Trabectedin for the treatment of advanced soft tissue sarcoma

TA185 Soft tissue sarcoma - trabectedin: review decision - April 2013 information

Appendix A - decision paper presented to the Institute's Guidance Executive (PDF 108 KB)

TA185 Soft tissue sarcoma - trabectedin: review proposal - February 2013 information

Appendix A: matrix of stakeholders (PDF 99 KB)

Appendix B: proposal paper presented to the Institute's Guidance Executive (PDF 261 KB)

Soft tissue sarcoma - trabectedin: final appraisal determination information

Soft tissue sarcoma - trabectedin: final appraisal determination (FAD) (PDF 110 KB)

Soft tissue sarcoma - trabectedin: response to comments (PDF 27 KB)

Soft tissue sarcoma - trabectedin: additional analysis from the Evidence Review Group and Patient Access Scheme submissions

Soft tissue sarcoma - trabectedin: additional analysis prepared by the School of Heatlh and Related Research Sheffield (PDF 42 KB)

Soft tissue sarcoma - trabectedin: patient access scheme submission prepared by Pharma Mar (PDF 343 KB)

Soft tissue sarcoma - trabectedin: patient treatment cycle record (PDF 108 KB)

Soft tissue sarcoma - trabectedin: patient treatment cycle claim form (PDF 25 KB)

Soft tissue sarcoma - trabectedin: consultee and comentator comments on the appraisal consultation document

Soft tissue sarcoma - trabectedin: Pharma Mar comments on the ACD (PDF 27 KB)

Soft tissue sarcoma - trabectedin: RCN comments on the ACD information

Soft tissue sarcoma - trabectedin: RCN comments on the ACD (PDF 23 KB)

Soft tissue sarcoma - trabectedin: RCP comments on the ACD (PDF 27 KB)

Soft tissue sarcoma - trabectedin: DH comments on the ACD (PDF 27 KB)

Soft tissue sarcoma - trabectedin: WAG comments on the ACD (PDF 29 KB)

Soft tissue sarcoma - trabectedin: update to consultees and commentators (PDF 10 KB)

Soft tissue sarcoma - trabectedin: appraisal consultation

Soft tissue sarcoma - trabectedin: appraisal consultation document information

Soft tissue sarcoma - trabectedin: evaluation report

Pre-meeting briefing (PDF 91 KB)

Evidence review group report (PDF 206 KB)

Addendum to evidence review group report (PDF 19 KB)

Non-manufacturer submissions

British Sarcoma Group (PDF 34 KB)

Rarer Cancers Forum (PDF 44 KB)

Royal College of Nursing (PDF 13 KB)

Royal College of Pathologists (PDF 179 KB)

Royal College of Physicians on behalf of the NCRI/RCP/RCR/ACP/JCCO (PDF 49 KB)

Sarcoma UK (PDF 499 KB)

Manufacturer submission

Manufacturer's submission (PDF 907 KB)

EMEA Scientific Discussion (PDF 1.04 MB)

NICE request for clarification (PDF 49 KB)

Manufacturer's response to request for clarification (PDF 195 KB)

NICE additional clarification questions (PDF 42 KB)

Manufacturer's reponse to additional clarification (PDF 168 KB)

Expert written personal statements

Judson (PDF 23 KB)

Pendleton (PDF 17 KB)

Wilson (PDF 15 KB)

Soft tissue sarcoma - trabectedin: letter to consultees and commentators about extension to timelines (PDF 20 KB)

Soft tissue sarcoma - trabectedin: final scope (PDF 28 KB)

Soft tissue sarcoma - trabectedin: response to consultee and commentator comments on the draft scope (PDF 83 KB)

Soft tissue sarcoma - trabectedin: response to consultee and commentator comments on the provisional matrix (PDF 25 KB)