Helping healthcare companies enable patients gain rapid and maintained access to life saving and enhancing healthcare, through innovative Market Access solutions globally

Market Access

GlobalMarketAccess

A Challenging EnvironmentEconomic crises and slow economic growth across Europe with cost containment agenda

Slowdown in economic growth in Emerging Markets with evolving reimbursement processes

US environment changes due to ACAand economic challenge on rising costof healthcare

Affordability questions andchallenges on sustainability of pricesof innovative medicines

Questions on price setting transparency

Generics as Standard of Care inmany diseases

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The Challenge of Multiple Stakeholders Internally and ExternallyDefining the Market Access value strategy which aligns with and delivers the commercial strategy

Defining the evidence requirements which deliver the value strategy across customer groups

Mapping and managing the relationships across complex customer decision making organisations

Defining the appropriate Value Proposition and Value Story for specific customers and archetypes

Engaging with cross-functional colleagues who may not have Market Access as their key priority

Engaging with local teams who are responsible for multiple brands

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The challenge of gaining successful reimbursement, price and funding approval

Market Access

The Challenge ofThe Right Toolsand ProcessesA Market Access framework embedded throughout the company Payer requirements built into clinical and HEOR evidence development comparators and end points

Payer requirements developed in the right time frame to be included in Phase III

A target reimbursable product profile

A compelling Value Proposition and Value Story which maximizes the brand value

Ensuring the Value Story is robust through in-depth Payer market research

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Capability andCapacity ChallengesThe right competencies and capabilities in place

The right head count for the workload

Clarity on roles and responsibilities; Global region-country, cross-functionally

A clear competency framework,cross-functional

A capabilities curriculum which delivers the competencies

An appropriate training program inplace to build the capabilities andembed the processes

Customer-facing teams engagedto build passion and belief as wellas competence and confidence

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Global Market Access Thought Leader with 18 years successful experience delivering world-class solutions tailored to your specific business needs.

Delivering bold, challenging and innovative solutions for clinical and HEOR evidence development and brand commercialisation, because market access is the single most important determinant of commercial success.

Highly experienced consultant team with senior level Pharma experience in complex, international organizations with proven ability to deliver, roll out, embed and operationalise solutions and build capabilities for client teams on the ground across North and South America, Europe, Africa, Middle East and Asia Pacific.

Solutions which work in practice, delivering measurable business impact from day 1.

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Market Access

Our Philosophy and Approach to Market Access

Develop the commercial,

Market Accessand regulatory

strategy to maximise the value

(e.g. NPV) of the asset or franchise to the client by delivering

greatest value to patients, physiciansand payers

Identify the evidence whichwill be requiredby regulatory

agencies, pricing and

reimbursement (P&R) and HTA agencies and

budget holders to enable

achievementof the strategy

Generation of the clinical, HEOR and Real World Evidence

to meet the requirements

and criteria forthe regulatory

agencies,P&R / HTA

agencies and budget holders

Develop, test and train

the materials required to

communicate the evidenceto regulatory

agencies,P&R / HTA

agencies, Policy makers and

budget holders

Demonstrationof the value

being deliveredto the

healthcare system through

prospective patient

outcomes data

VALUESTRATEGY

VALUEIDENTIFICATION

VALUEEVIDENCE

GENERATIONVALUE

COMMUNICATIONVALUE

DELIVERY

GalbraithWight leads the agenda in developing innovative market access solutions at international meetings with Payer Customers

Thought Leadership and Innovation in Market Access

Key Facts1. Founded in 1997 18 years successful experience2. Offices in UK, Italy and USA3. Three Centres of Excellence: Market Access Brand and Launch Excellence Insight Market Research and Access Intelligence4. Highly experienced Consultant team in Europe, US and Asia Pacific

5. Extensive international Payer network

GalbraithWight symposium Do we need innovative measures to measure innovation in Market AccessISPOR Conference, Berlin 2012

GalbraithWight symposium Building, Embedding and Optimizing Market Access Capabilities From Strategy to ExecutionISPOR Conference, Dublin 2013

Silver sponsor of HTAI Key annual global meeting with over 600 delegates from HTA agencies, Health Ministries and academia.HTAI Conference, Washington DC 2014

