Association Between Drug Characteristics and Manufacturer Spending on Direct-to-Consumer Advertising.

Importance: Some drugs are heavily marketed through direct-to-consumer advertising. Objective: To identify drug characteristics associated with a greater share of promotional spending on advertising directly to consumers. Design, Setting, and Participants: Exploratory cross-sectional analysis of drug characteristics and promotional spending for the 150 top-selling branded prescription drugs in the US in 2020 as identified from IQVIA National Sales Perspectives data. Promotional spending data were provided by IQVIA ChannelDynamics. Exposures: Drug characteristics (total 2020 sales; total 2020 promotional spending; clinical benefit ratings; number of indications, off-label use; molecule type; nature of condition treated; administration type; generic availability; US Food and Drug Administration [FDA] approval year, World Health Organization anatomical therapeutic chemical classification; Medicare annual mean spending per beneficiary; percent sales attributable to the drug; market size; market competitiveness) assessed from health technology assessment agencies (France's Haute Autorité de Santé and Canada's Patented Medicine Prices Review Board) and drug data sources (Drugs@FDA, the FDA Purple Book, Lexicomp, Merative Marketscan Research Databases, and Medicare Spending by Drug data). Main Outcomes and Measures: Proportion of total promotional spending allocated to direct-to-consumer-advertising for each drug. Results: The 2020 median proportion of promotional spending allocated to direct-to-consumer advertising was 13.5% (IQR, 1.96%-36.6%); median promotional spending, $20.9 million (IQR, $2.72-$131 million); and median total sales, $1.51 billion (IQR, $0.97-$2.26 billion). Of the 150 best-selling drugs, 16 were missing data and key covariates; therefore, the primary study sample comprised 134 drugs. After adjustment for multiple drug characteristics, the mean proportion of total promotional spending allocated to direct-to-consumer advertising for the remaining 134 drugs was an absolute 14.3% (95% CI, 1.43%-27.2%; P = .03) higher for those with low added clinical benefit than for those with high added clinical benefit and an absolute 1.5% (95% CI, 0.44%-2.56%; P = .005) higher for each 10% increase in total sales. Conclusions and Relevance: Among top-selling US drugs in 2020, a rating of lower added benefit and higher total drug sales were associated with a higher proportion of manufacturer total promotional spending allocated to direct-to-consumer advertising. Further research is needed to understand the implications of these findings.

Direct-to-Consumer Hospital Advertising and Domestic Medical Travel in the United States.

EXECUTIVE SUMMARY: Expanding hospitals' geographic market area has been proposed as a means to increase competition and reduce healthcare costs. However, most patients in the United States receive care locally and are unlikely to seek out distant hospitals, effectively limiting competition to local markets. We hypothesize that mass media advertising can help overcome patients' reluctance to travel for elective medical care. We examined hospitals' advertising in distant markets to determine whether their expenditures predict the number of patients who travel to those hospitals.We obtained data on 2015 advertising expenditures by 273 U.S. academic medical centers from a market research firm. Regression models examined associations between hospitals' advertising expenditures and patient volume metrics: inpatients, encounters, and charges originating from distant markets where the medical centers advertised. Results showed that hospitals' advertising expenditures in distant markets were associated with higher numbers of inpatient admissions, patient visits, and charges from those markets. Compared to the distant markets where they advertised, the hometown markets of these hospitals are smaller with lower per capita income, suggesting hospitals are seeking incremental patient volume from more lucrative markets.Findings suggest that advertising may familiarize patients with distant facilities, encouraging domestic medical travel and enabling broader geographic competition among hospitals.

Direct-To-Consumer Advertising of Over-the-Counter Sinonasal Remedies: A History of Mixed Messages.

Sinus, cold, and allergy remedies comprise the most widely used sector of the over-the-counter (OTC) drug market. Direct-to-consumer advertising (DTCA) of pharmaceutical products has increased over the past 30 years, including the promotion of OTC drugs. The influence of DTCA on OTC sinonasal remedies comprises several positive and negative effects. Favorable aspects of this influence include empowerment and promotion of autonomy among patients, avoidance of low-value clinical encounters, self-directed education, and decreased healthcare expenditures. This is balanced by potential concerns, including the lack of rigorous regulation of OTC drugs, the burden of self-diagnosis, the risk of unsupervised use resulting in adverse effects or drug interactions, and redistribution of pharmacy costs to the consumer. Despite the proliferation of product options and consumer-directed information, healthcare utilization and cost of treating sinonasal disease remains high. Moreover, the availability of OTC sinonasal remedies and exposure to DTCA has had mixed effects without apparent overall benefit to patient and consumer health. Laryngoscope, 130:2114-2119, 2020.

