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Case Study

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Manufacturer sought advice to inform launch decision, as well as access and reimbursement strategy, for a pre-Notice of Compliance (NOC) asset with a novel mechanism of action with evolving evidence to support its use in a subpopulation of a prevalent chronic disease where the standard of care is
heavily genericized.

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Developed product pricing & reimbursement assessment that involved reviewing results from pivotal trials. The assessment evaluated potential place(s) in therapy and informed health technology assessment (HTA) submission strategy and reimbursement ask. In addition, it provided a “payer perspective” on likely areas of concern for payers and suggested options to mitigate risks, including engagement strategies and real world evidence generation.

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Provided client with early identification of HTA and payer concerns with specific advice on mechanisms to minimize risks at time of submission. Informed client’s Canadian market access strategies (public and private) and HTA reimbursement request and product positioning. In addition, the client benefited from early development of payer value messages and negotiation strategies.

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