3 Stakeholders identified six key recommendations for European health systems to recover from COVID-19 disruption, while becoming better able to deal with future shocks. 3. Continue the intensified European Continue the adoption of digital 4. collaboration in clinical assessment health to increase remote care and to use scarce HTA resources more use healthcare resources more efficiently after the pandemic efficiently after the pandemic 2. Maintain the proven agility of Maintain and build adaptive surge 5. R&D and Marketing Authorisation capacity to be ready for future processes disruptions to cancer care Safeguard cancer budgets Clear the cancer backlog 6. 1. as a critical enabler for now, using innovative improving continuity, practices which emerged efficiency, and sustainability during the pandemic of cancer care 10 Executive summary Executive summary 11
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe 1. Clear the cancer backlog • Reducing the frequency of administering 4. Continue the adoption 5. Maintain and build now, using innovative infusions through an adjusted dosing of digital health to increase adaptive surge capacity scheme practices which emerged remote care and use to be ready for future • Mailing oral cancer drugs to patients’ during the pandemic homes healthcare resources disruptions to cancer care • Piloting devices which allow patients to more efficiently after the Clear the cancer screening backlog using the draw their own blood pandemic A structural scaling up of resources to respond following practices, which emerged during the • Increasing usage of telemedicine and digital to future surges in demand may not be possible pandemic: tools to monitor patients and collect data Digital health and remote care have an enormous or efficient. Flexible and agile practices that • Strengthening collaborations between potential for increasing patient satisfaction and emerged during the pandemic can be used to • Infrastructure for COVID-19 testing and pharmaceutical companies, clinical allocating hospital resources in a more efficient maintain and build adaptive surge capacity: vaccination (e.g. drive-in centres) trial sites and regulators to streamline way. • Public-private partnerships to offer trial design and approval through rolling • EMA dedicated taskforces to ensure rapid additional cancer screening sites regulatory reviews • Cancer drug prescriptions can be made evaluations of COVID-19 vaccines and • The use of e.g. “teledermatology” as a online safeguard non-COVID-19 activities screening tool • Some medical treatments, especially • COVID-free cancer centres 3. Continue the intensified oral and subcutaneous treatments, can • Temporary field hospitals Clear the cancer treatment backlog using the European collaboration be delivered to community pharmacies • Hospital (cross-border) collaboration following practices which emerged during the in clinical assessment to or patients’ homes, and can even be • Pool of reserve healthcare staff pandemic: use scarce HTA resources administered at home • Changes in the health worker skill mix more efficiently after the • Blood testing can be performed at home or • Dedicated specialist taskforces to clear closer to home pandemic backlogs • Some follow-ups can also be transferred 6. Safeguard cancer budgets • Virtual multi-disciplinary team meetings away from the traditional hospital setting as a critical enabler for to reduce demands on staff and hospital Increased European HTA collaboration in clinical improving continuity, capacity assessments would speed up patient access. It Telehealth is an important facilitator in moving • Optimised treatment schedules to avoid would also reduce the duplication of efforts and these forms of cancer care from the hospital to efficiency, and sustainability hospital visits allow for more efficient use of scarce human home. Patient organisations can play a key role of cancer care • Collaboration within regional care networks and financial resources in a post-COVID era. in remote counselling. Implementing new, more efficient ways of delivering remote cancer care One key learning from the crisis is that investing • The COVID-19 pandemic and related will require better research and co-operation, in strong and resilient health systems is crucial 2. Maintain the proven vaccine development have clearly shown appropriate regulatory and reimbursement to mitigate the impact of external shocks on agility of R&D and joint clinical assessments are possible frameworks, and recognition and funding of the wider economy. Countries should invest in patient organisations. innovation that can lead to more efficient health Marketing Authorisation The lessons learned should be considered in the systems. Several learnings from 2020 and early processes European Proposal for a Regulation on Health 2021 could help in this regard, as described in Technology Assessment, which is currently this report. A key prerequisite of using these Maintain innovations in R&D, such as: being discussed. learnings to improve cancer care is to safeguard and optimise the use of healthcare and cancer • Signing consent forms electronically and care budgets. remotely 12 Executive summary Executive summary 13
