APPLICATION TO CONSIDER A CHANGE TO A SIGN GUIDELINE

Transcription

1 APPLICATION TO CONSIDER A CHANGE TO A SIGN GUIDELINE 1. Contact person(s) proposing change to the guideline Roberta James on behalf of the SIGN/SMC/SDTC working group 2. Title and number of SIGN guideline SIGN 135: Management of epithelial ovarian cancer 3. Please define the nature of the change being requested? For example due to new evidence or mandatory advice, such as a NICE MTA or new government policy. Changes to SMC advice and HIS endorsement of a NICE MTA have introduced conflicts within SIGN 135. Bevacizumab was accepted for restricted use within NHS Scotland November 2015 in combination with carboplatin and paclitaxel, for the front-line treatment of advanced (International Federation of Gynaecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. umab_avastin_2nd_resubmission Healthcare Improvement Scotland endorsed the NICE MTA Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer ( in April The NICE MTA does not recommend gemcitabine in combination with carboplatin for treating first recurrence. The recommendation to use platinum plus pegylated liposomal doxorubicin hydrocholoride (PLDH) is evidence based but unlicensed and not routinely offered in Scottish practice. The removal of the licensed combination of platinum and gemcitabine is possibly detrimental to patients who cannot receive paclitaxel or PLDH for other reasons and are therefore left without effective platinum combination therapy. The side effect profiles of these drugs are very different and therefore highly plausible that a patient not eligible for paclitaxel or PLDH would be eligible for gemcitabine. Bevacizumab is licensed in combination with carboplatin and gemcitabine, although not recommended. Topotecan, is less commonly used but is also not recommended but patients with ovarian cancer can often tolerate many lines of therapy. The review covers topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer, which suggests it is inclusive of all lines of recurrence. However for the economics, only first relapse was considered and these agents are compared against each other, when they would likely be used sequentially. There is also no consideration for bevacizumab in combination with weekly paclitaxel, which is available in Scotland and is key in the treatment pathway. Bevacizumab was accepted by SMC for restricted use within NHS Scotland in September 2015 in Produced by: Roberta James Page 1 of 7 Review date: 21/03/2017

2 combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents. zumab_avastin 4. Please highlight which sections, recommendations and/or key question that would change under this request Section on biological therapy for early disease No recommendation is made for bevacizumab Section on systemic therapy in recurrent ovarian cancer A Grade recommendation: Women with platinum-sensitive relapsed ovarian cancer should be treated with a platinum based combination with paclitaxel, pegylated liposomal doxorubicin hydrocholoride or gemcitabine. No recommendation is made for bevacizumab. 5. Will the requested change give rise to a new key question? If so please include. no 6. Please give a brief indication of the size and strength of the evidence base on which the potential change to the guideline would be based including existing guidelines or systematic reviews in this area. NICE MTA Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer ( (published in April 2016) 7. Provide any further information which you would like to be considered (e.g. links with audit programmes, educational initiatives, economic considerations, benefits of implementation, priorities for patients and carers) HIS endorsement; rces/appraisal_389.aspx Produced by: Roberta James Page 2 of 7 Review date: 21/03/2017

3 Signature Date: 06/07/2016 Thank you for completing this form Please return to: Roberta James SIGN Programme Lead SIGN Executive, Healthcare Improvement Scotland, Gyle Square 1 South Gyle Crescent Edinburgh EH12 9EB t: e:roberta.james@nhs.net Data Protection Your details will be stored on a database for the purposes of managing this guideline topic proposal. We may retain your details so that we can contact you about future Healthcare Improvement Scotland activities. We will not pass these details on to any third parties. Please indicate if you do not want your details to be stored after the proposal is published. Produced by: Roberta James Page 3 of 7 Review date: 21/03/2017

4 Initial screen Purpose: initial screening by SIGN Senior Management Team to exclude proposals that are neither clinical, nor multi-professional, nor appropriate for the SIGN process. 1. Is this an appropriate clinical topic for a SIGN guideline? Is it a clinical topic, what is the breadth of the topic and is there a need for the guideline as identified in the proposal? Yes, this would result in a refresh of SIGN Is there a suitable alternative product which would address this topic? Would another Healthcare Improvement Scotland product better address the topic? No SIGN 135 already exists. 3. Has this topic been considered before and rejected? What were the reasons for rejection and are they still applicable No 4. Outcome Go forward to the next stage of topic selection YES Reject Produced by: Roberta James Page 4 of 7 Review date: 21/03/2017

