Market Access, Pricing and Reimbursement streamlined

9th

- 10th

June

Hilton London Kensington Hotel

United Kingdom

Market Access, Pricing and

Reimbursement

2016

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Dr. Simone Breitkopf, Head HEOR, Governmental and Public Affairs, Alcon.

Dr. Frank Zhang, Global Head, Pricing and Market Access, Celgene.

Dr. Frans van Andel, Market Access of Health Technologies Directo9r HEAP Research BV Board Director, PPi Healthcare Consulting Ltd.

Ms. Ritva Lehtonen, Market Access & External Affairs Director, Hospital Tenders, Sanofi.

Mr. Steve Bradshaw, Managing Director, Valid Insight.

Mr. Toro Şahin, Head of Market Access and Health Economics, Sanofi.

Mr. Thomas Temme, Head if Market Access & Public Affairs, Shire.

Mr. Richard Marsh, Head of Market Access, Allergan.

Dr. Pearl Gumbs, Senior HEOR Manager, Daiichi Sankyo.

Dr. Adam Kundzweicz, Senior Global Payer Strategy Manager, Head of Pricing, Borhringer Ingelheim.

Mr. Sascha Glanemann, Head of Market Access, Teva.

Mr. Ulf Staginnus, Head Patient Access Oncology, Region Europe, Baxalta.*

Mr Jordi Marti, Vice President and General Manager, Celgene.*

Ms. Carla Niven, Senior Principal, IMS Health.*

Mr. Yariv Hefez, Vice President Head Global Oncology Marketed Products Biopharma|Global Business Fran-chise Oncology, Merck.*

Ms. Gwilym Thompson, Health Economics Lead, Diabetes, Janssen.*

Dr. Carmelo Formica, Vice President, Global Market Access, Takeda.*

Featuring Key Industry Experts

ASSOSCIATE SPONSORS EXHIBITORS

9th

- 10th

June Hilton London Kensington Hotel United

Kingdom

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Market Access, Pricing and Reimbursement 2016

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E m a i l : i n f o @ p a r a d i g m g l o b a l e v e n t s . c o m

W e b : w w w . p a r a d i g m g l o b a l e v e n t s . c o m


Dr. Frank Zhang, Global Head, Pricing and Market Access, Celgene.

Dr. Frans van Andel, Market Access of Health Technologies Directo9r HEAP Research BV Board Director, PPi

Healthcare Consulting Ltd.

Ms. Ritva Lehtonen, Market Access & External Affairs Director, Hospital Tenders, Sanofi.

Mr. Steve Bradshaw, Managing Director, Valid Insight.


Mr. Thomas Temme, Head if Market Access & Public Affairs, Shire.

Mr. Richard Marsh, Head of Market Access, Allergan.



Mr. Sascha Glanemann, Head of Market Access, Teva.

Mr. Ulf Staginnus, Head Patient Access Oncology, Region Europe, Baxalta.*

Mr Jordi Marti, Vice President and General Manager, Celgene.*

Ms. Carla Niven, Senior Principal, IMS Health.*

Mr. Yariv Hefez, Vice President Head Global Oncology Marketed Products Biopharma|Global Business Fran-

chise Oncology, Merck.*

Ms. Gwilym Thompson, Health Economics Lead, Diabetes, Janssen.*

Dr. Carmelo Formica, Vice President, Global Market Access, Takeda.*

Featuring Key Industry Experts

ASSOSCIATE SPONSORS EXHIBITORS

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Market access is a complex and protracted process that pharmaceutical and biotech companies go through in order to ensure their products are made available in as many countries as possible and most importantly that these products are reimbursed and made available to patients who needs them. Due to the development of more and more hi-tech drugs coming to the market, market access has become very important over the last 5-10 years resulting in increasing pressure on healthcare systems and/or governments to cut the costs of their drugs bills. For example, the National Institute of Clinical Excellence (NICE) plays a key role in the UK market – deciding whether or not new treatments are cost effective. In order for companies to have their products reimbursed at the best price possible by the NHs they must work harder, gather many data around the health economic impact and cost effectiveness of their products and present their data to NICE.

