COVID-19 "Round 2" - Findings & way forward - Summary June 12th, 2020 - Efpia

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COVID-19 "Round 2" - Findings & way forward - Summary June 12th, 2020 - Efpia
COVID-19 “Round 2” –
Findings &
way forward

Summary
June 12th, 2020
COVID-19 "Round 2" - Findings & way forward - Summary June 12th, 2020 - Efpia
Legal disclaimer   – This report is preliminary. Analyses and conclusions may change
                     subject to additional data.
                   – To the fullest extent permitted by law, no representation or warranty,
                     express or implied, is or will be made and no responsibility, duty or
                     liability is or will be accepted by Medicines for Europe or Kearney, any
                     other person or by any of their respective directors, officers, servants,
                     advisers, agents or affiliates as to or in relation to the accuracy,
                     sufficiency, reliability or completeness of this document or the
                     information forming the basis of this document or for any errors,
                     omissions or misstatements relating thereto.
                   – Neither Medicines for Europe nor Kearney, nor any other person
                     accepts any duty of care nor undertakes any obligation to provide the
                     recipient with access to any additional information or to update this
                     document or additional information, or to correct any inaccuracies herein
                     which may become apparent.

2                  Source: Medicines for Europe; Kearney
COVID-19 "Round 2" - Findings & way forward - Summary June 12th, 2020 - Efpia
Objectives of this
document
                                   Briefly introduce scenario planning for a potential second
                                   COVID-19 wave

                                   Compare supply vs. demand for the next months under
                                   various scenarios

                                   Present results from API survey
3                    Source: Medicines for Europe; Kearney
1.   Executive Summary
2.   Demand
3.   Supply vs. demand
4.   API Survey

4
1 2 3
Executive
summary

            We have developed                       … EU/ EEA shortage           …preliminary analyses
            three scenarios for a                   during the summer            suggest a second
            second COVID-19 wave                    months is unlikely,          COVID-19 wave may hit
            indicating that...                      but…                         member states hard!

            Scenario planning                       The available data           Preliminary analyses
            suggests that                           indicates that               suggest that
            – A best case, base                     – Stock levels will drop     – Shortages in Oct/ Nov
              case and worst case                     significantly from their     are a real possibility,
              could occur                             peaks in May                 especially for NMBs
            – Governments need to                   – But a shortage of any      – The industry needs a
              consider additional                     class of molecules           clear demand signal
              factors (e.g., tourism)                 during June, July and        from member states to
              in their planning                       August is unlikely           prepare adequately

5           Source: Medicines for Europe; Kearney
1.   Executive Summary
2.   Demand
3.   Supply vs. demand
4.   API Survey

6
Demand              Estimations are based on the following:
forecasting model
                    – This calculator is not an epidemiology model. The inputs, such as projected deaths, no. of days on
Legal disclaimer      ventilation, choice of ventilation medicines are based on the available information as well as expert and
                      academic opinion.
                    – This calculator is not a prediction of the expected effects of COVID-19.
                    – This model was created solely to estimate the potential demand for critical medicines due to Covid-19.
                    – The parameters in the scenario are estimates intended to support public health preparedness and
                      planning.
                    – These inputs and corresponding outputs may not reflect the reality of what users will ultimately see.
                    – The forecasting does not reflect the impact of any behavioral changes, social distancing, or other
                      interventions.
                    – Users are discouraged from drawing strong conclusions about deaths or new cases on the basis of
                      these estimates.
                    – To the fullest extent permitted by law, no representation or warranty, express or implied, is or will be
                      made and no responsibility, duty or liability is or will be accepted by Accord, Kearney or Medicines for
                      Europe, any other person or by any of their respective directors, officers, servants, advisers, agents or
                      affiliates as to or in relation to the accuracy, sufficiency, reliability or completeness of this document or
                      the information forming the basis of this document or for any errors, omissions or misstatements relating
                      thereto.
                    – Neither Accord, nor Kearney, nor Medicines for Europe, nor any other person accepts any duty of care
                      nor undertakes any obligation to provide the recipient with access to any additional information or to
                      update this document or additional information, or to correct any inaccuracies herein which may
                      become apparent.

