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The Rise of Patient Stakeholders: What CMS’s Shared Decision-Making Policies Mean for Medtech

Posted by Kate Templeton on June 13, 2019



2250_SM_DecisionMaking_BlogThis post is the first in a multipart series on how the rules of the road are changing in medtech, and the implications on commercial strategy. Sundeep Karnik contributed to this blog post.

A few months ago, I attended the 2019 American College of Cardiology conference and was surprised by the number and diversity of sessions on shared decision-making. The concept has taken on a more prominent role in conversations lately thanks to CMS, whose changing policies have opened the door for patients to play an expanding role in therapy selection. In fact, for the second time in six months, the rising role of the patient in the treatment decision-making process was a talking point at a major conference: It was also on display rather poignantly during TCT 2018, when patients joined key opinion leaders on several panels to share their experiences and perspectives on topics ranging from clinical trial design to the impact of particular technologies.

The notion of shared decision-making is an odd one because, after all, patients are on the receiving end of care and you’d hope that their wishes are always taken into account. While physicians certainly discussed treatment options with patients in the past, it’s time that we formally include, acknowledge and empower the role of the patient in medtech, recognizing the individuality of each situation. This is critically important with the rise of “messy” diseases—heart failure, valvular disease (especially mitral), cardiac arrhythmias, stroke—where there isn’t a one-size-fits-all answer for how a physician “should” treat a certain patient.

While the tremendous progress within healthcare over the last 50 years is a victory on the side of science, it left in its place a much more complicated state of affairs. Instead of relatively young patients suffering from one or two acute issues, physicians are faced with the daunting task of treating increasingly elderly patients suffering from multiple co-morbidities and possessing worse underlying health issues thanks to decades of chronic disease. To make matters worse, we often don’t fully understand how these diseases interact, which complicates decision-making and expectation-setting when it comes to treatment options.

Acknowledging the nuances between patients’ unique (and increasingly complex) situations, CMS has begun including shared decision-making as a reimbursement criterion for certain types of lung cancer screening, left atrial appendage closure and implantable cardioverter defibrillators. In doing so, the organization has recognized that many modern treatment conundrums are too complex to be reduced to a straightforward list of clinical criteria, and that such lists fail to take into account hard-to-measure factors such as drug tolerance or patient adherence. For example, in the case of left atrial appendage closure (LAAC), documented shared decision-making concluding that the patient is unsuitable for long-term oral anti-coagulation is a criteria for CMS reimbursement for a left atrial appendage closure procedure. The numerous permutations of individuals’ risks for bleeding, adherence missteps and stroke make it difficult to apply a generic set of criteria to reach that same conclusion, so CMS has left it to the patient and physician to weigh all of the factors with the help of a decision aid.

As companies continue to add new devices to physicians’ tool boxes, they need to be cognizant of the fact that with messy diseases there’s often less clarity on what’s appropriate to use when, or how to weigh different treatment options. This is further complicated by the fact that the tool box includes devices and pharmaceuticals, and traditionally pharma has been more focused on the patient as a stakeholder than most medical device companies. At the risk of being outmaneuvered as shared decision-making becomes more widely adopted, medical device companies need to more holistically understand the patients they serve instead of focusing on the physician and nurse—the users of their technology—and the hospital administrators who approve it. Going back to the example of LAAC, Boston Scientific (the manufacturer of Watchman, a LAAC device) has started addressing some of these dynamics by providing patient selection aids on their website.

If this trend continues, five years from now patients will play a much more active role in their care, and provider organizations will require additional information and expertise to support their institutionalized shared decision-making procedures. Here are five strategies to consider as a medical device marketer, particularly with messy diseases:

  1. Undertake market research to understand the patient journey holistically, the treatment and lifestyle trade-offs that patients face, and the criteria they weigh when making those decisions. As shared decision making becomes more prominent, providing patients with the information they need to feel comfortable choosing a given treatment path will become a necessary (but not sufficient) criteria for adoption.
  2. Develop campaign materials that specifically address those trade-offs and pain points rather than touting product features or clinical endpoints. Patients are increasingly educated about their health and often actively seek information that relates to the situation they’re facing. The goal is ultimately to empower patients and physicians with the information they need to make the best decision for the situation at hand, recognizing that no two situations are the same.
  3. Consider developing evidence or tools to support shared decision-making or patient selection tools to aid physicians in translating the patient selection criteria from the clinical trial into their day-to-day practices. With more connected devices on the market, device manufacturers are in a unique position to contribute to the overall understanding of treatment pathways.
  4. Evaluate the use of real-world data to provide additional clarity on treatment options and outcomes. One recent example is iRhythm’s research relating a patient’s atrial fibrillation burden to stroke risk, enabling physicians to make more informed decisions about which patients have significant enough non-valvular atrial fibrillation to require anticoagulation or other interventions.
  5. Evaluate partnerships with other companies or academic societies, as we’ve seen in the TVT registry for TAVR valves. The ecosystem as a whole benefits by having a central data repository, and no one company bears the cost of maintaining it as a company would with a single-sponsor registry. While this example is specific to a registry, that need not be the only type of partnership.

With the widespread adoption of technology platforms like Amazon striving to provide personalized recommendations to ease your path to purchase, our expectations of the type and quality of information that should be available has risen significantly. That consumer mindset is trickling over into what we expect from our healthcare ecosystem as well, whether the role we play is as a patient, a provider or an administrator. CMS weighing in just accelerates that shift as it relates to shared decision-making, increasing the appetite for more—and better—data as patients take up their new, more formal role. Marketers need to be prepared for both the questions and opportunities that presents.


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Topics: Patients, medical devices, medtech, Centers for Medicare and Medicaid Services, CMS, patient centricity, ACC, shared decision-making, patient stakeholders, TCT 2018, medtech commercial strategy

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AUTHORS
Brian_Chapman_thumbnail
Brian Chapman
Principal,
ZS Associates
Tobi_Laczkowski_thumbnail
Tobi Laczkowski
Principal,
ZS Associates
Will_Randall_thumbnail
Will Randall
Manager,
ZS Associates
Matt-Scheitlin-London_thumbnail
Matt Scheitlin
Associate Principal,
ZS Associates
Andy-kach_thumbnail
Andy Kach
Associate Principal,
ZS Associates
Bhargav_Mantha_thumbnail
Bhargav Mantha
Associate Principal,
ZS Associates
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