IDEAS home Printed from https://ideas.repec.org/a/spr/pharme/v31y2013i5p403-413.html
   My bibliography  Save this article

Rituximab for the First-Line Maintenance Treatment of Follicular Non-Hodgkin’s Lymphoma

Author

Listed:
  • Janette Greenhalgh
  • Adrian Bagust
  • Angela Boland
  • Michaela Blundell
  • James Oyee
  • Sophie Beale
  • Yenal Dundar
  • Juliet Hockenhull
  • Chris Proudlove
  • Patrick Chu

Abstract

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of rituximab (RTX) [Roche] to submit evidence for the clinical and cost effectiveness of RTX as first-line maintenance treatment for patients with follicular non-Hodgkin’s lymphoma (fNHL) whose disease has responded to induction therapy with RTX plus cytotoxic chemotherapy (R-CTX) in accordance with the Institute’s Single Technology Appraisal (STA) process. The Liverpool Reviews and Implementation Group (LRiG) at the University of Liverpool was commissioned to act as the Evidence Review Group (ERG). This article summarizes the ERG’s review of the evidence submitted by the manufacturer and provides a summary of the Appraisal Committee’s (AC) decision. The clinical evidence was derived from a multi-centred, open-label, randomized phase III study (PRIMA) comparing first-line maintenance treatment with RTX with observation only in 1,018 patients with previously untreated advanced fNHL. Median time to event (MTE) for the primary endpoint of progression-free survival (PFS) in the RTX arm was not estimable due to data immaturity; median PFS in the observation arm was 48.36 months. A statistically significant benefit of RTX maintenance therapy for PFS was reported (hazard ratio [HR] 0.55, 95 % CI 0.44–0.68; p > 0.0001). Statistically significant differences in favour of RTX were also reported for a range of secondary endpoints. Assessment of overall survival benefit could be not made due to insufficient events. The ERG’s main concern with the clinical-effectiveness data presented was their lack of maturity. The submitted incremental cost-effectiveness ratio was within the NICE threshold. The ERG questioned the model on a number of grounds, particularly the use of Markov methodology rather than patient simulations, the impact of patient age on the outcome and the projective PFS modelling. The ERG considered it impossible to draw firm conclusions regarding the clinical or cost effectiveness of the intervention as the dataset was as yet too immature. At a third meeting, the AC concluded that RTX could be recommended as first-line maintenance treatment for patients with fNHL whose disease has responded to induction R-CTX. Copyright The Author(s) 2013

Suggested Citation

  • Janette Greenhalgh & Adrian Bagust & Angela Boland & Michaela Blundell & James Oyee & Sophie Beale & Yenal Dundar & Juliet Hockenhull & Chris Proudlove & Patrick Chu, 2013. "Rituximab for the First-Line Maintenance Treatment of Follicular Non-Hodgkin’s Lymphoma," PharmacoEconomics, Springer, vol. 31(5), pages 403-413, May.
  • Handle: RePEc:spr:pharme:v:31:y:2013:i:5:p:403-413
    DOI: 10.1007/s40273-013-0043-8
    as

    Download full text from publisher

    File URL: http://hdl.handle.net/10.1007/s40273-013-0043-8
    Download Restriction: Access to full text is restricted to subscribers.

