HTA Assessment of Clinical-care Pathways: Peritoneal Dialysis Vs Hemodialysis – Content Summary

Background

Prevention and home care are the two pillars underpinning the new course of the Italian Society of Nephrology (SIN), in keeping with PNRR (Italian National Recovery and Resilience Plan) M6 guidelines and the therapy innovations which are radically changing nephrological clinical practice. In relation to the performance of dialysis treatment at home, SIN is working on incentivizing the use in Italy of peritoneal dialysis (PD), the first and leading hospital treatment provided at home, performed in 80% of cases by patients themselves, or if necessary with the help of a caregiver. As of today, 37% of Nephrology and Dialysis Units in Italy do not prescribe PD and 22% of the Units treat fewer than 10 patients. The result is that PD is used in less than 10% of dialyzed patients despite significant improvements in terms of effectiveness and safety, in association with the implementation of remote monitoring. To be noted, finally, is that the cost of PD is over 40% less today than that of in-center hemodialysis (HD). This favorable benefit-cost-ratio was confirmed by the Health Technology Assessment (HTA) analysis completed in September 2025 by the Graduate School of Health Economics and Management (ALTEMS) of the Catholic University of the Sacred Heart in Rome. We therefore believe it to be essential to represent and report the results of this original analysis of international importance. The ALTEMS HTA has a political dimension: the results will be used in the ongoing consultation on PD with the Ministry of Health and the Italian National Agency for Regional Health (AGENAS), but they may also be represented by nephrologists regionally and by individual Hospital Trusts. SIN’s main aim is to rekindle the interest of health authorities – and nephrologists themselves – in PD, elevating it to the status of first-choice dialysis therapy.

 

The ALTEMS research

Notwithstanding the positive results of PD in the treatment of patients with End-Stage Kidney Disease (ESKD), data surveying the PD services offered in Italy show its use is rather limited, and above all strongly differentiated between the various Regions.

In order to determine whether this is justifiable on economic and organizational grounds associated with the treatment itself, in 2023 the Graduate School of Health Economics and Management (ALTEMS) launched a research project using Health Technology Assessment (HTA) methodology.

Published in 2023 (and recently updated to the new 2025 tariffs) [1], the ALTEMS report was presented at the Health Ministry on May 8^th 2024 during a dedicated conference entitled “Dialysis: everything is changing”. In this context, as announced at the XXII Congress of SIN’s Peritoneal Dialysis Project Group (Brescia, 15-17/05/25), SIN is presenting a proposal to the Ministry to include explicit objectives to increase home peritoneal dialysis service coverage in its Essential Levels of Care review.

Set out following HTA principles, the paper first examines the clinical and management context, and then analyzes the economic and organizational aspects.

 

Health Technology Assessment

HTA is an approach to the assessment of technological innovation in health that is increasingly gaining ground in Italy. It is a “multidisciplinary process which analyzes and summarizes scientific knowledge on health, social, economic and ethical aspects associated with the use of a health technology in order to transform it into information for decision-makers in a systematic, transparent, objective and robust manner” [2].

Within the context of the HTA, medical devices and drugs are not alone in being considered “technologies”. Organizational service provision models are as well, as is the entire diagnostic, therapeutic and rehabilitation pathway proposed to patients more in general. These technologies are assessed according to their various defining “dimensions”: 1) the problem of health and the current use of the technology under consideration, 2) its technical and technological characteristics, 3) safety, 4) clinical effectiveness, 5) costs and economic evaluation, 6) organizational aspects, 7) ethical aspects, 8) social aspects and 9) legal aspects. Each of these “dimensions” contributes to the determination of the “value” of the technology, and therefore its desirability and sustainability within the context of the Health System concerned.

HTAs were first applied in Italy within individual hospital – public or private – contexts in the early 2000s, but the focus soon shifted to the macro level (Ministry, the medicines agency AIFA, AGENAS and Regions). However, whereas over the years the use of HTAs had remained largely optional, in 2025 the approach has become mandatory. As a matter of fact, the European HTA regulation approved at the end of 2022 envisaged that as from January 2025 certain parts of the HTA (effectiveness and safety) are to be assessed a single time on a European level, with the results being made available to all EU countries, which are then to analyze the dimensions which are more locally-dependent (in particular the organization of services and the economic aspects, which depend heavily on national contexts).

A further important role of the HTA is in the definition of the new LEA (Essential Levels of Care) provided for under the 2019-2021 Health Pact in which the use of this methodology is agreed “in order to measure the real current and prospective impact of the proposal on the upgrading of the entire health system in terms of benefits, emerging costs and avoided costs” within the framework of the periodic review of LEAs.

