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Request Reference: 8421 Request Date: 27 Mar 2019
Request: Dear FoI Team, Part IX of the Drug Tariff Please see below a list of questions for which we are hereby submitting an FOI request on behalf of our client [redacted]: 1. What clinical criteria is analysed on the safety and efficacy of a medical device as part of applications for reimbursement on Part IX of the Drug Tariff? 2. What standard of health economic data on the cost efficiencies of a medical device is required for submissions to Part IX of the Drug Tariff? 3. What health-related quality of life data is considered when submitting evidence on a medical device in support of an application to be listed on Part IX of the Drug Tariff? 4. What evidence was submitted for the evaluation of a) Dansac Novalife Tre 1 and b) Dansac Novalife Tre 1 Open Convex? 5. What evidence was submitted for the evaluation of Moderma Flex CeraPlus? I would be grateful if you could please confirm receipt and provide a response within the timeframe specified by the Freedom of Information Act 2000. Yours sincerely, [name redacted] [On 11 June you clarified your request as follows: Taking into account your requests for clarification I have reworded our original FOI questions to help you and your team – please see below. 1. What information was provided as part of Dansac Ltd''s Drug Tariff application for ‘NovaLife TRE 1 ileostomy bag maxi’ (Prod Ord No: 3018-15), specifically in terms of data relating to clinical effectiveness, patient outcomes and clinical/user feedback, and any other information that was used to established the reimbursement price of ‘NovaLife TRE 1 ileostomy bag maxi’ (Prod Ord No: 3018-15)? 2. What information was provided as part of Hollister Ltd’s Drug Tariff application for ‘Moderma Flex ileostomy bag with filter, FlexWear skin barrier and Lock''n''Roll closure, maxi’ (Prod Ord No: 58300), specifically in terms of data relating to clinical effectiveness, patient outcomes and clinical/user feedback, and any other information that was used to established the reimbursement price of ‘Moderma Flex ileostomy bag with filter, FlexWear skin barrier and Lock''n''Roll closure, maxi’ (Prod Ord No: 58300)? 3. What information was provided as part of Hollister Ltd’s Drug Tariff application for ‘Moderma Flex convex ileostomy bag with filter, FlexWear skin barrier and Lock''n''Roll closure, maxi’ (Prod Ord No: 56800), specifically in terms of data relating to clinical effectiveness, patient outcomes and clinical/user feedback, and any other information that was used to established the reimbursement price of ‘Moderma Flex convex ileostomy bag with filter, FlexWear skin barrier and Lock''n''Roll closure, maxi’ (Prod Ord No: 56800)? 4. What information was provided as part of Dansac Ltd''s Drug Tariff application for ‘NovaLife TRE 1 open convex ileostomy bag maxi’ (Prod Ord No: 3042-59), specifically in terms of data relating to clinical effectiveness, patient outcomes and clinical/user feedback, and any other information that was used to established the reimbursement price of ‘NovaLife TRE 1 open convex ileostomy bag maxi’ (Prod Ord No: 3042-59)? If you are unsure about any of these or would like to discuss them, please feel free to contact me directly.

Status: Complete
Response Date: 06 Aug 2019
Response: Please see attached response

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