Everolimus for the Treatment of Advanced Renal Cell Carcinoma (arcc ) - Additional Analysis Using RPSFT
|
|
- Robert Green
- 6 years ago
- Views:
Transcription
1 for the Treatment of Advanced Renal Cell Carcinoma (arcc ) - Additional Analysis Using RPSFT Thank you very much for the opportunity to submit additional analysis in relation to the above technology appraisal of everolimus for the treatment of arcc. Background When the data from the pivotal, randomised, placebo-controlled trial (RECORD-1) were analysed, it became apparent that the intention-to-treat (ITT) overall survival (OS) analysis was of limited value in demonstrating the survival benefits associated with everolimus treatment. This was because at the February 2008 data cut-off, 76% of the patients randomised to the placebo arm of the RECORD-1 trial had switched to everolimus treatment following progression. In addition, more than half of these patients switched to everolimus treatment within 8 weeks of randomisation. Therefore the ITT OS results are highly confounded and do not represent a meaningful comparison of treatment effect on survival. In order to correct for this confounding a number of statistical approaches were considered including the (inverse probability of censoring weights) IPCW and the rank preserving structural failure time (RPSFT) method. At that time there was no guidance or precedents that would indicate which approach would be preferred by NICE. In the absence of such information, it was decided at a global level that we would use the IPCW approach to inform our economic analysis. Although, there is academic debate regarding the most appropriate statistical approach, our choice was based mainly on the perceived simplicity of the practical application of a HR directly within the current economic model. The base case results as presented in our submission, are therefore based on the IPCW approach using data from the February 2008 data-cut. No economic analysis using results from a RPSFT approach have been available until now. The global Novartis statistics team instigated an RPSFT analysis based on longer term follow up data from RECORD-1, that has become available (November 2008 data-cut). It should be noted that by the time of this analysis, 81% of the patients randomised to the placebo arm of the RECORD-1 trial had switched to everolimus treatment following progression. Following a review of the ERG Report, and in acknowledgement that a comparison of the results from both the IPCW and RPSFT approaches would be informative, we have now conducted an analysis using the results from the RPSFT method in our economic model which was originally submitted on 30 th September The results of this analysis are presented below. 1
2 RPSFT Analysis The RPSFT statistical analysis is fully described in Appendix 1, and is based on the November 2008 data-cut. It was also presented in poster format at the 15 th and 34 th ESMO Congress, Berlin 20 th -24 th September i At this analysis, based on the ITT analysis the median OS for the everolimus arm was months and for the placebo arm the median OS was months (HR=0.87, 95% CI: , p=0.177). In addition, 81% of patients randomised to placebo had switched to everolimus treatment following progression (compared to 76% reported in the submission for the February 2008 cut-off). A post-hoc exploratory analysis of OS was conducted using the RPSFT method. This is an accelerated failure time model which uses a structural assumption of time proportionality. This method provides an estimate of treatment effect based on randomisation thus correcting for the bias introduced due to patients switching from the placebo arm to the everolimus arm of the trial. Using the RPSFT approach, the corrected median OS for the placebo arm is 10 months versus the unadjusted median OS of 14.4 months. i The results from this analysis estimate a relative survival time that is 1.93 fold longer in the everolimus arm than the placebo arm (95% CI: ). i These data were used to generate an RPSFT corrected Kaplan Meier OS curve for the placebo arm of the trial. The Kaplan Meier curves of OS based on the raw data for the two treatment arms and the RPSFT corrected OS for the placebo arm are presented in the figure below. Figure 1 - Kaplan Meier Curves of OS based on November 2008 Data-cut i 2
3 Application of the RPSFT Results in the Economic Model The Kaplan Meier curve for the RPSFT corrected OS for the placebo arm of the study was used to generate the transition probabilities to death ie for following state transitions: progression to death; stable disease without adverse events (AE s) to death and stable disease with AE s to death. As the RPSFT results do not allow differentiation of the conditional probability of death by health state we have assumed the same transition probabilities to death in the placebo arm for each of the states to death. The remaining transition probabilities for the arm are calculated directly from the RECORD-1 trial using the November 2008 data-cut ie for the following state transitions: stable disease with AE s to progression; stable disease without AE s to progression and risk of AE s. All of the transition probabilities for the everolimus arm were calculated directly from the RECORD-1 trial using the November 2008 data-cut. All other base case assumptions in the model remain unchanged. The transition probabilities are presented in Table 1, below. Table 1 RPSFT corrected transition probabilities Per Patient Model : RPSFT-Adjusted Cycle >2 AE Risk 1->3 Progression Risk SD w/o AE 2->3 Prog. Risk from SD w/ae 3->4 Death from PD 1->4 Stable N-Death 2->4 Stable w/ AE N-Death 11 to 18 Per Patient Model Afinitor Cycle >2 AE Risk 1->3 Progression Risk SD w/o AE 2->3 Prog. Risk from SD w/ae 3->4 Death from PD 1->4 Stable N-Death 2->4 Stable w/ AE N-Death 11 to 18 3
