Designing for the ACNU consumer experience
By: Marc Lafleur & Dan Frey
The United States Food and Drug Administration’s (FDA) new rule: “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU) allows for some prescription drugs to be switched to non-prescription status and made available to consumers without the involvement of a healthcare professional (HCP). From a public health perspective, an ACNU promises improved access to generally safe and effective medications for chronic conditions. From a consumer perspective, the rule represents a paradigm shift in how the public will purchase and access critically important medicines for managing highly prevalent, chronic conditions — such as high cholesterol, respiratory illness or hypertension. For pharmaceutical companies who have traditionally only seen a consumer through the lens of over-the-counter (OTC) transaction data, the rule represents a first-time opportunity to directly engage consumers as individuals throughout their healthcare journey; supporting them through the fundamentals of medication access, use and adherence, but also potentially offering broader support for condition management.
Prior articles have examined the ACNU rule and how it will affect HCPs, pharmaceutical manufacturers and other stakeholders and we have explored how decision-makers can take a business lens to determine which assets are most relevant. In this article, we will focus on the importance of the consumer experience (CX) in ACNU.
Beyond a smart questionnaire
The core component for many ACNUs will be an FDA-approved risk-reductive tool that helps consumers safely choose a drug without the assistance of an HCP. Self-selection is something that consumers do day-in and day-out with OTC medications by reading the drug facts label, but the decision factors for self-selection of an ACNU drug are simply too complex and lengthy to be communicated on a standard drug facts label. Showing that consumers can consistently and accurately determine that a drug is appropriate for their use by leveraging the power of digital has been at the heart of the regulation.
Designing an effective self-selection smart survey is no simple task: It needs to consider the many challenges for accessibility and health literacy and must be simple and fast enough to ensure that consumers are not overburdened and abandon the process while also serving the core purpose of reducing risk. Indeed, there’s an art, as well as optimal technology, to designing a self-selection survey in which complexity is reduced and drop-out is minimized. And while self-selection is at the heart, it’s just one component of the overall ACNU experience. The ACNU CX strategy needs to consider the entire consumer journey from learning about an ACNU, considering a product, completing self-selection, purchasing, and receiving continued support.
Let’s take the example of an ACNU for a statin to lower cholesterol. According to the U.S. Centers for Disease Control and Prevention (CDC), there are almost 90 million people in the U.S. who could benefit, but prescription statins remain under-prescribed, under-filled, with poor refill rates. The consumer experience for an ACNU statin would probably need to start by helping consumers understand what an ACNU product is, how it differs from a generic prescription (Rx), how they purchase it and how much it would cost. Only once a consumer has considered their options will they engage in self-selection to determine if the statin is right for them. Once the product is determined to be right, the consumer needs to go through the process of purchasing the drug. Then, they would probably want to know more about the importance of lowering and managing their cholesterol. They will want to have access to additional health education and management tools. All these elements in the consideration through the post-purchase journey should be contained in a cohesive, simple-to-use digital experience.
While the FDA will take an eagle eye on the all-important self-selection algorithm, the implementation plan for the entire digital process from start to finish will be important to regulators. As manufacturers build their ACNU CX for ACNU, they should be keeping in view the full breadth of using medicine as a consumer. An ACNU has the potential to do much more than just improve access, and as the market for ACNUs matures, digital engagement channels will likely take a more feature-rich, holistic approach to condition management and support.
In preparing for an ACNU, a critical step in the regulatory submission is the pre-investigational new drug (Pre-IND) submission and meeting. This is a consultation with the agency in which the manufacturer lays out their plans for the basis of their application, including self-selection and planned clinical studies. It’s also a moment for communicating to the agency how consumers will engage through the digital experience. While all elements of an ACNU CX design don’t need to be finalized before the Pre-IND, the manufacturer must consider the digital strategy. Furthermore, that strategy may inform the design of label comprehension studies, human factors studies and actual use studies.
The stakes with ACNU are high and designing a simple-to-use experience is critically important. While a label comprehension study and implementation plan may pass muster with the agency, it may fail as a CX if it collapses under the weight of an overburdened digital experience. To that end, let’s highlight some areas that are critical to a good ACNU CX:
- Reducing complexity: The CX should simplify the number of steps or clicks required to go from building awareness to completing a purchase of the medication.
- Simplifying navigation: Make it easy for consumers to get around the digital environment, navigate access and get the information they need to get the job done.
