OFFICE OF THE Remarks to the AMSUS 2018 ANNUAL MEETING Admiral Brett P. Giroir, M.D. Assistant Secretary for Health Senior Advisor for Opioid Policy @HHS_ASH November 27, 2018
U.S. LIFE EXPECTANCY: 1900-2015 Life Expectancy (years) 90 80 70 60 50 40 30 1900 1903 1906 1909 1912 1915 1918 1921 1924 1927 1930 1933 1936 1939 1942 1945 1948 1951 1954 1957 1960 1963 1966 1969 1972 1975 1978 1981 1984 1987 1990 1993 1996 1999 2002 2005 2008 2011 2014 PUBLIC HEALTH SUCCESSES Influenza and Pneumonia Enteric Diseases Stroke and CV Disease Tuberculosis Cancer Accidents https://www.cdc.gov/nchs/data-visualization/mortality-trends/index.htm 2
U.S. HEALTH CHALLENGES IN THE 21 st CENTURY Highest global spending on health: $3.3 trillion (17.9% of GNP) MASS GENERAL S INPATIENT ADJUSTED COSTS PER LIVE DISCHARGE Health care spending is predicted to reach $5.7 trillion by 2026 Meyer GS et al. N Engl J Med 2012;366:2147-2149 3
U.S. HEALTH CHALLENGES IN THE 21 st CENTURY Life Expectancy - Among the 36 OECD* nations, the U.S. ranks 28th in life expectancy; 33rd in infant mortality; 32nd in suicide rate - In 2015 and 2016 life expectancy decreased in the United States Sexually Transmitted Diseases - Highest number ever reported in U.S. in 2016; - >2 million; 50% in adolescents and young adults Influenza and Infectious Diseases - Enhanced risks from pandemic influenza, emerging infectious diseases, anti-microbial resistance Rogue States and Organizations - Intentional chemical, biological, radiological, and nuclear attack *Organization for Economic Development and Cooperation 4
5 U.S. DRUG OVERDOSE DEATHS THE MOST CRITICAL PUBLIC HEALTH CHALLENGE OF OUR TIME 5
6 OVERDOSE MORTALITY BY CLASS OF DRUG ADAPTED FROM CDC STATISTICS, NOVEMBER 2018 HEROIN NAT & SEMI SYNTHETIC METHADONE SYNTHETIC OPIOIDS COCAINE PSYCHO- STIMULANTS APRIL 2017 * 16,345 15,405 3,419 24,234 12,565 8,787 APRIL 2018 * 15,357 14,264 3,279 30,545 14,830 11,398 Change -6.0% -7.4% -4.1% +26.0% +18.0% +29.7% * Number of deaths for the 12 months ending in April of the indicated year. 6
CRITICAL ROLE OF LAW ENFORCEMENT CURBING ILLICIT IMPORTATION May 25, 2018 Inside a truck in Nebraska, troopers found enough fentanyl to kill millions of people State troopers seized 118 pounds of fentanyl That amount of fentanyl would contain enough lethal doses to potentially kill more than 26 million people Largest fentanyl seizure in state history and one of the largest in the United States Nebraska State Patrol, courtesy 7
U.S. HEALTH CHALLENGES IN THE 21 ST CENTURY June 27, 2014 Recruits' Ineligibility Tests the Military More Than Two-Thirds of American Youth Wouldn't Qualify for Service, Pentagon Says the Defense Department estimates 71% of the roughly 34 million 17- to 24-year-olds in the U.S. would fail to qualify to enlist in the military if they tried... Physical Fitness, Drug Abuse, Education 8
PREDICTED OBESITY OF TODAY S TWO YEAR OLDS Ward ZJ et al. N Engl J Med 2017;377:2145-2153 N Engl J Med Volume 377(22):2145-2153, November 30, 2017 9
INEQUALITIES IN LIFE EXPECTANCY AMONG U.S. COUNTIES 1980 2014 (DWYER-LINDGREN, 2017) Inequalities in life expectancy among counties are large and increasing over time Difference in life expectancy between the lowest ranking county and the highest ranking county is 20.1 years (66.8 86.9 years) 10
GLOBAL HEALTH CHALLENGES IN THE 21 st CENTURY Ebola Cases, DRC INFECTIOUS DISEASE Malaria: 216M cases and 445,000 deaths annually Tuberculosis: 25% of world population infected 1.7M deaths annually HIV/AIDS: 36.9M people infected 1.8M new cases in 2017 Neglected Tropical Diseases: >140 diverse communicable diseases affecting the poorest 1B people on the planet (examples include Dengue, Hookworm, Schistosomiasis) RISKS OF PANDEMICS: Influenza, SARS, MERS, Ebola, others NON COMMUNICABLE DISEASE Cancer, Cardiovascular Disease, Diabetes, Chronic Lung Disease caused 37% of deaths even in low income countries 16,000+ Children Die Every Day of Preventable Diseases 11