Every day counts - The impact of COVID19 on patient access to cancer care in Europe TABLE OF CONTENT Colophon 2 Six recommendations for improving patient access to oncology care 36 A message of thanks to all healthcare professionals 2 1. Clear the cancer backlog now, using innovative practices that emerged 38 during the pandemic About this report 4 2. Maintain the proven agility of R&D and Marketing Authorisation processes 40 Executive summary 6 3. Continue the intensified European collaboration in clinical assessment to 42 Table of content 14 use scarce HTA resources more efficiently after the pandemic Introduction 16 4. Continue the adoption of digital health to increase remote care and use 44 COVID-19 has had a detrimental impact on access to cancer care 20 healthcare resources more efficiently after the pandemic Research and development 22 5. Maintain and build adaptive surge capacity to be ready for future 46 disruptions to cancer care Marketing Authorisation 24 6. Safeguard cancer budgets as a critical en-abler for improving continuity, 48 Market Access 25 efficiency, and sustainability of cancer care Patient Access 27 Contributors 50 Screening & Diagnosis 27 Reference 52 Treatment & Follow-up 31 14 Executive Table of summary content Table of content 15
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe Introduction COVID-19 has had an unprecedented impact on to prevent disease and avoidable mortality has A significant negative impact obstacles – which will be described in the next European health systems. By 10 March 2021, 2.6 been put under strain by the pandemic. In 2020 on outcomes for cancer chapter – are in addition to existing access million COVID-19 deaths had been reported to and early 2021, European countries saw excess delays due to pricing and reimbursement patients WHO (WHO, 2021), making the virus one of the deaths both as a direct result of COVID-19 processes, national reimbursement criteria and major direct causes of death in 2020/2021, after (Eurostat, 2021) and the indirect strain COVID-19 the variation in readiness of European health cardiovascular diseases (17.8 million deaths has put on health systems (Whiting, 2020; Woolf COVID-19 has impacted on cancer patients in two systems to integrate new therapies in clinical per year), cancer (9.6 million deaths per year) et al., 2020). ways. It had a disproportional effect on mortality practice (Vintura, 2020). and respiratory diseases and lower respiratory in cancer patients (European Commission, infections (6.5 million deaths per year) according Health systems across Europe are overloaded, 2021). Patients with cancer have an increased Outcomes for cancer patients are likely to be to the latest data on the global burden of disease unable to cope with the surge of COVID-19 risk of severe outcomes from coronavirus negatively affected if the usual standard of (Institute for Health Metrics and Evaluation, patients (Saini et al., 2020). In most European infection. Cancer and cancer-related treatments care is delayed. (Whiting, 2020). A treatment 2017). countries, a lack of health personnel is proving commonly cause immunosuppression, which delay of four weeks is associated with a 6-13% to be the main bottleneck in scaling up hospital makes cancer patients more susceptible to increase in the risk of death (Hanna et al., 2020). While average life expectancy in the European bed capacity to respond to surges in demand severe coronavirus disease. Most cancer Estimates are that breast and colon cancer region has increased significantly in past (OECD, 2020). patients are over 65 years old and have one or deaths will increase by 8% to 17% respectively decades (Hofmarcher et al., 2019), our ability more comorbidities. up to five years after diagnosis (Maringe et al., 2020). For European economies, this means a The COVID-19 pandemic has also resulted decrease in the life expectancy and productivity in hurdles to accessing cancer care. These of their citizens (Hofmarcher et al., 2019). 16 Executive summary Introduction 17
1900 Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe Spanish Flu HIV/AIDS 40-50M 1925 Figure 4 25-35M 1918-1919 1981- present New pandemics will occur, and outbreaks are Asian Flu here to stay (LePan, 2020) 1.1M 1957-1958 1950 Hong Kong Flu 1M 1968-1970 1975 SARS Swine Flu 770 2000 MERS 2002-2003 COVID-19 200K 850 Ebola 2009-2010 2012 - present 2.6M 11.3K 2019 - MARCH 10, 2021 (ONGOING) 2025 2014-2016 Disruptions are here to stay be accompanied by a drop in the population of What have we learned? • Patient Access: local screening, diagnosis, working age. This will add to existing pressure treatment and follow-up of patients New pandemics will occur, and outbreaks are on healthcare resources through declining This multi-stakeholder report captures the here to stay. Following the first outbreaks of social contributions, and challenges the status learnings from investigators, government It describes the threats posed by COVID-19, and human coronaviruses (SARS-CoV in 2002 and quo. While European countries face healthcare agencies, pharmaceutical companies, the positive developments and learnings which MERS-CoV2 in 2012, see Figure 4), researchers budget constraints, the number of people professional societies, and patient organisations have arisen because of efforts to mitigate the warned that novel coronaviruses were among the diagnosed with cancer across Europe has risen about the impact of COVID-19 on patient access detrimental effects of the pandemic on cancer pathogens most likely to cause a global health by approximately 50% over the past two decades to cancer care in Europe. patients. emergency. This is due to the many reservoirs and is projected to increase to an additional of e.g. SARS-related coronaviruses (SARS-CoV), 775,000 diagnoses by 2040 (Hofmarcher et al., It focuses on the key patient access milestones Even though realising change in healthcare is a which will continue to lead to the spill over of 2019). Cancer spending has stayed generally that formed the basis of the report “Every Day difficult and lengthy process, the way in which viruses from natural hosts to humans and other constant as a proportion of total health Counts - Improving Time to Patient Access to stakeholders were able to develop, approve, animals as we continue to reduce the barriers expenditure over the last two