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Gruppo di lavoro Soci APRE HORIZON 2020

“UNIT COSTS IN CLINICAL TRIALS”

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Index

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.

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APRE 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

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The 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

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Could 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.

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The 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.

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Appendix 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.

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Appendix 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

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Appendix 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

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Appendix 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