The exciting trend toward increased integration of patient, caregiver, and patient advocate experience earlier in the drug development process runs the risk of overshadowing the proven value of engagement around marketed products in general, including legacy brands. While this trend heralds innovative opportunities for teams working across the entire drug development continuum, the benefits for legacy brands must not be forgotten.
Will End-to-End Advocacy Be Realized?
In the April 2018 issue of PM360, Elizabeth Elfenbein imagines “living in a world where being understood was the most valued expectation from a brand.” Not that long ago, asking for, gathering, and utilizing input from patients on research and development was a rarity. Patient input was reserved for market preparation through disease awareness and ensuring a “patient-centered” approach. But a shift occurred that called into question the very nature of industry’s patient centeredness: Patient advocates began asking what patient centeredness means? What are the objective ways that a company demonstrates “patient centricity”?
Patients and their advocates created social media platforms to share their and others’ experiences. They also weighed in loudly on issues such as pricing and clinical trials. The phrase “nothing about us without us” became an oft heard cry across the globe. Patient organizations’ expectations focused on active partnerships and collaboration with industry rather than passive receipt of sponsorship dollars. Payers and regulators ramped up pressure to ensure products addressed true unmet needs based on patient input and preferences.
Today, we see a vast migration toward understanding of the patient as Elfenbein’s “most valued expectation of the brand” along the full continuum of drug development and commercialization. “End-to-end” advocacy opens the door for realignment of more traditional advocacy relations with the commercial side of the business in a respectful and compliant fashion.
Patient Input Impact on Drug Commercialization
Pre- and post-product launch advocacy relations activities historically consist of identifying appropriate ways industry and patient groups work together to address their shared interests, including use of a medication. In general, unmet needs fall into these categories:
- Disease awareness. What do patients and providers know about a particular disease or condition? Patients with less well-known diseases and conditions often are the true experts. Even their doctors learn from them. Those with more common diseases face other challenges, including stigma. Lung cancer is an excellent example. Lung cancer patients may not be offered support and treatment even when new effective treatments are available because they are blamed for their illness.
- Improvement in treatment. How well does the new product treat what patients care about? How does a drug’s efficacy impact treatment decision making and patient choice? What tools and resources do patients need to have informed conversations with their HCPs?
- Activating patients. What shapes the ability and willingness of patients to embrace innovation, participate in treatment decision making, and adhere to treatment regimens? Increasingly, patients embrace the chance to take responsibility for choosing their treatments and managing their illness. Still, others are not ready and willing; how can advocacy and industry collaborate to help?
- Channels and messaging for reaching patients. How and where do patients receive information? What is required to help them make informed choices and how can underserved populations be included? With so much noise online, how do we ensure patients receive credible information?
- Access barriers. If patients can’t afford a medication, what systems must be in place to ensure appropriate patients are able to access it?
Supporting Legacy Brands Today
When a product approaches the end of its lifecycle, a different approach is needed. Because legacy brands have built significant equity with patients, caregivers, and providers, finding new ways to work together poses both challenges and opportunities. It is also the time to harvest the knowledge and engagement of advocates shown earlier in the lifecycle.
These four ideas show how engagement with patients and patient organizations can work for legacy brands:
- Abandon ideas of “advocacy exit strategies.” Legacy brands are seldom assigned significant funding. A small number of advocacy activities are worth considering in this cost-constrained part of the lifecycle. Ensuring advocates well acquainted with the drug are ready to respond in the event of a crisis is one example. Another is tapping into these advocates’ insights into the next generation of treatments.
- Increase awareness of treatment guidelines and analyze their use. Patient organizations are invested in making sure that patients receive consistent, evidence-based care. In collaboration with advocates, determine where treatment with a legacy brand is falling short of the guidelines and address the concerns in a particular region, state, or locale. Conduct retrospective, collaborative reviews to look at treatment patterns and identify gaps where patients are not receiving appropriate care. When gaps in treatment with a legacy brand exists, work with advocates to develop patient-friendly treatment guidelines to stimulate conversations with their providers.
- Build strong collaborations to address adherence. Only if patients take their medications in the way they are prescribed will they achieve the full benefit. Adherence to treatment regimens is an untapped area for collaboration between patient organizations and industry, which can impact the sustainability of a legacy brand. Yet it is largely set aside as too difficult and complex to tackle. The introduction of a pill that tracks when taken as well as “smart pill” dispensing technologies open a new wave of opportunity. Greater understanding about adherence can be a low cost, low risk opportunity to test ideas that might be suitable for pipeline and recently approved medicines.
- Create a template advocacy toolkit for legacy brands and include metrics. Recognizing that investment in these drugs is often minimal, identify the small number of steps needed to ensure advocacy support during the last part of the lifecycle. Provide template materials that ensure ease of use. Include quantitative and qualitative measures that show the value of the limited effort and that evolve best practices.
When the sun begins to set on legacy brands, a light can still be shown on them through new, albeit limited, types of collaborations with patients and patient organizations. The movement toward end-to-end advocacy encourages us to think creatively about how we sustain and maintain advocacy relations far past the launch of reliable brands to bring value to the company and patients. While funding will be limited, the value of the legacy will not only be in the brand, but in the continued emphasis on long-term relationships with patient organizations whose collaboration was key in ensuring access to and awareness of a once new, important innovation.