4 The cost-effectiveness results based on the RPSFT approach are presented in Table 2 below. Table 2 Cost-effectiveness results from the RPSFT analysis using the November 2008 cut off Base case with PAS* (IPCW Feb 2008 cutoff) With PAS: RPSFT (Nov 2008 cut-off) Without PAS: RPSFT (Nov 2008 cut-off) LYG ( ( ( (15.18 LYG ( ( ( (7.67 * As presented in the original Novartis submission. Inc LYG ( ( ( (7.51 Inc cost ( ) cost ( ) Inc cost ( ) ICER for everolimus versus ( /) ,222 9,517 15,704 51, ,168 11,824 24,344 53, ,312 11,824 26,488 57,808 The results from the RPSFT analysis give an incremental cost-effectiveness ratio (ICER) of 53,128 with PAS. Conclusion and Discussion As acknowledged in the ERG Report, the appropriate statistical approach to correct for confounding due to crossover is still an area of genuine academic debate. Therefore the opportunity to compare estimates of cost-effectiveness based on two different statistical approaches is of interest as well as providing reassurance that the original IPCW method we adopted does not generate overly favourable results compared to the RPSFT approach. The results generated when applying the RPSFT statistical approach suggest that everolimus, within it s licensed indication, is likely to be cost-effective within acceptable limits when applying the end of life criteria. It should be noted that the longer term, November 2008 data-cut suggests greater survival than the February 2008 data-cut. This means that using the November analysis there are more everolimus patients still alive in the final cycle of the economic model. Unfortunately, there was insufficient time to add further cycles to the model to account for this. However, the overall impact will be to reduce the ICER as there will be greater LYG in the everolimus arm but no further everolimus treatment costs as these are only applicable for the stable disease states. In summary, everolimus fulfils an unmet clinical need as it is a clinically-effective treatment for a small population of arcc patients who do not have any NICE recommended, licensed or effective treatment options. If left untreated these patients are likely to have limited life expectancy and poor prognosis. is the only available oral mtor inhibitor to be licensed for the treatment of arcc and therefore represents an innovative approach to treating arcc. Results from the double-blind, RCT, RECORD-1 trial demonstrated that everolimus reduced the risk of disease progression by 67% (HR=0.33, 95%CI: ) and improved median progression free survival by 3 months. For these reasons it is anticipated that everolimus will meet the end of life criteria. Furthermore, in order to facilitate early access for 4
5 patients, Novartis are offering a Patient Access Scheme (PAS) to be considered as part of this appraisal. The Department of Health have confirmed that they are happy for NICE to consider the PAS as part of this appraisal. References i Korhonen P, Haas T, Zuber E, Kay A, Lebwohl D, Motzer R. Overall Survival Among Metastatic Renal Cell Carcinoma Patients Corrected for Crossover Using a Rank Preserving Structural Failure Time (PSFT) Model: Analyses From the Phase 3 Trial. Abstract, P-7155, Joint ECCO 15 th and 34 th ESMO Congress, Berlin 20 th -24 th September
Dealing with Treatment Switches in Cost effectiveness Analysis: Martin Pitt Martin Hoyle Peninsula Technology Assessment Group Exeter
Dealing with Treatment Switches in Cost effectiveness Analysis: The NICE Experience Martin Pitt Martin Hoyle Peninsula Technology Assessment Group Exeter Presentation Martin Pitt : The Nice Context and
More informationAdjusting the Crossover Effect in Overall Survival Analysis Using a Rank Preserving Structural Failure Time Model: The Case of Sunitinib GIST Trial
Adjusting the Crossover Effect in Overall Survival Analysis Using a Rank Preserving Structural Failure Time Model: The Case of Sunitinib GIST Trial Xin Huang 1 and Qiang (Casey) Xu 2 1 Pfizer Oncology
More informationTechnology appraisal guidance Published: 21 March 2018 nice.org.uk/guidance/ta512
Tivozanib for treating advanced renal cell carcinoma Technology appraisal guidance Published: March 2018 nice.org.uk/guidance/ta512 NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationDabrafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma
Dabrafenib for treating unresectable or metastatic BRAF V600 Issued: October 2014 guidance.nice.org.uk/ta321 NICE has accredited the process used by the Centre for Health Technology Evaluation at NICE
More informationTechnology appraisal guidance Published: 12 December 2012 nice.org.uk/guidance/ta269
Vemurafenib for treating locally advanced or metastatic BRAF V600 mutation-positive malignant melanoma Technology appraisal guidance Published: 12 December 2012 nice.org.uk/guidance/ta269 NICE 2018. All
More informationTechnology appraisal guidance Published: 22 October 2014 nice.org.uk/guidance/ta321
Dabrafenib afenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma Technology appraisal guidance Published: 22 October 2014 nice.org.uk/guidance/ta321 NICE 2018. All rights
More informationTechnology appraisal guidance Published: 25 February 2015 nice.org.uk/guidance/ta333
Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment Technology appraisal guidance Published: 25 February 2015 nice.org.uk/guidance/ta333 NICE 2018. All rights
More informationvemurafenib 240mg film-coated tablet (Zelboraf ) SMC No. (792/12) Roche Products Ltd.
