Spanish National Health System Research Articles

Comorbidities and Complications in People Admitted for Leprosy in Spain, 1997–2021

This study aims to describe the epidemiological and clinical characteristics and trends of these admissions in Spain. This retrospective study drew data from the Hospital Discharge Records Database of the Spanish National Health System. We used the diagnostic codes for leprosy from the International Classification of Diseases, ninth and tenth revisions, to retrieve leprosy admissions from 1997 to 2021. There were 1387 hospitalizations for leprosy The number of annual cases decreased gradually, from 341 cases in 1997–2001 to 232 in 2017–2021 (p < 0.001). Patients’ median age increased, from 65 years in 1997–2001 to 76 years in 2017–2021 (p < 0.001), as did the prevalence of some comorbidities, such as hypertension (15% in 1997–2001 to 27.6% in 2017–2021; p < 0.001). The mortality rate (6%) and the frequency of leprosy complications remained stable. After Spain (79.1%), the most common country of origin was Paraguay (4.4%). Admissions decreased significantly in Andalusia, from 42% in 1997–2001 to 10.8% in 2017–2021 (p < 0.001), and in the Canary Islands, from 7.9% in 1997–2001 to 2.6% in 2017–2021 (p = 0.001), whereas they increased in Madrid, from 5.9% in 1997–2001 to 12.1% in 2017–2021 (p = 0.005). Overall, leprosy admissions in Spain have declined, even in the regions with the highest prevalence. Patients admitted for leprosy have become older and sicker.

Analysis of the Complexity of Palliative Care for Cancer Patients.

The Spanish National Health System has defined complexity as a set of factors of increased difficulty that require the intervention of a palliative care team. Palliative care aims to improve the quality of life of patients with chronic terminal illnesses. This study aims to describe the degree of complexity of cancer patients in palliative care, to determine which elements of complexity are most prevalent and to determine which other hospital clinical factors are associated with the level of complexity. This study is a descriptive, observational, and cross-sectional analysis that included patients diagnosed with advanced oncological pathology undergoing palliative treatment who were admitted to the Medical Oncology ward of the Miguel Servet University Hospital between March and April 2023. A total of 100 patients were selected for the study. According to the IDC-Pal, 68% of patients were classified as highly complex, 26% of patients were complex and only 6% of patients were classified as non-complex. The presence of pain (P < .001), nausea and vomiting (P = .027), depression (P = .033) and functional status (P = .011) were statistically independent predictors of high complexity. This study has shown that a high proportion of hospitalized palliative care cancer patients have high complexity, suggesting a good matching of healthcare resources to patient complexity. Four factors related to complexity have been identified, namely pain, nausea and vomiting, depression and a bedridden functional state. The presence of any of the 4 factors could help healthcare professionals to identify patients for early specialized palliative care.

Economic assessment of abemaciclib for the adjuvant treatment of luminal HER2- breast cancer from the perspective of the Spanish health system.

Abemaciclib is an oral inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Data from the clinical trial monarchE (2023) showed improved survival from invasive disease. The aim of the present article was to conduct an economic assessment of adjuvant treatment with abemaciclib in women with luminal, HER2- and node-positive breast cancer. A Markov model was constructed with four mutually exclusive health states (disease-free, local recurrence, distal recurrence and death). Analyses were based on the clinical trial monarchE which compared an intervention group (abemaciclib + hormone therapy [HT]) with HT alone. The effectiveness measure used was quality-adjusted life years (QALY), with unit costs and utilities being obtained from existing literature. The incremental cost-utility ratio (ICUR) was used to compare the two treatment strategies. Total costs were €98,765 and €17,935 for the abemaciclib plus HT group and the HT alone group, respectively. The health outcome was 10.076QALY for the intervention group and 9.495QALY for the control group, with the ICUR being€139,173/QALY. Despite the significant gains of abemaciclib as adjuvant treatment in terms of progression-free survival, this treatment is not cost-effective for the Spanish National Health System at published prices. It may be cost-effective with an appropriate discount on the official price.

Economic analysis of the robotic approach to inguinal hernia versus laparoscopic: is it sustainable for the healthcare system?

