Can Endangered Biosimilar Markets be Rescued? The Need to Bridge Competing Interests for Long-Term Gain.

Market signals such as: (1) the limited number of biosimilars in the development pipeline, (2) the focus of biosimilar development on high-profit therapeutic areas only, and (3) the increase in the number of biosimilar discontinuations and withdrawals, are indicative of sustainability threats facing biosimilar markets in Europe. Two prominent factors that undermine sustainability are: competing interests between the various stakeholders and a preferential focus on short-term gains, disregarding future sustainability threats, hence the need for effective policies that create sustainable competition in biologic markets. Thus far, measures implemented to foster biosimilar adoption have not been necessarily complied with and have had mixed success. Further, these policies have not consistently led to improving access to affordable biologics. In this commentary, we aim to raise awareness of vulnerabilities of biosimilar markets and of difficulties relating to reaching an agreement on policy solutions with a long-term vision. We propose to build on knowledge from collective action theory to advance in reconciling stakeholder interests. This first-of-its-kind approach can inform long-term solutions for biosimilar markets.

Determinants of prescribing decisions for off-patent biological medicines in Belgium: a qualitative study.

BACKGROUND: A competitive market for off-patent biologicals leads to more affordable and high-quality healthcare. In recent years, Belgium has been characterized by its low use of biosimilars and by its shifts from off-patent biologicals toward new alternative therapies. Yet, the prescribing decisions involved in these observations are poorly understood. This study aims to better understand prescribing choices among Belgian physicians in the ambulatory care setting. METHODS: This study consisted of two phases. First, a scoping literature review to identify determinants of prescribing choices was conducted. Scientific databases (Embase and PubMed) were searched until 4 November 2021. Second, the nominal group technique (NGT) was employed during focus group discussions with Belgian physicians to consider and validate these determinants for off-patent biologicals in the Belgian context. The qualitative data resulting from the literature review and focus group discussions were analyzed using the thematic framework method. RESULTS: Fifty-three scientific articles that discussed elements that determine prescribing choices were identified. Out of these, 17 determinants of prescribing choices were found. These were divided into five categories: (1) product-related, (2) physicians' personal, (3) healthcare system-related, (4) patient-related, and (5) determinants related to the pharmaceutical company or brand. Nineteen Belgian physicians from different therapeutic areas that regularly prescribe biologicals then participated in focus group discussions. Using the NGT, the group discussions revealed that prescribing choices for off-patent biologicals are determined by a complex set of elements. Clinical data, geographical region, working environment, pharmaceutical marketing, patient profile, clinical guidelines, and preference of key opinion leaders (KOL) were considered most influential. Physicians indicated that the importance of these determinants differs depending on product classes or therapeutic domain. CONCLUSIONS: Multiple elements determine the choice of an off-patent biological or biosimilar product. The importance of each of these determinants varies depending on the context in which the prescribing choice is made. To increase the prescription of best-value biologicals in the Belgian ambulatory care, a set of synergistic measures is required including information for healthcare providers (HCP) and patients, prescribing feedback, prescribing targets, tangible incentives, KOL involvement, guidelines regarding pharmaceutical promotion, and regular revision of reimbursement modalities.

Applications of Behavioral Economics to Pharmaceutical Policymaking: A Scoping Review with Implications for Best-Value Biological Medicines.

BACKGROUND AND OBJECTIVE: Pharmaceutical policies are generally based on the assumption that involved stakeholders make rational decisions. However, behavioral economics has taught us that this is not always the case as people deviate from rational behavior in rather predictable patterns. This scoping review examined to what extent behavioral concepts have already been applied in the pharmaceutical domain and what evidence exists about their effectiveness, with the aim of formulating future applications and research hypotheses on policymaking for best-value biologicals. METHODS: A scoping literature review was conducted on the evidence of behavioral applications to pharmaceuticals. Scientific databases (Embase, MEDLINE, APA PsycArticles, and Scopus) were searched up to 20 October, 2021. RESULTS: Forty-four full-text scientific articles were identified and narratively described in this article. Pharmaceutical domains where behavioral concepts have been investigated relate to influencing prescribing behavior, improving medication adherence, and increasing vaccination uptake. Multiple behavioral concepts were examined in the identified studies, such as social norms, defaults, framing, loss aversion, availability, and present bias. The effectiveness of the applied interventions was generally positive, but depended on the context. Some of the examined interventions can easily be translated into effective policy interventions for best-value biological medicines. However, some applications require further investigation in a research context. CONCLUSIONS: Applications of behavioral economics to pharmaceutical policymaking are promising. However, further research is required to investigate the effect of behavioral applications on policy interventions for a more sustainable market environment for best-value biological medicines.

Conceptual model and economic experiments to explain nonpersistence and enable mechanism designs fostering behavioral change.

