A model for the clinical management of the introduction of new medicines in a large University Hospital in Spain

ABSTRACT

Background

New medicines offer therapeutic opportunities but also challenge healthcare system organisation and sustainability. This study aims to describe a model based on regular multidisciplinary meetings to manage and monitor the introduction of new medicines for Hospital Outpatient Treatments (HOT) in a Spanish tertiary hospital, and the observed results after its implementation.

Methods

Meetings held during 2016–2023 and related documents were retrospectively reviewed. The meeting agenda and minutes included information on new drugs, follow-up of compliance with data collection in the Register of Patients and Treatments, drug expenditure, number of treated patients, quality/efficiency indicators, and agreements. An observational, descriptive study with a mixed approach (quantitative analysis of expenditure and activity data and qualitative documentary analysis) was performed. Percentage changes are expressed as relative changes.

Results

During this period, 242 meetings with 12 selected clinical departments/units were held. A total of 284 agreements were reached, most of them related to the need to improve registry data (37.7%), and promoting the use of generic/biosimilar drugs (18.3%). A 40.2% increase in HOT expenditure, a 55.4% increase in the number of treated patients, and a 9.7% decrease in the cost per patient were documented in these departments from 2016 to 2023. The greatest HOT expenditure was observed in Haematology and Oncology (reaching around 39 and 28 million euros annually in 2023, respectively). The most marked increases occurred in Pneumology and Allergology. The use of generic/biosimilar drugs in Infectious diseases and Rheumatology departments had a more noticeable impact, with decreases in HOT expenditure of 15.8% and 6.6%, respectively. While caution is needed when interpreting the data, a lower increase in HOT expenditure was observed in the departments/units in which meetings were held.

Conclusion

Having a consolidated method for the introduction and monitoring of new medications helps to set up an organised and reasoned decision-making process.

Background

The introduction of new medicines into clinical practice can be good news but it also may constitute a challenge for the health care systems. Some new medicines have been shown to be very effective in treating diseases like hepatitis C, whereas others, including some drugs for cancer or orphan diseases, reveal limited health gain according to evidence based on their effects on surrogate outcomes (Godman et al., 2015). Regulators have organised specific processes to accelerate the approval of innovative medicines: the Food and Drug Administration (FDA) proposes ‘Accelerated Approval Pathways' and the European Medicines Agency (EMA) the ‘Accelerated Adaptive Pathways to Patients' (Scavone et al., 2019). However, there are considerable concerns in this regard and the concept of ‘innovative medicines’ is a source of scientific controversy (Godman et al., 2021). High prices of new drugs add complexity to the scientific and clinical challenge to guarantee access to new medicines with, sometimes, questionable therapeutic value, in health care systems facing ever-growing unmet need and changing demographics, and may represent a threat to the sustainability of health care systems.

Vall d’Hebron University Hospital (VHUH) in Barcelona, Spain, is a 1,100-bed hospital with almost all medical and surgical specialties (Vall d’Hebron Barcelona Hospital Campus, 2025). It is a public hospital belonging to the Catalan Institute of Health, and the largest hospital complex in Catalonia. Expenditure on medications at the VHUH is mainly due to Hospital Outpatient Treatments (HOT), and represented 42.6% of the budget in assets and services in 2022. In our country, the majority of medicines prescribed for the treatment of cancer, multiple sclerosis, HIV, rheumatoid arthritis, cystic fibrosis, among other severe conditions, must be dispensed from hospital pharmacy departments and are referred to as HOT. Some of these medicines are administered at day hospital facilities.