12 HHS PRIORITIES THE OPIOID CRISIS HHS is committed to ending the crisis of opioid addiction and overdose in America HEALTH INSURANCE REFORM HHS is working to improve the availability and affordability of health insurance Secretary Alex M. Azar II DRUG PRICING HHS is determined to lower the costs of prescription drugs for all Americans without discouraging innovation VALUE-BASED CARE HHS is working to transform our system to one that pays for value 12
Assistant Secretary for Health Senior Advisor for Opioid Policy OPPORTUNITIES TO EFFECT CHANGE USPHS Commissioned Corps World Health Organization 13
OASH OPPORTUNITY - Develop and coordinate the implementation of policies, investments, and frameworks to transform the current sick-care system into a health-promoting system OPIOID POLICY OPPORTUNITY - Whole of society, evidence-based, public health approach emphasizing prevention, naloxone access, treatment of addiction as a disease, and holistic needs for successful recovery USPHS OPPORTUNITY - Modernize the Commissioned Corps and employ it as an agent of change for those with the highest acute and/or chronic public health needs WHO OPPORTUNITY - Build resilient national public health primary care systems to enhance global health security 14
OASH: DEVELOPING THE ROADMAP FOR A HEALTHIER NATION 15
BULLY PULPIT OF THE SURGEON GENERAL VADM Jerome Adams 16
SELECT OASH PRIORITY INITIATIVES Infectious Diseases - Reducing new cases of HIV by 50% within 5 years - Increasing HPV coverage rate to 80% within 5 years - Incentivizing adult vaccination through reimbursement reform - Developing a national plan to combat STDs Meeting the Physical Activity Guidelines for Americans - Developing a national plan for youth sports participation and physical activity targeting underserved communities and girls 17
SELECT OASH PRIORITY INITIATIVES Digital Determinants of Health - Developing the ethical, legal, and scientific frameworks to fully leverage social media for public health applications Chronic Kidney Disease - HHS wide comprehensive plan to improve the outcomes and cost of chronic renal failure Implementing the revised Common Rule 18
SELECT OASH PRIORITY INITIATIVES Health Disparities - Developing Office of Minority Health programs that serve as a catalyst and new framework for change - Implementing public health turn around teams focused on zip codes suffering worst health inequities - Improving sudden cardiac death and availability of CPR - Developing exemplar initiatives 19
SICKLE CELL DISEASE NEW FEDERAL WORKING GROUP Together with OASH and multisector partners, developing a national action plan for sickle cell disease OMH s #SickleCellStories 20
TOOLS AND APPROACHES Guidelines Global Agreements Policies Grants and Contracts Regulations Reimbursement and Workforce 21
22 https://www.hhs.gov/opioids/ 22
23 HHS OPIOIDS STRATEGY UPDATE RELEASED SEPTEMBER 17, 2018 The five-point HHS strategy to end the opioid crisis, unveiled under President Trump in 2017, uses the best science and evidence to directly address this public health emergency. Now, HHS is expanding the scope and improving the effectiveness of the strategy. Secretary Alex Azar 23
WHAT DOES EVIDENCE-BASED TREATMENT LOOK LIKE? FDA-approved medication (MAT) - Naltrexone: once a month injectable medication, blocks effects of opioids; - Methadone: long acting, once-daily, opioid from specially licensed programs; - Buprenorphine/naloxone: long acting, once daily/once monthly, opioid from prescriber offices Psychosocial Therapies - Education, coping skills, relapse prevention, PDMP monitoring and toxicology screening Recovery Services - Rebuilding One s Life - Social supports to welcome into a healthy community: family, friends, peers, faith-based supports - Assistance with needs that can impact treatment - recovery housing, transportation and child care - Employment/Vocational training/education Naloxone 24
1 ACHIEVING RESULTS IN COMBATTING THE OPIOID EPIDEMIC SINCE JANUARY 2017 The total morphine milligram equivalents dispensed monthly by retail and mail-order pharmacies declined by 27.8%. Number of unique patients receiving buprenorphine monthly from retail pharmacies increased by 21%. The number of naltrexone prescriptions per month from retail pharmacies has increased more than 47%. Naloxone prescriptions dispensed monthly by retail and mail-order pharmacies have increased by 367%. 25
