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Walter Robinson Vice President Government Affairs October 30, 2014 PPF – Purpose of Today A salient discussion to bring together senior leaders from across sectors to explore opportunities for collaboration in sustainably managing drug costs and enhancing health access in the Atlantic region Rx&D – Purpose of Today A salient discussion to bring together senior leaders from across sectors to explore opportunities to collaborate in sustainably managing drug costs and enhancing health access and improving health outcomes in the Atlantic region and across Canada Health System Sustainability Asking the right questions … • Do our solutions support patients? • Are policy solutions rooted in evidence? • Do proposed approaches align with other policies? • Are we thinking short-term & long-term … $$$ and outcomes? • Have we unleashed the value of medicines? About Rx&D Our Members Contribution to Canada • 55 research-based companies (international and Canadian start-up) • Account for 46,000 Canadians jobs (direct and indirect) • Annually invest over $1B into pharmaceutical R&D and related activities • 3,000+ clinical trials across Canada • $750M into hospitals/communities • Annually contribute $3B to GDP • Support a vibrant and national life-sciences community About Rx&D Rx Medicines in Context Rx Medicines in Context • Life expectancy in Canada 1914 2014 52 80 57 84 • Public Health partner in newborn, school-age, seasonal and pandemic vaccination efforts • Steady increases in cancer, cardiovascular, diabetes, HIV/AIDs and other disease survival rates due to new innovative therapies – Cancer survival rates, especially in prostate, breast, lung and colorectal cancers have declined steadily since Canada’s peak of deaths/1,000 in 1988 • Total Rx medicines spend (public & private) in Canada -- 6.2%* * PMPRB/CIHI derivation -- 2012 Value of Medicines: Life and Longevity Acute Myocardial Infarction* 0% -10% Heart Disease** -20% Respiratory Illnesses** -26% -30% -40% -50% -34% -40% -45% Breast Cancer**** Colon Cancer* -60% HIV*** -70% -80% -77% -76% -78% Prostate Cancer***** Sources: OECD Health Data, *1980-2009; ** 1970-2009, ***1995-2009; *****1990-2004; Canadian Cancer Society, Canadian Cancer Statistics, ****1986-2012. Value of Medicines: System Impacts Fewer days in hospital: Canada Asthma 0% Breast Cancer -8% -10% Diabetes -20% -20% -30% -29% -31% -40% -50% -80% Acute Myocardial Infarction HIV/AIDS** -50% -50% -60% -70% Hypertensive diseases Prostate Cancer -60% -71% -70% Respiratory Infections/Influenza Ulcers Sources: OECD Health Data, *1980-2009; ** 1970-2009, ***1995-2009; *****1990-2004; Canadian Cancer Society, Canadian Cancer Statistics, ****1986-2012. Source: OECD Health Data 2012, 1980-2009, except **: 1986-2008. About Rx&D Rx Medicines in Context Pan-Canadian Pharmaceutical Alliance (PCPA) PCPA: Background • August 2010 – “Bulk Purchasing” discussion at Council of the Federation (CoF) • August 2014 – CoF announces $260M in total annual savings – Quebec to join, rumours of Federal Plans too, name change • Pricing is the driver … value of medicines, patient access, and system sustainability are tertiary considerations PCPA: Objectives * • Increase access to drug treatment options • Improve the consistency of drug listing decisions across the country • Capitalize on combined buying power of jurisdictions • Achieve consistent pricing and lower drug costs • Reduce duplication of negotiations and improve utilize of resources * Presented by PCPA – February 2013 at Pharmacare 2020 conference in Vancouver PCPA: Objectives • Increase access to drug treatment options • Improve the consistency of drug listing decisions across the country • Capitalize on combined buying power of jurisdictions • Achieve consistent pricing and lower drug costs • Reduce duplication of negotiations and improve utilization of resources PCPA: Status as of September 30, 2014 Therapeutic Area Oncology Completed 22 CVS 8 COPD 3 MS 4 Allergy 1 C-Difficile 1 CF 1 HCV 1 HIV 1 PKU 1 Rare 2 Rheumatoid Arthritis 1 37 