Cigarette and smokeless tobacco company smartphone applications.

PURPOSE: Two previous studies indicate that prosmoking apps might encourage smoking behaviour via smoking cues. The current paper seeks to build on these studies and provide an updated overview of the characteristics of tobacco industry-sponsored apps. METHODS: In November 2017, we identified 19 unique top-selling cigarette brands, 20 smokeless tobacco brands, 30 e-cigarette brands and 43 cigar brands based on Nielsen sales from 2016 Nielsen Scantrack data and 2016 Kantar advertising data from the Kantar Media Stradegy database. We searched for these brand-sponsored apps in the Google Play and Apple iTunes US online stores. RESULTS: We identified four cigarette and one smokeless tobacco brand-sponsored apps on the Google Play store, but none in the Apple store. The apps sponsored by Grizzly, Newport, Skoal, Camel and Winston used the last four digits of the users' social security number to verify age. The Marlboro app offered another option in addition to providing a partial social security number-providing a valid home address. The main feature of all apps was location-based, time-sensitive coupons. Some apps had additional functions such as additional detailed product information, interactive help menus and games. DISCUSSION: This paper provides an up-to-date description of apps that are sponsored by tobacco companies. Cessation interventions could consider reminding their target audience to delete these apps to support quit attempts.

Direct-to-Member Household or Targeted Mailings: Incentivizing Medicaid Calls for Quitline Services.

INTRODUCTION: Innovative methods are needed to promote tobacco cessation services. The Medi-Cal Incentives to Quit Smoking project (2012-2015) promoted modest financial and medication incentives to encourage Medi-Cal smokers to utilize the California Smokers' Helpline (Helpline). This article describes the implementation and impact of two different direct-to-member mailing approaches. METHODS: Medi-Cal Incentives to Quit Smoking promotional materials were mailed directly to members using two approaches: (1) household mailings: households identified through centralized membership divisions and (2) individually targeted mailings: smokers identified by medical codes from Medi-Cal managed care plans. Mailings included messaging on incentives, such as gift cards or nicotine patches. Number of calls per month, calls per unit mailed, and associated printing costs per call were compared during and 1 month after mailings. Activated caller response was based on reporting a household mailing promotional code or based on requesting financial incentives for individually targeted mailings. Analyses were conducted in 2018. RESULTS: Direct-to-member mailings, particularly with incentive messaging, demonstrated an increase in call volumes during and 1 month after mailing, and increased Medi-Cal calls to the Helpline per unit mailed. Mailings with only counseling messages had the lowest percentage of activated calls per unit mailed, whereas the incentive messaging mailings were consistently higher. Although household mailings demonstrated lower printing costs per call, individually targeted mailings had a higher percentage of activated calls per unit mailed. CONCLUSIONS: Household and individually targeted mailings are feasible approaches to increase Medi-Cal calls to the Helpline, particularly with incentive messaging. Choosing an approach and messaging depends on available resources, timing, and purpose. SUPPLEMENT INFORMATION: This article is part of a supplement entitled Advancing Smoking Cessation in California's Medicaid Population, which is sponsored by the California Department of Public Health.

Receipt of Tobacco Direct Mail Coupons and Changes in Smoking Status in a Nationally Representative Sample of US Adults.