In Spain, public hospitals operate within a tax-funded, decentralised National Health System, where healthcare governance and budgeting responsibilities are transferred to the regional governments. Hospitals are mainly financed through global annual budgets, with limited linkage to activity or outcomes, and hospital medicines are funded directly from these budgets (Bernal-Delgado et al., 2024). The increasing impact of high-cost innovative medicines has led to the development of local governance mechanisms and efficiency-oriented strategies to control pharmaceutical expenditure while ensuring patient access. The members of the Drug and Therapeutics Committee (DTC) of our hospital identified the need to set up a model for a fair decision-making process to support the introduction of effective, safe new medicines, balancing rising costs and limited budget. Since pre-launch and peri-launch activities are beyond the DTC’s possibilities, efforts have been concentrated in post-launch activities to face the challenge of new expensive medicines. A model was set up in late 2015, with the support of hospital managers. It is based on collaboration between different professional profiles sharing clinical, scientific and economic information. The main goal of our model is to facilitate access to new, safe, effective medicines for patients treated at VHUH, assuming that the budget is limited. This model takes advantage of two existing factors in our milieu. The first is the Register of Patients and Treatments (RPT), a compulsory register set up for HOT by the Catalan Health Service (CHS), which gathers information both on new expensive medicines and on patients’ characteristics and health outcomes (Roig Izquierdo et al., 2020). The second is the legal obligation to register and supervise the use of medicines in special circumstances such as off-label prescription in hospitals in our country (CatSalut, 2010; Royal Decree, 1015/2009). The DTC of our hospital hosts the model. In Catalonia, a number of HOT selected by the CHS are subjected to a harmonisation programme that defines their prescribing conditions (CatSalut, 2017). Such HOT are not refunded if hospitals have not previously registered their treated patients in the RPT; since 2014, it is the compulsory register for patients treated with selected HOT.

Two working groups were organised in the frame of our DTC in order to set up our model: the Hospital Outpatient Treatments Committee (HOTC) and the Committee for the Evaluation of Treatments under Special Use Situations (CETSUS). In the CETSUS, requests for special medications are evaluated for specific patients (off-label use, compassionate use or medications not included in the hospital formulary, mainly due to pending financial decisions). Part of the activity of CETSUS has already been described (Danés, Agustí, et al., 2014; Danés, Alerany, et al., 2014; Sans-Pola et al., 2023). The current study aims to describe our model for the clinical management of new medicines at VHUH with the attention focused on the activity developed by the HOTC.

Methods

HOTC’s responsibility is the clinical management of HOT at VHUH. Members of HOTC include prescribing physicians from the different hospital departments or units using HOT, clinical pharmacologists, pharmacists, and hospital managers. Meetings with 12 selected clinical departments/units are organised on a regular basis, and are arranged by the Medical Direction. Each single clinical department meets with the HOTC about three times a year. These departments were selected because they generated the most spending on this type of medication when the meetings began. The fixed agenda of the meetings includes:

1. Information on recently approved drugs of special interest for that department/unit (including scientific information, price and financing conditions set by the Ministry of Health and conditions for their use proposed by the CHS harmonisation programme, if already available) and on drugs in advanced stages of investigation and not yet launched into the market.

2. Review of potential new clinical guidelines, recommendations for use and reference protocols.

3. Monitoring compliance with data registration in the RPT, including health outcomes and possible incidents.

4. Follow-up of drug expenditure and of the number of treated patients and its comparison with the same period of the previous year.

5. Follow-up of quality/efficiency indicators, if available.

6. Agreements.

All activities began at the same time, except for the quality/efficiency indicators, which were included in 2017 by the CHS and are updated/modified every year. Before each meeting, a document containing information on recently approved medications of special interest to that department/unit is emailed to all members. It includes information about their current approval, funding status, and links to information of interest, such as publications of clinical trials. Details on new drugs or new indications under evaluation by the EMA and investigational therapies are also included. An additional document on the HOT expenditure is also sent to all convened members. It includes the accumulated expenditure up to that point compared to the same period of the previous year, the number of patients treated and the expenditure per patient for that department. Details of the drugs with the greatest budgetary impact and the most notable changes compared to the same period of the previous year are also detailed. These documents are provided by Clinical Pharmacology and Pharmacy Departments, respectively. After each meeting, a minute is drawn up.