Pricingand

Market Access Strategy

Development and

Pricing Research

Embedding Market Access requirements

into global Clinical

Development Decision Gates

Market Access Value Story

Developmentand

Research Testing

HealthEconomic Modelling

Early Scientific Advice

Regulatoryand

HTA

Market Access Disease Area

andPayer

Landscape Insight

Research

Brand Marketing Planning

process with Market Access

embedded

Health Economics

andOutcomes Research Planning

andPublications

Our services which help you achieve successful reimbursement, price and funding approval

Clinical Development and Commercialisation Process

Our services which help you achieve successful reimbursement, price and funding approval

Clinical Development and Commercialisation Process

Payer Networks and

Strategic Advisory Boards

Training Market Access Teams in Value Story

Deliveryand

Payer Engagement

Market Access Communication

Materials development

Launch Excellence Tools

andProcesses with Market Access

embedded

Pricingand

Reimbursement Agency

Engagementand

Negotiation

Core Market Access

Value Pack/Value Dossier Development

Market Access

Case Study 01Breakthrough Innovation Affordability ChallengeClient Challenge:Innovation in metastatic melanoma. Novel dosing four induction infusions. High price ~$120k. Potential for long term survival. Payers unaware of disease burden and poor prognosis. Economic crisis in Europe. GalbraithWight commissioned to develop Value Story for Europe and train European access teams within six months.

Our Solution:Value Story developed in collaboration with key markets and tested in 4 months. Launch then accelerated by three months. Teams trained from nineteen countries, in nine languages to build belief and passion to handle challenges from Payers.Our Value Story then adapted for the European MSL team. As a result GalbraithWight commissioned to develop versions for Latin America, Middle East and Emerging Markets, and input to global team.Result:Access to sales of over $1.2b since launch*.Having GalbraithWight as a partner for the Access activities on YERVOY has been invaluable.Their core strengths clearly lie in Market Access, this is what they do day in day out, unlike other agencies where Access is an add on capability, and this shows. Executive Director, BMS

Case Study 02Optimizing Phase III Trial DesignClient Challenge:Successful Phase II showed much promise for new treatment for respiratory disease. Critical that Phase III design included key Payer requirements, not just regulatoryagency requirements to ensure successful access at launch. GalbraithWight commissioned to build specific European Payer recommendations for Phase III design.

Our Solution:Key Payers in Europe identified who could provide high quality input to Phase III design. We have conducted interviews with top-level European Payers to understand their reactions to the clinical profile and pricing potential for this new product. We tested two product profiles and gained insights from the Advisors concerning questions from the Market access and Commercial team. We then developed a comprehensive report for the client with strategic recommendations on the further development of the product.Result:As a result, the Chiesi Global team feel that they have a better understanding of the market opportunity for the product in development. Not only are they able to provide guidance to the clinical teams on which evidence data endpoints would be necessary to achieve a positive HTA evaluation, but they are also clear on the product pricing potential, and what approaches to pricing they should take to ensure optimal price negotiation.

Realising the value forour clients

* BMS Annual Reports 2011- 2014 Yervoy ex-US sales

Case Study 03Archetype Specific Value StoriesClient Challenge:Innovation in metastatic breast cancer FDA breakthrough status. Payers unaware of disease burden and poor prognosis specifically in ER+/HER2- population. GalbraithWight commissioned to develop market access archetypes for key global markets and develop archetype-specific Value Story variants.

Our Solution:Payer archetypes developed for key markets at national, regional and local level. Market Access case studies developed to build key learning from recent relevant market access decisions and evidence requirements. Key markets engaged directly to ensure high level of buy-in to the process to enhance subsequent adoption of solution. Five archetype-specific Value Story variants developed to ensure high degree of Payer relevance in different archetype settings.Quickly ramped up on palbociclib, which I was pleased about because we had brought them in especially as a fresh pair of eyes on the product. Very good. Very excellent. The responsivenessand flexibility was very high. Senior Director, Global Health & Value

Case Study 04New Evidence for Life Cycle EvolutionClient Challenge:Saxagliptin originally launched in 2009. Results from three year CV outcomes study imminent (SAVOR Study). In addition many European HTA agencies opened a review of DDP4 inhibitor class. GalbraithWight commissioned to develop and test global SAVOR Value Story, localise the Value Story and gain Payer input on economic model.