decades, despite Innovative Oncology Therapies in Europe” (see produce, and provide access to vaccines between natural reservoirs and human society increasing incidence. Innovations in treatment Figure 1): has shown how stakeholders can join forces (Hu et al., 2018, Cui et al., 2018). including a shift from inpatient to outpatient successfully to solve serious challenges and care have so far kept survival gains rising, but • Research & Development: global clinical ensure rapid patient access. Declining fertility and mortality rates mean the this is a system under pressure (Hofmarcher et trials to demonstrate the safety and efficacy health workforce is shrinking relative to the total al., 2019). of a therapy With cancer increasing as a global primary cause population. The shortage of health workers in • Marketing Authorisation: European of death, we have the opportunity to learn from the EU27 and the United Kingdom is projected The challenge is, therefore, both to overcome the authorisation to market an innovative this experience, capture this common spirit and to reach 4.1 million by 2030 (World Health current crisis and look beyond it to make sure therapy sense of urgency and unify efforts to speed up Organization, 2016). cancer care delivery becomes more resilient • Market Access: national pricing and patient access to cancer care. against future disruptions and sustainability reimbursement for innovative therapies The decline in the health worker population will challenges. 18 Introduction Introduction 19
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe England France In France, delayed diagnoses could lead In England, delays in diagnosis and to excess mortality of 10‑15% per month treatment are expected to increase the of delay (OECD, 2020b). number of cancer deaths from 5% to 17% (depending on cancer type) within 5 years of diagnosis (Marigne et al., 2020). COVID-19 has had a Global study detrimental impact on A global study found that a treatment delay of four weeks is associated with a 6-13% increase in the risk of death. Delays of up to twelve weeks further increase this risk. In breast cancer, access to cancer care for example, an eight-week delay in surgery increases the risk of death by 17%, while a twelve- week delay increases it by 26% (Hanna et al., 2020). Following the start of the pandemic in early 2020, The exact magnitude of effects on survival will cancer patients across Europe experienced only become apparent in the next few years. But delays in accessing cancer care as health following the first peak of the pandemic and its systems became overloaded and restriction observed effect of delaying cancer diagnosis measures were implemented. and treatment, researchers have already begun to make forecasts of the impact of these delays Research and Marketing Market Patient Delays in cancer diagnosis, treatment and on patient survival rates (Hannah et al., 2020; development Authorisation Access Access follow-up have led to more patients receiving Maringe et al., 2020; OECD, 2020b; Sud et al., their diagnoses at a more advanced stage of 2020). Figures vary depending on national their disease. This means both that they will context, the methods used, and the type of require more complex treatments than they cancer. But all the studies paint a bleak picture. would otherwise, and that there will be more deaths from cancers (Maringe et al., 2020). This This chapter describes ways in which COVID-19 has reduced cancer patients’ chances both of has reduced patient access to cancer care in surviving their cancer, and of enjoying a good 2020 and 2021. It describes the delays in access quality of life. to cancer care due to the impact of COVID-19 on four patient access milestones (see Figure 1): 20 COVID-19 has had a detrimental impact on access to cancer care 21
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe “In one of the clinical trials I am involved in, a forecast was made a year ago on the number of patients with stage III lung cancer that would be included. However, a year after COVID-19, the same doctors are no longer seeing that many patients with stage III lung Research and cancer, as patient are now presenting themselves when they are development UK already in stage IV of the disease. These patients are collateral damage of COVID-19, as they lost the opportunity to access a Clinical trials of potential new cancer treatments In March 2020, the National Institute for potentially better treatment for their disease.” Health Research (NIHR) in the United are a key step in bringing new therapeutic options Kingdom decided to prioritise COVID-19 - Patient representative in the EOP European multi-stakeholder Sounding Board to patients. These experimental therapies are related trials and paused all other new often a last hope for patients with no other or ongoing trials, as well as non-COVID treatment options left. The continuity of the laboratory-based medical research research and development process has been (United Kingdom Lung Cancer Coalition, severely impacted by the COVID-19 pandemic in Clinical trials which were able to continue faced Clinical trials outcomes have 2020). multiple ways. delays as research ethics committees who been compromised would normally approve such trials were often Clinical trials have been engaged with COVID research (Lorgelly & Adler, Not only were clinical trials cancelled or delayed, delayed or put on hold 2020), laboratories were forced to close (Ledford, but those trials which could continue often 2020), staff were reassigned and resources were required significant changes in set-up. In May Medical institutions started cancelling clinical Spain redirected to manage the rapid influx of patients 2020, COVID-19 led to protocol changes which trials in March 2020 (Voisin