Health economics & reimbursement
Assessment and positioning
Medextens is expert in HEO assessment and positioning of medical devices, in vitro diagnostic systems and drug-device combinations in European countries. Our services aim at establishing product value propositions relevant to health care providers and health care payers.
Reimbursement and funding reviews
The review focuses on target markets and documents the need for conducting a microcosting substudy. It maps the clinical pathways, related funding and number of patients concerned. Results such as burden of illness and trends are used as inputs to a decision model that relate outcomes and costs given the perpective (hospital, payer or societal).
Health economic decision modeling
We develop health-economic models according to ISPOR guidelines, specific to a product to aid decision-making about its health value for money. We guide you in formulating the question to be addressed, to identify relevant evidence, to define assumptions that will serve as inputs to the model.
We program models in TreeAge software or in Microsoft Excel. Depending on the situation, the model will be a fixed time decision tree or a cycle tree that describes changes in risk over time and events.
Base case analysis producs the expected values of the targeted outcomes and determine the optimal treatment using the expected value of each input.
Deterministic and probabilistic sensitivity analyses modify input parameters to identify critical values that change the opitmal treatment path. Adequate calibration should enable the model to predict with enough accuracy observed output data from patient samples when their inputs are also known.
Validation is performed by testing the model with a panel of target stakeholders who check of if inputs and predicted outputs are consistent with their own experience.
One preferred approach for using a model as supportive tool to convince stakeholders that technology is worth funding or purchasing at the asked price, is to submit an article about the case to a peer-reviewed journal. Publication provides both some credit and visibility to the model and its results. The model may also be presented in posters or slide decks during meetings.
These substudies are conducted along a clinical investigation or an observational clinical study. They are necessary when the cost of using the product and its relation to outcomes have not been proven. Their objective is to collect health care resource utilization required when using the studied product and comparator in the same patients who provided clinical data. They should take into account relevant context, time horizon and perspective. A validated health-related quality of life questionnaire designed to derive patient utility is associated whenever relevant to the context. When decision model inputs rely too much on assumptions and not enough on evidence, the model should trace into the health economic substudy design and CRF in order to collect the missing evidence.
Substudy set up and conduct
The protocol, CRF and study conduct are usually subject to the same regulations as the clinical study that they are planned with.
In international studies, resource utilization collection may needs to be adapted to the country's resource accounting system and health-related quality of life need to be translated.
Health economic data analysis
Descriptive statistics and hypothesis tests are performed according to a statistical plan. Joint distributions of cost and treatment as well as cost and outcomes are estimated. The preliminary health economic model is re-analysed using clinical and economic study results in order to predict evidence-based cost-effectiveness, cost-utility when applicable and budget impact. These can be compared to market constraints in order to position the product in terms of clinical and economic value. Substudy reports is usually structured according to GCPs when applicable. A version is usually written according to the standards of target stakeholders.
Reimbursement listing & pricing
Reimbursement listing and pricing applications
Medextens has developped listing and pricing applications for medical devices in countries with product-specific funding. We have also specified procedure codes and DRG supplements for certain types of medical devices. These assignments involved forecasting health care volume and budget impact. Our role has also involved processing submissions and follow-up with payer and hospital stakeholders. These assignments have been commissioned by individual product suppliers or through industry joint actions coordinated by medical technology trade associations such as EUCOMED, SNITEM or ABHI.