Market Access Consulting

Market Access Consulting

Table of contents 01 Optimize your drug development journey 02 Overcome your unique challenges 03 Transform your results 04 Unlock your value story 05 Solutions for your success 06 Partner for a competitive edge 07 Why Covance?

Optimize your drug development journey Innovative strategies for the new market access environment. The journey to successful commercialization of your drug or medical device is changing. New economic drivers, decision-makers, reimbursement models, and regulations impact the way your assets move through the drug development process and the health care delivery system. Demonstrating your product value is becoming as important as establishing safety and efficacy. Payments will increasingly be determined by outcomes, rather than intermediate outcomes or device utilities. The earlier you begin creating your value story, the greater the potential reward. Past approaches may no longer be effective or help you prepare for future challenges. Proactive strategies based on experience and insights are needed to optimize your journey from early clinical development to successful launch and commercialization. Covance can get you there. Our Global Health & Economic Outcomes Together, we can make faster, Research (GHEOR) and Access & Commercial Strategy (ACS) more experts informed decisions, provide unique perspectives to transform your drug development successfully journey. navigate the global regulatory environment, and accelerate your path to market. Together, we will work to transform today s possibilities into tomorrow s reality: your success. Phase IIIA/B challenges: Developing PRO and economic endpoints Developing the HEOR sections of your NDA/BLA Scheduling clinical and payer advisory boards Phase IIA/B challenges: NDA/BLA Life Identifying Completing Cycle challenges: Management economic key burden of illness Challenges opinion leaders to support your launch studies Obtaining Providing Completing an Phase FDA your IV post-marketing payer trial landscape support commitment and launch sequence plan Defining current treatment patterns Determining Planning to the build need share for Phase of voice IV into studies Conducting label real world and reimbursement effectiveness, safety, your launch reviews or meeting Preclinical Planning of Defining for payment post-launch policies real-world for more effectiveness, complicated safety, competing comparative products effectiveness analyses products or comparative effectiveness analyses (coding, coverage, etc.) Strategically Planning Conducting for adapting time patient and to reported motion changes outcomes studies in formulary (PROs) status, in Understanding the effect of new payment systems (rewards, Phase I reimbursement Conducting Phase III trials new policy, retrospective or new drug analyses entrants: penalties, risk sharing, ACOs) Selecting -Conducting economic new retrospective endpoints for analyses Phase III trials -Planning Understanding competitive new decision-makers messaging advisory and their boards levers Planning Phase II (hospitals, competitive health systems, messaging ACOs, advisory others) boards Together, -Creating we updated can: models and dossiers Updating Clarifying models policies and that dossiers may affect product adoption Together, Define your we can: market size (number of patients, Advisory (pay-for-performance, boards, market quality analytics measurement) Create financial trial-based value) models Phase III Create Together, Understand Developing budget we abstracts the impact can: competitive models and manuscripts landscape Create Define Complete cost-effectiveness/cost your your product Phase profile III trial and utility design label models and analysis Create Together, NDA/BLA Create Develop AMCP, we your the can: economic PRO NICE sections (U.K.), value proposition of PBAC your NDA (Australia) or BLA, and including additional Assist Define label language with potential reimbursement FDA post-marketing stakeholders dossiers commitments and understand Develop Support their Update perspectives formulary new your indications global kits value and and dossier presentation label with claims Phase III results Life Cycle Infuse a unique perspective of what Management matters Conduct Begin Model payer and to the observational assemble economic message why into your impact testing studies a well-supported product of your company product information Implement value Provide Begin Develop real story market for provider/payer tactical world plans efficacy, to your preparation product, key ensure safety, crafted opinion product and Gain leader comparative uptake: insights advisory data into the boards needs Develop valid endpoints and early -Coding Conduct Conduct the applications development new payer value interviews message process. and testing advisory of providers and messaging board and meetings patients, updates gather evidence required to Gain -Billing Complete Conduct desired guides market formulary contract research terms updates with on the build range strong of factors relationships, influencing support a successful label payers, -Web distributors, content and PBMs drive loyalty to your brand, claim, including challenging and connect product adoption -Training programs your product with more and help patients start and PRO claims. patients Develop worldwide. reimbursement landscape stay studies on treatment. and launch plan Better define unmet needs through epidemiologic analyses, abstracts, and manuscripts How do you measure success? Drug/device approval. Achieving target labeling. Favorable reimbursement & formulary placement. Increased prescriptions & sales.