There has been a rapid proliferation of the robotic approach to inguinal hernia, mainly in the United States, as it has shown similar outcomes to the laparoscopic approach but with a significant increase in associated costs. Our objective is to conduct a cost analysis in our setting (Spanish National Health System). A retrospective single-center comparative study on inguinal hernia repair using a robotic approach versus laparoscopic approach. A total of 98 patients who underwent either robotic or laparoscopic TAPP inguinal hernia repair between October 2021 and July 2023 were analyzed. Out of these 98 patients, 20 (20.4%) were treated with the robotic approach, while 78 (79.6%) underwent the laparoscopic approach. When comparing both approaches, no significant differences were found in terms of complications, recurrences, or readmissions. However, the robotic group exhibited a longer surgical time (86 ± 33.07min vs. 40 ± 14.46min, p < 0.001), an extended hospital stays (1.6 ± 0.503days vs. 1.13 ± 0.727days, p < 0.007), as well as higher procedural costs (2318.63 ± 205.15 € vs. 356.81 ± 110.14 €, p < 0.001) and total hospitalization costs (3272.48 ± 408.49 € vs. 1048.61 ± 460.06 €, p < 0.001). These results were consistent when performing subgroup analysis for unilateral and bilateral hernias. The benefits observed in terms of recurrence rates and post-surgical complications do not justify the additional costs incurred by the robotic approach to inguinal hernia within the national public healthcare system. Nevertheless, it represents a simpler way to initiate the robotic learning curve, justifying its use in a training context.

Economic impact of managing invasive mold disease with isavuconazole compared with liposomal amphotericin B followed by posaconazole in Spain

ABSTRACT Background Invasive fungal infections (IFI) are associated with significant morbidity and mortality. The objective of this work was to compare the costs per adult patient, associated with intravenous isavuconazole (ISAV) followed by oral ISAV versus the regimen of liposomal amphotericin B followed by posaconazole (L-AMB→POSA) in the treatment of IFI. The comparison was conducted from the perspective of the Spanish National Health System (SNS). Methods As indirect comparisons have demonstrated similar efficacy between the comparators, a cost-minimization approach was taken. Drug acquisition, administration, hospitalization, laboratory tests and adverse events costs were evaluated from SNS perspective. Deterministic and probabilistic sensitivity analyzes were performed. Results Total costs per-patient were €24,715.54 with ISAV versus €29,753.53 with L-AMB→POSA, resulting in cost-savings per patient treated with ISAV of €5,037.99 (−16.9%). Treatment costs of IFI remained lower for ISAV than for L-AMB→POSA across all sensitivity analyses (−7,968.89€ to −326.59€), being treatment duration the most influential parameter. Conclusion According to the present model, the treatment of IFIs with ISAV would generate savings for the SNS compared to L-AMB→POSA. These savings are attributed to the shorter duration of IV treatment, reduced use of healthcare resources and lower costs associated with managing adverse effects when ISAV was employed.

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis

BackgroundThe reimbursement of erenumab in Spain and other European countries is currently restricted because of the cost of this novel therapy to patients with migraine who have experienced previous failures to traditional preventive treatments. However, this reimbursement policy should be preferably based on cost-effectiveness studies, among other criteria. This study performed a cost-effectiveness analysis of erenumab versus topiramate for the prophylactic treatment of episodic migraine (EM) and versus placebo for chronic migraine (CM).MethodsA Markov model with a 10-year time horizon, from the perspective of the Spanish National Healthcare System, was constructed based on data from responder and non-responder patients. A responder was defined as having a minimum 50% reduction in the number of monthly migraine days (MMD). A hypothetical cohort of patients with EM with one or more prior preventive treatment failures and patients with CM with more than two treatment failures was considered. The effectiveness score was measured as an incremental cost per quality-adjusted life year (QALY) gained and cost per migraine day (MD) avoided. Data from clinical outcomes and patient characteristics were obtained from erenumab clinical trials (NCT02066415, STRIVE, ARISE, LIBERTY and HER-MES). Deterministic and probabilistic sensitivity analyses were performed to validate the robustness of the model.ResultsAfter a 10-year follow-up, the estimated QALYs were 5.88 and 6.11 for patients with EM treated with topiramate and erenumab, respectively. Erenumab showed an incremental cost per patient of €4,420 vs topiramate. For CM patients, erenumab resulted in 0.756 QALYs gained vs placebo; and an incremental cost of €1,814. Patients treated with erenumab achieved reductions in MD for both EM and CM (172 and 568 MDs, respectively). The incremental cost per QALY gained with erenumab was below the Spanish threshold of €30,000/QALY for both health and societal perspectives (EM €19,122/QALY and CM €2,398/QALY).ConclusionsErenumab is cost-effective versus topiramate as a preventive treatment for EM and versus placebo for patients with CM from the perspective of the Spanish National Health System.

