Pharmaceutical Industry Past Paper PDF - Oct 2024

DPT. OF SOCIAL AND CLINICAL PHARMACY OCT, 2024 JIŘÍ KLIMEŠ [email protected] Pharmaceutical industry (original and generic) I. Population aging In the context of an aging population, it is necessary and the need to to invest in the h...

DPT. OF SOCIAL AND CLINICAL PHARMACY OCT, 2024 JIŘÍ KLIMEŠ [email protected] Pharmaceutical industry (original and generic) I. Population aging In the context of an aging population, it is necessary and the need to to invest in the health / health of the population and thus prolong the period in good health invest in health 2 Health care costs in the EU, in absolute terms and by% of GDP, 2022 3 Annual real growth in per capita health expenditure and GDP, OECD, 2006-22 Health expenditures mirrors the GDP growth Unless expectational situations come appear 4 Drug costs in OECD countries In absolute terms (USD / capita), developed countries spend more on medicines Relatively, the share of drug costs is rather lower (compared to countries with lower economic performance) Relative share of drug costs Absolut vaues vs. total healthcare costs (USD/ capita) 5 Annual average growth in retail and hospital and other non-retail pharmaceutical expenditure, in real terms, 2011-21 (or nearest years) 6 Availability of innovative therapy to patients 7 Czech Republic Country Profile Key Economic Indicators Key Healthcare and Pharmaceuticals Metrics GDP/capita demonstrated 0,7 % growth in 2023. Based on World Bank 9,1% 9,3% 9,1% projections, Czechia will experience average 2% yearly growth during 2024- 8,2% 8,3% In 2022, healthcare spending in 2029 Czechia slightly decreased to 9.1%. In 2020, Czechia's healthcare CAGR +2% spending matched the EU average +2,4% -0,5% +0,7% for the first time Source: OECD 2018 2019 2020 2021 2022 19 546 20 024 19 926 20 065 20 467 20 897 21 356 21 847 22 372 Pharmaceutical spending Pharmaceutical spending (Rx medicines, governmental schemes) (Rx + OTC) in CEE in 2021 2021 2022 2023 2024 2025 2026 2027 2028 2029 +11% Real GDP per capita GDP forecast (WB) +13% +10% +10% AT $4.683B CZ $3.829B $4.215B $ 4.03B The Czech Republic is the 18th largest economy in the EU by real GDP $3.074B $3.386B $ 4.02B per capita. Though below the EU average ($19,930 vs. $31,360), it surpasses Poland ($16,000) and Slovakia ($17,890). The Czech GDP SK growth rate (1.94%) is forecasted to exceed the European average SI $ 1.9B (1.55%), according to the World Bank. HU $ 0.7B 2021 2022 2023 2024 2025 $ 1.4B Source: National distributors data Source: OECD Expenditures on medicines in the Czech Republic by sources of their financing, 2015–2019 - basic indicators CZK 95 billion total drug costs in the Czech Republic CZK 65 billion is the Health Insurance Company's drug costs Prescription drugs - CZK 35 billion Medicines in the hospital, in the centers - 30 billion USD CZK 30 billion Costs of medicines financed from one's own pocket CZK 12 billion - surcharges CZK 16 billion - over-the-counter drugs 10  The availability of innovative medicines is at a good Availability of level in the Czech Republic innovative therapy The question is to what extent / restriction to patients Is this access on the systematic basis? 11 Already at the level of the registration process, patients' access to innovative therapies can be accelerated 12 Content Industry - innovative Generic Pharma EU legislation Roles / job functions in the farm-industry 13 AIFP Code of Ethics First of all, PATIENTS ARE THE CENTER OF EVERYTHING WE DO. We try to ensure that everything we do is for the benefit of patients. Our main benefit for society is the development of high-quality medicines and the support of their appropriate and justified use in medical procedures. We act honestly and act responsibly to ensure that our communications with stakeholders are accurate, legitimate and balanced. We take full responsibility for our decisions, actions and interactions, and we encourage others to adhere to the same stringent ethical standards. We negotiate with RESPECT with all interested parties. We are committed to dealing with them openly, responsibly and constructively, with a willingness to learn and with mutual respect. We recognize the importance of independent stakeholder decision-making, evidence-based and patient-centered. As for society, we listen to what he expects of us and adapt our way of working. When processing personal health data, we comply with applicable legislation and make ethical decisions. We strive to ensure TRANSPARENCY. We act openly about our activities and interactions with others, and we call on stakeholders to act with the same openness. 