LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 10 of total 124

Search options

  1. Article ; Online: Correspondence on 'Cost-effectiveness of transcatheter edge-to-edge repair in secondary mitral regurgitation does need confirmation' by Cohen

    Armoiry, Xavier / Connock, Martin

    Heart (British Cardiac Society)

    2022  Volume 108, Issue 13, Page(s) 1071

    MeSH term(s) Cardiac Catheterization ; Cost-Benefit Analysis ; Heart Valve Prosthesis Implantation/adverse effects ; Humans ; Mitral Valve/surgery ; Mitral Valve Insufficiency/surgery ; Treatment Outcome
    Language English
    Publishing date 2022-06-10
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 1303417-0
    ISSN 1468-201X ; 1355-6037
    ISSN (online) 1468-201X
    ISSN 1355-6037
    DOI 10.1136/heartjnl-2022-321179
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ui IV Zs.40: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 112: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  2. Article ; Online: Cost-effectiveness of the MitraClip device in secondary mitral regurgitation: comment upon the article by Estler et al.

    Connock, Martin / Armoiry, Xavier

    The European journal of health economics : HEPAC : health economics in prevention and care

    2022  Volume 24, Issue 5, Page(s) 783–784

    MeSH term(s) Humans ; Mitral Valve Insufficiency/surgery ; Cost-Benefit Analysis ; Heart Failure ; Heart Valve Prosthesis Implantation ; Cost-Effectiveness Analysis
    Language English
    Publishing date 2022-09-04
    Publishing country Germany
    Document type Journal Article ; Comment
    ZDB-ID 2045253-6
    ISSN 1618-7601 ; 1618-7598
    ISSN (online) 1618-7601
    ISSN 1618-7598
    DOI 10.1007/s10198-022-01508-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5475: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article ; Online: Potential impact on cost-effectiveness estimates of using immature survival data: a case study based on transcatheter edge-to-edge repair (TEER) used for patients with severe mitral regurgitation at high surgical risk.

    Connock, Martin / Auguste, Peter / Capelle, Aude / Hénaine, Anna-Maria / Obadia, Jean-François / Armoiry, Xavier

    BMJ open

    2023  Volume 13, Issue 3, Page(s) e060423

    Abstract: Objective: To review the survival modelling used in cost-effectiveness studies evaluating an interventional procedure and to discuss implications for decision-makers.: Design: A case study of three economic evaluations that each used immature data ... ...

    Abstract Objective: To review the survival modelling used in cost-effectiveness studies evaluating an interventional procedure and to discuss implications for decision-makers.
    Design: A case study of three economic evaluations that each used immature data from the EVEREST II High Surgical Risk (HSR) Study of transcatheter edge-to-edge repair (TEER) for patients with severe mitral regurgitation (MR) who were at high risk of surgery.
    Setting: Estimation of patient survival in cost-effectiveness studies.
    Participants: The EVEREST II HSR Study included 78 patients who had TEER of the mitral valve using the MitraClip device and a retrospectively identified control group of 36 patients who received medical management and were followed up for 12 months. Observed survival (TEER arm only) was updated at 5 years.
    Results: Two studies used 12-month observed mortality from EVEREST II HSR to model survival over lifetime horizons. Observed and modelled survival were associated with considerable uncertainty due to short follow-up and small numbers of participants. Modelling control patients' survival required an approximate 10-fold extrapolation based on 12-month observation of only 38 patients. Observed 5-year survival in the TEER group differed from that less mature follow-up suggesting that survival modelling based on shorter follow-up was unsatisfactory. No public domain data for the control group are available beyond 12-month follow-up so meaningful estimates using mature data for both arms are currently not possible. A third study developed survival models using incompletely reported transitions between MR grades in EVEREST II HSR and mortality rates observed for different MR grades derived from a study in an unrelated population.
    Conclusions: Modelling survival in such small samples followed up for only 12 months is associated with great uncertainty, and cost-effectiveness results based on these analyses should be viewed as premature and used cautiously in reimbursement decisions.
    MeSH term(s) Humans ; Mitral Valve Insufficiency/surgery ; Cost-Benefit Analysis ; Retrospective Studies ; Mitral Valve/surgery ; Treatment Outcome ; Heart Valve Prosthesis Implantation/methods ; Cardiac Catheterization
    Language English
    Publishing date 2023-03-14
    Publishing country England
    Document type Journal Article
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2021-060423
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  4. Article ; Online: Impact of updated trial data on the cost-effectiveness of percutaneous mitral repair.