Diferencias regionales en la epidemiología y los resultados de la endocarditis infecciosa en España. Un estudio poblacional contemporáneo

Introduction and objectivesOur aim was to describe the contemporary epidemiological profile of infective endocarditis (IE) in Spain, and to evaluate variations in IE incidence, characteristics, and outcomes among the different Spanish regions (autonomous communities [AC]). MethodsWe conducted a retrospective, population-based study, using data obtained from national in-patient hospital activity of all patients discharged with a diagnosis of IE from hospitals included in the Spanish National Health System, from January 2016 to December 2019. Differences in the IE profile between the 17 Spanish AC were analyzed. ResultsA total of 9008 hospitalization episodes were identified during the study period. Standardized incidence of IE was 5.77 (95%CI, 5.12-6.41) cases per 100 000 population. Regarding predisposing conditions, 26.8% of episodes occurred in prosthetic valve carriers, 36.8% had some kind of valve heart disease, and 10.6% had a cardiac implantable electronic device. Significant differences were found between AC in terms of incidence, predisposing conditions, and microbiological profile. Cardiac surgery was performed in 19.3% of episodes in the total cohort, and in 33.4% of the episodes treated in high-volume referral centers, with wide variations among AC. Overall in-hospital mortality was 27.2%. Risk-adjusted mortality rates also varied significantly among regions. ConclusionsWe found wide heterogeneity among Spanish AC in terms of incidence rates and the clinical and microbiological characteristics of IE episodes. The proportion of patients undergoing surgery was low and in-hospital mortality rates were high, with wide differences among regions. The development of regional networks with referral centers for IE could facilitate early surgery and improve outcomes.

Coste-efectividad del ciclosilicato de sodio y zirconio para el tratamiento de la hiperpotasemia en pacientes con enfermedad renal crónica o insuficiencia cardiaca en España

Background and objectiveHyperkalemia (HK) is an electrolyte disturbance in the concentration of potassium ions (K+), whose risk increases in patients with chronic kidney disease (CKD) or heart failure (HF) and/or in patients being treated with renin-angiotensin-aldosterone system inhibitors (RAASi). The new oral K+ chelators offer a safe and effective treatment to maintain normokalemia in these patients. The objective of the analysis is to estimate the cost-effectiveness of sodium zirconium cyclosilicate (SZC) for the treatment of chronic HK in patients with CKD or HF versus standard treatment (calcium polystyrene sulfonate and lifestyle modifications) from the perspective of the Spanish National Health System. Materials and methodsTwo microsimulation models reflecting the natural history of CKD and HF were used. In both models, K+ levels were simulated individually. Based on efficacy (reduction of K+ levels), quality of life of patients (utilities according to health states, and disutilities of events derived from each pathology and adverse events [AEs] of treatment) and costs considered (cost of treatment for HK, of RAASi treatment and its modification, health states, management of events derived from each pathology, HK episodes, and AEs treatment) (€, 2022), clinical benefit (quality-adjusted life years [QALYs]) and cost results were obtained. A time horizon of the patient's lifetime was used and a discount rate of 3% was applied for costs and outcomes. ResultsSZC is a more effective option in both pathologies, with a difference in QALYs of 0.476 in CKD and 0.978 in HF compared to standard treatment, and it represents an incremental cost of € 3,616 and € 14,749, respectively, obtaining an incremental cost-utility ratio of € 7,605 /QALY in CKD and € 15,078 /QALY in HF. ConclusionsSZC is a cost-effective alternative for the treatment of HK in patients with CKD or HF, taking into account the reference efficiency values commonly used in Spain.

