Gruppo di lavoro Soci APRE - HORIZON 2020 "UNIT COSTS IN CLINICAL TRIALS" - UnivPM
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Gruppo di lavoro Soci APRE
HORIZON 2020
“UNIT COSTS IN CLINICAL TRIALS”
1Index
Introduction and Scope...................................................................................................................................... 3
APRE Working Group ......................................................................................................................................... 3
Methodology...................................................................................................................................................... 3
The situation in Italy .......................................................................................................................................... 4
Outcome ............................................................................................................................................................ 5
Update April 28, 2015: APRE Working Group presentation and webinar discussion ....................................... 5
Appendix 1: Unit Cost Questionnaire ................................................................................................................ 7
Appendix 2: Agenda participant list and supporting documents ...................................................................... 8
Appendix 3: Participant list and supporting documents ................................................................................... 9
Appendix 4: Agenda April 28, 2015 ................................................................................................................. 10
Il presente documento è il risultato del Gruppo di Lavoro “Unit Costs negli Studi Clinici” in
Horizon2020, organizzato da APRE (Agenzia per la Promozione della Ricerca Europea) insieme alla sua
rete di Soci.
Il Gruppo di Lavoro è stato coordinato da Marco Asioli (Fondazione IRCCS Istituto Nazionale dei Tumori
di Milano) con il supporto di Caterina Buonocore e Bruno Mourenza, Punti di Contatto Nazionale (NCP)
per Horizon 2020 – Health, Demographic change and Wellbeing.
Si ringraziano i Soci APRE per il loro contributo.
2APRE WORKING GROUP ON “UNIT COSTS IN CLINICAL TRIALS”
Introduction and scope:
The European Commission established that costs related to clinical trials (CTs) in Horizon 2020 can be
reimbursed either as actual costs or as unit costs. The use of grants for reimbursement of eligible costs
of clinical studies declared by beneficiaries on the basis of unit costs has been authorised under
‘Societal Challenge 1: Health, Demographic Change and Wellbeing’ of the Horizon 2020 Framework
Programme by the Commission Decision C (2014) 1393.
The unit costs option shall be specified in the grant agreement to be used throughout the duration of
the action. Costs of clinical studies declared by beneficiaries on the basis of unit costs shall be eligible if
they correspond to the amount per unit set out in Annex 2 to the grant agreement multiplied by the
number of actual units (patients or subjects) included in the clinical studies conducted under the
action.
Based on this EC’s decision the aim of the APRE working group is to assess the impact of the unit costs
model in the administrative practices evaluating advantages and disadvantages of this instrument at
national level among APRE members.
APRE Working Group:
During the APRE working group many issues arose from the discussion on the possibility to use “the
unit costs in clinical trial” and which kind of existing national/regional and local instruments could be
used to overcome the difficulties related to set up the “unit costs model” for the Italian beneficiaries.
According to Commission Decision C (2014) 1393, each beneficiary has to determine direct costs by
reference to the beneficiary’s historical costs and the estimated resources consumed per task and per
patient or subject. The beneficiary must use, as historical costs, the costs recorded in its certified or
auditable profit and loss accounts for year N-1 (last closed financial year at the time of submission of
the grant application). When a beneficiary intends to use unit costs, the detailed and complete
calculation must be provided in Table(s) X.9 of the ”Template for essential information to be provided
for proposals including clinical trials / studies / investigations”, according to the methodology
described in Commission Decision C(2014) 1393. Only unit costs calculated according to this
methodology are eligible. Beneficiaries cannot use their own methodology to calculate unit costs.
Methodology
The APRE working group has adopted a two steps consultation to discuss and assess the impact of the
unit costs model in clinical trial:
- A meeting of the working group held in Rome among some APRE members able to attend the
meeting
- The collection of input through a questionnaire send to all the APRE members who could not
participate to the first round of exchange in Rome
3The situation in Italy
In Italy there are many concerns on the use of historical costs to set up the unit costs as described by
the EC because it’s very hard to have these administrative information available in one hand.
