Kraków, 23 marca 2017

Market Access Sentinel

for Central & Eastern Europe

(MAS INT + CEE)

Kraków, 2017

Contact person:

Karolina Skora

Chief Operating Officer

Tel.: +48 669 774 776

E-mail: kskora@inar.pl

Kasia Kocyan

International Project Coordinator

Tel.: +48 669 322 632

E-mail: kkocyan@inar.pl

Instytut Arcana

Plk. St. Dabka 8 street

30-732 Cracow, Poland

Tel. +48 12 26 36 038

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TABLE OF CONTENTS

1. COMPANY BACKGROUND ......................................................................................................................3

2. MAS CEE BACKGROUND ...........................................................................................................................4

3. MAS DATABASE: NEWSLETTER & PORTAL .........................................................................................5

3.1 News Item Sources ................................................................................................................................... 5

3.2 Newsletter Monitoring & Preparation .................................................................................................. 7

3.3 MAS Portal ................................................................................................................................................... 7

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1. COMPANY BACKGROUND

History

Arcana Institute (INAR) is the leading HTA and market access (MA) service provider for the Polish

market. Since beginning operation in 2002, we have supported our clients in product development and

MA using an evidence-based approach to bring safe and effective treatments to the market worldwide.

As an integrated part of LASER Analytica, an international scientific and research organisation, INAR

provides comprehensive HTA and MA assistance to the pharmaceutical, bio-tech and medical device

industries across Central & Eastern Europe (CEE).

About Us

Our team consists of 40 experts specialised in pharmacoeconomics, medicine, mathematics,

biotechnology, economics and statistics that serve our Clients and their needs. Our expert employees

have a wealth of cross-industry experience, having worked in regulation, HTA agencies, Ministries of

Health and pharmaceutical companies, to name a few.

We are proudly the first Polish provider of the complex MA support service in the CEE Region.

We offer full support throughout the entire reimbursement process and beyond. In the past five years

alone, we have completed 250 HTA dossiers throughout the CEE, all validated by the appropriate

regulatory bodies. Our portfolio includes HTA reports for both innovative technologies and generic

drugs supported by our researchers experienced in international projects in cooperation with LASER

partners from the USA, France, Germany, Spain and the UK. Just last year we participated in about 30

projects carried out for both international companies and foreign public organizations (such as EFSA).

Within the LASER Group we are considered the ‘centre of excellence’ for carrying out systematic

reviews and preparing HTA reports for the CEE region.

Our understanding of global healthcare trends and MA requirements enable us to offer strategic

HTA-related services to our clients, helping reach their business objectives and their sustainability

goals. We assist our Clients with the following, but not limited to:

Development and implementation of MA strategies

Legal counselling

Pharmacoeconomic modelling

Systematic reviews

Preparation of reimbursement dossiers in accordance with requirements in CEE countries.

INAR offers its Clients necessary support throughout the reimbursement dossier submission process.

Our company’s Client range encompasses Romania, Bulgaria, Greece, Slovenia, Hungary, Czech

Republic, Poland, Slovakia, Croatia, Serbia, Baltic States.

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2. MAS CEE BACKGROUND

MARKET ACCESS SENTINEL FOR CENTRAL AND EASTERN EUROPE (MAS CEE)

The CEE region consists of 380 million people spanning over twenty countries. Our experience

working with HTA in the CEE region has shown us that the region holds great potential for MA ready

to be uncovered.

Due to a strong competitive environment and existing legal restrictions in local and international

markets, activities related to reimbursement require excellent knowledge of all risks and opportunities

occurring in the selected market(s). Such knowledge is attained by gathering relevant information from

various sources. However, as MA information in the CEE region is supplied in foreign languages, it may

be difficult to find and access. In response, we have created the Market Access Sentinel (MAS) CEE

service to allow users quick and easy access to information from multiple sources all in one place,

providing the most important and up-to-date MA-related information across the CEE region and

beyond.

