10.14639/0392-100X-N1937
Objectives. The study aims to define the economic resources needed to manage chronic rhinosinusitis with nasal polyposis (CRSwNP), assuming the hospital perspective, based on different patient characteristics, within a 24-month time horizon. Methods. Real-world data were collected in 3 Italian hospitals. A time-driven activity-based costing approach was implemented to map and assess the pathways for CRSwNP. The following drivers were considered: diagnostic services, drugs, consumables, human resources, equipment and overhead costs based on the length of stay. Costs related to management of comorbidities and adverse events were evaluated. Three main groups of patients were identified: ineligible for surgery; having 1 intervention; having more than 1 intervention. The economic absorption of patients who continued corticosteroid treatment was analysed. Results. Patients experiencing 1 intervention had a cost of 3,453.31 € that increased to 4,705.03 € for those who required additional surgery. The cost of intranasal corticosteroids was 649.20 €, whereas the cost of oral corticosteroids was 37.60 € per patient. Conclusions. The results demonstrate the strategic relevance of analytical cost definitions of the clinical pathway for CRSwNP, which can help to support decision makers in the review of internal procedures and in the definition of proper reimbursement tariffs.
text/xml
1827-675X
1937
en
Lorenzo Pignataro
http://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
time-driven activity-based costing
Determination of costs for the CSRwNP pathway. A time-driven activity-based costing experiment
Text.Serial.Journal
https://www.actaitalica.it/
42
Rhinology
2022-11-23
2021-11-24
2022-12-13
2022-12-13
450-457
1
Lorenzo Pignataro
2022/11/23
10.14639/0392-100X-N1937
450
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy
1827-675X
time-driven activity-based costing
en
457
Determination of costs for the CSRwNP pathway. A time-driven activity-based costing experiment
https://www.actaitalica.it/article/download/1937/871
42
ACTA OTORHINOLARYNGOLOGICA ITALICA 2022;42:450-457; doi: 10.14639/0392-100X-N1937




Rhinology


Determination of costs for the CSRwNP pathway.
A time-driven activity-based costing experiment
La stima dei costi nel percorso della CRSwNP.
L’approccio del time-driven activity-based costing
Matteo Trimarchi1, Emanuela Foglia2, Fabrizio Schettini2, Daniele Bellavia2, Alessandro Vinciguerra1, Paolo Petrone3,
Sara Torretta4,5, Lorenzo Pignataro4,5
1
 Department of Otorhinolaryngology, University Vita Salute, IRCCS San Raffaele Hospital, Milan, Italy; 2 Centre for
Health Economics, Social and Health Care Management, LIUC - Università Cattaneo, Castellanza, Italy; 3 Department of
Otorhinolaryngology, Ospedale Di Venere, ASL BA, Bari, Italy; 4 Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, Milan, Italy; 5 Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy


SUMMARY
Objectives. The study aims to define the economic resources needed to manage chronic
rhinosinusitis with nasal polyposis (CRSwNP), assuming the hospital perspective, based on
different patient characteristics, within a 24-month time horizon.
Methods. Real-world data were collected in 3 Italian hospitals. A time-driven activity-based
costing approach was implemented to map and assess the pathways for CRSwNP. The fol-
lowing drivers were considered: diagnostic services, drugs, consumables, human resources,
equipment and overhead costs based on the length of stay. Costs related to management
of comorbidities and adverse events were evaluated. Three main groups of patients were
identified: ineligible for surgery; having 1 intervention; having more than 1 intervention.
The economic absorption of patients who continued corticosteroid treatment was analysed.
Results. Patients experiencing 1 intervention had a cost of 3,453.31 € that increased to
4,705.03 € for those who required additional surgery. The cost of intranasal corticosteroids
was 649.20 €, whereas the cost of oral corticosteroids was 37.60 € per patient.
Conclusions. The results demonstrate the strategic relevance of analytical cost definitions            Received: December 18, 2021
                                                                                                       Accepted: August 16, 2022
of the clinical pathway for CRSwNP, which can help to support decision makers in the re-
view of internal procedures and in the definition of proper reimbursement tariffs.
                                                                                                       Correspondence
KEY WORDS: chronic rhinosinusitis with nasal polyposis, CRSwNP, surgical pathway,                      Daniele Bellavia
process mapping, time-driven activity-based costing                                                    Centre for Health Economics, Social and Health
                                                                                                       Care Management, LIUC - Università Cattaneo,
                                                                                                       corso Matteotti 22, 21053 Castellanza (VA), Italy
RIASSUNTO                                                                                              Tel. +39 0331 572 516. Fax +39 0331 572 513.
Obiettivi. Lo studio mira a definire i costi per la gestione della rinosinusite cronica con po-        E-mail: dbellavia@liuc.it
liposi nasale (CRSwNP), assumendo la prospettiva ospedaliera, in base alle caratteristiche
dei pazienti, in un orizzonte temporale di 24 mesi.                                                      How to cite this article: Trimarchi M, Foglia
Metodi. Dati reali sono stati raccolti in 3 ospedali italiani con il supporto di dati gestionali         E, Schettini F, et al. Determination of costs
di contabilità analitica. L’approccio Time-driven Activity-Based Costing è stato adottato per            for the CSRwNP pathway. A time-driven ac-
valorizzare i costi di: servizi diagnostici, farmaci, materiali di consumo, risorse umane, at-           tivity-based costing experiment. Acta Otorhi-
trezzature e costi generali, in base alla durata della degenza. Inoltre, sono stati valutati i costi     nolaryngol Ital 2022;42:450-457. https://doi.
per la gestione delle comorbilità e degli eventi avversi. Sono stati identificati tre gruppi di          org/10.14639/0392-100X-N1937
pazienti: non idonei all’intervento; sottoposti a 1 intervento; sottoposti a più di 1 intervento.
Risultati. Per i pazienti sottoposti a 1 intervento i costi sono 3.453,31 €, che aumentano a           © Società Italiana di Otorinolaringoiatria
                                                                                                       e Chirurgia Cervico-Facciale
4.705,03 € in caso si presentino recidive. Il costo per i corticosteroidi infranasali (INCS) è
pari a 649,20 € a paziente, mentre quello relativo alla somministrazione dei corticosteroidi
                                                                                                                      OPEN ACCESS
orali (OCS) è di 37,60 €.
Conclusioni. I risultati dimostrano la rilevanza strategica della definizione analitica dei            This is an open access article distributed in accordance with
                                                                                                       the CC-BY-NC-ND (Creative Commons Attribution-Non-
costi del percorso clinico, che può aiutare a supportare i decisori nella revisione delle              Commercial-NoDerivatives 4.0 International) license. The
procedure interne e nella definizione di tariffe di rimborso adeguate.                                 article can be used by giving appropriate credit and mentio-
                                                                                                       ning the license, but only for non-commercial purposes and
PAROLE CHIAVE: rinosinusite cronica con poliposi nasale, CRSwNP, percorso chirurgico,                  only in the original version. For further information: https://
mappatura dei processi, time-driven activity-based costing                                             creativecommons.org/licenses/by-nc-nd/4.0/deed.en




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                                                                               CRSwNP and a time-driven activity-based costing experiment