 

The context of the research: clinical problem and current management

Chronic Kidney Disease

CKD is characterized by a gradual deterioration of kidney function and structure, with a resulting accumulation of toxins in the blood and alteration of the hydrosaline balance. The condition is irreversible and progresses slowly, leading to end-stage kidney disease (ESKD) which requires replacement therapies such as kidney transplantation or dialysis. A CKD diagnosis is based on two main indicators: Glomerular Filtration Rate (GFR) and albuminuria. The combination of the values of these parameters makes it possible to classify CKD in five stages of increasing severity and to assess the risk of progression of the disease [3]. CKD is a complex condition. Familial predisposition and common conditions/comorbidities such as hypertension, diabetes, cardiovascular disease, lithiasis, prostatic hypertrophy, nephrotoxic drugs or procedures, disorders of the immune system and neoplasms increase the risk of developing CKD, which – in turn – worsens in particular cardiovascular outcomes.

As CKD progresses, in particular into stages IV and V, fatigue and anemia appear, alongside a reduction in appetite and loss of lean body mass, difficulty in concentrating, changes in blood volume (resistant hypertension, edemas), hyperpotassemia, hyperphosphatemia and uremic osteodystrophy, hyperazotemia with negative consequences on the state of health of the entire organism and a high risk of death in the absence of timely renal replacement therapy, in other words dialysis or kidney transplantation.

Epidemiology of CKD

The prevalence of CKD is on the increase globally due to an ageing population and the increased incidence of diabetes mellitus, obesity and hypertension. It is estimated that by 2040 CKD will become the fifth cause of death in the world. Italian epidemiological data collected in 2008-2012 by the Italian Institute of Health and the Italian Society of Nephrology (SIN) indicate a prevalence of 7.05% (95% CI 6.48–7.65) in the general population aged 35-79 [4]. Considering the global increase in the incidence of CKD, it is possible to estimate a prevalence in Italy today of around 10%, which corresponds to 4-5 million people affected by CKD.

With regard to the end stage, Italian Dialysis and Transplant Register (RIDT) data published in 2024 and relating to 2022 indicate that the incidence in Italy of ESKD on dialysis was 173 pmp, while prevalence was 764 pmp. The Region with the highest incidence was Marche (303 pmp), while the one with the highest prevalence was Liguria (1099 pmp). As of 31 December 2022, approximately 45,000 patients were being treated in Italy with dialysis, while around 25,000 had undergone a kidney transplant. The mortality rate in dialysis remained high (16.7 per 100 patients/year) – higher in HD (17%) than PD (12%) – and in any case markedly higher than that of transplantation (3.9%).

Management of CKD

Early identification and correct management of CKD are of vital importance in preventing serious complications and improving patient quality of life, while the epidemiological challenges and the growing burden of CKD underline the importance of research and prevention. Early diagnosis and combined treatment (traditional and new drugs, limitation of salt and protein intake) are cornerstones of its management. Renal transplantation is the optimal treatment for severe CKD, but failing this due to contra-indications HD and PD are the therapy options. Deciding which modality to use should be based on the specific condition of the patient and their own preference.

Choice of dialysis treatment

RIDT and the Census by SIN’s Peritoneal Dialysis Project Group (GPDP) analyze the percentages of use of the two methods in incident and prevalent patients on dialysis. Referring to the latest 2024 data, the percentage incidence of PD in Italy is 14.1%, while the prevalence is 9.5% [5, 6]. The Region in which PD is most widely-used is Trentino-Alto Adige (31.4%), while it is least used in Calabria (4.0%).

The results of the ninth GPDP-SIN census relating to 2024 involving all the Centers which used PD in 2024 (228 Centers) show a good level of use in Italy [6]. The constant reduction in the incidence of peritonitis (down to 1 episode every 73 months in 2024) and EPS (Encapsulating peritoneal sclerosis) (0.1 episode every 100 patient years), the percentage of assisted PD of 21% (almost completely family members), the prescription measured on the residual renal function in an incremental, structured manner, the ever-increasing use of APD (Automated Peritoneal Dialysis), the continuous reduction in mortality (9.4 episodes/100 patient years in 2024) represent a constant improvement in the method. However, the number of new entries (1656 patients – 1398 incident, 201 from HD and 57 from transplant), the number of prevalent patients at 31/12/2024 (4322 patients) and the lack of regional uniformity are not very different to those found 20 years ago [6].

Effectiveness and safety: PD and HD compared

The full report [1] reviews the literature published up to 2022 extensively, finding, on the one hand, that there are no substantial differences in effectiveness and safety between PD and HD, and on the other highlighting the clinical potential of the PD-based care pathway as the bridge technology to transplantation capable of guaranteeing a better quality of life during this phase of the disease. The issue was examined in various presentations given by clinical experts at the PD Congress in Brescia soon to be published for consultation in a Supplement to GIN (Italian Journal of Nephrology).

