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November 12, 2024 0

The election of Donald Trump is having pharmaceutical companies evaluate how things may change in terms of legislation and regulation. Trump is not yet clear on his moves regarding pharma. In his first term, he criticized the drug companies for pricing higher in the U.S. than other developed countries. Republicans in Congress have generally not allowed punitive legislation on price controls. They understand the negative impact price controls would have on R&D. Trump wants lower prices and that is publicly popular.  Acting on PBMs would be one option. Another would be allowing and promoting reimportation of drugs.

The DTC Industry should be nervous about Robert Kennedy Jr. being given a large role in healthcare policy. He said on 11/4 that he wanted to get Trump back in D.C. so they can “ban pharmaceutical advertising on TV.”  Scary comment. Kennedy is known for anti-vaccine sentiment and the desire to get corporate influence reduced. He is anxious to focus on prevention of disease which he feels is neglected in budgetary decisions. Kennedy thinks DTC advertisers exert influence on editorial coverage. Anyone who has watched news coverage knows the drug industry has not historically been favorably covered.

I doubt Trump will act on DTC advertising. He did not in his first term and a Republican Congress will recognize the free speech rights to advertise. I do expect Trump to speed up the regulatory drug approval process and that should be a net positive for innovation. In fact, expansion of drug use and DTC ads promoting such should help in the disease prevention goal of Kennedy.

Will FDA be asked by Kennedy and Trump to make DTC harder to execute? It is already harder with the latest OPDP rule recently implemented. Can it be made so restrictive that DTC ads are impractical? That is certainly a possibility, but the drug, media, and advertising agency lobby is strong and persuasive. Usually, the pro advertising forces have prevailed. Republicans have historically been pro-advertising, and I expect Trump not to act even if Kennedy proposes a ban.

Uncertainty is never helpful in DTC planning and the anti-DTC proponents will make a lot of noise. I remain confident, however, that no actions will be taken to ban or further restrict DTC.

Bob Ehrlich

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November 6, 2024 0

On September 24, Novo Nordisk CEO Lars Jørgensen testified before the Senate which I watched on C-SPAN. He was asked to appear to discuss the reasons for high prices for GLP-1 diabetes drug Ozempic and its weight loss sister drug Wegovy. The savaging of drug company pricing policies is an ongoing cause for Sen. Sanders.

Bernie pointed out in his opening statement that US prices for Ozempic and Wegovy are multiples of their price in Germany, the UK, Canada, and other European countries. With his usual outrage, Bernie demanded answers from big pharma. Mr. Jørgensen had a few reasons for higher prices, most important that the list prices are high because Pharmacy Benefit Managers (PBMs) want drugs with high list prices. This is because rebates to them are a percent of list price. According to Mr. Jørgensen, Novo only gets 26% of the list price, the rest going to PBMs.

He also said that insurance companies set the net price consumers pay, not drug companies. Bernie then said that even with PBM rebates US prices are still too high. There was no definitive answer given by Mr. Jørgensen on the reasons for the difference between US and European pricing. What was clear was neither Republicans nor Democrats were satisfied they got their answers. Senators seemed frustrated with the complex nature of drug pricing and want legislative action on how PBMs get compensated.

The reality is that US drug prices are higher because the drug makers face price controls in most other countries. Prices would be lower if PBMs were cut out of the loop but still be higher than Canada or Europe. The US consumer partially subsidizes R&D for the world. That is unfair, of course, but reality. If Bernie got his wish and drug companies charged the European price, we would have less R&D. Mr. Jørgensen pointed out Novo Nordisk is spending $30 billion on increasing manufacturing capacity and $4.2 billion on Diabetes R&D last year. He said their annual R&D budget was more than the National Institutes of Health spent. If US drug prices historically matched Europe, it is likely we would not have Ozempic or Wegovy available today.

Innovative drugs like Wegovy will come down in price as production is ramped up and competitors enter the market. The obesity market is huge and Wegovy and Lilly’s Mounjaro will grow exponentially if price comes down significantly. Their makers know this and once they have enough production capacity, they will cut prices and vastly expand usage. Their large DTC spending shows how much they think they can grow the market.

As the GLPs increasingly show health benefits beyond diabetes and obesity, such as for cardiovascular and kidney disease, it is imperative that prices are low enough to get mass use covered by insurers and affordable for direct pay patients. Our collective health may depend on a significant cut in prices.

Bob Ehrlich

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October 22, 2024 0

On 8/29/24, AbbVie received a notice from FDA’s OPDP that their Serena Williams DTC television ad violated the FD&C Act. The reasons cited are for overstating the benefits of Ubrelvy. The untitled letter illustrates the difficulties pharmaceutical companies face in presenting benefit information that satisfies FDA requirements.