    Connock, Martin / Auguste, Peter / Obadia, Jean-François / Andronis, Lazaros / Armoiry, Xavier

    PloS one

    2023  Volume 18, Issue 1, Page(s) e0280554

    Abstract: When updated clinical trial data becomes available reassessing the cost-effectiveness of technologies may modify estimates and influence decision-making. We investigated the impact of updated trial outcomes on the cost-effectiveness of percutaneous ... ...

    Abstract When updated clinical trial data becomes available reassessing the cost-effectiveness of technologies may modify estimates and influence decision-making. We investigated the impact of updated trial outcomes on the cost-effectiveness of percutaneous mitral repair (PR) for secondary mitral regurgitation. We updated our previous three-state time-varying Markov model to assess the cost-effectiveness of PR + guideline directed medical treatment (GDMT) versus GDMT alone. Key clinical inputs (overall survival (OS) and heart failure hospitalisations (HFH)) were obtained using the 3-year trial findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) RCT. We calculated incremental cost-effectiveness ratios (ICER) and report how these differ between analyses based on early (2-year) and updated (3-year) evidence. Updated trial data showed an increase in mortality in the intervention arm between two and three years follow-up that was not seen in the control arm. Deterministic and multivariate cost-effectiveness modelling yielded incremental cost effectiveness ratios ICERs of €38,123 and €31,227 /QALY. Compared to our 2-year based estimate (€21,918 / QALY) these results imply an approximate 1.5-fold increase in ICER. The availability of updated survival analyses from the COAPT pivotal trial suggests previous estimates based on 2-year trial findings were over optimistic for the intervention.
    MeSH term(s) Humans ; Cost-Benefit Analysis ; Mitral Valve Insufficiency/complications ; Heart Failure/therapy ; Outcome Assessment, Health Care ; Treatment Outcome
    Language English
    Publishing date 2023-01-26
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0280554
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Article ; Online: A comparison of published time invariant Markov models with Partitioned Survival models for cost effectiveness estimation; three case studies of treatments for glioblastoma multiforme.

    Connock, Martin / Auguste, Peter / Armoiry, Xavier

    The European journal of health economics : HEPAC : health economics in prevention and care

    2020  Volume 22, Issue 1, Page(s) 89–100

    Abstract: Background: Cost-effectiveness analyses of treatments for glioblastoma multiforme (GBM) have mostly used state transition Markov models with time invariant transition probabilities (TIMMs). In three case studies of GBM treatments, we compared ... ...

    Abstract Background: Cost-effectiveness analyses of treatments for glioblastoma multiforme (GBM) have mostly used state transition Markov models with time invariant transition probabilities (TIMMs). In three case studies of GBM treatments, we compared Partitioned Survival model (PSM) results with published outputs from TIMMs.
    Methods: PSMs used the same RCT data sources, utility values, time horizons, cycle times and annual discounting used in published TIMMs. Reported overall survival and progression-free survival plots were digitised and fitted with a range of parametric models. Economic model outputs were generated in the same form as reported for the TIMMs. PSM output uncertainty was explored in univariate and in multivariate sensitivity analyses.
    Results: PSMs generated incremental cost-effectiveness ratios that were different to the published TIMMs. The magnitude of difference was substantial in two cases. The PSMs were reasonably robust and in sensitivity analyses were sensitive to variations in the same model inputs as were the TIMMs. When compared to the RCT data, the TIMMs tended to generate underestimates of the likely overall survival gain. TIMM estimates for depletion of individuals from the stable disease state and for accumulation in the dead state had relatively poor resemblance to the source RCT data.
    Conclusion: TIMMs delivered different cost-effectiveness estimates to PSMs; in two cases, TIMMs produced substantially lower ICER values than PSMs. Model output differences appear attributable to less realistic cost-and-benefit estimates generated in TIMMs due to rapid depletion from the stable disease state and/or accumulation in the dead state.
    MeSH term(s) Cost-Benefit Analysis ; Glioblastoma ; Humans ; Markov Chains ; Models, Economic ; Probability ; Quality-Adjusted Life Years
    Language English
    Publishing date 2020-11-01
    Publishing country Germany
    Document type Comparative Study ; Journal Article
    ZDB-ID 2045253-6
    ISSN 1618-7601 ; 1618-7598
    ISSN (online) 1618-7601
    ISSN 1618-7598
    DOI 10.1007/s10198-020-01239-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5475: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  6. Article ; Online: How Do Pharmaceutical Companies Model Survival of Cancer Patients? A Review of NICE Single Technology Appraisals in 2017.

