To get new medicines to patients you have to look beyond gaining EU regulatory approval. Every country in Europe has their own methods and criteria to decide whether a new medicine is approved to be marketed in their country and will be reimbursed or not, and at which level. With approximately 100 European bodies having a financial stake in the reimbursement of medicines today, it is even more challenging to ensure that good medicines reach the patients that need them.
At NDA, we have brought together some of the leading minds in the field of Health Technology Assessment in Europe to effectively support clients in addressing any HTA aspects or health economics challenges (NDA HTA Advisory Board). Together with the NDA Regulatory Advisory Board, the team is uniquely positioned to understand the requirements of regulators and payers simultaneously. This joint up approach creates another unique opportunity – to systematically align drug development to the needs of both regulators and payers.
How NDA can support you
We will help you to reduce the uncertainty on how your product and value file will be received by HTA and/or pricing and reimbursement agencies in EU. We can support you build your case to both the regulators and payers, simultaneously. Our HTA team can assist you in every stage of drug development, from early decision-making on new candidates to advice on value file preparation, submission, assessment and post authorisation real-life evidence generation. This service is useful for all kinds of pharmaceutical companies, from small biotech to big pharma companies, tailoring our services to your needs. At the core of our services is giving strategic advice and assessment of your on-value files in order to deliver a second opinion that aligns with internal viewpoints.