Go beyond today s limits and plan for tomorrow s challenges Understanding your world. Expanding your opportunities. Your therapeutic and disease focus, product profile, target patient Commercializing If you are a small a biopharmaceutical biosimilar? Payers, company providers, looking and patients to sell population(s), and business objectives all pose unique challenges. don t or license want your to take drug, chances: you need They a strong want compelling market access proof strategy. of Customized approaches are key to successful drug development safety, Proof of efficacy, safety, efficacy, and value. and Our quality experts is just can part provide of the it, story; with unique planning and execution. perspectives market access and and years reimbursement of specialty round experience it out. to Covance address has your Aim higher we ll help you get there. Whether you are a large drug more development than 20 years needs of success and post-launch in assisting challenges clients with including products biopharmaceutical company, a small startup, or a medical device customer and compounds support. of all sizes through drug development and manufacturer, Covance understands your world and your specific needs. commercialization. Together, we can unlock the right We will reveal new opportunities for your success with our depth and opportunities for your company or product and breadth of experience across the entire market access universe: Customized increase solutions based on Unsurpassed medical device proficiency the market value of both. real-world data In-depth understanding of some of the most complex and & expertise Make better decisions faster, driven by important therapeutic areas Proven success across a range Support of your product s value proposition Innovative approaches to Creativity and innovation evidence-based that results. Covance has critical therapeutic areas with key stakeholders and maximize Biosimilar demonstrating patient Product product Support. value translates to the real Support world for Small Biopharmas. Deep understanding of drug commercialization integrated our clinical and commercial Meet your goals with customized access. Our recognized device experts Gain have full insight into market trends, Need real-world expertise? expertise, resources, We ve and services across the Insight into upcoming market trends solutions, based on our industryleading experience across complex propositions. Their insights can reveal products new for specialty, complex, unique solutions to your achieve project success is relevant to the market and extensive experience in developing based value on our deep experience with got it and we can globe. provide A balanced you with approach ensures that Our passion is solving your problems with transformative solutions. and important therapeutic areas. possibilities for you. chronic, and rare diseases. in an ever-changing poised market. for commercial success. Together, we can achieve more. We ve been there and we can help you get there. Overcome your unique therapeutic challenges. Maximize patient access to your medical device. Accelerate your commercial success. Deliver value in the marketplace. Reduce timelines, increase opportunities.