Post-event follow-up costs in patients with atherosclerotic cardiovascular disease in Spain.

Atherosclerotic cardiovascular disease (ASCVD) is one of the main causes of morbidity and mortality in developed countries and entails high resources use and costs for health systems. The risk of suffering future cardiovascular (CV) events and the consequent resources use is higher in those patients who have already had a previous cardiovascular event. The objective of the study was to determine the average annual cost of patients with a new or recurrent atherosclerotic CV event during the 2 years after the event. Retrospective observational study of electronic medical records of patients from the BIG-PAC® database (7 integrated health areas of 7 Autonomous Communities; n = 1.8 million). Patients with a new or recurrent episode of ASCVD (angina, acute myocardial infarction, transient ischemic attack, stroke, or peripheral arterial disease) between 1-Jan-2017 and 31-Dec-2018 were included. The resources use within two years of the diagnosis was estimated in order to estimate the average cost of patient follow-up. A total of 26,976 patients with an ASCVD episode were identified during the recruitment period; Out of them, 6,798 had a recurrent event during the follow-up period and 2,414 died. The average costs per patient were €11,171 during the first year and €9,944 during the second year. Patients with ASCVD represent a significant economic burden for the health system and for society. Despite the perception that drug costs in the follow-up of chronic patients imply a high percentage of the costs, these accounted for only one tenth of the total amount. Implementing preventive programs and increasing the control of cardiovascular risk factors may have a significant social and health impact by helping to reduce mortality and costs for the Spanish National Health System. The costs derived from pharmacological treatments were obtained from the NHS pricing nomenclator database (https://www.sanidad.gob.es/profesionales/nomenclator.do).

[Pay for performance in public directly managed healthcare centers. Part 2: The Spanish National Health System. SESPAS Report 2024].

In Spain, the compensation model for statutory health personnel is complex, heterogeneous, and more oriented to rewarding complementary functions and activities, than to paying for the actual performance in the position of employee. The various attempts to incorporate incentives have been distorted by a civil service egalitarianist culture, and weak systemic governance. External attractors (private practice, etc.) for healthcare professionals are becoming more important and neutralize many intramural incentives. There are few prospects of relevant or general changes, since the main actors involved are reforms-averse; but some environmental factors can lead to incremental improvements in employment contracts, in the information available to improve benchmarking, and in the creation of islands of good clinical governance and management. The economic scenario, increasingly concerned about inflationary trends and sustainability risks, may have a revitalizing effect of some governance and management reforms.

Regional differences in infective endocarditis epidemiology and outcomes in Spain. A contemporary population-based study

Introduction and objectivesOur aim was to describe the contemporary epidemiological profile of infective endocarditis (IE) in Spain, and to evaluate variations in IE incidence, characteristics, and outcomes among the different Spanish regions (autonomous communities [AC]). MethodsWe conducted a retrospective, population-based study, using data obtained from national in-patient hospital activity of all patients discharged with a diagnosis of IE from hospitals included in the Spanish National Health System, from January 2016 to December 2019. Differences in the IE profile between the 17 Spanish AC were analyzed. ResultsA total of 9008 hospitalization episodes were identified during the study period. Standardized incidence of IE was 5.77 (95%CI, 5.12-6.41) cases per 100 000 population. Regarding predisposing conditions, 26.8% of episodes occurred in prosthetic valve carriers, 36.8% had some kind of valve heart disease, and 10.6% had a cardiac implantable electronic device. Significant differences were found between AC in terms of incidence, predisposing conditions, and microbiological profile. Cardiac surgery was performed in 19.3% of episodes in the total cohort, and in 33.4% of the episodes treated in high-volume referral centers, with wide variations among AC. Overall in-hospital mortality was 27.2%. Risk-adjusted mortality rates also varied significantly among regions. ConclusionsWe found wide heterogeneity among Spanish AC in terms of incidence rates and the clinical and microbiological characteristics of IE episodes. The proportion of patients undergoing surgery was low and in-hospital mortality rates were high, with wide differences among regions. The development of regional networks with referral centers for IE could facilitate early surgery and improve outcomes.