et al., 2020). A large university hospital in Spain with COVID-19 (Saini et al., 2020, Ledford, 2020). affected 16% of brain tumour patients enrolled in reported that in March and April 2020, a clinical trial (Voisin et al., 2020). These protocol the number of cancer patients enrolled in There was also a slowdown in patient enrolment. deviations are highly likely to lead to difficulties clinical trials decreased by 43% (Manso Worldwide, COVID-19 negatively affected 34% in convincing stakeholders of the efficacy of of decisions by patients with brain tumours on promising therapies. Global et al., 2020). whether they would enrol in a clinical trial (Voisin In May 2020, a global survey found that et al., 2020). Cancer patients with depressed • In cases where biopsies and imaging had to 19% of brain tumour patients could immune systems due to the treatment they were be cancelled, it is likely that demonstrating no longer enrol in clinical trials due to receiving had to be shielded during the pandemic progression-free survival endpoints based COVID-19 (Voisin et al., 2020). In July Europe (Tempest & Taylor, 2020), and travel restrictions on clinical (rather than patient-reported) 2020, over 20% of global oncology trials often prevented trial participants from visiting outcomes measures will be difficult. were halted because of the pandemic, In March and April 2020, a survey among hospitals for research-related appointments • Quality of life endpoints will be affected if with breast, prostate and lung cancer seven investigators leading trials in (Saini et al., 2020). patients miss study visits, and reporting of trials impacted the most (Tempest & Europe indicated that patient enrolment adverse events could well be jeopardised. Taylor, 2020). in active oncology clinical trials was • COVID-19-related deaths are likely to affect negatively affected at the time of the survival endpoints in some studies (Lorgelly survey, with only 14% of the institutions & Adler, 2020, Saini et al., 2020). continuing to enrol patients at the usual rate (Upadhaya et al., 2020) 22 COVID-19 has had a detrimental impact on access to cancer care COVID-19 has had a detrimental impact on access to cancer care 23
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe Charitable research funds Marketing Market Access have been reduced and private Authorisation France equity funds are expected to Once a new therapy has received Marketing decrease Once cancer treatment has successfully Authorisation, national authorities must In France, the Haute Autorité de Santé progressed through the clinical trial phase and decide on reimbursement. A health technology (HAS) released an updated agenda The pandemic has a negative effect on the the European Medicine Agency (EMA) has made assessment (HTA) is conducted to evaluate prioritising assessments for drugs funding of clinical trials. Venture capital funding a positive assessment of its quality, safety and the medical need, the clinical effectiveness intended to manage the COVID-19 is more difficult to secure during a recession efficacy, a new cancer therapy will receive a in relation to the current standard of care, the epidemic as well as treatments for (Lorgelly & Adler, 2020) and many charitable Marketing Authorisation allowing it to be brought cost-effectiveness, and/or the overall potential oncology, paediatric conditions and research funds have had to reduce their research to European markets. Delays have occurred in budget impact of the therapy. diseases with a high unmet need (Haute expenditure considerably as fundraising this phase despite the dedicated taskforces set Autorité de Santé, 2020). opportunities had to be cancelled (Erasmus MC, up to safeguard EMA’s non-COVID-19 activities, The COVID-19 pandemic has impacted on this 2020). while ensuring rapid evaluations of COVID-19 process in (some) European countries in three vaccines. different ways. All these factors may decrease In the medium to longer term, these trial speed of access to innovative oncology cancellations and delays will lead to delays The scientific evaluation and treatments for current patients and reduce the Italy in making new treatment options available to marketing authorisation rate of reimbursement of innovative therapies patients. process has slowed for future patients. The Italian team had to withdraw from its authoring role in a joint EUnetHTA The EMA has focused on expediting the The health technology assessment due to the COVID-19 development of COVID-19 medicines and assessment (HTA) process has outbreak (EUnetHTA, 2020). UK vaccines to fight and prevent the spread of slowed COVID-19. At the same time, it has aimed to Cancer Research UK was forced to ensure the assessment and monitoring of cancer Ongoing HTAs for cancer treatments have reduce research expenditures by £150 medicines is not disrupted (European Medicines been delayed. As with regulatory agencies, HTA bodies are also experiencing delayed million per year for the 2021-2023 period, Agency, 2020). Regulatory committees are, HTA committees face staffing challenges and responses to their questions from representing a 50% cut (UK Lung Cancer however, likely to face staffing challenges, as delays due to the need to implement secure pharmaceutical companies. Delays in HTA and Coalition, 2020). many members are clinicians, public health or videoconferencing platforms. Additionally, reimbursement decisions could lead to serious allied health professionals. There will also be patient participation in these committees may post-crisis backlogs which could prevent one-off delays due to identifying, procuring, have been negatively affected by the switch patients from accessing promising drugs as and implementing secure videoconferencing from physical to virtual meetings (Lorgelly & quickly as would otherwise be possible. platforms. Patient participation in these Adler, 2020). committees may also have been negatively affected by the switch from physical to virtual meetings. (Lorgelly & Adler, 2020). 24 COVID-19 has had a detrimental impact on access to cancer care COVID-19 has had a detrimental impact on access to cancer care 25
