Bringing a product to the UK or EU market involves a number of market access hurdles. Developing individual products in all indications from the earliest point is key to the realisation of the full potential technologies offer. Gaining expert input in relation to the key steps in the process can inform decisions about evidence generation and product registrations. Guidance can also be pivotal to evidence submission and Patient Access Scheme choices in Technology appraisal.  The markets of Europe have differing entry criteria, evidence dossier requirements and assessment mechanisms. Post marketing authorisation steps are equally challenging and expert advice a key component of the systems for successful placement and reimbursement.

Marketing authorisation from EMA is a significant hurdle – but for specialised technologies it is the start for various forms of value assessment and negotiation. Health technology assessment (HTA) is well established in the UK, EU5 and other countries of Europe. Managed Entry schemes are now a fundamental part of the process, for example an average of 50% of medicines gaining a positive recommendations by NICE include a PAS. Such schemes can also be used for Diagnostics and are increasingly part of the Device reimbursement landscape. Successful navigation of such systems across Europe requires expert input to ensure the correct approach is made, tailored to the health systems which will be making the appraisals and reimbursement decisions. One size rarely fits all.

Research Health, with partners organisations including Kantar Health and Stisali Solutions, offers a range of educational support which includes tailored or bespoke workshops or to outline the processes involved in

• Technology Appraisal
• Managed Entry (risk-share) Patient Access Schemes
• Device assessment
• Reimbursement processes
• Commissioning through evaluation

The scope for the workshops or interactive presentations can be specific to the UK (England and Wales and/or Scotland) the main EU countries.

Materials can be tailored to review a specific class of product in a particular market or at a more general level the processes which might be involved in one market or the European market. Packages can be tailored to your needs even if you are not certain about the gaps in knowledge.

We are able to source relevant market intelligence from the key decision makers. This includes the clinicians, pharmacists and procurement specialist involved with:

• Making reimbursement decisions and policy for medicines
• Making reimbursement decisions and policy for medicines
• Making reimbursement decisions and policy for diagnostics or devices
• implementing a patients access scheme
• leading the assessment of devices and procedures

This input will guide the development of submissions to the HTA process and to reimbursement discussions with and tenders to purchasers. The correct submission saves time and improves the probability of positive coverage decisions. Our aim is to assist you have a better understanding of your product’s value in the relevant market and demonstrate this to the purchaser.

Patients and carers input can be pivotal in many remuneration decisions. Appraisal Committee and Patient Access Scheme assessments take account of the positive attributes new medicines may bring. Our expertise can assist in bringing clarity to the benefits your new medicine may offer to patients.

Research Health is working closely with charitable trusts in Romania and elsewhere to bring new medicines at affordable prices into European and other markets. Our activities include the stop hepatitis campaign.