Creating a Successful Global Value Dossier Anne Heyes Head Market - PowerPoint PPT Presentation

May 9, 2018 Creating a Successful Global Value Dossier

Anne Heyes Head Market Access and Outcomes Strategy (Europe) Stephanie Barrows Caroline Ling Senior Director Senior Director Market Access and Market Access and Outcomes Strategy Outcomes Strategy 2

Key Learning Objectives • Learn how to develop and incorporate value messages and supporting evidence into a Global Value Dossier that will demonstrate your product's value to a variety of stakeholders. • Understand the process for developing an accessible and usable GVD that addresses the stakeholders’ needs. • Learn how to use a GVD to support development of local submissions. • Choose among the variety of platforms for communicating GVD evidence • Review best practices for successful GVD development. 3

Creating Product Value Messages Stephanie Barrows Senior Director Market Access and Outcomes Strategy 4

What are Value Messages? The value the product Provide concise offers to the stakeholders description of the product 5

Which comes first – the Value Message or the data? 6 6

Generating value messages Understand Burden of Understand the disease value of the Identify and product review key data for competition Identify value story for differentiation • Burden messages reflect the unmet need that will be addressed by the • Develop burden product messages based on the hypothesized value of the product 7

Sample Value Messages Chronic Disease Oncology Disease Burden Disease Burden • PsA is a chronic, progressive, and debilitating • Lung cancer has a high mortality burden and is condition that causes joint pain and damage the leading cause of cancer deaths worldwide. as well as skin and nail disease. • Symptoms of cough, shortness of breath, and • Patients experience severe complications fatigue impact patient HRQOL. and sequelae from invasive meningococcal • The advanced stages of NSCLC and toxicities disease. related to treatment result in significant decrement in health-state utilities. Clinical Value – Efficacy • Novel oral inhibitor for PsA that has a faster Clinical Value – Efficacy onset of action and likely more sustainable long-term efficacy. • Significantly improves PFS compared with platinum-based chemotherapy in • Demonstrated non-inferior efficacy and safety previously untreated patients with advanced to the standard of care for PsA. nonsquamous NSCLC. • Demonstrates robust bactericidal activity • Demonstrated numerical improvement (not against epidemiologically diverse strains of statistically significant) in overall survival Neisseria meningitidis in adolescents and compared with platinum-based chemotherapy. young adults. 8

Sample Value Messages Chronic Disease Oncology Humanistic Value Humanistic Value • Associated with a significantly longer time to • Leads to a significantly greater improvement deterioration in the symptoms of pain in chest, from baseline in emotional functioning, dyspnea, or cough (composite endpoint) physical functioning, role functioning, and compared with platinum-based chemotherapy in social functioning. previously untreated patients. Economic Value • Provides cost-effective benefits based on cost Economic Value per life-year gained (cost/LYG) and cost per • With a price [X%] lower than TNFis and quality-adjusted life-year (cost/QALY). comparable safety and efficacy, Product X • Treating advanced NSCLC patients could lead offers opportunities for budget savings. to a decrease in total cost of administration and monitoring in advanced NSCLC. 9

Helpful Tips for Creating Value Messages Start early Interact with to define product entire product value messages. team to gain consensus Understand the added value of Creation of background messages the product in relation to the and product value messages is competitors—differentiation. an iterative process . 10

GVD Process and Format Caroline Ling Senior Director Market Access and Outcomes Strategy 11

GVD Content to Meet Needs Across Markets • Usually include the following sections of relevance to many HTA markets Introduction Disease Product Clinical Humanistic Economic And Executive background Description Evidence Evidence Evidence Summary • Overview of GVD • Disease • Formulation • Key clinical trial • Key clinical trial • Overview of results description, and dosage results core cost- • Summary of value pathophysiology effectiveness − Utility E.g. EQ- • Efficacy story i.e. “elevator • Mechanism of model pitch” • Burden of action 5D • Safety disease in terms • Key CE results − Generic or • Value messages • Innovation of: • Comparative characteristics disease-specific • Overview of BIM efficacy − Epidemiology PRO measures • Indications, • Key BI results − Head to head − Humanistic contraindications if available burden and restrictions − Based on − Economic • Based on final systematic burden label (EMA or literature FDA) review and • Treatment network patterns and guidelines meta-analysis • Current treatment options and reimbursement • Unmet needs in the disease area 12

Evidence Taken from a Range of Robust Sources Core budget Key impact model observational Pivotal FDA label and study reports clinical trial study EPAR summary reports and publications Structured literature reviews for the Network burden of illness and Systematic meta- analysis current treatment literature reviews sections to support NMA and economic models Core economic cost- effectiveness model 13

Develop in Sections as Data Become Available • Disease burden sections can be developed early – Peer-reviewed literature (based on structured literature) – Authoritative national/international sources – Build the unmet need, economic and humanistic burden of disease, and competitor gap analysis – Include information from key markets, others will need to identify local data • Product value will be based primarily on outcomes of pivotal studies – Product labels (FDA and EMA) will be important to include in the Product Description Section when they are available 14

Supplemental Evidence Generation and Local Requirements Must Be Factored Into Timeline Example only 15

Dossier updates • It is important for the end-users that dossiers and associated materials are up-to-date Plan for updates, particularly around Process for updates any major anticipated changes • Update literature search • Label wording • Provide internal publications in • Publication of new data development / recently published - New burden of disease studies - New product data(clinical studies, RWE, • Liaise with your team for additional economic analyses) evidence that should be included • Changing competitor landscape • Consider the approval/sign-off required: - Adding new comparators - Has the internal team changed? - Amending unmet needs to reflect the new - Does the new evidence have wider landscape implications for other dossier sections? - Does only new information need to be approved? 16

Coordination of a GVD with Local Submissions Caroline Ling Senior Director Market Access and Outcomes Strategy 17

Use of the GVD is Likely to Vary Between Markets Smaller markets with more flexible Larger markets with specific HTA requirements HTA requirements • GVD provides the most value to: • GVD provides the most value to: - Give affiliates a robust value story and - Provide background information on the strategy to guide their local discussions disease and product to include in dossiers - Bring the local team up to speed on a new - Provide clinical data in support of the product disease or product - Provide example presentations of economic - Provide background information on the data for base case market disease and product to include in dossiers - Will still need to tailor country-specific aspects - Identify availability of key clinical data, • Likely to copy or translate GVD text directly to although CSR used as the source populate dossier template • GVD should be available when local markets start planning their submission, at launch is too late 18

Global GVD Providing for Local Needs What the Global GVD brings Need for country-specific data • Value story and messages • Epidemiology • Unmet needs • Standard of care – important for clinical and economic considerations in terms of • Burden of disease comparator / reference drugs • Current treatment options • Treatment guidelines • Product description • Economic burden • Key clinical trial results • SLRs and NMAs conducted to country standards • Comparative efficacy (head-to-head) • Adaptation of economic model(s) • Systematic literature reviews • Network meta-analyses • Standard and disease-specific PROs 19

Key Success Factors to Maximize the Use of the GVD in Local HTA Submissions • Seek input from key affiliates • Evidence feeding into the GVD should adhere to country-specific HTA guidelines • Highlight clearly the country-specific information • Highlight where further local information needs to be gathered • Provide links to relevant associated information stored on your intranet and that will be relevant for local submissions 20