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

Abstract

ContextRecent 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.MethodA 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.FindingsChanges 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.ConclusionA 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.

Precision Dosing Priority Criteria: Drug, Disease, and Patient Population Variables

“…Drugs for cancer, bleeding disorders, infectious diseases, autoimmune disorders, and transplantation account for disproportionately high costs and their demand will continue to rise (Durvasula et al, 2018). Specifically, costly drugs in recent years include tyrosine kinase inhibitors, anti-hepatitis C virus polymerase inhibitors, cystic fibrosis drugs, and mAbs, though many more exist and are frequently unaffordable even in high income countries (Gronde et al, 2017;Hwang et al, 2017). Costly drugs that are used in a value-based or pay-forperformance health care model must lower the total cost of care despite their high price.…”

Precision Medicine in Non-Communicable Diseases

“…The outcomes measured in development are then to be repealed as a continuum in actual clinical care to provide the real-world data and much-needed evidence to define not only efficacy but effectiveness and actual value. The failure of many medical products also involves an economic problem as very expensive drugs have limited effectiveness [11]. It is estimated that genetic factors can account for 20 to 95 percent of the variability in drug disposition, efficacy, and adverse effects [12].…”

Prospects and Challenges of Precision Medicine in Lower- and Middle-Income Countries: A Brief Overview

“…However, researchers of the Department Health Economics and Health Care Policy, Harvard Medical School, Boston, USA, recommended that the US government should carefully control medicine prices 163 . Subsequently, the question arises precision technology prices can be controlled by the national government exclusively of LMICs and ensure the people healthcare and promote public health 97,154,164 . Moreover, almost all significant innovations, particularly in healthcare, belong to the transnational corporate house 155,165,166 .…”