Ubrelvy tried to meet FDA requirements and do it in a :30 second ad. For drug ads, this is very hard to do given most drug ads need :60 and :90 seconds because of complex benefit claims and fair balance. AbbVie has used Serena Williams as a migraine relief spokesperson for several years. She has been an excellent example of a celebrity endorser. Serena has the migraine condition and the ads are presented in a unique creative style.

What happened in this case that OPDP called the ad violative? In sum, OPDP said the stated benefit of providing one dose rapid relief was not consistent with clinical data. That data showed only a minority of users got relief that quickly. The television ad claimed in a large super, “Ubrelvy Quickly Eliminates Migraine Pain”. Serena’s audio says, “One dose works fast to eliminate migraine pain.”

OPDP also had concerns that Serena, as a celebrity, further added to the potential for consumers to believe the one dose rapid relief claim was true for all users of Ubrelvy. OPDP cites several studies supporting the idea celebrities add to claim believability.

OPDP acknowledges that the ad had a small qualifying super saying “some people had pain freedom within 2 hours.” That small super was insufficient in balancing the ad’s stated claims of rapid relief. OPDP says the speed of relief and one dose claims are misleading because they do not work for everyone.

The Ubrelvy case is important because it illustrates the difficulty drug makers have distilling complicated clinical results into concise advertising claims. Ubrelvy and almost all other prescription drugs provide benefits for some but not all users. Trying to get to that one compelling benefit in DTC ads is difficult given that clinical data is mixed in patient outcomes. Drug claims need to have significant enough disclaimers on efficacy to clearly communicate the extent of the benefit.

In this case, OPDP felt Ubrelvy did not present the proven clinical benefits clearly enough. I should point out the Serena ad in question is not vastly different from the other Ubrelvy ads run from 2022. The earliest ads from 2020-2021 were less declarative, however, in the claim using the word “can” help relieve migraines.

I am not sure if OPDP questioned prior ads or had discussions with Ubrelvy during the pre-clearance process. There is a redacted paragraph in the letter that indicated previous OPDP concerns about Ubrelvy ads. This was when Allergan owned the brand before being acquired by AbbVie. Most drug ads are pre-cleared at least for the first campaign used. Sometimes new versions are not pre-cleared if similar enough to earlier ads.

AbbVie has been asked to stop running the ad and it will be interesting to see their response to OPDP. Usually if the pharmaceutical company stops running the ad, the FDA will not take further action requiring corrective advertising.

 

 

 

Bob Ehrlich

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August 12, 2024 0

The recently passed Washington My Health My Data (MHMD) Act stands as a significant legislative milestone, reshaping data requirements for pharmaceutical companies and raises a new specter of non-compliance. Against a backdrop of increasing regulatory scrutiny and privacy concerns, understanding the implications of the MHMD Act is a critical first step and learning that they may not be in compliance is weighing on the minds of CEOs, CMOs and Chief Privacy Officers (CPOs) across the industry. Compliance Officers are asking what the impact of the MHMD Act will be, and, more importantly, how can they ensure that their companies are aligned with changing regulations?

 

What is the Legislation?

Enacted on March 31, 2024, the Washington My Health My Data Act represents a comprehensive framework aimed at enhancing health data ownership and privacy. Key provisions of the MHMD Act include obtaining explicit authorization from consumers before selling or sharing their health data, expanding the definition of health data to encompass various aspects of physical and mental health, increased transparency regarding data privacy practices, and stricter accountability measures in case of breaches or violations including enforcement actions by the Attorney General and private litigants.

 

Of course, the MHMD Act has profound implications for pharmaceutical companies, reshaping their approach to data privacy and compliance. In an industry characterized by stringent regulations and waning consumer trust, adherence to the MHMD Act is critical for several reasons, not the least of which being Regulatory Compliance. Healthcare companies operate within a complex regulatory landscape, subject to oversight from federal agencies such as the FDA, FTC and DEA. The MHMD Act introduces additional compliance requirements, necessitating proactive measures to ensure adherence and avoid negative PR and costly penalties.

 

Identifying the source of one’s FOFO: Fear of Finding Out

 

Pharmaceutical companies, their agencies, and internal compliance have always been a critically important part of program execution, but the stakes have just gone up. In fact, in this new compliance environment, one could now consider a proactive approach to data compliance management as a competitive advantage for the business. Specifically, the companies with the right approach and toolset to automate workflow, will have a new competitive advantage whenever engaging in marketing programs and at all digital consumer touchpoints. It also means the end of FOFO, because finding out about your level of compliance shouldn’t be a fearful situation.