Today market access has become far more challenging due to a number of factors: the increase of competing drugs in the same therapeutic area, the need to contain rising costs, dependence of evidence based medicine and health technology assessment to influence payer decision. In addition, Biosimilar drugs have given payers more choice in deciding what products they will cover.

It has been said that the emerging markets are a key driver of the global pharmaceutical industry’s growth and will be for years to come. IMS Health has predicted that by 2017 they’ll account for one-third of industry sales and still be growing at double-digit rates.

The two-day Market Access, Pricing and Reimbursement 2016 Europe will provide a unique platform for the convergence of stakeholders in the industry to interact, discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals and non-profit organizations as well as regional and local manufacturers to discuss and share on the macroeconomic factors, policies, issues and drivers that will steer pharmaceutical industry.


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Who Will You Meet

Presidents, Heads/Chiefs, Directors, VPs and Managers of:

Market Access

Pricing and Reimbursement

Patient Outcomes

Health Economics and Outcomes Research

Payer Relations/ Evidence

Data Management/ Analysis

Regulatory Affairs

Public/ Government Affairs

Payers, HTA Officials and Physicians

Gain Latest Insights On

Market Access strategies: How can we maximize our strategies?

Early Market Access of Health Technologies: The implications.

Challenges & Opportunities in pharma pricing, reimbursement and market access: Changing market trends and influences

Emerging Markets: What knowledge, strategies and resources will be needed to maximize pricing and access and hurdles faced.

Pricing & Reimbursement: for Orphan Drugs and Biosimilar

Patient Access: How can this continue to improve?

Data Collection & Management: Using Real World Evidence and Patient Reported Outcomes for pricing and access

International Collaboration: Where do we agree and differ?

Looking to the Future: What lies ahead?

HILTON LONDON KENSINGTON

179-199 HOLLAND PARK AVENUE,

LONDON,

W11 4UL,

UNITED KINGDOM

Reservations: 020

7603 3355

Website:

www.hilton.com

KEY INDUSTRY EXPERT SPEAKERS

Dr. Simone Breitkopf, MD PhD

Head HEOR, Governmental and Public Affairs, at Alcon, Germany since 2012

Medical Doctor, trained in Psychiatry and Neurology, PhD in Neuropathology, since 1999 different leading positions in Pharmaceutical Industry, from 2006 to 2011 Head Clinical Research and Pharmacovigilance at BPI, German Pharmaceutical Industry Association. Expert in Outcomes Research, Health Care Research, HTA and Pharmacoeconomy, long experience in Public and Governmental Affairs. Since joining Alcon responsibility for pharmaceuticals and devices, involved in German AMNOG procedures and new regulatory framework for devices. Member in various scientific associations like dggoe, DNebM,

Dr. Frank Zhang

Global Head, Pricing and Market Access, Celgene.

Frank is Global Head, Pricing and Market Access of Immunology & Inflammation, Celgene. Prior to

joining Celgene in 2010, Frank held leading global Pricing and Market Access positions at J&J and

Wyeth. Frank specializes in strategically creating and enhancing value, demonstrating value

proposition, and maximizing pricing and market access potentials of pharmaceutical products and

portfolios. Frank has a track record of Building franchise P&MA teams from ground up; Driving

corporate executive P&MA decisions; Optimizing P&MA potentials through innovative HEOR

strategies; and Building creative, effective and comprehensive P&R toolkit with successful

launches.