Introduction                                                       (without considering treatment with biological drugs), fo-
                                                                   cusing on the analysis of financial sustainability related to a
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is            routine use of surgical procedures in this population.
a disease that is often associated with considerable impact        The achievement of the above objective would help to de-
on the quality of life of subjects who suffer from it, gener-      fine what resources are needed for hospital management of
ating not only direct healthcare costs for management of           a patient with CRSwNP on the basis of the different clinical
patients, but also disability and high social costs related        conditions, considering the entire hospital stay, from diag-
to both CRSwNP and associated comorbidities (indirect              nosis to surgical intervention, also defining discharge and
costs) 1. Treating this disorder is not easy for clinicians; the   follow-up monitoring procedures.
available therapeutic strategies mainly consist of drugs or        It is not the objective of the present study to compare sur-
surgery, which in many cases may be ineffective due to the         gical treatment with innovative pharmacological alterna-
high risk of disease recurrence 1. In addition, the current-       tives, paving only the way for future discussions based on
ly-available medical treatments are limited, and focused           quantitative information concerning the economic burden
mainly on decreasing inflammation in sinuses and nasal             of surgical procedures. This comparison and related con-
passages to reduce symptoms. The most used and wide-               siderations will be dealt with, in prospective studies.
spread medical therapy is corticosteroid-based drugs, via
spray application (intranasal corticosteroids, INCS) or in
repeated cycles with oral assumption (oral corticosteroids,        Methods
OCS). Antibiotics, antifungals, and antihistamines are also        A micro-costing technique using time-driven activity-based
used to treat the various comorbidities associated with the        costing (TDABC) analysis 6,7 was performed to quantify
disorder.                                                          the resources related to hospital management of CRSwNP
When these pharmacological approaches are not effective,           patients, assuming the hospital’s point of view and consid-
surgery is required, in particular Functional Endoscopic Si-       ering a 24-month time horizon.
nus Surgery (FESS), which is effective in the short-term,          The economic assessment of the CRSwNP clinical pathway
but it is associated with high recurrence rates after treat-       was conducted using real-life data collected in 3 Italian
ment 2. In a healthcare context, innovation plays a key role.      hospitals: two public and one private. Data were collected
In fact, innovative healthcare technologies (such as novel         from October 2020 to February 2021 using a data collec-
drugs, medical devices, medical procedures, or organiza-           tion form in which information was requested regarding the
tional models) can positively impact the optimisation of the       management pathway for CRSwNP, stratified as follows: i)
patient journey 3. Focusing on the CRSwNP setting, one             patients who were not eligible for surgery; ii) patients who
possible innovation is represented by biologic therapies,          underwent a single intervention; iii) patients who under-
which have been introduced in recent years and act on the          went more than one intervention.
underlying type 2 inflammation that causes clinical symp-          The clinical pathway of CRSwNP was divided into the fol-
toms 4. Trials for biological therapies for the treatment of       lowing phases: 1) Diagnosis - consisting in the definition
CRSwNP generate the opportunity to raise important is-             of procedures and related costs, concerning all diagnostic
sues for future cost-effectiveness analyses alongside clini-       activities conducted for clinical confirmation of CRSwNP;
cal evidence to define the benefits that these drugs have for      2) Treatment - considering both medical and surgical
patients 5.                                                        treatments offered to patients with CRSwNP. Concerning
Considering the importance of CRSwNP from clinical, so-            medical treatments, both out-of-pocket drug therapy and
cial and economic points of view, analysis of the economic         corticosteroid medications were analysed. Focusing on the
aspects related to the diagnostic and therapeutic pathway          surgical procedure, Functional Endoscopic Sinus Surgery
of this disorder is acquiring strategic relevance to under-        (FESS) was based on different hospitalization regimens
stand the consumption of economic resources, assuming              (ordinary, with one night hospitalisation, or day-hospital in
the point of view of the healthcare facility that manages          case of no hospital stay); 3) Management of comorbidities
these patients.                                                    and adverse events - in terms of costs related to the hospital
Coverage of the above knowledge gap represents an urgent           resolution of complications or concomitant diseases, based
priority that is useful to support decision-making for allo-       on the occurrence rate derived from literature evidence 8; 4)
cation of healthcare resources devoted to treatment options        Follow-up - all activities and hospital procedures adminis-
offered to patients with CRSwNP. Herein, the present paper         tered to CRSwNP patients after a surgical procedure or for
had the aim of defining the economic resources needed for          drug monitoring.
management of CRSwNP patients with traditional methods             The above phases were economically evaluated for each



