• Menu
  • Skip to right header navigation
  • Skip to main content
  • Skip to primary sidebar

Before Header

 

Link Medical Research

  • Home
  • About Us
    • Our Management
    • How We Work
    • Case Studies
    • Our Memberships
  • Solutions
    • Early Development
    • Clinical Development
    • Post-Marketing
    • LINK Advantage
    • Market Access & RWE
    • Medical Device
    • Medical Writing
    • Pharmacovigilance
    • Clinical Operations
    • Project Management
    • Quality Assurance
    • Regulatory Affairs
    • Marketing Compliance
    • Biometrics
  • Therapeutic areas
  • News & Events
    • News
    • Events
    • Publications
  • Contact
  • Careers
    • Our Careers
    • Jobs
    • Testimonials
  • Search
  • Home
  • About Us
    • Our Management
    • How We Work
    • Case Studies
    • Our Memberships
  • Solutions
    • Early Development
    • Clinical Development
    • Post-Marketing
    • LINK Advantage
    • Market Access & RWE
    • Medical Device
    • Medical Writing
    • Pharmacovigilance
    • Clinical Operations
    • Project Management
    • Quality Assurance
    • Regulatory Affairs
    • Marketing Compliance
    • Biometrics
  • Therapeutic areas
  • News & Events
    • News
    • Events
    • Publications
  • Contact
  • Careers
    • Our Careers
    • Jobs
    • Testimonials
  • Search

Top Content

Market Access and Real World Evidence

Home / Solutions / Market Access and Real World Evidence

Market Access and Real World Evidence

Reducing risk with Health Economics (HE)

On the route to market, pharmaceutical or medical device products must reach many challenging milestones before the first patients will benefit from its therapeutic use and it becomes regularly reimbursed. For this reason, companies and their investors need to mitigate risk with accurate cost estimates on the specific stages of the market access process. Through a strategic partnership with LINK Medical, you will have access to our highly competent team that can help you accomplish this challenging task. We communicate actively with our customers to understand their business needs, and employ a variety of health economic tools and methods to provide full-service support throughout product development.

Getting the process right with Early Benefit Assessments

We utilize a variety of rigorous analytical methods for early assessments of pharmaceutical and medical device products, and keep them up-to-date as development progresses. To achieve this, we work in close collaboration with you to define the development phases of the regulatory and reimbursement strategies, as well as the milestones for allocating funding support. When bringing a new product to market, medical technology companies must present models of cost-effectiveness, cost-utility and cost-benefit to compare their products to standard treatments and devices on the market. Our uniquely talented staff have the deep understanding and experience to develop impactful health economic models that will support your entry into the market.

Creating market success

Obtaining reimbursement can often be a long-term project and success depends on various terms and regulations. Our experts can advise and guide you through the opportunities and potential risks of different reimbursement strategies. Our key local knowledge of markets across Northern Europe ensures that the reimbursement applications we produce adhere to all requirements and submission deadlines of local health authorities. Our team is highly experienced in the execution of every required step before launching a new commercial operation.

The value of Real World Evidence (RWE)

RWE is an increasingly crucial component of benefit, risk and value demonstration, particularly for cases where the collection of data via traditional routes is difficult. These challenging studies can involve innovative medical device products, advanced medicinal therapies, or treatments for orphan and rare diseases. Our RWE services accelerate clinical development by providing indication prioritization along with faster and smaller randomized control trials (RCTs). Our iterative approach to evidence generation and early value proposition will ensure that your product reaches the market as soon as possible. In the post-marketing stage, we offer life cycle management services that maximize the value of your product after loss of exclusivity.

To find out more about how effective use of RWE and HE analyses can accelerate your product development, contact our Head of Department, Yngve Mikkelsen at yngve.mikkelsen@linkmedical.eu.

Overview of RWE and HE services:

  • Reimbursement applications for pharmaceutical products and medical devices
  • Health Economic models
  • Budget impact models
  • Burden of illness studies
  • Guidance on market access environment
  • Real World Evidence and registry studies
  • HTA/STA assessment and appraisal
  • Literature reviews

Head of Department

Beate Bjørnstad Løkke,
Director Market Access

Beate is the Director for our Market Access team, she has 5+ years of health economics (HE), market access (MA) and real world evidence (RWE) experience, covering therapeutic areas such as oncology, neurology, and immunology. She has hands on experience in Project management in HE, MA, and RWE projects, as well as strategic market access, advice within pharmaceuticals and medical device product life-cycle in addition to experience with developing health economic models. 

Beate Løkke, holds a master of Health Economics, Policy and Management (Mphil) from the University of Oslo, with specialization within economic evaluation. 
​

beate.lokke@LINKMedical.eu

Related links

  • Case Study: Exploring market access of a medical device with health economic modelling
Systematic literature review
A systematic literature review (SLR) is required by the Norwegian Medicines Agency (NoMA) when submitting a reimbursement application. This is also required for medical devices. Additionally, a SLR is crucial in the development of Global Value Dossiers (GVD), and it contributes to the value of the product.

A standard SLR project includes the development of a protocol including search strategies, literature search, quality appraisal and documentation of the literature search, data extraction, synthesis, and finally, reporting. Depending on the objectives of the literature review, the search is conducted in three or more databases such as PubMed, Cochrane and EMBASE, and YORK (health economics) or MAUDE (medical device).

The total time spent on the evaluation and selection of the material from the review, is depending on the number of searches and articles. We often assume a maximum of 300 abstracts and 50 full-text articles for review, quality appraisal and data extraction.

Technology Assessments
Before new medicines are to be used, a health economic (HE) evaluation and documentation of the medicine in form of a Single Technology Assessment (STA) is required. In a standard STA project we prepare the reimbursement application for the customer.

The company usually has one or more phase III trials, a Global Value Dossier (GVD), a global health economic model, and some relevant publications. Our job is to adapt this information and gather local data were necessary, to complete an assessment in line with the templet and guidelines by national authorities.

In Norway, the process of writing a STA includes pre-meeting with the Norwegian Medicines Agency (NoMA), general guidance and discussion with the customer, gathering of information on patient flow, clinical practice, comparator, epidemiology, unit cost and consultation with a clinical expert.

In our experience, some health economic models do not contain all the required information needed in order to fulfill the requirements from the national authorities. In these cases, the team will adjust the model with the necessary information, and we may also design models from scratch when necessary.

Primary Sidebar

  • Solutions
    • Early Development
    • Clinical Development
    • Post-Marketing
  • LINK Advantage
  • Market Access & RWE
  • Medical Device
  • Medical Writing
  • Pharmacovigilance
  • Clinical Operations
  • Project Management
  • Quality Assurance
  • Regulatory Affairs
    • Marketing Compliance
  • Biometrics

Site Footer

Don't miss out on the latest updates

Be the first to hear our breaking news at LINK Medical

    • Home
    • About Us
    • Solutions
    • Therapeutic areas
    • News & Events
    • Contact
    • Careers
    • Search

    © 2021 Link Medical Research
    Privacy Policy