COMMITTED TO PEOPLE: PHARMACEUTICAL INDUSTRY CHALLENGES IN EUROPE INNOVATION IN PORTUGAL: BRIEF OVERVIEW
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1 COMMITTED TO PEOPLE: PHARMACEUTICAL INDUSTRY CHALLENGES IN EUROPE INNOVATION IN PORTUGAL: BRIEF OVERVIEW Heitor Costa, Executive Director of APIFARMA July Conference
2 The Portuguese Healthcare system The Portuguese healthcare system includes three coexisting, overlapping systems: the NHS, special public and private insurance schemes and pure private providers Is a network of public and private healthcare providers: Hospitals and primary care centers owned by public sector complemented by a private ambulatory and hospital medical system 1 Source: HiT Portugal Health System Review 2011
3 Healthcare Performance Portugal continues to improve indicators on patient rights and information, results and prevention. According to the Euro Health Consumer Index (EHCI), in 2017, Portugal is in 14 th place among an assessment of 35 countries, the same position of 2016 after having ranked 20 th in Source: Euro Health Consumer Index
4 Health Expenditure and Medicines Market Health Expenditure in 2017 was 17,3 KM with medicines representing 21,6% of the total. HEALTH EXPENDITURE ,344.8 M ; V.H.=+3.0% MEDICINES MARKET ,747.5 M ; V.H.=+2.2% Privada 33% Pública 67% Private Market*; 1.393,0; 37% NHS Expenditur e; 2.354,5; 63% Source: INE Source: INFARMED, INE * Private Market - includes out-of-pocket and private insure schemes 3
5 Increasing access to medicines at decreasing prices NHS outpatient medicines are increasing in volume and simultaneously the average price per package is decreasing NHS OUTPATIENT MEDICINES VOLUME (MILLION PACKAGES) AVERAGE UNIT PRICE OF NHS AMBULATORY MEDICINES ( ) 160,0 150,0 140,0 139,9 139,9 140,0 149,1 153,0 155,0 156,0 157,3 18,0 16,0 14,0 12,0 10,0 16,8 15,2 13,3 12,4 12,2 12,2 12,1 12,2 130,0 8,0 120,0 6,0 4,0 110,0 2,0 100, , Source: INFARMED 4
6 Innovation in Health: Portuguese Context Research and innovation in the health sector are essential for the improvement of health and quality of life, and a source of economic wealth creation. This sector has been steadily growing in Portugal, as the key indicators below show. KEY INDICATORS - ANNUAL COMPOUND GROWTH RATE 5 Source: Health Cluster Portugal; CARG between 2007 and 2016
7 EU Portugal Health Drivers: Demographic pressure Life expectancy in Portugal is at the EU average level. Furthermore Portugal has an older population, with one of the highest and increasing old-age dependency ratio, combined with less healthy years after age 65 than the EU average. OLD-AGE DEPENDENCY RATIO LIFE EXPECTANCY AT AGE 65 TOTAL AND HEALTHY (YEARS) 2020 F 31,7% 34,6% Total 18 21, ,9% 32,5% 27,0% 28,0% 29,0% 30,0% 31,0% 32,0% 33,0% 34,0% 35,0% Healthy Total 6,4 7,7 18,2 21,6 EU PT Healthy 9,8 10,1 6 Source: Eurostat
8 Health Drivers: Increasing burden of chronic diseases In Portugal, similar to EU, the two main causes of death are the diseases of the circulatory system and the malignant neoplams, which account for more than half of deaths, and are increasing over the years. % DEATH BY CAUSES EVOLUTION OF THE Nº DEATHS BETWEEN % 21% Malignant neoplasms Other diseases of the circulatory system Cerebrovascular disease (stroke) Ischemic Disease Total Malignant neoplasms Other diseases of the circulatory Cerebrovascular disease (stroke) 3,8% 5,5% 3,4% -4,4% 2% 3% 3% Pneumonia Digestive system diseases Ischemic Disease Pneumonia 6,2% 1,2% 3% Other respiratory diseases Digestive system diseases 8,7% 8% 4% 5% 6% 9% 20% Diabetes Dementia Genitourinary diseases COPD Other respiratory diseases Diabetes Dementia Genitourinary diseases 5,9% -4,2% 17,4% 71,3% Others COPD 10,0% 7 Source: INE
9 Health Expenditure: Key Figures Portugal is one of the European countries where the public investment in Health is lower, both in % of GDP and per capita, as well as in the % of the total State expenditure. PUBLIC HEALTH EXPENDITURE % of total State expenditure 16,0% 14,0% 12,0% 10,0% 15,3% 13,2% 8,0% 6,0% 4,0% 2,0% 0,0% EU Average Portugal 8 Source: OCDE Average of 23 countries with available data (not included: Romania, Croatia, Malta, Bulgaria and Cyprus)
10 Health Expenditure: Key Figures At the same time the out-of-pocket effort is one of the highest, well above average; In addition Between 2010 and 2016, Portugal were one of the countries where public health spending most declined, with a dynamic contrary to the EU average. A wide range of measures have been implemented to reduce spending in the health sector, focusing mainly on the medicine value chain OUT-OF-POCKET EXPENDITURE 2016 PUBLIC HEALTH EXPENDITURE PER CAPITA EVOLUTION % 19,0% 15% 10% 5% 0% EU Average Portugal -5% -3,4% 9 Source: OCDE Average of 23 countries with available data (not included: Romania, Croatia, Malta, Bulgaria and Cyprus) Source: Eurostat
