Finding Truth in a World Full of Spin: Myth-Busting in the Case of Sovaldi.

PURPOSE: Public discourse regarding the hepatitis C virus (HCV) drug Sovaldi® (sofosbuvir) has become inflamed, generating much heat but little light concerning the clinical, health economic, and quality-of-life merits of Sovaldi®. The purpose of this article is to provide a factual basis for evaluating the claims regarding the benefits of Sovaldi® relative to its costs.

METHODS

A comprehensive review was conducted of news stories highlighted in the daily updates of the electronic newsletters BIO SmartBrief, FiercePharma, FierceBiotech and BioCentury Extra published from November 1, 2013, through December 31, 2014, on the topics of the HCV market, Sovaldi®, and other HCV therapeutics. Also reviewed were recent practice guidelines on the management of HCV infections, prescribing information on all HCV drugs approved by the US Food and Drug Administration, and health technology assessments of Sovaldi® and Harvoni(TM) (sofosbuvir/ledipasvir).

FINDINGS: Sovaldi® and Harvoni(TM) have provided significant improvements in the treatment of HCV, with all-oral regimens and cure rates exceeding 90% in some populations of patients with HCV. Sovaldi® prevents significant health care resource utilization in patients who would otherwise develop cirrhosis and require a liver transplant; however, only a small proportion of patients with HCV develop cirrhosis, and fewer require liver transplants. Because it is not possible to identify those patients whose HCV will progress to severe liver disease, it would be necessary to treat a large number of patients with HCV to prevent disease progression in this subpopulation, resulting in a considerable loss to health plans even over a 20-year horizon. The claim that treating all patients with HCV with Sovaldi® would cost nearly as much as the current total US expenditure on all prescription drugs, while factually correct, is not a realistic scenario. Many patients with HCV will continue to go undiagnosed. In addition, the medical expense for those who are treated will be spread out over many years. However, the unexpectedly large, up-front cost of covering these drugs has had a major impact on health plan budgets, resulting in losses for some plans.

IMPLICATIONS: Sovaldi® represents an enormous advance in the care of some populations of HCV-infected patients, but also a major cost burden to health plans. As the first of a number of anticipated, paradigm-changing drugs to treat medical conditions affecting large patient populations, Sovaldi® should act as a wake-up call for all health care stakeholders to engage in a meaningful, fact-based discussion about managing the cost of innovative new drugs to balance the needs of drug manufacturers, health plans, providers, and, above all, patients.