Health economics

Cost-benefit analysis is an integral part of market access

Health insurance companies, healthcare providers, and medical societies often complement clinical evidence during healthcare decision making, such as economic cost-benefit assessments of new therapies. Incorporating those assessments into market access strategies is an integral part of communicating with various stakeholders in the healthcare system. As personalized medicine makes its way from bench to bedside, the value of cost–benefit and health economic analyses grows, enabling pharmaceutical manufacturers to improve internal planning and to develop and test multiple scenarios.

For more than 20 years, Xcenda has been at the forefront of discussions on methodological standards and has made several leading contributions to current German health economic guidelines, including the Hannoveraner Konsens. The competence of Xcenda Europe is reinforced by more than 40 European and American experts in our global health economics team, allowing us to successfully implement large, multinational health economic projects.

Cost-effectiveness analysis

Comparing the costs and benefits of different treatments

The cost-effectiveness analysis (CEA) helps you compare measurable clinical outcomes and their associated costs. The results are presented as price per unit for medical parameters (surrogate parameters or a patient-relevant endpoint). The CEA allows you to compare 2 or more effective interventions, enabling the additional costs to be compared with the added effectiveness—the incremental cost-effectiveness ratio (ICER). The most commonly used parameters are cost per life-year gained or quality-adjusted life-years.

Health economic analyses, like the multifactorial CEA, have been key aspects of Xcenda’s portfolio since our company was founded. Our experienced professionals offer you individual and goal-oriented advice on the choice and implementation of appropriate models to evaluate a treatment’s cost-effectiveness.

Budget impact analyses

Evaluating affordability within the healthcare system 

Budget impact analyses (BIA) enable you to judge the affordability of an intervention, a new therapy, or a new drug. The BIA can be used for product marketing we well as price negotiations in the context of the Pharmaceutical Market Restructuring Act (AMNOG).

While cost-effectiveness analyses are useful for discussions in a broader economic sense, these tools are generally less relevant to the decision-making process for payers. However, budget impact analyses regarding issues of financial feasibility within the healthcare system have recently become more relevant.

Because the German healthcare system is composed of a multitude of individual budgets to finance treatments and decision making is based on absolute costs, budget impact of a treatment can be difficult to analyze. When faced with those challenges, Xcenda can help define targeted analyses for relevant fields and periods of interest based on a well-structured BIA.

Pricing and reimbursement 

Consulting and considering different stakeholder groups

To achieve a successful market introduction, the benefit of an innovative pharmaceutical should be based on scientific evidence. It’s important to receive information on the new therapeutic option, comparable pharmaceuticals, and existing market authorizations from a single source at the same time. Health technology assessments (HTAs), health economic evaluations, and health services research can also be important sources for this information.

Xcenda has a comprehensive understanding of the stakeholders in the German healthcare sector—as well as knowledge of their functions and insight into current reimbursement regulations—and can advise you on strategic questions regarding the pricing and reimbursement of your products.

Market access strategy for outpatient and hospital sectors

Gaining acceptance by service providers and health insurance companies 

Market access strategy considerations must be addressed well before product launch to ensure that the many parallel processes are initiated at the correct time. Regulatory market approval or even a successful AMNOG/HTA procedure doesn’t guarantee revenue—additional hurdles could hinder market growth.

To ensure success, a market access strategy must include both targeted communication with service providers and integration of health insurance companies. Uncovering the right answers for financing innovative therapies is crucial. Due to differences in pricing and reimbursement, the outpatient and inpatient sector must be assessed in completely different ways and mapped into the market access strategy from the beginning.

Xcenda can assist you in the development of market access strategies and materials, including involving other partners, whose level of involvement can depend on the task at hand.

Health insurance fund audits

New approaches for investigating and applying methods of treatment and medical services 

A lack of additional reimbursement information and unclear patient populations can severely impede market access and market share.

A market access plan anticipates and addresses many critical measures well in advance of product launch, including:

  • Support for hospitals in the process of approving additional compensation for new investigation and treatment methods (NUB). Hospitals in Germany are primarily reimbursed by case-based billing (diagnosis-related groups [DRGs]), depending on the indication. Compensation is recalculated annually based on past costs. For innovative therapies entering the market, costs cannot be represented in the DRGs. There are options to help hospitals avoid bearing the cost alone, such as applying for NUB reimbursement or individual applications, which each hospital must submit separately.
  • The Medical Service of the Health Insurance Funds (MDK) is commissioned by health insurance companies to perform audits, checking billing and correct use of medications. This is often the case for expensive, innovative medicines, making it important to inform service providers what to expect.
  • Xcenda can also assist you with questions about market access during a successful launch as well as after marketing approval and the completed AMNOG process.
Thomas Mittendorf

Meet our expert

Dr. Thomas Mittendorf, Health Economics and Market Access

Thomas Mittendorf