Policy objective of generic medicines from the investment perspective: The case of clopidogrel

Abstract

The objective of generic drug policies in most countries is defined from a disinvestment perspective: reduction in expenditures without compromising health outcomes. However, in countries with restricted access of patients to original patented drugs, the objective of generic drug policies can also be defined from an investment perspective: health gain by improved patient access without need for additional health budget. This study examines the investment aspect of generic medicines by analyzing clopidogrel utilization in European countries between 2004 and 2014 using multilevel panel data models. We find that clopidogrel consumption was strongly affected by affordability constraints before the generic entry around 2009, but this effect decayed by 2014. After controlling for other variables, utilization had a substantially larger trend increase in lower-income European countries than in the higher-income ones. Generic entry increased clopidogrel consumption only in lower- and average-income countries but not in the highest-income ones. An earlier generic entry was associated with a larger effect. The case of clopidogrel indicates that the entrance of generics may increase patient access to effective medicines, most notably in lower-income countries, thereby reducing inequalities between European patients. Policymakers should also consider this investment aspect of generic medicines when designing pharmaceutical policies.

The Impact of Reimbursement Practices on the Pharmaceutical Market for Off-Patent Medicines in Slovakia

“…However, the specific plan for biosimilar policies can be defined differently in countries experiencing significant resource limitations, where access to expensive reference medicines is limited ( Brodszky et al, 2016 ; Inotai and Kaló, 2019 ). In countries with limited or no access to reference medicines, the key benefit of biosimilars is not related to their cost-saving potential; therefore, the target for biosimilar policies should be characterized from an investment point of view ( Elek et al, 2017 ; Harsányi et al, 2020 ) by increasing patient access and by improving the number of treated patients ( Inotai et al, 2018 ; Ferrario et al, 2020 ).…”

Lessons from the International Experience with Biosimilar Implementation: An Application of the Diffusion of Innovations Model

“…Increasing biosimilar uptake has a clear, observable advantage: biosimilars are less expensive than biologics, with no significantly different clinical results (Health Canada 2017), although this is contested to varying degrees depending on the available published evidence. This advantage can lead to improved access to biologics treatment and cost savings for healthcare systems or patients (Elek et al 2017). Biosimilar introduction also has the potential for leveraging the adaptiveness of organizational structures, systems and tools required for implementation, which is an important innovation quality that supports implementation.…”

“…Biosimilars, an economical alternative to traditional biologic treatment, offer exciting opportunities to improve access to treatment (Elek et al 2017) and cost savings as Canadian healthcare costs rise. However, despite these potential benefits, biosimilar uptake is lower than expected (Health Canada 2017).…”

Foreword

“…The use of a cheaper generic equivalent (or in some cases, a cheaper, therapeutically interchangeable drug from the same therapeutic class) in lieu of an originator medicine can generate significant cost savings. Moreover, the market entry of generics can also enhance patient access, particularly in lower-income countries (Elek et al, 2017).…”