“Market access and reimbursement of innovative health technologies”

Capacity Statement Seijgraaf BV

 “Market access and reimbursement of innovative health technologies”

Ron de Graaff, LLM 
Frans van Andel, MSc, MPH, PhD
email: info@seijgraaf.nl
tel 00 31 6 53 32 35 08

Introduction to Seijgraaf BV

Seijgraaf BV is a Dutch company with over 36 years experience in supporting health technology companies in gaining pricing and reimbursement of their innovative technologies.

Over the years, Seijgraaf BV implemented more than 2,000 assignments for well over 800 different organizations in the Netherlands and the EU. With such a track record, Seijgraaf BV is one of the oldest advisory companies in the Netherlands in the area of market access of health technologies.

In addition to its activities in the Netherlands, Seijgraaf BV is a founding member and shareholder of a global company in market access of health technologies. This company has in-market expertise available in all EU markets and is very well suited to accomplish and resolve complicated market access and reimbursement issues of health technologies in many countries simultaneously. The usual scenario for this is when a health technology company intends to launch a new product in many EU markets at the same time, but lacks the expertise to achieve reimbursement in a process of parallel tracks in many countries. 

Importance of “early market access” of innovative health technologies.

In addition to clinical development, it is important for innovative medical technology, such as pharmaceuticals, medical devices and ehealth products, that at an early stage of product development it becomes clear (1) what a possible selling price of a new technology could be and (2) if the technology will be reimbursed by means of health insurance or otherwise.

These questions are important for well established health technology companies as well as for start-ups, as gaining reimbursement is generally regarded as one of the key success factors of product development.

For innovative health technologies, Seijgraaf BV has developed a new discipline: early market access. This discipline will assess an indication of product value, price and reimbursement potential at an early stage of product development (preclinical and clinical).

Early market access primarily focuses on exploring a proxy value for a new product and uses this for early pricing and reimbursement and to map out a possible reimbursement strategy and path. An important element in the approach is the early assessment of the clinical features of a new medical technology.

The determination of a proxy value of a health technology can be investigated using various methodologies based on pharma-economic theory or follow a more pragmatic microeconomic approach. The selection which method is appropriate depends among others on the availability of data on the new compound or technology.

Services of Seijgraaf BV: process starts with assessing a
market access strategy and development of a plan to achieve reimbursement

Seijgraaf BV has developed a unique approach for market access positioning of innovative medical technology, the objective of which is to support medical technology companies defining  a price and reimbursement track for their technologies, as well as to formulate and implement plans to achieve this in the marketplace.

On the basis of an assessment of all clinical data, as well as business plans and other relevant documents, we will initially estimate the likelihood that a technology can and will achieve reimbursement. In addition, we assess the external framework of the positioning of a new technology, among others by looking at the state of  legislation, the opinion of patients, health insurers and professional medical organizations as well as the  expected market development of an innovative product.

Our analysis will initially result in a strategy for adequate price and reimbursement of a new technology. Once a  strategy that may result in reimbursement of a technology has been determined and an action plan and timeline established, Seijgraaf BV offers a wide range of services to achieve the objectives of the plan, ultimately resulting in the reimbursement of an innovative health technology.

  •  

Seijgraaf BV offers the following suite of activities to achieve reimbursement:

  • Economic modeling studies
  • Cost-effectiveness research
  • Clinical and quality of life research
  • Multi-country clinical trial design
  • Surveys among Key Opinion Leaders – Physicians and Patients
  • Setting up consensus meetings according to Delphi method
  • Preparation and writing of scientific publications in the clinical and economic field
  • Price and reimbursement systems in the Netherlands and the EU
  • Price and reimbursement strategy studies
  • Price referencing and sequencing of global pricing and reimbursement
  • Development of core value files
  • Development of price and reimbursement dossiers
  • Negotiations with pricing and reimbursement authorities
  • Support on price reference systems
  • Set up and implement multi-country price and reimbursement projects
  • Consultation on general health political topics