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe Assessment and Downward pressure on But European cancer diagnosis rates plummeted reimbursement of non- budgets for innovative when the pandemic started. This problem has COVID therapies have been therapies is expected to been reported in several countries: deprioritised increase Pricing and reimbursement assessment processes for oncology therapies are being At the EU level the economy contracted in 2020, leading to a decrease in GDP and increases in Patient access France delayed or put on hold. government deficit and unemployment rates In France, the number of cancer diagnoses (Eurostat, 2021). This may lead to long-term According to the World Health Organization decreased by 36% in April 2020 compared healthcare budget cuts, as was the case after (WHO), 55% of countries reported disruptions to April 2019. Three months later, doctors the global economic crisis in 2008. to their cancer services due to the pandemic. reported the 18 cancer centres concerned Poland Disruptions to screening, diagnosis, treatment, had not started catching up with this In 2010, after years of continuous growth, OECD and follow-up are apparent in many European In April 2020, the Ministry of Health in backlog (Santi & Pineau, 2020). countries reported close to zero growth in health countries. Poland announced their reimbursement expenditure due to a combination of reductions list would not change until after the in government spending and reductions in In Germany for example, the German Cancer pandemic was over (APM International, wage-based contributions. Every sector of the Research Centre (DKFZ), German Cancer Aid 2020). There was a delay of two months healthcare system faced reduced budgets, with and the German Cancer Society (DKG) set up a as the country missed one bimonthly Germany pharmaceuticals and public health & prevention joint task force in March 2020 to assess possible list update, after which the regular services hit hardest (OECD, 2014). The trend of access barriers for cancer patients and inform In German hospitals, cancer cases assessment process was restored. decreasing European healthcare budgets has decision-makers and the public. Their research decreased during the first national continued since then (Eurostat, 2021b). among German Comprehensive Cancer Centres lockdown (between March 12 and April in the period of April to August 2020, found a 19, 2020) by between 14% (for breast In addition to reductions in healthcare “significant disruption of care”, although barriers cancer) and 23% (for prostate cancer) expenditures, potential reallocations of budgets to acute oncology care were not consistent (Initiative Qualitätsmedizin, 2020; Kampf Scotland towards infectious diseases may lead to payers during this period (Fröhling & Volker, 2020). & Kulldorff, 2021). In May 2020, Scotland suspended making harsher prioritisation decisions. These meetings of its HTA body and halted choices could negatively impact already tight new submissions due to COVID-19 (APM budgets for cancer care, new cancer treatments Screening & Diagnosis International, 2020). and HTA bodies. For cancer patients, early diagnosis is a key Austria determinant of timely treatment and survival Eighteen Austrian cancer centres outcomes. reported a 40% drop in breast cancer diagnoses between March and May Europe If breast cancer is detected at stage I, the 5-year 2020 (Österreichischen Gesellschaft für survival rate is nearly 100%. If detected at stage EUnetHTA decided to deprioritise non- Senologie, 2020). III it falls to 72% (John & Broggio, 2019). Lung COVID-19 initiatives until the end of May cancer follows the same pattern, with one-year 2021 (EUnetHTA, 2020). This is a result of survival reaching 87.3% for stage I disease, but some 23 EUnetHTA Rolling Collaborative only 18.7% for stage IV (Hawkes, 2019). Reviews (RCR) currently being performed for COVID-19 treatments (EUnetHTA, 2020). 26 COVID-19 has had a detrimental impact on access to cancer care COVID-19 has had a detrimental impact on access to cancer care 27
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe Screening programmes for Patients experiencing early detection of cancer have symptoms have visited Netherlands been suspended Netherlands primary care services less often The Netherlands saw a 25% decrease A major factor behind the decline in cancer As of March 2020, the Netherlands halted in cancer diagnoses in March 2020 diagnosis was the closure of screening national screening programmes for breast, Another reason for a lower number of diagnoses (Dinmohamed et al., 2020). The accrued programmes in many countries. Globally, 41% of colorectal, and cervical cancer. Screening is that patients are reluctant to visit primary care backlog of cancer diagnoses was largely nations (including several European countries) was continued during the summer due to the fear of getting infected, assumed cleared during the autumn of 2020, with reported they had taken this measure in response period, but the number of invitations or actual limited capacity in primary care a remaining backlog of 4,000 (3.5%) to the pandemic (World Health Organization, was lower than usual (Rijksinstituut voor centres, or because patients do not want to cancer diagnoses at the end of 2020. The 2020). Volkgsgezondheid & Milieu, 2020). For waste a doctor’s time for non-COVID-19-related backlog was largest for breast cancer