    File URL: https://libkey.io/10.1007/s40273-013-0043-8?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Jonathan Tosh & Rachel Archer & Sarah Davis & Matt Stevenson & John Stevens, 2013. "Golimumab for the Treatment of Rheumatoid Arthritis After the Failure of Previous Disease-Modifying Antirheumatic Drugs: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(8), pages 653-661, August.
    2. Huiqin Yang & Dawn Craig & David Epstein & Laura Bojke & Kate Light & Ian Bruce & Mark Sculpher & Nerys Woolacott, 2012. "Golimumab for the Treatment of Psoriatic Arthritis," PharmacoEconomics, Springer, vol. 30(4), pages 257-270, April.
    3. Rachid Rafia & Emma Simpson & Matt Stevenson & Diana Papaioannou, 2013. "Trabectedin for the Treatment of Advanced Metastatic Soft Tissue Sarcoma: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(6), pages 471-478, June.
    4. Ben Kearns & Myfanwy Lloyd Jones & Matt Stevenson & Chris Littlewood, 2013. "Cabazitaxel for the Second-Line Treatment of Metastatic Hormone-Refractory Prostate Cancer: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(6), pages 479-488, June.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Nigel Armstrong & Manuela Joore & Thea Asselt & Kate Misso & Nathan Manning & Florian Tomini & Jos Kleijnen & Rob Riemsma, 2013. "Golimumab for the Treatment of Ankylosing Spondylitis: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(5), pages 415-425, May.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Nigel Armstrong & Manuela Joore & Thea Asselt & Kate Misso & Nathan Manning & Florian Tomini & Jos Kleijnen & Rob Riemsma, 2013. "Golimumab for the Treatment of Ankylosing Spondylitis: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(5), pages 415-425, May.
    2. Ben Kearns & Myfanwy Lloyd Jones & Matt Stevenson & Chris Littlewood, 2013. "Cabazitaxel for the Second-Line Treatment of Metastatic Hormone-Refractory Prostate Cancer: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(6), pages 479-488, June.
    3. Rachid Rafia & Emma Simpson & Matt Stevenson & Diana Papaioannou, 2013. "Trabectedin for the Treatment of Advanced Metastatic Soft Tissue Sarcoma: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(6), pages 471-478, June.
    4. László Gulácsi & Fanni Rencz & Márta Péntek & Valentin Brodszky & Ruth Lopert & Noémi Hevér & Petra Baji, 2014. "Transferability of results of cost utility analyses for biologicals in inflammatory conditions for Central and Eastern European countries," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 15(1), pages 27-34, May.
    5. Nicholas Latimer & Christopher Carroll & Ruth Wong & Paul Tappenden & Michael Venning & Raashid Luqmani, 2014. "Rituximab in Combination with Corticosteroids for the Treatment of Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 32(12), pages 1171-1183, December.
    6. Lesley Uttley & Ben Kearns & Shijie Ren & Matt Stevenson, 2013. "Aripiprazole for the Treatment and Prevention of Acute Manic and Mixed Episodes in Bipolar I Disorder in Children and Adolescents: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(11), pages 981-990, November.
    7. Mary Kilonzo & Jenni Hislop & Andrew Elders & Cynthia Fraser & Donald Bissett & Samuel McClinton & Graham Mowatt & Luke Vale, 2013. "Pazopanib for the First-Line Treatment of Patients with Advanced and/or Metastatic Renal Cell Carcinoma," PharmacoEconomics, Springer, vol. 31(1), pages 15-24, January.
    8. Jane Burch & Susan Griffin & Claire McKenna & Simon Walker & James Paton & Kath Wright & Nerys Woolacott, 2012. "Omalizumab for the Treatment of Severe Persistent Allergic Asthma in Children Aged 6–11 Years," PharmacoEconomics, Springer, vol. 30(11), pages 991-1004, November.
    9. E. Simpson & P. Fitzgerald & P. Evans & P. Tappenden & N. Kalita & J. Reckless & A. Bakhai, 2013. "Bivalirudin for the Treatment of ST-Segment Elevation Myocardial Infarction: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(4), pages 269-275, April.
    10. Karen Smith & Su Golder & Abeed Sarker & Yoon Loke & Karen O’Connor & Graciela Gonzalez-Hernandez, 2018. "Methods to Compare Adverse Events in Twitter to FAERS, Drug Information Databases, and Systematic Reviews: Proof of Concept with Adalimumab," Drug Safety, Springer, vol. 41(12), pages 1397-1410, December.
    11. Sophie Whyte & Abdullah Pandor & Matt Stevenson, 2012. "Bevacizumab for Metastatic Colorectal Cancer," PharmacoEconomics, Springer, vol. 30(12), pages 1119-1132, December.
    12. Sophie Whyte & Abdullah Pandor & Matt Stevenson, 2012. "Bevacizumab for Metastatic Colorectal Cancer," PharmacoEconomics, Springer, vol. 30(12), pages 1119-1132, December.
    13. Eleftherios Sideris & Mark Corbett & Stephen Palmer & Nerys Woolacott & Laura Bojke, 2016. "The Clinical and Cost Effectiveness of Apremilast for Treating Active Psoriatic Arthritis: A Critique of the Evidence," PharmacoEconomics, Springer, vol. 34(11), pages 1101-1110, November.
    14. Jonathan Tosh & Rachel Archer & Sarah Davis & Matt Stevenson & John Stevens, 2013. "Golimumab for the Treatment of Rheumatoid Arthritis After the Failure of Previous Disease-Modifying Antirheumatic Drugs: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(8), pages 653-661, August.
    15. Eldon Spackman & Stephen Rice & Gill Norman & Dong-Churl Suh & Alison Eastwood & Stephen Palmer, 2013. "Trastuzumab for the Treatment of HER2-Positive Metastatic Gastric Cancer," PharmacoEconomics, Springer, vol. 31(3), pages 185-194, March.
    16. Laura Bojke & Andrea Manca & Miqdad Asaria & Ronan Mahon & Shijie Ren & Stephen Palmer, 2017. "How to Appropriately Extrapolate Costs and Utilities in Cost-Effectiveness Analysis," PharmacoEconomics, Springer, vol. 35(8), pages 767-776, August.
    17. Rita Faria & Eldon Spackman & Jane Burch & Belen Corbacho & Derick Todd & Chris Pepper & Nerys Woolacott & Stephen Palmer, 2013. "Dabigatran for the Prevention of Stroke and Systemic Embolism in Atrial Fibrillation: A NICE Single Technology Appraisal," PharmacoEconomics, Springer, vol. 31(7), pages 551-562, July.
    18. Afschin Gandjour & Dennis A. Ostwald, 2020. "Cost Effectiveness of Secukinumab Versus Other Biologics and Apremilast in the Treatment of Active Psoriatic Arthritis in Germany," Applied Health Economics and Health Policy, Springer, vol. 18(1), pages 109-125, February.
    19. Angelis, A. & Linch, M. & Montibeller, G. & Molina-Lopez, T. & Zawada, A. & Orzel, K. & Arickx, F. & Espin, J. & Kanavos, P., 2020. "Multiple Criteria Decision Analysis for HTA across four EU Member States: Piloting the Advance Value Framework," Social Science & Medicine, Elsevier, vol. 246(C).
    20. Joanne O’Connor & Stephen Rice & Alison Smith & Mark Rodgers & Rocio Rodriguez Lopez & Dawn Craig & Nerys Woolacott, 2016. "The Clinical and Cost Effectiveness of Ustekinumab for the Treatment of Psoriatic Arthritis: A Critique of the Evidence," PharmacoEconomics, Springer, vol. 34(4), pages 337-348, April.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:pharme:v:31:y:2013:i:5:p:403-413. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.