    Gallacher, Daniel / Auguste, Peter / Connock, Martin

    International journal of technology assessment in health care

    2019  Volume 35, Issue 2, Page(s) 160–167

    Abstract: Objectives: Before an intervention is publicly funded within the United Kingdom, the cost-effectiveness is assessed by the National Institute of Health and Care Excellence (NICE). The efficacy of an intervention across the patients' lifetime is often ... ...

    Abstract Objectives: Before an intervention is publicly funded within the United Kingdom, the cost-effectiveness is assessed by the National Institute of Health and Care Excellence (NICE). The efficacy of an intervention across the patients' lifetime is often influential of the cost-effectiveness analyses, but is associated with large uncertainties. We reviewed committee documents containing company submissions and evidence review group (ERG) reports to establish the methods used when extrapolating survival data, whether these adhered to NICE Technical Support Document (TSD) 14, and how uncertainty was addressed.
    Methods: A systematic search was completed on the NHS Evidence Search webpage limited to single technology appraisals of cancer interventions published in 2017, with information obtained from the NICE Web site.
    Results: Twenty-eight appraisals were identified, covering twenty-two interventions across eighteen diseases. Every economic model used parametric curves to model survival. All submissions used goodness-of-fit statistics and plausibility of extrapolations when selecting a parametric curve. Twenty-five submissions considered alternate parametric curves in scenario analyses. Six submissions reported including the parameters of the survival curves in the probabilistic sensitivity analysis. ERGs agreed with the company's choice of parametric curve in nine appraisals, and agreed with all major survival-related assumptions in two appraisals.
    Conclusions: TSD 14 on survival extrapolation was followed in all appraisals. Despite this, the choice of parametric curve remains subjective. Recent developments in Bayesian approaches to extrapolation are not implemented. More precise guidance on the selection of curves and modelling of uncertainty may reduce subjectivity, accelerating the appraisal process.
    MeSH term(s) Bayes Theorem ; Cost-Benefit Analysis ; Drug Industry/organization & administration ; Drug Industry/standards ; Humans ; Models, Economic ; Models, Statistical ; Neoplasms/mortality ; Quality-Adjusted Life Years ; State Medicine ; Survival Analysis ; Technology Assessment, Biomedical/organization & administration ; Technology Assessment, Biomedical/standards ; United Kingdom
    Language English
    Publishing date 2019-04-24
    Publishing country England
    Document type Journal Article
    ZDB-ID 632573-7
    ISSN 1471-6348 ; 0266-4623
    ISSN (online) 1471-6348
    ISSN 0266-4623
    DOI 10.1017/S0266462319000175
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 2073: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  7. Article ; Online: Conflicting findings between the Mitra-Fr and the Coapt trials: Implications regarding the cost-effectiveness of percutaneous repair for heart failure patients with severe secondary mitral regurgitation.

    Armoiry, Xavier / Obadia, Jean-François / Auguste, Peter / Connock, Martin

    PloS one

    2020  Volume 15, Issue 11, Page(s) e0241361

    Abstract: Purpose: Two randomized controlled trials (RCTs), Mitra-Fr and Coapt, evaluating the benefit of percutaneous repair (PR) for heart failure (HF) patients with severe mitral regurgitation, have led to conflicting results. We aimed to evaluate the impact ... ...

