BALANCING THE INDIVIDUAL NEED FOR CARE WITH THE NEEDS OF THE COMMUNITY How often would you Incidence: trial number of patients expected to have this ‘new’ expect to request this condition per 100,000 population per year: treatment for this condition at this stage of progression of the condition for a given size of population? Prevalence: state the number of patients expected to have this condition per 100,000 population at any one time: Please provide references for the stated incidence & prevalence here and attach full text articles in your submission. What are the exceptional To meet the definition of clinical circumstances’ your ‘exceptional clinical circumstances that patient must demonstrate that they are both: make the standard intervention inappropriate Significantly different clinically to the group of patients with the for this patient? condition in question and at the same stage of progression of the condition. AND Likely to gain significantly more clinical benefit than others in the group of patients with the condition in question and at the same stage of progression of the condition. Please give your reasons: If the drug were to be funded for this patient on an individual basis, would the decision set a precedent for other requests? EVIDENCE OF CLINICAL AND COST EFFECTIVENESS/SAFETY Is the drug licensed in the UK for the intended use?
BALANCING THE INDIVIDUAL NEED FOR CARE WITH THE NEEDS OF THE COMMUNITY How often would you expect to request this treatment for this condition at this stage of progression of the condition for a given size of population? Incidence: number of ‘new’ patients expected to have this condition per 100,000 population per year: Prevalence: state the number of patients expected to have this condition per 100,000 population at any one time: Please provide references for the stated incidence & prevalence here and attach full text articles in your submission. What are the exceptional clinical circumstances that make the standard intervention inappropriate for this patient? To meet the definition of ‘exceptional clinical circumstances’ your patient must demonstrate that they are both: Significantly different clinically to the group of patients with the condition in question and at the same stage of progression of the condition. AND Likely to gain significantly more clinical benefit than others in the group of patients with the condition in question and at the same stage of progression of the condition. Please give your reasons: If the drug were to be funded for this patient on an individual basis, would the decision set a precedent for other requests? EVIDENCE OF CLINICAL AND COST EFFECTIVENESS/SAFETY Is the drug licensed in the UK for the intended use? trial
iefr_submission_2016_t5_v0102.docx