7                   Source: Medicines for Europe; Accord Healthcare; Kearney
A model was          Demand forecasting model
developed to         – Initially developed by Medicines for Europe and Accord Healthcare for the first COVID-19 wave
estimate the
                     – Enhanced with additional parameters by Kearney for a potential second COVID-19 wave
demand of critical
medicines for a
potential second
COVID-19 wave        Approach                                                   Data sources                         Key assumptions
                     – Favoring overestimation of                               – Actual data of number of daily     – Herd immunity will not be
                       cases due to the fact that the                             deaths as of May 21st 2020           achieved by any country
                       risk of underestimating is                                                                      during first COVID-19 wave
                       higher than the risk of                                  – Worldometer Coronavirus
                       overestimating                                             reports                            – Individual country
                                                                                                                       responses to a second
                     – Not reflecting the impact of                             – WHO Situation Reports                COVID-19 wave will be
                       any behavioral changes, social                           – Expert opinions                      identical to responses to the
                       distancing, or other                                                                            first wave
                       interventions which could                                – Secondary research, e.g.
                                                                                                                     – The development of the
                       influence case numbers                                     – Robert-Koch-Institute,
                                                                                                                       second COVID-19 wave will be
                                                                                    Germany
                     – Not addressing the impact of                                                                    similar to the first wave
                       tourism potentially occurring in                           – International Long-Term Care
                       late summer/ early autumn                                    Policy Network                   – Only COVID-19 related deaths
                                                                                    (https://ltccovid.org/)            occurring in ICUs will cause
                     – Using number of reported                                   – ICNARC – Intensive Care            demand in critical medicines
                       deaths per country as base                                   National Audit & Research
                       for estimation                                                                                – Number of daily deaths will
                                                                                    Centre                             decrease around 28-days
                     – Using three different                                      – Various scientific articles        post-lockdown
                       parameters to plan for future                                (e.g., Grasselli et al., JAMA;
                       demand scenarios (# deaths,                                  Bhatraju et al., NEJM)
                       MV usage, treatment duration)
8                    Source: Medicines for Europe; Accord Healthcare; Kearney
Selected scenario overview for a second COVID-19 wave
Three different        Key characteristics
scenarios – best,
base and worst
case – will indicate                                               Best Case            Base Case    Worst Case
medicines demand        Scenario
for a potential         illustration for                      Lowest absolute   Likely demand (kg)       Highest likely
second COVID-19         molecule demand                       demand (kg)                                demand (kg)
wave
                                            # of new deaths
                                                                      - 50%                Same        + 50%
                                            vs. first wave

                         Model parameters   % patients
                                                                       50%                  50%        100%
                                            on MV

                                            Treatment
                                                                                           Likely
                                            duration

                        Total # new ICU
                        patients (October 1st –                      33’153               66’306       99’459
                        November 30th 2020)

9                      Source: Kearney
Expected number of new COVID-19 ICU patients per million inhabitants (01.10.-30.11.2020)
                                                               13                                  26                                      39
Even countries                  Austria
                                Belgium                                           166                                           331                      497
that were less                  Bulgaria                      5                                10                                     14

affected in a first             Croatia
                                                              2
                                                               5                               11
                                                                                               3
                                                                                                                                      16
                                                                                                                                      5
                                Cyprus
COVID-19 wave                   Czechia                        6                               13                                         19
need to prepare                 Denmark                            25                                   50                                      76
                                Estonia                        11                                  22                                     32
for a potential                 Finland                        14                                  27                                      41
second wave                     France                                   82                                         164                                              245
                                Germany                           18                               35                                          53
                                Greece                        3                                6                                      9
                                Hungary                           16                               32                                          49
                                Iceland                        5                               11                                     16
                                Ireland                                 60                                    121                                              181
                                Italy                                    81                                         162                                              243
Illustrative –                  Latvia                        3                                6                                      9
based on data from 21.05.2020   Lithuania                     5                                10                                     15
                                Luxembourg                         35                                    69                                         104
                                Malta                         3                                6                                      9
                                Netherlands                             66                                     132                                              198
                                Norway                         6                               11                                     17
                                Poland                         6                               13                                         19
                                Portugal                           30                                   60                                          89
                                Romania                         14                                 28                                      43
                                Slovakia                      1                                2                                      4
                                Slovenia                       12                                  24                                      36
                                Spain                                   57                                    114                                          172
                                Sweden                                       95                                      191                                                   286
                                Switzerland                        36                                    73                                          109
                                UK                                                 185                         370                                                   555

10                              Source: Medicines for Europe; Kearney              Best case                        Base case                              Worst case
Governments         Illustration                                              “Tourism factor”: Explanation
should consider a   Example:                                                  – Situation:
“tourism factor”    Tourism in Greece during summer months                      – Popular holiday destinations are likely to re-
                                                                                  open for tourists during summer months
when planning for                                                               – This is currently not figured into the second
a second                                                                          wave projection
COVID-19 wave
                                                                              – Impact:
                                                                                – Population within holiday destination will grow
                                                                                  by factor X during summer months
                                                                                – Number of cases will be larger than assumed
                                                                                  in the model (due to increased number of
                                                                                  visitors) for both host and destination country

Illustrative                                                                  – Example:
                                                                                – Greece had 28mn visitors in 2018, which is
                                                                                  almost 3x its population
                                                                                – Tourism numbers for 2020 are likely to be
                                                                                  significantly lower
                                                                                – Assuming around 10mn visitors in the summer
                                                                                  of 2020 would double Greece’s population
                                                                                  susceptible to a COVID-19 infection

