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Request Reference: 9240 Request Date: 10 Jun 2020
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 as per guidance 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 information was submitted for the evaluation of a) Smith & Nephew Pico 14- Sizes including 10cm x 20ccm, 10cm x 30cm,10cm x 40cm, 15cm x 15cm, 15cm x 20cm,15cm x 30cm, 20cm x 20cm, 25cm x 25cm – which was added to drug tariff Specifically in terms of data relating to clinical effectiveness, cost-effectiveness, patient outcomes and clinical/user feedback, and any other information that was used to established the reimbursement price of Pico 14 Sizes including 10cm x 20ccm, 10cm x 30cm,10cm x 40cm, 15cm x 15cm, 15cm x 20cm,15cm x 30cm, 20cm x 20cm, 25cm x 25cm – b) Smith & Nephew Pico 14 Multisite -15cm x 20cm, 20cm x 25cm –which was added to drug tariff Specifically in terms of data relating to clinical effectiveness, cost-effectiveness, patient outcomes and clinical/user feedback, and any other information that was used to establish the reimbursement price of Pico 14 Multisite 15cm x 20cm, 20cm x 25cm If you are unsure about any of these or would like to discuss them, please feel free to contact me directly. Many thanks

Status: Complete
Response Date: 08 Jul 2020
Response: Please see attached data

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