A comprehensive database on drug assements and HTAs in Spain. Market access and its impact on decision making. Objectives: (1) To provide a comprehensive overview on HTA and its increasing impact on market access of these new drugs and technologies in Primary Healthcare Centers (PHCs) and hospital. (2) To offer an effective tool to identify new and current assessments published in Spain on your product and competitors focused on the outcome measures used for its recommendations in its specific area; PHCs or hospitals. (3) To assess the real impact of a recommendation on prescription patterns in daily practice. Key messages: (1) There are numerous drug unit departments of CCAAs and collaborations between CCAAs (CmEVN) and hospitals (GENESIS) that perform drug assessments, each using different guidelines and protocols for their assessments. (2) Spain also has one national HTA agency and several regional HTA agencies. Publication of HTAs has been more structured with the founding of AUnETS from which all agencies are member. (3) Despite all initiatives to collaborate more on drug assessments and HTAs, a lot of reports and their recommendations are published at a regional or hospital level. (4) Investigation of the impact of drug assessments and HTAs on a regional and hospital level therefore is crucial for the successful market access of a new drug or technology. (5) Knowledge on the scientific evidence and outcome measures to be investigated (e.g. efficacy, effectiveness, safety, costs, cost-effectiveness, budget impact etc.) is important to guarantee a successful appraisal. (6) Evaluation of the ranging impact of recommendations on prescription in daily practice in different settings; e.g. one region versus another region etc.

1. A COMPREHENSIVE DATABASE ON
DRUG ASSEMENTS AND HTAs IN
SPAIN
MARKET ACCESS AND ITS IMPACT ON
DECISION MAKING
BCN HEALTH
Travessera de Gracia 62, 5-6
08006 Barcelona
Spain
enquiries@bcnhealth.com
Tel: +34 932 091 865
www.bcnhealth.com
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2. BACKGROUND
Spanish Healthcare System
o Spain has a public National Health Service, providing universal, comprehensive care
and full access to health services as general practitioner (GP) services, hospital services
and emergency treatment free at the point of delivery. In the public sector, the only
time a patient may have to make a co-payment for care is when a prescription
medication is dispensed at a retail pharmacy.
o The Spanish healthcare system is a highly decentralized one, although the inclusion of
health care services are arranged at a national level. The country is divided into 17
Autonomous Communities (CCAAs) each with similar but slightly different healthcare
systems.
o Each CCAA can set additional requirements for including healthcare services as
pharmaceuticals, medical devices, diagnostics and other new technologies in their
region. For example, they can set lower drug prices or limit the use of expensive services
by introducing a visa for specific treatments. The most important CCAAs are Andalucia,
Catalonia, Madrid, Basque country and Valencia, because of their population and/or
economic interests.
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Spain has a decentralized healthcare system. Each of the 17
Autonomous Communities have a similar but slightly different
healthcare system with its own responsibility for resource allocation
and budget planning, as well as drug assessments and HTA.

3. OBJECTIVES
1) To provide a comprehensive overview on HTA and its increasing
impact on market access of these new drugs and technologies in
Primary Healthcare Centers (PHCs) and hospital.
2) To offer an effective tool to identify new and current assessments
published in Spain on your product and competitors focused
on the outcome measures used for its recommendations in its
specific area; PHCs or hospitals.
3) To assess the real impact of a recommendation on prescription
patterns in daily practice.
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4. MARKET ACCESS
Considerations for market access
o Payers are gaining increasing influence over the access to drugs and new technologies
(e.g. cost-containment measures, prior authorisation, reference pricing etc).
o Payers who are managing healthcare budgets are under increasing pressure to balance
their budgets on the short as well as on the long term.
o To make decisions payers are now increasingly demanding more information on new
drugs and technologies including data on economic parameters like costs, budget impact
and cost-effectiveness of drugs and new technologies .
o As healthcare is regionally organised in Spain CCAAs can add additional requirements on
data for market access of new drugs or new technologies in their PHCs.
o On a hospital level, the real decision makers for the introduction for a new drug or
technology are medical personnel. Apart from clinical evidence that need to convince
physicians to use the drug, the hospital budget is another constraint as the new drug or
technology will have to compete with standard treatments for the same budget.
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The main objective of Market Access is to facilitate the successful and
rapid uptake of a new drug or technology at an optimal reimbursed
price. The role of the payer in determining treatment paradigms for
patients is crucial. At the hospital level the real decision-makers for the
introduction of a new drug or technology are medical personnel.

5. SERVICES
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1) We will identify all drug assessments and HTA reports on
´your product´ and its ´primary competitors´ at your level of
interest (region and/or hospital)
2) We will summarize the outcome measures assessed and its
final recommendations
3) We will evaluate the real impact and influence of the actual
recommendations.
4) We will provide you with a roadmap regarding the steps to
follow to succeed on your level of interest.
To optimize the preparation for a successful market access
strategy for ´your product´ at your level of interest

6. C0NTACT INFORMATION
Pricing & Market Access Services
Travessera de Gracia 62, 5-6 08006 Barcelona - Spain
enquiries@bcnhealth.com
Tel: +34 932 091 865 Tel: +34 659 860 948
www.bcnhealth.com
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