Resubmission vemurafenib 240mg film-coated tablet (Zelboraf ) SMC No. (792/12) Roche Products Ltd. 08 November 2013 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationEverolimus, lutetium-177 DOTATATE and sunitinib for treating unresectable or metastatic neuroendocrine tumours with disease progression MTA
Everolimus, lutetium-177 DOTATATE and sunitinib for treating unresectable or metastatic neuroendocrine tumours with disease progression MTA 1 st Appraisal Committee meeting Cost Effectiveness Committee
More informationIbrutinib for the treatment of relapsed or refractory mantle cell lymphoma (MCL)
Ibrutinib for the treatment of relapsed or refractory mantle cell lymphoma (MCL) Post consultation appraisal committee meeting Dr Jane Adam 2 nd November 2017 Slides for Projector and Public 1 Preliminary
More informationSlides for Committee CIC redacted
Chair s presentation Ribociclib in combination with an aromatase inhibitor for previously untreated advanced or metastatic hormone receptor-positive, HER2-negative breast cancer 3rd Appraisal Committee
More informationTechnology appraisal guidance Published: 27 July 2016 nice.org.uk/guidance/ta399
Azacitidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts Technology appraisal guidance Published: 27 July 2016 nice.org.uk/guidance/ta399 NICE 2018. All rights reserved. Subject
More informationTreatment changes in cancer clinical trials: design and analysis
Treatment changes in cancer clinical trials: design and analysis Ian White Statistical methods and designs in clinical oncology Paris, 9 th November 2017 Plan 1. Treatment changes
More informationCost-effectiveness of osimertinib (Tagrisso )
Cost-effectiveness of osimertinib (Tagrisso ) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung
More informationTechnology appraisal guidance Published: 18 July 2018 nice.org.uk/guidance/ta531
Pembrolizumab for untreated PD- L1-positive metastatic non-small-cell lung cancer Technology appraisal guidance Published: 18 July 2018 nice.org.uk/guidance/ta531 NICE 2018. All rights reserved. Subject
More informationTechnology appraisal guidance Published: 7 October 2015 nice.org.uk/guidance/ta357
Pembrolizumab for treating advanced melanoma after disease progression with ipilimumab Technology appraisal guidance Published: 7 October 2015 nice.org.uk/guidance/ta357 NICE 2018. All rights reserved.
More informationTechnology appraisal guidance Published: 22 May 2013 nice.org.uk/guidance/ta284
Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer Technology appraisal guidance Published: 22 May 2013 nice.org.uk/guidance/ta284 NICE 2017.