Our Solution:Value Story developed in collaboration with key markets and tested in EU5, Canada, Mexico and China. Value Story then adapted post research testing and incorporating final SAVOR results. Value Story rolled out and localised with key markets through workshops run locally in local language. Economic model researched with Payers to ensure a robust final version.

Result:Continued access to the monotherapy and combination brands and contribution to AZ diabetes franchise sales of over $1.8b annually**.For Payer strategy, positioning with payers, market landscape research, value story creation and message testing, absolutely would recommend. Senior Director, AZ

** www.astrazeneca.com

Realising the value forour clients

Case Study 05Building Advanced Market Access CapabilitiesClient Challenge:Requirement to build high level Market Access capabilities for the global Market Access teams based in Basel, Switzerland and Hyderabad, India. GalbraithWight commissioned to develop two waves of intensive training, including WebEx-based plus face to face training sessions in India.Our Solution:Comprehensive curriculum developed based on defined Learning Outcomes for global Market Access and HEOR teams. Content based on latest academic theory plus practical case studies and examples of real-life decisions and evidence requirements. First wave conducted via WebEx. Second wave conducted face-to-face in India plus WebEx sessions with expert Faculty on wide range of subjects including country healthcare systems, HTA, HEOR and RWE.Result:Program delivered to global teams.Pricing and MA is quite complex and exhaustive if youre looking for something under one roof GW is an agency that can cover this. GW is a good resource and an institution where youll find trainers with extensive working experience across a range of modules. If youre looking for real-time examples to supplement or complement learning thats a huge advantage youll have from attending a course with GW. Global Market Access and HEOR team delegates, Novartis

Case Study 06Building Core Market Access Capabilities forGlobal MarketingClient Challenge:Requirement to build market access understanding into global brand planning process. GalbraithWight commissioned to develop and deliver highly relevant up to date training program for global Marketing Directors using case studies, working with global Market Access and global L&D team.Our Solution:Multi-channel training program developed including e-Learning modules, WebEx Q&A sessions plus case-study based face-to-face training. Content for face to face training built using BMS brand planning process to ensure direct relevance and application by target audience. Two Market Access case studies developed to demonstrate Payer requirements. Train the Trainer session developed to enable Client Market Access team to work as co-deliverers of the program.Result:Program piloted then rolled out for global Marketing. Highest feedback rating ever achieved (9.3/10).Best training that I have been to in all my years at BMS. I thought I understood access, but I really learned some things that will be helpful in my day-to-day [work]. Executive & Senior Director and Director delegates, BMS

Realising the value forour clients

Our Philosophy and Approach to Market Access

Global Market Access Thought Leader with 18 years successful experience delivering world-class solutions tailored to your specific business needs.

Delivering bold, challenging and innovative solutions for clinical and HEOR evidence development and brand commercialisation, because market access is the single most important determinant of commercial success.

Highly experienced consultant team with senior level Pharma experience in complex, international organizations with proven ability to deliver, roll out, embed and operationalise solutions and build capabilities for client teams on the ground across North and South America, Europe, Africa, Middle East and Asia Pacific.

Solutions which work in practice, delivering measurable business impact from day 1.

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Market Access

ContactGalbraithWight Head Office

GalbraithWight LtdGalbraithWight HouseChaucer Business ParkDittons RoadPolegateEast SussexBN26 6QHUnited Kingdom

Tel: +44 1323 482 208info@galbraithwight.comwww.galbraithwight.com

GalbraithWight USA Office

GalbraithWight Ltd148 Fairway DrivePrincetonNew Jersey08540USA

Tel: +1 609 924 5486info@galbraithwight.comwww.galbraithwight.com

GalbraithWight Italy Office

GalbraithWight LtdMilanofiori, Strada 6, Assago,Edificio A, Scala 13, Piano 1,20090 Milano,Italy

Tel: +39 342 1487703info@galbraithwight.comwww.galbraithwight.com