Recent years have brought significant innovation in potentially curative therapies for several diseases. To expedite patient access to these therapies, the U.S. Food and Drug Administration (FDA) has undertaken progressive efforts to accelerate drug approval. For example, the FDA’s Breakthrough Therapy Program, enacted in 2012, has approved nearly 140 breakthrough therapies and shortened novel drug approval times by almost a year. By 2025, the FDA anticipates approving 10 to 20 cell and gene therapy products per year, many of which are intended to be one-time curative treatments.
Making Life-Saving Medical Treatments More Affordable
A look at the challenges and some innovative solutions.
October 25, 2019
Summary.
Despite efforts to accelerate the evaluation of drug safety and efficacy, uptake of many new therapies has been much slower than expected. Why the lag? The delays in uptake are largely due to the high cost of new treatments and the hurdles in coverage and reimbursement faced by commercial and public payers. This has caused many patients to either be denied coverage of therapies or to experience significant delays in getting coverage. Addressing these obstacles is critical if we want to ensure patients have access to new life-changing treatments, many of which need to be administered early on to be most effective. Fortunately, there are a number of innovative solutions being tested now that are worth paying attention to.
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Accelerate your career with Harvard ManageMentor®. HBR Learning’s online leadership training helps you hone your skills with courses like Sharpening Your Business Acumen. Earn badges to share on LinkedIn and your resume. Access more than 40 courses trusted by Fortune 500 companies.
Take your career to the next level by learning business and finance basics, and developing an enterprise mindset.