BACKGROUND: Medical nonpersistence is a worldwide problem of striking magnitude. Although many fields of studies including epidemiology, sociology, and psychology try to identify determinants for medical nonpersistence, comprehensive research to explain medical nonpersistence from an economics perspective is rather scarce. OBJECTIVES: The aim of the study was to develop a conceptual framework that augments standard economic choice theory with psychological concepts of behavioral economics to understand how patients' preferences for discontinuing with therapy arise over the course of the medical treatment. The availability of such a framework allows the targeted design of mechanisms for intervention strategies. METHODS: Our conceptual framework models the patient as an active economic agent who evaluates the benefits and costs for continuing with therapy. We argue that a combination of loss aversion and mental accounting operations explains why patients discontinue with therapy at a specific point in time. We designed a randomized laboratory economic experiment with a student subject pool to investigate the behavioral predictions. RESULTS: Subjects continue with therapy as long as experienced utility losses have to be compensated. As soon as previous losses are evened out, subjects perceive the marginal benefit of persistence lower than in the beginning of the treatment. Consequently, subjects start to discontinue with therapy. CONCLUSIONS: Our results highlight that concepts of behavioral economics capture the dynamic structure of medical nonpersistence better than does standard economic choice theory. We recommend that behavioral economics should be a mandatory part of the development of possible intervention strategies aimed at improving patients' compliance and persistence behavior.

Data generalizability, data transferability, and the political economy of pharmacoeconomic guidelines.

OBJECTIVE: There are several methodological and practical issues surrounding the transferability of economic data that are important to address. A review of what national guidelines for economic evaluations say about transferability is important to understand the context in which transferability is currently practiced and discussed. Aim of this editorial is to discuss the results of a study reviewing the positions of various national guidelines in relation to the transferability and generalizability of data and the methods suggested for addressing issues of transferability presented in this issue. CONCLUSION: The recommendations on good research practices for dealing with aspects of transferability are filling an important gap. However, in order for the applied science of Pharmacoeconomics and Outcomes Research to make up for its epistemological aim and the aim of providing normative judgments, the methodological foundation of normative judgments has to be given the same importance as the methodological foundation the scientific community is seeking to establish as good research practices.

Impact of patient sample on costs of events in pharmacoeconomic models.

Pharmacoeconomic guidelines have focused on improving the measurement of effectiveness, but have largely ignored the assessment of cost inputs. We explored differences in adverse event cost estimates derived from three different sources in a case study of selective COX2 NSAIDs. We found substantial differences in costs of adverse events across data sources. We also determined that treatment costs associated with adverse events differed substantially based upon inclusion/exclusion criteria. Health services researchers should be deliberate in the choice of adverse event treatment costs that are used in decision analytic models. Future guidelines should seek to delineate best practices for cost calculations.

Preferences and utilities for the symptoms of moderate to severe allergic asthma.

INTRODUCTION: Patients with moderate to severe allergic asthma have persistent poorly controlled asthma despite inhaled or systemic corticosteroid therapy. New therapies are becoming more widely available to treat such patients, but their value needs to be formally assessed in an economic evaluation. Within a publicly funded health care system such an analysis should reflect societal preferences when measuring treatment benefits. The aim of this study was to elicit societal preferences for the symptom burden associated with moderate to severe allergic asthma. METHOD: Existing daily symptom diary data from a clinical trial were used to develop health state descriptions for evaluation in a standard gamble interview. Five health states were produced that reflected five distinct levels of control ranging from 'complete control of asthma' to 'worsening of asthma', as defined by another outcome measure. The symptom diary data were also used as attributes in a discrete choice experiment (DCE) to estimate willingness to pay for improvements in symptoms. Members of the general public (n = 101) completed the interview. RESULTS: Thirteen participants failed the consistency checks and were excluded from the analysis. Societal utility ratings for the health states ranged from 0.71 (worsening of asthma) to 0.78 (complete control of asthma). The participants were also willing to pay 160 pounds a month for the avoidance of all symptoms. CONCLUSIONS: The range of utility values (0.71-0.78) demonstrates the severity of moderate to severe allergic asthma. However the spread of scores between complete control of asthma and worsening of asthma was lower than was expected. The community sample placed only a moderate value on the avoidance of all asthma symptoms in the DCE survey. The results suggest that the community sample may not have fully understood the benefits of control over asthma symptoms and the limitations such symptoms can impose on everyday life.

Factors associated with mortality after an asthma admission: a national United Kingdom database analysis.

BACKGROUND: Lack of a United Kingdom (UK) fatal asthma registry has resulted in few recent analyses regarding patient characteristics, co-morbidities, and admission type in relation to mortality post an asthma admission. This study aims to report these factors in addition to season of event for the years 2000-2005 to provide data regarding asthma burden in the in-patient hospital setting. METHODS: Data were analysed from the CHKS database collated from UK National Health Service data providing 70% of in-patient coverage in the UK. Patients with admissions under ICD-10 codes J45 "Asthma" and J46 "acute severe asthma" were included. Codes for associated co-morbidity at time of admission were identified, as well as month of admission and death, age, gender and length of stay. RESULTS: The mortality rate over the 5-year period was 1063 patients from 250,043 asthma admissions (0.43%). Critical care mortality was far higher and an annual rate indicated that for every 100,000 admissions 2878 (95% CI 2091;3857) patients died. Respiratory infection, cardiovascular disease and diabetes were common co-morbidities for all admissions. December and January had the peak number of deaths post asthma admission which were nearly all in adults, death being rarer in children. Women and those over 45 years had the highest rate of death which may reflect asthma prevalence. CONCLUSIONS: Co-morbid conditions experienced by older asthma patients may contribute to mortality post an asthma admission and greater understanding of risk factors contributing to fatality are required.