HiTT’s deliverables

Client:

  • spanish start-up

Challenge:

  • Design a feasible regulatory and MA pathway

HiTT’s role: 

  • HiTT had a MD&MAD interim
  • Provided continued support during 12 months, in the design of strategies and Business Model

Result:

  • Clinical Trial has been initiated
  • The company was able to raise the largest amount ever I Spain for a Device

Client:

  • A spin-off company from a University

Challenge:

  • To prepare with the management team a solid business plan to be presented to potential investors

HiTT’s role:

  • HiTT guided (advisor role) the development of the Business plan and landscape analysis, including Guideline review, SRE, competitor landscape and pricing corridor
  • HiTT prepared a development plan, backed up with a market and competitive landscape analysis

Result:

  • The company raised 420 K€ from a national investor

Client:

  • A private start-up company

Challenge:

  • To define a development strategy and prepare an investor pitch that for first non-public investors

HiTT’s role:

  • HiTT prepared a development plan, backed up with a market and competitive landscape analysis
  • HiTT prepared for the company investor decks

Result:

  • The company raised 300 K€ from several investors
  • The project was presented to several multinational pharma companies

Client:

  • A licensing project from a research department at a University

Challenge:

  • To review the potential market of a newly developed patent and the potential partners & investors

HiTT’s role:

  • HiTT reviewed the state of the art, including market competitors, features, capabilities and potential markets
  • HiTT developed a Cost-effectiveness analysis of the potential technology to establish its potential usage in a real world setting

Result:

  • Despite optimal PoC tests, the developer was discouraged form pursuing the project given the lack of a viable product.

Client:

  • A multinational company

Challenge:

  • To decide whether to invest in a new asset

HiTT’s role:

  • HiTT analysed the potential market, the pricing landscape, target population and access hurdles
  • HiTT modelled the potential costs & revenues at launch in the EU market

Result:

  • Company discontinued the research project

Client:

  • A multinational company

Challenge:

  • To decide whether to in-licencing an advanced therapy for RD

HiTT’s role:

  • HiTT analysed the potential market, the pricing landscape, target population and access hurdles
  • HiTT coordinated a EU-5 analysis that was presented to the business development

Result:

  • Company purchased rights of the compound
  • Financials were adjusted accordingly

Client:

  • A multinational company, broad portfolio (not only OMP)

Challenge:

  • To design strategy and value arguments for a new Value Dossier

HiTT’s role:

  • HiTT reviewed the approval records on similar diseases by the MoH, and developed a Mock IPT and raised evidence gaps.
  • HiTT developed additional evidence on incidence, prevalence and unmet needs
  • HiTT prepared an economic model that showed cost savings to the MoH

Result:

  • Product was launched successfully at the proposed price

Client:

  • A generic company, entering for the first time into Biosimilar business

Challenge:

  • To decide who the stakeholders were, the potential market share and price corridors

HiTT’s role:

  • HiTT surveyed several regions in Spain to understand and quantify who the prescribers were
  • Prepared a Business model for the company
  • Suggested how to approach the market and how to build a new field team

Result:

  • Company is structuring its newly created business unit accordingly

Client:

  • The Spanish affiliate of a multinational company

Challenge:

  • Within Global plans of expansion, the company wanted to create a Market Access position, and the team

HiTT’s role:

  • HiTT had a MAD interim role
  • Provided continued support during 18 months, in the design and implementation of the team & roles
  • Helped to prepare for challenging launches

Result:

  • At the end of the period, the team was well established
  • Spanish affiliate was well positioned at Global headquarters
  • 2 successful launches were prepared

Client:

  • The Spanish affiliate of a multinational company

Challenge:

  • had to introduce a new compound in a crowded disease
  • was uncertain about access strategy when facing MoH negotiation

HiTT’s role:

  • Report of the regional evaluation requirements
  • Analysis of the regional access differences
  • Estimation of evaluation times and success probabilities

Result:

  • Negotiation strategy was modified to allow for negotiation in Regions
  • Expectations set on price, positioning and timings

Client:

  • The Spanish affiliate of a multinational company

Challenge:

  • … had to face negotiations with MoH
  • … were uncertain about IPT result

HiTT’s role:

  • Prepared a Mock IPT
  • Agreed with client to include added Value features (beyond GVD)
  • Searched for relevant Spanish Literature to adjust for Standard of Care and relevant comparators
  • Designed a neutral Budget Impact model

Result:

  • Company obtained desired price and access conditions
  • Company could defend their position at MoH whilst having negotiation room in Regions

Client:

  • The Spanish affiliate of a multinational company

Challenge:

  • … had a challenging price given competitors
  • … were willing to establish MEA to mitigate risks at the Hospital level

HiTT’s role:

  • Analysed technology
  • Tested alternative value arguments with KOL & Payers
  • Prepared a Risk Sharing Agreement contract
  • Introduced the new technology to several Hospitals across several Regions in Spain

Result:

  • The access curve at the regional / hospital level was less challenging
  • Company is currently completing their RWD