    Abstract Purpose: Two randomized controlled trials (RCTs), Mitra-Fr and Coapt, evaluating the benefit of percutaneous repair (PR) for heart failure (HF) patients with severe mitral regurgitation, have led to conflicting results. We aimed to evaluate the impact of these trial results on the cost-effectiveness of PR using effectiveness inputs from the two RCTs.
    Methods: We developed a time varying Markov type model with three mutually exclusive health states: alive without HF hospitalisation, alive with HF hospitalisation, and dead. Clinically plausible extrapolations beyond observed data were obtained by developing parametric modelling for overall survival and HF hospitalisations using published data from each trial. We adopted the perspective of the French Health System and used a 30-year time horizon. Results were expressed as € / quality-adjusted life year (QALY) gained using utility inputs from literature.
    Findings: Results are presented using treatment efficacy measures from Mitra-F and Coapt trials respectively. With the Mitra-Fr data, after annual discounting, the base case model generated an incremental 0.00387 QALY at a cost of €25,010, yielding an incremental cost effectiveness ratio (ICER) of €6,467,032 / QALY. The model was sensitive to changes made to model inputs. There was no potential of PR being cost-effective. With the Coapt data, the model generated 1.19 QALY gain at a cost of €26,130 yielding an ICER of €21,918 / QALY and at a threshold of >€50,000/QALY PR had a probability of 1 of being cost-effective.
    Implications: Cost effectiveness results were conflicting; reconciling differences between trials is a priority and could promote optimal cost effectiveness analyses and resource allocation.
    MeSH term(s) Cost-Benefit Analysis ; Heart Failure/complications ; Heart Failure/economics ; Humans ; Mitral Valve Insufficiency/complications ; Mitral Valve Insufficiency/economics ; Percutaneous Coronary Intervention/economics ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2020-11-09
    Publishing country United States
    Document type Journal Article
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0241361
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  8. Article ; Online: Will the US$5 million onasemnogene abeparvosec treatment for spinal muscular atrophy represent 'value for money' for the NHS? A rapid inquiry into suggestions that it may be cost-effective.

    Connock, Martin / Andronis, Lazaros / Auguste, Peter / Dussart, Claude / Armoiry, Xavier

    Expert opinion on biological therapy

    2020  Volume 20, Issue 7, Page(s) 823–827

    Abstract: Objectives: Nusinersen (Spinraza®, Biogen) and onasemnogene abeparvosec (Zolgensma®, Novartis) are novel gene-based therapies for the orphan disease Spinal Muscular Atrophy. Onasemnogene abeparvosec has been allocated an acquisition cost of up to US$5 ... ...

    Abstract Objectives: Nusinersen (Spinraza®, Biogen) and onasemnogene abeparvosec (Zolgensma®, Novartis) are novel gene-based therapies for the orphan disease Spinal Muscular Atrophy. Onasemnogene abeparvosec has been allocated an acquisition cost of up to US$5 million per patient. We undertook a rapid inquiry to evaluate if onasemnogene abeparvosec is likely to be cost-effective for the UK NHS.
    Methods: We used publicly available cost-effectiveness data and recommended methodology to perform cost-utility evaluation of onasemnogene abeparvosec versus best supportive care and nusinersen.
    Results: Our evaluations highlight wide variations in cost and benefit estimates of nusinersen and indicate that onasemnogene abeparvosec is unlikely to represent value for money according to current standards of reimbursement. Results are discussed in the context of reimbursement decisions for orphan diseases.
    Conclusion: Commonly implemented commercial confidentiality practices combined with uncertain data obscure scrutiny and justification of past and present reimbursement decisions for orphan drugs. Future cutting edge expensive therapies will be numerous, they will entail very substantial economic strains. We conclude that there is an urgent and increasing need for the development of improved procedures that can lead to equitable, consistent, and transparent decision-making.
    MeSH term(s) Biological Products/therapeutic use ; Cost-Benefit Analysis ; Genetic Therapy/economics ; Humans ; Muscular Atrophy, Spinal/therapy ; Oligonucleotides/therapeutic use ; Palliative Care ; Quality of Life ; Recombinant Fusion Proteins/therapeutic use ; Regression Analysis
    Chemical Substances Biological Products ; Oligonucleotides ; Recombinant Fusion Proteins ; Zolgensma ; nusinersen (5Z9SP3X666)
    Language English
    Publishing date 2020-06-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2020.1772747
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 6094: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  9. Article ; Online: Cost-effectiveness of tumor-treating fields added to maintenance temozolomide in patients with glioblastoma: an updated evaluation using a partitioned survival model.

    Connock, Martin / Auguste, Peter / Dussart, Claude / Guyotat, Jacques / Armoiry, Xavier

    Journal of neuro-oncology

    2019  Volume 143, Issue 3, Page(s) 605–611

    Abstract: Purpose: A first cost-effectiveness analysis has raised a strong concern regarding the cost of tumor treatment fields (TTF) added to maintenance temozolomide for patients with glioblastoma. This evaluation was based on effectiveness outcomes from an ... ...

