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thepharmaconnect is here with our first blog post on a new age buzzworthy topic of Patient Centricity in the Pharma Industry - its feasibility, future, and everything about this modernistic approach of the industry.
Various health care bodies request patient input in their decision-making processes. This represents a shift from disease-centered to patient-centered approaches to health care.
What does this "patient centricity" mean for the pharmaceutical industry? Why does the pharmaceutical industry need to be part of the patient-centric movement? How can the industry become patient-centric? and what a patient-centric company actually does.
Today, patients are more knowledgeable than ever before.
The technological and scientific advances of recent years have enabled easy access to information; patients are online and can connect with peers, exchange experiences and knowledge in real-time, take part in advocacy and patient support groups, and contribute to real-time data generation. As a result, patients feel empowered and expect their voices to be heard.
Patients are increasingly being recognized as important stakeholders in the health care dialogue: regulatory agencies(Food and Drug Administration [FDA] and European Medicines Agency -EMA), academia, and healthcare providers are requesting patient input in their decision-making.
Why Does the Pharmaceutical Industry Need to Be Part of the Patient-Centric Movement?
Transformation into a patient-centric organization requires an answer to this key question: Why are we doing this? Historically, the pharmaceutical industry’s role has been to develop the science and medicines for the treatment of prevention or treatment of disease. Patient centricity involves the patient in this scientific process. In essence, this is an innovative mindset where the industry is challenged to engage and collaborate with patients when deciding the best course of action. Therefore,patient-centric initiatives should start with a simple question: how can we make a difference for patients? Is patient centricity feasible from a commercial standpoint? It is accepted that pharmaceutical companies need to make a profit. It is how they get and use that profit that is important, and this must be aligned with any assertion of patient centricity. If the vision is directed at providing value to patients and carers, companies must be seen to be breaking out of the cycle of “recover costs of R&D—make a profit—invest in new drugs—make more profit.” This commitment, in turn, will help to generate credibility with external stakeholders (patients, regulatory, media, etc.).
How Can the Pharmaceutical Industry Become Patient-Centric in a Modern Business Environment?
Shifting the cultural mindset
Patient centricity demands a shift in cultural mindset within the pharmaceutical industry. At the highest level, it involves listening to and partnering with the patient, and understanding the patient perspective, rather than simply inserting patient views into the established process. Only then can patient-centered outcomes truly be the core of the strategy.
This change in mindset requires leadership from the top and drives the need to redefine core strategy, organizational structure and processes, and capabilities to focus on transparency and value for the patient. A corresponding change in the organizational model is also needed, with medical affairs, market access, regulatory, pharmacovigilance, and commercial teams at global and regional levels all collaborating with a common goal—to capture patient perspectives and insights and to respond to their needs. If patient centricity is to be the responsibility of everyone in a pharmaceutical company, key development and performance indicators should be adapted to reflect this change in mindset.
Building trust
Indeed, the starting point of placing the patient at the heart of health care initiatives is trust. The industry has started to address questions about past behavior and public perception, and this positive intent, direction, and action is a vital component of rebuilding the industry’s reputation and forming the foundation for new trusted partnerships. Trust between the pharmaceutical industry and the public can be built through clear communication about medicine risk-benefit profiles and a transparent drug development process. In this context, the relationships between patients, industry, and health care practitioners are essential to building credibility: “trust your doctor, trust the medicine, and trust the data.”
Learning from others and collaboration
Creating a patient-centric culture requires an understanding of its implications for information flow, decision-making processes, and institutional habits. To achieve this, the pharmaceutical industry could gain insights from organizations that already have experience with patient interaction. For example, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has a patient-centered special interest working group; the Medical Device Innovation Consortium (MDIC) is a partnership between public and private stakeholders in the medical device industry. Furthermore, there is an ongoing collaboration between the FDA and EMA on patient involvement, that is, the FDA/EMA Patient Engagement Cluster, which enables the agencies to share best practices for patient selection and training throughout drug regulatory life cycles. The Patient Engagement Cluster focuses on cancer treatment and orphan drugs, among other topics. Furthermore, the MDIC has also established a framework for introducing patient preference information into regulatory risk-benefit assessments, specifically on medical devices. It is taking in the lessons learned by these collaborations and consortia that will help pharmaceutical companies reduce barriers to patient engagement.
What are the challenges?
Several challenges exist that need to be overcome before the pharmaceutical industry can adopt the patient-centricity concept. Challenges to address include skepticism about commercial success; lack of process standardization as it relates to involving lay people in a highly regulated environment; lack of sufficient sharing of practices and lessons learned across the industry; lack of understanding of, and respect for, qualitative research methods that often form the foundation of patient centricity research; lack of alignment and measurements of collective progress; internal habits of going back to established information sources (“let’s just ask the clinicians”); compliance frameworks and the perception that direct engagement of industry with patients is inappropriate or unauthorized; and last but not the least, the conflict of responsibilities: the perception that industry should not be the party that engages with patients. Most of these challenges concern the pharmaceutical industry as a whole and can only be solved in a collaborative fashion, as discussed above. Some solutions are beginning to emerge, highlighting the need to share and learn from each other's experiences. For instance, a compliance framework has already been developed and is available to guide that direct engagement with patients by industry.
What Does a Patient-Centric Company Actually Do?
