Health Economic Evaluations & Modelling
Nowadays, most of the payers and health technology assessment (HTA) agencies are more responsive to the interventions that have a long term health economic benefits. Sometimes, it is recommended to provide the life time health economic consequences for a particular device. As economic evaluation alongside the clinical trial is arguably less feasible, economic modelling is one of the recommended methods to develop your device’s long term health economic value.
Countries and several umbrella organizations are trying to develop the ‘Good Practice’ guidelines for economic modeling and HTA submissions. Knowing this country and region specific HTA and modeling guidelines is one of the key challenge to develop economic value for your products. The basic process and activities to develop a model are as following:
Process for Model Development:
- Defining decision problem clearly in terms of disease – intervention and comparators
- Review the basic clinical trial data related to the disease or technology area
- Perform a systematic literature review
- Gather other available evidence from databases, observational studies and subject matter experts or Key opinion leaders
- Develop a conceptual framework for the model that is consistent to the disease
- Run validation checks for clinical and structural logic
- Quality Control
- Run primary and sensitivity analyses and summarize the results
Decision tree and markov model is the most frequently used structural method of developing economic modeling. There are other statistical and mathematical simulation methods to build the economic argument.
Decision tree can provide short term effectiveness with a limited extent data that is quite common at the early phase development of any medical device.
Markov model is appropriate to show the long term rational although it is quite data and evidence demanding.
From recent critical appraisal reports of different HTA agencies, five major drawbacks were identified in economic evaluation studies (both model-based and trial-based) and manufacturer’s submissions. These were:
- Not using effectiveness data from RCTs
- Not maintaining the relevance to the country specific clinical and economic settings
- Lack of appropriateness in assumptions used in the model
- Not using a long enough time horizon to capture all possible clinical and cost outcomes
- Not formulating the clinically appropriate risk stratification
Synergus can help you to assess and communicate your product’s value throughout its lifecycle. We understand the needs that patients, health care providers, payers and regulators have for health economic information and how it impacts their decisions about your products.
The ways that Synergus can help you to develop your products economic value are:
- Provide the total health economic evaluation and the HTA report for a country specific submission.
- Update or relevant modification of your base model for European perspective
- Project support to supplement your already developed model, by providing European specific clinical, costing or Quality of life data etc.
- Assessments on the existing competitor’s models and their criticisms done by different HTA agencies to compile the questions to addressed in your device’s model.