 


Shailee Vimadalal, a partner at ZS Associates is a global management consulting and technology firm specializing in transforming healthcare and beyond said about these marketplace changes, “The Washington My Health My Data Act (MHMD) brings a renewed focus on consumer consent for data use by the US pharmaceutical industry. This necessitates investments in personal data collection and handling practices to ensure greater transparency, commitment, and control for the consumers on how their data and how it is being used. Implementing a robust consent and preference management solution can be a strategic step for pharma companies to navigate this evolving landscape.”

 

In the pharmaceutical industry, ignorance is never an acceptable reason for being out of compliance. In addition, once a company becomes aware of an issue, its leaders are obligated to act. 

 

This draws a direct line from the CEO to the office of Compliance and across to the head of IT as Data Management challenges begin to emerge. Pharmaceutical companies handle vast amounts of sensitive patient data, including clinical trial results, medical records, and adverse event reports. Laws like this touch even simple “request more information” type functionality on product websites and extend throughout all brand digital media. Compliance with the MHMD Act requires attention to robust data management systems to safeguard the privacy and security of this information.

 

This Washington act will also impact Marketing Practices. The MHMD Act’s provisions for consumer authorization and data-based targeting have significant implications for pharmaceutical marketing strategies. Companies must ensure compliance with opt-in requirements and adopt data privacy-centric approaches to these campaigns while ensuring strict compliance with data-usage disclosures. In other words, proactive and skillful compliance in marketing workflows will become a key strategic and tactical competitive advantage for pharmaceutical brands in 2024.

 

Pete Dannenfelser, a pioneer of digital healthcare marketing communications, offers insights into the impact of the MHMD Act on pharmaceutical company compliance. “The industry’s historical commitment to conservatism and caution may make change easier. But the consequences of non-compliance underscores the importance of leveraging tools to assess the current state of a company’s digital platforms and readiness for what’s next.” 

 

Dannnfelser goes on to say, “While these newly enacted requirements will hit the entire industry, pharmaceutical companies operating under Corporate Integrity Agreements (CIAs) must be able to act quickly to uphold stringent compliance standards. Non-compliance with the MHMD Act could jeopardize adherence to CIAs, leading to severe consequences.”

 

Amidst the challenges posed by the MHMD Act, Dannenfelser recommends leveraging new AI-powered digital tools to navigate compliance requirements effectively. In fact, adding these powerful new tools to workflow should foster a competitive advantage, not only in day-to-day tactical execution, but also with strategic planning in a rapidly evolving new regulatory environment.

 

“Advertisers can only effectively manage what they can measure, so optimal integration of compliance standards into workflows become an essential element of all digital media campaigns and web properties,” says Jamie Barnard, CEO of COMPLIANT, the industry leader in AI SaaS compliance software.

 

A.I. algorithms analyze vast amounts of data to assess compliance risk levels, identifying potential areas of non-compliance and guiding companies in prioritizing remediation efforts. These learnings can help pharmaceutical companies create comprehensive compliance roadmaps, outlining steps to ensure compliance with data privacy regulations, opt-in requirements, and data-based marketing practices. Beyond that, AI technologies enable real-time monitoring of compliance activities, allowing companies to detect and address compliance issues promptly and proactively, minimizing the risk of regulatory violations and associated penalties. As any seasoned Rx marketer can tell you, a little proactivity can go a long way when dealing with regulatory bodies. 

 

 

The Washington My Health My Data Act ushers in the next era of significant regulatory data requirements with far-reaching implications for the healthcare industry among others. So, what should pharmaceutical companies be doing now to manage FOFO and stay ahead of this and other emerging data laws?

 

  • Embrace A.I.-driven tools to reactively assess active current content and proactively review new digital assets.

 

  • Adopt proactive compliance strategies leveraging tools and revising policies to be flexible enough to change with new laws.

 

  • Respond quickly when issues are identified – oftentimes, the remediation is not as intimidating as it seems, especially if repeatable processes and guidance is enacted.

 

Ian Wolfman & Pete Dannenfelser

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August 1, 2024 0

What’s happening with TikTok?

As many of you have heard, TikTok has been formally banned in the U.S. (it will take effect by January 2025 at the earliest). The major reason for the ban is the national security threat from the Chinese government, which could potentially use it to spy on Americans or weaponize it to covertly influence the U.S. public by amplifying or suppressing certain content. While TikTok management is willing to fight the ban in court and looking for various workarounds, it is forecasted that the platform will most likely be purchased by one of the U.S. tech companies. Under the bill, TikTok will now have 270 days to divest. However, an additional provision could also see TikTok apply for an extra three months under certain conditions (e.g., if it’s negotiating with buyers and needs more time to finalize the deal).

