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Despite its relatively small market size, testosterone replacement therapy (TRT) has been gaining considerable attention among physicians and consumers due to its core patient base of maturing males and its primary ability to either curb loss of virility or, in some cases, restore virility. TRT, or Low T therapy as it is commonly called, is a hormone therapy for men designed to counteract the effects of diminished activity in the gonads, or hypogonadism.
Encuity Research, the industry leader in syndicated market research data, has found that the increase in attention for TRT is likely the result of aggressive direct-to-consumer (DTC) advertising by certain products within the market. Data from Encuity’s PromotionalAnswers™ audit line shows
that, in 2009, the top six branded products spent approximately $55 million on promotion, but by 2013 that number had grown five-fold to just over $282 million (Figure 1).
The ramp-up of promotional activity is clearly having its desired effect. According to Encuity’s
TreatmentAnswers™ audit, over the course of the last five years, the TRT market has seen dramatic
growth in patient visits, up 55% from 1.2 million in 2009 to 1.9 million in 2013. Physician intent to prescribe has also increased as a result of these visits, up 56% from 1.08 million in 2009 to 1.7 million in 2013 (Figure 2).
While data from TreatmentAnwers shows steady growth in the TRT market over the last five years, the recent rise in office visits during the latter part of 2013 and early 2014 might be directly related to negative findings regarding a potential risk of increased cardiovascular events associated with the use of prescription testosterone products. This growth may signal patients visiting their doctors to discuss the potential risks and next steps.
Testosterone Replacement Therapy
Data Trends Report
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Figure 1 Total Promotional Spend for Top TRT Products
Source: Encuity’s PromotionalAnswers™
Total Market Axiron AndroGel Testim Foretesta Androderm Testopel $300 $250 $200 $150 $100 $50 $0 2009 2012 Figure 2 Visits and Intended Drug Uses for Low T
Source: Encuity’s TreatmentAnwers™
Visits Uses 2,000 1,800 1,600 1,400 1,200 1,000 800 600 400 200 0 2013 2011 2010 Total Pr
omotional Spend (Millions)
Visits/Uses (
Thousands)
Links to Cardiovascular Events
According to two recent studies, the use of testosterone products may increase the risk of certain cardiovascular events, including heart attack and stroke, sometimes resulting in death. The PLOS ONE study by Finkle et al1 published in January 2014 and funded by the National
Institutes of Health (NIH) reported that within 90 days of taking testosterone treatment, the risk of heart attack can double in men 65 and older, and the risk may triple for men younger than 65.
In November 2013, the Vigen et al. study published in JAMA2 of men in the Veterans Affairs (VA)
health system who underwent testosterone therapy showed a 30% higher risk of heart attack, stroke, and death than those who did not use testosterone therapy.
As a result of these recent study findings, the US Food and Drug Administration (FDA) announced in late January that it would be investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. In the announcement, the FDA stated that it had been studying the risk for some time and that the release of the findings in the two above-cited studies suggested that a link may exist between increased cardiovascular events and prescribed testosterone therapy.
Critics point to several factors to cast doubt on the results linking testosterone therapy to increased cardiovascular risk:
• Results in the NIH study were based on prescription claim data of patients who were
prescribed testosterone therapy, but it was never verified as to whether or not these patients took the medication.
• Overall, patients may not have been thoroughly screened via blood testing to see if other factors may have led to increased cardiovascular events.
• In the Vigen study, prior to study adjustments, a good portion of the men who were identified to have increased risk actually saw their risk of cardiovascular events go down. Regardless of where doctors, researchers, and advocates stand in the debate, the hope is that the FDA-commissioned study will be based on randomized trials to provide evidence-based guidelines for testosterone treatment and move away from the current observational data.
Observations from Encuity Data
Encuity’s TreatmentAnswers tracks the interaction between physicians and patients seeking treatment and can shed light on the effects of negative publicity. A key measure within the audit is the ability to track patient visits by therapy area of indication. By looking at the number of patient visits in October 2013, the month prior to the first study, and the following three months ending in January 2014 when the second study was published, we can observe a dramatic increase in patient visits for Low T, which may be a result of patient concerns over the negative study findings.
In October 2013, 109,000 office visits for Low T were recorded, but in November, the month of the first study, the number of office visits jumps to 149,000, a 37% increase (Figure 3). In December, the number increases another 3% to 153,000 visits, and in January 2014 the number of visits reaches a high water mark of 232,000, another 51% increase. In total, the number of office visits for Low T increased 113% between October 2013 and January 2014.
Key Messages
In an effort to get ahead of the negative publicity, a few of the key products in the market have targeted physicians with messages specific to cardiovascular risk and the published studies. According to Encuity’s DetailAnswers Plus™, reps from AbbVie promoting AndroGel® and Eli
Lilly reps promoting Axiron® have woven mentions of cardiovascular risk into their messaging.
