Pfizer Limited Walton Oaks Dorking Road Walton-on-the-Hill Surrey. KT20 7NS

1.  Life is our life’s work. The National Institute for Clinical Excellence The National Institute for Clinical Excellence (NICE) was established as a special health authority for England and Wales on 1st April 1999 on a statutory basis. Its purpose is to promote the clinical excellence and the effective use of resources within the NHS. It aims to provide patients, carers, health professionals and NHS managers with authoritative and reliable guidance. This is based on evidence of clinical and cost effectiveness, to inform their decisions about treatment and healthcare. NICE’s guidance covers individual health technologies, including medicines, the clinical management of specific conditions, and clinical audit methods. One of the institute’s objectives is the promotion of faster patient access to innovative technologies that provide improved health outcomes for patients, while eliminating ineffective or outmoded treatments. While Pfizer fully supports the objective of faster patient access to innovative, new technologies across England and Wales, the company is opposed to any intention for NICE to be used as a method for cost-containment. Pfizer is concerned that the issue of affordability influences the work of NICE at the expense of the impact on patients and cost effectiveness, which should be the important criteria. If affordability is viewed as being the main influence on NICE guidance this will undermine the credibility of the institute, its processes and its guidance. Decisions on affordability of medicines should be transparent and be decided by health ministers after NICE has completed its work independently of the Department of Health. Ongoing dialogue should take place between companies, the Department of Health and NICE throughout the product development period to improve understanding of a new medicine, its potential impact on the condition and its potential value to the NHS. Pfizer recognises and supports the NHS’s need for early information on new products but fundamentally disagrees with any intention to provide specific guidance on the use of all new products at launch. The Government needs to consider the significant time and financial investment that is made by pharmaceutical companies engaged in the research and development of a new medicine when it introduces new requirements for approval in the UK. Pharmaceutical R&D programmes are designed and implemented over a period of up to ten years and unexpected changes in the requirements for product approval can undermine the commercial viability of a new product. Any changes for product assessment should therefore be phased in to enable appropriate changes to ongoing R&D programmes without jeopardising long-term investment in the UK. NICE - 0903 Pfizer Limited Walton Oaks Dorking Road Walton-on-the-Hill Surrey. KT20 7NS www.pfizer.co.uk policyuk@pfizer.com Tel: 01737 330478 Fax: 01737 332526 2001 2000 2003 AWARDED TO PFIZER LIMITED