14 Impact on mortality by disease - data worldwide 15 Pharma industry as a major driver of progress - innovation Out of all the industries, it is the farm that spends the highest share on R&D - 15% of total net sales / profit On the example of AIDS - progress in therapy - results 16 17  EUR 943 700 million at producer prices Pharma market – The US and Canada still account for the largest share of about 50% Europe makes up about 25% During the period 2015-2020 the Brazilian, Chinese and Indian World wide(2020) markets grew by 11.3%, 4.8% and 10.0%, respectively compared to an average market growth of 5.0% for the top 5 European Union markets and 4.9% for the US market Distribution of drug revenues - worldwide (2020) 18 Innovative medicine has significantly reduced mortality and improved QoL 19 Number of employees in the Pharma industry (innovative) Recent studies in some countries have shown that frama research generates about three times more employment indirectly than directly (PwC, Economic and Social Pharmaceutical Industry in Europe, June 2019). In addition, a significant proportion of these are valuable skilled jobs, for example in academic or clinical sciences, which can help maintain a high level of knowledge base and prevent the loss of know-how 20 Research and Development - Farm Industry 12-13 years is the average time from molecule synthesis to launch of a new innovative LP ~ $ 2.5 billion average estimated cost of new LP development (DiMasi et al, Journal of Health Economics, January 2016) 1: 10,000 molecules / substances will eventually be successfully marketed 21 22 PHARMACEUTICAL INDUSTRY RESEARCH AND DEVELOPMENT IN EUROPE In Europe, approximately EUR 37 million was spent on R&D in 2019 Both clinical trial costs account for the largest (up to 50%) share of R&D R&D costs are still growing at a rate of about 5% year on year Recently, these are growing more in the US 23 24 25  Autoimmune diseases Top 20 innovative farm Hemato / Oncology companies worldwide Neurology Cardiology and top20 brands Diabetes 26 Company market capitalization 2023 Innovative industry in the Czech Republic Studie Ernst & Young 2010: The share of AIFP member companies' expenditures on science and research is almost 8 times higher than the average share of these expenditures in the entire Czech Republic, and significantly exceeds the traditional industrial sectors, such as the automobile industry. AIFP member companies employ 30 times more employees in science and research than the Czech average Uncertainty in the development of new drugs Between 2007-2010, 83 projects (NCEs) had to be completed in phase III / registration Content Industry - innovative Generic Pharma EU legislation Roles / job functions in the farm-industry 30  Medicines - Basic terms Medicine The Pharmaceuticals Act defines a medicinal product as a substance or combination of substances with therapeutic or preventive properties that can be used either to restore, modify or affect physiological functions through a pharmacological, immunological or metabolic effect, or to make a medical diagnosis. The original medicine An original medicinal product (sometimes referred to as a 'reference medicinal product') is the first authorized medicinal product with a new medicinal product that has not yet been contained in any other medicinal product. The active substance and possibly also the production process (know-how) is protected by a patent. An original medicinal product that successfully passes the marketing authorization will then have a withdrawal period during which no one will be able to place copies of such a product on the market. The manufacturer thus gains the opportunity to compensate for the costs he has invested in its development by selling the newly registered drug Generic medicine (generic) A generic is a legal copy of an original medicine. At the end of the withdrawal period, during which only the original drug could be on the market, generic products that contain the same active substance in the same pharmaceutical form (eg tablets or injections) come very quickly. Generics may contain other excipients. No complex research precedes the launch of a generic drug. However, all medicines, including generics, must be registered with the relevant medicines agency. However, generics have to provide much less evidence than the original medicinal product. In principle, the most important thing is to prove that they have the same properties as the original, ie the same effect, including the rate of onset, the duration of this effect, etc. does a generic medicine enter the market at a price that is on average 20 to 40% lower than the price of the original product? Generics thus bring savings to patients and also to health insurance companies, which are involved in the reimbursement of medicines to their policyholders. 31 Generics and The proportion / use of generics / biosimilar varies significantly around the world biosimilars The OECD average is 25% (financially), 52% (volume) Highest UK, Germany Czech Republic 26% (financially), 64% (volume) 32 Top 20 generic PharmaCo Sandoz Teva Stada Glenmark 33 Share of generics / biosimilars The ratio of original and generic in total market volume (at prescription drugs issued in the producer prices) - 2019 United States between 2005 and 2020 34 Generic industry benefits / healthcare systems savings and patient availability 35 Generic industry benefits / healthcare systems savings and patient availability Higher availability and treatment of cholesterol-lowering therapies is certainly one of the causes of declining standardized mortality from heart disease 36 „BIOSIMILARS“? it does not use the term "generic drug" for copies of biological medicines, but "biosimilars". This designation indicates that the drug is manufactured in a similar but not entirely identical manner and therefore may not be identical to the original. The European Union institutions in charge of drug regulation therefore stipulate that in order to place biosimilars on the market, its manufacturer must demonstrate not only chemical equivalence but also therapeutic compliance. Thus, unlike generics, a similar biosimal drug must undergo some clinical trial, but to a lesser extent than the original biological drug. It must therefore demonstrate efficacy in the treatment of the disease, not just chemical and pharmaceutical identity as in the case of traditional generic medicines. This ensures that biosimal drugs are a safe and effective alternative for patients. The specificity of biosimilars is also taken into account by the European Union in that it recommends not using only the name of the active substance (which is common in conventional drugs) to label biosimilars. Labeling several drugs with the same active ingredient can be confusing for both patients and physicians. At the same time, it would reduce the traceability of the causative agent of possible side effects. 