Can Public Policy Control Rising Drug Prices?

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1 Can Public Policy Control Rising Drug Prices? Vivian Ho, PhD James A. Baker III Institute Chair in Health Economics Director, Center for Health and Biosciences Professor, Department of Economics at Rice University Professor, Department of Medicine at Baylor College of Medicine The Houston Economics Club November 7, 2018 #BakerHealth

2 What is the problem? Outline Policy Options Legislation Expert Recommendations Trump Administration

3 Billions $4,000 $3,500 $3,000 $2,500 $2,000 $1,500 $1,000 $500 $ National Health Expenditures Total Expenditures Percent Growth * 2018* 14.0% 12.0% 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% Percent Change from Previous Year * projected

4 Average Annual Percent Change from Previous Year National Health Expenditures Hospital Care Physician and Clinical Services Prescription Drugs Epipen $264 Epipen $349 Daraprim $750 Epipen $461 Epipen $608 * projected

5 Medicare Trustees Estimates for 17-27: Average Annual Growth in Medicare Beneficiary Costs for Part A, Part B, and Part D Between 2017 and Part A Part B Part D Per beneficiary spending: 2017 $5,160 $5,915 $2, $7,443 $10,004 $3,296 Source: 2018 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and Federal Supplemental Medical Insurance Trust Funds

6 National Health Expenditures Hospital Care Physician and Clinical Services Prescription Drugs Percent Distribution

7 Old drug price inflation - Valeant Pharmaceuticals

8 Average Annual Prescription Drug Price Change vs. Inflation Source: Trends in Retail Prices of Prescription Drugs Widely Used by Older Americans: , AARP Public Policy Institute 2017.

9 Annual Percentage Change in Retail Prices by Drug Type, Source: Trends in Retail Prices of Prescription Drugs Widely Used by Older Americans: , AARP Public Policy Institute 2017.

10 Commonly Prescribed Drugs for Seniors The top 20 most commonly prescribed brand-name drugs for seniors in Medicare Part D in 2015 were: Advair Diskus Nexium Restasis Ventolin HFA Crestor Nitrostat Spiriva Handihaler Voltaren Gel Januvia Novolog Symbicort Xarelto Lantus/Lantus Solostar Premarin Synthroid Zetia Lyrica Proair HFA Tamiflu Zostavax Source: US Senate Homeland Security and Government Affairs Committee, Minority Office, March 2016

11 Popular Drug Price Change vs. Inflation Source: US Senate Homeland Security and Government Affairs Committee, Minority Office, March 2016

12 Total U.S. Prescriptions of Most Commonly Prescribed Brand-Name Drugs Product 2012 Prescriptions 2017 Prescriptions Prescription Difference Percent Change (U.S. Total) (U.S. Total) ( ) ( ) Ventolin HFA 17,414,376 27,069,765 9,655,389 55% Proair HFA 24,873,170 25,977,546 1,104,376 4% Synthroid 23,073,988 18,411,640-4,662,348-20% Lantus/Lantus Solostar 18,558,937 17,004,123-1,554,814-8% Advair Diskus 17,018,219 10,700,788-6,317,431-37% Lyrica 9,114,028 10,373,276 1,259,248 14% Januvia 8,893,922 9,913,198 1,019,276 11% Symbicort 5,246,325 9,888,532 4,642,207 88% Xarelto 1,078,207 9,593,823 8,515, % Spiriva Handihaler 9,625,240 5,759,976-3,865,264-40% Novolog 3,385,303 5,045,237 1,659,934 49% Restasis 2,818,474 3,037, ,797 8% Nexium 22,021,459 2,246,968-19,774,491-90% Tamiflu 3,313,707 2,143,796-1,172,911-35% Premarin 5,223,690 2,046,125-3,177,565-61% Voltaren Gel 2,954,278 1,964, ,613-33% Zetia 7,915,532 1,730,633-6,184,899-78% Crestor 25,337,566 1,604,070-23,733,496-94% Zostavax 2,291,538 1,344, ,921-41% Nitrostat 4,273, ,442-3,963,971-93% Total 214,434, ,165,491-48,268,881-33%

13 Price Prescription Drug Demand P 2017 P 2012 D Q 2017 Q 2012 Quantity

14 Prices Matter

15 15 Historical prices for one week of treatment with Enbrel and Gleevec

16 Declining value Prices of Gleevec vs. iphone over time $3,000 $2,500 Cost ($) $2,000 $1,500 $1,000 $500 Price of iphone/ghz with contract AWP of 1 week treatment of 400mg Gleevec $ Year