Introduction: Direct-to-consumer tobacco marketing, including direct mail and email coupons, is a potentially influential marketing strategy. We examined the associations between receipt of tobacco direct mail/email coupons and trajectories of smoking behavior among US adults. Methods: Data were from the US Population Assessment on Tobacco and Health (PATH) Study adult sample (n = 32160) collected during 2013-2014. Participants self-reported their smoking status (every day, some days, not at all) 12 months prior to the survey (T0) and at the time of the survey (T1). Three smoking trajectories were identified: nonsmokers progressing to current smokers, current smokers continuing to smoke, and among current smokers at T0, progressing to or continuing with daily smoking. Participants also reported receipt of direct mail/email tobacco coupons in the 6 months preceding T1 (yes/no). Weighted multiple logistic regression models were used to test the associations between receiving direct mail/email tobacco coupons and different smoking trajectories adjusted for demographic characteristics. Results: One in eight (12.4%) US adult nonsmokers and 36.2% adult smokers at T0 reported receiving tobacco coupons. Receipt of tobacco coupons was negatively associated with poverty status. Receipt of tobacco coupons was associated with increased odds of progression to current smoking (AOR = 1.76, 95% CI = 1.45 to 2.12), continuation of smoking (AOR = 1.34, 95% CI = 1.09 to 1.65), and current smokers' progression to or continuation with daily smoking (AOR = 1.70, 95% CI = 1.50 to 1.91). Conclusions: Direct-to-consumer tobacco coupons may promote progression of smoking among nonsmokers, and continuation of smoking and progression to daily smoking among smokers in US adults. Implications: Distributing direct mail coupons is a strategy employed by tobacco companies to promote their products. We found, in a US national study, that many adults received tobacco coupons, and receiving these coupons was associated with subsequent progression of smoking among nonsmokers, and continuation of smoking and daily smoking among smokers. Scrutiny over the use of direct mail coupons and its effects on population health is warranted. Future research is needed to evaluate the effect of different interventions to reduce the impact of these coupons on smoking behaviors.

Do coverage mandates affect direct-to-consumer advertising for pharmaceuticals? Evidence from parity laws.

Direct-to-consumer advertising (DTCA) for prescription drugs is a relatively unique feature of the US health care system and a source of tens of billions of dollars in annual spending. It has also garnered the attention of researchers and policymakers interested in its implications for firm and consumer behavior. However, few economic studies have explored the DTCA response to public policies, especially those mandating coverage of these products. We use detailed advertising expenditure data to assess if pharmaceutical firms increase their marketing efforts after the implementation of relevant state and federal health insurance laws. We focus on mental health parity statutes and related drug therapies-a potentially ripe setting for inducing stronger consumer demand. We find no clear indication that firms expect greater value from DTCA after these regulatory changes. DTCA appears driven by other considerations (e.g., product debut); however, it remains a possibility that firms respond to these laws through other, unobserved channels (e.g., provider detailing).

The possibility of obtaining marketing authorization of orphan pharmaceutical compounding preparations: 3,4-DAP for Lambert-Eaton Myasthenic Syndrome.

BACKGROUND: Pharmaceutical compounding preparations, produced by (hospital) pharmacies, usually do not have marketing authorization. As a consequence, some of these pharmaceutical compounding preparations can be picked-up by a pharmaceutical company to obtain marketing authorization, often leading to price increases. An example is the 3,4-diaminopyridine slow release (3,4-DAP SR) tablets for Lambert-Eaton Myasthenic Syndrome (LEMS). In 2009 marketing authorization was given for the commercial immediate release phosphate salt of the drug, including a fifty-fold price increase compared to the pharmaceutical compounding preparation. Obtaining marketing authorization for 3,4-DAP SR by academia might have been a solution to prevent this price increase. To determine whether the available data of a pharmaceutical compounding preparation with long-term experience in regular care are adequate to obtain marketing authorization, 3,4-DAP SR is used as a case study. METHODS: A retrospective qualitative case-study was performed. Initially, document analysis was executed by collecting the required data for marketing authorization in general and whether data of Firdapse® and 3,4-DAP SR met these requirements. Secondly, the (non-) available data of the two formulations were compared with each other to determine the differences in availability. RESULTS: At the time of approval, almost all data were available for both Firdapse® and 3,4-DAP SR. Conversely, much of the data used for the approval of Firdapse® originated from the 3,4-DAP immediate release (3,4-DAP IR) formulation. Only two bioequivalence studies and one pharmacology safety study was performed with Firdapse® before marketing authorization application. CONCLUSIONS: In conclusion, at time Firdapse® obtained approval, the data available did not differ substantially from 3,4-DAP SR, indicating that approval with 3,4-DAP SR would have been possible. We make a plea for approval of orphan medicinal products developed and manufactured by academic institutions as to keep utilization of these products affordable.

Alcohol promotions in Australian supermarket catalogues.

