Our Unique Selling Point

Arcana Institute offers Clients an unique selling point by providing strategic support on every stage of product development. Our team of experts will examine with you through all the phases of the drug development to understand the payer, physician and patient needs, which form the basis of the market access strategy.

 

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Evidence-based Market Access

Pharmaceutical, medical devices and biotech companies need the tools and knowledge necessary to use scientific and health outcomes data for proving product value and gaining access to the local and global market.

Arcana Institute is experienced in developing, implementing and managing evidence-based approaches for Market Access. As demand grows for proof that new therapies offer both clinical and economic value, we help demonstrate the value of healthcare products through evidence-based evaluations and health related outcomes research (HEOR).

Market Access activities executed by Arcana Institute will contribute to strengthening your business image as a modern pharmaceutical company – reliable and credible, acting according to the latest trends in medicine, based on the EBM and HTA guidelines.

 

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Comprehensive support from the decision-maker point of view

The experience of Arcana Institute in dealing with limited resources in the Polish market and the experience of our team in decision making structures gives us the necessary knowledge and a foundation to create tailor- made products in a pragmatic way. This ensures that we provide the highest quality of services.

The experience of  key leaders of Arcana Institute is drawn from the following institutions:

  • Drug Policy Department at the Polish Ministry of Health
  • Polish Agency of Health Technology Assessment
  • Accreditation Office at the Polish Ministry of Health
  • National Center for Quality Assessment

 

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Innovative tools for rational decision making

 BAYESIAN HTA

 

What is a Bayesian HTA/Mixed Treatment Comparison?

  • Methodological  and statistical approach that makes systematic review more flexible (allows to use "ignored" scientific evidence like observational studies or indirect evidence ), more transparent  (presentation of results in the form of probabilities facilitates inference), complete (focused on both statistical and clinical significance major for clinically relevant end points);
  • Systematic reviews which synthesize information over a network of comparisons involving all alternative treatment options for the same condition. By taking into account of the entire network of evidence simultaneously we are able to rank interventions in terms of effectiveness and safety. 

 

 

REIMBURSEMENT & PRICE LIMITS BASE

 

Reimbursement and Price Limits Database is an innovative tool which gathers all lists of drugs eligible for public funding together with their prices and other conditions of reimbursement. These lists are published periodically in a form of regulations by the Polish Minister of Health.

The database enables to:

  • obtain the right data faster and more efficiently,
  • have a holistic perspective on the pricing and reimbursement processes and their outcomes in Poland,
  • better foresee possible changes in public funding conditions of a drug we advise on,
  • develop more successful Market Access strategies for a Company.

 

 

ECONOMIC MODELS


Arcana Institute develops universal, user-friendly models which can be used in pharmacoeconomics. Examples of diseases for which universal models are prepared are diabetes and osteoporosis.

The purpose of modeling is to structure evidence on clinical and economic outcomes in a form that can generate valuable information to support health policy decision-makers allocate scarce health care resources efficiently.

Models are created for a life time horizon with a possibility of its modification. The length of cycles in the model is determined based on the specific disease - a monthly, semi-annual or annual. Calculations are performed using various techniques: classical Markov model, individual simulation (microsimulation), probabilistic sensitivity analysis (PSA).

Models synthesize relevant data from a variety of sources, including clinical trials, observational studies, case registries, public health statistics, and preference surveys. Costs and resource use data from different countries could be implemented as well.

To prepare models TreeAge Pro and MS Office Excel software is used.

 

 

HEALTH CARE UTILIZATION QUESTIONNAIRES

 

Data collected on the basis of our questionnaires can be used to conduct pharmacoeconomic evaluation of the assessed intervention and comparator/-s.

Detailed questionnaire concerning health care utilization include questions about:

  • Resource use, which generate direct and indirect cost: resource use are distinguish between: related strictly to patient vs to public payer; required only with the trial vs required in real life.
  • Lifetime horizon of treatment consequences: answers concerning this subject are used to implement time horizon in the model longer than follow up of the clinical trial.
  • Assessment of patient's health state: an adequate scale is chosen to assess health related quality of life.

All questionnaires are validated by the medical expert/-s and later consulted and accepted by the Client.

 

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Tailor-made products for global and local needs

“Market access is about packaging data in the right way, for the right customer at the right time”

 

In Market Access there is no one-size-fits-all solution. The various barriers to market entry will vary from product to product according to drug profile, therapy area and treatment setting.

Arcana Institute offers Clients an optimal guide-post to public funding by gathering adequate information to enable solutions which work best.

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Projects in international markets

Arcana Institute operates in international and national markets with a special attention to know-how in the Polish regulatory framework. We provide evidence-based reimbursement support for market access in Central and Eastern Europe and emerging markets.

An overview of the network of our partners is available here.