17 Value (benefits in relation to costs) declining

18 Why we should care patient access Access Spending

19

20

21 Policy Drug Policy Legislation Introduced since 2015 Allow Importation / Re importation Boost Generic Competition Reduce Branded Monopolies Ban/Restrict DTC Advertising Require Price & Cost Transparency Use Value-based payment Apply Price Inflation Limiters Let Government be the Purchaser Legislate Access to Treatment Require Rebates to Mcare/caid Legislators McCain (R-AZ), Franken (D-MN), Klobuchar (D-MN), Sanders (I-VT), Ellison (D-MN) Cruz (R-TX), Smith (D-WA), Stivers (R-OH), Brown (D-OH), Franken (D-MN), Klobuchar (D-MN), Shrander (D-OR), Sanders (I-VT), Vitter (R-LA), Leahy (D-VT), Collins (R-ME), McKinley (R-WV), Goodlatte (R- VA) Wyden (D-OR), Franken (D-MN), Sanders (I-VT), Lance (R-NJ), Ryan (R-WI) DeLauro (D-CT), Franken (D-MN) Franken (D-MN), Wyden (D-OR), Sanders (I-VT), Baldwin (D-WI), Durbin (D-IL), Perlmutter (D-CO), Collins (R-GA) Ryan (R-WI), President Donald Trump Franken (D-MN), Wyden (D-OR), Brown (D-OH), DeLauro (D-CT) Sanders (I-VT), Baldwin (D-WI), Franken (D-MN), Klobuchar (D-MN) Sanders (I-VT) Sanders (I-VT)

22 Released: November 30, 2017

23 NASEM Rec A: Boost Generic Competition Pass legislation to eliminate pay-for-delay practice. Stop brand-name drugs from unfairly restricting access to samples that generic makers need to formulate competing drugs.

24

25 May 17, November 8,

26 Requested Listed Drug Inquiries Drug Company # Inquiries Absorica (isotretinoin) Ranbaxy 5 Exjade (deferasirox) Novartis 6 Letairis (ambrisentan) Giliad 10 Revlimid (lenalidomide) Celgene 13 Source: s/abbreviatednewdrugapplicationandagenerics/ucm htm

27 NASEM Rec B: Let Government be the Purchaser Because prices tend to be lower when the purchaser has bargaining power that is at least comparable to that of the seller, the United States could achieve lower prices for prescription drugs by consolidating bargaining power The law bars the govt. from negotiating drug prices for Medicare Part D. Other countries are able achieve lower prices through regulations and negotiation. But U.S. policy makers were lobbied heavily by drug companies.

28

29 NASEM Rec C: Require Greater Price and Cost Transparency Source: National Academies of Sciences, Engineering, and Medicine Making medicines affordable: A national imperative.

30 Source: National Academies of Sciences, Engineering, and Medicine Making medicines affordable: A national imperative.

31 Source: National Academies of Sciences, Engineering, and Medicine Making medicines affordable: A national imperative.

32 Source: National Academies of Sciences, Engineering, and Medicine Making medicines affordable: A national imperative.

33 Source: National Academies of Sciences, Engineering, and Medicine Making medicines affordable: A national imperative.

34 Source: Kaiser Health News, May 30, 2018

35 Frequency and Mean Overpayment Among Pharmacy Claims with Patient Co-pay, 2013 Drugs No. of Claims Frequency of Claims % with overpayment Mean All 9,539, Generic 7,295, Brand 2,244, Source: Van Nuys K. et al, JAMA 2018.

36 NASEM Rec G: Modify the 1983 Orphan Drug Act Cures for rare diseases those affecting less than 200,000 persons in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from the sale in the United States. Health Promotion and Disease Prevention Amendments of 1984, Public Law , 98 Stat 2815 (1984), 4.

37 Benefits to Orphan Drug Makers 7 add l years of patent protection. Expedited regulatory review process. Including fewer patients required for clinical trials. Tax credits to help support drug testing. Orphan drugs have higher prices.

38 Problems with Orphan Drug Act Orphan drug status granted for a subset of possible patients, then use is marketed to a larger population. Rituximab granted orphan drug status to treat lymphoma Now used for non-hodgkin s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and several skin disorders. Orphan drugs that have reached blockbuster status (>$1b in sales) Vioxx, Cialis, Botox Some drugs received multiple orphan designations. Gleevec has had 9, w/ $3.3b in sales for 2016.

39 Top lobbying industries in the U.S Top lobbying industries in the United States in 2017, by total lobbying spending (in million U.S. dollars) Spending in million U.S. dollars Pharmaceuticals/Health Products Insurance Electronics Mfg & Equip Business Associations Oil & Gas Electric Utilities Real Estate Hospitals/Nursing Homes Securities & Investment Health Professionals Misc Manufacturing & Distributing Air Transport Telecom Services Health Services/HMOs Education Note: United States; 2017 Further information regarding this statistic can be found on page 8. Source: opensecrets.org; CRP ID

40

41 4 Challenges High list prices for drugs Seniors and government programs overpaying for drugs due to lack of the latest negotiation tools High and rising out-of-pocket costs for consumers Foreign governments free-riding off of American investment in innovation

42 4 Key Strategies Improved competition Better negotiation Incentives for lower list prices Lowering out-of-pocket costs

43 Examples Stop brand name drugs from restricting access to samples needed by generic drug makers. Experiment with value-based purchasing in federal programs. Require manufacturers to include list prices in advertising. Prohibit gag clauses from insurer-pharmacist contracts.

44

45

46 rumps-dramatic-new-proposal-to-lower-medicare-drugprices-by-linking-to-an-international-index/#25d27c554c3a

47 Concluding Remarks Rising drug prices are a threat to the affordability of health care and health insurance. Multiple policy options exist for restraining cost growth. Many options unlikely to discourage innovation. Lobbying by drug companies is preventing forceful policy action.

48 Can Public Policy Control Rising Drug Prices? Thank you! For a copy of the presentation bakerchb@rice.edu

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