Item

Greece

France

Sweden

Bulgaria

Establishment: Relationship with the MoH and other organi- zations

Committee for the Evalu- ation and Compensation of Medicinal Products for Human Use and Commit- tee for the Trading of Pric- es of Medicinal Products (2018)
Government service

HAS (2004) Autono.
mous public scientific
authority Established
by the Ministry of
Health

SBU (2002)
Government Service

NPRC (2015)
Under the supervi- sion of the MoH

Objective:
Broader political ob- jectives

The opinion is issued to
the Minister of Health,
following an evaluation
of the medicinal products
authorized and circulated
in Greece

Provide health au-
thorities with the in-
formation required
to make decisions
on compensation for
health technologies,
to improve the quality
of care, to provide in.
formation to the pub.
lic on the quality of
care, to provide health
economy assessments
and opinions on the
most effective strat-
egies for healthcare,
prescribing or man.
agement

Acting on the pricing and compensation of medicinal products, review of medicinal products already re- turned, improvement of the quality of the phar- maceutical care pro- vided supervision of certain areas of the pharmaceutical mar- ket

Sets price limits for prescription drugs, records the maxi- mum retail prices, and
decides on the in- clusion, amend- ments, or exclusion of pharmaceuticals from the positive list of medicinal prod- ucts

Application: Scope

All licensed medications, 726/2004/EC (OJ L 136),
are subject to an assess- ment and are included in the List of Repensating Medicinal Products only if they are compensated at least two thirds (2/3) of the European Member States and should not be less than nine (9) and at least half of them should be: Austria, Belgium, Great Britain, France, Spain, the Netherlands, Portugal, Sweden, and Finland.

All new medicines
marketed (clinical
evaluation).
From OctotRr 2013:
financial evaluation
for all new innova-
tive medicines with
a possible significant
impact on healths
or on the
organization [provision of health care]

New medicines mar-
keted applying for
compensation
All medicines in-
cluded in the
efits system before 2002

For newly marketed innovative medi- cines, products not included in the pos- itive drug list

Implementation:
Role in the final decision.making

Published in the Gazette as state law

Recommendation Fi- nal return decision: UNCAM and MoH

Final decision with legal force

Recommendation Final decision: MoH

Transparency

It is posted on the E.O.F. website.

The final evaluation
report and the deci-
Sion are published on
the HAS website

Decisions and eval- uation reports are available to the pub- lic

The decision and
assessments are not
vailable to the public

SBU: Statens Beredning for Utvardering av Medicinsk Teknologi -Swedish Council on Technology Assessment in Healthcare, HAS: Haute Autorité de Santé -National Authority for Health, UNCAM: Union National des Caisses d' Assurance Maladie (French National Union of Health Insurance Funds). MoH: Ministry of Health, EOF: National Medicines Agency, NPRC: Na- tional Pricing and Reimbursement Council
Sources: 1.AlexandraBeletsi (2018) Comparing Use of Health Technology Assessment in Pharmaceutical Policy among Earlier and More Recent Adopters in the European Union, 2. Law 4512/2018 - Government Gazed 5/A/17-1-2018 ( Articles 239 - 406)

Table 1: HTA System Policy Implementation

Item	Greece	France	Sweden	Bulgaria
Competent body (preparation, process- ing, and reporting)	MoH, Greek HTA	HAS	SBU/ and/or Swedish health assessment and evaluation service	NPRC
Competent body	Committee for the Evaluation and Com- pensation of Medici- nal Products for Hu- man Use	Department of Drug Eval- uation (clinical evaluation) Department of Economic and Public Health (eco- nomic health assessment)	SBU Workgroups	Expert opinion: HTA Committee
Competent body / com- mittee	Greek HTA	Committee on Transpar- ency (compensation) Eco- nomic and Public Health Assessment Committee CEPS (pricing)	SBU Council on Pharnaceutical Benefits	Expert opinion
Clinical data/safety	Yes	Yes	Yes	Yes
Relative efficacy	Yes	Yes	Yes	Yes
Economic analysis	CBA/CEA/CUA	CEA / CUA (tidy)	CEA/CUA, cost com- parison, cost, depend- ing on the treatment	CEA/CUA
Evaluation criteria	Clinical benefit, parison with the medicines already avalible degree of reliability of clinical studies Cost/etttciency ratio. pact on the budget.	Clinical benefit, disease se-varities avalibility of other atments. Purpose of use revendve, svznptomatic„ therapeutic) Ettects on public health. Cost,'ettjcacy ratio - ces in European coun-	Principle of human val- Principle of need and solidaritv Principle Of cost-effectiveness Negative disease Managed entry agree- ment between countrv councils and pharmaceutical company	Scorecard with specific criteria: Clinical effectivene ss and safety Economic dence Budget evidence impact analvsis Opinion France, the Unit- ed Kingdom, and HTA assessments of other EU countries
Minimum cost / QALY	Not	Not	Not	No
The evaluation report is available to the public	Yes	Yes	Yes	No
ETA: Health Technology Assessment, SBU: Swedish Council on Technologv Assessment in Healthcare, HAS: Haute Autofité Santé -National Authontv for Health, MoH: Ministry of Health, NPRC: National Pricing and Reinlbursement Council, CBA: cost-benefit analysis, CEA: cost-effectiveness analysis, CUA: cost-utility analysis Sources: l. AÄandra Beletsi (2018) Use of Health Technology Assessment in Pharmaceutical Policy among Earlier and More Recent Adopters in the European 2. Law 4512/2018 - Government Gazed 5/A/17-1-201S ( Articles 239 - 406)

Table 2: HTA system data: technological decisions of Greece, France Sweden, and Bulgaria: evaluation and evaluation

Tables at a glance