Cost-Effectiveness Analysis of Abrocitinib Compared with Other Systemic Treatments for Severe Atopic Dermatitis in Spain.

Atopic dermatitis (AD) is a chronic, inflammatory skin disease characterized by itchy, painful, and dry skin. Despite the great number of available therapies, economic evaluations are still needed to provide evidence on their cost efficiency. This research aimed to evaluate the cost effectiveness of the Janus kinase (JAK) inhibitor abrocitinib (200mg) compared with dupilumab (300mg), tralokinumab (300mg), baricitinib (2 and 4mg), and upadacitinib (15 and 30mg) for the treatment of patients with severe AD from the Spanish National Health System (NHS) perspective. A hybrid model consisting of a decision tree linked to a Markov model was developed to estimate costs, quality-adjusted life-years (QALYs), total years in response and incremental cost-per-QALY gained (willingness-to-pay [WTP] threshold: €25,000/QALY). Adults with severe AD entered the decision tree and response (75% reduction in baseline Eczema Area and Severity Index score, EASI-75) was considered at 16 and 52 weeks. After this time, patients entered the Markov model (remainder of the 10-year time horizon), which consisted of three health states: maintenance with active therapy, subsequent treatment, or death. All costs were presented in 2022 euros (€). Additionally, cost per number-needed-to-treat (NNT) was calculated for abrocitinib and dupilumab based on a head-to-head post-hoc analysis. Abrocitinib 200mg was dominant (i.e., lower incremental costs and higher incremental benefit) compared with all studied alternatives (dupilumab 300mg, tralokinumab 300mg, baricitinib 2 and 4mg, upadacitinib 15 and 30mg) with a QALYs gain of 0.49, 0.60, 0.64, 0.43, 0.45, and 0.08, respectively, and per-person costs savings of €22,097, €24,140, €14,825, €7,116, €12,805, and €45,189, respectively. Considering the WTP threshold, abrocitinib was dominant or cost effective compared with all alternatives for most simulations. Additionally, abrocitinib was dominant compared with all alternatives when evaluating the cost effectiveness over a 5-year time horizon. NNT showed that abrocitinib was dominant versus dupilumab. The results of the study show that abrocitinib is a cost-effective therapy compared with other JAK inhibitors and biological therapies from the Spanish NHS perspective.

Analysis of the circumstances associated with death and predictors of mortality in Spanish adults with Down syndrome, 1997-2014.

Characterise the circumstances associated with death during admission of adults with Down syndrome (DS) and to identify predictors of mortality. Observational study based on data on all emergent admissions of adults with DS to hospitals of the Spanish National Health System between 1997 and 2014. We analysed epidemiological and clinical variables. We analysed admissions of 11,594 adults with DS, mean age 47 years. 1715 patients died (15%), being the highest mortality (35%) in individuals aged 50-59. A past medical history of cerebrovascular disease (aOR 2.95 [2.30-3.77]) or cancer (aOR 2.79 [2.07-3.75]), gross aspiration's admission (aOR 2.59 [2.20-3.04]), immobility (aOR 2.31 [1.46-3-62]), and readmission within 30 days (aOR 2.43 [2.06-2.86]) were identified as predictors of mortality. Adults with DS have a high in-hospital mortality rate. The main predictors of death were cerebrovascular disease, cancer, early readmission, and conditions commonly associated with advanced dementia.

Ingresos en fines de semana y festivos por insuficiencia cardiaca descompensada y mortalidad intrahospitalaria. ¿Un efecto acumulativo de los «días no laborables»?

