Giuditta Callea

The impact of HTA and procurement practices on the selection and prices of medical devices

Technological innovation in healthcare yields better health outcomes but also drives healthcare expenditure, and governments are struggling to maintain an appropriate balance between patient access to modern care and the economic sustainability of healthcare systems. Health Technology Assessment (HTA) and centralized procurement are increasingly used to govern the introduction and diffusion of new technologies in an effort to make access to innovation financially sustainable. However, little empirical evidence is available to determine how they affect the selection of new technologies and unit prices. This paper focuses on medical devices (MDs) and investigates the combined effect of various HTA governance models and procurement practices on the two steps of the MD purchasing process (i.e., selecting the product and setting the unit price). Our analyses are based on primary data collected through a national survey of Italian public hospitals. The Italian National Health Service is an ideal case study because it is highly decentralized and because regions have adopted different HTA governance models (i.e., regional, hospital-based, double-level or no HTA), often in combination with centralized regional procurement programs. Hence, the Italian case allows us to test the impact of different combinations of HTA models and procurement programs in the various regions. The results show that regional HTA increases the probability of purchasing the costliest devices, whereas hospital-based HTA functions more like a cost-containment unit. Centralized regional procurement does not significantly affect MD selection and is associated with a reduction in the MD unit price: on average, hospitals located in regions with centralized procurement pay 10.1% less for the same product. Hospitals located in regions with active regional HTA programs pay higher prices for the same device (+23.2% for inexpensive products), whereas hospitals that have developed internal HTA programs pay 8.3% on average more for the same product.

Improving the Methods for the Economic Evaluation of Medical Devices

Medical devices (MDs) have distinctive features, such as incremental innovation, dynamic pricing, the learning curve and organisational impact, that need to be considered when they are evaluated. This paper investigates how MDs have been assessed in practice, in order to identify methodological gaps that need to be addressed to improve the decision-making process for their adoption. We used the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist supplemented by some additional categories to assess the quality of reporting and consideration of the distinctive features of MDs. Two case studies were considered: transcatheter aortic valve implantation (TAVI) representing an emerging technology and implantable cardioverter defibrillators (ICDs) representing a mature technology. Economic evaluation studies published as journal articles or within Health Technology Assessment reports were identified through a systematic literature review. A total of 19 studies on TAVI and 41 studies on ICDs were analysed. Learning curve was considered in only 16% of studies on TAVI. Incremental innovation was more frequently mentioned in the studies of ICDs, but its impact was considered in only 34% of the cases. Dynamic pricing was the most recognised feature but was empirically tested in less than half of studies of TAVI and only 32% of studies on ICDs. Finally, organisational impact was considered in only one study of ICDs and in almost all studies on TAVI, but none of them estimated its impact. By their very nature, most of the distinctive features of MDs cannot be fully assessed at market entry. However, their potential impact could be modelled, based on the experience with previous MDs, in order to make a preliminary recommendation. Then, well-designed post-market studies could help in reducing uncertainties and make policymakers more confident to achieve conclusive recommendations.

The role of hospital payments in the adoption of new medical technologies: an international survey of current practice

This study examined the role of prospective payment systems in the adoption of new medical technologies across different countries. A literature review was conducted to provide background for the study and guide development of a survey instrument. The survey was disseminated to hospital payment systems experts in 15 jurisdictions. Fifty-one surveys were disseminated, with 34 returned. The surveys returned covered 14 of the 15 jurisdictions invited to participate. The majority (71%) of countries update the patient classification system and/or payment tariffs on an annual basis to try to account for new technologies. Use of short-term separate or supplementary payments for new technologies occurs in 79% of countries to ensure adequate funding and facilitate adoption. A minority (43%) of countries use evidence of therapeutic benefit and/or costs to determine or update payment tariffs, although it is somewhat more common in establishing short-term payments. The main barrier to using evidence is uncertain or unavailable clinical evidence. Almost three-fourths of respondents believed diagnosis-related group systems incentivize or deter technology adoption, depending on the particular circumstances. Improvements are needed, such as enhanced strategies for evidence generation and linking evidence of value to payments, national and international collaboration and training to improve existing practice, and flexible timelines for short-term payments. Importantly, additional research is needed to understand how different payment policies impact technology uptake as well as quality of care and costs.

Impatto del sistema di finanziamento a DRG sull’innovazione tecnologica in sanità. Il caso italiano

Negli ultimi vent’anni, la maggior parte dei paesi sviluppati ha introdotto schemi di pagamento prospettico basati sui DRG per rimborsare l’attivita di ricovero ospedaliero. Tali schemi di pagamento possono giocare un ruolo importante nell’adozione di nuovi dispositivi medici: quando un nuovo dispositivo entra sul mercato, la sua adozione puo dipendere da valutazioni circa l’aumento dei costi e il valore terapeutico aggiunto. L’obiettivo della presente ricerca e quello di (i) identificare, in un campione di regioni italiane, le caratteristiche dei sistemi regionali di rimborso dei ricoveri ospedalieri basati sui DRG rilevanti ai fini dell’adozione dell’innovazione tecnologica, descrivendo i meccanismi di aggiornamento del sistema di codici e tariffe che assicurano che essa sia incorporata nel sistema di rimborso e individuando strumenti specifici di pagamento alternativi utilizzati in ambito ospedaliero per incentivarla; (ii) investigare le opinioni e le percezioni degli operatori del Sistema Sanitario Nazionale sul ruolo del sistema di finanziamento basato sui DRG sull’adozione e sulla diffusione di dispositivi medici innovativi negli ospedali italiani.

The economic impact of a medical device company's location in Italy

There is a lack of scientific evidence on the impact of a biomedical industry on the surrounding economy. The assessment of this issue would allow policy makers to identify the impact on production, local employment and wages in addition to public sector costs. With this aim, the paper evaluates the socio-economic impact of a medical devices firm’s decision to set up its manufacturing plants in Italy, i.e. the effect of industrial activity on employment, earnings and output, using information on production processes to derive the associated interactions with suppliers for the primary industry and secondary industries. Besides being amongst the major contributors of health outcomes, medical technology manufacturers provide additional benefits to public sector and to the economy as a whole. This suggests that a broad perspective needs to be endorsed by policy makers when deciding about the introduction of new technologies in the healthcare sector in order to achieve optimal outcomes for society as a whole.

Il governo dell’innovazione tecnologica in sanità. Il caso dell’impianto di valvola aortica transcatetere: stato dell’arte delle indicazioni e della rimborsabilità nelle regioni italiane

La stenosi aortica degenerativa calcifica e la valvulopatia piu frequente nella popolazione occidentale, con circa 5 milioni di pazienti nei soli paesi europei. Per un terzo circa di questi, giudicati inoperabili, e disponibile dal 2007 una nuova tecnica di trattamento, l’impianto di valvola aortica transcatetere (TAVI). L’obiettivo del presente lavoro e stato di realizzare una mappatura delle politiche e degli strumenti di governo regionali che hanno guidato l’introduzione della TAVI in Italia, finalizzata a fornire raccomandazioni ai decisori pubblici. I dati sono stati acquisiti attraverso la revisione della letteratura internazionale e delle delibere regionali ed il confronto con attori istituzionali. L’analisi ha messo in luce la crescente diffusione della TAVI nelle regioni italiane e al tempo stesso la grande eterogeneita interregionale dei percorsi intrapresi per il governo della sua introduzione, diffusione e rimborsabilita in Italia.