Table of Contents

The Changing Direct-to-Consumer Advertising Landscape: How Direct-to-Consumer Advertising Affects Return on Investment - An analysis of how direct-to-consumer advertising has evolved in the US and Europe, and any future changes likely to be implemented. Case studies are used to illustrate whether a campaign generated return on investment (ROI).

Product Code: dmhc2469

Publication Date: 09-Dec-2008

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Overview

Introduction

An effective DTC strategy can catapult a drug into blockbuster status. However, after a 10 year period of skyrocketing DTC budgets, Pharma is now opting for lower cost and more targeted approaches. Pharma faces tighter DTC regulations in the US, while in Europe there may be suggestions that DTC will be employed, but is this likely to work given the differences in culture and market?

Scope

· Analysis of a return on investment model for DTC advertising

· Case study analysis of DTC and disease awareness ads

· Overview of DTC regulation in the US

· Overview of patient communication for prescription drugs in Europe

Highlights

The more serious a disease, the more life threatening it is for the patient, as a result the patient is more empowered as it is keen to find out new potential treatments for the life-threatening condition. In this case, targeted media such as online tools are more suited as they can provide an educational platform and a great source of information.

If a drug is the only one on the market, unbranded advertising is good to raise awarenessfor example Lyrica adopted this strategy as it was first-to-marketin cases such as these, diagnosis is the limiting stage so unbranded advertising is beneficial to leverage this hurdle.

In the absence of direct DTC advertising, information provided online is of paramount importance. The strategic value of online tools for Europe is second to none: although traditional media can increase disease awareness to a wide audience, the internet can provide information to keen consumers.

Reasons to Purchase

· Utilize a return on investment model for a DTC advertising to understand how to make a campaign a success

· Identify the differences between advertising regulations in the US and Europe, and what changes are likely to happen in the near future

· Understand if recent DTC or disease awareness campaigns have been successful, and if not, why not

