Policy framework on biosimilars introduction

Abstract

At present, in Malta, there is no published national policy available for clinicians to follow up in case of switching from a biologic to a biosimilar. In the first part of the study, the objectives were to focus on the aspect within the international and local scenarios, identify the outlook on competition within the local market assessing the concept of value-based pricing without compromising the quality and safety of the patient treatment. In the second part of the study, the objective was to draft a policy document from the data collated through the interviews undertaken in the previous study titled “Market Entry and Competition: Biologics and Biosimilars” in relation to recent published evidence to evaluate the proposed policy. A policy was drafted post Strengths, Weakness, Opportunity and Threats analysis from the first part of the study results. The relevant questions for psychometric analysis were compiled and validated. The proposed policy was referred to the expert group for review and validation. The study was carried out within the local Health system – involving clinical, policy and procurement professionals. The endpoint of this study was to have a validated policy for clinicians and policymakers to refer to when switching from a biologic to a biosimilar or to other biosimilars. These results, together with a literature review, aided in the creation of a policy draft with the aim of encouraging interchangeability. A set of questions where assembled in order to validate the policy draft. The proposed policy was created to include a guidance note in terms of interchangeability so that the clinical decision is accountable and supported. Introduction of the policy will aid in more biosimilar prescribing and hence, reduction of costs that will allow the introduction of new medicines on the formulary leading to more treatment options for the patient.