In the last decade, market access has become a core discipline in the innovative pharmaceutical industry. Reimbursement processes are more or less clearly defined; clinical evidence generation is an integral part of the development and commercialization process and health technology assessments are widely used.
In comparison the world of in vitro diagnostics presents unique challenges. What are these challenges and what are their potential implications from the industry point of view?
1. Diagnostics are complex solutions
In vitro diagnostics are complex solutions. Instruments, tests, software and algorithms contribute to the value of the entire solution, to accurate and timely diagnostic information. Instruments and software improve operational efficiency, while tests and algorithms medical decisions, resource use and patient outcomes.
Potential action: Capture holistic value of the entire solution by taking into account all relevant players (laboratory, hospital, physician, patients, society) in the healthcare delivery, over time.
2. Less clinical investment
The peak sales of diagnostics solutions are much lower than innovative medicines. Manufacturers have fewer financial means to invest in large scale clinical trials, supporting access and adoption.
Potential action: Utilize regulators’ growing evidence requirements to increase development budget. Apply Real World Evidence (RWE) techniques.
3. Cost-based reimbursement
Reimbursement systems in general do not incentivize the development of high medical value diagnostic solutions. Reimbursement & pricing are mainly based on testing methods, level of automation, time required to generate results
Potential action: On long-term: advocate for Health Technology Assessment (HTA) and value-based reimbursement. On short-term: initiate outcome-based payer agreements
4. Lack of clear funding processes and guidelines
Reimbursement pathways in general lack clear processes, guidelines, and most importantly systematic HTA’s. Top-down, pharmaceutical-like reimbursement applies in a few countries, bottom-up, hospital-based funding is quite common.
Potential action: On long-term: advocate for more transparent processes and guidelines. On short term: factor in longer reimbursement processes, be open to experiment, be ready for field-based market access solutions
5. Limited-use cases in digital diagnostics reimbursement
There are increasing number of digital diagnostics solutions, disrupting current IVD business model. These products enable the combination of physiological, behavioural and biological patient data to generate actionable insights. Classical reimbursement pathways do not, or partially cover these solutions, they tend to fall in-between current healthcare funding options.
Potential action: Be open for alternative market access options, experiment, initiate pilot payer agreements.
This list of challenges is far from being complete. What are your thoughts? Please comment!