Health Economics Communication and FDAMA Section 114

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1 Health Economics Communication and FDAMA Section 114 Peter Neumann May 2, 2013 Presentation to Chicago ISPOR Chapter

3 CEVR All Rights Reserved 3 At a January conference, Assistant U.S. Attorney for the District of Massachusetts Sara Bloom flagged unsupported promotional claims of economic superiority as a potential area for future enforcement. From Sutter, S. Will the FDA s view on health economic claims change with more government-funded research? The Pink Sheet. 27 Feb 2012.

4 What is permissible? Section 114 is an interesting section, and it s not entirely simple to figure out what s included and what s not included. - Robert Temple, Feb 9, 2012 Cited in Sutter, S. Will the FDA s view on health economic claims change with more government-funded research? The Pink Sheet. 27 Feb CEVR All Rights Reserved 4

7 CEVR All Rights Reserved 7 The FDA Modernization Act of 1997 (Section 114) health care economic information formulary committee competent and reliable scientific evidence directly relates to an indication approved

8 AN EXAMPLE: RCT Model Drug LDL Cost/QALY

9 Other examples Utilization endpoints? Adherence claims? Extrapolations to other populations? Extrapolations to other dosages?

11 Who is using FDAMA Section 114?

12 Survey of Outcomes Directors at PhRMA companies, 2010 Internet survey HEOR directors at all PhRMA-member companies and top 11 biotech (n=33) 16/33 respondents (RR=46%) Source: Neumann et al., Pharmacoeconomics, 2011

13 Use of Section 114 Question % Stating familiar or very familiar How familiar are you with the FDAMA Section 114? 93.8%

14 Question % Stating frequently or always How often do you consider using Section 114 when making promotional claims? 81.3%

15 Question % Saying yes Does your company have internal legal/regulatory guidance on Section 114? 100%

16 Question % Stating < 50% For what percent of your drugs that had evidence to support their economic value, did you create a Section 114 promotional piece? 56.3%

17 Question % Saying 0-2 pieces For drugs that had evidence to support their economic value, how many Section 114 pieces do you create per drug year? 93.7%

18 Question % Agree What value does your company place on Section 114 promotion, compared to economic information contained in AMCP dossiers? Promotional economic information is more valuable 62.5% Equal in value 31.3% Economic information in AMCP dossiers is more valuable 6.3%

19 Question % Saying more often Did you expect to use Section 114 more often or less often in the future? 75.0%

20 Question % Agree If the FDA were to release guidance on Section 114, what area would be the most critical to address? Competent and reliable scientific evidence 48.3% Health care economic information 37.5% Directly related to an approved indication 12.5% Formulary committee or other similar entity 6.2%

22 CEVR All Rights Reserved 22 Objectives Investigate FDA letters regarding drug firms health economic promotions. How frequently has FDA considered such promotions false or misleading? Under what circumstances?

25 CEVR All Rights Reserved 25 Health economic violations categories Violation Productivity Comparative clinical claim in economic claim Cost-saving claims to broader audience Cost claims of incomparable dosages Other misleading price or cost comparisons Section 114

26 CEVR All Rights Reserved 26 Results Violation n % Productivity Comparative clinical claim in economic claim 7 19 Cost-saving claims to broader audience 3 8 Cost claims of incomparable dosages 3 8 Other misleading price or cost comparisons 3 8 Section Total 36* 100 *35 letters considered, one letter contained two types of violations

34 CEVR All Rights Reserved 34 Misleading comparison in economic claim Many prescription plans are raising the co-payment cost of Clarinex*, Zyrtec*, and Allegra*. But 99% of prescription plans cover FLONASE.*

37 CEVR All Rights Reserved 37 Conclusions Companies are actively promoting on value FDA concerns about work function and backdoor clinical claims within economic promotions Absence of letters citing Section 114 More guidance from FDA needed?

41 CEVR All Rights Reserved 41 Proposal Type of information Evidentiary standard Intended Audience Legal authority Clinical data from RCTs Substantial evidence Physician and consumers FDCA Health care economic information CRSE* Payers FDAMA Section 114 CER using observational data CRSE* Payers Proposed legislative change *Competent and reliable scientific evidence

43 CEVR All Rights Reserved 43 Challenges Already existing channels for CER promotion E.g., unsolicited requests, peer-reviewed articles Concerns about misleading audiences with non- RCT data Remove incentive to conduct actual RCTs

44 Conclusions Intense interest in promoting on value FDA concerns about backdoor clinical claims within economic promotions. Section 114 allows promotion of HCEI to health plans but has restrictions and there has been no guidance. New legislation extending 114 to CER may CEVR All Rights Reserved help 44

WASHINGTON LEGAL FOUNDATION

Docket No. FDA-2016-D-1307 COMMENTS of WASHINGTON LEGAL FOUNDATION to the FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH & HUMAN SERVICES Concerning DRUG AND DEVICE MANUFACTURER COMMUNICATIONS WITH