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CHAPTER 1 EXECUTIVE SUMMARY	4
Scope of the report	4
Key findings	4
CHAPTER 2 OVERVIEW OF DTC	10
What is direct-to-consumer (DTC) advertising?	11
Several Big Pharma companies have cut their advertising budgets for 2007	13
Is DTC suitable for all types of drugs?	14
The pros and cons of DTC	15
Drivers for DTC	16
DTC increases consumer awareness of new products	16
DTC increases patient empowerment	17
Barriers to DTC	19
Safety concerns can have a negative impact on a DTC campaign	19
Costs for DTC are incredibly high but rewarding	20
Long-term effectiveness of DTC is questionable	20
CHAPTER 3 ROI FOR DTC	22
The ROI model for a successful DTC campaign	23
Patient-specific issues affecting DTC ROI	25
Awareness - patients must have access to the DTC channel	25
Acceptance - DTC ads need to instill patient trust and brand loyalty	27
Action - DTC ads need to encourage patients to question why they are not on the advertised drug	27
Influence - DTC ads must stimulate patients to influence their prescribing physician	28
Market-specific factors affecting return on investment for DTC	28
Chronicity of a disease - the more chronic the disease, the longer the DTC campaign	29
Seriousness of a disease - for empowered patients, targeted DTC is preferred	30
Effects of disease - targeting carers is important for treatments of debilitating diseases	30
Size of patient population - larger patient populations justify expensive DTC ads	30
Fragmentation of patient population - the need to optimize patient targeting	31
Cost of treatment - non-reimbursed drugs require bolder and more intense campaigns	31
Product-specific issues affecting return on investment for DTC	31
Efficacy - if the drug is a me-too, advertisers will have to be particularly creative to differentiate the brand	32
Safety and side effects - a poor side-effect profile can lessen the positive DTC message	32
Stage of lifecycle - DTC strategies must be tailored to stage of drug lifecycle	32
Competition-specific issues affecting return on investment for DTC	33
How to measure success of a DTC strategy	34
Pre-DTC campaign launch	34
Post-DTC campaign launch	35
Analysis of DTC campaigns using the DTC model	37
Rozerem: a complex campaign failed to generate return on investment	38
Takeda's honorable decision to delay Rozerem's DTC campaign following launch gave competitors a commercial advantage	38
Rozerem advert pulled by FDA	39
Relaunched Rozerem campaign was too complicated for the public	40
Rozerem had minimal market share after its first year on the market	41
Ambien CR: a DTC campaign marred by negative publicity over parent brand	42
Ambien CR DTC campaign marred by negative publicity over Ambien	44
Pfizer boosted awareness of the unfamiliar disease fibromyalgia	46
Criticism of Pfizer's 'battered woman' disease awareness campaign, but well designed FibroCenter website	47
Pfizer adds branded DTC campaigns to boost product promotion in light of future competition	47
Gardasil: a successful campaign for the cervical cancer vaccine	48
A strong DTC campaign for a first-to-market vaccine	49
Merck & Co employs a disease awareness campaign for HPV to dilute any untoward brand negativity	50
CHAPTER 4 DTC IN THE US	52
Current DTC regulations in the US	53
Advertisements that do not follow regulations are flagged	54
Concern over FDA's policing of DTC adverts	55
Questions over FDA's DTC prioritization strategy	55
FDA was slow to issue warning letters	56
Recent changes have attempted to make DTC regulations more stringent	58
Failure of the Food and Drug Administration Revitalization Act to adequately improve DTC regulation	59
FDAAA has strengthened DTC regulations for prescription drugs, but not by as much as originally planned	59
Further tightening of DTC rules for four pharmaceutical companies	61
PhRMA set to update its Guiding Principles on DTC advertising	62
An effort to increase transparency on DTC advertising	63
FDA and EthicAd launch consumer DTC education website	63
Pfizer launches self-regulation of DTC ads	64
PhRMA's voluntary DTC guidelines offer some protection	65
Case studies of television DTC advertisements that did not comply with regulations	65
Nasonex: the distracting bee diverts attention from side effects	65
Vytorin: commercial was withdrawn due to negative clinical trial results	67
Lipitor: use of a 'celebrity' caused advertisement to be scrutinized	68
Procrit: advertising was halted due to lack of evidence supporting marketing claims	70
Shift from TV alone, to a combination of TV and internet DTC	71
The internet has opened a new door for DTC	72
My Time to Quit: aggressive unbranded advertising is inspected after clinical trial results	73
CHAPTER 5 DTC IN EUROPE	75
Current EU regulations: no DTC but disease awareness permitted	76
Alternatives to DTC in Europe	77
Disease awareness campaigns encourage patients to seek medical advice	77
Internet is the key media channel for disseminating disease awareness information	78
Working with patient advocacy groups is essential in Europe in the absence of DTC	78
Patient support websites/programs can improve patient outcomes and satisfaction	79
Compliance programs can enhance communication with the patient	80
Rules and regulations for disseminating information in Europe	80
Pharmaceutical advertising in the UK is governed by the MHRA	81
40over40: disease awareness or DTC advertising in the UK?	83
Will DTP be allowed in Europe in the near future?	84
Will DTP work in Europe?	85
CHAPTER 6 BIBLIOGRAPHY	87
Publications and online articles	87
Datamonitor resources	91
Glossary	92
List of Tables
Table 1: The best remembered advertisements for 2007 are also the ones which ran into difficulties	21
List of Figures
Figure 1: Big Pharma's top 13 advertising budgets, 2006-07	13
Figure 2: Drivers and barriers for DTC advertising, 2008	15
Figure 3: DTC results in increased patient empowerment	18
Figure 4: The DTC process can break at any stage	19
Figure 5: Model for return on DTC investment	24
Figure 6: Sequence of events likely to affect the patient when designing a DTC strategy	25
Figure 7: Advice and warnings when formulating a DTC strategy	34
Figure 8: Model for return on DTC investment	37
Figure 9: Timeline and US sales of the top three insomnia franchises, Q1 2005-Q2 2008	40
Figure 10: US market share of the top five insomnia drugs, 2006	42
Figure 11: Timeline and US sales of the top three insomnia franchises, Q1 2005-Q2 2008	44
Figure 12: The FDA describes three types of DTC advertising	53
Figure 13: The FDA has become less efficient as more DTC material is submitted	57
Figure 14: A 2008 GAO report found two main issues with how the FDA deals with DTC advertising	58
Figure 15: FDAAA has strengthened DTC regulations for prescription drugs	61
Figure 16: The Nasonex commercial: how the most remembered DTC advert ran into trouble	66
Figure 17: One of the Vytorin vignettes associating family members with foods to suggest the drug treats both sources of cholesterol	67
Figure 18: Dr Jarvik - not licensed to practice medicine so could not actually prescribe Lipitor	69
Figure 19: Five major European markets have differing levels of stringency	81

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