11 Key Framework constrains: Underfunding and Debt The NHS is underfunded and has deficits year after year, with strong repercussions on the ability to provide the necessary level of care, namely innovation access, and a direct implication on arrears. SNS DEFICIT (M ) HOSPITAL DEBT TO INDUSTRY (M ) , , , ,9 948,0 730,2 682,2 814,7 906,1 933,7 891,0 852,1 858,3 699,3 664,6 621,8 633, P Total Debt Debt overdue 10 Source: DGO jun-17 ago-17 out-17 dez-17 fev-18 abr-18 Source: APIFARMA
12 Deficit of the Portuguese NHS 11 Fonte: Ministério da Saúde
13 Pharma Innovation With over compounds in development in 2011, over 80% of projects were focused on degenerative diseases, Non Communicable Diseases and cancer Pharma industry continues to work hardly to give answers to unmeet needs, with over 7000 medicines in development at moment. Registered Pipeline Compounds end of year 2011 Finding solutions for unmet needs in cancer has been a major recent focus for the industry. Growth in early stage investment in CNS reflects appreciation for the need to identify breakthroughs in major challenge of degenerative mental health diseases. Decreasing activity in areas like cardiovascular care reflect the adequate nature of existing standards of treatment in some areas (e.g. hypertension) and some residual unmet needs (e.g. stroke prevention). Only a small proportion of these compounds in development will reach market and of those a small proportion will be profitable 12 Source: Business Insight Database end Year 2011 via Lifescience Analytics (2012); A.T. Kearney analysis
14 Innovation Access in Portugal INFARMED activity regarding HTA has been improving with increasing number of dossiers decided. Nº OF PROCESS CLOSED REGARDING NEW MEDICINES AND NEW INDICATIONS Source: INFARMED 13
15 Access to Innovation There is still a large number of innovative medicines with MA awaiting a public financing decision compromising access of patients to innovative therapies. DISTRIBUTION OF NSAS AWAITING FINANCING DECISION BY THERAPEUTIC CLASS YTD 2018 Total of 59 new medicines (1) (1st indication) waiting for public financing decision Median waiting time (2) for new DCIs of 14.4 months Most of the medicines are in the oncology area 14 Source: APIFARMA, universe of associates; (1) accounted by number of NSAs (new active substances); (2) time that elapses between the date of the request for financing and the 31/05/2018, for processes still under evaluation;
16 Innovation Access in Portugal Considering the cohort of new medicines (1 st indication) that obtained a MA between , only 32,2%, as of today, have a financing decision. 79% of them have been approved => rate of availability of 25,3% The average time of decision for this cohort was 15,7 months, but 74% of the cases took more than 12 months. DISTRIBUTION OF NSAS (%) FOR DECISION TIME RATE OF AVAILABILITY, YTD 2018, FOR THE COHORT OF NEW MEDICINES THAT OBTAINED A MA BETWEEN ,2% Not Decided Decided 21% 68% 15 Source: APIFARMA, INFARMED; Decision time - time that elapses between the date of the request for financing by the companie and the decision date 79% Rejected / withdraw Public Financed
17 Innovation Access EU Benchmark When compared with other European countries, Portugal has an availability rate similar to eastern countries, and below majority of western European countries (e.g. Spain, Italy, France and UK). 16 Source: EFIA, W.A.I.T Indicator from 2017, cohort of NSAs from
18 Value of medicines and Outcomes-Based Healthcare Examples, non exhaustive: 17
19 Future Challenges: It is necessary To value health and see it as an investment To guarantee access to the most appropriate therapies, on an equal footing with other European citizens To take into account the short- and medium-term savings that innovation makes possible by avoiding additional and dispensable surgeries or treatments Therefore it is imperative to create the necessary conditions to guarantee the sustainability of the Health services, namely: o The need to increase health financing by 0.15 percentage points of GDP per year to 7% to converge to the EU average (Eurostats) o o The need of multi-annual budgets The need to improve and promote health prevention, considering the allocation of an additional 0.25 points of the NHS budget every year 18
20 Thank you for your attention
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