More informationTechnology appraisal guidance Published: 16 May 2018 nice.org.uk/guidance/ta520
Atezolizumab for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy Technology appraisal guidance Published: 16 May 2018 nice.org.uk/guidance/ta520 NICE 2018. All rights
More informationAdjusting overall survival for treatment switch
Adjusting overall survival for treatment switch Recommendations of a crossinstitutional statistical working group Claire Watkins Director and Consultant Statistician, Clarostat Consulting Ltd Cytel East
More informationTechnology appraisal guidance Published: 23 July 2014 nice.org.uk/guidance/ta319
Ipilimumab for previously untreated advanced (unresectable or metastatic) melanoma Technology appraisal guidance Published: 23 July 2014 nice.org.uk/guidance/ta319 NICE 2018. All rights reserved. Subject
More informationTechnology appraisal guidance Published: 20 December 2017 nice.org.uk/guidance/ta496
Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor- positive, HER2-negative, e, locally advanced or metastatic breast cancer Technology appraisal guidance Published: 20 December
More informationTechnology appraisal guidance Published: 7 March 2018 nice.org.uk/guidance/ta509
Pertuzumab with trastuzumab and docetaxel el for treating HER2-positive breast cancer Technology appraisal guidance Published: 7 March 20 nice.org.uk/guidance/ta509 NICE 20. All rights reserved. Subject
More information1 st Appraisal Committee meeting Background & Clinical Effectiveness Gillian Ells & Malcolm Oswald 24/11/2016
Lead team presentation Nivolumab for treating recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum-based chemotherapy [ID971] 1 st Appraisal Committee meeting Background
More informationTechnology appraisal guidance Published: 23 February 2011 nice.org.uk/guidance/ta214
Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer Technology appraisal guidance Published: 23 February 2011 nice.org.uk/guidance/ta214 NICE 2018. All rights
More informationMethods for adjusting survival estimates in the presence of treatment crossover a simulation study
Methods for adjusting survival estimates in the presence of treatment crossover a simulation study Nicholas Latimer, University of Sheffield Collaborators: Paul Lambert, Keith Abrams, Michael Crowther
More informationsunitinib 12.5mg, 25mg, 37.5mg, 50mg hard capsules (Sutent ) SMC No. (698/11) Pfizer Limited
sunitinib 12.5mg, 25mg, 37.5mg, 50mg hard capsules (Sutent ) SMC No. (698/11) Pfizer Limited 08 April 2011 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and
More informationTechnology appraisal guidance Published: 11 January 2017 nice.org.uk/guidance/ta428
Pembrolizumab for treating PD- L1-positive non-small-cell lung cancer after chemotherapy Technology appraisal guidance Published: 11 January 2017 nice.org.uk/guidance/ta428 NICE 2018. All rights reserved.
More informationTechnology appraisal guidance Published: 21 December 2016 nice.org.uk/guidance/ta422
Crizotinib for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer Technology appraisal guidance Published: 21 December 2016 nice.org.uk/guidance/ta422 NICE 2018.
More informationNivolumab for adjuvant treatment of resected stage III and IV melanoma [ID1316] STA Lead team presentation: Cost Effectiveness Part 1
For public no AIC or CIC Nivolumab for adjuvant treatment of resected stage III and IV melanoma [ID1316] STA Lead team presentation: Cost Effectiveness Part 1 1st Appraisal Committee meeting Committee
More informationBevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer
Issue date: February 2011 Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer This guidance was developed using the single technology appraisal process NICE
More informationTechnology appraisal guidance Published: 6 December 2017 nice.org.uk/guidance/ta492
Atezolizumab for untreated PD- L1-positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable Technology appraisal guidance Published: 6 December 2017 nice.org.uk/guidance/ta492
More informationTechnology appraisal guidance Published: 31 January 2018 nice.org.uk/guidance/ta502
Ibrutinib for treating relapsed or refractory mantle cell lymphoma Technology appraisal guidance Published: 31 January 2018 nice.org.uk/guidance/ta502 NICE 2018. All rights reserved. Subject to Notice
More informationBackground 1. Comparative effectiveness of nintedanib
NCPE report on the cost effectiveness of nintedanib (Vargatef ) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung
More informationTechnology appraisal guidance Published: 27 January 2016 nice.org.uk/guidance/ta380
Panobinostat for treating multiple myeloma after at least 2 previous treatments Technology appraisal guidance Published: 27 January 2016 nice.org.uk/guidance/ta380 NICE 2017. All rights reserved. Subject
More informationTechnology appraisal guidance Published: 24 January 2018 nice.org.uk/guidance/ta500
Ceritinib for untreated ALK-positive non- small-cell lung cancer Technology appraisal guidance Published: 24 January 2018 nice.org.uk/guidance/ta500 NICE 2018. All rights reserved. Subject to Notice of
More informationBevacizumab in combination with gemcitabine and carboplatin for treating the first recurrence of platinum-sensitive advanced ovarian cancer
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Final appraisal determination Bevacizumab in combination with gemcitabine and carboplatin for treating the first recurrence of platinum-sensitive advanced
More informationBevacizumab for the treatment of recurrent advanced ovarian cancer
Bevacizumab for the treatment of recurrent advanced ovarian cancer ERRATUM This report was commissioned by the NIHR HTA Programme as project number 11/40 Page 2 This document contains errata in respect
More informationTechnology appraisal guidance Published: 23 March 2016 nice.org.uk/guidance/ta386
Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis Technology appraisal guidance Published: 23 March 2016 nice.org.uk/guidance/ta386 NICE 2017. All rights reserved.