Scientific and database analysis expertise: transformative results Creating insights through experience. Through our alliance with M2Gen, a wholly-owned subsidiary of the H. Lee Moffitt Cancer Center & Research Institute, Covance has enhanced capabilities to identify patients for prospective and retrospective observational studies using M2Gen s Total Cancer Your product s value story isn t complete without valid scientific and economic data based on expert analysis of the right Care (TCC) Data Warehouse. This Data Warehouse is one of the retrospective data. Our secondary database studies support your value story most robust oncology data resources in the world, containing over in the most cost-efficient way by utilizing real-world The most effective product strategies embrace data, the such economics as medical of claims, electronic medical records 100,000 consented cancer patients from Moffitt and a consortium (EMR), hospital administrative data, and survey of data. several other centers across multiple states. These patients have the healthcare marketplace, consider economic issues from the start Support of product your value development, story with secondary Access up-to-date data on dialysis and chronic kidney agreed to be followed over the course of their lifetime and to be and reflect market economics in product database analysis. Our configuration, The positioning, key team to of successful and physician retrospective, disease targeting ensuring database patients from the largest global dialysis provider! that re-contacted, providing unique opportunities for retrospective epidemiologists, biostatisticians, analysis is controlling and identifying Additionally, the best data access large private-payer claims databases, possible. statistical market programmers uptake source for your can and, perform product finding is meaningful as rapid as results hidden oncology EMR data, and hospital administrative analysis of longitudinal data as well as prospective data collection. analyses to examine: volumes of data. Our analytics databases team is through our agreements with established Leveraging data M2Gen s TCC Data Warehouse Covance can provide If additional data on your product are needed to support a successful Comparative safety committed and effiectiveness to applying proper methodological vendors, as well as our in-house databases for the most Secure the capital you need to you with data-rich analytics for building real-world launch, Covance can conduct in-depth strategic analyses using Burden of illness techniques and has extensive experience current available in: data at low cost: Maximize the acquisition price for your stay on track with your product s evidence in product oncology. and/or company development plan Incidence large secondary and prevalence Multivariate databases. of disease You regression can and avoid the time Centers and for cost Medicare of a and Medicaid Services Medicare Just as critical product safety, efficacy, and With a proven track record of claims databases comorbid prospective conditions study Time-dependent while gaining survival the scientifically analysis valid insights quality is integrating market access and working with venture capital National Center for Health Statistics survey databases Treatment you need. and prescribing Propensity patterns score weighting and matching reimbursement in your strategic planning. companies, we are primed to help (inpatient and ambulatory) Clearly define burden of illness and market you illustrate the full value of your Adherence Nonlinear and nonparametric models The Agency for Healthcare Research and Quality Variations We are invested care Instrumental in your success. variable Whether analysis your specific goal is to sell potential as early as end of Phase I and product to secure the capital you Nationwide Inpatient Survey database maximize the acquisition price for your need to stay on track with your Medical or license resource your use compound Marginal and cost structural or your modeling company, or bring a new drug to 100% Florida fee-for-service Medicaid database product and/or company. product s development plan. market yourself, we can help you build and demonstrate your value and Learn more about our alliance to deliver superior data maximize your return on investment. analytics in oncology. Get the analytical perspective. Find meaning through experience. Control costs, expand knowledge. The formula for market success: Maximize value. Support venture capital & acquisition arrangements.

Unlock new opportunities Transforming data into actionable insight and a compelling value story. Data alone are not enough to launch your product into the market stratosphere. Starting in the early clinical phase, you need to identify patterns to translate that data into a story one that defines and demonstrates your product s value proposition to decision-makers across key markets and countries. Supported value proposition Building successful market access for your product starts early in development. Together, Dissemination we can: Identify the core elements of your value proposition Translation Discover new opportunities through our: Understand stakeholder needs (data into through story) a market access assessment Focus on strategic and tactical data dissemination Develop the right aspirational value messages for your product and audiences Evidence generation High-quality source of medical writing and medical communications (safety, efficacy, quality, PROs, and health economics) products and services Identify the evidence that you need to support your value messages through a gap analysis Empirically based, readily testable, and differentiating value messages Save time and resources and gain Aspirational value Increase the chances of your product s Develop the missing message evidence development through detailed studies and analyses Integrated resources and experience in GHEOR and reimbursement Better understand your market, valuable information for critical success in the marketplace drug value, and disease state and product development decisions Customize your messages Gain a competitive to meet the advantage needs Your value through of various story needs stakeholders to convey the Knowledge of the legislative/payer landscape and the ability give to your product a significant Be better prepared to account for our strong relationships full with value important of your product in a clear and effectively target your value proposition to each audience competitive advantage clinical outcomes Disseminate in diverse this Market populations information market landscape access to stakeholders target assessment audiences compelling way. through Our integrated value We match your access needs with with multiple publications, comorbidities conferences, with Identify our emerging and other trends methods communications that can reveal group transforms Translation of data and value messages into successful thought leaders who are shaping exclusive access to a leading database new commercial opportunities hard data for your into resonant value messages Health Technology Assessments (HTAs) the market. You gain transformative of clinical and epidemiological research. product. Our robust network demonstrating of market the advantages of your Value Proposition insight, helping you make timely We and can help you save time and inform access stakeholder groups product is poised and to help increasing the chances of informed decisions. your critical development decisions. you succeed. your success. Access insight. Profit from experience. Gain competitive advantage. Make informed decisions. Reveal new commercial opportunities. Extract real value from your story.