    Abstract Purpose: A first cost-effectiveness analysis has raised a strong concern regarding the cost of tumor treatment fields (TTF) added to maintenance temozolomide for patients with glioblastoma. This evaluation was based on effectiveness outcomes from an interim analysis of the pivotal trial, moreover it used a "standard" Markov model. Our objective was to update the cost-effectiveness evaluation using the more flexible potential of the "partitioned survival" model design and using the latest effectiveness data.
    Methods: We developed the model with three mutually exclusive health states: stable disease, progressive disease, and dead. Good fit parametric models were developed for overall survival and progression free survival and these generated clinically plausible extrapolations beyond the observed data. We adopted the perspective of the French national health insurance and used a 20-year time horizon. Results were expressed as cost/life-years (LY) gained (LYG).
    Results: The base case model generated incremental benefit of 0.604 LY at a cost of €453,848 which, after 4% annual discounting of benefits and costs, yielded an incremental cost effectiveness ratio (ICER) of €510,273/LYG. Using sensitivity analyses and bootstrapping methods results were found to be relatively robust and were only sensitive to TTF device costs and the modelling of overall survival. To achieve an ICER below €100,000/LYG would require a reduction in TTF device cost of approximately 85%.
    Conclusions: Using a different type of model and updated survival outcomes, our results show TTF remains an intervention that is not cost-effective, which greatly restrains its diffusion to potentially eligible patients.
    MeSH term(s) Antineoplastic Agents, Alkylating/economics ; Antineoplastic Agents, Alkylating/therapeutic use ; Bayes Theorem ; Cost-Benefit Analysis ; Glioblastoma/drug therapy ; Glioblastoma/economics ; Health Care Costs/statistics & numerical data ; Humans ; Prognosis ; Quality-Adjusted Life Years ; Survival Rate ; Temozolomide/economics ; Temozolomide/therapeutic use
    Chemical Substances Antineoplastic Agents, Alkylating ; Temozolomide (YF1K15M17Y)
    Language English
    Publishing date 2019-05-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 604875-4
    ISSN 1573-7373 ; 0167-594X
    ISSN (online) 1573-7373
    ISSN 0167-594X
    DOI 10.1007/s11060-019-03197-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1825: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  10. Article ; Online: Ocrelizumab not recommended in France for patients with primary progressive multiple sclerosis while recommended in England: a review comparing the assessment by HAS and NICE.

    Armoiry, Xavier / Späth, Hans-Martin / Henaine, Anna-Maria / Dussart, Claude / Counsell, Carl / Connock, Martin

    Expert opinion on biological therapy

    2020  Volume 21, Issue 6, Page(s) 741–747

    Abstract: Introduction: Ocrelizumab is the first approved drug for primary progressive multiple sclerosis. Following appraisal by health technology assessment (HTA) bodies, this medicine has not been widely covered across European countries. We have compared the ... ...

    Abstract Introduction: Ocrelizumab is the first approved drug for primary progressive multiple sclerosis. Following appraisal by health technology assessment (HTA) bodies, this medicine has not been widely covered across European countries. We have compared the HTA process in England and France.
    Area covered: We undertook an analysis of relevant documents that were published by the two HTA bodies. We analyzed patients' availability of Ocrelizumab at the different stages of the process.
    Expert opinion: We identified differences in the assessment, one being the use of a different population of the pivotal trial, which has resulted in the consideration of distinct clinical effectiveness estimates. Ocrelizumab became available earlier in France as part of an early access program. However, rapid access was discontinued for newly eligible patients following an opinion concluding that Ocrelizumab yielded no additional benefit over placebo. This opinion was not compatible with the criteria allowing reimbursement in France.In England, there was no early access program and following an appraisal that included cost-effectiveness evaluation combined with pricing agreements, medicine was finally recommended. In conclusion, differences in the HTA process may result in appreciable differences in timing and outcome from marketing authorization to the adoption of newly licensed drugs.
    MeSH term(s) Antibodies, Monoclonal, Humanized ; Cost-Benefit Analysis ; England ; France ; Humans ; Multiple Sclerosis ; Multiple Sclerosis, Chronic Progressive
    Chemical Substances Antibodies, Monoclonal, Humanized ; ocrelizumab (A10SJL62JY)
    Language English
    Publishing date 2020-12-24
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2021.1865305
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 6094: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

To top