negotiations w/ 18 Rx&D Members 46 PCPA in Context 10 million of 35 million Canadians covered by public drug plans After 4 yrs: $260M saved through CVPI / PCPA or $7.43 per CDN 10 public drug plans in 2014/2015 invest $11.3 billion $260M represents 2.3% of this amount Provinces in 2014/2015 devote $138 billion to healthcare $260M represents 0.19% of this amount Let’s address the other 99.81% ? About Rx&D Rx Medicines in Context Pan-Canadian Pharmaceutical Alliance (PCPA) The Real Driver: Utilization The Real Driver is Utilization • Patented Medicines Price increases have grown below the rate of inflation for 23 of the last 25 years (PMPRB PMPI -- 2013 Annual Report) • Canadian prices below MIP for last 12 years … 2001 to 2013 • “Growth in use, not price, is driving cost increases” (PMPRB October 2011) – – – – – – Canada’s population is growing The demographic mix is changing There is a rise in the incidence of health problems that require drug therapy The prescribing practices of physicians have changed Drug therapy is becoming more popular than other forms of treatment There are new drug therapies to treat conditions for which no effective treatment was previously available • Provincial transformation efforts can drive pharmacotherapy – Primary Care reform, age-in-place strategies and expanded scope of practice 25-Year Expenditure Trendline $2,500.00 $2,000.00 Hospitals, Institutions, Capital Physicians, Professionals Public Health, Administration, Other *Prescribed Drugs *Estimated Direct Spending on Patented Prescribed Drugs $1,500.00 $1,000.00 $500.00 $0.00 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012f Analysis: Canadian Health Policy Institute (CHPI). Data: Canadian Institute for Health Information (CIHI), Patented Medicine Prices Review Board (PMPRB). Public System Use of Funds Prov’l/Territorial Government Health Expenditure by use of funds vs. GDP 5-year Aggregate Growth 2006-07 to 2011-12 in current $ 60.0% 53.4% 50.0% 40.0% 44.2% 34.5% 43.6% 34.4% 33.3% 27.2% 26.7% 30.0% 21.7% 18.2% 20.0% 10.4% 10.0% 0.9% 0.0% Hospitals Other Institutions Physicians Other Professionals Drugs Capital Public Health Administration Other Health Spending Total GDP Sources: CIHI NHEX 2012; patented drugs estimated using PMPRB 2011 Annual Report. Calculations: B. Skinner. Patented Drugs (est) Rx Cost Curve: Already Bent About Rx&D Rx Medicines in Context Pan-Canadian Pharmaceutical Alliance (PCPA) The Real Driver: Utilization Adherence Supports Sustainability WHO: Adherence is the Issue • Poor adherence to treatment of chronic diseases is a worldwide problem of striking magnitude • The impact of poor adherence grows as the burden of chronic disease grows worldwide • The consequences of poor adherence to long-term therapies are poor health outcomes and increased health care costs • Improving adherence also enhances patients’ safety • Adherence is an important modifier of health system effectiveness Predictors of Non-Adherence • • • • • Disease with no symptoms Complexity of regimen: once vs multiple times/day Time gap around a visit to a healthcare professional Side effects of a medication, adverse events tolerability Levels of education, income, age, cognitive function, insurance coverage • 1/3 to 2/3 of medication related hospital visits • Diabetes: less than 40% adherence, 15% hospitalization rate close to 100% adherence, 4% hospitalization rate Non-Adherence by Disease State * - CVS up to 50%; Depression up to 57% - COPD (Asthma), Diabetes, GI disorders, neurological and HIV/AIDS * Risk Management and Healthcare Policy July 2014 – Johns Hopkins University School of Medicine Public Drug Programs – Clients/Conditions • • • • • Disease with no symptoms Complexity of regimen: once vs multiple times/day Time gap around a visit to a healthcare professional Side effects of a medication, adverse events tolerability Levels of education, income, age, cognitive function, insurance coverage • 1/3 to 2/3 of medication related hospital visits • Diabetes: less than 40% adherence, 15% hospitalization rate close to 100% adherence, 4% hospitalization rate Major Conditions Treated - CVS, Mental Health - COPD, Diabetes, GI disorders Magnitude of Non-Adherence 50% According to the WHO 50% of patients don’t take their medications and 33% never even fill their first prescription 1 $290 billion New England health care Institute (NEHI) estimates that overall poor adherence cost as much as $290 billion/year 2 3.5X Non-adherent chronic diseases patients cost their plan 3.5X more in claims 3 4% to 11% of US $2.7 trillion spend on healthcare 1 - Adherence to long-term therapies, Evidence for action, World Health Organization. 