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group of patients, considering the following healthcare              costs were included in both the surgical treatment and
items of expenditure, representing the input data for the            diagnostic phases;
economic evaluation:                                              • Hospital consumables - considered the different con-
• Human resources - in terms of assistance minutes spent             sumables, such as sterile gowns, canvas with/without
   by clinicians, anaesthesiologist nurses, and socio-health-        adhesive border, and gloves used by healthcare profes-
   care operators, were quantified in accordance with the            sionals and patients. These costs were included only in
   Italian National Labour Contracts per professional class,         the evaluation of surgical treatment phase;
   as labour cost. To allocate a cost to each activity in terms   • Laboratory exams and diagnostic procedures during
   of the work factor, it was necessary to calculate a cost          hospitalisation follow-up, and management of adverse
   per minute for each professional involved in each phase           events and complications, in terms of quantity and type
   of CRSwNP clinical pathway. Thus, the labour factor               of procedures, multiplying the quantity of each proce-
   cost per activity was calculated, multiplying the “cost           dure to determine the related hospital costs;
   per minute” and the number of minutes spent by each            • General and fixed costs - all items of expenditure dif-
   healthcare professional for clinical activities. This cost        ferent from labour, consumables, and equipment, which
   was considered for the diagnostic phase, surgical treat-          are strictly required for management of CRSwNP given
   ment, management of comorbidities and adverse events,             their role in logistic and infrastructure support. Specifi-
   and follow-up;                                                    cally, energy, water, gas, general hospital maintenance
• Drugs administered - evaluated considering medication              services, sterilisation services, laundry, managerial and
   therapies administered to CRSwNP patients based on                administrative support costs were considered. General
   the specific dosage and duration. Drugs were stratified           costs are common in all phases of the management path-
   in those directly purchased by CRSwNP patients (repre-            way.
   senting an “out of pocket expenditure” item of cost), and      All cost items derived from anonymous administrative and
   drugs whose costs are directly sustained by hospitals and      accounting flows related to hospitals cost centres, provided
   by National Healthcare Service (NHS). The total cost of        by the management controls of the hospitals involved, al-
   drugs was calculated multiplying the related acquisi-          lowed for estimation of the overall costs of CRSwNP man-
   tion cost by the duration of administration, as prescribed     agement.
   by clinicians. In this view, INCS treatment, used to re-       After definition of CRSwNP management costs directly
   duce nasal polyp size 2, represents an out-of-pocket ex-       sustained by hospitals, an additional economic analysis
   penditure, whose cost was determined according to the          was performed assuming the NHS perspective to under-
   typology of INCS therapy, usually fluticasone furoate          stand the financial sustainability of the surgical procedure.
   (27.5 mcg), mometasone furoate (50 mcg), or budeso-            According to the above, the Diagnosis Related Group
   nide (50 mcg). The average therapy cost was calculated         (DRG) and associated charges (provided by the NHS) were
   using a weighted average of cost estimates and prescrip-       considered, based on the different hospitalization regimens
   tion rates of the different active agents, as collected in     for surgical procedures, as well as for all activities required
   real-life practice, in hospitals involved in the analysis.     for management of adverse events and complications.
   In contrast, the costs of OCS is directly sustained by         Bayesian statistics were used 9,10. Gamma distributions
   the NHS. The following medications were considered:            were developed to verify the robustness of the results in the
   prednisone (40 mg), triamcinolone (25 mg), and defla-          presence of uncertainty factors, concerning costs related to
   zacort (30 mg). In addition to OCS, the costs for antibi-      management of CRSwNP, considering the different patien-
   otic and antimycotic therapy were evaluated considering        tis’ subgroups.
   infections and other complications and the cost of drugs
   needed to treat. Thus, this was considered for the treat-
   ment phase and for management of comorbidities and
                                                                  Results
   adverse events;                                                Patients’ distribution
• Equipment - measured as the type of equipment or dif-           Table I shows that the majority of CRSwNP patients
   ferent types of equipment, useful for surgical procedures      (90.82%) are eligible for surgical treatment. Only 9.18% of
   (fiberscopes, microdebrider, endoscopy and other surgi-        patients did not undergo intervention and were thus treated
   cal equipment) and during hospital stay for CRSwNP.            with specific drugs.
   The economic analysis considered acquisition costs of          Focusing on the economic results, considering both the
   equipment (integrated with VAT), as well as the related        hospital and the NHS perspectives, Table II reports the
   life cycle costs and equipment maintenance. Equipment          costs related to the diagnosis phase for the three clinical



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Table I. Distribution of patients according to treatments.
 Pathway                                                       Average       Average number of        Average number of        Average number of
                                                             distribution   patients in Hospital A   patients in Hospital B   patients in Hospital C
                                                                                in 24 months             in 24 months             in 24 months
 Patients not eligible for surgery                              9.18%                38                        14                       20
 Patients with 1 intervention                                  67.46%                318                      148                      152
 Patients with more than 1 intervention                        23.37%                150                       54                       52