- Decision-making support: Consumers face a significant burden when it comes to making the right choices for their health and navigating an already complex ecosystem around their medications. A good ACNU experience should anticipate the consumer decision-making process and put the right support in place with information and on-demand help.
Evolution of an ACNU marketplace
An ACNU represents a paradigm shift for consumers who will be receiving chronic care medications without the engagement of doctors or pharmacists. The first ACNUs will likely take a “brand-by-brand” approach with consumers needing to go to a digital destination that is defined around the specific brand or the pharmaceutical company.
We believe that the ACNU rule will open the door for a marketplace of drugs for consumers, offering optionality and choices for managing chronic conditions. Moreover, consumers will need a destination or several digital destinations where they’ll consider medication options and make smart comparisons and choices. In a world where there are multiple choices for, say lowering one’s cholesterol, a “brand.com” destination may not be as effective for finding and garnering consumers. Whereas “manufacturer.com” may be a better choice, in a world where multiple manufacturers have ACNU products, eyeballs and clicks may gravitate to consolidators. We don’t know if there will be one consolidator or multiple, but it’s not difficult to imagine what a winning consolidator strategy might look like.
Emerging online pharmacies such as Hims & Hers Health, Costplus Drugs, Amazon Pharmacy and others have focused on designing experiences that are simple, convenient, trustworthy and consistent. These early leaders can also be beacons for defining best-in-class experience digital design principles that can translated to the ACNU landscape.
At the heart of a consolidation strategy is the notion of a digital front door (DFD). While DFDs come in many shapes and sizes, when done correctly, they can enable a single unified local for informing, assessing and triaging consumers while ensuring they get the right support, allowing them to seamlessly go from awareness to access without being redirected from one place to another. Digital front doors connect to robust back-end support and fulfillment systems and create simplified on-ramps for consumers, enabling flexible engagement that can accommodate those who want to learn, consider, and return to complete transactions later.
A human-centered approach:
As a new non-prescription channel for chronic medication that doesn’t directly involve pharmacists or physicians, an ACNU will likely be met with enthusiasm by many due to improved convenience. For others, however, there will be uncertainty in eliminating what has been the traditional oversight of their care ecosystem. While patients may still consult with their physician to make medication choices, consumers may feel uncertain throughout the ACNU access journey. Manufacturers, in designing the ACNU CX need to take a human-centered approach to ensure that they are providing supportive information and decision-making tools that allow users to feel confident and secure in their self-selection, purchase and use decisions.
Approaching an ACNU from a regulatory and labeling perspective alone risks missing critical consumer needs across a range of dimensions, including their emotional and support requirements, informational and educational opportunities as well as logistical necessities. In preparation, it will be important to develop a nuanced understanding of end-user needs both according to the therapeutic area that they’re seeking support for and based on where they are in their journey with a condition and with medication. Creating ACNU experiences that anticipate and proactively address key questions and uncertainties, while enabling the right support and information to be delivered to consumers at the right moments, will be a foundation of success. The first step will be to ground the experience design in research with consumers that assesses and addresses their health journeys, and the needs and motivations they’ll inevitably bring into their first encounters with an ACNU channel.
We believe that ACNU digital channels offer the opportunity to creatively re-imagine care interactions for all parties involved. For patients it will mean easier, informed access to the medications they need, while for HCPs it could mean more time spent on patient care and less on administrative and lower-value tasks — like prescription renewal. Our job will be to assess, define and create the right experience that speaks to this new care journey while emphasizing convenience, speed, and personalization. This could mean creating pathways for two-way conversations, employing AI to create personalized wellness plans that complement medications, ensuring consumers have access to more holistic health management resources at their fingertips and that information, and tools for medication management and adherence are surfaced where and when they are needed.
An ACNU presents a rare opportunity to reinvent and reimagine existing care pathways and models — where ACNU-endorsed channels and experiences will inevitably take many flavors. Some will opt for a basic stripped-down experience that focuses exclusively on the “smart survey”. However, the true value of an ACNU lies in the engagement potential that a more robust and holistic experience will bring about.
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Dan Frey is a Principal at ZS Associates
Marc Lafleur is one of the leaders in ZS’ Design Studio
Special thank you to contributions and collaborations from Vidya Viswanathan, Todd Greenwood, and Salma Kazmi for their contributions to this article.