                                                                              – Recommendations:
                                                                                – Governments should include a “tourism
                                                                                  factor” in planning for second COVID-19 wave
                                                                                – This factor needs to consider tourists within
                                                            Tourism streams
                                                                                  the country as well as returning citizens

11                  Source: Medicines for Europe; Kearney
1.   Executive Summary
2.   Demand
3.   Supply vs. demand
4.   API Survey

12
Demand was         Reported supply vs.                     – Two scenarios:
                   extrapolated supply                       – Only actual supply reported back by MAH
compared against
supply under                                                 – Actual supply reported back by MAH,
                                                               extrapolated to full market size (based on 2019
twelve different                                               figures)
scenarios

                   Second wave scenario                    – Three scenarios:
                   planning                                  – Best case:
                                                               lowest absolute demand
                                                             – Base case:
                                                               likely demand
                                                             – Worst case:
                                                               highest likely demand

                   Available supply for                    – Two scenarios:
                   COVID-19 patients                         – Avg. 50 % of supply available for COVID-19
                                                             – Avg. 75 % of supply available for COVID-19

13                 Source: Medicines for Europe; Kearney
1 2 3
Summary:
The summer
months should be
used to restock in
preparation for a
potential second
COVID-19 wave in
autumn
                     The industry scaled                     The industry         However, in the
                     up supplies                             analysis, based on   event of a second
                     massively during                        experts’             wave in autumn,
                     April/ May 2020 –                       hypotheses,          there are supply
                     however, this may                       suggests             risks for Europe,
                     not be maintained                       shortages across     most poignantly in
                     over the summer                         Europe are less      neuromuscular
                     months!                                 likely during the    blockers.
                                                             summer months.

14                   Source: Medicines for Europe; Kearney
1.   Executive Summary
2.   Demand
3.   Supply vs. demand
4.   API Survey

15
Our survey of              We asked MAH the following question:
participating MAH          “Do you experience notable API
suggests that API          challenges that pose a significant
challenges                 threat to manufacturing in terms
currently do not           of quantity, quality or time of
seem to pose a             delivery?”
major risk for the
industry

Illustrative;
data based on 08.06.2020

                           Results                                    Implications
                           – Only few manufacturers report at least   – Generally, API supply does not seem
                             one notable API challenge                  to be a major risk factor
                           – These are restricted to neuromuscular    – However, capacity constraints may
                             blockers and sedatives                     cause manufacturing bottlenecks
                           – Common themes are short-term             – This conclusion needs to be
                             supplier capacity, committed volumes       corroborated from the perspective of
                             and own use of API by supplier             non-EU manufacturers

16                         Source: Medicines for Europe; Kearney
This document is exclusively intended for selected client employees. Distribution, quotations and duplications –
even in the form of extracts – for third parties is only permitted upon prior written consent of Kearney.

Kearney used the text and charts compiled in this report in a presentation; they do not represent a complete
documentation of the presentation.

                                                                              Image by Ch. Germino
1. Appendix

18
Key model          Rationale and sources for key demand model parameters
                   Non-exhaustive, high-level
parameters were
defined using
various sources,   Model
                                                   Rationale                                        Key sources
                   parameter
including from
governmental       Number of                       – The number of deaths is a more reliable        – Worldometer
                   COVID-19                          indicator than the number of cases
agencies           related deaths
                   % of COVID-19 – Only patients who are admitted to ICU                            – Robert-Koch-Institute, Germany
                   related deaths  consume ICU medicines – therefore, patients                      – International Long-Term Care
                   in hospital     who died outside of hospitals should not be                        Policy Network
                                   included                                                         – ICNARC – Intensive Care National
                                                                                                      Audit & Research Centre
                   MV rates for                    – There is a mounting trend towards putting      – Grasselli et al., JAMA, 2020
                   COVID-19                          fewer patients with COVID-19 on MV as an       – Bhatraju et al., NEJM, 2020
                   patients                          adverse impact on treatment outcome as been    – Yang et al., Lancet Resp Med,
                                                     observed in some studies                         2020
                                                   – A 50% MV rate was used as a “lower-bound”      – Wang et al., Annals of Intensive
                                                     estimate based on available studies              Care, 2020
                                                   – All patients not on MV are assumed to be on    – Gattinoni et al., AJRCCM, 2020
                                                     non-invasive ventilation                       – Clinical experts
                   ICU treatment                   – Dosage and duration of ICU treatment differs   – Clinical experts from various
                                                     by molecule class                                countries
                                                   – Country-specific differences need to be        – Various scientific articles (e.g.,
                                                     “averaged out”                                   Grasselli et al., JAMA, 2020)

19                 Source: Medicines for Europe; Kearney
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