Dataset Information

The Memokath-051 Stent for the Treatment of Ureteric Obstruction: A NICE Medical Technology Guidance.

ABSTRACT: Memokath-051 is a thermo-expandable, nickel-titanium alloy spiral stent used to treat ureteric obstruction resulting from malignant or benign strictures. The National Institute for Health and Care Excellence (NICE) selected Memokath-051 for evaluation. The company, PNN Medical, claimed Memokath-051 has clinical superiority and cost savings compared with double-J stents. It identified five studies reporting clinical evidence on Memokath-051 and constructed a de novo cost model comparing Memokath-051 to double-J stents. Results indicated that Memokath-051 generated cost savings of £4156 per patient over 2.5 years. The External Assessment Centre (EAC) critiqued the company's submission and completed substantial additional work. Sixteen studies were identified assessing Memokath-051 and all listed comparators in the scope (double-J stents, reconstructive surgery and metallic and alloy stents) except nephrostomy. Similar success rates were reported for Memokath-051 compared with double-J and Resonance stents and worse outcomes compared with other options with evidence available. The EAC updated the company's cost model structure and modified several inputs. The EAC's model estimated that Memokath-051 generated savings of at least £1619 per patient over 5 years compared with double-J stents, was cost neutral compared with other metallic stents and was cost saving compared with surgery up to month 55. Overall, Memokath-051 is likely to be cost saving in patients not indicated for reconstructive surgery and those expected to require a ureteral stent for at least 30 months. The Medical Technologies Advisory Committee (MTAC) reviewed the evidence and supported the case for adoption, issuing partially supportive recommendations published after public consultation as Medical Technologies Guidance 35.

SUBMITTER: Eaton Turner E

PROVIDER: S-EPMC6028873 | biostudies-other | 2018 Aug

REPOSITORIES: biostudies-other

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The Memokath-051 Stent for the Treatment of Ureteric Obstruction: A NICE Medical Technology Guidance.

Eaton Turner Emily E Jenks Michelle M McCool Rachael R Marshall Chris C Millar Liesl L Wood Hannah H Peel Alison A Craig Joyce J Sims Andrew J AJ

Applied health economics and health policy 20180801 4

Memokath-051 is a thermo-expandable, nickel-titanium alloy spiral stent used to treat ureteric obstruction resulting from malignant or benign strictures. The National Institute for Health and Care Excellence (NICE) selected Memokath-051 for evaluation. The company, PNN Medical, claimed Memokath-051 has clinical superiority and cost savings compared with double-J stents. It identified five studies reporting clinical evidence on Memokath-051 and constructed a de novo cost model comparing Memokath- ...[more]

PMID: 29616460

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Project description:ObjectivesTo assess how long the UK's National Institute for Health and Clinical Excellence's (NICE) Technology Appraisal Programme has taken to produce guidance and to determine independent predictors of time to guidance.DesignRetrospective time to event (survival) analysis.SettingTechnology Appraisal guidance produced by NICE. DATASOURCE: All appraisals referred to NICE by February 2010 were included, except those referred prior to 2001 and a number that were suspended.Outcome measureDuration from the start of an appraisal (when the scope document was released) until publication of guidance.ResultsSingle Technology Appraisals (STAs) were published significantly faster than Multiple Technology Appraisals (MTAs) with median durations of 48.0 (IQR; 44.3-75.4) and 74.0 (IQR; 60.9-114.0) weeks, respectively (p?<0.0001). Median time to publication exceeded published process timelines, even after adjusting for appeals. Results from the modelling suggest that STAs published guidance significantly faster than MTAs after adjusting for other covariates (by 36.2 weeks (95% CI -46.05 to -26.42 weeks)) and that appeals against provisional guidance significantly increased the time to publication (by 42.83 weeks (95% CI 35.50 to 50.17 weeks)). There was no evidence that STAs of cancer-related technologies took longer to complete compared with STAs of other technologies after adjusting for potentially confounding variables and only weak evidence suggesting that the time to produce guidance is increasing each year (by 1.40 weeks (95% CI -0.35 to 2.94 weeks)).ConclusionsThe results from this study suggest that the STA process has resulted in significantly faster guidance compared with the MTA process irrespective of the topic, but that these gains are lost if appeals are made against provisional guidance. While NICE processes continue to evolve over time, a trade-off might be that decisions take longer but at present there is no evidence of a significant increase in duration.

Project description:ObjectivesTo assess the feasibility of conducting a randomised controlled trial (RCT) to assess whether avoiding ureteric drainage is superior to performing ureteric drainage after Uncomplicated Ureteroscopy and/or Flexible Ureterorenoscopy (URS/FURS) treatment of a urinary tract stone in improving patient reported outcome measures (PROMs) and 30-day unplanned readmission rates. A secondary objective was to understand current practice of urologists regarding ureteric drainage after uncomplicated URS/FURS (UU).Material and methodsWe undertook an online survey of urologists, circulated amongst members of international urological societies and through social media platforms. Uncomplicated URS/FURS was defined as completion of URS/FURS treatment for a urinary tract stone, with the absence of: ureteral trauma, residual fragments requiring further lithotripsy procedures, significant bleeding, perforation, prior urinary tract infection or pregnancy. The ureteric drainage options considered included an indwelling stent, stent on a string or a ureteric catheter. The primary outcome was to determine the proportion of urologists willing to take part in a RCT, randomising patients after UU to a "no ureteric drainage" arm or ureteric drainage arm. Secondary outcomes included determining in their current practice, the proportion of clinicians performing routine ureteric drainage after UU, the reasons for performing ureteric drainage following UU and their preferred optimal duration for ureteric drainage if it is used. The study was reported according to the Checklist for Reporting Results of Internet E-Surveys (CHERRIES).ResultsTotal of 468 respondents from 45 countries took part in the survey, of whom 303 completed the entire survey (65%). The majority agreed that they would be willing to randomise patients (244/303, 81%) in the proposed RCT. Perceived lack of equipoise to randomise was the most common reason for not being willing to participate (59/303, 19%).92% (308/335) reported that they use ureteric drainage after UU. This was most often due to wanting to prevent possible complications from post-operative ureteric oedema (77%) or to aid passage of small fragments (43%). Complexity of the case (i.e. impacted stone 90%) and length of the procedure (46%) were the most important intraoperative factors influencing the decision to use ureteric drainage post procedure. If required, the median stated ideal duration of ureteric drainage was 5 days (IQR: 3-7 days) after UU. If having UU personally, 30% would want no stent postoperatively and over half would prefer a stent on a string.ConclusionWe have highlighted wide variation in practice regarding ureteric drainage after UU. Our results support the feasibility of an RCT evaluating if no ureteric drainage is superior to ureteric drainage in improving PROMs and 30-day unplanned readmission rates following UU.

Dataset Information

The Memokath-051 Stent for the Treatment of Ureteric Obstruction: A NICE Medical Technology Guidance.

Publications

The Memokath-051 Stent for the Treatment of Ureteric Obstruction: A NICE Medical Technology Guidance.

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