We already see conversations around potential platform buyers. Experts say that Meta is the least likely candidate in this case, and it is more realistic to consider companies such as Oracle, Microsoft, Walmart, and Triller.

What does it mean for us as pharma marketers?

It is hard to predict how the platform will evolve if TikTok wins its legal case or if either of the players acquires it. This means it is too early for pharma marketers to consider future strategic considerations.

Regardless of the outcome, it’s obvious that the situation casts a shadow on the platform’s reputation in the eyes of pharmaceutical marketing stakeholders who were considering it for potential social initiatives. It also may affect the U.S. social media landscape, where we can expect a spike in snackable video content on Instagram Reels or YouTube Shorts driven by migrated U.S. influencers.

We haven’t had a chance to produce any content for the platform in the past due to regulatory implications on our clients’ side. However, we are currently working on Instagram and Facebook Reel ads development for clients, which is a great opportunity to start exploring the format deeper as an alternative to TikTok.

When considering influencer marketing, it would be fair to eliminate TikTok as a platform for potential partnerships and focus on Instagram and YouTube. X (former Twitter) is a questionable platform for HCP influencers as it is still experiencing some market backlash and had a 7% drop in brand use in 2024.

The upcoming changes aren’t supposed to significantly affect the way we’ve been strategizing our clients’ social presence. However, we should keep exploring alternative platforms to help brands engage effectively with patient/HCP audiences while keeping a close eye on the next steps on the TikTok side. As an agency committed to staying ahead of the curve, we’re prepared to navigate these changes alongside our clients and help them thrive in the evolving social media landscape.

Helen Hoye

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August 1, 2024 0

Healthcare providers are analytical and methodical professionals who make important decisions every day affecting the lives of their patients. Constant learning is critical to their performance.

But HCPs are also human, with egos, personal lives, daily pressures, and jobs that impose long hours and high demands. Their time and attention are at a high premium.

To effectively educate HCPs about a brand and differentiate it in their minds, marketers must optimize product messaging so that it quickly and vividly resonates with each audience segment. An effective tool for doing this is heuristics, a term that encompasses a process of psychological shortcuts that simplify and accelerate decision-making.

We all use heuristics in our everyday lives, especially when faced with new or high-volume information and a limited time to process it. In a stressful situation, for example, we might base our response on how we successfully handled a similar situation in the past.

In healthcare marketing, there are numerous heuristics domains that commonly affect the decision-making of HCPs. Some of these include:

Background Contrast Effect: People are more likely to select an option when an inferior choice is present, i.e., they judge an option based on its contrast with a lesser option rather on its merits.

Instant Return: People want a return on their investment (time, effort or money) immediately.

Novelty Bias: People often think newer is better.

Negativity Bias: People pay more attention to and give more weight to negative things than positive things.

Zero-Risk Bias: People prefer reducing a small risk to zero rather than making a larger reduction in a bigger risk.

 

Understanding and prioritizing which heuristics are applicable in a specific situation – i.e., which are most relevant to target HCPs and pertinent to the features of a particular brand – is an important step in developing effective brand messaging. Here are some examples of how heuristics can guide and optimize messaging.

If the dominant heuristic is Instant Return, optimized messages will focus on how quickly results can be expected, e.g., “Observable results in two weeks, with proven significance at six weeks,” or “Improvement you and your patient can both see in as little as six weeks.”

If Novelty Bias is the dominant heuristic, what’s new and unique about the product will be the focus, e.g., “Only Product X has once-daily dosing and no meal restrictions, which may help your patients remain compliant.”

Similarly, if the dominant heuristic is Background Contrast Effect, optimized messaging will emphasize the drawbacks of an inferior choice (such as remaining untreated for a particular condition) to underscore the value of a different option, e.g., “The impact of body movements isn’t just physical; even mild body movements hold patients back from making meaningful connections and performing daily tasks”.

Of course, optimized messaging isn’t the end of the story. The next step in successfully connecting HCPs to a brand is delivering those messages through powerful creative that communicates quickly and is pertinent, impactful, and memorable. Powerful creative is also visually compelling – studies show that the vast majority of human communication is nonverbal, people process visual information much faster than text, and they retain more of what they see than what they read or hear.

