Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

PLoS One. 2017 Aug 16;12(8):e0182613. doi: 10.1371/journal.pone.0182613. eCollection 2017.

Abstract

Context: Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines.

Method: A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines.

Findings: Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered.

Conclusion: A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Biosimilar Pharmaceuticals
  • Drug Costs
  • Drug Discovery / economics
  • Drug Discovery / legislation & jurisprudence
  • Drug Industry
  • Drug and Narcotic Control
  • Drugs, Essential / economics
  • Health Expenditures
  • Humans
  • Patents as Topic / legislation & jurisprudence
  • Precision Medicine / economics*
  • Prescription Drugs / economics*
  • Public-Private Sector Partnerships
  • Research

Substances

  • Biosimilar Pharmaceuticals
  • Drugs, Essential
  • Prescription Drugs

Grants and funding

This study was performed in the context of regular research of the Division of Pharmacoepidemiology and Clinical Pharmacology (Utrecht University), employing authors TvdG and TP, and of the Institute for Medical Technology Assessment, Department of Health Policy & Management, Erasmus University, Rotterdam, employing CU. The university had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.