In an open-label, phase III study, ibrutinib significantly increased progression-free survival compared with an anti-CD20 antibody in patients with relapsed or refractory CLL. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ibrutinib.
Full Answer
Is ibrutinib a single agent for leukaemia?
The treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy. SMC published advice in August 2016 that ibrutinib was accepted for restricted use as a single agent for patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy (SMC 1151/16).
Is Ibrutinib (Imbruvica®) approved in Scotland?
following a resubmission assessed under the end of life and orphan medicine process: ibrutinib (Imbruvica®) is accepted for restricted use within NHS Scotland. Indication under review: the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Should ibrutinib be used to treat patients with TP53 mutations?
SMC published advice in August 2016 that ibrutinib was accepted for restricted use as a single agent for patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy (SMC 1151/16). This advice remains valid.
Is ibrutinib available on NHS?
NHS England have since assessed new evidence and are now making ibrutinib available on the NHS for people who relapse after previous treatment, even if they had a long remission.
How do I pay for ibrutinib?
If you have commercial insurance, you may be eligible to pay as little as $0 per prescription of IMBRUVICA® with the IMBRUVICA® Copay Card. You may have insurance coverage through the federal government or the state where you live. Common plans include Medicare, Medicare Part D, Medicaid, VA, and TRICARE.
How long can you survive ibrutinib?
The average duration of Imbruvica therapy in clinical trials has been around 41 months (range, 2–51 months). In people who have stopped Imbruvica, the average survival after treatment discontinuation was 8 months.
Is Imbruvica covered by Medicare Part B?
Yes. 100% of Medicare prescription drug plans cover this drug.
How much does ibrutinib cost in the UK?
The list price for a single tablet of ibrutinib (140 mg) is £51.10 (excluding VAT; British national formulary [BNF] online, accessed February 2016). The cost of a year's course of ibrutinib treatment is £55,954.50 (excluding VAT). The company has agreed a patient access scheme with the Department of Health.
What tier is ibrutinib?
Medicare prescription drug plans typically list Imbruvica on Tier 5 of their formulary. Generally, the higher the tier, the more you have to pay for the medication.
What happens when you stop ibrutinib?
Stopping ibrutinib can result in a disease flare-up in patients with chronic lymphocytic leukemia (CLL). A 2020 study in The Oncologist found that approximately 25% of ibrutinib patients with a median interruption period of 8 days experienced a flare or rapid CLL progression.
What comes after ibrutinib?
The most promising treatment option for ibrutinib-resistant patients is venetoclax, a BCL2 inhibitor, which was approved by the U.S. Food and Drug Administration (FDA) in June 2018 for all patients with previously treated CLL, regardless of del17p status – expanding on its initial approval for only patients who ...
Can ibrutinib cause death?
What are the possible side effects of IMBRUVICA®? IMBRUVICA® may cause serious side effects, including: Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA®, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine.
What is the average cost of Imbruvica?
Official answer. Imbruvica costs $484 per capsule/tablet regardless of the strength (70mg, 140mg, 280mg, 420mg, 560mg). This works out to $13,546 for a supply of 28 tablets/capsules. However, most people will not have to pay this much because most insurance plans and Medicare cover the cost of this medicine.
Is there a generic for Ibrutinib?
There is currently no therapeutically equivalent version of Imbruvica available in the United States. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Imbruvica.
When does Imbruvica patent expire?
Pharmacyclics owns the Imbruvica patents — the last of which is slated to expire in 2036 — and licenses them exclusively to Janssen.
How much does Ibrutinib cost in Canada?
Ibrutinib costs $90.65 per tablet of 140 mg. At the recommended dose of 420 mg, the daily cost of ibrutinib is $271.95.
When is Imbruvica generic?
In a recent SEC filing, AbbVie said that “no generic entry for any Imbruvica product is expected prior to March 30, 2032,” thanks to prior settlements with generic makers.