Pharmaceutical companies are at different stages along the patient-centric journey. The following section aims to highlight patient-centric initiatives taken by pharmaceutical companies that have adopted patient-centricity as a strategy. Examples of Initiatives at GSK Aimed at Building Trust With Patients and Physicians. Engagement with patients can only be possible if there is credibility.
Change in marketing practices: In 2011, GSK eliminated prescription sale targets in the US and introduced a new incentive model for sales and marketing practices based on value and feedback from prescribers; external speakers/convention travel support was discontinued (2016).
Clinical transparency: Since 2013 GSK has committed to promoting transparency of clinical research and is a leading example in the pharmaceutical industry—it was the first company to grant access to anonymized patient data; theAll trials campaign (2013) commits to publishing all trial data; the GSK patient-level data access site has become multi sponsored portal (2014).
Moving from a brand focus to a patient-value focus shift
In the industry environment and patient empowerment is dictating a change in how health care solutions are designed. We recognize that patient expectations and needs can differ considerably from the aims and objectives of health care providers, at both the policy and delivery levels. In fact, to be accepted by patients, the patient experience should be the key driver for the development of solutions (eg, medicines, devices, information, support programs, apps). A better understanding of patient experience at critical points (breakpoints) in the course of the disease will help to determine breakpoints that would benefit from pharmaceutical industry input. Roundtable discussions involving patients, or “patient valuables,” can be used to validate patient needs and understand the solutions patients seek or assess the effects of solutions already in place. UCB has involved patients in all internal meetings since 2002 and uses patient value discussions between patients, health care providers, regulators, and payers.AstraZeneca engages with patients through research and therapeutic area collaborations using online patient platforms and networks. Essentially, capturing information about the patient journey and gaining an understanding of patient needs will help to develop a true patient-led strategy within the industry and design solutions that treat the patient and not just the disease.
Involving patients in the research and development
Another approach to patient centricity is promoting patient involvement throughout the drug discovery and development process. Patient advisory groups already provide input on unmet needs, protocol design, trial conduct, data interpretation and dissemination, risk-benefit discussions, risk management plans (risk evaluation and mitigation strategies), and the interpretation of the value of treatment relevant to conversations with payers. However, the degree of input from patients, the frameworks used to gain input, and the implications of their input are not consistent across the industry. Patient engagement in research and development is expected to provide benefits at various stages of the drug development process, which include identification of unmet patient needs, enabling better-informed decision-making about target choices and required asset profiles for go/no go decisions;– study designs, and endpoints that are more relevant to patients, which in turn improves recruitment and retention and provides regulatory and reimbursement decision makers with clear patient-relevant evidence;– shorter trial cycle time, so medicines can move more quickly to regulatory submission;– a greater range of products that are of greater value to more patients;– improved patient adherence to drug regimens, leading to improved outcomes for patients; and– a growing body of evidence of patient preferences and unmet needs that will help focus future research.
Standardizing PROs
The industry has a responsibility to provide information about the medicine that will be relevant to patients. But what information are patients looking for? A patient would want to know, What can I expect in terms of symptoms/side effects? How will feel? and What will I be able to do? Measuring treatment benefit versus risk from patients’ perspectives is important because it highlights the value of treatment. The FDA defines PRO measures as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.”As only patients can report how they feel and function, this generates a need to define end-points that are important and relevant to patients. PRO assessments are increasingly becoming the primary trusted evidence for all stakeholders, including payers, regulators, and patients. The use of PRO measures in the industry began many years ago, as health-related quality-of-life instruments included in clinical trials. Patient-centered drug development is expected to change the way the pharmaceutical industry operates. PRO tools and measures are ideally developed in a pre-competitive collaborative way, to set standards across all medicines. A standardized approach will provide easier, more straightforward assessment by all key stakeholders, including regulators(FDA38and EMA44), patients, prescribers, payers, and everyone who reviews the data. A need exists to expand the pool of expert patients across a wide range of diseases.
Concluding Remarks
Bringing patient centricity to life—the role of the pharmaceutical industry
. Bringing patient centricity to life requires a vision shared by all stakeholders. We believe that the key steps the industry needs to take in order to make this happen are
(1) change the mindset—make patient-centricity a company-wide and industry-wide vision;
(2) collaborate—involve patients and other health care stakeholders to develop patient-centric solutions;
(3) share the learning—challenge the status quo, record the experience, learn from it, and share it in order that the industry may get better at being truly patient-centric.
Therefore, we encourage colleagues to publish case studies of what is working well in order to keep the discussion alive and advance our collective learning. In summary, a transformation into a patient-centric organization requires defining the answers to the following key questions: Why are we doing this? How should we do it? and What are the results we aim to achieve? Historically, the pharmaceutical industry’s role has been to develop the science and medicines for the prevention or treatment of disease. Patient centricity is an innovative mindset whereby we are challenged to engage and collaborate with patients to get critical input for determining the best strategy to improve patient outcomes. The industry is a major stakeholder in making patient-centricity a reality, but cannot bring this about alone, or set the agenda. Equally, however, neither can medical professionals, government, or policymakers. How and with whom to partner is the key challenge. The future of patient centricity lies in coordinated efforts and the alignment of multiple health care. How patient centricity can be achieved in the pharmaceutical industry (conceptual framework). PRO's, patient-reported outcomes. Patient centricity can be achieved only through collaborations and consortia that include all health care stakeholders, in which the pharmaceutical industry has a key role.
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