Solutions for your success Make faster, better decisions that lead to increased market access. Translate data into a compelling story that effectively Why should someone pay for your drug or device? communicates We can answer your that product s value proposition to your question together adding value to your product with target audience. customized, Capture and convey the value of your product comprehensive solutions based on valid data to address your most in a clinical trial or observational study with Global Value Dossier (GVD) submissions a well-designed PRO and health economic complex challenges. Strategic publication and communication plans strategy that enables you to meet regulatory Peer-reviewed publications Think beyond the tried and true. In today s evolving market access standards and enhance your chances for Congress/scientific meeting presentations Determine and communicate Demonstrate the successful economic the value product value of your commercialization. product in the real universe, you need fresh perspectives and new approaches Conference based support on of your product with a rigorously world with global experience, real-world industry knowledge, and Monographs operational Effectively communicate the clinical and economic designed PRO a retrospective, and and health observational, economic outcomes secondary executed, targeted, transparent, database well-documented, study for research strategy scientifically valid results in excellence. We provide all three. Whatever the size White of your papers value of your product to ensure optimal reimbursement. company and user-friendly economic less time model. and Supplements/reviewsDevelop a reimbursement dossier application that Registrational lower cost trial than support a prospective (Phase study. II IV) or development portfolio, you can rely on our guidance to: Cost Market assessment Literature reviews/alerts meets the comprehensive specifications required across PRO instrument development & validation Make faster, more informed decisions Industry symposia government and commercial payers Cost worldwide. offset Treatment epro patterns development and validation Advisory board meetings PBAC (Australia) Cost minimization Standard of Analyses care of medical resource use, productivity Demonstrate your product s value to key decision-makers Press releases NICE (U.K.) Budget impact Burden of and illness costs Obtain favorable coverage and reimbursement Key opinion leader strategic AMCP planning (U.S.) and engagement Cost-effectiveness Comparative Burden effectiveness of illness studies Legislative briefing submissions Cost utility Comparative Craft effective promotional strategies Chart safety reviews US Managed Care (U.S.) Slide decks Office economics Complex Time multivariate and motion regression studies Increase product uptake and patient access Editorial style and formatting CADTH (Canada) Business decision-making Propensity Disease score matching management and program evaluation Document QC/QA IQWiG (Germany) Understand policy developments and trends Forecasting Instrumental variables Graphics & printing HAS (France) Gather data on your audiences Understand and Disease market the current and Offer product and integrated future registries access solutions to address and their impact on access to your product Pricing developments (including and new understand Time-dependent NICE environment, guidelines the Risk incentives, Evaluation the survival for impact market analysis of and public and Mitigation access and private issues Strategies and position and develop strategic NHC and (Norway) tactical solutions to value-based pricing) Market access consulting: Global Health perspectives, Economic and decision-making & Outcomes Marginal payer policies (REMS) structural Research processes on your modeling (GHEOR) your product s product adoption, for success via: address policy issues through: what really works. Policy monitoring and Understand analysis the revenue potential of your stakeholders of your through: and the right strategies for a successful Market strategy execution launch by developing: Reimbursement intervention Value product, develop forecasts Qualitative and support Health that account interviews for Economic Analytics Reimbursement education - Program research (including benchmarking) Prospective Communications payment-related issues, Technology and Competitive educate your benchmarking Modeling Observational Bring your products to market faster and smarter Sales training Market strategy and consulting Global customers Value about Assessment the economic (HTA) impact of your - Program design Advisory boardsand Pricing Studies with targeted strategies from our Global Health Training materials Reimbursement Dossier assessment (GVD) product and within strategy the Submissions relevant Online care setting. - Patient access programs and other quantitative surveys Economic & Outcomes Research (GHEOR) and International reimbursement Submissions Billing and other guides Customer-facing research models Multiple and calculators stakeholders: to - Reimbursement programs payers, providers, Access & Commercial Strategy (ACS) teams. and assessment Sales tools demonstrate product value patients, or reimbursement and specialty - pharmacies Patient assistance programs Claims analyses Field team operations Patient assistance program Stakeholder exposure models panels - Field team strategy Drug compendia research Website content Data analysis - Drug compendia strategy development Access & Commercial Strategy (ACS) Policy Research and Analysis Market Access Modeling Market Research Market Access Strategy Customer, Sales, and Market Support

