By Ed Miseta, Chief Editor, Clinical Leader
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It seems like every day pharma companies are facing new demands from consumers, insurers, regulators, and independent groups. For the industry to improve clinical trials, as well as the entire drug discovery process, better links need to be forged between these stakeholder groups. Increasingly, it appears better engagements with patients and consumers may be the crucial link for pharma companies to achieve better and more efficient outcomes.
That’s the conclusion of a new report released by PwC Health Research Institute (HRI) titled, Patient Engagement: Pharma’s Strategy For Success In The New Health Economy. The report is based on an analysis of the state of patient engagement, including an analysis of 21 patient-engagement meetings and data from the FDA’s Orphan Drug Designations database. HRI also surveyed consumers in both 2015 and 2016 to determine their willingness to engage with the pharmaceutical industry, regulators, and other entities in the healthcare industry.
The issue of patient engagement is certainly a significant one for the pharma industry. The report notes consumers are taking charge of their wellness and asking to be more involved in decisions related to their healthcare. At the same time, regulators are tailoring their approvals to patients’ tolerance for risk and desire for benefits. All stakeholders, particularly insurers, are asking pharma companies for greater evidence that their products are producing favorable outcomes.
“While the pharmaceutical industry has always interacted with patients, in particular through clinical trials and marketing efforts, these types of engagement may no longer be sufficient for some companies as industry and regulatory changes take hold,” notes the report. “What is needed is proactive patient engagement that anticipates and meets the evolving needs and wants of consumers.”
New Value Will Require Additional Effort From Pharma
Although pharma companies will reap new value from improved patient interactions, getting there will not be a simple process. Many patients have a fundamental distrust of the industry, and regulators will require companies to find new ways of engaging with patients. Pharma will have to connect with more patients, do it more often, and start that engagement earlier in the development process. Partners and technology will certainly play a role in that engagement.
While this engagement effort will require some planning and effort, HRI notes the companies that are successful will increase their chances of regulatory and commercial success. That success will be made possible by better understanding the patient experience, their values and needs, and their willingness to assume risks in return for access to new treatments.
The report notes three factors are driving new patient engagement. The first is the emergence of consumerism, led by patients rejecting the once-paternalistic relationship of the healthcare industry. Today, patients want to take charge of their care. That includes searching for information on their condition, connecting with other patients on social media and sharing experiences, and searching for information on drugs under development or in clinical trials.
Emerging technologies, such as wearables and mobile applications, are also making it easier for patients to gather and track their own data. Additionally, 24 percent of consumers have used Facebook for healthcare purposes while 37 percent have sought healthcare information on at least one social media network. Still, the report notes finding the information they require is not a simple process.
While pharma has historically focused on regulatory approvals and product marketing, this change in consumerism will require companies to focus on the information patients want, how they want to access it, and where the information should reside.
The second factor is the shift from volume to value. Although this change primarily involves payers looking for new ways to control costs, it will most certainly involve tying reimbursement rates to a drug’s effect on patients. The report notes independent, third-party assessment groups, like the Institute for Clinical and Economic Review (ICER) and the American Society for Clinical Oncology (ASCO), are now publicizing their own judgments about drug value using formulas that take into account clinical performance, outcomes, and patient perspectives. This emphasis is expected to create new pressures for pharma companies already faced with increasing R&D costs and regulatory approvals.
The report notes a final factor being the increased regulatory interest in patients. The Food and Drug Administration Safety and Innovation Act of 2012 set up a Patient-Focused Drug Development program to better engage with patients. The FDA has already held 21 disease-specific meetings in which it asked patients for their perspectives on diseases, treatments, willingness to participate in clinical research, and tolerance for risk. The meetings will be used to guide regulatory decision making on new drug approvals.
HRI expects this approach to expand in the near future. “Part of the proposed revisions to the Prescription Drug User Fee Act (PDUFA), stipulate the FDA will release policies intended to further integrate patients into the regulatory process,” it states. “The FDA has proposed allowing independent groups, such as patient advocacy organizations, to conduct patient-focused drug development meetings, potentially accelerating and spreading their patient-engagement efforts.”
Barriers Will Need To Be Overcome
Although greater patient engagement will have to be a priority for pharma, there will be barriers that companies will need to overcome before realizing the benefits. HRI notes the primary ones will be trust between patients and pharma, access to relevant information, and regulatory compliance.
A 2016 HRI consumer survey found 88 percent of patients would be very or somewhat willing to share personal health data with their physician, 78 percent would do so with their hospital or health system, and 70 percent would do so with a university research center. Unfortunately, only 53 percent indicated they would be very or somewhat willing to share health data with a drug company and 47 percent noted they would be not very or not at all willing to share it. That has to be a concern for pharma companies hoping to forge closer relationships with patients. On a more positive note, between 60 percent and 70 percent of patients indicated they would be willing to share answers to some specific questions with sponsor companies. Those questions involved information such as symptoms, activities, risk factors, and the effectiveness of treatments.
Another concern that arises when discussing pharma companies is the lack of access to information regarding clinical trials. A survey conducted by the Memorial Sloan Kettering Cancer Center found 25 percent of respondent had no idea how clinical trials work, something that would tend to make most consumers reluctant to participate in one. If sponsors want patients to enroll in a study, information on what is being tested and how to enroll should be easy to locate and written in plain, easy-to-understand instructions. Trial Guide by Eli Lilly is noted as an example of a system currently in place that will help patients navigate the clinical trials process.
“Eli Lilly’s site has a simple explanation of what a clinical trial is and tells patients what they should expect while participating in one,” notes the report. “By making this process easier to navigate, companies can attract more patients to trials, and better manage expectations once they are enrolled. Bayer US, for example, is working with patient groups such as Friends of Cancer Research to ensure that patient perspectives are reflected in the design of their clinical trials.” By listening to patients and crafting solutions based on their feedback, pharma can better engage patients and help them overcome their trepidations.
What Does This Mean For Pharma?
Engaging with patients early on in the drug development process is the best way for pharma to design patient-friendly trials that will meet the needs of all stakeholders. This engagement can also be a market differentiator, allowing companies to capture added value in the reimbursement process. Incorporating wearable and mobile applications will also enhance the use of products by consumers and help increase patient adherence during the trial process, although care will have to be taken to ensure the data is not leaked or compromised.
Since patient perspectives can help to shape regulatory approval, proper engagement can also lead to improved chances for success. Regulators may be more willing to work with companies that are developing a product in close concert with engaged patient populations. Even a drug judged to be inferior to the current standard of care in safety and efficacy might be granted approval if it is shown to be desirable by patients.
Finally, the report recommends pharma companies invest in partnerships to collect and use data efficiently. With only 53 percent of patients willing to share information with drug companies, partnerships with hospitals, doctors, and patient advocacy groups become essential for sponsors. Companies should have controls in place to ensure these partnerships are HIPAA compliant and transparent to patients. Patients can be instrumental in determining if the information being collected is meaningful and important to them. And, never forget that failing to engage with patients can bring its own risks if a patient or patient group decides to take their unhappiness with a company to their thousands of followers on social media.
For more information on the report, please contact Kelly Barnes, U.S. Health Industries and Global Health Industries Consulting Leader, (214) 754 5172, firstname.lastname@example.org.