Table II. Diagnostic phase costs.
 Diagnostic phase economic                       Patients not eligible                  Patients                         Patients with more
 evaluation                                          for surgery                   with 1 intervention                   than 1 intervention
 Hospital perspective                                  239.48 €                         311.36 €                              583.60 €
 NHS perspective                                       310.07 €                         401.83 €                              755.15 €
 Difference                                             70.58 €                         90.47 €                               171.55 €



pathways, which differ based on the frequency of the pro-                   In contrast, costs related to adverse events are attributable
cedures performed.                                                          only to patients who underwent at least one surgical pro-
Concerning the pharmacological treatment phase, focus-                      cedure.
ing on medical management of CRSwNP patients, the                           Considering the cost of treating each comorbidity and its
total costs related to INCS administration were € 649.20,                   probability of occurrence, the expected costs were calcu-
whereas the total costs related to OCS administration were                  lated to be € 1,251.61 per patient with CRSwNP. Similarly,
€ 37.60. These costs are attributable to all three groups of                the cost related to the management of possible adverse
patients, as drug therapy is taken to keep the condition un-                events was calculated: € 65.19 represent the weighted ad-
der control, over the long term. It is important to specify                 verse events economic burden, devoted to each patient un-
that the entire cost of the CRSwNP treatment pathway is                     dergoing surgery, considering the probability of experienc-
borne by the Italian NHS, but the purchase of INCS is an                    ing all the possible adverse events. This value could appear
expense to be incurred by the patients. This last cited di-                 very low, but is justified by the fact that the occurrence rates
mension of cost represents the social burden of the clinical                of adverse events have very small orders of magnitude, and
condition.                                                                  in the calculation of the weighted cost they significantly
Evaluating surgical procedures, Table III shows detailed                    affect the related value. These results demonstrate that,
information regarding FESS surgery, considering an or-                      even if surgery has a high degree of safety, adverse events
dinary or day-hospital regimen. The costs of the surgery                    can occur, including subpalpebral haematoma and swell-
performed in the inpatient setting are higher than in the                   ing (oedema) of the face; post-operative haemorrhage that
day-hospital setting, since all costs related to the patient’s              may be provoked in the packing removal, usually in the
bed occupancy are included, increasing the total cost of the                first week after surgery, and could be solved by replacing
CRSwNP management pathway. Patients who are admit-                          or reinforcing the nasal tampon; neuralgia and altered sen-
ted as ordinary inpatients show an average hospital stay of                 sation at the supraorbital and infraorbital nerves or at the
2.5 days.                                                                   upper teeth; haematoma of the orbit, caused by intraorbital
To calculate the costs attributable to the category of patients             haemorrhage, which can cause compression and ischaemia
who underwent more than 1 operation in the 24-month                         of the orbit with consequent impairment of vision and vis-
time-horizon considered, the cost of a single operation was                 ual field; blindness due to traumatic sectioning of the optic
multiplied by the average number of operations per patient,                 nerve in its course along the lateral wall of the posterior
obtained from administrative flows of the 3 reference cen-                  ethmoid and/or sphenoid sinus; endocranial complications;
tres, which is 2.11.                                                        injury to the internal carotid artery or cerebral cavernous
The economic assessment of both comorbidities and poten-                    sinuses, that can lead to permanent neurological injury (pa-
tial adverse events of patients undergoing a surgical proce-                ralysis) or death; bacteriological infections, which occur
dure is detailed in Table IV.                                               rarely since antibiotics are usually administered.
Costs related to the management of type 2 comorbidities are                 The economic burden related to follow-up activities was
attributable to all three categories of patients considered.                investigated by considering the number of specialist visits



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Table III. Cost items considered for surgery evaluation.
 Cost items                                                            FESS intervention cost in case       FESS intervention cost in case
                                                                             of hospitalisation                    of day hospital
 Human resources                                                                 275.21 €                             275.21 €
 Equipment                                                                       299.08 €                             299.08 €
 Drugs and consumables                                                           325.13 €                             325.13 €
 Pre- and post- intervention visits                                              162.45 €                             162.45 €
 Length of stay                                                                  774.74 €                             178.24 €
 General costs                                                                   363.71 €                             246.77 €
 Total                                                                          2,200.32 €                           1,486.88 €
 Cost for NHS (considering national reimbursement tariffs)                      2,798.00 €                           1,790.00 €
 Difference                                                                      597.68 €                             303.12 €