How much does Zanubrutinib cost?
On Friday, BeiGene priced its drug zanubrutinib (Brukinsa), a mantle cell lymphoma (MCL) treatment, at $12,935 for a 30-day supply, Reuters reported. According to the article, the FDA on Thursday granted accelerated approval to zanubrutinib for adult patients with previously-treated MCL.
Is Imbruvica a chemo pill?
Ibrutinib is not a chemotherapy drug but one of what are termed "targeted therapies." Targeted therapy is the result of years of research dedicated to understanding the differences between cancer cells and normal cells.
Funding & Reimbursement
Several payment sources exist for cancer drugs in Ontario, depending on the drug, disease indication, and how and where it is delivered.
Symptom Management
Many people living with cancer experience nausea, diarrhea and other symptoms from their treatment or disease.
Abstract
As part of its Single Technology Appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer of ibrutinib (Janssen) to submit evidence on the clinical and cost effectiveness of ibrutinib for treating Waldenström’s macroglobulinaemia (WM).
Introduction
Health technologies must be shown to be clinically effective and to represent a cost-effective use of resources to be recommended for use within the National Health Service (NHS) in England.
Decision Problem
WM is an incurable lymphoproliferative B cell disorder characterised by infiltration of lymphoplasmacytic cells into the bone marrow and immunoglobulin (Ig) M monoclonal gammopathy [ 6 ].
Independent Evidence Review Group (ERG) Review
The company (Janssen) provided a submission to NICE on the clinical and cost effectiveness of ibrutinib for treating WM [ 8 ]. This submission was critically appraised by the ERG. Subsequently, the ERG identified areas requiring clarification, for which the company provided additional evidence prior to completion of the ERG report [ 12 ].
Methodological Issues
The principal uncertainties relate to the absence of any head-to-head randomised evidence through which to estimate the benefits of ibrutinib on clinically meaningful outcomes, and the potential for bias and confounding in the company’s indirect comparison of PFS outcomes.
National Institute for Health and Care Excellence (NICE) Guidance
The AC reviewed the data available on the clinical and cost effectiveness of ibrutinib, having considered evidence on the nature of WM and the value placed on the benefits of ibrutinib by people with the condition, those who represent them, and clinical experts. It also took into account the effective use of NHS resources.
Ethics declarations
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (Project No. 15/148/03) [see the HTA programme website for further project information; http://www.hta.ac.uk ]. This summary of the ERG report was compiled after NICE issued the FAD.
Abstract
As part of its Single Technology Appraisal process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer of ibrutinib (Janssen) to submit evidence on the clinical effectiveness and cost effectiveness of ibrutinib for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL).
Introduction
Health technologies must be shown to be clinically effective and to represent a cost-effective use of resources to be recommended for use within the National Health Service (NHS) in England.
The Decision Problem
Mantle cell lymphoma is a B-cell malignancy with unique biological, pathological and clinical features that accounts for approximately 3–10% of all non-Hodgkin lymphomas (NHLs). MCL typically arises in older adults, with a median age of presentation between 60 and 65 years of age. Approximately 75% of patients with MCL are male.
Independent Evidence Review Group (ERG) Review
The company (Janssen) provided a submission to NICE on the clinical effectiveness and cost effectiveness of ibrutinib for the treatment of R/R MCL [ 6 ]. The ERG critically appraised this submission and identified areas requiring clarification, for which the company provided additional evidence prior to completion of the ERG report [ 10 ].
Methodological Issues
The ERG noted problems relating to the robustness of the indirect comparison for OS.
National Institute for Health and Care Excellence (NICE) Guidance
The AC reviewed the data available on the clinical and cost effectiveness of ibrutinib, having considered evidence on the nature of R/R MCL and the value placed on the benefits of ibrutinib by people with the condition, those who represent them and clinical experts. It also took into account the effective use of NHS resources.
