health economics communication and fdama section · pdf filehealth economics communication...

Health Economics Communication and FDAMA Section 114

Peter Neumann May 2, 2013 Presentation to Chicago ISPOR Chapter

Why important?

Intense interest in value From payers

From life science companies

What are the rules for promoting health economic information?

©CEVR All Rights Reserved 2

“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.


What is permissible?

4

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 2012.

©CEVR All Rights Reserved

Health economics promotion Health economics promotion

Physicians & consumers

Physicians & consumers

“Substantial evidence” “Competent and reliable scientific evidence”

(Section 114)

Plans/payers Plans/payers


Non-promotional health economic information

Non-promotional health economic information

Unsolicited requests (AMCP dossiers)

6 ©CEVR All Rights Reserved

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”


Drug LDL Cost/QALY

AN EXAMPLE:

RCT Model

Other examples

Utilization endpoints?

Adherence claims?

Extrapolations to other populations?

Extrapolations to other dosages?

Previous papers


Who is using FDAMA Section 114?

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

Question % Stating familiar or

very familiar

How familiar are you with the FDAMA Section 114? 93.8%

Use of Section 114

Question % Stating

frequently or always

How often do you consider using Section 114 when making promotional claims?

81.3%

Question % Saying yes

Does your company have internal legal/regulatory guidance on Section 114?

100%

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%

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%

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%

Question % Saying more

often

Did you expect to use Section 114 more often or less often in the future?

75.0%

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%

21 ©CEVR All Rights Reserved

What does the FDA think?

Objectives

Investigate FDA letters regarding drug firms’ health economic promotions.

How frequently has FDA considered such promotions false or misleading?

Under what circumstances?


Methods


Reviewed warning letters and notices of violation (“untitled letters”) from DDMAC (OPDP).

Analyzed violations related to “health economic promotion.”

598 letters sent by FDA to drug companies, 2002-2011

291 DDMAC (OPDP) letters

120 candidate economic violation letters

35 economic violation letters (12% of DDMAC letters)

Methodology


“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


Violation n %

Productivity 20 56

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 114 0 0

Total 36* 100

Results

*35 letters considered, one letter contained two types of violations


No DDMAC letter pertained to FDAMA Section 114


Indication n %

Psychiatric 6 17

Pain 6 17

Cancer 4 12

HIV 3 9

Nasal/respiratory 3 9

Irritable bowel syndrome 2 6

Other 11 32

Total 35 100

By indication


Examples


Misleading productivity claim


“Today, David and his excellent sense of taste

are back on the job, making great wines…”


Misleading cost comparison


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.*”


Why no Section 114 letters?


Lack of 114 promotions?

Challenges in regulating such promotions?

Limitations


Don’t know how much economic promotion occurs

Did not include adherence/convenience or PRO claims

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?

Does Section 114 allow CER?


FDA concerns about “back-door” clinical claims embedded in HCEI


A proposal

Expand 114 to include CER

Remove “directly-related” from 114


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

Proposal


*Competent and reliable scientific evidence

Benefits

Allow promotion to plans of settings, endpoints not in RCTs

E.g., adherence, hospitalizations

Encourage standards for CER

Decrease “asymmetry”

Retain “guard rails”


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


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 help

Thank you!

[email protected]


health economics communication and fdama section · pdf filehealth economics communication...

Documents