On the other hand, the Italian National Health System (SSN) has adopted a fee-for-service system to
remunerate public and private healthcare providers (whether they provide in-patient and/or out-
patient care). This system is based on two Formulary Lists, both based on the ICD9-CM WHO
Classification of Diseases and Procedures:
the NTPA1 (Nomenclatore Tariffario delle Prestazioni Ambulatoriali), i.e. an out-patient
formulary list of medical acts and procedures which can be delivered in out-patient facilities
under SSN’ funding, and
the NTPO2 (Nomenclatore Tariffario delle Prestazioni Ospedaliere) which is a DRG based
(Diagnosis Related Group) in-patient formulary list, covering all hospital activity from acute or
day-hospital admissions to long-term care and nursing home assistance;
National and regional laws and regulations, both at the central level of the Ministry of Health and
within the Regions, periodically define and establish pre-determined tariffs.
Some institutes involved in CTs adopted a “institutional rate plan” (tariffario istituzionale) that has
been used to calculate costs for clinical trials sponsored by pharmaceutical companies. This instrument
is typically institutional/local and it’s calculated according to an activity-based costs analysis
considering personnel, equipments, consumables and basically a fee (e.g. the cost of a thoracic x-ray
includes the effort of the radiologist, the “depreciation” of the machine, CD-ROMs for images storage
etc).
In a Webinar report “Clinical Trial 9.9.2014” has been reported a question about the use of national
tariff system: “How are the unit costs audited and on what extent the details must be identifiable in
the accounts of the beneficiary? In other words, can we include in the unit costs that are usually used
by hospitals, based on a national tariff system?”
The following answer has been provided: “Unit costs that are usually used by hospitals may be a very
good option for estimates on some components of your unit costs per patient, yes. Please note that
costs which are paid for by the national health system cannot be charged to the project though. The
calculation of the unit costs (see table in template for clinical studies) will become part of the Grant
Agreement (Annex II). The methodology applied in order to calculate unit costs will thus be auditable
in the frame of a CFS or an official audit by the EC. The number of actual units claimed during the
action must comply with the following conditions:
- the units must be actually used during the project
- they must be necessary for implementing the action & identifiable and verifiable, in particular
supported by records and documentation.”
1
NTPA http://www.salute.gov.it/portale/temi/p2_6.jsp?id=1767&area=programmazioneSanitariaLea&menu=lea
2
NTPO http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=1349&area=ricoveriOspedalieri&menu=sistema
4Could this answer open a “different scenario” where national tariffs can contribute to the calculation
of unit costs? On the other hand this answer is also in contrast with the Commission Decision C (2014)
1393 because unit costs are not calculated taking into account the last closed financial year at the time
of submission of the grant application.
Outcome
APRE working group which started its work on the 18th of November 2014 focused its activities on the
impact of the unit costs model on the administrative practices of entities as Aziende Ospedaliere
Universitarie/Aziende Ospedaliere, Universities, ASL, Research centres.
This first round of exchange led to a discussion among participants reflecting the difficulties in the use
of the unit costs model from an administrative point of view: it’s very complicated to determine direct
costs using the beneficiary’s historical costs (last closed financial year at the time of submission of the
grant application) because the accounting system of the Public Administration is a very intricate
system and often is not possible to retrieve these information (e.g. cost of a single syringe or specific
blood test).
The second round (questionnaire) showed that several Italian institutions were involved in clinical
trials in FP7 and in the first calls of Horizon 2020 but none of these used the unit costs model to
calculate direct costs.
Based on these information and outcomes from the APRE working group we would like to circulate this
document and propose an open discussion among experts involved in CTs, the Italian Ministry of
Health and the European Commission in order to address these concerns in approaching the use of
this instrument/calculation method and to find an alignment between national and European
regulations on this matter.
Update April 28, 2015: APRE Working Group presentation and webinar discussion
In February 2015 the APRE Working Group established a preliminary contact with the European
Commission: the final document was sent the DG R&I and two representatives (Cornelius Schmaltz and
Mark Goldammer) have been invited to the presentation of the document in Brussels on April 28, 2015
(see agenda).
After an introduction led by Caterina Buonocore, the coordinator of the APRE WG explained the aims
of the document to the EC Officers giving them an overview of the Italian concerns in the use of the
unit costs in CTs.
