Has Pharma Given Up on Long-Term Adherence?

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Will the FDA ultimately step in and mandate a credible effort to eradicate the mindset that long-term adherence is not achievable?

Image credit: Anastasiia | stock.adobe.com

Image credit: Anastasiia | stock.adobe.com

It is not hard to understand why pharma has, for all intents and purposes, walked away from long-term adherence. The adherence problem has been around since Hippocrates launched our adventure into modern medicine all those centuries ago. His brutally honest observation and recommendation from 400 BC continues to ring true with all its painful, prescient glory:

“Keep a watch also on the faults of the patients, which often make them lie about the taking of things prescribed.”

To be fair, pharma, by necessity, has and will continue to spend billions on patient programs under the guise of “access and adherence.” Loreen Marshall, global head of Digital Patient Support Services at Medocity, helped pioneer the pharma hub industry, and she says it well. “Access and affordability are absolutely essential for patients to obtain their medications,” Marshall said. “But, when it comes to helping patients with long-term adherence, pharma spend is almost nonexistent outside of ultra-rare disease treatments.”

Indeed, long-term adherence has vexed modern medicine since 400 BC, and no one in pharma—whether it be the CEOs, the heads of R&D, brand marketing departments, field sales, or even the patient support program teams—is truly held accountable for long-term adherence.

As a result, the overwhelming majority of pharma’s commercial investment and marketing and sales efforts are focused on creating awareness (seen any pharma commercials lately?), educating clinicians, onboarding patients, enhancing affordability, and creating access.

From the commercials to the websites, to the hubs, to patient advocacy groups, to payer rebates, to pharmacy services, to the sales and support spend with healthcare providers, EVERYTHING is front-loaded to get patients from Rx to therapy quickly, and keep them adherent and compliant for as much of that initial six months as possible.

This front-loading of resources has reduced pharma’s R&D and commercial focus to a never ending “grinders game" to acquire new patients. This means, most, if not all of the abundant revenue and better outcomes achievable through long-term adherence are left at the mercy, mystery, and vagaries of patient behaviors.

Spoiler alert: The reason therapy education, disease literacy, medication reminders, even death threats have never really worked is because we humans ARE NOT rational creatures. If we were, adherence wouldn’t be a problem in oncology, congestive heart failure, and other innately life-threatening diseases, and we would all eat healthy, drink and smoke less, reduce social media time, stop talking politics, and exercise more.

If you’ve ever pondered why pharma has been so reticent in embracing value-based care, please consider patients not being rational creatures as exhibit A. The industry's lack of willingness to be held accountable for outcomes is in direct correlation with their inability to ensure that their drugs and biologics are being taken as directed.

The reason the front-loaded “all of the above” strategy and tactics have not significantly impacted long-term adherence is because pharma, nor any of the other entities that have historically endeavored to deliver healthcare, have heretofore been successful in addressing the fundamental problem that Hippocrates memorialized so many centuries ago: patient behavior.

A recent Time article screamed what has been staring us in the face forever: Behavior is a Miracle Drug For Our Health. The viability of value-based care is inextricably tied to our ability to address the behavior issue with patients. Thankfully, while Hippocrates in no uncertain terms bluntly highlighted the problem of, let's call them “patient untruths,” he was quite brilliant in illuminating the solution:

“It is more important to know what sort of person has a disease than to know what sort of disease a person has.”

We have a centuries old unaddressed and undeniable mandate if healthcare as we know it is to become sustainable: We must better understand, enable, and empower patients. While pharma has taken a few baby steps with behavior-based segmentation strategies, successfully executing this mandate requires a far more robust and personalized approach. The new paradigm has to entail engagement based around the concept of “knowing what sort of person has a disease” that moves beyond engagement to activation.

As we’ve all no doubt seen and heard ad nauseam since the explosive launch of ChatGPT, AI is primed to revolutionize our ability to engage and empower patients at scale. A big part of any successful effort will be fundamentally driven by our efforts to truly understand and change behaviors.

While there is still much work to do to safely, effectively, ethically, and morally execute on this impending mandate, we now have the technology to:

  • Develop comprehensive, preventive, and predictive qualitative and quantitative profiles for each unique patient.
  • Build scalable enduring personalized relationships with patients.
  • Provide tailored, behavior-based, asynchronous and synchronous interventions that align with the timing, content, channels, nudges, and real-time monitoring each unique patient profile requires.
  • Move the needle from what we now generously call patient engagement to patient activation such that patients are enabled and empowered to manage their own unique health and well-being ecosystem in real-time.
Credit: Medocity

Credit: Medocity

Is pharma’s long-term viability at stake?

Maybe! “The Times They Are A-Changin!”

You might have noticed that transparency in drug pricing is taking root, precision medicine is real, and the FDA is slowly but surely building the framework to hold pharma strictly accountable for inclusive clinical trials that reflect diversity and real-world evidence.

Is it implausible to think that at some point in the near term, at the behest of employers, commercial insurers, pharmacy benefit managers (PBMs), federal and state payers and now, newly empowered consumers, that we aren’t at the precipice of the FDA holding pharma accountable for real-world sustained outcomes. And why not?

Digitally-augmented engagement that facilitates automated monitoring, the collection of qualitative and quantitative data, and tailored digital interventions, is now in play with unlimited reach and frequency. The capability to conduct ongoing post-marketing studies with an entire patient population is doable today, and it enables regulators to hold all therapies accountable for delivering value throughout the product life cycle. The only questions left are when and whether pharma will be a vested partner or a victim?

The World Health Organization estimates that an eternally persistent 50% of Americans don’t take chronic disease therapies as prescribed. In the United States alone, poor adherence contributes more than $500 billion in avoidable healthcare costs, approximately 125,000 potentially preventable deaths, and up to 25% of the hospitalizations.

Against this backdrop, an aggressive mandate is unavoidable. AI-enabled technologies are being embraced at an unprecedented level and are putting governments, health insurers, PBMs, and hospitals in prime position to execute value-based care, with or without pharma.

To be a viable value-based care partner, pharma will need to recognize that there is a clear and present danger, initiate an urgent and aggressive top-to-bottom effort to eradicate the mindset that long-term adherence is not achievable, and manage the product life cycle, from clinical trials through patent expiration with an unrelenting focus on delivering optimal real world long-term outcomes.

About the Author

Victor Morrison is a market access pharma veteran and pioneering thought leader on the use of conversational AI to create therapeutic alliances with patients.

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