HTA & Payer Early Dialogue

We can support you in obtaining formal, or informal payer insights to your clinical trial designs to ensure they enhance your HTA submission.

Market Access

Why is HTA early dialogue important?

  • Early engagement with payers, health technology assessment (HTA) bodies, and scientific advice with European Medicines Agency (EMA) is a key driver to faster and more often, successful market access
  • The process of gaining HTA scientific advice can seem a daunting one, particularly for small companies and those that are new to the HTA payer environment
+ Read more
  • We have significant expertise in conducting early scientific advice with HTA bodies and undertaking EMA, to help you adapt your clinical trials to maximize your product’s value.
  • By ensuring that their clinical trials include the types of outcomes that regulators, HTA bodies, and payers will need, our clients face reduced hurdles around the time of submission for approval, pricing, and reimbursement.

Joint scientific consultations

Providing HTA and European regulators (EMA) feedback on your planned clinical trial program.

  • Joint Scientific Consultations (JSCs) provide HTA and European regulators (EMA) feedback on your planned clinical trial program and data needed to get EU regulatory approval, reimbursement, and market access
  • The advice is confidential, non-binding, but important for optimizing your Marketing authorisation and EU Joint Clinical Assessment
  • HTA and Payer engagement is essential to optimize your products regulatory, pricing and market access strategy
  • Our significant experience working with EU payers and regulators, developing briefing books and managing the process will help maximise your pharmaceutical launch plan

NICE scientific advice

Understanding what is required to achieve a positive NICE single technology appraisal (STA) is key to your Pharmaceutical Launch strategy.

  • Understanding what is required to achieve a positive NICE single technology appraisal (STA) is key to your Pharmaceutical Launch strategy
  • NICE scientific advice enables you to ask questions to NICE on your clinical trial program and cost effectiveness models, to understand if your evidence package is sufficient for a positive outcome
  • We’ve guided numerous companies through the NICE scientific advice process, helping them develop meaningful questions and developing briefing books that drive their product launch strategy

Office of Market Access

The Office of Market Access can provide guidance on positioning, uptake and adoption of your treatment in the NHS.

  • The Office of Market Access can provide guidance on positioning, uptake and adoption of your treatment in the NHS.
  • This is particularly important for novel and rare disease treatments, or when introducing a new paradigm changing product
  • The safe harbour meetings can bring together stakeholders from across the NHS and NICE to discuss the Pharma product launch strategy
  • Our expertise can ensure the questions posed and facilitate the process to ensure your product achieves its potential

Payer scientific advice / Payer early dialogues

Country scientific advice can provide detail, targeted guidance on critical pricing and market access topics.

  • Payer scientific advice can be sought from several countries, including Germany (G-BA’s early benefit assessments), France (HAS), Italy (AIFA), Sweden (TLV).
  • Country scientific advice can provide detail, targeted guidance on critical pricing and market access topics, to help your market access strategy and development plan.
  • Payer scientific advice can be sought at an individual country level or Payer scientific advice can be sought at a pan European or individual country level
  • Having undertaken many advice procedures, we can guide you through the complex process to get the answers you need to maximise your product’s value

Early access opportunities

The Innovative Licensing and Access Pathway ( ILAP ) aims to accelerate the time to market for products to help patient access to medicines.

  • The Innovative Licensing and Access Pathway ( ILAP ) aims to accelerate the time to market for products to help patient access to medicines
  • The Early access to medicines scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need

Payer advisory boards

Payer advisory boards are essential to understand payer evidence needs on a more informal basis.

  • Payer advisory boards are essential to understand payer evidence needs on a more informal basis.
  • Whilst they are less structured than formal HTA scientific advice, the insights can be equally as valuable, depending on the commercial challenges facing your product.
  • They are quicker to organise, give rapid feedback and can be used for ongoing or finalised clinical trials
  • Our extensive network of payers and country experts that can help you address your burning questions
  • We have significant experience in organising and moderating advisory boards to inform Pharmaceutical Launch strategy

Payer insights

Payer insights can be a rapid, efficient way to gain payer feedback to support your decision making.

  • Our international network of payer experts can provide the in-depth knowledge needs to ensure you get the latest healthcare payer insights
  • From a few targeted discussions to multi country payer discussion programs, our primary market research experience, coupled with strategic mindset, will deliver the payer insights needed for your products’ success