Health outcomes, Health outcome strategy, Health economics, Health economic modelling, Patient reported outcomes, Health Technology Assessment

Health Outcomes

prmaconsulting™ offers full-service strategic, technical and operational consultancy to support Health Outcomes business objectives.

Health outcome strategy development

What is the most appropriate health outcomes strategy?
How should this be incorporated into the clinical development programme?
What additional work is required in parallel to the clinical trials?

Clinical trial design to include relevant health economic endpoints

Which health economic endpoints should be included in the clinical trials?
Is it better to include these end-points in the trial or to develop the work in parallel?

Patient Reported Outcomes (PRO) assessment & strategy development

Will a PRO claim aid product differentiation?
What is the appropriate instrument to assess this claim?
Is there a valid conceptual framework within the FDA and EMEA guidelines for this instrument?
If not, what are the next steps?
When should these PROs begin being assessed in the trial programme?

Health Technology Assessment and pricing & reimbursement submissions

National Institute for Clinical Excellence (NICE), Scottish Medicines Consortium (SMC), Academy of Managed Care Pharmacy (AMCP), French National Authority for Health (HAS), Pharmaceutical Benefits Advisory Committee (PBAC) and other country submissions.

Health economic modeling

prmaconsulting™ builds internal and external health outcomes models to aid decision making at all stages of the product life cycle.

Literature reviews

What are the burden, epidemiology, cost and treatment patterns associated with the disease area?
Where are the gaps?
Where are the opportunities for value differentiation?

Budget impact modeling

prmaconsulting™ can assess the budget impact of the technology based on epidemiology, anticipated uptake and price. We provide interactive user-friendly front-ends to support these models.

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