Correspondence to: Douglas A. Abstract Background Non-Hodgkin lymphoma nhl is the most common hematologic malignancy.
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Correspondence to: Douglas A. Abstract Background Non-Hodgkin lymphoma nhl is the most common hematologic malignancy. Relative to intravenous IV rituximab, a subcutaneous sc formulation approved in has comparable pharmacokinetics, efficacy, and safety, and a greatly reduced administration time; it is also preferred by patients.
The objective of the present study was to estimate the effect on systemic therapy suite time and on the costs of drug acquisition and administration of implementing sc rituximab in the initial chemoimmunotherapy for fl and dlbcl over 3 years in the Canadian market. Key parameters and sensitivity analysis values were validated by clinical experts located in various Canadian jurisdictions.
Costs are reported in Canadian dollars from the perspective of the health care system. Sensitivity analyses suggest that the model is most sensitive to sc market uptake, number of induction therapy cycles, and eligible patients.
Conclusions Subcutaneous administration of rituximab can significantly reduce systemic therapy suite time and achieve substantial savings in drug and administration costs.
In Canada, the standard treatment for dlbcl is rituximab—chop cyclophosphamide—doxorubicin—vincristine—prednisone for 6 cycles, without rituximab maintenance. For fl, patients receive 6 cycles of rituximab—bendamustine [or 6—8 cycles of rituximab—cvp cyclophosphamide—vincristine—prednisone ], followed by 8 cycles of rituximab maintenance therapy given every 3 months, except in Quebec, where rituximab maintenance is not used after rituximab—bendamustine.
Studies have demonstrated that patients receiving IV rituximab in addition to chemotherapy not only experience improved progression-free survival, but also superior overall survival 5 — 7. The preparation and administration of IV rituximab is resource-intensive, requiring 2—6 hours to calculate the appropriate dose based on body surface area bsa , to prepare fluids, and to titrate and administer the infusion 4 , 8 — 10 —all of which occur in addition to the preparation and administration time associated with chemotherapy treatment, which is administered sequentially.
Recently, a subcutaneous sc formulation of rituximab was approved by Health Canada for use in dlbcl and fl The sc formulation has the same active ingredient as IV rituximab, but it has been concentrated to one twelfth of the IV format, with the enzyme recombinant human hyaluronidase acting as a permeation enhancer, increasing dispersion and absorption to support administration of the rituximab in high volume 4 , 8 , After one initial IV administration of rituximab is tolerated, sc rituximab administered as a fixed dose provides an alternative to the IV formulation in dlbcl and fl, as currently used in rituximab-containing regimens.
The sc administration of rituximab takes significantly less time than IV administration 9 , 13 ; however, to monitor for side effects, administration must still occur in a systemic therapy suite Nevertheless, sc rituximab simplifies administration and reduces the treatment burden both for patients and for already constrained health care resources, including systemic therapy suite time.
Phase i—iii studies comparing sc with IV rituximab for fl and dlbcl have demonstrated similar pharmacokinetics, similarity in rates of overall response and complete response cr or unconfirmed cr, and similar safety profiles with the exception of an increase in mild, but expected, local injection site reactions for sc rituximab 9 , 13 , Large proportions of nurses A decision to administer sc rituximab therefore has the potential to reduce the overall burden on systemic therapy suites, making that valuable and constrained health care system resource available for the treatment of other patients while maintaining the safety and effectiveness of rituximab treatment and improving patient satisfaction 8.
Making this change in administration format, with its reduced use of systemic therapy suites, is also expected to lower the cost to the health care system.
To date, several provinces in Canada have begun using the sc formulation; others are considering its use. In Quebec, the sc formulation is not being implemented at this time 14 , and IV administration of rituximab for all patients is assumed for Quebec in the present analysis. The findings from this study will support clinicians and health care administrators as they consider whether to implement sc rituximab into their clinical processes.
METHODS Using a health care system perspective, the impact on systemic therapy suite time, rituximab acquisition, and administration costs of providing sc rituximab were estimated. Year 1 of the 3-year analysis was assumed to begin January Key input parameters of the model were based on literature and chart review data and were validated by the clinical authors of this paper DAS, RF, JSB and by therapeutic-area experts taes located in three distinct jurisdictions of Canada Ontario, Alberta, and Quebec.
The chart review included charts collected from several provinces across Canada, including Ontario, Quebec, British Columbia, and several of the Atlantic provinces. National estimates were determined by weighting the data collected from the various provinces to reflect their expected proportional contribution according to Canadian Cancer Statistics 1.
The expert clinicians, working primarily in oncology settings, validated the appropriateness of the chart review and best-available-literature estimates to reflect Canadian practice. Sensitivity analyses sas for key parameters were conducted to reflect variations in province-specific estimates. Costs are reported in Canadian dollars. Key Parameters Population and Market Assumptions The target population incident patients with dlbcl or fl , corresponding to the clinical indication for rituximab in Canada 11 , was estimated using an epidemiologic approach, assuming that the sc formulation would be adopted where IV rituximab is currently used.
A Canadian-specific nhl incidence rate from the Canadian Cancer Society 1 of Table i summarizes the eligible Canadian-wide population of dlbcl and fl patients receiving rituximab for years —
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