Get the competitive edge Proactive support every step of the way. As you continue on the drug development journey, you can depend on our ongoing support to gain competitive advantage for your product. As your partner, we ll work together to enhance your product s value proposition and make a strong case for continued development and investment. Deep expertise and flexible approaches are required, and our consultants provide these advantages consistently, precisely, and proactively. You will gain: Expertise across all aspects of drug development and multiple therapeutic areas Advantage: seeing both sides Ability to leverage resources across our company and around the world Advantage: confidence Innovative perspectives supporting customized solutions and services Results: your project done right The result is the optimal market access strategy, tailor-made for you How we make it happen for you: combining clinical and economic data to demonstrate the value of A higher level of market access consulting experience your asset. A full range of services The drug development journey is different for everyone. We can guide Decades of experience in healthcare you along your particular path to success. science and analytics Dedication to your success Results: reduced project time and effort and maximized commercial opportunities How we make it happen for you: Integrated global clinical and commercial resources and expertise A comprehensive range of clinical and commercial solutions fully incorporated into your development plan The market access perspective brought into clinical planning and execution Advantage: a balanced perspective Results: market relevance and strategies that drive sales How we make it happen for you: A consultancy team with broad experience and expertise Balanced approach combining scientific and commercial focus Expert consultants guiding strategy informed by evidence-based results Navigating the journey together. Customized solutions based on experience. A dual perspective: market access and clinical science. Balance of scientific rigor and commercial insights.

Inspiring possibilities for your success Anticipating your needs and exceeding your expectations. Your drug development journey offers opportunities for success at every stage. We can help you uncover them. As your partner, our team becomes part of your team proactively anticipating your needs and exceeding your expectations when it matters most. Your path to success will be guided by our unique perspectives developed over 20 years of navigating the biopharma world and the market access universe. When you bring together the right combination of experience and insight, inspiring possibilities are revealed. Find out what s possible today. Contact your account executive or visit us online at www.covance.com/marketaccessconsulting. Long-term partnerships that deliver results Covance delivers what you need: results that make the difference between product potential and commercial success. Experienced staff invested in your success and your project Covance s expert consultants provide insights that give you a competitive advantage by helping identify, build, and sustain your product s advantage in the marketplace. Market-leading stability, reliability, and dependability Covance provides undisrupted service solutions and the confidence that we will see your project through all phases from beginning to successful completion. Covance is an independent, publicly held company with headquarters in Princeton, New Jersey, USA. Covance is the marketing name for Covance Inc. and its subsidiaries around the world. THE AMERICAS +1.888.COVANCE (+1-888-268-2623) +1-609.452.4440 EUROPE/AFRICA +800.2682.2682 +44.1423.500888 ASIA PACIFIC +800.6568.3000 +65.6.5686588 www.covance.com Solutions made real. Unique perspectives: successful results. Confidence delivered. Copyright 2014, Covance Inc. BROCMA008-0214 Contact Us