Developing highly personalized, or targeted, therapeutics is one way to help ensure value is delivered to specific patients and to health care systems overall.
Growing competition, escalating research and development (R&D) costs, and corporate earnings expectations continuously place pressure on pharmaceutical companies to add value to their therapeutic product portfolios. Developing highly personalized, or targeted, therapeutics is one way to help ensure value is delivered to specific patients and to health care systems overall.
However, successfully advancing personalized therapies and therapeutic approaches requires addressing key questions from the earliest stages of R&D portfolio management, including how effective a therapy might be and what its value is compared to other drugs.
Early in the development process is when strategies should be first identified and integrated into clinical development designs, with a focus on patient stratification using real-world clinical data and computer-based studies. Companies must establish criteria that spell out a distinct approach for delivering value, such as with the therapeutic alone, or by combining therapy and disease management services. Doing this requires:
Assessing value should start when the biological target is selected. Often at this point, a specific patient population defined genetically or genomically, can be identified. This is when insights into the disease, the potential benefits of a new treatment strategy, specific patient populations, and comparative perspectives on current therapeutic approaches can all be evaluated. It is important to understand both the disease state and the patient. Knowing for which patients a drug will be a therapy and knowing for which patients it won't adds a dimension of comparative value and increasingly defines the market for the drug.
Effectively Communicate Value
Another key consideration in delivering personalized, high-value, therapeutics is determining how this value is communicated to physicians and patients in a practical manner. This might be done by using diagnostics that more precisely predict the responders or non-responders to a specific therapeutic, or using electronic tools that guide the stratification of patients to different treatment approaches. Pharmaceutical companies are differentiating their approaches, defining the information or service aspects of their products, and how these can be delivered to providers.
These approaches are designed to increase the effectiveness of therapies and use a company's knowledge to benefit its health system partners and providers. Such strategies are utilizing data found in electronic medical records (EMRs) that relate to a patient's lifestyle or to specific genetic characteristics of the patient or disease. These data make a therapy more precise to the individual most likely to benefit. Companies also must assure they have the innovation ecosystem in place to advance the critical elements together with confidence -- academic center partners, clinical diagnostic partners, and mobile apps that can aid clinical decision making at the point of care.
Collaboration is key
Provider systems and pharma companies can both derive benefit from collaboration around these new approaches. Pharma companies bring deep experience in specific disease areas, integrating their scientific understanding of disease processes, clinical strategies, and practical approaches to identifying specific patients who will benefit from personalized care. For their part, health care providers can add practical considerations of care management, their knowledge of the requirements of diverse patient populations, and metrics of value that allow them to care for the broadest number of patients responsibly.
As partners, providers and pharmaceutical companies can help innovation move faster for highly specific therapies that require significant amounts of expertise and technology. Together they can address the economic and therapeutic value being created and how that can be accessed for mutual benefit. To create value, collaborators can put evidence-based information involving patient treatment, such as from protocols or care management plans, into clinical practice; determine selection criteria for patients; identify specific therapeutics that are most efficacious for specific patients; and understand the practical and behavioral aspects of care management that can assure better overall performance by health providers and patients.
Personalization and Value
Achieving value during the innovation process requires establishing formal ways of identifying scientific and clinical opportunities. Pharmaceutical company leaders are implementing strategies that assure that their companies can fully monetize their knowledge and become full participants in the value they create. These can include:
Organizing for Value
Creating value also requires internally integrating various functions, knowledge, and talent. A pharmaceutical company needs to build on the knowledge of its research teams and translational medicine experts in ways that are practical in community care contexts. The evidence-based medicine orhealth economics andoutcomes researchgroups that are part of a company's medical affairs or managed markets departments should play a role in assessing the value of current therapeutics. Similarly, the role of the medical affairs group should increase post-registration for personalized and more niche therapeutics.
The managed markets group must build value models and use external real-world clinical data to create a body of knowledge on new therapeutic approaches, and should determine how health systems and patients can be therapeutic and economic beneficiaries. Almost all programs and insights on care management approaches involve external partnerships, data and analytics capabilities. These must be integrated to make them more practical and efficient to minimize risks.
Together these functions can help create value for a portfolio and identify the value as part of a therapeutic solution. In this manner, companies can highlight key elements of their market solution that will be delivered with the therapeutic, such as a ‘performance warranty,’ or a care management driven solution of which the therapy may be an element.
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