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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
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    References listed on IDEAS

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    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.
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    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.
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