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Reimbursement Consulting: Planning.

Validating reimbursement strategy and designing clinical studies from a payer's perspective.

According to the conclusions in the Reimbursement Landscape report we devise the plan for developing the required evidence for the relevant decision makers.

(Back to main Reimbursement Process page).

Deliverables within this activity include:

Reimbursement Planning

Deliverables

The deliverables below would be relevant for all countries selected for the Reimbursement Landscape report (Activity 1).

a.

Value story:

The Value Story will verify the clinical and economic value of using the new device or drug in the eyes of the relevant decision makers (healthcare providers, payers) and would serve as the basis for the Economic Model.

b.

Economic model:

The Economic Model will allow for sensitivity analysis and will also be useful as a sales tool. In addition, this Economic Model may identify specific outcomes data that should be added to future clinical study protocols.

c.

Clinical data validation:

In order to verify that existing clinical data or any planned clinical studies could be used to derive the required evidence for the relevant decision makers, we will review existing clinical data and/or add reimbursement-related points to any clinical study protocol.

d.

Feedback from decision makers:

Prior to initiating clinical studies or applying for new reimbursement mechanisms, we will contact and coordinate phone interviews or face to face meeting with relevant decision makers. The purpose of these interviews is to obtain their feedback regarding the developed value story, the economic model and the reimbursement aspects of existing clinical data or the planned clinical study.

If needed, we will utilize specific pathways, established in different countries, through which our clients obtain payers' feedback in advance, before making strategic decisions regarding their regulatory pathway or clinical study design. In addition, these pathways may also be used to seek funding of planned clinical studies.

Methodology

Desk research plus interviews with:

a.

Company representatives:

Typically a few sessions with the management of the company to clarify the value story and the main clinical and economic claims.

b.

Relevant physicians:

Presenting relevant physicians with the value story and economic model in order to receive feedback and fine tune accordingly.

c.

Decision makers:

Obtaining feedback from actual decision makers, such as payer representatives and hospital management, regarding the developed value story, the economic model and the reimbursement aspects of existing clinical data or the planned clinical study.

Impact

The Evidence Planning step should be conducted prior to approaching potential investors or partners, and before the company launches any clinical studies as it may impact the following:

a.

Target market:

Target population and relevant indications according to benefits demonstrated in value story and supported by feedback received from interviewed stakeholders.

b.

Price:

The price of the device or the drug that provides the decision makers with economic value, as demonstrated in the economic model and supported by interviewed stakeholders.

c.

Clinical study protocol:

End points or other data generated from planned clinical studies required for supporting the claims in the value story.

Flat fees, concrete timelines, and support through your entire reimbursement process