1 PAIN RELIEVER USE DISORDER IS DECREASING NSDUH, 2017 Data; published Sept. 2018 26
27 NATIONAL SURVEY ON DRUG USE AND HEALTH, 2017 FIRST TIME HEROIN USERS DROPPED BY >50% (2016-2017) Past Year Heroin Initiates among People Aged 12 or Older (in Thousands): 2002-2017 NSDUH, 2017 Data; published Sept. 2018 27
28 ED VISITS FOR SUSPECTED DRUG OVERDOSE (% CHANGE) Q3 2017 Q4 2017 * 21 States Reporting * 25 States Reporting Source: CDC Enhanced State Opioid Overdose Surveillance Program (ESOOS) 28
29 12 MONTH OVERDOSE MORTALITY: CDC NOVEMBER 2018 12 MONTH MORTALITY 75000 70000 65000 60000 55000 HHS OPIODS TEAM GOAL: Reduce US drug overdose mortality by at least 15% (>10,000 lives annually) by January 2021 12-months ending in April 2018 50000 12 MONTHS ENDING IN MONTH 29
30 NALOXONE: AN ESSENTIAL PART OF THE OPIOIDS SOLUTION 30
LACK OF NALOXONE CO-PRESCRIBING TO PATIENTS AT RISK PDX, Inc - April June 2018 (verbal report to HHS) - 8600 pharmacies nationwide - For patients on MME > 50, rate of naloxone co-prescribing was 0.3% - For those prescribed naloxone, 40% never picked up prescription MEDICARE, 2017 - MME > 50: rate of naloxone co-filling was 1.3% - MME = 90 120: rate of naloxone co-filling was 1.6% - MME > 120: rate of naloxone co-filling was 5.2% Primary drivers of co-prescribing are states with mandatory co-prescription laws 31
NALOXONE PREFILLED SYRINGE OUT OF POCKET COSTS 2017 Payers Average OOP % Total Prefilled Syringe Rx % of Rx < $10 OOP % of Rx < $20 OOP WORKERS COMP - EMPLOYER $0.00 1.30% 100.00% 100.00% MODA HEALTH $0.52 1.80% 100.00% 100.00% FEDERAL EMPLOYEES/ FEHBP $3.57 6.70% 100.00% 100.00% HUMANA $4.42 1.30% 100.00% 100.00% COMMONWEALTH OF VIRGINIA (VA) $4.45 1.10% 85.70% 100.00% UNIONS-NATIONAL $4.63 2.80% 94.10% 94.10% BCBS CAREFIRST $4.93 2.00% 91.70% 100.00% BCBS ANTHEM/WELLPOINT/WELLCHOICE $5.01 7.50% 100.00% 100.00% PROVIDENCE HEALTH SYSTEMS $6.53 1.10% 100.00% 100.00% TRICARE $6.59 9.40% 98.30% 100.00% BCBS FLORIDA (FL) $7.55 3.10% 84.20% 89.50% CIGNA $7.82 2.80% 76.50% 100.00% BCBS/THE REGENCE GROUP $8.06 1.10% 85.70% 100.00% BLUE CROSS PREMERA $9.02 2.30% 78.60% 100.00% UNITED HEALTHCARE $9.46 8.00% 79.60% 93.90% SELECT HEALTH $11.21 2.10% 84.60% 100.00% BCBS SOUTH CAROLINA (SC) $12.14 1.30% 75.00% 75.00% KAISER FOUNDATION HEALTH PLANS $12.91 4.20% 50.00% 96.20% BCBS HEALTHCARE SERVICE CORP $13.12 2.60% 50.00% 87.50% OPTIMA HEALTH (VA) $17.12 1.50% 44.40% 55.60% 32
NARCAN OUT OF POCKET COSTS FOR LARGEST PAYERS 2017 Payers Average OOP % of Total Narcan Rx % Rx < $10 OOP % Rx < $20 OOP WORKERS COMP - EMPLOYER $0.93 1.30% 99.90% 100.00% PRESBYTERIAN HEALTH PLAN (NM) $8.52 1.80% 95.10% 95.30% TRICARE $10.48 7.60% 97.40% 97.80% OPTIMA HEALTH (VA) $18.37 2.10% 65.10% 67.20% UNIONS-NATIONAL $20.79 2.90% 38.60% 52.20% CIGNA $21.76 4.30% 54.00% 57.70% BCBS FLORIDA (FL) $22.11 1.40% 68.10% 69.00% UNITED HEALTHCARE $23.74 5.60% 58.40% 59.60% COMMONWEALTH OF VIRGINIA (VA) $24.32 1.60% 41.10% 45.80% BCBS ANTHEM/WELLPOINT/WELLCHOICE $24.73 6.20% 40.40% 54.30% BCBS HEALTHCARE SERVICE CORP $26.04 2.80% 47.60% 60.60% BCBS NORTH CAROLINA (NC) $27.65 2.60% 60.20% 66.10% AETNA INC $28.12 4.30% 40.90% 44.90% FEDERAL EMPLOYEES/ FEHBP $28.24 7.20% 46.50% 46.90% BCBS TENNESSEE (TN) $28.75 1.20% 62.70% 63.70% BCBS MICHIGAN (MI) $29.66 1.00% 43.50% 51.80% BCBS HIGHMARK $30.65 1.00% 29.80% 40.50% BCBS CAREFIRST $34.92 1.70% 22.00% 36.90% HUMANA $35.89 0.80% 42.00% 54.60% BLUE CROSS MASSACHUSETTS $48.02 0.90% 9.80% 23.20% 33
MEDICARE OUT OF POCKET COSTS The CY 2018 Part D plan-level formulary inclusion and prior authorization (PA) rates are: - Naloxone PF syringes: on 99.3% of plan formularies, PA on 0.3% - Narcan: on 94.7% of plan formularies; no plans require PA - Evzio: on 5.9% of plan formularies; PA on 44.7% The average cost-sharing (excludes low income subsidy enrollment) - Naloxone PF syringes: $13.86 per syringe (copay plans) or $4.57 (coinsurance plans) - Narcan: $51 per 2 nasal sprays (copay plans) or $39.20 (coinsurance plans) - Evzio: $90 per 2 injectors (copay plans) or $1,707.65 (coinsurance plans) 34