Ultimately, powerful and effective creative is distinguished by four key hallmarks. First, it’s quick, to the point, and communicates in the blink of an eye. Words and pictures work seamlessly together to deliver a disarmingly simple idea. Second, it’s relevant, telling a meaningful story that resonates with viewers and indelibly marks the brand message in their minds. Third, it makes an emotional impact, connecting with the hearts and minds of viewers and communicating benefits, not just product features. And fourth, it’s distinctive, standing out and delivering a message so fresh, daring and different that it’s impossible to overlook.

Optimized brand messaging that is guided by heuristics and realized by powerful creative is a solid foundation for effective advertising and a confirmed way of connecting HCP’s to your brand.

Jody Van Swearingen

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June 27, 2024 0

For some patients, particularly those with rare diseases, determining the cause of their symptoms can be a years-long struggle. To help them find the right diagnosis, they need educational materials that can connect them to appropriate care and empower them to take control of their health.

Tara Sheehy, Director of Client Experience at Phreesia, explained those needs in a recent webinar hosted by Phreesia and The DHC Group. The industry has made great progress with patient communication and care accessibility, Sheehy said, but “There is still a huge unmet need in the market, especially with patients who have rare or complex conditions.” Indeed, approximately half of rare-disease patients wait at least a year for a definitive diagnosis, and 20% wait more than five years.

And often, even after patients have gone through a lengthy process to obtain a diagnosis, they encounter an entire new set of challenges with their treatment. For that reason, patients need quick access to accurate information that can address their concerns, reduce their anxiety about the direction of their care and foster their adherence to treatment.

As patients look for specialist care and information about their symptoms or condition, there’s an industry opportunity to provide support that can shorten their path to diagnosis. Some patients have rare diseases that their physician has never seen, making them particularly difficult to diagnose, said Anthony Scatamacchia, SVP, Innovation, Patient Services at EVERSANA. With those difficulties in mind, he believes it’s critical to equip patients with resources to advocate for themselves in addressing some of the challenges that tend to crop up early in the treatment journey.

Claudia Kanaszyc, Associate Director at Amgen, explained how her group supports patients on their journey from developing symptoms to receiving treatment by advising them to tell their doctor how their symptoms are affecting their lives. For example, if a patient says double vision is preventing them from working or driving, their doctor is more likely to understand the symptomatic effects of a disease or condition and the pressing need for treatment.

“We want to prevent the long-term damage that can’t be reversed, so we are always educating them on providing the whole picture, not just the one part,” Kanaszyc explained.

Octapharma, meanwhile, has built online hubs to support patient education. As Eric Marrero, the company’s Director, Brand Marketing and Communications, described, the hubs allow patients to connect to educational materials or to talk one-on-one with nurse educators or clinicians.

“Those two programs are built out of the insights we got from our patients and everyone who takes care of them,” Marrero said. “Each one of them has to know what it is that they have to do to move that pendulum forward.”

Those insights, which Octapharma developed through market research with patients and healthcare professionals, are particularly important at a time when companies are trying to provide tailored resources. As Sheehy put it, “Personalization is power” and a key component of campaigns that prompt patients to act.

“You really have to meet the patient where they are, understand their mindset and give them content that’s really going to resonate and trigger them to say, ‘I need to take control of my own outcome,’” Phreesia’s Sheehy said. She sees that activation as key to help patients move along their care journey, “Whether that’s to seek a diagnosis or treatment, or be adherent to their medication,” she said.

Marrero emphasized the need to continue to assess the impact of a program throughout the lifecycle of a product. The patient population and treatment landscape will evolve over time, and campaigns need to shift with them to stay relevant, he said. Scatamacchia framed the need to assess what is working as part of the successful execution of omnichannel campaigns.

“You have to make sure that you’re providing benefit to the patient, so that they are leveraging those support services, and that also means showing up in different channels,” Scatamacchia said. “That means finding the different ways to be able to engage with them and offer value that extends beyond just providing their copay.”

Nick Paul Taylor

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March 22, 2024 0

The transformative power of artificial intelligence is just beginning to be realized in pharmaceutical marketing. While machine learning and AI have been around for years, it’s only recently that we’ve found ourselves in what I often describe as a technological Wild West. (Interesting sidenote affirming my choice of words: AI summarizes Wild West as “a complex and multifaceted period blending adventure, danger, and the pioneering spirit of those who shape the frontier.”)

Expanding into new territory is always challenging and perilous, especially for heavily regulated industries. With new AI capabilities and tools cropping up regularly and every industry trying to figure out the best way of harnessing them, pharma marketers have been advancing into AI cautiously.

