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.

ObjectivesThis paper aims at covering a literature gap on the effects of copayments, prescription quotas and therapeutic reference pricing on public and private expenditures and volumes (1) When these policies are implemented in different areas at different times, (2) estimating their impact in the short and long run, (3) assessing the extent to which these impacts are interdependent, (4) scrutinising the extent to which the effects are mediated by prescribers’ and patients’ behaviours.MethodsMonthly regional data on pharmaceutical expenditures, volumes and policies in Italy from 2000 to 2014 are analysed using a difference-in-differences model enriched to capture short- versus long-term effects and simultaneous and interactive effects. Sobel–Goodman test and bootstrap analyses were used to test for mediation.ResultsThe three policies have different short- and long-run effects. Interactions support the hypothesis of reinforcing effects. Behavioural reactions to policies such as reducing the demand or total per capita expenditures mediate the impact of policies, thus explaining the different effects between the short and long term.ConclusionsEvidence on the impact over time of regional policies diversely introduced in different times have important policy implications. First, pharmaceutical policies interact with each other, and the combined effect may be different from what we would expect from the sum of each single policy. Hence, policymakers should be very careful in designing mixed policies for their unexpected combined effects. Second, the impact of policies tends to reduce over time. If longer-term impact is desired, it would be appropriate to introduce some adjustments over time. Third, policies have multiple effects, and this should be considered when they are designed. Finally, pharmaceutical policies may have an unintended impact on health and health care.

Market access for pharmaceuticals has become a key issue in the Italian National Health Service, for at least three reasons: (i) market access delays are very high in Italy compared to other countries; (ii) drug policy is mostly driven by cost-containment both at national and regional/local levels; (iii) pharmaceutical policies have been decentralised, thus creating a very fragmented environment. These issues highlight the importance of market access and account management both at the national and the regional/local levels. The organization of market access by pharmaceutical companies in a complex environment, such as the Italian one, has never been investigated in the literature so far. Hence, this research contributes to fill the gap, surveying the industry's perceptions and reactions on a wide range of dimensions concerning market access. More specifically, this paper aims at answering the following research questions: how is market access defined and organised? In which phases of the product life-cycle do companies invest more in market access? Which are the perceived most appropriate tools for market access? Which are the perceived main obstacles to market access? How is the market access performance evaluated? The research question has been investigated through a structured questionnaire, which has been subject to a validation process. Responders were selected according to size (sales) in order to include firms that are more likely to introduce structural changes and to create sub-units. Overall, 43 companies accounting for a cumulated 80% market share (retail + hospitals) were involved. The questionnaire was sent to the General director/Chief executive, who selected the key informant(s). Results show that (i) market access is mostly associated with public affairs and pricing and reimbursement functions; only those companies, whose responder has associated market access with a commercial activity, invest more on actions aimed at fostering market penetration; (ii) market access benefits from tools that (a) increase the knowledge of the relevant target and (b) give evidence of the drug's value (economic evaluation and Health Technology Assessment) or its financial sustainability (budget impact analysis) and (iii) access to regional markets seems to be the most critical issue, thus confirming access problems deriving from decentralisation.

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The paper analyses the potential economic impact of switching drugs from prescription-only to over the counter status, using Italy as a case-study. The study assumes a societal perspective, investigating the effects of switches (and consequent delisting) on drugs spending, avoided visits by GPs (General Practitioners) and avoided time spent by patients for these visits. It overcomes the main pitfalls of previous studies, providing a rational for listing switchable products and applying both a static (no impact of switch on prices and volumes consumed) and a dynamic approach (impact on pricing policies and volumes depending on price-elasticity). Different scenarios were assumed including shorter/longer time spent for visits and inclusion/exclusion of the economic value of time of retiree patients. Results show that switching policy provides with societal savings ranging from 1 to 2.1 1 billion Euro. The economic impact on patients is less straightforward and depends on the scenarios used. If a longer time is spent on visits, the economic value of this time will compensate the cost of the switch to patients due to delisting. Despite the net economic benefit should be carefully interpreted, the results demonstrate how switching can contribute to the sustainability of the health care system in the middle-long run thanks to the more rational use of resources, combined with an increased awareness and responsibility of the involved stakeholders.