Introduction: While prescribing biosimilars to patients naive to a biologic treatment is a well-accepted practice, switching clinically stable patients from an originator to a biosimilar is an issue for clinicians. Well-designed clinical trials and real-world data which study the consequences of switching from an originator biologic treatment to its biosimilar alternative are limited, especially for monoclonal antibodies. Areas covered: A systematic literature review was conducted on PubMed to identify evidence of the consequences of switching from original biologics to biosimilars. References of included papers were also scrutinized. After a title-, abstract- and full text screening, out of the 153 original hits and 77 additional ones from screening the references, 58 papers (12 empirical papers, 5 systematic reviews and 41 non-empirical papers) were included. Expert opinion: Preventing patients on biologic medicines from switching to biosimilars due to anticipated risks seems to be disproportional compared to the expected cost savings and/or improved patient access. Indeed, it is the opinion of the authors that the concern of switching to biosimilars is overhyped.

This policy research aims to map patient access barriers to biologic treatments, to explore how increased uptake of biosimilars may lower these hurdles and to identify factors limiting the increased utilisation of biosimilars. A policy survey was developed to review these questions in 10 Central and Eastern European (CEE) and Commonwealth of Independent States (CIS) countries. Two experts (one public and one private sector representative) from each country completed the survey. Questions were related to patient access, purchasing, clinical practice, and real-world data collection on both original biologics and biosimilars. Restrictions on the number of patients that can be treated and related waiting lists were reported as key patient access barriers. According to respondents, for both clinicians and payers the primary benefit of switching patients to biosimilars would be to treat more patients. However, concerns with therapeutic equivalence and fear of immunogenicity may reduce utilisation of biosimilars. Similar limitations in patient access to both original biologics and biosimilars raise concerns about the appropriateness and success of current biosimilar policies in CEE and CIS countries. The conceptual framework for additional real-world data collection exists in all countries which may provide a basis for future risk-management activities including vigorous pharmacovigilance data collection.

Introduction: Multiple Criteria Decision Analysis (MCDA) is increasingly used in health care mainly because it moves decision-making from ad hoc to an evidence-based and comprehensive process. Developing countries with more restricted financial and human research capacities, however, should consider their own methods of MCDA development and implementation. Areas covered: An MCDA framework to improve procurement decisions of off-patent pharmaceuticals was developed for developing countries and adapted to Indonesia, Kazakhstan and Vietnam during three policy workshops. Based on the experience of these workshops and one joint workshop with international experts and decision makers from multiple developing countries, general recommendations were formulated on how to implement MCDA specifically in developing countries. We provide 17 practical MCDA implementation recommendations in four major areas, including (1) MCDA objectives; (2) technical considerations of MCDA tool; (3) development and customization of MCDA tool and (4) policy implementation of MCDA in decision-making. Expert commentary: These practical MCDA recommendations for developing countries contribute to feasible, transparent, stepwise, iterative and standardized decision-making in health care.

Off-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited. OPPs are comprised of off-patent originals, branded generics and unbranded generics; nonetheless, these products are not identical and often there are differences in their equivalence, manufacturing quality standards and reliability of supply. This necessitates reconsideration of the lowest price policy objective in pharmaceutical decision making. The aim of this study was to develop a Multi-Criteria Decision Analysis (MCDA) framework through a pilot workshop to inform the national procurement of OPPs in Indonesia. An initial list of potentially relevant criteria was identified based on previous work and a literature review. In a 2-day pilot policy workshop, twenty local experts representing different stakeholder groups and decision-making bodies selected the final criteria, approved the scoring function for each criterion, and assigned weights to each criterion. An MCDA framework was proposed for OPP drug decision making in developing countries, which included price and 8 non-price criteria. Based on the pilot policy workshop 6 + 1 criteria were considered relevant for Indonesia: pharmaceutical price (40% weight), manufacturing quality (18.8%), equivalence with the reference product (12.2%), product stability and drug formulation (12.2%), reliability of drug supply (8.4%), real world clinical or economic outcomes, such as adherence or non-drug costs (4.2%) and pharmacovigilance (3.6%). According to the pilot policy workshop, other criteria apart from price need to be strengthened in the tendering process. The introduction of additional criteria for OPP procurement in an MCDA framework creates incentives for manufacturers to invest into improved manufacturing standards, equivalence proof, product quality, reliability of supply or even additional real-world data collection, which ultimately may result in more health gain for the society.

INTRODUCTION: Trastuzumab, the standard treatment for HER-2 positive breast cancer, may be associated with access restrictions in countries with severe economic constraints. This study aimed to compare intravenous- (IVT) and subcutaneous trastuzumab (SCT) forms and to explore the transferability of value propositions to Central and Eastern European (CEE) countries. AREAS COVERED: After screening 376 abstracts, 42 articles were included in the final review. Statistical test results were rarely reported, therefore, the similarity of adverse event profiles of SCT and IVT could not be validated. Potential time savings for patients due to subcutaneous administration was not validated in CEE settings, where patient’s waiting time for treatment administration is fairly long. Standard patient reported outcome instruments were rarely used to confirm the preference of patients/health care professionals to SCT over IVT. Moreover, feasibility of self/home administration of SCT, especially in case of concomitant intravenous chemotherapies, was not considered. Cost comparisons considered neither the patent expiry of IVT nor the incremental cost of potential differences in adverse events. EXPERT COMMENTARY: Potential benefits of SCT were not tested by any studies in CEE countries. The main policy objective should be to facilitate the uptake of multi-source biologicals in lower income countries with access barriers.