Social media analysis is one of the first areas where the industry began successfully using AI tools. This involves extracting information and deriving insights from user-generated content across all major social media platforms globally. Using AI models enables pharma companies to identify trends with unprecedented scope and speed and gain real-time insights into public sentiment and patient needs.

As pharma marketers continue assessing AI and its significant opportunities, following are some important ways AI can be used to enhance DTC marketing.

  • Getting Personal: Personalized marketing is a key area where AI-based research models provide great value. Using AI tools to evaluate a variety of data – including social media engagement, click-through, and bounce rates – gives DTC marketers a deeper understanding of the patient journey and the touchpoints and issues that impact it. Ultimately, this information can drive more sophisticated targeting strategies and more relevant, personalized messaging. It also helps marketers anticipate market shifts more quickly and be more agile and focused in responding to them.
  • Growing Sentimental: Using AI to analyze unfiltered customer feedback on social media and review platforms gives DTC brands the ability to proactively address patient concerns and urgent issues. For example, a Facebook user posting a question about a new drug may immediately get hundreds or even thousands of comments addressing the query. An AI-powered tool can evaluate the posts in real time, assess opinions expressed, indicate misperceptions, and flag commentaries that require a proactive reply.  AI-assisted sentiment analysis can also identify what social media groups and influencers are developing around a specific disease state or drug. This enables pharma marketers to provide more relevant content, helping to increase conversion rates.
  • Correction Please! AI models are also useful in stopping the spread of misinformation and disinformation. By rapidly evaluating huge data sets and targeting the origins of bad information in real time, AI enables pharmaceutical companies to respond to misinformation both quickly and directly at its sources. This, in turn, can help companies correct the record and establish greater trust in their brands. Imagine if AI had been further developed during the pandemic to respond to the disease and vaccine misinformation prevalent at that time.

 

While the sophistication and accessibility of AI tools are thrilling, DTC marketers still need to balance traditional market research with AI-led models. Traditional market research generates large volumes of in-depth information, but that data is very time-consuming to analyze and limited in scope. AI-driven research is fast and broad in scope, but still subject to bias and misinterpretation in some areas, e.g., it can misinterpret sarcasm or context-specific nuances, which may skew results. The best approach for DTC marketers is to identify and verify where AI-driven research can most effectively complement traditional research and develop an integrated strategy that optimizes both.

While we don’t know what the next election will bring, we do know that privacy and governance in AI will be on the table. Pharmaceutical companies and their agencies must develop their use of AI within a strong data-governance framework, always asking themselves what the ethical boundaries of AI are and how data privacy and online patient information can be protected. Without this focus on privacy and governance, the industry risks major setbacks and penalties in its adoption of AI. Protecting the autonomy and privacy of the individual remains paramount.

Ultimately, the goal of using AI in DTC marketing is to help consumers better understand their health, the diseases that affect their health, and the options available for preventing, managing and treating those diseases. With imagination, skill, and proper guardrails and compliance, AI could well usher in a transformative new era in DTC marketing.

Sharlene Jenner

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March 22, 2024 0

ECG keeps a watchful eye on trends in women’s health. In 2023 we saw a birth rate that stabilized overall, with variability at local levels; unit closures; growing demand for high-risk services; and provider shortages. Will those trends continue in the new year?

Here are five key drivers that we expect to shape women’s health services in 2024.

  1. Consolidation, Closures, and Growing Maternity Deserts

ECG has written on OB unit closures and the resulting maternity deserts, which are largely driven by industry-wide staffing shortages and pressure on health systems to remain financially sustainable. This year, we foresee an increase in provider group consolidation as OB/GYNs seek relief from burdensome call demands. Impacts to patient access will be substantial; limited resources will be focused on the necessary coverage of inpatient services, to the detriment of outpatient care.

Implication: This is an opportunity for providers to differentiate themselves in their markets and serve their communities in new ways, such as reimaginging care team structure/roles, seeking new partners, embracing innovation, and enhancing operational efficiency.

  1. The Rise of Care Teams

As physician recruitment becomes more challenging and financial headwinds mount, successful women’s health programs are approaching care teams from a holistic perspective. To create the most efficient care model, health systems are partnering with obstetricians, midwives, doulas, physical therapists, and APPs to form teams that promote an expanded scope of services to meet patient preferences while allowing each team member to practice at the top of their license. These team-based models offer many advantages, including:

  • Expanded access through greater coverage and schedule availability.
  • More effective and culturally competent care delivery.
  • Increased patient and workforce satisfaction.

Implication: Creating a care model that coordinates and effectively communicates activities across functions and team members is key to overall program success. Identifying governance, span of control, and agreed-upon care standards is essential to ensuring quality is maintained while care models evolve. The consensus-building process is the most critical component to this type of work, so proper staff and provider involvement is imperative.