For this study, a descriptive analysis of meetings held between 2016 and 2023, the number and type of agreements that were reached, the evolution of expenditure on medications in HOT in the VHUH by department, and the evolution of quality/efficiency indicators was carried out. The minutes of the meetings and the annual reports of HOT expenditure at the VHUH were used as sources of information. A mixed approach analysis (quantitative analysis of expenditure and activity data and qualitative documentary analysis) was performed. The analysis of medication expenditure is based on data obtained from the pharmacy management system, using patient-level dispensing records as the primary data source. Expenditure is calculated at the hospital acquisition price. Risk sharing agreements are reflected in the analysis when discounts are applied directly to the purchase invoice; however, discounts granted through rebates independent of the purchase process are not captured in these data. The percentage changes in expenditure, number of patients treated, and cost per patient over time are provided in relative terms. The quality indicators and biosimilars use indicators detailed in the minutes are provided by the Pharmacy Department using information from CHS communications, while expenditure or consumption indicators are calculated from the pharmacy management system.

The agreements were initially recorded in uncategorised minutes, and the categories were defined later. Categories were developed inductively based on conceptually related themes rather than according to a predefined classification system. One researcher (ID) classified the agreements, a second researcher (EB) reviewed the classification, and a third researcher (AA) resolved any disagreements.

Statistical analysis of categorical and continuous variables was made by means of the distribution of frequencies, proportions, median and interquartile range (IQR). The statistical analysis was performed using IBM SPSS Statistics version 18 statistical package (IBM Corp., NY, USA).

Results

Meetings and agreements

Between 2016 and 2023, a total of 267 meetings were organised with the 12 clinical departments/units that generated the most relevant expenditure in HOT at the VHUH at the beginning of this period. Ninety per cent of the meetings (242) were held (Table 1), with a median of 32 meetings per year (IQR 8.5), and 20.5 (IQR 4) per department/unit. The reasons for cancellation were last-minute unforeseen events. The frequency of the meetings decreased in some departments (only two meetings per year began to be convened with the Hepatology Unit, since the majority of patients with chronic hepatitis C had already been treated). On the other hand, in 2021, meetings with the Neurology Department began when treatments with antagonists of peptides related to the calcitonin gene were initiated, but these meetings were not included in this analysis due to the much shorter follow-up period, with most of the study period being outside the dynamic of the meetings.

Table 1.

Number of meetings organised and held per clinical department/unit.

	Period 2016–2023
Clinical department/unit	Organised/Held
Allergology	22/21
Clinical neuroimmunology	25/24
Dermatologya	15/15
Gastroenterology	24/23
Haematology	23/22
Hepatology	20/17
Infectious diseases	23/19
Internal medicine	20/18
Medical oncology	24/22
Paediatric pneumology and allergology	24/22
Pneumology	23/20
Rheumatology	24/19
Total	267/242 (90.6%)

^aThe Dermatology Department was included in the regular meetings in 2017.

During the meetings, different types of agreements were reached after reviewing the information provided to all attendees, which has been detailed in the methodology. As shown in Table 2, most of the agreements (37.7%) were related to the need to improve registry data in the RPT. Some of them related to compliance with the inclusion of data in the registry, since the possibility of it being up to date varies (depending on the periodicity of the data required, the type of data and the number of patients treated) and, on other occasions, to the need to redress detected system errors. Other types of agreements were related to the promotion of the use of new generic or biosimilar drugs (18.3%). It was frequently agreed to propose actions related to clinical considerations to improve efficiency, in addition to promoting the use of biosimilar or generic medicines. For instance, we implemented the analysis of tumour necrosis factor-alpha (TNF) inhibitor and TNF-inhibitor antibody concentrations in unresponsive patients before increasing the dose or switching to another drug in patients with inflammatory bowel diseases. Other examples were changes in dosage guidelines (longer interval between doses or lower doses of some medications, if the published evidence and the disease supported this modification), or selecting the most efficient treatment among those available, especially in the first line of treatment with biological medicines or drugs for hepatitis C.