37 Original vs. generic clinical trials & costs R&D original R&D generic # of patients Up to thousands Up to hunderds (biosimilar –study only in the main diagnosis) Lenght of Months/ years 3-5 week obseravtion Comparator Placebo, other active treatment Original medicine Study Reason Regulatory approval + other indication and Reg. Approval only strength the value/ evidence Costs hundreds mil. EUR; (2.0 billion EUR) units mil. EUR Generics... The only purpose of generics is to save on treatment costs Most of them have not been tested for efficacy and safety in clinical trials The legislation considers them interchangeable (with the exception of biosimilars) There are no differences in costs in the reference LP and generics for health care payers in the Czech Republic -30% biosimilars -40% generics (chemical molecules) Where to look for balance? ORIGINALS GENERICS Innovation and Significant price development reduction New therapeutic Expanding the procedures availability of medicines Justifiably higher price Saves money on new Patent protection originals „Only unsuccessful originals do not have generics “ Roles (for original and generic companies) are given, but conditions need to be created for them Originals Generics, biosimilars They bring innovation Significant price reduction Real innovation should reach Extensions for all patients patients Tools: Tools: Quick generic entry (days) HTA Reference prices Risk-sharing Release prescription Reimbursement covered by Possibility to guarantee volume evidence If the generic does not get If innovation doesn't pay off, the volume, it will fix the original companies play a prices generic game Content Industry - innovative Generic Pharma EU legislation Roles / job functions in the farm-industry 41 Why is the US more attractive for R&D? 10/20/2024 ©2023 Eli Lilly and Company 42 Global Corporate Affairs Conference | 2023 Access inequality Global Corporate Affairs Conference | 2023 Overhaul of the 20 year pharmaceutical legislation in Europe – political objectives “There should be no first and second class citizens”, European Health Commissioner 44 Global Corporate Affairs Conference | 2023 Europe’s policy proposals Intellectual Property Regulatory Cut Regulatory Data Protection by 2 1. Advanced Analytics was identified as the highest Only real upside years priority, enterprise-level capability needed in Lilly to Simplify and streamline processes realize the firm’s long-term goals in 2025. Conditions to recoup: 51 day increase in speed for stand. assessments o + 2y: ‘launch and supply’ + 6m: Run comparator trials Sustainability + 6m: Meet Unmet Need definition Expands Bolar exemption to HTA & P&R New medicines can be rejected by EMA based on Environmental Risk Assessment (ERA) Unmet Medical Need More restrictive definition affects RDP Supply Chain No other product / continued high Greater supply obligations - 6 months morbidity/mortality advance notification of shortages Medicine results in meaningful reduction Shortage Prevention Plans (SPPs) required of morbidity / mortality for all products “If you think we have enough innovation or too much of it, then this subtraction idea will achieve that goal.” Dave Ricks European Pharma legislation - Patent protection 46 Content Industry - innovative Generic Pharma EU legislation Roles / job functions in the farm-industry 47  Roles / functions within the innovative farm-industry (branch without production capacities) Sales Brand management Responsible for marketing Medical and shaping the brand/ representatives/ key product throughout the account managers whole product life-cycle responsible for selling Preparing the omnichannel medicinal products and campaigns and mkt direct commercial strategy and materials, and contact with HCPs congresses Commercial (sales, marketing) & supportive functions to partner with health care systems stakeholders Legal & Compliance To ensure all activities are according to law and are meeting the high ethical standards Supportive (non-branded), non-commercial function 48 Sources ČSÚ: https://www.czso.cz/csu/czso/vysledky-zdravotnickych-uctu-cr-m6hwrlzbbw EFPIA: https://www.efpia.eu/publications/downloads/ UZIS: https://www.uzis.cz/index.php?pg=vystupy--mezinarodni-srovnani OECD Health: https://data.oecd.org/health.htm AIFP: https://www.aifp.cz/cs/ ČAFF: https://www.caff.eu/ AVEL: https://www.avel.cz/ FDA: http://www.fda.gov/ EMA: http://www.ema.europa.eu/ema/ SUKL: http://www.sukl.cz/modules/medication/search.php SUKL distribuce: https://www.sukl.cz/modules/distributors/index.php?filter%5Bname%5D=&filter%5Bcity%5D=&filter%5 Bperson%5D=&filter%5Btype%5D=&filter%5Brange%5D=&a%5Bindex%5D=Vyhledat 49  Thank you! 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