Addressing gaps in knowledge, aligning opinion and mobilising advocacy to support healthcare decision-making at national and sub-national levels.

Market Access: Where are we now?

The role of market access as a central discipline for healthcare industry companies has grown significantly and largely in step with the challenges that the biopharmaceutical industry continues to face in this area. Understanding and demonstrating the value of medical innovations to gain and maximise patient access to them continues to be a significant and ongoing focus for most organisations in our industry. This view is supported by 3 key trends that we think will influence the healthcare landscape for some years to come.

Impact of COVID-19 on the Delphi Process

As the central driver for the need of market access expertise is the changing ability of health systems to be able to pay for new (and existing) innovations, recent events have surely re-doubled this need. Dealing with COVID-19 has heaped additional financial pressure upon global governments, not only due to the necessary investments in supporting the healthcare industry directly but predominantly the wider economic impact of dealing with the pandemic. This only intensifies the challenge for health systems across the world to provide the desired level of access within the constraints of a potentially declining level of available funding and a growing backlog.

On the other hand, the COVID-19 pandemic has put health firmly in the international and domestic spotlight. Acute investment has been injected into health systems, largely to support the management of patient backlogs accrued.

Buoyant medical innovation

Biopharmaceutical innovation pipelines are particularly buoyant. According to the FDA, over 12,500 new molecular indications were in development through 2021 which compares to approximately 9,500 in 2017 and, over 70% of these are considered ‘first-in-class’. This raises expectation from patients, clinicians and companies for the prospect of more improved treatments being made available but may provide additional challenges for decision-makers responsible for reimbursement and/or prescribing policies.

Growing acceptance of Real-World Evidence (RWE)

Evidence available at the time of reimbursement decision making may have a higher degree of uncertainty; studies may be considered too short to assess long-term outcomes, lacking in important patient relevant outcomes and/or feature no standard of care comparison (as standard of care evolves during the timeframe of drug development). This is particularly the case for treatments such as cell therapies (such as CAR-T) and treatments for rare diseases which are a rapid growth area but affects most new products for which phase 3 data is usually focused on overcoming the questions from regulators rather than addressing individual payer needs.

Beyond phase 3 studies, collecting and generating new data following launch and across the product lifecycle is becoming an increasingly important activity for Medical and Market Access Teams. This is needed to support existing and future access, and to support the ready availability and use of treatments for the right patients in the right care settings – assisting health systems to optimise outcomes and resource use.

Delphi consensus and the role it can play in supporting market access

The Delphi method: widely used in healthcare

The Delphi Method is a well-established and accepted approach to understanding and building expert level of consensus. The method is a systematic and iterative approach to communication and evidence generation that seeks to aggregate expert opinions from a diverse group of experts to generate clarity and support (evidence) based on collective wisdom. It can be used to help forecast future impact, consolidate a position, or to define policy and many sectors are using it today including the public health sector. Many treatment or management guidelines have been developed using a version of the Delphi method applied in healthcare. Interestingly, during the early phase of the COVID-19 pandemic, there were 52 Delphi projects used to determine the best way ahead.1

The anonymous collection of group opinion coupled with a tightly structured process and quantitatively described results provides a strong level of credibility in the outputs. Healthcare evidence generated in this way is graded in the evidence hierarchy and recognised by HTA bodies around the world. ​​​​​​​

Additionally, communication or evidence generated using this method is, by definition, peer-advocacy. Because outputs from Delphi programs are generated by stakeholders who represent an important constituent of the health system itself, they help create social proof for the direction recommended as a result of the work. An important coalition of experts now have a clearer and more confident voice to call for change across peer groups and across other disciplines they work with. The larger the group involved, the stronger the peer-advocacy and the social proof. Using an amplified consensus method, Triducive routinely develop consensus with +100 informed stakeholders and sometimes as large as 500 or 1000 with international (above-country) programs.

Typical applications and benefits for market access

Evidence and advocacy developed using Delphi consensus can be applied to a range of market access situations at national and sub-national level:

  • Closing evidence gaps to strengthen HTA submissions or re-submissions

  • Validation of specific patient cohort needs to identify and evidence where value is greatest

  • Building the case for policy change (local/national/international)

  • Supporting re-definition and application of optimal patient care pathways

The benefits of this approach are:

The recommendations and conclusions developed through the work are expert-led and peer-validated rather than being proposed solely by a single organisation. In addition, when published, the work sits within the evidence hierarchy and enables confident citation for subsequent activities.

Generation of new evidence with a robust level of credibility can be achieved within <6 months which is unlikely to be matched by other methods.

The original nature of the work and potential for strengthening messages in support of an overall value story lends well to PR, medical education and promotional activities.

This work not only produces powerful new messages, but it delivers them in an informed and iterative way with experts who are aligned to the goal. This supports a strong basis for development and mobilisation of advocates.

Triducive have case studies of supporting a range of market access challenges including a number of examples that were delivered to achieve market access objectives, for example:

Discover How Triducive Can Help

If you would like to discuss your market access challenges with us and understand how we would help develop relevant objectives, align with expert stakeholders and design a Delphi-based campaign to support your goals please contact us: email: info@triducive.com Phone  Nick Williams, Managing Partner Director +44 (0)7590 042598

Ref: Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021;11(4):116-129. Published 2021 Jul 20.

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