Frans van Andel Access of Health Technologies, Board Director PPi Healthcare Consulting Ltd

Short bio: Dutch nationality. Board Director of PPi Healthcare Consulting Ltd. Degrees in health economics (Universities of Groningen and Utrecht) and public health (Harvard, USA). PhD in pharmaceutical economics. More than 25 years of experience in market access issues involving pharmaceuticals and medical devices with work experience in the pharmaceutical industry, CRO's and WHO. In addition, investment and healthcare restructuring projects (especially rehabilitation facilities for handicapped persons) for the public and private sector in Central and Eastern Europe, Africa, Middle East and Asia. Assignments from the health insurance sector, medical technology and pharmaceutical industries as well as institutional agencies such as the European Union, the World Bank and the Netherlands' Government. Expert in market access issues involving pharmaceuticals and medical devices, project development sourcing, health financing and insurance and public/private mix. Fluent in Dutch, English, German. Conversant in French and Russian.


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Dr. Pearl Gumbs Senior HEOR Manager, DAIICHI SANKYO, GERMANY

Dr. Pearl Gumbs acquired her MSc in Health Economics and Policy Administration from Maastricht University and MSc in Health Services Research from Erasmus University, Rotterdam. She later obtained her PhD degree in Pharmaco-Economics and Pharmaco-Epidemiology from the Utrecht University. Pearl has over 13 years of experience in both Academia setting and the pharmaceutical industry. She has had the opportunity to lecture and train students on various Market Access and HEOR disciplines across various European Universities. Her pharmaceutical industry experience encompasses over 8 years focusing on Health Economic topics which has led her to fulfil various roles at a Local, Regional and Global setting. Pear is currently working at Daiichi-Sankyo Europe where she is the Regional Sr Manager, Health Economics and Outcomes Research (HEOR) within the Market Access Department. Pearl Gumbs is currently living in Munich, Germany and enjoys various outdoor activities.

Richard Marsh, Head of Market Access, Allergan

Richard Marsh is Head of Market Access for the UK and Ireland for Allergan, a position he has held since 2013. Prior to that he has worked in market access and government affairs roles for two other major pharmaceutical companies as well as in consultancy. Richard has over 20 years of experience of working with the NHS and in health policy, having also been for five years the special adviser to the Secretary of State for Health.

Ritva Lehtonen

Patient Access and External Affairs Director, Hospital tender, Sanofi

Ritva is currently leading the access and pricing team in Finland for Sanofi group that is responsible for market access strategy and implementation including health economic, pricing and reimbursement as well as hospital tender strategy and implementation. External affairs and stakeholder management is essential part of the access activity. She has more than 20-year experience in the pharma industry for several functions including business as a business unit director, medical as medical director and regulatory as a regulatory manager. She is also working closely with other European countries especially with Nordic and Baltic countries. She is master in pharmacy by training from Helsinki University and eMBA from Helsinki University of Technology, Business Economics. She had taken several continuing education courses in relation to professional tasks like health economic and pricing.


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Place holder

Thomas Temme

Head of Market Access & Public Affairs Germany, Austria & Switzerland, Shire

Thomas started his career as a business development manager at a biopharmaceutical

startup company, working on 8-digit in- and out-licensing and M&A projects as well as the

company’s IPO. In his role as project manager in a strategy consulting firm, he consulted

various large German health insurances and medical technology companies and worked on

AMNOG processes with a large number of pharmaceutical companies. In 2014, Thomas

joined Shire to head the market access and public affairs work in Germany, Austria and Swit-

zerland. He holds a master’s degree in sociology and an MBA.

Toros Şahin

Head of Market Access and Health Economics, Sanofi

Toros Şahin is Market Access & Health Economics Director at Sanofi Group Turkey,

responsible for pricing, reimbursement and health economics activities under the

umbrella of Sanofi Group (Sanofi, Zentiva, Genzyme). He has received his undergraduate

and graduate (M.sc.) degrees from Boğaziçi University, on Molecular Biology & Genetics.

He has also completed a postgraduate program in Health Economics for Healthcare

Professionals at the University of York, UK. He previously worked for Sandoz in business

development and pricing & reimbursement fields and is working for Sanofi since 2008.

He is married with one daughter, fluent in English and beginner in German and Japanese.


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DAY ONE CONGRESS | THURSDAY 9TH JUNE 2016 08.00 Registration

09.00 Chairperson’s Opening Remarks

MARKET ACCESS & STRATEGIES

09.10

<Presentation>

Early parallel scientific advice EMA/HTAs for successful market access in Europe.