Table 2.

Number and type of agreements reached during the meetings.

	n	%
Improve registry information	107	37.7
Actions to enhance the use of biosimilar or generic drugs	52	18.3
Identify specific actions to improve efficiency (other than the use of biosimilar or generic medicines)	24	8.5
Price update/financing agreements	23	8.1
Evaluate the degree of compliance with the recommendations of the Health System for certain drugs and/or their effectiveness	22	7.7
Review of achievement of indicators/objectives, or definition of new indicators	22	7.7
Review the drug status in the health system/drug availability in the hospital	19	6.7
Search for published information on a specific topic	7	2.5
Others	8	2.8
Total	284	100

Drug expenditure and number of treated patients

The drug expenditure on HOT, the number of treated patients, the cost per patient, and their evolution during the study period per department/unit where meetings were held are represented in Table 3, and in Figures 1–3. The overall drug expenditure on HOT per year of all the VHUH clinical departments increased from 131,327,947 euros in 2016 (this figure refers to the total expense of all hospital departments) to 202,584,714 euros in 2023 (54.3% relative increase). The overall number of treated patients with HOT at the VHUH also increased, from 19,570 in 2016 to 34,258 in 2023 (75.1% increase), and the cost per patient decreased from 6,710.7 euros in 2016 to 5,913.5 euros in 2023 (−11.9%). The expenditure on HOT regarding only the departments where meetings were held increased from 109,417,804 euros in 2016 to 153,447,229 euros in 2023 (40.2% increase), and the number of treated patients from 11,518 to 17,897 (55.4% increase). The cost per patient decreased from 9,500 euros in 2016 to 8,574 euros in 2023 (−9.7%). Patients treated in these clinical departments/units represented 58.9% and 52.2% of the total patients treated with HOT at VHUH in 2016 and 2023, respectively, and expenditure accounted for 83.3% and 75.7% of total HOT expenditure, respectively. In the departments where meetings were not held, 124.3% and 103.2% increases in expenditure on HOT and in the number of treated patients from 2016 to 2023 were observed, and the cost per patient increased from 2,721 euros to 3,003 euros (10.4%). Of these other departments, Neurology, Nephrology, and Endocrinology, both for adults and children, Paediatric Oncohaematology and Ophthalmology (adults) had the greatest economic impact. The same trend was observed after excluding Neurology Department data (2016–2023: +109% HOT expenditure, +95% treated patients, +7.3% cost per patient).

Table 3.

Total drug expenditure (euros), number of treated patients, and cost per patient per clinical department/unit where meetings were held in 2016 and 2023, and percentage of variation.

Clinical department/unit	Expenditure (euros)			Number of treated patients			Cost per patient (euros)
	2016	2023	% of change in 2023 vs. 2016	2016	2023	% of change in 2023 vs. 2016	2016	2023	% of change in 2023 vs. 2016
Allergology	1,316,562	3,883,916	+195.0	158	395	+150.0	8,333	9,833	+18.0
Clinical neuroimmunology	12,543,977	13,934,932	+11.1	1,269	2,007	+58.2	9,885	6,943	−29.8
Dermatology	1,661,682	3,171,428	+90.9	175	612	+249.7	9,495	5,182	−45.4
Gastroenterology	4,704,926	6,914,060	+47.0	530	997	+88.1	8,877	6,935	−21.9
Haematology	23,086,054	39,579,376	+71.4	1,145	1,701	+48.6	20,162	23,268	+15.4
Hepatology	16,178,012	1,928,533	−88.1	911	767	−15.8	17,759	2,514	−85.8
Infectious diseases	14,350,527	12,076,137	−15.8	2,188	3,167	+44.7	6,559	3,813	−41.9
Internal Medicine	4,167,446	6,204,607	+48.9	331	763	+130.5	12,590	8,132	−35.4
Medical oncology	14,354,197	28,355,117	+97.5	2,613	3,573	+36.7	5,493	7,936	+44.5
Paediatric pneumology and allergology	3,118,461	15,732,597	+404.5	464	631	+36.0	6,721	24,933	+271.0
Pneumology	5,852,145	14,119,053	+141.3	726	1,169	+61.0	8,061	12,078	+49.8
Rheumatology	8,083,815	7,547,473	−6.6	1,008	2,115	+109.8	8,020	3,569	−55.5
Total	109,417,804	153,447,229	+40.2	11,518	17,897	+55.4	9,500	8,574	−9.7%

Figure 1.

