Market Access

Our core focus at VCLS is the integration of value-based payer evidence requirements into clinical development programs. This has become a critical, yet often neglected, aspect of drug development. Several things contribute to making the pharmaceutical environment a challenging place to launch a product:

  • Major global shifts in health care systems to control costs
  • Regulators’ and payers’ requirements are not the same – the importance of bridging this gap is not always fully appreciated by all stakeholders
    • HEOR end points are often perceived to be less important because they are unlikely to lead to labelled claims
    • "Too little too late" is a common outcome with products receiving marketing authorization and launching without the required evidence to support their value proposition
  • HTA environment is incredibly fragmented with 77 HTA organisations spread across 29 different countries
  • Ongoing real world evidence (RWE) generation and dissemination post launch is additionally required to fill gaps and defend value in the face of new competitors and changing treatment paradigms
    • Payers review a different evidence base when making coverage policies
    • Some payers cover specialty drugs more restrictively than others
  • Linking future pricing models to real-world data and patient outcomes has become the global strategic imperative for Pharma

 

Inconsistency in specialty drug coverage across payers

Market Access - Coverage Specialty Drugs US
Source: Tufts Medical Centre, CEVR.

The Cone of Evidence Development is Changing

Market Access - Evidence Development
  • Differing age groups (elderly, pediatrics)
  • Race, ethnicity & gender variance
  • Unstudied co-morbid conditions
  • Differing concomitant drugs (including OTC)
  • Lifestyle variances including smoking, dietary habits
  • Differences in disease severity
  • Varying levels of compliance

Our Market Access Offering:

  • Provide strategic recommendations for positioning product value to ensure optimal patient access and reimbursement
  • Advise on HTA requirements and design of appropriate clinical trials to support efficient market access strategies
  • Working with the VCLS regulatory team, undertake protocol assessment and provide guidance for the integration of market access components within global clinical development programs (e.g. study design, including choice of subgroups, choice of comparator, primary and secondary endpoints, patient reported outcomes (PRO), etc.);
  • Provide writing and consulting service to support production of HEOR materials, briefing packages/HTA submissions and Global Value Dossiers
  • Support collaborations with external partners and investors, including independent opportunity analysis
  • Support VCLS clients in consulting with KOLs, key payers and HTA bodies at national and European levels, participate in early dialogue programs and EMA/EUnetHTA parallel consultation, National Agency/HTA Meetings, PRIME, EAMS applications, etc.
  • Utilise our extended Network to provide a comprehensive geographical service
  • Provide market access intelligence, analogue analysis and price benchmarking
Market Access - VCLS Offering

The VCLS Regulatory, Clinical and Market Access Integrated Approach

  • Develop Target Product Profile (TPP) and value proposition
  • Accelerate product development
  • Avoid unnecessary additional costs through duplication of research studies
  • Design global strategies
  • Adapt execution in each market
  • Shorten time to reimbursement
  • Integrated set of product- and market-specific expertise
  • Successful commercialization track record
Market Access - VCLS Integrated Approach