140DAI55300模块备件

140DAI55300

自体干细胞移植后复发或进展风险增加的淋巴瘤
移植
8.通过数据解决了与化疗后和布伦妥昔单抗后韦多汀干细胞移植的相对比率相关的不确定性
CDF中的集合。在这一领域没有发表其他证据。
9.AETHERA（2018）的安全性分析发现布伦妥昔单抗的不良事件
ASCT后的巩固是可管理和可逆的。
是否有任何与本评估相关的NICE指南？
如果是，这对现有指南有什么影响？
10.自从TA446（TA524 CDF评论之前的原始版本）出版以来，NICE已经
发表了霍奇金淋巴瘤的其他指南（TA462、TA540，
TA594）。本提案文件的建议没有任何
对其他指导意见的影响。
补充意见
11.原始ERG报告（2016）中的搜索策略适用于
Cochrane图书馆、Medline、Medlinein-Process和Embase。来自
2018年1月至2021 2月进行了审查。其他临床搜索
还进行了试验登记和其他来源。结果
文献检索在“证据和含义摘要”中进行了讨论
上面的“回顾”部分。
平等问题
12.原始指南中未提出潜在的平等问题。
决策文件签署
Janet Robertson–技术评估和级
专业技术
2021 6月15日
©NICE 2021。保留所有权利。以权利通知为准。第4页，共9页
本文的贡献者
信息专家：托尼·肖
技术分析师：托马斯·佩林
项目经理：夏洛特·唐宁
©NICE 2021。保留所有权利。以权利通知为准。第5页，共9页
附录A——现有指南中的信息
原始汇款
评价布伦妥昔单抗韦多汀（Adcetris）的临床和成本效益
在其治疗成人CD30阳性霍奇金淋巴瘤的许可适应证范围内。
当前指南
1.1建议将布伦妥昔单抗韦多汀作为治疗CD30阳性的一种选择
复发或难治性疾病的成人霍奇金淋巴瘤，仅在以下情况下：
•他们已经进行了自体干细胞移植，或
•他们之前至少接受过2次自体干细胞移植治疗
细胞移植或多药化疗不适用，且
•根据商业协议，公司提供布伦妥昔单抗韦多汀
安排
1.2这些建议无意影响布伦妥昔单抗的治疗
在本指南发布之前，在NHS中开始使用维多汀。人
接受这些建议以外的治疗可能会继续，不会发生变化
在本指南发布之前，为其制定的融资安排
直到他们和他们的NHS临床医生认为应该停止。
原始指南中的研究建议
不适用
©NICE 2021。保留所有权利。以权利通知为准。第6页，共9页
附录B——选项说明
在考虑是否审查其技术评估时，NICE必须：
在下表中选择一个选项：
所选结果的选项
–是/否
对指南的审查应：
纳入评估计划
工作方案。审查将：
通过指定
STA或MTA过程。
将计划对评估进行审查
进入尼斯的工作计划。
不
审查
指导应推迟到：
指定日期或试验。
尼斯将重新考虑是否进行审查
在指定日期需要。
不
指南应该是交叉的
转为正在进行的临床
指南
持续的指导方针将包括：
技术建议
评价技术评估将：
与指南保持一致。
通常，还建议：
技术评估指南
在以下时间之前保持相关：
考虑审查临床指南。
此选项具有保留
与正面相关的资金方向
在一个不错的技术中推荐
评价

140DAI55300

140DAI55300

Lymphoma at increased risk of relapse or progression after autologous stem cell
transplant.
8. Uncertainties relating to relative rate of post-chemotherapy and postbrentuximab vedotin stem cell transplants were addressed through data
collection in the CDF. No other evidence has been published in this area.
9. Safety analysis from AETHERA (2018) found adverse events from brentuximab
consolidation after ASCT to be manageable and reversible.
Are there any related pieces of NICE guidance relevant to this appraisal?
If so, what implications might this have for the existing guidance?
10. Since the publication of TA446 (original before TA524 CDF review) NICE has
published other pieces of guidance for Hodgkin’s Lymphoma (TA462, TA540,
TA594). The recommendation of this proposal paper does not have any
implications for those other pieces of guidance.
Additional comments
11. The search strategy from the original ERG report (2016) was adapted for the
Cochrane Library, Medline, Medline In-Process and Embase. References from
January 2018 to February 2021 were reviewed. Additional searches of clinical
trials registries and other sources were also carried out. The results of the
literature search are discussed in the ‘Summary of evidence and implications for
review’ section above.
Equality issues
12. No potential equalities issues were raised in the original piece of guidance.
Decision paper sign off
Janet Robertson – Associate Director, Technology Appraisals and Highly
Specialised Technologies
15 June 2021 
© NICE 2021. All rights reserved. Subject to Notice of rights. 4 of 9
Contributors to this paper
Information Specialist: Toni Shaw
Technical Analyst: Thomas Paling
Project Manager: Charlotte Downing
© NICE 2021. All rights reserved. Subject to Notice of rights. 5 of 9
Appendix A – Information from existing guidance
Original remit
To appraise the clinical and cost effectiveness of brentuximab vedotin (Adcetris)
within its licensed indication for treating CD30-positive Hodgkin lymphoma in adults.
Current guidance
1.1 Brentuximab vedotin is recommended as an option for treating CD30‑positive
Hodgkin lymphoma in adults with relapsed or refractory disease, only if:
• they have already had autologous stem cell transplant or
• they have already had at least 2 previous therapies when autologous stem
cell transplant or multi-agent chemotherapy are not suitable and
• the company provides brentuximab vedotin according to the commercial
arrangement.
1.2 These recommendations are not intended to affect treatment with brentuximab
vedotin that was started in the NHS before this guidance was published. People
having treatment outside these recommendations may continue without change
to the funding arrangements in place for them before this guidance was
published, until they and their NHS clinician consider it appropriate to stop.
Research recommendations from original guidance
N/A
© NICE 2021. All rights reserved. Subject to Notice of rights. 6 of 9
Appendix B – Explanation of options
When considering whether to review one of its Technology Appraisals NICE must
select one of the options in the table below:
Options Consequence Selected
– ‘Yes/No’
A review of the guidance should
be planned into the appraisal
work programme. The review will
be conducted through the specify
STA or MTA process.
A review of the appraisal will be planned
into the NICE’s work programme.
No
The decision to review the
guidance should be deferred to
specify date or trial.
NICE will reconsider whether a review is
necessary at the specified date.
No
The guidance should be Cross
referred into an on-going clinical
guideline.
The on-going guideline will include the
recommendations of the technology
appraisal. The technology appraisal will
remain extant alongside the guideline.
Normally it will also be recommended that
the technology appraisal guidance
remains relevant until such time as the
clinical guideline is considered for review.
This option has the effect of preserving the
funding direction associated with a positive
recommendation in a NICE technology
appraisal