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Gaining access to a national market is a key hurdle in a drug’s lifecycle, as is getting through the maze of the different health technology assessments (HTAs) and pricing and reimbursement processes. Once this point is reached, many biopharma executives breathe a sigh of relief. However, this is really only the beginning of the story – companies still need to push beyond the national market access hurdle and engage with regional and local healthcare economies to make sure that their products get onto formularies and their use is properly funded.

Focusing on local stakeholder networks

The awareness of national pricing, reimbursement and HTAs has grown over the past few years, and many biopharma companies have become adept at working their way through the processes. This is as a result of investments from biopharma companies in building market access capabilities at European and country affiliate levels and better collaboration between companies, regulatory authorities and HTA agencies, for example through the provision of scientific advice during the clinical development phase. Once national pricing, reimbursement and HTA approval have been achieved though, the challenges do not stop there.

In some countries, such as Italy, the UK and Germany, regional and local bodies have different needs and budgets. There are specific sub-national regulations in place which influence the price due to further negotiated commercial terms. This can result in products not reaching all of the patients that require them, because companies might not understand the processes and expectations of key stakeholders in regional and local healthcare economies within countries, and have not created the appropriate local stakeholder networks.

The National Healthcare System in Italy is managed by the Ministry of Health (MoH), however, the administration is devolved to 21 regional governments. These are then further divided into almost 140 local health authorities and over 800 hospitals. Purchasing may be at a regional or local level, with drugs paid for from each region or individual hospitals’ budgets, making the Italian market access environment fragmented and complex.

In the UK, NHS England, NHS Scotland and NHS Wales make decisions at national levels over specialised commissioning. At a regional and local level in England, prices and formulary access are negotiated with over 200 local clinical commissioning groups (CCGs), as well as area prescribing committees (APCs) and hospital trusts. At this level, the focus is very much on cost-effectiveness, making economics models and hospital-specific business cases must-have requirements. This level of complexity can make the process slow and rather daunting.

In Germany, there are regional and local regulations in addition to the centralised market access regulations. The 118 gesetzliche Krankenkassen (statutory health insurance funds) are an integral part of the national price negotiation.  The Spitzenverband der gesetzlichen Krankenkassen (head association of the statutory health insurance funds) negotiates regional regulations with the 17 ASHIPs (Association of Statutory Health Insurance Physicians) on a yearly basis for the office-based market. In general Germany has a healthcare budget for the office-based market and a separate one for the hospital market.  The 1,980 hospitals are paid through the DRG (German diagnosis related groups) system.  In addition, 40 purchasing groups and hospital chains define the usage of products within their member hospitals. Hospital pharmacists and controllers are important stakeholders in addition to the hospital physicians.

Ensuring that patients get access to new products

Making the most of these more complex markets and getting the right products to the right patients at the right price takes additional time and field-based resources that operate at a subnational level. To create a coherent subnational market access strategy and improve the chance of adoption at all levels of the market requires a greater understanding of the needs of physicians and patients at regional and local levels. This needs to be factored in as early as possible during the drug development pipeline, starting with close analysis of the local and regional market landscape. This should include:

  • Prescribing, adherence and compliance patterns
  • Existing treatments, including physicians’ preferred treatment regimens
  • Late stage pipeline drugs
  • Local clinical guidelines
  • Local stakeholder needs and expectations
  • Local care pathways, including specific local patterns and challenges

Ideally this needs to be supported by local real-world data and real-world evidence from clinical trials and post-launch studies elsewhere in the world. All of these can be built into a drug value story that can be used globally but needs to be tailored to local markets, and that will demonstrate the product’s value in everyday use.

Quintiles’ expertise in market access, built up over many years and in many countries, is based on its network of experienced field-based subnational staff, stakeholders and key opinion leaders. By creating an integrated strategy that takes into account the national, regional and local needs in each market, and works across the different stakeholders from patients to payers, Quintiles can support the process of gaining market access even in the most fragmented market.

 

This piece co-athoured by Olaf Zorzi, Principal, Advisory Services, QuintilesIMS.

Topics in this blog post: Biopharma, EMA, EU, Evidence, HTA, Value, Market Access