More informationTechnology appraisal guidance Published: 29 June 2011 nice.org.uk/guidance/ta227
Erlotinib monotherapy for maintenance treatment of non-small-cell lung cancer Technology appraisal guidance Published: 29 June 2011 nice.org.uk/guidance/ta227 NICE 2018. All rights reserved. Subject to
More informationNICE DSU TECHNICAL SUPPORT DOCUMENT 16: ADJUSTING SURVIVAL TIME ESTIMATES IN THE PRESENCE OF TREATMENT SWITCHING
NICE DSU TECHNICAL SUPPORT DOCUMENT 16: ADJUSTING SURVIVAL TIME ESTIMATES IN THE PRESENCE OF TREATMENT SWITCHING REPORT BY THE DECISION SUPPORT UNIT July 2014 Nicholas R Latimer 1 Keith R Abrams 2 1 School
More informationDISCLOSURE SLIDE. ARGOS: research funding, scientific advisory board
INTERIM ANALYSIS OF THE PHASE 3 ADAPT TRIAL EVALUATING ROCAPULDENCEL-T (AGS-003), AN INDIVIDUALIZED IMMUNOTHERAPY FOR THE TREATMENT OF NEWLY-DIAGNOSED PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (MRCC)
More informationTechnology appraisal guidance Published: 22 June 2016 nice.org.uk/guidance/ta395
Ceritinib for previously treated anaplastic lymphoma kinase positive non- small-cell lung cancer Technology appraisal guidance Published: 22 June 2016 nice.org.uk/guidance/ta5 NICE 2018. All rights reserved.
More informationTechnology appraisal guidance Published: 6 September 2017 nice.org.uk/guidance/ta476
Paclitaxel as albumin-bound nanoparticles with gemcitabine for untreated metastatic pancreatic cancer Technology appraisal guidance Published: 6 September 2017 nice.org.uk/guidance/ta476 NICE 2018. All
More informationCDF Rapid Reconsideration
CDF Rapid Reconsideration Everolimus in combination with exemestane for treating advanced HER2- negative hormone-receptor-positive breast cancer after endocrine therapy (Cancer Drugs Fund reconsideration
More informationTechnology appraisal guidance Published: 22 August 2012 nice.org.uk/guidance/ta263
Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast cancer Technology appraisal guidance Published: 22 August 2012 nice.org.uk/guidance/ta263 NICE 2018. All rights
More informationBevacizumab in combination with capecitabine for the first-line treatment of metastatic breast cancer
ERRATUM Bevacizumab in combination with capecitabine for the first-line treatment of metastatic breast cancer This report was commissioned by the NIHR HTA Programme as project number 08/206/02 Completed
More informationTechnology appraisal guidance Published: 28 September 2016 nice.org.uk/guidance/ta411
Necitumumab for untreated advanced or metastatic squamous non-small-cell lung cancer Technology appraisal guidance Published: 28 September 2016 nice.org.uk/guidance/ta411 NICE 2017. All rights reserved.
More informationLead team presentation:
Lead team presentation: Nivolumab for previously treated locally advanced or metastatic nonsquamous non-small-cell lung cancer 1 st Appraisal Committee meeting Background & Clinical Effectiveness Iain
More informationTechnology appraisal guidance Published: 4 July 2018 nice.org.uk/guidance/ta528
Niraparib for maintenance treatment of relapsed, platinum-sensitive e ovarian, fallopian tube and peritoneal cancer Technology appraisal guidance Published: 4 July 2018 nice.org.uk/guidance/ta528 NICE
More informationChair s presentation Lutetium (177lu) oxodotreotide for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
Public slides Chair s presentation Lutetium (177lu) oxodotreotide for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease 2 nd Appraisal Committee meeting Committee
More informationTechnology appraisal guidance Published: 28 October 2015 nice.org.uk/guidance/ta359
Idelalisib for treating chronic lymphocytic leukaemia Technology appraisal guidance Published: 28 October 2015 nice.org.uk/guidance/ta359 NICE 2017. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationTechnology appraisal guidance Published: 28 March 2018 nice.org.uk/guidance/ta516
Cabozantinib for treating medullary thyroid cancer Technology appraisal guidance Published: 28 March 2018 nice.org.uk/guidance/ta516 NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationNICE decisions on health care provisions in England
