Pricing, Reimbursement & Market Access Consulting - Pharmaceutical and Biotech industries

We work on a diverse range of projects but our mantra is always:

What is the problem? How will payers view this? What is the solution? What are the trade-offs? What are the insights? Answering these questions is key to ensuring the best possible market access outcome for you and your product.

Development of an MA–HEOR roadmap in a rapidly evolving landscape

Client situation

An emerging biotech was developing a PD-1 inhibitor for two different solid-tumor indications, both in rapidly evolving therapeutic landscapes.

PRMA Consulting solution

  • Critical assessment of the current and emerging treatment landscape in each tumor type
  • Characterization of the current and emerging market access environment for PD-1 inhibitors
  • Development of a market access and HEOR road map, setting out evidence generation strategies and actionable market access solutions

Client value

  • We delivered actionable insights to inform trial design, including comparators, target patient populations, subgroups, and endpoints
  • For each indication, we developed alternative market access positioning scenarios and highlighted key gaps and vulnerabilities
  • We identified and prioritized evidence generation activities and provided detailed, practical recommendations to support product value in payer-relevant terms

Conceptualization and specification of a cost-effectiveness model

Client situation

The client wanted to understand the best way to demonstrate the cost-effectiveness of their product to support HTA submissions.

PRMA Consulting solution

  • Discussions to understand the client’s strategy and objectives, informed by in-depth review of the product, therapy area, and relevant HTAs and models
  • Conceptualization and specification of the model, based on best practice: model type, structure, method of analysis, and integration of comparator; source and use of intermediate and long-term outcomes; HRU, costs, HRQL, and utility data

Client value

  • Early conceptualization and planning ensured the model aligned with the clinical and economic value proposition, including understanding how data would be used and how the results would support the product
  • Changes to the design and specification were incorporated before model development, allowing rapid iterations with no lost time or project overrun
  • The completed model matched the client’s data and expectations; outputs were easily used in value dossiers and local HTA submissions

Payer-guided PRO strategy

Client situation

A global pharma company finalizing the design of a Phase 3 study wanted to collect patient-centered outcomes data, including HRQL and utility data, to support HTA.

PRMA Consulting solution

  • Critical analysis of previous HTAs, methodological guidelines issued by HTA and regulatory agencies, and HRQL/utility studies
  • Pan-European payer advisory board to identify relevant instruments, optimal timing of assessments, and payer expectations
  • Development of an actionable strategy for measurement of patient-relevant endpoints within the clinical development program, taking into account evidence requirements of regulatory and HTA agencies

Client value

  • Informed and practical recommendations on the efficient and timely collection of payer-relevant patient-centered outcomes data
  • Identification of opportunities to augment the Phase 3 trial protocol to meet the expectations of HTA agencies, including statistical analysis
  • Back-up strategy should an instrument not perform appropriately in the study

Clinician survey to understand real-world clinical practice

Client situation

In the absence of specific clinical guidelines, the client wanted to understand current options for the diagnosis and treatment of the proposed target population in clinical practice, in order to develop a stringent definition of the eligible patient to support reimbursement negotiations.

PRMA Consulting solution

  • Web-based survey of 780 clinicians across 13 countries to obtain quantitative data on current practice for the proposed patient population
  • The survey identified:
    • Usual diagnostic and treatment practice
    • The importance clinicians attached to particular diagnostic strategies
    • The influence of individual patient characteristics on decision-making
  • The results were validated by clinical experts at a subsequent advisory board

Client value

  • Definition of a distinct patient population with high unmet need, recognized and validated by clinicians
  • Scientifically rigorous approach approved by a duly constituted ethics committee, enabling publication in a peer-reviewed journal
  • Country-specific description of current treatment practice for affiliates to reference in HTA submissions

Pricing and reimbursement opportunity for a novel small molecule

Client situation

The client wanted to understand the P&R opportunity and feasibility of launching into a complex treatment landscape that included non-drug interventions and OTC and off-label medications, in the major five EU markets, Canada, and Australia.

PRMA Consulting solution

  • Development of interview materials covering the treatment landscape and pathway, unmet need in target patients, clinical value of the client’s product, qualitative pricing using van Westendorp and Gabor–Granger methodologies, and evidence requirements
  • Telephone interviews with a large cohort of payer experts covering private and public systems, and KOLs from primary and specialist care
  • Development of comprehensive, actionable insights and recommendations based on critical analysis of country-specific and aggregate results

Client value

  • Comprehensive view of payer perceptions, opportunities, and barriers based on disease landscape, product value, and place in the treatment algorithm
  • Understanding of potential tensions between clinical and payer perspectives; insights into potential private payer opportunities
  • Indicative pricing corridor for each country for the full indication and possible subgroups, and required supporting evidence

Development and validation of a payer-focused value proposition

Client situation

A medium-sized biotech wanted to develop and test the value proposition and messaging for a targeted biologic being launched into a crowded indication, as the basis for the GVD.