and breast cancer screening, it was decided symptoms. This is fuelled by public health colon cancer (Integraal Kankercentrum to reduce screening frequency from messages encouraging people to stay at home Nederland, 2021; Maag Lever Darm every two years to every three years, and media attention on the postponement of Stichting, 2021). Italy due to a shortage of health personnel elective care (Dinmohamed et al., 2020, Ipsen, which was exacerbated by the pandemic 2020). In Italy, an estimated 1.4 million fewer (Bevolkingsonderzoek Nederland, 2020). screening exams were performed during the first five months of 2020, compared Belgium to the same period in 2019 (OECD, 2020b). In April 2020, the number of cancer diagnoses in Belgium decreased by Spain almost 50% compared to the same period Screening numbers in Spain dropped in 2019. Subsequent months showed a Germany dramatically: the number of colorectal partial recovery. However, a backlog of cancer patients diagnosed based on one month of cancer diagnoses remained, In Germany, the Joint Federal Committee screening dropped from 33.3% in March and the second wave of the pandemic suspended mammography screening in to June 2019 to 5.2% in the same period was still to come at the time of analysis April 2020 to reduce unnecessary contact in 2020 (Suarez et al., 2020). (Belgian Cancer Registry, 2020). between people (Fröhling & Volker, 2020). UK Austria 10 weeks of lockdown in the UK led suspended breast Similarly, Austria to a two million procedure backlog in cancer screening for two screening (Tempest & Taylor, 2020), as months, but was able to make up the screening services were formally ‘paused’ backlog after radiological departments in Scotland, Wales, and Northern Ireland, reopened (Österreichische Krebshilfe, and effectively paused in England as 2020). invitations were halted (Hiom, 2020). 28 COVID-19 has had a detrimental impact on access to cancer care COVID-19 has had a detrimental impact on access to cancer care 29
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe Treatment & Follow-up We should prevent late detection of cancer patients, Health outcomes for cancer patients are likely to Netherlands resulting in more late-stage cancers, lower survival rates, be negatively affected if care takes longer than 30% of patients in the Netherlands complications and overall degeneration of quality of life, it did before the disruption caused by COVID-19 (Whiting, 2020). Lung cancer specialists, for reported consequences for their and higher costs and human misery. example, are concerned that some people cancer treatment or follow-up. Most with early-stage lung cancers are having their consultations were switched to an - Patient representative in the EOP European multi-stakeholder Sounding Board online meeting, and chemotherapy treatment delayed for three months or more, after which time it is less likely surgery will cure and immunotherapy treatments were their cancer (UK Lung Cancer Coalition, 2020). adjusted (de Joode et al., 2020). Doctors have referred Hospital diagnostic capacity fewer patients for further has been reduced Countries across the globe report the pandemic examination has resulted in lower outpatient care attendance The decline in cancer diagnoses is due to (World Health Organization, 2020), and hospital diagnostic tests being deferred, following admissions have also fallen in European Europe a reallocation of scarce resources towards countries. England COVID-19 (Dinmohamed et al., 2020). Seven comprehensive care centres in Europe reported that in April 2020 the At the start of the outbreak in England, number of cancer patients admitted fell urgent referrals for early diagnosis of by 20-30% (Van de Haar et al, 2020). suspected cancers decreased by 76% England compared with pre-COVID-19 levels (Lai UK In England, hospital admissions for et al., 2020; Kampf & Kulldorff, 2021). chemotherapy appointments have fallen In the United Kingdom, appointments for These disruptions in treatment (including life- (PET-)CT scanning were put on hold for by 60% (Kampf & Kulldorf, 2021; Lai, saving interventions) result from the impact of three months during the initial phase of 2020). COVID-19 on patient’s care-seeking behaviour, the pandemic. At the same time, infection clinical decision-making and the availability of control measures almost doubled the hospital resources, for example facility closures, Spain time required per diagnostic scan. staff shortages or supply issues (World Health Diagnostic capacity is thus likely to be a Organization, 2020). A fall in oncology referrals was reported Spain key bottleneck, leading to further delays in Spain (OECD, 2020b). once cancer services are resumed and In Spain (Madrid), outpatient visits backlogs start to be addressed (UK Lung to oncology departments fell by 23% Many consultations for non-acute issues Cancer Coalition, 2020, Tempest & Taylor, between 9 March and 13 April 2020 have been transitioned to telehealth, delaying 2020). compared with the same period in 2019 physical examinations for symptoms which (OECD, 2020b). do not directly suggest cancer (Dinmohamed et al., 2020). Doctors may also be reluctant to These factors have led to a significant backlog send patients to a hospital for fear of COVID-19 in screening and diagnosis across Europe. This infection (Hiom, 2020). In the case of lung is expected to lead to delays lasting beyond the cancer, delays are worsened, as early lung current restriction measures. The exact impact cancer symptoms may easily be misdiagnosed on cancer deaths has yet to become clear, but as COVID-19 (UK Lung Cancer Coalition, 2020). projections suggest it may be severe. 30 COVID-19 has had a detrimental impact on access to cancer care COVID-19 has had a detrimental impact on access to cancer care 31