Evolution of expenditure (euros) in HOT per year and clinical department/unit.

Figure 2.

Evolution of number of treated patients with HOT per year and clinical department/unit.

Figure 3.

Evolution of cost (euros) per patient treated with HOT per year and clinical department/unit.

The clinical departments that generated the highest HOT expenditure were Haematology and Medical oncology, and the most marked increases occurred in Pneumology and Allergology, both for adults and paediatrics (Table 3 and Figure 1). The number of treated patients increased in all the departments, except in Hepatology, during the study period (Table 3 and Figure 2). The cost per patient was especially high in Haematology, where treatments for haematological malignancies and new treatments for haemophilia are included, and, more recently, in Paediatric pneumology and allergology, where new therapies for cystic fibrosis were incorporated (Table 3 and Figure 3).

In other departments, a decrease in HOT expenditure was observed. At the beginning of the study, many patients with chronic hepatitis C virus infection were being treated in the Hepatology Unit, and since it is not a chronic treatment, a decrease in patients and costs was observed throughout this period, when most of the patients had already been treated. In departments such as Infectious diseases or Rheumatology, the effort made to substitute treatments with generics or biosimilars, when available, and to use the most efficient drugs (always taking into account the best treatment available for each patient) translated into an impact on expenditure. Although no decrease in HOT expenditure was observed during the study, this same policy had some impact on units or departments such as Clinical neuroimmunology, Dermatology, Gastroenterology, and Internal medicine, where a decrease in the cost per patient was observed. Biosimilar drugs have been progressively introduced in VHUH (Figure 4).

Figure 4.

Evolution of number of patients treated with biosimiliar drugs in the studied department/unit.

Quality/efficiency

During the study period, indicators were progressively established by the CHS to evaluate both the quality and efficiency of the consumption of HOT. Some indicators referred to the prescription percentage of specific biosimilars. Other indicators assessed the degree of agreement with CHS recommendations for first or second line treatments in specific diseases (non-small cell lung cancer or colorectal cancer), and others analysed health outcomes in specific diseases (i.e. proportion of patients with undetectable viral load with antiretroviral treatment for HIV, or with a sustained virological response with direct antiviral treatments for chronic hepatitis C, or with clinical response to selective immunosuppressants for moderately active rheumatoid arthritis). The status of the indicators was reviewed at least twice a year. The number of indicators, available since 2017, increased over the years and ranged from 7 in 2017 to 14 per year in 2022 and 2023. The level required to consider that indicators were reached also increased over the years, and the degree of achievement varied from 50% to 100%, depending on the year. A trend to an increase in the degree of achievement was observed between 2019 and 2022. Having information on the status of the indicators allowed us to intensify efforts in aspects where there was room for improvement.

The appropriateness of the use of HOT or their effectiveness was assessed as part of an agreement. Allergology and Gastroenterology were the departments most frequently involved in actions related to patient follow-up. Analysis of the doses of C1 esterase inhibitors used in prophylaxis, the use of mepolizumab in asthma, and of omalizumab for desensitisation in food-allergy were agreed with the Allergology department. The outcomes of the application of a protocol for detecting anti-TNF and antibody levels to differentiate lack of efficacy from insufficient dosage, and the assessment of the use and effectiveness of vedolizumab and golimumab in inflammatory bowel diseases were carried out by the Gastroenterology department.

