Health economics and market access

Understanding how price, revenue and profit margins can be maximised is key to commercial success.

The differences between cell and gene therapies and other types of therapies mean developing robust pricing and reimbursement strategies demands additional considerations to those of conventional pharmaceuticals. These considerations also need to be addressed earlier in development given the higher commercial risk cell and gene therapies present.

The health economics and market access team provides health economics, pricing, reimbursement and market access expertise to accelerate and maximise cell therapy uptake across global healthcare market.

Together, with our dedicated team, we can help develop your health-economic arguments and models, your value story and pricing and reimbursement strategy to accelerate and maximise your therapy’s uptake and revenue potential.

We can help you optimise the use of your resources – selecting the right target population and therapeutic position before you start clinical development so that there is enough room for innovation to accommodate a high cost therapy.

We’ll work with you on your product design, and target product profile, to help your therapy become a commercial success.

We can help with planning your evidence generation so that it meets the requirements of key market access stakeholders.

Given the high manufacturing and delivery costs, we help define product performance and manufacturing cost thresholds for commercial viability so that your clinical and manufacturing strategies are informed accordingly.

We’ll help you work out a clear pathway for reimbursement and adoption of your therapy across major global healthcare markets.

For typical assessments undertaken by our market access team, please view the following document: The Cell and Gene therapy Catapult approach to pricing and reimbursement strategy development.

We provide health economic and market access support along all stages of a cell and gene therapy’s route to market with an emphasis on addressing the unique challenges that ATMPs present including:

  • shaping value proposition and evidence generation plans in order to secure commercially viable profit margins (by defining product performance and manufacturing cost thresholds)
  • addressing key ATMP challenges at launch including data uncertainty, affordability and NHS readiness for therapy adoption

For examples of how we help optimise adoption potential in the pre-clinical and pre-pivotal stages of development, please view the following document: Early Stage Commercial Risk Mitigation

Our health economists and market access professionals are the only team in Europe that focus exclusively on cell and gene therapies, which has helped us to understand and develop strategies that address the unique barriers to reimbursement you would face.

Furthermore through the Cell and Gene Therapy Catapult’s coordinating role of the Advanced Therapy Treatment Centres in the UK, we have first-hand experience on NHS preparedness matters for therapy adoption and how this differs across different types of ATMPs.

In addition, we are directly involved in a variety of environmental shaping initiatives that help pave the way for enabling timely adoption of cell and gene therapies. We actively identify industry-wide bottlenecks to reimbursement and adoption, and work together with HTA bodies, healthcare systems and their commissioners, policy makers and industry associations across European and North American countries to ensure that assessments, policies, processes and infrastructure can accommodate the specific needs of ATMPs.

In response to the lack of sufficient information on market access processes for cell and gene therapies in the major European markets, we compiled a set of reimbursement roadmaps and in-depth presentations covering the Big5 EU: France, Germany, Italy, Spain and the UK.

For additional examples of our health economics and market access work, please see:

CAR T-cell therapies and the use of outcomes-based reimbursement in the five major European countries

Quantifying the cost of implementing an outcomes-based managed entry agreement in acute lymphoblastic leukaemia (ALL)

Can the existing data collection infrastructures for patient outcomes enable outcomes-based reimbursement in the UK?

A framework for quantifying digital infrastructure upgrade costs in order to address data needs of outcomes-based reimbursement

Enabling outcomes-based reimbursement through a universal platform for outcomes data

    Enabling a valuable engagement with EMA and HTA bodies as part of the Parallel Consultation procedure

    Identifying the price and access potential of a novel ATMP in the United States

    Optimisation of indication selection and prioritisation

    Undertaking a health economic assessment to understand the reimbursed price potential of MULTISTEM ® in acute respiratory distress syndrome

    How uncertainty around the value claims of cell and gene–based immunotherapies can be addressed in payer negotiations

    Opportunities and challenges with performance based pricing schemes for ATMPs

    For our peer reviewed-publications by our health economics and market access team, please see:

    The use of innovative payment mechanisms for gene therapies in Europe and the USA

    Outcomes-based reimbursement for gene therapies in practice: the experience of recently launched CAR-T cell therapies in major European countries

    Upgrading the SACT dataset and EBMT registry to enable outcomes-based reimbursement in oncology in England: a gap analysis and top-level cost estimate, Journal of Market Access & Health Policy 2019, VOL. 7.1, 1635842

    Data collection infrastructure for patient outcomes in the UK – opportunities and challenges for cell and gene therapies launching, Journal of Market Access & Health Policy, 7:1, 2019

    Establishing the Cost of Implementing a Performance-Based, Managed Entry Agreement for a Hypothetical CAR T-cell Therapy. J Mark Access Health Policy 2018, VOL. 6, 1511679

    The potential price and access implications of the cost-utility and budget impact methodologies applied by NICE in England and ICER in the US for a novel gene therapy in Parkinson’s. J Mark Access Health Policy 2018, VOL. 6, 1500419

    Annuity payments can increase patient access to innovative cell and gene therapies under England’s net budget impact test  European healthcare markets. J Mark Access Health Policy 2017 5:1, 1355203

    The High Cost of High Tech Medicine: Planning Ahead for Market Access. Stem Cell Translational Medicine 2017 6: 1723

    A price comparison of recently launched proprietary pharmaceuticals in the UK and the US. J Mark Access Health Policy 2016 4: 32754

    Reimbursement of licensed cell and gene therapies across the major European healthcare markets. J Mark Access Health Policy 2015 3: 29321

    Market access pathways for cell therapies in France. J Mark Access Health Policy 2015 3: 29094

    Bringing regenerative medicines to the clinic: the future for regulation and reimbursement. Regen Med 2015 13;10(7): 897-911

    Cell-based therapy technology classifications and translational challenges. Philos Trans R Soc Lond B Biol Sci 2015 Oct; 370 (1680): 20150017

    Innovator cell therapies present barriers to the entry of copy versions regardless of patent protection

    Contact us to find out more about our health economics and market access capabilities.

    Related Publications

    05 April 2022
    CGT Catapult Guidance for ATMP
    Cell and Gene Therapy Catapult
    25 March 2022
    Preparing for the future of advanced therapies: The need for a National Cell and Gene Therapy Vision for the UK
    Cell and Gene Therapy Catapult
    09 December 2021
    CGT Catapult Guidance on the development and marketing of ATMPs in the UK and EU at this position post-BREXIT
    Cell and Gene Therapy Catapult
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