Introduction and objectivesThe aim of this study was to analyze whether nonelective admissions in patients with heart failure (HF) on nonworking days (NWD) are associated with higher in-hospital mortality. MethodsWe conducted a retrospective (2018-2019) observational study of episodes of nonelective admissions in patients aged 18 years and older discharged with a principal diagnosis of HF in acute general hospitals of the Spanish National Health System. NWD at admission were defined as Fridays after 14:00hours, Saturdays, Sundays, and national and regional holidays. In-hospital mortality was analyzed with logistic regression models. The length of NWD was considered as an independent continuous variable. Propensity score matching was used as a sensitivity analysis. ResultsWe selected 235 281 episodes of nonelective HF admissions. When the NWD periods were included in the in-hospital mortality model, the increases in in-hospital mortality compared with weekday admission were as follows: 1 NWD day (OR, 1.11; 95%CI, 1.07-1.16); 2 days (OR, 1.13; 95%CI, 1.09-1.17); 3 (OR, 1.16; 95%CI, 1.05-1.27); and ≥4 days (OR, 1.20; 95%CI, 1.09-1.32). There was a statistically significant association between a linear increase in NWD and higher risk-adjusted in-hospital mortality (chi-square trend P=.0002). After propensity score matching, patients with HF admitted on NWD had higher in-hospital mortality than those admitted on weekdays (OR, 1.11; average treatment effect, 12.2% vs 11.1%; P<.001). ConclusionsWe found an association between admissions for decompensated HF on an NWD and higher in-hospital mortality. The excess mortality is likely not explained by differences in severity. In this study, the “weekend effect” tended to increase as the NWD period became longer.Full English text available from:www.revespcardiol.org/en

Does Sex Matter to the Biomedical Approach in Clinical Practice Guidelines (CPGs)?: A Systematic Review of Methodology Documents Used in the Spanish National Health System.

Sex and gender are important variables in health, although their incorporation in medicine has been very slow. If research is sensitive and yields fruitful sex and gender evidence, these results should be included in the guidelines for clinical practices. However, literature claims that clinical practice guidelines devote very little space to these categories. The present systematic review addresses the relevance of sex and gender dimensions through methodology documents for the development of clinical practice guidelines based on three sources: the AGREE Reporting Checklist, the GRADE Handbook, and the Spanish GuíaSalud NHS Clinical Guideline Program. Findings suggest that neglecting sex and gender issues in the biomedical approach may lead to continuing to ignore relevant evidence on biological and social dimensions that do indeed influence people's health and diseases.

Cost-effectiveness of olaparib plus bevacizumab versus bevacizumab monotherapy in the maintenance of patients with homologous recombination deficiency-positive advanced ovarian cancer after response to first-line platinum-based chemotherapy

ObjectiveThe PAOLA-1 trial confirmed that adding olaparib to bevacizumab significantly increased clinical benefit following response to platinum-based chemotherapy in homologous recombination deficiency-positive ovarian cancer. The objective of this analysis was...

[Translated article] Cost of Treating Cutaneous T-Cell Lymphoma in Spain: Analysis of MICADOS Study Data by Disease Stage

Background and objectiveThe cost of treating cutaneous T-cell lymphoma (CTCL) in Spain is unknown. With the advent of new treatments, it is more important than ever to gain an accurate picture of the true costs involved. The MICADOS study had 2 primary objectives: 1)to evaluate the impact of CTCL on patient quality of life, and 2)to evaluate the costs associated with the disease. This article reports the results of the cost analysis. MethodsWe estimated the cost of treating CTCL over a period of 1year from the perspective of the Spanish National Health System. Twenty-three dermatologists and hematologists from 15 public hospitals analyzed data for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS). ResultsA total of 141 patients (57.4% male) with a mean age of 63.6 years (95%CI: 61.4-65.7 years) were included. The mean direct annual cost of treating CTCL was €34,214 per patient. The corresponding costs by stage were €11,952.47 for stageI disease, €23,506.21 for stageII disease, €38,771.81 for stageIII disease, and €72,748.84 for stageIV disease. The total direct annual cost of treating MF/SS in public hospitals in Spain was estimated at €78,301,171; stageI disease accounted for 81% of all costs, stageII for 7%, and stagesIII andIV for 6% each. ConclusionsThe MICADOS study offers an accurate picture of the direct cost of treating CTCL in patients with MF/SS in Spain and shows that costs vary significantly according to disease stage. Patient-borne and indirect costs should be analyzed in future studies.

