Market Access is the process to ensure that all appropriate patients who would benefit, get rapid and maintained access to the brand at the right price.

Understanding the process:

It is important to understand all the processes that impact market access, both internal and external:

  • Payers have processes – at national level this includes HTA (Health Technology Assessment), pricing and reimbursement approval; and at local level, Drugs and Therapeutics committees.
  • The R&D process: there is a series of ‘decision gates’ to guide investment decisions throughout drug development to manage the huge cost of R&D (~$1bn) linked to the likelihood of success.
  • Some companies may have a commercial launch excellence process; preparing the brand for the market, preparing the company for the brand, preparing the market for the brand.

Market Access needs a good process which links:

  • Value identification based on payer customer insights.
  • Value creation through clinical and health economic outcomes and research (HEOR) data.
  • Value communication through the value proposition & value dossier to the R&D and commercial ‘decision gates’; what gets done when (early enough for consideration in clinical study design) and how.

The market access process must link the requirements at global level, which guide the clinical development process to the needs at local country level. The global value proposition and global value dossier must be adapted to specific market access customers at national and local level, as each healthcare system is unique.

The key challenge is linking all these processes together – for payers, for R&D, for commercial and for market access, to deliver commercial success.

EU take first steps

Enabling EU Market Access:

For companies that operate in non-EU countries and wish to release batches of medicinal product into the European Union, they may face a number of barriers to entry. In Europe, no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). For a QP to batch release a drug product (Batch Disposition) the QP is required to be on a license known as an MIA (Manufacturer’s / Importation Authorisation).

How can MIAS Pharma help:

MIAS Pharma specialises in offering a license platform and batch release services for both commercial and clinical human medicinal products. MIAS holds an MIA for Investigational Medicinal Product (IMP) and Commercial Medicinal Product.

This enables MIAS Pharma to partner with you to provide EU Qualified Person (QP), Manufacturer/ Importer Authorisation (MIA) and MA support services for the importation and release of your Investigational Medicinal Product or Commercial Product in the EU.

webinar presentation on mia

Key benefits of choosing MIAS Pharma:

Time to market: Will be reduced on average of 3-4 months lead time versus typical 9-12 months lead time to develop a PQS and obtain authorisation.

Reduced risk to the client company: Drugs typically have a high failure rate in the clinical phase. Once a product proves itself in clinical trials and is targeted for commercialisation, you can continue outsourcing to MIAS Pharma while you establish your operations in the EU/ EEA.

Access to industry experts: MIAS Pharma has access to QPs from various industry backgrounds to match your project requirements.
Reduced overheads: Pay for only time incurred on projects rather than having to invest in your own staffing.

Access to the MIAS Pharma network: MIAS Pharma has links with CMO’s, contract laboratories, distribution providers and to a range of consultancy firms specialising in Regulatory Affairs, Quality Management and Reimbursement should you require additional services as part of your project.

Sourced information:

If you would like to receive more information about our services or get in touch with MIAS Pharma, please use this contact form or call us on +353 (1) 846 3605.

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