NICE decisions on health care provisions in England Matt Stevenson, Professor of Health Technology Assessment (HTA), ScHARR, University of Sheffield, UK A quick introduction I am Technical Director of
More informationReal-world observational data in costeffectiveness analyses: Herceptin as a case study
Real-world observational data in costeffectiveness analyses: Herceptin as a case study DR BONNY PARKINSON, PROFESSOR ROSALIE VINEY, ASSOCIATE PROFESSOR STEPHEN GOODALL AND PROFESSOR MARION HAAS ISPOR AUSTRALIA
More informationBendamustine for the first-line treatment of chronic lymphocytic leukaemia
Bendamustine for the first-line treatment of chronic lymphocytic leukaemia Issued: February 2011 guidance.nice.org.uk/ta216 NICE has accredited the process used by the Centre for Health Technology Evaluation
More informationTechnology appraisal guidance Published: 23 April 2014 nice.org.uk/guidance/ta310
Afatinib for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer Technology appraisal guidance Published: 23 April 2014 nice.org.uk/guidance/ta310
More informationTechnology appraisal guidance Published: 22 November 2017 nice.org.uk/guidance/ta489
Vismodegib for treating basal cell carcinoma Technology appraisal guidance Published: 22 November 2017 nice.org.uk/guidance/ta489 NICE 2017. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationEVIDENCE IN BRIEF OVERALL CLINICAL BENEFIT
ipilimumab aligned with patient values. Although few patients had direct experience using this combination agent, patients indicated that side effects associated with nivolumab plus ipilimumab were few
More informationStatistical, clinical and ethical considerations when minimizing confounding for overall survival in cancer immunotherapy trials
Statistical, clinical and ethical considerations when minimizing confounding for overall survival in cancer immunotherapy trials Dominik Heinzmann, PhD Global Development Team Leader HER2 Associate Director
More informationScottish Medicines Consortium
Scottish Medicines Consortium cetuximab 2mg/ml intravenous infusion (Erbitux ) (279/06) MerckKGaA No 9 June 2006 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product
More informationThe Logic of Causal Inference. Uwe Siebert, MD, MPH, MSc, ScD
The Logic of Causal Inference Uwe Siebert, MD, MPH, MSc, ScD (1) Dept. of Public Health, Health Services Research and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics
More informationResponse to NICE ACD on Sunitinib for the treatment of GIST February This is a joint submission by Sarcoma UK, GIST Support UK
Response to NICE ACD on Sunitinib for the treatment of GIST February 2009 This is a joint submission by Sarcoma UK, GIST Support UK and the Rarer Cancers Forum. We address the four general questions on
More informationTechnology appraisal guidance Published: 24 January 2018 nice.org.uk/guidance/ta499
Glecaprevir pibrentasvir for treating chronic hepatitis C Technology appraisal guidance Published: 24 January 2018 nice.org.uk/guidance/ta499 NICE 2018. All rights reserved. Subject to Notice of rights
More informationTechnology appraisal guidance Published: 24 September 2014 nice.org.uk/guidance/ta322
Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality Technology appraisal guidance Published: 24 September 2014 nice.org.uk/guidance/ta322
More informationTechnology appraisal guidance Published: 9 August 2017 nice.org.uk/guidance/ta465
Olaratumab atumab in combination with doxorubicin orubicin for treating advanced soft tissue sarcoma Technology appraisal guidance Published: 9 August 17 nice.org.uk/guidance/ta465 NICE 17. All rights
More informationYONDELIS (TRABECTEDIN) FOR THE TREATMENT OF SOFT TISSUE SARCOMA. RESPONSE TO EVIDENCE REVIEW GROUP QUERIES (15 th April 2009)
YONDELIS (TRABECTEDIN) FOR THE TREATMENT OF SOFT TISSUE SARCOMA RESPONSE TO EVIDENCE REVIEW GROUP QUERIES (15 th April 2009) 24 th APRIL 2009 Trabectedin for the treatment of advanced metastatic soft tissue
More informationEVIDENCE IN BRIEF OVERALL CLINICAL BENEFIT
into consideration the concerns of the patient. Upon reconsideration of the perc Initial Recommendation,the Committee discussed feedback from the patient advocacy group reporting concerns that the definition