PRMA Consulting solution

  • Targeted literature review and competitor benchmarking to inform development of draft value messages, including defining the unmet need and identifying key differentiating clinical and economic factors
  • A face-to-face cross-functional workshop with the product team to refine the value story and identify gaps in the supporting evidence and how to bridge those gaps
  • Testing of the value story with payers and clinicians

Client value

  • The workshop ensured that internal stakeholders were aligned on the value proposition and supporting evidence requirements
  • A coherent evidence-based global value story was developed that clearly differentiated the client’s product from current and future competitors, adaptable to different payer archetypes
  • Early identification of the evidence required to support the value proposition, ensuring timely generation of payer-relevant evidence alongside and within the trial program

GVD to support a new immuno-oncology agent

Client situation

The client was launching an immuno-oncology agent in an indication for which they had an established portfolio and wanted a GVD to demonstrate its value in different reimbursement scenarios.

PRMA Consulting solution

  • The product and therapy area were reviewed to inform detailed discussions of the client’s strategy and objectives for the product
  • Value messages were assessed to ensure they were fully supported with relevant data; clarification or rewording was proposed where needed
  • A GVD was developed that defined the scenarios and navigated readers through the vast amount of data to highlight the product strengths; potential data gaps were explored and solutions presented
  • Strategic insights for each reimbursement scenario, and information about endpoints and their value, were presented to further guide users
  • A fully interactive document was developed, supported by a summary slide deck and objection handler

Client value

  • The key outcomes within each scenario were presented in a concise but detailed way that affiliates could adapt for local reimbursement submissions
  • Further information for readers was hyperlinked to carefully considered supporting data in appendices

Coordinated market access strategic partnership

Client situation

A global biopharma wanted a partner to develop and implement a market access strategy for a novel agent.

PRMA Consulting solution

  • Our team comprised health economists, biostatisticians, clinicians, and market access and reimbursement experts
  • An evidence generation plan was developed based on critical review of market access and payer issues
  • Executed projects included a clinician survey to characterize current practice and decision drivers; generation of health state utility values using TTO methodology; development of preliminary cost-effectiveness and budget impact models; an international advisory board to gather payer and clinician perceptions of evidence; development and testing of key value messages; and development of the GVD

Client value

  • Our cross-functional team provided broader input and insight than the client could achieve in-house
  • Our coordinated approach over 2 years ensured consistency, optimal sequencing, synergy, and efficiency across projects and deliverables
  • Value communication was based on in-depth understanding of the product and evidence base, developed in an accessible format and language for affiliates

A global pharmaceutical company with a novel drug for a chronic inflammatory condition

Client situation

The client wanted to understand the pricing and reimbursement opportunity and feasibility of launching in the EU5, Canada, and Australia, into a complex treatment landscape including non-drug interventions as well as over-the-counter and off-label medications.

PRMA Consulting solution

  • Recruitment of 70 participants for primary research – 35 payers with knowledge of private and public systems, and 35 KOLs covering primary and specialist care
  • Development of interview materials covering treatment landscape and pathway, unmet need in target patients, clinical value of the product, qualitative pricing using van Westendorp and Gabor–Granger methodologies, and future evidence generation plans to support target patient population
  • Analysis of country specific and aggregate results, and development of a comprehensive set of strategic insights and recommendations

Client value

  • Comprehensive view of payer perceptions, opportunities and barriers based on disease landscape, product value and place in the treatment algorithm
  • Understanding of the potential tensions between clinical and payer perspectives in this functional illness; insights into potential private payer opportunities
  • Indicative pricing corridor for each country, for the full indication and possible subgroups, to inform decision making on the value of additional evidence generation

Leading pharma company with a product for an oncology indication

Client situation

The client would have PFS data at launch but not mature OS data; predictive models to estimate OS were in development. The client wanted to ensure the relevance of the predictive model to HTA agencies in key European countries (France, Germany, the UK) and to understand how the data would be assessed.

PRMA Consulting solution

  • Predictive models were developed to estimate the correlation between the PFS and OS
  • Advisory boards were held with clinicians and HTA methodology experts, in each of the three markets, to discuss the HTA perspective:
    • Discuss and agree HTA requirements regarding surrogate endpoints
    • Present results of analyses and discuss applicability to HTA
    • Identify areas of uncertainty and potential ways to mitigate those
    • Identify additional applications of the analyses along with potential advantages and limitations
  • A report was developed summarizing the findings of the workshops, focusing on adapting the current project to meet the needs of each HTA agency

Client value

  • Understanding of the value of the predictive model for HTA in each market
  • Identification of potential limitations and work required to support the key concepts
  • Clear plan of additional analyses to support the product through HTA

info@prmaconsulting.com
UK (HQ) +44 (0)1252 786284
US +1 (415) 655 6798
Terms and conditions
Company registration number: 05893400

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