U.S. PUBLIC HEALTH SERVICE COMMISSIONED CORPS the Commissioned Corps a mobile, duty-bound group of health officers willing to go anywhere, at any time, to meet the nation s most urgent public health needs. Craig Collins The PHS Commissioned Corps Two Centuries and Counting 35
36 NOTABLE DEPLOYMENTS USPHS COMMISSIONED CORPS 36
PUBLIC HEALTH SERVICE COMMISSIONED CORPS MODERNIZATION SELF ASSESSMENT Strong HHS and inter-departmental support for Commissioned Officers expertise and leadership Between 2013 and 2018, officers deployed over 6,000 times, contributing more than 116,000 deployment-days to more than 110 missions ~50% of officers participated in intra-agency response missions since 2016 Projected increase demand for officers: deployments and agency missions Persistent provider shortages for underserved and vulnerable populations of up to 25% could be best filled by officers A bold strategic vision to enhance the capabilities, responsiveness, mission set, and focus of our service 37
38 VISION FOR A 21 st CENTURY COMMISSIONED CORPS A highly-trained, always-ready, fully-deployable national asset to preserve public health and national security during national or global public health emergencies A fundamental instrument of national response for non-emergent, yet critical, public health challenges within the United States and territories A provider of direct health care, public health leadership, and scientific expertise when specifically needed to fulfill U.S. Government requirements An innovation engine for public health technologies, communications, systems, and systems of systems MISSION DRIVES THE REQUIREMENTS; REQUIREMENTS DRIVE THE FORCE STRUCTURE 38
PUBLIC HEALTH INNOVATION CONTEXT AND CONTINUUM BASIC RESEARCH TRANSFORMATIONAL APPLICATIONS TEST AND EVALUATION DISSEMINATION AND ADOPTION NIH NSF NGOs Biotech DARPA: High risk early and intermediate development (tech and capabilities push) BARDA: Intermediate and advanced development within authorized areas Accelerating Clinical Innovation: Clinical needs and opportunities pull; systems demonstrations USPHS Commissioned Corps: Deployments and PHEs Public health turnaround teams and missions Clinical care in underserved and rural environments Military Medicine HHS Operational Divisions: CMS, HRSA, CDC, SAMHSA, others Federal Partners (VA, DoD) Integrated Health Systems NGOs, WHO, and international partners 39
PRIORITIES FOR PUBLIC HEALTH INNOVATION Orthogonal technologies and paradigms for the current most costly medical issues (for example, hemodialysis, falls, sepsis, pain) Technologies and approaches that allow for more advanced care outside of hospital settings including in rural environments (strong synergy with military medicine) Socio-behavioral approaches and distributive technologies to transform the current sick care system into a health promoting system Big data, social networks, and digital platforms for public health, including epidemiology, prediction, prevention, and treatment 40
PRIORITIES FOR PUBLIC HEALTH INNOVATION Models to minimize U.S. regional health disparities End U.S. infectious disease epidemics within our technical control: HIV, HCV, HPV, influenza Integration of genetic cures and immunotherapies as cornerstones of the health care system Developing a new paradigm for understanding and treating neurodegeneration Global health security: an endogenous global capacity, early warning, detection, diagnosis, rapid mitigation, and assured effective response 41
WHERE WILL WE STAND ON BEHALF OF PUBLIC HEALTH? The New York Times The flying machine which will really fly might be evolved by the combined and continuous efforts of mathematicians and mechanicians in from one million to ten million years We started assembly today Orville Wright s Diary October 9, 1903 October 9, 1903 42
BRETT P. GIROIR, M.D. ADM, U.S. Public Health Service Assistant Secretary for Health, Senior Advisor for Opioid Policy WWW.HHS.GOV/ASH WWW.USPHS.GOV @HHS_ASH Brett.Giroir@hhs.gov 43