Author information
Paul Tappenden, Emma Simpson, Jean Hamilton, Daniel Pollard, Mark Clowes & Eva Kaltenthaler
Clinical Evidence Submitted by The Company
- The CS identified one relevant single-arm study, Study 1118E [13], in which 63 previously treated adult patients with WM from three sites in the US were allocated to receive ibrutinib at a dose of 420 mg/day. Treatment was administered for a median of 19.1 months (range 0.5–29.7), and 43/63 patients (68%) remained on treatment after the final data cut-off (DCO) of 19 December 2…
Critique of Clinical Effectiveness Evidence and Interpretation
- The ERG considered the company’s reviews of clinical efficacy and safety evidence to be poorly reported and noted a lack of high-quality evidence. There were no randomised controlled trials (RCTs) or non-RCTs of ibrutinib in the relevant populations listed in the NICE scope [11]. The clinical evidence consisted of one phase II, single-arm, open-label study of ibrutinib in adult patie…
Cost-Effectiveness Evidence Submitted by The Company
- The company’s health economic model adopted a sequence-based Markov approach to estimate the health outcomes and costs for ibrutinib versus rituximab/chemotherapy for patients with R/R WM from the perspective of the NHS and Personal Social Services (PSS) over a 30-year (lifetime) horizon. The model included five health states: (1) second-line progr...
Additional Work Undertaken by The Erg
- The ERG undertook ten sets of exploratory analyses. These analyses explored the impact of correcting the drug acquisition and follow-up costs, the use of alternative PFS treatment effect estimates, the use of observed pre-progression mortality rates for ibrutinib from Study 1118E, the removal of all assumed survival gains, the use of a Weibull distribution for pre-progression morta…
Conclusion of The Erg Report
- The absence of any head-to-head RCT evidence for ibrutinib versus standard therapies and concerns regarding the company’s adjusted arm-based indirect comparison result in considerable uncertainty surrounding the clinical benefits of ibrutinib for the treatment of WM. Given the weaknesses in the company’s model and the evidence used to inform it, the true ICER for ibrutin…
Clinical Evidence Submitted by The Company
- Clinical-effectiveness data were taken from three studies: one randomised controlled trial (RCT) [RAY (MCL3001)] and two single-arm studies [PCYC1104 and SPARK (MCL2001)] [11,12,13]. One additional study of temsirolimus versus physicians’ choice of therapy (the OPTIMAL study [14]) was included in an indirect comparison of ibrutinib versus single-agent chemotherapy. At the tim…
Critique of Clinical-Effectiveness Evidence and Interpretation
- The ERG believed that all relevant studies had been included in the CS [6]. The studies presented were relevant to the population, intervention and outcomes of the decision problem. The CS did not identify any RCTs that included head-to-head comparisons of ibrutinib versus any of the comparators listed in the final NICE scope [9]. Temsirolimus, the comparator in the RAY trial, is …
Cost-Effectiveness Evidence Submitted by The Company
- The company submitted a de novo health economic model that assessed the cost effectiveness of ibrutinib versus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone) for the treatment of patients with R/R MCL over a 15-year (lifetime) horizon from the perspective of the UK NHS and Personal Social Services (PSS). Costs and h...
Additional Work Undertaken by The Erg
- The ERG undertook two sets of exploratory analyses: ‘Set A’ and ‘Set B’. Exploratory analysis Set A was undertaken using the company’s Markov model. The ERG’s preferred analysis involved using the HR for PFS derived from the ERG’s random effects NMA, applying the observed Kaplan–Meier curve for TTD/D for the ibrutinib group and truncating the R-chemo disutility follow…
Conclusion of The Erg Report
- As R/R MCL is a relatively rare disease, few real-world data are available. Only three studies of ibrutinib in patients with R/R MCL were identified, and these did not reflect treatment pathways relevant to current clinical practice in England. Based on the ERG’s additional analyses, ibrutinib was associated with a slower rate of disease progression than R-chemo (random effects HR 0.2…