OP149 How To Improve The Impact Of Health Technology Assessment: Stakeholders’ Perspectives In Spain

IntroductionHealth technology assessment (HTA) agencies in Spain have an important role in informing decisions about the introduction and use of health technologies in the Spanish National Health System. However, although different approaches have been taken to measure and improve their impact, no study to date has explored the perceived impact of HTA products at the national level. The aim of this study was to explore the perspectives of macro-, meso-, and micro-level decision makers on how to improve the impact of HTA.MethodsThree online focus groups were conducted with policy makers, healthcare managers, clinicians, and patients. The transcripts were evaluated using a deductive thematic analysis based on a multidimensional framework to explore mechanisms of impact.ResultsFour key themes were identified:(i)Timeliness and use of HTA assessments: Although the quality of the reports was recognized, the time taken for the elaboration and extension of reports negatively affected their use. Participants considered that reports should be tailored to the needs of end users (e.g., briefer versions available for meso-and micro-level use);(ii)Effective engagement and external communications: The engagement of multiple stakeholders (policy makers, manufacturers, clinicians, and patients) in the elaboration process was considered crucial to improve HTA impact and ensure adequate communication of results;(iii)Good institutional reputation and fit within the healthcare and policy making system: Stakeholders agreed on the need to strengthen collaboration at the national level and increase public understanding of the value of HTA and its use in healthcare decision-making; and(iv)Effective implementation of policy change regarding health technologies: Stakeholders were very receptive to the results and recommendations of HTA reports when new technologies are demanded, but the identification and selection process should be improved to guarantee that these reports are available on time.ConclusionsThis study has identified different proposals and mechanisms that could improve the impact of HTA in Spain.

PP38 Immersion in water during childbirth: A survey to the Spanish National Health System

IntroductionCertain doubts about immersion in water during birth mainly regarding the safety of the infant, warrant analysis of the data to determine whether immersion in water during childbirth is safe and effective. The aim is to describe the situation regarding the use of water immersion during childbirth in hospitals of the Spanish National Health System across Spanish Autonomous Regions and Cities.MethodsA questionnaire was developed to assess the use of water immersion on maternity wards of National Health System hospitals. The survey was reviewed by several categories of health professionals and stakeholders. The online questionnaire was distributed via email. A database was created using the Microsoft Excel 365® computer program. Quantitative results were described through percentages and frequency distributions. In the case of free responses, a content analysis was performed, coding the responses into different categories.ResultsRegarding the status of water birth in Spain, the availability of the option of water birth varies across hospitals of the National Health System. Forty-six hospitals in 13 autonomous regions indicated that they had birthing pools on their delivery wards. Among these hospitals, 20 percent reported having more than 10 years of experience in water births, 45 percent between five and 10 years and 35 percent less than five years. Of the 46 responses received, 78 percent of the hospitals indicated that there was a demand for information on waterbirth by pregnant women. Regarding the existence of criteria for the adequate selection of pregnant women who could opt for immersion in water during childbirth, 89 percent of the hospitals indicated that these did exist, while 11 percent indicated that they did not have agreed criteria for the selection of candidates for water birth.ConclusionsThe availability of the option of water birth varies in hospitals across the Spanish National System. All the hospitals that have birthing pools offer them in the first stage of labor (dilation), while 32 percent also use them in the pushing stage and 15 percent during delivery of the placenta. It would be advisable to have standardized protocols and training to ensure the possibility that all pregnant women, regardless of their place of residence, can safely opt for water immersion during childbirth with satisfactory results.

EE394 Understanding Reasons of Negative Reimbursement Decisions for Orphan Drugs in the Spanish National Health System (APRIL 2019-MAY 2023)

EE394 Understanding Reasons of Negative Reimbursement Decisions for Orphan Drugs in the Spanish National Health System (APRIL 2019-MAY 2023)