Source: Encuity’s TreatmentAnswers™
Figure 3 Visits for TRT 250,000 200,000 150,000 100,000 50,000 0
Oct-13 Nov-13 Dec-13 Jan-14
Vigen Study Released (JAMA) NIH Study Released (PLoS One)
Asked to recall the topics they discussed with reps, physicians surveyed as part of the
DetailAnswers Plus audit provided the following example responses:
AndroGel (AbbVie):
• “Reviewed formulary coverage, different topics in the medical literature recently, in JAMA article about VA men and Low T and risk for cardiac events or stroke. Discussed overall safety and efficacy.” —Endocrinologist, Northeast
• “Trying to quell concerns over cardiac risk.” —Primary Care Physician, Midwest
• “Need to be selective about who you test for low testosterone as it’s not appropriate to treat everyone based on blood levels alone; consider age, symptoms, underlying medical illness, increased risks of cardiovascular morbidity and mortality.” —Primary Care Physician, New England
Axiron (Eli Lilly):
• “Need to discuss and decrease talk of cardiovascular risk given recent study findings.” — Endocrinoogist, West
• “Cardiovascular risk has all of the sudden become a discussion topic.” —Primary Care Physician, Southwest
TRT Market Promotional Spend
While the success of any product is firmly dependent on how effective it is in treating the approved indication, there is little doubt that marketing budgets have an effect as well. As we have outlined previously, the marketing spend in the TRT market has exploded over the course of the last five years, growing five-fold from $55 million in 2009 to just under $283 million in 2013. Companies in this market—including Eli Lilly (Axiron), AbbVie (AndroGel), Auxillium/ GSK (Testim®), and Endo (Fortesta®)—have invested heavily in detailing, meetings and events,
and DTC to get their messaging out to the key audiences of healthcare practitioners and consumers to promote their products and their key advantages.
Many of the key products in the market, such as Testim, Fortesta, and Androderm®, have
used a more traditional mix of detailing with meetings and events and some ePromotion, but spending leaders Axiron and AndroGel have been more aggressive in targeting consumers with DTC advertising (Figure 4). Much of the strategy in utilizing DTC is no doubt tied to the fact the products are produced by large manufacturers with big, existing DTC budgets. However, the DTC strategy may also be due, in part, to the products’ relatively new entry into the market or the launching of new formulations.
Looking at the growth in promotional spend for the TRT market, DTC has been the key driver. In 2013, the TRT market had two of the top 20 products in terms of DTC spend, Axiron (16th) and AndroGel (18th). And in 2013, DTC accounted for 52% of the market’s total spend, up from just 9% in 2011 to 38% in 2012. Manufacturers have taken note of how successful DTC advertising has been for driving market share in other lifestyle markets, such as erectile dysfunction, dermatology, and eye care.
The DTC spend for both Axiron at $84 million and AndroGel at $64 million were higher than the total spends for any other product in the market in 2013. Both products utilized television at around the same rate (77% for Axiron and 78% for AndroGel), followed by magazines for the vast majority of their spend allocation (Figure 5).
It will be worth observing how the recent publication of potentially negative cardiovascular side effect data will affect spending strategy. Will the marketers of Axiron and AndroGel continue to spend money on DTC advertising despite the negative publicity, or will they go the way of the erectile dysfunction market, in which marketers suspended DTC ads in the face
Figure 4 Promotional Mix for Top TRT Products
Source: Encuity’s PromotionalAnswers™ 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
DTC Physician Detailing NP/PA Detailing Meeting and Events ePromo Journal
Axiron ($122M) Fortesta ($13M) Androderm ($5M) Testim ($21M) AndroGel ($119M) Testopel ($1M)
Conclusion
Verbatim comments from Encuity’s DetailAnswers Plus show that representatives from some companies in the TRT market are already addressing the increased cardiovascular risk in messaging to their physician targets in recent months. Reps are shown to be both reacting to physician questions and concerns and proactively easing fears of cardiovascular risk.
Encuity’s PromotionalAnswers shows that companies have increased promotional spend to help foster TRT market growth. Recently, growth in spending has been driven by DTC advertising for market leaders Axiron and AndroGel. However, history has shown that in other markets where safety concerns have arisen, such as erectile dysfunction, promotional efforts may be affected as companies look to switch strategies and engage physicians via personal promotion or move away from promoting their products to patients when a legitimate health risk may be present.
1 Finkle WD et al. Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy
Prescription in Men. PLoS ONE. 2014. 9(1).
2 Vigen R et al.Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men
With Low Testosterone Levels. JAMA. 2013. 310(17).
Figure 5 Axiron DTC Spend
2013
Source: Encuity’s PromotionalAnswers™
Base = $84M Base = $64M
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AndroGel DTC Spend 2013 TV 78% Outdoor 0% Radio 1% Internet 5% Magazine 16% TV 77% Internet 3% Newspaper 8% Magazine 12%
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The following Encuity services were used for this report:
TreatmentAnswersTreatmentAnswers audit is the pharmaceutical and biotech industry’s premier drug and
diagnosis audit. This audit offers unique insight into physician-intended prescribing habits through quantitative drug and diagnosis analysis. It provides national-level disease state and associated therapy data using a more robust data sample than similar diagnosis audit services.
PromotionalAnswers
Encuity’s suite of promotional tracking audits provides insights into the volume of promotional activity and spending in all major channels including detailing, events, ePromotion, DTC, professional journals, and sampling. Key reports drawn from the
PromotionalAnswers suite include share of voice, marketing mix, and message uptake. DetailAnswers Plus
Designed to provide a more granular view of physician detailing, DetailAnswers Plus utilizes company targets, regions, and key prescriber groups to analyze detail/sample volume and share of voice at the region or segment level. DetailAnswers Plus also provides analysis of key quality metrics like detail frequency, reach, rating, formulary, and messaging.