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe Patients are less likely to visit temporary discontinuation of treatment (Hannah Availability of healthcare the hospital for their cancer et al., 2020; Van de Haar et al., 2020). personnel has been limited care The immunosuppressant impact and side “Surgery was the most In many European countries, a lack of health During the pandemic, many cancer patients have effects of chemotherapy meant this treatment affected modality being personnel has been a key bottleneck in ensuring been faced with a dilemma. They must choose was largely stopped during the initial wave of delayed or cancelled in continuity of care during surges in demand between attending their hospital appointment the pandemic, with patients switched to less (Hiom, 2020; OECD, 2020). At the initial stages of and risking exposure to COVID-19 or staying toxic treatments. Intravenous treatments were more than 10% of patients the pandemic staff were frequently redeployed at home and risking their cancer progressing swapped for oral or subcutaneous treatments in 34% of the centres, to provide COVID-19 relief, did not have enough further. (Van de Haar et al., 2020). Treatment delivery protective equipment, or were not available due whereas early cessation schedules were amended to reduce the to physical or mental health issues related to frequency or dosing of administration, and of palliative treatment was working through the pandemic (Hiom, 2020; Poland targeted treatments have been moved forward reported in 32.1% of the WHO, 2020). along the treatment pathway (UK Lung Cancer In Poland, 20% of patients with cancer Coalition, 2020). These changes were not centres” considered postponing chemotherapy necessarily to the detriment of patients, as and 5% considered abandoning further - Findings from a survey among sometimes they improved care. However, 109 medical oncologists from 18 Italy cancer treatment during the pandemic, patients expressed concerns about the changes countries in Europe (Onesti et al., despite a fear of cancer progression (De Joode et al., 2020; Voisin et al., 2020). In the areas most affected by COVID-19 2021) (Ciążynska et al., 2020). in Italy, 38 to 51% of oncologists were Surgeries and regular palliative care therapies reassigned to take care of COVID-19 Furthermore, lockdown and quarantine have were often cancelled, postponed, or adjusted patients (Indini et al., 2020). made travelling to appointments or obtaining as the risks were deemed too high for patients of the latest, original scientific clinical trial which essential medicines more difficult (Dinmohamed and staff (Hiom, 2020; Onesti et al., 2021; Saini demonstrate remarkable therapeutic benefit, et al., 2020). In some cases, financial difficulties et al, 2020; UK Lung Cancer Coalition, 2020; Van scientific insight, or progress in an area of unmet Staff health and morale are a major concern, caused by the lockdown negatively impacted de Haar et al., 2020). While not all changes were need (ESMO, 2021). In some instances, these especially as health professionals were care-seeking behaviour (Voisin et al., 2020, negative for patients, surgery being delayed by Virtual Plenaries allowed even more participants contracting COVID-19 infections. Many are World Health Organization, 2020). two or three months can significantly affect to attend than the face-to-face events held struggling with the psychological impact of outcomes, especially since it is difficult to before the pandemic. the decisions the pandemic is forcing them to Doctors have had to made predict future capacity problems which may be make, and the resulting impact on their patients. new trade-offs between the caused by new peaks of the pandemic (Battisti Making an optimal assessment of treatment (Hiom, 2020; Saini et al., 2020). More than one risks and benefits of cancer et al., 2020; Van de Haar et al., 2020). benefits and risks in this context is especially third of oncologists reported an increase in the treatment challenging in the case of older cancer patients. demand for cancer patient support services due Doctors had fewer opportunities – especially As elderly patients are more likely to have to COVID-19 concerns or anxiety (IQVIA, 2020). Therapeutic decisions should normally favour the at the start of the pandemic – to learn about comorbidities such as cardiovascular disease, They are concerned about the lack of support most effective and least invasive approach with the latest research findings and new cancer diabetes, chronic respiratory disease and and treatment options they can provide to their the lowest risk of adverse outcomes. For many treatments, as large-scale congresses, which chronic renal impairment, they are at additional cancer patients. cancer patients at the onset of the pandemic the are usually the opportunity for dissemination risk for worse outcomes from COVID-19. For risk of weakening the immune system through of this information, were cancelled (Lancet this group, a thorough geriatric assessment These demanding conditions could make staff exposure to a novel and poorly understood Oncology, 2020). This negative impact has and personalised care will help avoid over- or vulnerable to moral injury – psychological virus was deemed unacceptable. This led to been mitigated through the organisation of under-treatment. Offering this level of care distress that occurs from actions (or the lack adjustment of medication, radiotherapy, surgery virtual conferences, such as the ESMO Virtual is particularly challenging in the context of of actions) that go against an individual’s moral and palliative care for cancer patients, or the Plenaries. These are monthly live presentations overloaded health systems (Battisti et al., 2020). code (Davies et al., 2020). Studies have reported 32 COVID-19 has had a detrimental impact on access to cancer care COVID-19 has had a detrimental impact on access to cancer care 33