5 Title of guideline SIGN 135: Management of epithelial ovarian cancer Date of publication November 2013 SIGN scoping search sources SIGN summary of the scoping search Other guidelines/htas GIN National Guidelines Clearinghouse NICE Cochrane Library CRD databases INAHTA UKHTA Medline Dates searched: 2013 to current Guidelines (6) Health Technology Assessments (1) Cochrane reviews (11) Other Systematic reviews (18) Health economic assessments (9) RCTs (41) Cancer Australia. Recommendations for the use of first-line chemotherapy for the treatment of women with epithelial ovarian cancer Strawberry Hill, Australia NICE. Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer London NICE. Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer London NICE. Bevacizumab in combination with gemcitabine and carboplatin for treating the first recurrence of platinum-sensitive advanced ovarian cancer London Vergote I, Vlayen J, Heus P, Hoogendam J.P, Damen J.A.A.G, van de Wetering F t, van der Baan F.H, Bourgain C, De Grève J, Debruyne D, Fastrez M, Goffin F, Huizing M, Kerger J, Kridelka F, Stroobants S, Tjalma W, Van Dam P, Van de Caveye V, Villeirs G, Vuylsteke P, Fairon N, Zweemer R.P, Hooft L, Scholten R.J.P.M, Verleye L. Ovarian cancer: diagnosis, treatment and follow-up. Good Clinical Practice (GCP) Brussels: Belgian Health Care Knowledge Centre (KCE) KCE Reports 268. D/2016/10.273/49. Main conclusions from new evidence Wright AA, Bohlke K, Armstrong DK, Bookman MA, Cliby WA, Coleman RL, et al. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: Society of Gynecologic Oncology and American Society of Clinical Oncology Clinical Practice Guideline. Gynecol Oncol 2016;143(1):3-15 Edwards SJ, Barton S, Thurgar E,Trevor N. Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for advanced recurrent or refractory ovarian cancer: a systematic review and economic evaluation. Health Technol Assess 2015;19(7): Combination chemotherapy and bevacizumab delayed progression for newly diagnosed and recurrent ovarian cancer, Produced by: Roberta James Page 5 of 7 Review date: 21/03/2017

6 and improved survival for newly diagnosed ovarian cancer. Combination chemotherapy and bevacizumab prolongs progression-free survival and overall survival compared with bevacizumab alone. Bevacizumab continuation treatment seems to be associated with a small but clinically significant decrement in QoL compared with standard treatment for women with ovarian cancer. The trade-off between the prolongation of progression-free survival and the quality of that period of time needs to be considered in clinical practice when making treatment decisions Paclitaxel in combination with platinum or as monotherapy is recommended within its marketing authorisation as an option for treating recurrent ovarian cancer. Pegylated liposomal doxorubicin hydrochloride (PLDH) as monotherapy is recommended within its marketing authorisation as an option for treating recurrent ovarian cancer. PLDH in combination with platinum is recommended as an option for treating recurrent ovarian cancer.[1][2] The following are not recommended within their marketing authorisations for treating the first recurrence of platinum-sensitive ovarian cancer: o gemcitabine in combination with carboplatin o trabectedin in combination with PLDH o topotecan Summary of the recommendations that could be updated New areas that could be added to the guideline New recommendation for bevacizumab (biological therapy for early disease) A Women with platinum-sensitive relapsed ovarian cancer should be treated with a platinum based combination with paclitaxel, pegylated liposomal doxorubicin hydrocholoride or gemcitabine. New recommendation for bevacizumab (on systemic therapy in recurrent ovarian cancer) n/a Section Section Produced by: Roberta James Page 6 of 7 Review date: 21/03/2017

7 Suitability screen Purpose: screening by the Guideline Programme Advisory Board to select applications suitable for inclusion in the SIGN topic selection process. 1. Is there an owner for the project? (preferably an individual) Yes 2. Is this a clinical priority area for NHSScotland? The request came via the National Clinical Lead Cancer Medicine. 3. Is there a gap between current and optimal practice? OR Is there wide variation in current practice? (is this an area of clinical uncertainty) There is a gap between current and optimal practice 4. Is there a suitable guideline already available that could be adapted? (not necessarily by SIGN) This would update SIGN 135 on ovarian cancer 5. Is there adequate literature to make an evidence-based decision about appropriate practice? (is effective intervention proven and would it reduce mortality or morbidity) Yes, recent advice from SMC and NICE MTAs 6. Would the proposed practice change result in sufficient change in outcomes (health status, provider and consumer satisfaction and cost) to justify the effort? Yes, it would recommend access to medicines How big is the gap? Not sure How much effort will it take to close the gap? Little as would be promoted by National Clinical Lead and Area drug and Therapeutic Collaborative 7. Is there a perceived need for the guideline, as indicated by a network of relevant stakeholders? Yes, National Clinical Lead, Managed Clinical Networks and Area drug and Therapeutic Collaborative 8. Is there a reasonable likelihood that NHSScotland could implement the change? Yes 9. Does the proposer have any conflicts of interest? If so how will these be managed? No, proposal from within Healthcare Improvement Scotland. 10. Outcome Go forward to the next stage of topic selection Reject 11. Decision Ratified by SIGN Council for inclusion on the SIGN guideline development programme YES Date 08/02/2017 Comment Produced by: Roberta James Page 7 of 7 Review date: 21/03/2017