3.2 Current therapeutic approach Click here to enter text What existing and approved therapeutic good(s) is/are used for the clinical condition? 3.3 Comparison to current Click here to enter text therapeutic approach Describe how the proposed use of the therapeutic good differs from each of these: Significant clinical advantages over existing treatment- for example- No worse than existing treatment in terms of effectiveness/toxicity or Less effective than existing treatment, but less complication 3.3 Patient population Click here to enter text What are the subgroups of the patient population that will benefit from the use of this therapeutic good? 3.4 Number of patients to receive Click here to enter text the therapeutic good If this number is expected to increase over time, please specify the predicted number of patients per year for 5 years Section 4: Evidence of safety, efficacy and clinical effectiveness 4.1 Safety evidence Click here to enter text Comment on safety evidence base 4.2 Side effects Click here to enter text List nature and incidents of side effects, contraindications, cautions, warnings and adverse effects for the therapeutic good and the source of this information 4.3 Comparison to current Click here to enter text therapeutic approach What are the main differences between the side effects, contra indications, cautions warnings and adverse effects between the unapproved therapeutic good and existing treatments and the source of this information 4.4 Efficacy and clinical Click here to enter text effectiveness Summarise the best available evidence, outlining key aspects, for clinical effectiveness of the therapeutic good for defines clinical problems including Supporting references and source of evidence Section 5: Clinical feasibility 5.1 Operator competency Click here to enter text
3.2 Current therapeutic approach What existing and approved therapeutic good(s) is/are used for the clinical condition? Click here to enter text 3.3 Comparison to current therapeutic approach Describe how the proposed use of the therapeutic good differs from each of these: Significant clinical advantages over existing treatment- for example- No worse than existing treatment in terms of effectiveness/toxicity or Less effective than existing treatment, but less complication Click here to enter text 3.3 Patient population What are the subgroups of the patient population that will benefit from the use of this therapeutic good? Click here to enter text 3.4 Number of patients to receive the therapeutic good If this number is expected to increase over time, please specify the predicted number of patients per year for 5 years Click here to enter text Section 4: Evidence of safety, efficacy and clinical effectiveness 4.1 Safety evidence Comment on safety evidence base Click here to enter text 4.2 Side effects List nature and incidents of side effects, contraindications, cautions, warnings and adverse effects for the therapeutic good and the source of this information Click here to enter text 4.3 Comparison to current therapeutic approach What are the main differences between the side effects, contra indications, cautions warnings and adverse effects between the unapproved therapeutic good and existing treatments and the source of this information Click here to enter text 4.4 Efficacy and clinical effectiveness Summarise the best available evidence, outlining key aspects, for clinical effectiveness of the therapeutic good for defines clinical problems including Supporting references and source of evidence Click here to enter text Section 5: Clinical feasibility 5.1 Operator competency Click here to enter text
authorised-prescriber-endorsement-form.docx