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    Retention

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    • G
      GMC last edited by

      Can a signed letter from the Patient Support Program vendor, accompanied with a data table be used as data on file to support a message of length of time patients are on therapy i.e. retention?

      Jennifer Carroll 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @GMC last edited by

        Hello @tmcd

        As per the document Tips on Claims Relating to Patient Assistance Programs,:
        “Observational data on retention could be considered if the program has a valid and reliable mechanism to monitor when prescriptions are filled. Sufficient information about the program must be provided to enable PAAB to make this assessment. The APS claim/data from a manufacturer’s patient support programs should be non-comparative (as it relates to the manufacturer’s product), it should reflect past study findings (i.e. formatted in the past-tense), and it should be structured so as to limit the findings to the support program. Study parameters such as the time period pertaining to the claim/data could be relegated to a footnote. Note that retention data will be required to be updated every 6 months as changes in the market place can impact retention.”

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