Discussion

The activity started by the HOTC in 2016 at the VHUH has been maintained and consolidated so far. Meetings with 12 clinical departments or units, in which different documents and information were addressed in an orderly manner, were organised. A median of 20.5 meetings per clinical department/unit were held between 2016 and 2023. Agreements were reached primarily on the need to improve some data in the HOT registry, and on actions to promote the use of biosimilar medications. An increase in HOT expenditure (40.2%) and in the number of treated patients (55.4%) in these clinical departments/units was observed during this period, as well as a decrease in cost per patient (−9.7%). Notable differences regarding these parameters between clinical departments/units were documented. No other studies describing this kind of activity and reporting similar data have been published.

It is known that most of the recently marketed drugs with a high budgetary impact are prescribed to treat patients with solid or haematological tumours to an increasing large number of patients. This trend was observed in our hospital in Haematology and Medical oncology departments, despite efforts to replace medications with generics or biosimilars when they were available and to include patients in clinical trials when possible. The increased expenditure on cancer medicines is also due to higher prices for new cancer medicines, rising by up to 10-fold during the last decade (Godman et al., 2021). Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications have been discussed, but most of the proposed actions fall outside the scope of a hospital centre. Moreover, the added clinical benefit of some drugs, particularly those approved through conditional marketing authorisations, may not be related to their high cost (Brinkhuis et al., 2024).

The critical increases in expenditure observed in the Pneumology and Allergology departments are explained by several facts. New biological drugs were marketed for the treatment of patients with severe asthma, which have been added to the usual treatment, and new cystic fibrosis transmembrane conductance regulator modulator therapies were marketed and caused, especially in paediatrics, two noticeable increases, in 2020 and 2022. On the other hand, no biosimilar drugs were still available for use by these clinical departments. Also, other conditions treated by the Allergology department have contributed to the expenditure and number of treated patients increase, such as new treatments for chronic urticaria, hereditary angioedema, or the use of omalizumab to decrease the incidence of adverse effects during the desensitisation process (off-label use).

In the 2016–2023 period, the overall HOT expenditure per year increased more in the whole VHUH and in the whole CHS (54.3% and 73.8% respectively) than in the selected clinical departments where meetings were scheduled (40.2%) (Health, Quality and Assessment Agency of Catalonia, 2025). The same trend was observed in the number of treated patients (relative increase of 75.1%, 78.2% vs 55.4%, respectively). The observed trend in expenditure and cost per patient can be associated with other factors than the meetings. It seems difficult to schedule when a new medicine to treat patients can start to be prescribed in a particular clinical department or unit, especially when it is already financed by the National Health Service and has shown to provide a relevant clinical benefit. However, its introduction can be anticipated, clinical and budgetary impact can be predicted and its use and clinical outcomes can be followed up. Moreover, the rest of HOT drugs prescribed by a specific clinical department can be optimised. Such a clinical management of the introduction of new HOT medicines with a multidisciplinary approach is within the reach of hospital centres and is the purpose of our model. Its impact is, nevertheless, difficult to be measured with observational data, since there are many factors that influence the evolution of the market and the use of medications in different clinical departments.

A document with information on recently approved drugs of special interest for that department was sent to all the members before every meeting. This document aims to promote awareness and discussion about the clinical relevance of these particular drugs, their degree of clinical innovation, and to share information on their availability at that time. Drugs and indications approved by the EMA have to be financed by our National Health System before they can be prescribed in the public system. Sometimes additional requirements are established for their use, either by the Ministry of Health or by the CHS, in order to reimburse their cost to the hospital where they are prescribed. So, although exceptions for specific patients may be made by the other committee (CETSUS), we advise physicians not to prescribe these drugs and wait until the entire financing and positioning process has been completed as a general rule.