The process

Experience and key learnings

Impact on clinical development process

Impact on national HTA


09.50

<Presentation>

Holistic pricing and market access strategy and

collaborative implementation throughout

pharmaceutical lifecycle development

Dr. Frank Zhang, Global Head, Pr icing and Market Access, Celgene.

10.30 Morning Break & Networking

11.10

<Presentation>

Patient Data – The gateway to Market Access

Developing an effecting market access

strategy using field-based research

Communicating the value of the product to

a range of customers who influence uptake

Understanding the changing healthcare

market and its effect on patients/ customers.

Adapting strategies in response to it.

11.50

<Presentation>

Very Early Market Access of Health Technologies: What Are the Implications?

Dr. Frans van Andel, Market Access of Health Technologies Directo9r HEAP Research BV Board Director, PPi Healthcare Consulting Ltd.

12.30

<Presentation>

<Spotlight Presentation>

13.10 Networking Lunch


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CHALLENGES & OPPORTUNITIES

14.10

<Presentation>

Challenges in pharma pricing and market access'

Challenges in access environment including equitable access

What are the needs of our stakeholders, budget holders and influencers?

Challenges to a long term sight for access strategy

What are the issues in localization of the value stories?

Finland have suffered economic regression for some years and we are facing several cost containment challenges and saving plans by the government that is very similar to other European countries and the presentation will reflect this.

Ms Ritva Lehtonen, Market Access & External Affairs Director, Hospital Tenders, Sanofi.

MARKET ACCESS EXCELLENCE FOR EMERGING MARKETS

16.50

<Presentation>

What knowledge, strategies and resources will be required in order to maximize your company’s pricing and access in the emerging markets?

Understanding which types of markets offer

the greatest potential returns and what those markets want from you.

Gain insight on the ever-shifting payer

landscape and be better prepared to innovate in market access.

Hurdles faced in Emerging markets.

Which emerging markets are considered as

most relevant today and in the future?

Resources needed to maximize pricing and

access in the emerging markets. 17.30

<Presentation>

Market Access in Turkey: Risks and opportunities in the post Healthcare Transformation Era

Overview of Turkish Market Access & Healthcare Environment

Basics of the Turkish Pricing & Reimbursement System

Changing dynamics of the reimbursement system: Alternative models

Government’s mid-long term vision on pharmaceutical industry


18.10 Chairperson’s Closing Remark & End of Day 1

14.50

<Presentation>

How to overcome the challenges?

Ways in which market access can be made

successful

Local and global knowledge – Keeping up to

date on pricing and market access.

Understanding the local payer and decision-

maker needs as these relate to pricing, reimbursement and market access.

Identify and remove all barriers to

prescribing, ensuring a rapid uptake of a new

product at an optimum price.

Steve Bradshaw, Managing Director, Valid Insight.

15.30

<Panel Discussion>

The effect of global trends on payer decision-making and market access

Current market trends and influences.

The impact of market changes on drug

development and marketing needs.

What is the current and future market value?

What is the pricing and reimbursement

structure for orphan drugs in US and Europe?

16.10 Tea Break & Networking


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DAY TWO CONGRESS | F RIDAY 10TH JUNE 2016 08.00 Registration

09.00 Chairperson’s Opening Remarks

PRICING, REIMBURSEMENT & PATIENT ACCESS

09.10

<Presentation>

The evolving Oncology P&MA landscape

Pricing and market access trends for novel oncology products

Evolving payer evidence requirements (including impact of Immuno-oncologics)

Implications for novel oncology products

Ms Carla Niven, Senior Principal, IMS Health. 09.50

<Presentation>

To what extent does pricing need to be co-ordinated

What is a fair price? – taking into account

‘cost’ and ‘value’

How can price in Europe be made

consistent or compatible?