More informationUPDATE FROM ASCO GU FEBRUARY 2018, SAN FRANCISCO, USA. Prof. David Pfister University Hospital of Cologne Germany RENAL CELL CARCINOMA
UPDATE FROM ASCO GU FEBRUARY 2018, SAN FRANCISCO, USA Prof. David Pfister University Hospital of Cologne Germany RENAL CELL CARCINOMA DISCLAIMER Please note: The views expressed within this presentation
More informationTechnology appraisal guidance Published: 27 June 2012 nice.org.uk/guidance/ta257
Lapatinib or trastuzumab in combination with an aromatase inhibitor for the firstline treatment of metastatic hormone- receptor-positive e breast cancer that overexpresses HER2 Technology appraisal guidance
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Final appraisal determination Bevacizumab (first-line), sorafenib (first- and second-line),
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Final appraisal determination Bevacizumab (first-line), sorafenib (first- and secondline), sunitinib (second-line) and temsirolimus (firstline) for
More informationNICE Single Technology Appraisal of cetuximab for the treatment of recurrent and /or metastatic squamous cell carcinoma of the head and neck
NICE Single Technology Appraisal of cetuximab for the treatment of recurrent and /or metastatic squamous cell carcinoma of the head and neck Introduction Merck Serono appreciates the opportunity to comment
More informationTechnology appraisal guidance Published: 11 April 2018 nice.org.uk/guidance/ta517
Avelumab for treating metastatic Merkelel cell carcinoma Technology appraisal guidance Published: 11 April 2018 nice.org.uk/guidance/ta517 NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationTechnology appraisal guidance Published: 28 May 2014 nice.org.uk/guidance/ta312
Alemtuzumab for treating relapsing-remitting multiple sclerosis Technology appraisal guidance Published: 28 May 2014 nice.org.uk/guidance/ta312 NICE 2017. All rights reserved. Subject to Notice of rights
More informationAssessing methods for dealing with treatment switching in clinical trials: A follow-up simulation study
Article Assessing methods for dealing with treatment switching in clinical trials: A follow-up simulation study Statistical Methods in Medical Research 2018, Vol. 27(3) 765 784! The Author(s) 2016 Reprints
More informationNegative Trials in RCC: Where Did We Go Wrong? Can We Do Better?
Negative Trials in RCC: Where Did We Go Wrong? Can We Do Better? 9 th European Kidney Cancer Symposium, Dublin, April 2014 Tim Eisen Tim Eisen - Disclosures Company Research Support Advisory Board Trial
More informationThe NCPE has issued a recommendation regarding the use of pertuzumab for this indication. The NCPE do not recommend reimbursement of pertuzumab.
Cost Effectiveness of Pertuzumab (Perjeta ) in Combination with Trastuzumab and Docetaxel in Adults with HER2-Positive Metastatic or Locally Recurrent Unresectable Breast Cancer Who Have Not Received Previous
More informationLead team presentation Eribulin for treating locally advanced or metastatic breast cancer after two or more prior chemotherapy regimens STA
For projector and public [noacic] Lead team presentation Eribulin for treating locally advanced or metastatic breast cancer after two or more prior chemotherapy regimens STA 1 st Appraisal Committee meeting
More informationTechnology appraisal guidance Published: 21 February 2018 nice.org.uk/guidance/ta507
Sofosbuvir velpatasvir voxilaprevir for treating chronic hepatitis C Technology appraisal guidance Published: 21 February 2018 nice.org.uk/guidance/ta507 NICE 2018. All rights reserved. Subject to Notice
More informationcombination with everolimus with other relevant treatment options, perc considered the results of a submitted indirect treatment comparison (ITC) that included comparisons of lenvatinib in combination
More informationTechnology appraisal guidance Published: 30 August 2017 nice.org.uk/guidance/ta472
Obinutuzumab with bendamustine for treating follicular lymphoma refractory to rituximab Technology appraisal guidance Published: 30 August 2017 nice.org.uk/guidance/ta472 NICE 2018. All rights reserved.