A webinar session has been also organized to facilitate the interaction between the EC Officers and 20
Italian stakeholders during the Officers’ presentation on CTs and the methodology to calculate unit
costs in Horizon 2020.
5The EC Officers explained to the audience that there is no other way to calculate unit costs if not using
the methodology described in the Commission Decision C (2014) 1393 and no exceptions are allowed
from an administrative and financial point of view.
According to the Commission Decision C (2014) 1393 every beneficiary must use, as historical costs,
the costs recorded in its certified or auditable profit and loss accounts (for year N-1).
The instruments proposed at Italian level: Formulary Lists (NTPO, NTPA) based on the ICD9-CM WHO
Classification of Diseases and Procedures and specific, local institutional rate plans are not aligned with
the methodology applied to the calculation of the unit costs.
A dialogue should be set up with the Administrative department of the different hospitals to explain
the Unit costs method of calculation and evaluate with them the advantages of this system compared
to the actual cost method.
6Appendix 1
Institution name:
1. Experience(s) using “actual costs” under FP7
(Did you participate in a FP7 project using actual costs for clinical trials? If yes, did you find it a useful
instrument? Which role did you have in the project?)
2. Experience(s) using “unit costs” under Horizon 2020
(Did you participate in a H2020 proposal using the unit costs model? If yes, did you find it a useful
instrument? Which role did you have in the project?)
3. Remarks and comments
(Potential instruments available to set up the “unit costs model” (DRG? Institutional rate plan?
other?). Any positive or critical issues using those instruments? Are they applicable in your
administrative practice?)
4. Open questions
NEXT STEPS:
Please send you comments by January 12, 2015 to: marco.asioli@istitutotumori.mi.it;
buonocore@apre.it; mourenza@apre.it
We would like to collect different input/questions/perspectives from you to summarize a document that
will be shared among participants of the working group, as well as posted on the APRE intranet for any
other APRE member interested.
7Appendix 2
Roma, 18 novembre, 2014
ore 10.30-13.30
Coordinatore: Marco Asioli, Fondazione IRCCS Istituto Nazionale dei Tumori (INT)
Ore 10.30
Introduzione, modalità e finalità del Gruppo di Lavoro
Marco Asioli, INT
Ore 10.45
Gli Studi clinici in Horizon 2020
Caterina Buonocore NCP SC 1
Bruno Mourenza, NCP SC 1
Sabrina Bozzoli, NCP Legal and Financial
Ore 11. 15
Discussione sui punti indicati dal Coordinatore del gruppo e dai partecipanti:
Esperienze di rendicontazioni dei trials clinici nel VII PQ
Unit costs in H2020, eventuali esperienze dei partecipanti
Pro e contro dell’utilizzo degli unit costs
Possibili strumenti per l’individuazione dei costi
Wrap up e futuri passi
13.30 Chiusura
8Appendix 3
Lista dei partecipanti
NOME PARTECIPANTE ENTE
Asioli Marco Fondazione IRCCS Istituto
Nazionale dei Tumori di Milano
Bergonzi Concesi Nicola Ospedale Pediatrico Bambino
Gesù
Bustacchini Silvia INRCA
Drigo Laura Università di Padova
Genovesi Valeria Università di Bologna
Mustarelli Chiara CNR, Dip. Scienze Fisiche e
Tecnologie della Materia
Pourabbas Elaheh CNR, Istituto di Analisi dei Sistemi
ed Informatica
Documentazione di supporti ai lavori:
http://download.apre.it/Salute18nov2014.zip
9Appendix 4
APRE Working Group: presentation of the document and webinar discussion
Brussels, April 28th, 2015
15.15-17.30
15.15
Introduction, scope of the Working Group
Caterina Buonocore, APRE, NCP SC 1
15.15
Presentation of the Italian document “Unit costs in clinical trial”
Marco Asioli, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Chair of the
Working Group
15.45
The European experience on clinical trials in Horizon 2020 (broadcasted in webinar
from APRE Brussels office).
Cornelius Schmaltz/Mark Goldammer, European Commission
16.15
Q&A and Closing remarks
17.30
End of meeting
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