Table IV. Comorbidities and adverse events with economic evaluation.
 Type 2 comorbidities                                                         Prevalence of comorbidities         Cost for management
                                                                                 among NP patients 9                  of each case
 Asthma                                                                                 37.10%                         1,583.00 €
 Allergic rhinitis                                                                      32.20%                          386.00 €
 Eosinophilic oesophagitis                                                               8.30%                          629.43 €
 Atopic dermatitis                                                                      12.60%                         1,248.00 €
 Food allergies                                                                         7.40%                          2,065.40 €
 Chronic obsructive pulmonary disease                                                   8.60%                          2,066.22 €
 Adverse events                                                                      Prevalence 8                Cost related to adverse
                                                                                                                   event management
 Haemorrhage                                                                            1.21%                            715.66 €
 Cerebrospinal fluid leakage                                                            0.56%                           1,428.00 €
 Orbital haematoma                                                                      0.59%                             20.66 €
 Orbital subcutaneous emphysema                                                         0.12%                             20.66 €
 Meningitis                                                                             0.06%                           4,066.00 €
 Pulmonary embolism                                                                     0.12%                           4,466.00 €
 Neuralgia                                                                              0.12%                             81.96 €
 Toxic shock                                                                            0.06%                           1,440.00 €
 Blindness                                                                              0.12%                          16,803.00 €
 Other complications related to the surgery                                             1.50%                          1,334.00 €



performed and the different clinical conditions of patients,                tion in both hospitalisation regimens analysed. The same
as reported in Table V.                                                     consideration could be proposed for patients undergoing
Therefore, depending on the category of patients and the                    a surgical procedure based on an ordinary hospitalisation
hospital in which they are treated, different costs are in-                 regimen, whose economic resource consumption was al-
curred, ranging from a minimum of € 1,653.22 (patients                      ways higher than patients treated with a day-hospital proce-
not eligible for surgery) to a maximum of € 8,098.34 (pa-
                                                                            dure. The management of patients experiencing more than
tients undergoing more than 1 surgery).
                                                                            one surgical procedure required more resources (+2%) if
The robustness of the proposed economic results was
strengthened by Bayesian statistics (Fig. 1).                               they are treated with ordinary hospitalisation. Patients ex-
With reference to patients who underwent a surgical pro-                    periencing an ordinary admission for surgical procedure
cedure, patients with more than 1 intervention always had                   had a probability of 0.6% in consuming more economic
(probability equal to 100%) greater absorption of economic                  resources than patients requiring more than one surgical in-
resources compared to those undergoing a single interven-                   tervention, but in a day-hospital setting.



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Table V. Follow-up evaluation.
 Pathway                          Patients not eligible              Patients with                     Patients with more than
                                      for surgery                    1 intervention                         1 intervention
 Number of visits                        3.33                             5.33                                  8.5
 Cost for healthcare                   211.42 €                         338.27 €                              539.12 €
 Reimbursement tariff                  270.93 €                         433.49 €                              690.88 €
 Difference                            59.51 €                          95.22 €                               151.76 €



                                                                 Pocket Expenditure (OOPE)”, which represents the costs
                                                                 directly sustained by each patient for treatments aimed at
                                                                 treating their health condition. A study in the United King-
                                                                 dom estimated the OOPE to be £ 304.84 per year, per pa-
                                                                 tient. Comparing this value in euros, within a 24-month
                                                                 time-horizon the economic burden is € 712.66, thus be-
                                                                 ing consistent with the results of the present study (i.e.
                                                                 € 649.20). The difference is related to the fact that this latter
                                                                 value only refers to direct patient expenditure for the pur-
                                                                 chase of INCS, without considering the costs required for
                                                                 transportation to the hospital for diagnosis and treatment 11,
Figure 1. Bayesian statistic.                                    thus only partially exploring the actual social and indirect
                                                                 costs related to CRSwNP.
                                                                 Other studies have analysed the impact of direct costs for
Discussion                                                       treating CRSwNP on the hospital budget. Lourijsen and
                                                                 colleagues 12 estimated that direct facility costs (including
In the present paper, the results regarding costs of the path-   those for the diagnostic pathway, surgery, and hospitali-
way for taking care of patients with CRSwNP were deter-          sation) in the Netherlands were € 1,501.20: this could be
mined, with a particular focus on surgery and assuming           considered very similar to the € 1,777.58 found herein for
that each patient receives the most appropriate treatment        the diagnostic pathway and for FESS (including hospitali-
according to the clinical condition. CRSwNP is a very diffi-     sation).
cult condition to manage because of its high recurrence rate     The rates of occurrence of adverse events may seem high
and the large number of comorbidities associated with it.        from a clinical point of view: this arises from a study that
In the hospital settings investigated, it was found that there   collected a 25-year experience and also considers several
are also some patients who receive corticosteroid treatment      risk factors, such as age, revision surgery, anatomic varia-
even if they are eligible for surgery (130 in hospital A, 54     tion, extensive disease, general health status and any drug
in hospital B and 70 in hospital C). An economic analy-          treatments 2. The CRSwNP pathway is therefore lengthy,
sis similar to the previous one highlighted that this specif-    prolonged over time, and subject to direct and indirect costs
ic subgroup of patients is characterised by an expense of        that are not always easy to estimate, as for other chronic con-
€ 290.70 borne by the hospital for diagnostic examinations       ditions. Moreover, the treatments, quality of life and costs of
and a follow-up cost of € 147.99 for the hospital. Consider-     the pathway differ substantially depending on the complex-
ing the expenditure for INCS, OCS and the cost to manage         ity of the disease, rate of recurrence, and number of associ-
comorbidities, the total cost for this category of patients is   ated comorbidities, as well as their related severity.
€ 1,690.30 in 2 years.                                           To map the process and analyse the consumption of re-
The study attempts to outline the pathway of a patient suf-      sources, it is essential to identify possible areas for im-
fering from CRSwNP considering consumption of direct             provement, deciding to intervene by eliminating inefficien-
costs and reimbursement tariffs, due to the development of       cies, focusing on core activities which are decisive for the
complications that can significantly impact the sustainabil-     success of patient management. This approach is also rel-
ity of the entire pathway.                                       evant to retrieve important information about the current
In particular, the costs related to CRSwNP management            situation, redesign the pathways, and stratify treatments
have been analysed in recent years in a specific stream          according to different patient needs.
of literature specifically devoted to the so-called “Out Of      The current evaluation was carried out considering a time