More informationTechnology appraisal guidance Published: 27 January 2016 nice.org.uk/guidance/ta381
Olaparib for maintenance treatment of relapsed, platinum-sensitive, e, BRCA mutation-positive ovarian, fallopian tube and peritoneal cancer after response to second-line or subsequent platinum- based chemotherapy
More informationSummary 1. Comparative effectiveness
Cost-effectiveness of Sacubitril/Valsartan (Entresto) for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction. The NCPE has issued a recommendation regarding
More informationLONDON CANCER NEW DRUGS GROUP RAPID REVIEW. Erlotinib for the third or fourth-line treatment of NSCLC January 2012
Disease background LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Erlotinib for the third or fourth-line treatment of NSCLC January 2012 Lung cancer is the second most common cancer in the UK (after breast),
More informationScottish Medicines Consortium
Scottish Medicines Consortium ustekinumab, 45mg solution for injection (Stelara ) No. (572/09) Janssen-Cilag Ltd 15 January 2010 The Scottish Medicines Consortium (SMC) has completed its assessment of
More informationSummary Background 1. Comparative effectiveness of ramucirumab
Cost-effectiveness of ramucirumab (Cyramza ) for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression following previous treatment
More informationTechnology appraisal guidance Published: 8 June 2015 nice.org.uk/guidance/ta339
Omalizumab for previously treated chronic spontaneous urticaria Technology appraisal guidance Published: 8 June 2015 nice.org.uk/guidance/ta339 NICE 2018. All rights reserved. Subject to Notice of rights
More informationTechnology appraisal guidance Published: 28 June 2017 nice.org.uk/guidance/ta446
Brentuximab vedotin for treating CD30-positive Hodgkin lymphoma Technology appraisal guidance Published: 28 June 2017 nice.org.uk/guidance/ta446 NICE 2017. All rights reserved. Subject to Notice of rights
More informationTechnology appraisal guidance Published: 14 December 2011 nice.org.uk/guidance/ta239
Fulvestrant for the treatment of locally advanced or metastatic breast cancer Technology appraisal guidance Published: 14 December 2011 nice.org.uk/guidance/ta239 NICE 2018. All rights reserved. Subject
More informationEvidence Review Group Report commissioned by the NIHR HTA Programme on behalf of NICE
Evidence Review Group Report commissioned by the NIHR HTA Programme on behalf of NICE Bevacizumab in combination with paclitaxel and carboplatin for the first-line treatment of ovarian cancer Produced
More informationTechnology appraisal guidance Published: 25 May 2016 nice.org.uk/guidance/ta391
Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxelel Technology appraisal guidance Published: 25 May 2016 nice.org.uk/guidance/ta391 NICE 2017. All rights reserved. Subject
More informationBackground Comparative effectiveness of nivolumab
NCPE report on the cost effectiveness of nivolumab (Opdivo ) for the treatment of locally advanced or metastatic squamous non-small cell lung cancer after prior chemotherapy in adults. The NCPE has issued
More information4. Aflibercept showed significant improvement in overall survival (OS), the primary
Cost effectiveness of aflibercept (Zaltrap ) in combination with FOLFIRI in the treatment of adult patients with metastatic colorectal cancer (mcrc) that is resistant to or has progressed after an oxaliplatin
More informationRe: Final Appraisal Determination Vinflunine for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract.
24 March 2011 xxxxxxxxxxxxxxxxxxxxx Chair, Appeal Committee National Institute for Health and Clinical Excellence MidCity Place 71 High Holborn London WC1V 6NA Dear xxxxxxxx Re: Final Appraisal Determination
More informationSummary 1. Comparative effectiveness of ataluren Study 007
Cost-effectiveness of Ataluren (Transarna TM ) for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophy gene in ambulatory patients aged 5 years and older The
More informationCheckMate 025, as patients may derive a benefit, based on the opinion of the CGP and the mechanism of action of nivolumab.
CheckMate 025, as patients may derive a benefit, based on the opinion of the CGP and the mechanism of action of nivolumab. perc noted that patients with brain metastases were excluded from the CheckMate
More informationAWMSG SECRETARIAT ASSESSMENT REPORT. Imatinib (Glivec ) 100 mg and 400 mg film-coated tablets. Reference number: 1653 FULL SUBMISSION
AWMSG SECRETARIAT ASSESSMENT REPORT Imatinib (Glivec ) 100 mg and 400 mg film-coated tablets Reference number: 1653 FULL SUBMISSION This report has been prepared by the All Wales Therapeutics and Toxicology
More informationCetuximab for the first-line treatment of metastatic colorectal cancer
Cetuximab for the first-line treatment of metastatic colorectal cancer Issued: August 2009 guidance.nice.org.uk/ta176 NICE has accredited the process used by the Centre for Health Technology Evaluation
More informationPart 1 Public handouts
Part 1 Public handouts Chair s presentation Trastuzumab emtansine for treating HER2- positive, unresectable locally advanced or metastatic breast cancer after treatment with trastuzumab and a taxane Rapid
More informationTechnology appraisal guidance Published: 6 December 2017 nice.org.uk/guidance/ta493
Cladribine tablets for treating relapsing remitting multiple sclerosis Technology appraisal guidance Published: 6 December 2017 nice.org.uk/guidance/ta493 NICE 2018. All rights reserved. Subject to Notice
More informationLONDON CANCER NEW DRUGS GROUP RAPID REVIEW
LONDON CANCER NEW DRUGS GROUP RAPID REVIEW Adjuvant imatinib after complete resection of primary gastrointestinal stromal tumour (GIST) in patients at high risk of relapse May 2012 Summary NICE guidance
More information