How the Biopharmaceutical Industry Can Navigate a Healthcare Ecosystem Increasingly Driven by Demands for Comparative Ef
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How the Biopharmaceutical Industry Can Navigate a Healthcare Ecosystem Increasingly Driven by Demands for Comparative Effectiveness Research John J. Doyle and Nathalie Horowicz-Mehler Consulting at Quintiles, Hawthorne, New York, USA
Abstract
While the approval of biopharmaceuticals hinges on a demonstration of safety and efficacy through randomized clinical trials, other stakeholders have historically evaluated the approved product based on repackaged clinical trial data with limited ‘real-world’ validity. The US healthcare system is now evolving into a more complex ‘ecosystem’ where regulatory approval is just a first step toward successful market access. Indeed, the adoption and financial success of a product relies on stakeholder preference modulated by environmental and competitive factors, such as the clinical burden of a disease or the availability of cheaper alternative therapies. One market challenge faced by the biopharmaceutical industry is that of measuring product performance under the imperfect research conditions of the real world, replete with its confounders and effect modifiers. This has led to discordance in the healthcare ecosystem; regulators have the data they need but other stakeholders are left with blind spots when making decisions. Comparative effectiveness research (CER) has the potential to fill these data gaps, helping to ensure optimal market access for innovative products. This article examines how companies can meet increasing demands for CER using a three-step planning approach involving CER diagnosis, CER prognosis and CER prescription. The approach assesses (i) the likelihood of a drug or device being included in a CER study, the parameters of such a study (e.g. comparators, endpoints, patient population) and the groups likely to conduct and fund the research; (ii) the potential for the drug or device to receive a positive evaluation as well as the conditions that can optimize the evaluation; and (iii) the activities to be undertaken throughout the clinical development process to best position a drug or device for CER. If initiated prior to approval, these steps will ensure that the data developed for each intervention is relevant to the web of healthcare stakeholders that will determine its success in the marketplace.
1. Rationale In the US, a product’s ‘approvability’ is governed by the US FDA and hinges on efficacy and safety data generated by clinical trials. Historically, other stakeholders, such as policymakers, payers, physicians and patients have evaluated the approved product based on repackaged clinical trial data that are internally valid but of limited external validity. With the advent of healthcare reform, the US healthcare system is evolving into a more complex ‘ecosystem’ in which regulatory approval is but an initial step towards successful market access for a biopharmaceutical or medical device. Indeed, the adoption and financial success of a product relies on stakeholder preference modula
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