Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, in reference to the ongoing reform of Part IX of the Drug Tariff, a) what the objective is of introducing renewed product clusters for products listed on Part IX of the Drug Tariff, b) how his Department plans to ensure all products are placed into clinically interchangeable categories with no unintended consequences to patient care and c) how his Department aims to i) assess and ii) differentiate a product’s value through the categorisation process and enhanced assessment framework.

The ongoing reform of Part IX of the Drug Tariff is intended to ensure that the system remains clinically appropriate, delivers value for money for the National Health Service, and supports patient access to high-quality medical devices.

Previous arrangements were resulting in a long list of devices and chemical reagents on Part IX, in many cases grouped by manufacturer, rather than in comparable categories. The department, led by input from clinical panels, is updating Part IX of the Drug Tariff to group products together where appropriate and make the tariff easier to navigate.

The aim is to create comparable categories. However, products within a category will not necessarily be clinically interchangeable. The updated categories do not replace clinical judgment and is not prescribing guidance. Clinicians should continue to choose the product that best meets the need for each patient. The department recognises that patients have differing needs. These categories of devices are not generally made to technical standards however they do have comparable functions.

New clusters are not created for every distinguishing feature but may be created where features add value to the NHS. The Enhanced Assessment Framework considers quality, including broader value, social and price together to support value for money for the NHS. Quality, beyond the minimum requirements, may include evidence of product effectiveness, supporting self-care, supporting system savings and reducing inequalities.

In the circumstance a product is delisted either as a result of the process or a company choosing not to apply, we will give at least six months’ notice supported by communications to stakeholders.