INTRODUCTION AND AIMS: In Australia, most alcohol is sold as packaged liquor from off-premises retailers, a market increasingly dominated by supermarket chains. Competition between retailers may encourage marketing approaches, for example, discounting, that evidence indicates contribute to alcohol-related harms. This research documented the nature and variety of promotional methods used by two major supermarket retailers to promote alcohol products in their supermarket catalogues. DESIGN AND METHODS: Weekly catalogues from the two largest Australian supermarket chains were reviewed for alcohol-related content over 12 months. Alcohol promotions were assessed for promotion type, product type, number of standard drinks, purchase price and price/standard drink. RESULTS: Each store catalogue included, on average, 13 alcohol promotions/week, with price-based promotions most common. Forty-five percent of promotions required the purchase of multiple alcohol items. Wine was the most frequently promoted product (44%), followed by beer (24%) and spirits (18%). Most (99%) wine cask (2-5 L container) promotions required multiple (two to three) casks to be purchased. The average number of standard drinks required to be purchased to participate in catalogue promotions was 31.7 (SD = 24.9; median = 23.1). The median price per standard drink was $1.49 (range $0.19-$9.81). Cask wines had the lowest cost per standard drink across all product types. DISCUSSION AND CONCLUSIONS: Supermarket catalogues' emphasis on low prices/high volumes of alcohol reflects that retailers are taking advantage of limited restrictions on off-premise sales and promotion, which allow them to approach market competition in ways that may increase alcohol-related harms in consumers. Regulation of alcohol marketing should address retailer catalogue promotions. [Johnston R, Stafford J, Pierce H, Daube M. Alcohol promotions in Australian supermarket catalogues. Drug Alcohol Rev 2017;36:456-463].

Direct-to-consumer Marketing to People with Hemophilia.

Adriane Fugh-Berman and colleagues describe how strategies similar to those used to market drugs to physicians are directed towards people with hemophilia.

Differences in the design and sale of e-cigarettes by cigarette manufacturers and non-cigarette manufacturers in the USA.

BACKGROUND: Three categories of e-cigarette brands have emerged within the US market: e-cigarette brands developed by cigarette manufacturers, brands acquired by cigarette manufacturers and brands with no cigarette manufacturer affiliation. In the absence of federal regulatory oversight of e-cigarettes, we assessed differences in e-cigarette products and sales practices across these categories. METHODS: Brand websites for top-selling e-cigarette brands from each of these categories were examined in October of 2015 to compare website access restrictions, online sales practices and products sold, including e-cigarette model type (eg, 'cigalike' vs advanced systems) and options available (eg, flavoured, nicotine free). RESULTS: Website access to brands developed by cigarette manufacturers was restricted to users aged 21 years or older, and one website required user registration. In addition, these brands were exclusively reusable/rechargeable 'cigalikes.' Limited flavour options were available for these products, and nicotine-free options were not sold. In contrast, brands acquired by cigarette manufacturers and brands with no cigarette manufacturer affiliation generally required website visitors to be 18, offered a nicotine-free option, and most offered disposable products and an array of flavoured products (eg, fruit/candy flavours). CONCLUSIONS: This exploratory study finds differences in e-cigarette products and sales practices across these three e-cigarette brand categories, with brands developed by cigarette manufacturers adopting a particularly distinctive product and sales strategy. Anticipated regulation of e-cigarettes in the USA may be influencing these product and sales decisions.

BMI and Healthcare Cost Impact of Eliminating Tax Subsidy for Advertising Unhealthy Food to Youth.

INTRODUCTION: Food and beverage TV advertising contributes to childhood obesity. The current tax treatment of advertising as an ordinary business expense in the U.S. subsidizes marketing of nutritionally poor foods and beverages to children. This study models the effect of a national intervention that eliminates the tax subsidy of advertising nutritionally poor foods and beverages on TV to children aged 2-19 years. METHODS: We adapted and modified the Assessing Cost Effectiveness framework and methods to create the Childhood Obesity Intervention Cost Effectiveness Study model to simulate the impact of the intervention over the 2015-2025 period for the U.S. population, including short-term effects on BMI and 10-year healthcare expenditures. We simulated uncertainty intervals (UIs) using probabilistic sensitivity analysis and discounted outcomes at 3% annually. Data were analyzed in 2014. RESULTS: We estimated the intervention would reduce an aggregate 2.13 million (95% UI=0.83 million, 3.52 million) BMI units in the population and would cost $1.16 per BMI unit reduced (95% UI=$0.51, $2.63). From 2015 to 2025, the intervention would result in $352 million (95% UI=$138 million, $581 million) in healthcare cost savings and gain 4,538 (95% UI=1,752, 7,489) quality-adjusted life-years. CONCLUSIONS: Eliminating the tax subsidy of TV advertising costs for nutritionally poor foods and beverages advertised to children and adolescents would likely be a cost-saving strategy to reduce childhood obesity and related healthcare expenditures.