Market access update
What is a landscape assessment and how is it used in market access?
A landscape assessment helps identify market access challenges and opportunities for a new pharmaceutical or biotechnology asset. Landscape assessments can include current and potential future treatment options, pricing, and reimbursement in the target therapy area.
Landscape assessments help understand how key stakeholders are likely to perceive a drug
By considering the pricing and reimbursement (P&R) landscape from multiple perspectives, including patient, clinicians, regulators, and payers, a robust assessment helps to understand:
- how key stakeholders are likely to perceive a new drug
- the best approaches to demonstrate the drug’s value and mitigate any risks
- the likely P&R outcomes in each of the scope markets.
Early in drug development, manufacturers need to understand the market access potential of assets to make business decisions, such as go/no-go decisions on the continued investment for the drug. Later, they need to understand market access challenges to develop strategies to support the value of their drug.
Key elements of a landscape assessment
Identify challenges and opportunities
High-quality assessment of the current and potential future treatment and pricing and reimbursement landscapes in
High-value insights on how key stakeholders are likely to perceive your asset, the best approaches to maximize value, likely challenges, risk mitigation, and likely P&R outcomes.
Identify challenges and opportunities for new entrants
What does a landscape assessment typically involve?
Typically, a landscape assessment involves a targeted search to understand the background of the condition being targeted and the market for therapies targeting that condition: for example, epidemiology, costs, current treatments, comparators, and drugs in development. Together, these elements show the disease burden and the unmet need, which are crucial components of understanding market access potential.
Primary research can be used to confirm findings from secondary research and to test a blinded target product profile, containing information about trial design and outcomes of a drug, to assess its perceived value and likely P&R position.
Examining similar drugs in a similar indication that have undergone the reimbursement process can also help understand potential challenges for a new drug. The acceptability of specific price points for the drug may also be tested with primary research.
Landscape assessments are typically used from early pipeline to Phase 2 and 3 development
Landscape assessments can happen at any stage of product development but are typically most used when the asset is in Phase 2 or 3 development, as the findings may then be used to influence trial design or statistical analysis.
However, external factors are now driving the increasing need to assess the value potential for assets in the early pipeline. Scientific breakthroughs and regulatory policies are driving an increase in, and expediting, drug approvals, which requires market access input into early decision-making during the development of pipeline assets.
Thank you for all the work in preparing, facilitating, and presenting the landscape assessments in the multiple markets. Having the opportunity to review current and future factors that can influence evidence needs, prioritizing these gaps, and discussing possible solutions, was extremely valuable to the markets.
Regional Market Access Director, top-10 pharmaceutical company
An example of how a landscape assessment is used in market access
In this example, a top-10 pharmaceutical manufacturer was conducting Phase 2 trials of a treatment for relapsed or refractory multiple myeloma (RRMM). With the market becoming increasingly crowded, the manufacturer required a comprehensive understanding of the competitive landscape to aid strategic planning and identify potential opportunities.
The manufacturer partnered with PRMA Consulting, part of Fishawack Health, to conduct a market access landscape assessment.
The landscape assessment included:
Overview of current and emerging treatments and trends over time
We summarized the regulatory landscape in 7 markets, focusing on 8 drugs of interest, and outlined a timeline of drug development and trends over time to set the scene for the current competitive environment. We identified key emerging competitors that may have become relevant by the time of our client’s payer submissions, focusing on potential areas of differentiation or unmet need, such as route of administration or drugs with a novel mechanism of action.
Summary of clinical practice
We analyzed major clinical management guidelines to establish how those current agents were recommended to be used in clinical practice, to aid understanding of standard of care and potential comparators in each market.
Critical review of health technology assessment (HTA) outcomes
We analyzed HTA outcomes for each drug in all the markets of interest, providing easy-to-view summaries as well as more detailed content covering outcomes and rationales in payer decision-making. We considered payer commentary on burden and unmet need, current treatment options, and clinical evidence (efficacy, safety, PROs), as well as economic evidence for those markets that consider cost. Together with the regulatory landscape and clinical practice environment, these HTA findings informed our overall assessment of the landscape, its challenges, and its opportunities, allowing us to develop specific recommendations for market access success that were tailored to our client’s specific situation.
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