It is to be remembered that the comparison between the two methods would require a randomized controlled trial (RCT), which is practically impossible in clinical practice as the choice of dialysis treatment is determined by not only clinical conditions pointing to one or the other, but also – and above all – patient choice. Of the 84 studies considered in a recent Cochrane Library analysis [7], only two were RCTs. However, despite these limitations the Cochrane analysis confirms the positive results of PD compared to HD. In detail, PD has a significantly lower rate of mortality for all causes (42 studies, 700,093 patients: RR 0.87, 95% CI 0.77 to 0.98), confirmed in the two RCTs, a lower number of septic episodes, a lower risk of stroke and above all of loss of Residual Renal Function (RRF). Although they are not significant, positive effects of PD compared to HD have been found for cardiovascular mortality, coronary heart disease, heart attack and ischemic heart disease, hospital admissions [7]. 

Economic and organizational aspects

In order to study the economic dimension, a mathematical model fed according to the indications of literature and the suggestions of clinical experts based on field data was used to perform two types of economic/organizational analysis (for the numerous bibliographical references and specialist sitography, reference can be made to the full report online [1]).

The first was Budget Impact Analysis (BIA), in other words the study and comparison of real costs per patient – both social and relating to the National Health Service (SSN) – on an annual basis of different, alternative treatments for the same condition (in our case PD and HD).

The second type was Cost Utility Analysis (CUA), by means of which the cost of a given treatment (for its duration) is compared with the health units produced. The latter is measured in QALY (Quality Adjusted Life Years), given by the product of time of treatment (in years) and the Quality of Life recorded during the treatment. The maximum unit value is 1.0 and corresponds to one year lived in full health (with a Quality of Life which is unaffected by the disease). For the analysis of the costs and economic effectiveness (CUA) of the clinical care pathways of renal function replacement therapies a Markov model was used in which HD, PD, transplant and death are the four alternative states in the evolution of end-stage CKD. The model considered a hypothetical cohort of 1000 patients, a lifetime horizon (i.e. the hypothetical cohort of patients is observed in terms of both costs and QALY for an entire lifetime) and a one-year length of cycle (the unit of time considered for the evaluation of the costs and QALY is each year of treatment, in other words annual).

The cost analysis, as already mentioned, included two different perspectives: that of the National Health Service (SSN) and the social perspective. The SSN perspective took into account all the health costs, both direct (the therapy itself, hospitalizations, the number and time of personnel involved in the care, etc.) and indirect (for example, transport to the Center). The social perspective considered all the costs borne by citizens/patients (transport if incurred directly by the patient, hours of work lost by the patient and/or person accompanying the patient if necessary, etc.), adding them to the SSN costs. Used to determine the costs from the SSN perspective were the tariffs of the various services included in the pathways compared (PD and HD) and/or the costs taken from the most recent public tenders found online, which were put together and analyzed using Activity Based Costing (ABC) methodology, reviewing in detail all the human and material resources used to provide the services envisaged.

In order to assess the robustness of the results obtained, One-way DSA (Deterministic Sensitivity Analysis) and Multi-way PSA (Probabilistic Sensitivity Analysis) were performed. This type of analysis is carried out to assess how results change in relation to a possible variability in one or more of the reference values used. Different scenarios are therefore developed to simulate these uncertainties, precisely in order to verify the robustness of the final results.

The processed data show that the PD pathway is “dominant” compared to the HD pathway. In other words, it offers lower costs with a better quality of life. This result was analyzed in various scenarios based on different numbers of patients started on PD and imagining a possible variability (usually +/- 25%) of the single cost and effectiveness items entered into the model. The result was confirmed in all scenarios.

Analysis of the results of the various scenarios investigated shows how PD always has a lower total cost per patient than HD.

More in detail, from the social perspective and according to Activity Based Costing (ABC) methodology, the CUA analysis shows how PD has a lower total cost per patient than HD (€ 31,172 and € 39,395 respectively per unit of QALY).

The BIA analysis performed from a social perspective further reinforced the results, due to the considerable costs borne by patients and family members for the need for constant travel to access the hemodialysis services provided in hospital, which can be avoided using PD. In short, from a social perspective the real annual cost per patient is € 24,142 for PD and € 42,231 for HD.