Several approaches have been proposed for different levels in health care systems to introduce new expensive medicines while taking care of sustainability. They are based on three main pillars: pre-launch, peri-launch and post-launch activities (Godman et al., 2015, 2018). Horizon scanning and budgetary planning are pre-launch activities, while the assessment of the value and role of new medicines using robust methodologies as well as appraising Management Entry Agreements (MEA) are peri-launch activities (Godman et al., 2018). Post-launch activities include the evaluation of the effectiveness and safety of new medicines in routine clinical practice using registries or Electronic Health Records, evaluating ongoing MEAs, assessing prescribing against agreed guidelines, recommendations or quality indicators, developing educational activities in collaboration with DTC and additional demand-side measures if needed. Our model is based on the implementation of post-launch activities (Gasol et al., 2022; Godman et al., 2015, 2018). Although a forecast is made before the drugs are marketed, it is not broad, complete, or robust enough to be considered a horizon scanning activity. As a post-launch activity, the aim of our model is to provide treatments with added value to patients while ensuring public health care sustainability.

We have started to evaluate HOT drug effectiveness prescribed at VHUH. A considerable effort is being made to increase this activity in the future by extending clinical outcomes follow-up as part of the routine work of HOTC. In addition to the analyses reported in the results section, the use in clinical practice of antifibrotics for lung diseases, immunoglobulins and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors has been studied to assess the characteristics of the treated patients and health outcomes. In order to retrieve reliable clinical information, we have used both RPT and patient’s electronic clinical records. The actions carried out to improve the quality of RPT data should be useful in obtaining health results more easily. A robust HOT registry with reliable data is a cornerstone for our model. It is not only needed for reimbursement purposes but also to enable monitoring of patients’ health outcomes. Clinical outcomes evaluation is expected to become essential in our model. We plan to include data on effectiveness as a fixed point on the agenda of the HOTC meetings.

This study has some limitations. Firstly, it is an observational study with a retrospective analysis and without a control group; thus, the interpretation of some results might be subject to bias. In addition, it has been carried out in a single centre and therefore the activity and results observed should be extrapolated carefully to other centres. Variability in the dynamics and impact of the meetings cannot also be ruled out, not only because they are carried out with departments that deal with different types of pathologies but also due to interpersonal variability between people attending the meetings. The main strength of our study is that it describes how an organised method to introduce and to follow up new medicines and treated patients has been established, and has been maintained so far since 2016. This model has been accepted by the different clinical departments as a routine activity and has involved the physicians in clinical management actions. We have built a framework to deal with certain controversial issues related to HOT medications that favours and promotes the exchange of opinions and the reaching of agreements. No other similar experiences regarding third-level hospitals with all medical and surgical specialties and a high level of complexity have been published.

Conclusion

A multidisciplinary model for the clinical management and follow-up of new medications has been maintained and consolidated in our hospital. It is based on routine meetings with a fixed agenda for the analysis of the introduction and follow-up of drugs used by specific clinical departments. In the departments in which meetings have been held, a certain containment of expenditure has been observed in comparison with other departments of the hospital or the overall CHS. The impact of our model is difficult to measure with observational data, since many factors influence the evolution of the market and the use of medications in the different clinical departments. Having a method for the introduction and monitoring of new medications helps to set up an organised and reasoned decision-making process. As a post-launch activity, our model aims to guarantee the provision of treatments with added clinical value and benefit to the maximum number of patients while ensuring public healthcare sustainability.

Abbreviations

CHS

Catalan Health Service

CETSUS

Committee for the Evaluation of Treatments under Special Use Situations

DTC

Drug and Therapeutics Committee

EMA

European Medicines Agency

FDA

Food and Drug Administration

HIV

Human Immunodeficiency Virus

HOT

Hospital Outpatient Treatments

HOTC

Hospital Outpatient Treatments Committee

IQR

Interquartile range

MEA

Managed Entry Agreement(s)

PCSK9

Proprotein convertase subtilisin/kexin type 9

RPT

Register of Patients and Treatments

TNF

Tumour necrosis factor

VHUH

Vall d’Hebron University Hospital

Disclosure statement

No potential conflict of interest was reported by the author(s).