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe increased rates of depression, anxiety, stress, Furthermore, the pandemic has exacerbated insomnia, symptoms of post-traumatic stress existing shortages in blood supply (Schlesinger disorders and other mental health conditions et al, 2020). Cancer patients may require blood among health professionals from England, transfusions in case of blood loss during cancer Wales, Italy, and Spain (OECD, 2020b). In July surgery, or to replenish functioning blood cells 2020, 18% of medical oncologists indicated lost during chemotherapy, radiation or because that the well-being of healthcare staff would not of the cancer itself. Blood donation centres have recover by the end of 2020 (Onesti et al., 2021). closed, and donations have fallen due to social distancing or (self-)quarantine (Shander et al., Resources for blood 2020). This is leading to shortages of blood and transfusion and surgical care the postponement of elective surgery and other have been in short supply cancer treatments (Gehrie et al., 2020). The above-mentioned trade-offs between the Apart from emergency operations, essential risks and benefits of treatment and the limited procedures may include those which are termed availability of health personnel have forced elective, but where a delay of two to three months hospitals around the world have to postpone could significantly affect outcomes, and/or planned elective surgical interventions. those where surgery is a crucial component of managing cancers including breast, colon, The pressure on ICUs has meant cancer patients gastric, pancreatic, liver, bladder, renal, lung and are unable to have surgery due to a lack of brain tumours (Battisti et al, 2020; COVID19 recovery beds with ventilation, and a lack of ICU Subcommittee of the O.R. Executive Committee beds if surgery were to go wrong (Hiom, 2020; at Memorial Sloan Kettering, 2020). UK Lung Cancer Coalition, 2020). 34 COVID-19 has had a detrimental impact on access to cancer care COVID-19 has had a detrimental impact on access to cancer care 35
Every day counts - The impact of COVID19 on patient access to cancer care in Europe Every day counts - The impact of COVID19 on patient access to cancer care in Europe The way in which COVID-19 vaccines were brought to patients at record-breaking speed, while emergency access to care was protected, shows how stakeholders can join forces to solve serious challenges successfully and provide rapid patient access. A common goal, a sense of urgency, mutual trust and combining efforts allows us to break down silos and refocus divergent interests. If stakeholders are willing to apply these lessons to addressing patient access in cancer care, the following recommendations offer a good starting point for improving patient access to cancer care in Europe. Figure 5 Disruptions are here to stay: this chapter describes 6 recommendations to optimally recover Six recommendations for and adapt to improve performance of oncology care in Europe (OECD, 2020). improving patient access Future Disruption disruption to oncology care Health The impact systemsof disruptions must absorb described the impact in the of The In addition lessons generated to disrupting duringpatient the pandemic access areto previous chapter disruptions causedis felt byduring COVID-19 the pandemic, both during as translated oncology into care,recommendations the pandemic also for European provided Prepare Absorb Recover health and after systems the pandemic, have to absorb when systems its impact. willBut try to it health learnings. systems It served to help as them a catalyst recoverforoptimally positive is also felt recover andbeyond catch the up. immediate pandemic, as from developments the COVID-19withdisruption, the potential while to adapting improveto systems try to recover and catch up on services. be future ablepatient to absorb access futuretoshocks cancermore care.effectively. The challenge is to look beyond the current crisis and make sure health systems adapt to make Some of the recommendations may not be new. Future Disruption cancer care delivery more resilient to future Many of the changes required to make European disruption At the same shocks and sustainability time, the challenge challengesis to(OECD, look health This chapter systems describes more sustainable a set haveof multi- been beyond World 2020b; the current Economic crisis,Forum, to make 2021; sureWorld that known stakeholder for years. recommendations Yet realising these for changes Europeanis health Organization, Health systems adapt 2020, to see makeFigure cancer 3). care both health a difficult systems and tolengthy optimally process recover (Braithwaite, from the delivery more resilient to future shocks and 2018). COVID-19 COVID-19 disruption,provides while adapting momentum to enable to sustainability In addition to challenges disrupting patient (OECD,access 2020b; to optimally better absorption use the ofbest future practices shocks. and learnings World Economic oncology care, theForum, pandemic2021;hasWorld servedHealth as a generated during the pandemic. Now is the time Organization, catalyst for new, 2020, improved see Figure healthcare 3). techniques, to prioritise these recommendations to realise models, partnerships, and policies in cancer lasting changes to strengthen patient access to care. If they are heeded, they can improve patient cancer care throughout Europe. access to cancer care for generations to come. Prepare Absorb Recover Adapt 36 Six recommendations for improving patient access to oncology care 37
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