Review of NICE Technology Appraisal Guidance no.’s 96, 153, 154 and 173; Entecavir, telbivudine, tenofovir disoproxil fumarate, adefovir dipivoxil and peginterferon alfa-2a for the treatment of chronic hepatitis B

TA96 – guidance was issued in February 2006. The original review date was February 2007, at which time it was decided to defer the review proposal until the outcomes of TA153 and TA154 were known.

TA154 – guidance was issued in August 2008. The original review date was February 2009.

TA153 – guidance was issued in August 2008. The original review date was February 2009.

In May 2009, there was insufficient new evidence that would materially affect the recommendations in TA96, TA153 and TA154. It was decided to defer the review proposal until March 2012 so that results from ongoing clinical trials comparing combination versus monotherapy for hepatitis B would be available.

TA173 – guidance was issued in July 2009. Review date is March 2012.

Having re-looked at the guidance and the possible scope for a review, we believe that this topic would be better dealt with within the context of a clinical guideline. Consequently we propose that the recommendations from TA153, TA154, TA173 and recommendation 1.1 of TA96 be incorporated, verbatim, into the ongoing clinical guideline on ‘The diagnosis and management of hepatitis B in children, adolescents and adults’. The technology appraisals will be moved to the static list and will remain extant when the guideline is published. This has the consequence of preserving the funding direction for TA153, TA173 and recommendation 1.1 of TA96. The guideline will contextualise this guidance by considering the place of the recommended options within treatment sequences and combination drug regimens.

Recommendations 1.2–1.4 of TA96 will be updated by the clinical guideline and these technology appraisal recommendations will be withdrawn when the guideline is published.

In order to be completely confident that this is appropriate, we are asking all relevant consultees and commentators, to inform us of any evidence which will help us decide the best way to update this guidance.  Please see appendix A for a full list of the organisations we have contacted.