Setting a pricing structure and patient

access

Maximizing access to consumers – How

to overcome barriers to access in

10.30

<Presentation>

Market access and pricing for Biosimilars

Factors affecting market access of

Biosimilars – Registration, similarity, comparability studies, substitution, pricing and reimbursement.

Developing a consistent payer and pricing

strategy.

What impact will Biosimilars have on

healthcare costs? 11.10 Morning Break & Networking

11.50

<Presentation>

Three German dossiers: European Orphan Drug access diversity in the DACH nutshell

The effects of European rare diseases policy in the last 15 years

Similarities and dissimilarities of today’s access procedures for Orphans

Some success factors for orphan drug manufacturers accessing diverse European market

Country specific and joint themes and outlooks in Orphan drug politics & regulation

Mr Thomas Temme, Head if Market Access & Public Affairs, Shire.

12.30

<Presentation>

Accelerated Access: Delusion or Deliverable?

Richard Marsh, Head of Market Access,

13.10 Networking Lunch

14.50

<Presentation>

Implementing Patient Reported Outcomes to improve market access initiatives

The Key benefits of Patient Reported

Outcomes

Organising dedicated PRO teams to

enhance strategic focus and regulatory compliance.

Advantages of ePRO technology –

maximizing PRO efficiency.

15.30 Tea Break & Networking

COLLABORATIONS & LOOKING TO THE FUTURE

16.10

<Panel Discussion>

Future of pharma pricing, reimbursement and market access: What lies ahead?

Is the industry ready and equipped to meet the challenges presented?

How can the industry respond positively to rising concerns around cost, clinical data and involvement in the research process?

How can stakeholders collaborate in order to progress whilst continuing to provide safe and efficacy products?

Panelist:


16.50

<Presentation>

Are we ready for the Healthcare Future?

Connected Health is reality, Big data is already there, 3D Printing happen

Genomics is getting faster. Healthcare is getting customized, getting individualized.

Are our standardized HTA, pricing & reimbursement instruments prepared for this challenges.

Mr. Sascha Glanemann, Head of Market Access,

17.30

<Presentation>

Developments in pricing and reimbursement in leading pharma markets

Overall analysis of pricing and reimbursement in leading pharmaceutical markets.

How will the pricing and reimbursement landscape change from now to 2025?

Implications of pharma pricing and reimbursement legislation and related developments in the principal European pharm market.

Current & Future trends in the pricing and reimbursement sector.

18.10 Chairperson’s Closing Remark & End of Conference

DATA COLLECTION & MANAGEMENT

14.10

<Presentation>

Observational Data (OD) for Market Access purposes: Mind the Gap

The gap between research and market access

How to craft your data collection strategy?

How to disseminate the OD internally and externally?

How to close the gap between research and market access?



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SPONSOR SPACE


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EXHIBITOR/PANEL SPACE

Adam Kundzewicz – Senior Global Payer Strategy Manager, Head of Pricing UK, Boehringer Ingelheim

Adam is a Senior Global Payer Strategy Manager working in oncology pipeline at Boehringer

Ingelheim. He is managing global pricing and market access strategies for the oncology portfolio

and driving the development of innovative market access approaches and payment schemes.

Since September 2015 he is also heading the Boehringer Ingelheim Pricing Team working across

the whole Boehringer Ingelheim prescription medicines portfolio.

Prior to joining Boehringer Ingelheim Adam worked as a life sciences strategy consultant for IMS

Consulting, Truven Analytics and Simon-Kucher & Partners in Belgium, France, Germany, Poland,

Romania and The United States. He also worked as a research assistant at Jules Gonin Eye

Hospital in Lausanne, Switzerland and as a Junior Project Leader at AnalyCen in Poland and

Sweden.

Adam holds a M.Sc. in Molecular Biology and Biotechnology from University of Warsaw, Poland,

and a Ph.D. in Neurosciences from University of Geneva, University of Lausanne and EPFL,

Switzerland. He has published several articles in international peer reviewed journals, and

lectured at international conferences on developmental neuroscience and retinal degeneration.

Market Access, Pricing and Reimbursement streamlined

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