  1. Investment in Women’s Health

Market fragmentation, enhanced consumerism, and rise in overall demand for women’s health offerings has drawn the attention of private equity (PE) investors. Investment in women’s health services has more than tripled in recent years, and more deals are anticipated in 2024 as venture capitalists see opportunities in areas such as fertility/reproductive health, menopausal medicine, coordinated pregnancy care, and postpartum recovery. Investment drives innovation, as seen by the multitude of new technologies and services emerging in the women’s health sector. Depending on the perspective, specific investments may be considered a welcome addition or additional hurdle for providers.

  • New care models offer opportunities for diversification for systems looking to expand their offerings with fewer resources. Apps, digital patient education, home monitoring, and virtual services augment the traditional patient care experience.
  • Women’s health is becoming an increasingly competitive space. New service provider entrants to the market offer medical services to niche patient populations, potentially siphoning patients who may otherwise have sought services from existing providers and facilities.

Implication: Rapid innovation and technology gives providers an opportunity to differentiate their offerings. Providers should be watchful of the investments in women’s health and consider the impacts to their organizations. As PE investment expands, most health systems will have to make a choice: compete directly with PE-backed companies through targeted alignment, acqusition, and investment in incubator spaces, or partner with PE firms in a structure that maximizes capital investment and the system’s own management expertise.

  1. Focus on Quality and Access

The maternal mortality rate continues to rise, particularly for women of color. In 2022, the White House released a Blueprint for Addressing the Maternal Health Crisis, which puts an increased focus on addressing quality and access challenges for maternal care. The report recommends several initiatives—including an expansion of programming, an increase in price transparency, and the “Birthing-Friendly” designation—that will shape the future of women’s healthcare services by holding facilities accountable.

Implication: Strategies to support operational efficiencies (particularly around outcomes) will be imperative to remaining competitive. Providers and facilities should consider targeted investments, establish transparent communication/marketing positioning, and optimize outpatient operations to remain financially sustainable.

  1. Changing Regulatory and Legislative Landscape

Providers face a fluid regulatory and legislative landscape, which will continue to impact access to services as well as the cost of doing business.

  • Reproductive Health: Access and regulations have changed on a state-by-state basis, potentially shifting the provision of services and resulting risk. Structuring meaningful care pathways will help organizations to maintain quality and outcomes while mitigating risks.
  • Malpractice Costs: Costs for malpractice insurance are already among women’s health providers’ greatest expenses, and obstetricians are the most likely of all physicians to be sued for malpractice. While malpractice caps help balance providers’ risk, several states are proposing increases to those caps—which would heighten financial risk for providers. This may prove to be a driver of change among provider groups, adding pressure to consolidate practices, discontinue services, or retire earlier in an effort to reduce risk exposure and expenses.
  • Chaperone Laws: State requirements for chaperoning physical exams vary, but women’s health providers are the most impacted. These laws continue to evolve—as is evident from recent legislation in Oregon and Wisconsin—and have the potential to impact business operations via staffing and workflow adjustments.

Implication: For many providers and facilities, women’s health is a core service—a foundational offering that must be provided regardless of the constraints. The key will be the ability to shift through changes and create operations that will enable healthcare providers to remain sustainable—and potentially grow—in an uncertain environment.

Tessa Kirby

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March 12, 2024 0

Career highs and lows sometimes feel random: We often call a success “lucky” and a setback “unfortunate.” In biopharma, we may think of a drug launch that turns out to be a blockbuster as such a lucky break. But possible setbacks lurk all along the drug life cycle: The molecule might not meet its endpoints, or we might hit a snag with approvals or with payer formularies, or the market might be much tougher to penetrate than anticipated. Our minds don’t need to wander all the way to the spectacular ethical and legal failures of the Sacklers, Shkrelis, and Holmeses of the world to understand that, in our industry, you can find boom as well as bust.

However, here’s the truth: Even if you can’t control your successes and setbacks completely, they’re not entirely random either. Our careers have higher peaks and flatter valleys if we pay attention to certain seemingly minor details that could blow up to become major problems. The fear of becoming the next Purdue or the next Turing can sometimes cause some degree of paralysis. But it would be foolish to try and solve business problems by refraining from doing business. More often than not, it’s the omission of regulatory and ethical precautions, rather than the actual conduct of marketing, that’s the problem.