In relation to effectiveness, expressed in terms of Quality Adjusted Life Years (QALY), PD is shown to be the more effective first line of intervention, with total QALY values (sum of each annual QALY) of 1.20 per patient compared to 0.94 for HD. Finally, as PD is less costly and more effective (“dominant treatment”) than HD, it is the dominant frontline treatment strategy for stage-5 CKD, so it was not necessary to calculate the Incremental Cost-Effectiveness Ratio (ICER). The results obtained from the base case analysis were also confirmed by variability analysis.

 

Future prospects

The report therefore highlights the opportunities offered by a possible – and merited – expansion of the use of home PD-based treatments in terms of:

• improvement in patient quality of life for greater safety and effectiveness of PD;
• reduction in regional variability in the service offering, guaranteeing more equitable access to treatments nationwide;
• reduction in both SSN and patient-borne costs.

In order to seize these opportunities, the wider use of PD needs to be encouraged.

Firstly, by raising awareness in operatives involved in the care pathways, both by the promotion of PD during specialist training and through the sharing of Diagnostic Therapeutic Assistance Pathways (PDTA) (Figure 1) which set a valid nationwide benchmark standard.

Furthermore, from the perspective of improved organization of the SSN overall, it seems appropriate to define an LEA objective supporting extended use of PD, if possible with the establishment also of financial incentives to reach specific patient coverage targets.

A fruitful collaboration between SIN and ALTEMS is already underway on these points.

To be highlighted among the specific objectives of the CKD management plan are the following two points: the creation of a CKD pathway which allows for customization of the dialysis therapy while keeping patients at home; the testing of home dialysis – both peritoneal and HD – using assisted teledialysis tools

Analysis of the stage 4-5 CKD patient pathway has shown the need for the enhancement of the following aspects:

• Encouragement of the wider use and development of low clearance clinics for stage 4-5 patient care management planning and follow up, with the aim also of enabling timely transplantation or dialysis;
• Encouragement of home dialysis therapy, also for patients in residential healthcare homes;
• Offering patients on PD, as with those on HD, the option of free or refundable transport to/from the dialysis center.

In order to determine the potential burden on the Italian SSN and society as a whole resulting from gradual greater use in clinical practice of PD compared to HD in stage 4-5 CKD patients, a further Budget Impact Analysis was carried out. Considering the total annual cost (SSN and social) of PD and HD as reported herein (PD = € 24,143; HD = € 42,232), an annual 5% increase in patients on PD would produce a saving over 5 years of close to 100 million euro.

 

Acknowledgements

The ALTEMS research was made possible by Baxter S.r.l. (now Vantive S.r.l.). Publication of the results is not subject to the sponsor’s approval. The results reported therefore represent the point of view of the authors and not necessarily of the sponsor.

 

Bibliography

1. ALTEMS – “Valutazione HTA di percorsi clinico assistenziali: dialisi peritoneale vs emodialisi”. https://altems.unicatt.it/altems-report-hta-valutazione-hta-di-percorsi-clinico-assistenziali-dialisi-peritoneale-vs-emodialisi.
2. Position Paper SIHTA. 2020 https://www.sihta.it/site/position-paper-sihta-2/.
3. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. https://doi.org/10.1016/j.kint.2023.10.018. PMID: 38490803.
4. De Nicola L, Donfrancesco C, Minutolo R, Lo Noce C, Palmieri L, De Curtis A, Iacoviello L, Zoccali C, Gesualdo L, Conte G, Vanuzzo D, Giampaoli S; ANMCO-SIN Research Group. Prevalence and cardiovascular risk profile of chronic kidney disease in Italy: results of the 2008-12 National Health Examination Survey. Nephrol Dial Transplant. 2015 May;30(5):806-14. https://doi.org/10.1093/ndt/gfu383. Epub 2014 Dec 18. PMID: 25523453.
5. Società Italiana di Nefrologia. Registro Italiano di Dialisi e Trapianto. Report Annuale 2022. https://ridt.sinitaly.org/2024/11/21/report-2022-2/.
6. Neri L, Giuliani A, Heidempergher M, Zeiler M, Maxia S, Mastropaolo C, Viglino G, Marinangeli G, Cabiddu G. Peritoneal Dialysis in Italy: the 9th GPDP-SIN Census 2024. Twenty Years of Monitoring Peritoneal Dialysis. G Ital Nefrol. 2025 Aug 29;42(4):2025-vol4. https://doi.org/10.69097/42-04-2025-02. PMID: 40923577.
7. Ethier I, Hayat A, Pei J, Hawley CM, Francis RS, Wong G, Craig JC, Viecelli AK, Htay H, Ng S, Leibowitz S, Johnson DW, Cho Y. Peritoneal dialysis versus haemodialysis for people commencing dialysis. Cochrane Database of Systematic Reviews 2024, Issue 6. Art. No.: CD013800. https://doi.org/10.1002/14651858.cd013800.pub2.