Expertise

Access & Value

We are living in an exciting time of sustained drug innovation with the entry of disruptive personalized therapies and new innovative Mechanisms of Action.

While this is tackling critical unmet needs for patients across a range of diseases, we cannot ignore the strain on drug spending and scrutiny on pricing.

As we look forward to the future, we expect increasingly smaller and targeted patient populations to gain access to innovative therapies.

This emphasizes the need for regulatory and HTA processes to evolve and innovative ways to demonstrate value in these small populations.

This begs the question of how we really unlock the value of Real-World Evidence as well as this provides one potential solution in demonstrating value.

Whilst the growth of disruptive technologies is providing therapies and potential cures for many patients, we must not forget other conditions such as those of a more chronic nature, where millions of patients need access to innovative medicines for chronic use.

Getting the balance of these complex elements right makes the access and value function more critical than ever in our opinion – especially in early development in order to ensure payers’ expectations are addressed as early as possible.

Our commitment is to guide our clients on Access & Value strategies as early as possible, to ultimately support patients’ access to innovation.

Projects in This Space

01. Early Stages

  • Landscape assessment
  • Early value proposition
  • Early market access strategy
  • Early scientific advice and health economic model
  • TPP development
  • Facilitation of payer adboards

02. Pre-Launch (PhI Onwards)

  • Payer value story
  • Market access strategy
  • Pricing strategy
  • Payer scientific advice (EunetHTA)
  • Innovative contracting strategy
  • Competitive readiness / wargame
  • Navigating access pathways
  • Policy and public affairs

03. Post-Launch

  • MA&P strategy adjustment
  • Competitive strategy review
  • Value proposition adjustment
  • Evidence generation and RWE

04. Corporate Strategy

  • Market access excellence: developing a cross- functional team with access and value at the core, driving access and value from molecule conception

Case Studies

Unlocking the Potential of Gene Therapies Across Europe +

Our client is a US based biotech developing innovative gene therapies for a number of rare conditions. Given the challenges and barriers to accessing gene therapies in key European markets, our client wanted to take a more holistic view of driving access and decided to invest in the wider gene therapy agenda.

Bionest worked with the client to (1) understand the European landscape for gene therapies (2) map key influencers for gene therapy decision making across Europe (3) build a policy and advocacy plan to drive a more favorable environment for these therapies.

Market Access Impact of Generics Entry in Multiple Sclerosis & Mitigation Strategies+

Our client was a leader in the Multiple Sclerosis space facing the entry of generic fingolimod, looking to understand the Market Access impact for their portfolio of competitive products.

We worked on: (1) developing a set of analogs and benchmarks, (2) quantifying the impact for their portfolio of products, from a pricing and market share perspective, (3) recommending a set of actionable market access mitigation strategies.

Building and Validating a Target Product Profile for a New Therapy+

We helped our client build and validate a target product profile for a new therapy in Oncology.

This was done through a mix of Quantitative research, 1:1 KOL / Payer live discussion and debate, 1:1 Individual discussions.

The method and dialogue enabled us to grasp what tradeoffs may be acceptable while ensuring a positive HTA outcome.