Value-based pricing (VBP) is well established in markets for common goods and services, but wide consensus on VBP for pharmaceuticals is lacking. In principle, VBP implies that prices are mainly driven by a drug's value (value for money) and that the impact on budget (sustainability) is a second-order driver of price regulation. Although the literature provides descriptive analyses on regulations governing medicine price negotiation, there are few insights on whether and how price negotiation regulations have been implemented. The goal of this article was to cover this information gap for 5 European countries and the United States. VBP has been applied according to two models: (1) direct models in which cost-effectiveness is a driver; and (2) indirect, multi-attribute models characterized by greater discretion on the integration between the different value domains and the evaluation of consistency between costs and value. In these models, cost-effectiveness is not a driver. In addition, it is hard to evaluate within these models the actual implementation of VBP. Identifying whether and how VBP is applied requires a clear predefined link between added value and the premium price, as well as transparency in the way added value is converted into a premium price. In general, for these countries, it remains difficult to determine whether pricing is mostly driven by value (value-for-money) or impact on budget (sustainability). In instances in which thresholds on the incremental cost-effectiveness ratio are used, it becomes easier to understand whether VBP has been implemented. If VBP relies on a multicriteria approach, greater transparency on which criteria have been used to assess a new drug and how they have been converted into a reasonable price may help in understanding whether a value-based approach has been used.

Introduction: The codes used to report hospital admissions due to influenza viruses are likely to underestimate the real incidence of influenza-related cases. Methods: In order to estimate this burden we ran a negative binomial model, in which the numbers of weekly admissions for respiratory and cardiovascular diseases were regressed based on influenza syndrome surveillance data (InfluNet), average temperature and seasonality terms. Results: On average over the 2008-2015 period, in addition to 4,407 admissions coded as influenza, we estimated 15,206 additional admissions attributable to influenza. Overall, the total estimated hospital burden attributable to influenza/ influenza-like cases is about €37m per year. Discussion: This estimate should be used for policy making (e.g., vaccine strategies) and operation management choices (e.g., planning and staffing beds during influenza peaks) and encourage the involvement of general practitioners and pediatricians for early symptom control to avoid hospitalization for less severe cases.

Background and Objectives Second-generation antipsychotics (SGAs) for schizophrenia show different risk profiles, whose evidence has been evaluated through comparative reviews on randomized controlled trials (RCTs) and observational studies. Methods We performed a systematic review and meta-analysis of weight gains, metabolic and cardiovascular side effects of SGAs, relying on both RCTs and observational studies, by comparing variations between the start of treatment and the end of follow-up. The systematic review refers to papers published from June 2009 to November 2020. PRISMA criteria were followed. No restrictions on heterogeneity level have been considered for meta-analysis. A test for the summary effect measure and heterogeneity (I 2 metric) was used. Results Seventy-nine papers were selected from 3076 studies (61% RCTs, 39% observational studies). Olanzapine and risperidone reported the greatest weight gain and olanzapine the largest BMI increase. Paliperidone showed the highest increase in total cholesterol, but is the only drug reporting an increase in the HDL cholesterol. Quetiapine XR showed the highest decrease in fasting glucose. Lurasidone showed the lowest increase in body weight and a reduction in BMI and was also the only treatment reporting a decrease in total cholesterol and triglycerides. The highest increase in systolic and diastolic blood pressure was reported by quetiapine XR. Conclusions Despite some limitations (differences in the mean dosages per patient and other side effects not included) this paper provides the first complete meta-analysis on SGAs in variations on metabolic risk profile between start of treatment and end of follow-up, with useful results for clinical practice and possibly for future economic evaluation studies.

Introduction: This article aims at investigating the 5-year budget impact of rituximab biosimilars in Italy. Methods: A budget impact analysis model was developed in accordance with the International Society For Pharmacoeconomics and Outcomes Research recommendations. Drug acquisition and drug administration costs were considered since the risk/benefit profile of biosimilars and the originator was assumed to be overlapping. The perspectives of hospitals and payers were used. Input data were retrieved from the literature and validated/integrated by an expert panel of seven clinicians from various Italian regions. A dynamic incidence-based approach was used. Results: From the hospital perspective, adopting a rituximab biosimilar would produce savings of €79.2 and €153.6 million over 3 and 5 years, respectively. The results are very similar if the payer perspective is considered, with a cumulated savings of about €153.4 million in 5 years. Lymphoma and chronic lymphocytic leukaemia would account for the most significant savings. Discussion: Despite its limitations, this study provides the first Italian evaluation of the financial impact of rituximab biosimilars and also incorporates the effects of biosimilars on the pricing strategies of the originator (dynamic impact). This dynamic effect is more relevant than the impact of the treatment shift from the originator to biosimilars. Our hope is that these savings will be used to cover new cost-effective drugs and not just for cost-cutting policies.

Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side, the literature has mainly concentrated on interchangeability and substitutability recommendations, issued by national or regional policymakers. Information on actions taken by healthcare organisations (HCOs) regarding prescribing behaviour is limited. Furthermore, there is no evidence on whether local authorities implemented a policy framework aimed to appropriately reallocate resources gained through patent expiration. This paper aims to fill these gaps, investigating policies on biosimilars implemented at the local level in the Italian National Health Service. Materials and Methods: Data were retrieved through a structured, validated questionnaire, administered online to all 199 public HCOs. Results: Seventy-six organizations in 16 of 21 Italian regions completed the survey, 89% of HCOs implemented information/educational initiatives on biosimilars. Prescription targets on biosimilars versus originators and off-patent versus in-patent molecules were introduced in 62% and 75% of HCOs, respectively. Prescribers reaching targets are mostly rewarded through monetary incentives. 75% of HCOs performed systematic impact evaluation of biosimilars. However, only 21% of HCOs detect patient under-treatment due to budget constraints and how availability of cheaper drugs could help. Furthermore, according to 25% of respondents, their HCO is involved in studies on biosimilars, but respondents did not provide any evidence of these studies. Discussion and conclusions: The study shows a high level of proactivity by Italian HCOs regarding actions on prescribing behaviour for off-patent biologicals. However, it seems that structured actions aimed at appropriately reallocating resources gained through patent expiration are still lacking.

Introduction: Dedicated Funds for Innovative Medicines were introduced in 2017 for cancer and non-cancer drugs in Italy. After three years, their impact on patient access to the relevant treatments and critical issues about their management has been poorly investigated. Aims and scope. This paper aims at bridging the literature gap and providing possible reforms scenarios. Methods: Our analysis relied on a qualitative approach. The personal opinions of twelve Italian experts coming from the Ministry of Economy and Finance, the Scientific Committee of the Italian Medicines Agency, the Regions and Patient Associations, the Oncologists’ Scientific Societies and Hospital Pharmacists were elicited through a Delphi approach. A consensus on final recommendations was reached in two rounds. Results: Experts were in favour of maintaining dedicated Funds for Innovative Medicines and had a distinct preference for a single Fund. Most of them suggested to extend access to Funds to more than three years, if, for the relevant indication, there are no alternatives to the innovative drug and provided that this does not represent a barrier to new entries. Responders advocated for Funds being covered by on top resources and the production of more evidence on their impact. They finally claimed a speeder flow of information to the regions on expenditure for innovative treatments and an enhancement of controls on prescribing behaviour, to avoid prescriptions be dependent on Funds capacity. Conclusions: The consensus document provides for eight recommendations that could be taken into account for possible reforms and future research on this topic.

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