Working with the Consumer

Take patient engagement, for example. It’s a crucial part of any medical marketing plan, and not only because the other strategies are becoming harder to execute—we all know that pharma reps have a harder time getting in front of doctors. But more profoundly, the empowerment of patients in their healthcare decisions has revolutionized the way pharmaceutical companies approach the market. It’s not just about keeping pace with industry trends, it’s about leading the charge in a healthcare environment that increasingly values personalized care. In today’s digital age, patients have access to a wealth of information and a voice through social media platforms, patient forums, and advocacy groups. They are well-informed advocates for their health, often arriving at the doctor’s office armed with research and questions about their treatment options. This shift requires pharma marketers to engage in two-way conversations, where listening becomes as crucial as informing. In this environment, the role of the marketer evolves to that of an educator and facilitator, providing the tools and information necessary for patients to make informed decisions about their care. If you’re a pharma marketer in 2024, whatever you do, don’t ignore the consumer.

But not everybody seems to understand that working with consumers in the pharma industry differs from working with consumers in other industries in important ways. If you let inexperienced marketers implement strategies that might work in other industries, you can expect FDA warning letters, or worse, to land on your desk. Does this mean patient engagement is dangerous or a bad thing for companies or patients? Of course not! What it means is that biopharma marketing requires an approach, expertise, and infrastructure that are specialized. A Patient Ambassador® Program is not like running any other speaker bureau. A patient video is unlike a consumer review, and a patient advisory board is unlike conventional market research. To a layperson, the difference may not be instantly apparent, but regulators can tell what is what and will enforce their rules.

Efficient Compliance

First, the agency handling patient engagement must be familiar with the regulatory rules and obligations that apply. This starts with thorough training. From adverse event reporting to privacy protections, from fair balance to approval processes and honoraria, teams can only be successful in this if everyone receives training on how to handle any given situation. This requirement extends to all members of the organization, not just those directly interacting with patients. These trainings also need to be regularly updated and refreshed annually.

Second, your patient engagement agency also needs to invest in the technical infrastructure that enables team members to efficiently fulfill or even automate their regulatory duties. It can’t work if, for every adverse event, the exact reporting procedure has to be reinvented or rediscovered by someone who hasn’t submitted a report before. It also won’t work if compliance with GDPR is left to individual team members to sort out which piece of data needs to be purged on any given day.

An Authentic Perspective

Third, beyond the rigidity of regulatory compliance, your agency must also understand the softer, yet equally vital, nuances that come into play when working with patients. Your initiative must emphasize authenticity over brand promise. With consumer goods, it’s commonplace to market with a brand promise that’s aspirational and exaggerated: By buying this or that beverage, car, or vacation, you hope to get closer to—or become a little bit more like—the person you see in the commercial. Drugs are no status symbols, and nobody wishes to become a little bit more like a sick person. You’re not interested in being enticed by someone who doesn’t know anything about your condition, no matter how good-looking or otherwise admirable they may be. The perspective that counts is that of people who know what you’re going through. Most of the time that will be other patients or caregivers. Actors and models have no place in this unless they also happen to be real patients.

Finally, the team you put together must treat patients like the human beings they are. This includes being realistic in expectations and anticipating limits of any kind: Mobility, cognition, fatigue, dietary restrictions, vision, hearing, and emotional trauma are some of the factors that commonly play a role. If you expect a patient or caregiver to open their heart (or home) to your team, make sure you enter with respect and leave things the way they were. You don’t want to roll up with a crew truck and run over the patient’s manicured garden (figuratively or literally). You also don’t want to rush patients along or disrespect them with insensitive lines of questioning. You’re not dealing with career talent but with individuals who can provide tremendous value if you allow them to show their true selves.

Setting a Standard

Companies and executives find themselves in very uncomfortable positions if their teams and vendors neglect to take care of important steps like these that keep the organization safe. Incidentally, by safeguarding their reputations and legal compliance, biopharma teams also happen to serve and protect patients’ interests, so it’s a win-win. Nobody wants to be on the front page of the Wall Street Journal for the wrong reasons. Companies that manage to strike the delicate balance between assertive market presence and steadfast legal and ethical adherence do not just avoid the ignominy of negative press—they set a standard for the industry. By fostering a culture of compliance, championing patient-centric approaches, and continuously innovating on engagement strategies, biopharma entities not only propel their brands to the forefront but also underwrite the narrative of their own integrity.

Walking the tightrope of biopharma marketing requires a blend of agility, foresight, and unwavering ethical commitment. Compliance and patient satisfaction aren’t lofty goals, they’re the foundations of success, the cornerstones of marketing excellence. That’s how pharma marketers extend career highs and mitigate any potential lows.

Oliver Portmann