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M. Trimarchi et al.




horizon of 24 months, with the awareness that the manage-          Conclusions
ment of a patient with severe nasal polyposis could require
                                                                   The present analysis has provided a snapshot of the direct
a longer period, with more recurrences and events related
                                                                   costs for a patient suffering from CRSwNP (stratified for
to comorbidities, with consequent persistence of symptoms
                                                                   severity), with particular attention to surgical treatment and
in the long term that compromise the patients’ quality of
                                                                   management of recurrences and adverse events. In this con-
life.
                                                                   text, the analysis has shown that the cost of a single patient
In this context, it also becomes important to evaluate poten-
                                                                   suffering from CRSwNP has a significant impact, not only
tial alternatives to current surgical and medical treatments,
                                                                   on the Operative Unit that manages the patient, but also
with the possibility to manage those who may be ineligible
                                                                   on the entire hospital and on patients and their families.
for corticosteroid-based drug therapies or surgery. Based
                                                                   CRSwNP is a pathology that has substantial social burden,
on this consideration, an alternative is represented by bio-
                                                                   especially in case of relapse and repeated re-interventions.
logical drugs, such as an anti-IL-4Rα (blocking IL-4/13
activities) agent, which in recent years have been studied
                                                                   Conflict of interest statement
with particular attention to type 2 inflammation, the disor-
                                                                   The authors declare no conflict of interest.
der underlying nasal polyposis4. Although structured long-
term data are not yet available, it has been shown that in         Funding
the short-term biological agents are able to significantly         The study was supported by an unconditional grant of Sa-
improve the quality of life of patients, by acting with pre-       nofi, related to the writing of the paper.
cision on type 2 inflammation: in addition to effectively
treating polyposis, they can also mitigate most comorbidi-         Author contributions
ties and reduce the need for surgery and OCS treatment 4.          MT, AV, PP, ST and LP retrieved anonymous data in their
The administration of targeted agents might thus reduce            respective hospitals and described process activities, thanks
the management complexity associated with the disease,             to their clinical know-how. EF, FS and DB performed the
freeing-up organisational healthcare resources (in terms of        time-driven activity-based costing, statistical and economi-
beds, operating rooms, and staff), which could be used for         cal elaborations. All authors cooperated in validating re-
other purposes and avoid the indirect costs of productivity        sults and in writing the Discussion chapter.
losses.
The comparison between surgical and biological drugs was           Ethical consideration
not an objective of the present paper. Nevertheless, the re-       No Ethical Committee had to approve the study, since there
sults obtained during this analysis could support the discus-      are no patient data.
sion concerning the definition of criteria and the population
stratification to investigate potential treatment alternatives.
According to the above, and since healthcare decision-
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