2003 2 - NEHI, How many more studies will it take? A collection of evidence that our health care system can do better. Low range around $100 billion/year. 2008 3 - Green Shield, GSC 2013 Drug Study, the inside story. 2013 Adherence Impact in Canada $215 billion spend (public and private) 11% estimate: $24 4% estimate: billion in cost avoidance $8.6 billion in cost avoidance About Rx&D Rx Medicines in Context Pan-Canadian Pharmaceutical Alliance (PCPA) The Real Driver: Utilization Adherence Supports Sustainability Partnership = Leadership Partnership = Leadership • Agree to collaborate, involve all stakeholders • Research, develop, fund and implement a Plan • Support patients, don’t blame them – Tailor solutions to diseases and patients • Train healthcare professionals • Integrate adherence efforts into system transformation • Multidisciplinary approach – HCPs, industry, governments, private payers, academe, PATIENTS • Measure it, be accountable, improve and report to Canadians Health System Sustainability Asking the right questions about Adherence … • Do our solutions support patients? • Are policy solutions rooted in evidence? • Do proposed approaches align with other policies? • Are we thinking short-term & long-term … $$$ and outcomes? • Have we truly unleashed the value of medicines? @RxandD @walterrobinson [email protected] Value of Medicines Broader Society Broader Economy Health Spending Better Health Outcomes • Superior clinical outcomes and prevent downstream complication • Better SE profile • Better adherence Health Spending • Decreased need for adjacent health services • Increased efficiency in health care resources • Better value compared to alternative therapies Broader Economy • • Productivity gains Reduced disability and absenteeism claims Health Status Broader Society • Better quality of life for patients and for the informal caregivers Milestones Drug Funding Process: Patent Filing to PCPA Negotiations Drug Discovery Patent Filing Pre-discovery Pre-Clinical 3-6 Years Recommendation issued (CDR, pCODR) Phase I Clinical Trials Phase II 6-7 Years Health Canada Submission Up to 2 Years Manufacturer submits to CDR/pCODR pERC/CDEC makes recommendation to drug plans PCPA/provincial review Manufacturer Submission HC issues NOC & DIN CDR Reviews Product HTA Review Up to 1 Year Tabled at next PCPA bi-weekly teleconference Phase III Completion of Phase III Research HC Submission ≤ 2 weeks OR pCODR Reviews Product ≤ 2 weeks Confirm no negotiation on “DO NOT LIST” FILES Participation confirmed and lead assigned ≤ 2 weeks Letter sent to manufacturer informing of decision Variable Negotiation with Payers Variable Negotiation with Provinces OR Negotiation with PCPA Negotiation PhamaFocus 2018 (IMS Brogan) C $Billions Country United States Japan China Germany France Italy United Kingdom Brazil* Spain Canada 10 Key Markets Worldwide Sales, US $ % Market Billions, Share, MAT June MAT June 2014 2014 354.8 39.2 82.2 72.2 45.5 37.9 28.7 23.8 22.9 21.2 21.0 710.1 904.7 9.1 8.0 5.0 4.2 3.2 2.6 2.5 2.3 2.3 78.5 100.0 % Growth, Constant US $, MAT June 2014 +10.7 +2.5 +13.0 +5.3 -0.6 +4.0 +7.5 +15.1 CAGR 2009-2013 +2.7 +2.5 +23.2 +2.9 -0.9 +2.0 +2.8 +17.7 +3.4 +2.7 8.2 7.7 Notes: Prices are reported at the ex-manufacturer level (price when sold from manufacturer to wholesaler or direct to pharmacies). Information includes OTC products where available. *Pharmacy market only. % growth, constant US $. Source: IMS Health. MIDAS. MAT June 2014 -1.0 +0.5 3.9 4.9