# Guidelines on the pricing of ACBS products

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/85a92e85-5633-4c8d-8c30-8385c43010c8
Type: Guidance
Published: April 12, 2019

> This guidance document outlines the criteria used by the Advisory Committee on Borderline Substances (ACBS) to evaluate the pricing of nutritional and dermatological products within the UK regulatory framework. The ACBS ensures that products recommended for prescription on the NHS provide therapeutic value at a cost-effective price point. The document details the committee's approach to three specific categories: Type 1 applications for new products, Type 2 applications for product variations, and Type 3 applications for price increases. In Type 1 reviews, pricing is benchmarked against current market alternatives to establish value. Type 2 reviews focus on maintaining price stability during formulation or brand changes, while Type 3 reviews require manufacturers to provide extensive justification for any requested price adjustments. Although this document is a general guidance rather than a specific inspection report for a single company, it functions under the NHS Drug Tariff framework. Required actions for manufacturers include the submission of comprehensive pricing data and comparative analyses to support their applications. This process ensures that the 'issue of price' is handled with transparency and consistency, protecting the healthcare system from excessive costs while maintaining access to specialized treatments.

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## Content

This document details how the ‘issue of price’ is considered by the ACBS , when reviewing nutritional and dermatological products. It contains information on how pricing factors into decisions on type 1, 2 and 3 applications.

## Attachments

- [Information on the pricing of ACBS products](/government/publications/guidelines-on-the-pricing-of-acbs-products/information-on-the-pricing-of-acbs-products)