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3. MAS DATABASE: NEWSLETTER & PORTAL

QUICK AND EASY ACCESS TO MAS NEWS

MAS News is a daily service that delivers the most up-to-date MA related news, hand-picked by experts

in reimbursement. The service is available in the following formats:

Daily electronic Newsletter delivered daily to user’s e-mail

Online news Portal (www.MASentinel.com) that includes an advanced search engine and

other features to enable quick tracking

o E.g. Tracking marketing authorisation history of a specific product in different countries,

reimbursement recommendations and decisions worldwide

MAS is based on constant monitoring of CEE and other international MA news sources, carefully

selected for importance and delivered MAS subscribers via a newsletter and the MAS Portal

(www.MASentinel.com).

All news information is presented in short, comprehensive and interactive English news leads

summarised from foreign sources. MAS aims to ensure that its users are always up-to-date on the

latest MA news without wasting time browsing through dozens of websites and filtering unnecessary

details.

3.1 News Item Sources

LOCAL EXPERTS AND THE INTERNET

Information generated for the MAS service comes from news sources provided by local experts, either

online or print, which is then assessed, selected and prepared by CEE and INAR experts. We consider

collaborating experts to be the most significant part of our service as they possess a wealth of

knowledge and experience in MA and reimbursement. This personal approach ensures that only the

highest quality of MA information is provided.

MORE THAN 600 INTERNATIONAL NEWS SOURCES CONSTANTLY MONITORED

News for MAS is collected from a network of MA experts in the CEE region and from more than

600 international sources. News sources may include websites of public authorities, regulatory and

HTA agencies, as well as popular pharmaceuticals websites and news Portals. Some agencies that are

monitored by our experts include NICE, SMC PBAC, HAS, PTAC, NCPE, IQWiG, CADTH, SBU,

ICER, AHRQ KCE, AWMSG, AQuAS, Prescrire as well as local HTA Agencies in CEE countries for

news that include new/updated reimbursement recommendations, legal changes, marketing

authorisations, safety records, clinical trial milestones and important events.

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THE MAS SERVICE IS DIVIDED INTO CEE AND INTERNATIONAL PARTS

EXAMPLE OF MAS CEE NEWS SOURCES

MAS International

• Provides information about registration and drug safety published by, but not limited to, EMA, FDA, HMA, MHRA and reimbursement recommendations published by national agencies (from EU5, USA, Canada, Australia, New Zealand)

MAS CEE

• Created in collaboration with a network of experts from the countries of Central and Eastern Europe, covering 25 CEE countries, including Greece & Turkey. All news is provided in English.

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3.2 Newsletter Monitoring & Preparation

INAR MAS system monitors multiple sources on a daily basis for MA related news items. Our local

experts then select all relevant news items and prepare news leads in English. INAR incorporates final

news leads and sources, which are sent out via MAS Newsletter to subscribers daily and available on

the MAS Portal.

3.3 MAS Portal

MAS SERVICE FEATURES

While the Newsletter offers a quick look at daily news leads, it also allows users to connect to the

MAS Portal at MASentinel.com. The MAS online Portal offers the following features:

Advanced search engine to find necessary news

Tagging of news items for easy access to similar topics

Thread to earlier news of the same news item

Bookmarking favourite or important news

Access to original news source from news leads

‘Ask an expert’ option for more information regarding a specific news item

o This function allows user to ask for more information on news item or the original source

o This is useful when original news sources are in languages foreign to users

List of most popular news accessed by users

Calendar of relevant events and conferences

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The most commonly used feature of the Portal is the advanced search engine that allows for browsing

of news from 2012 up to the present day. This feature allows users to quickly view news information

of a specified topic (e.g. history of a specific product in different countries in terms of obtaining

marketing authorisation). Another commonly used feature of the MAS Portal is ‘MY TAGS’, which

allows the user to personalise the newsletter to view all important information based on specified

topics (e.g. reimbursement recommendations of chosen country or most important information on a

specific product).

Advanced search engine

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To receive the daily MAS newsletter and test out all the features of the Portal, sign up for a FREE 30-

day trial today by contacting us at ceedevelopment@inar.pl or filling out a form on our website at

www.inar.pl.