Budget Impact Analysis of Fixed Dose Versus Weight-Based Dosing Regimen of Nivolumab and Pembrolizumab in the Treatment of Non-Small Cell Lung Cancer
Abstract
:1. Introduction
1.1. Economic Impact
1.2. New Dosage Strategy
2. Materials and Methods
2.1. Methodological Overview
2.2. Database
- -
- the number of patients treated with each drug according to the treatment line,
- -
- the number of cures received per year per patient,
- -
- the average number of cures received per year by all patients treated.
2.3. Time Horizon
2.4. Target Population
- ▪
- in 1st line, patients treated with pembrolizumab as monotherapy indicated for metastatic NSCLC in adults whose tumors express PD-L1 with a ≥ 50% tumor proportion score (TPS), with no EGFR or ALK positive tumor mutations.
- ▪
- in 2nd line, patients included were:
- ◦
- patients treated with nivolumab, as monotherapy for the treatment of locally advanced or metastatic NSCLC, without scoring condition,
- ◦
- patients treated with pembrolizumab as monotherapy for the treatment of locally advanced or metastatic NSCLC in adults whose tumors express PD-L1 with a TPS greater than or equal to 1%.
- ▪
- In the first line, due to an altered general condition, an advanced age of the patients or the presence of comorbidities, the HAS, in its opinion, considers that around 80% of patients will receive treatment. In addition, in the first line, the number of patients likely to benefit from pembrolizumab is low due to tumor overexpression of PD-L1 ≥ 50%. Among the patients included in the pivotal Keynote 024 study [28], approximately 25% had a PD-L1 status ≥ 50%. More conservatively, in this study, we assumed that 20% of patients have a PD-L1 status ≥ 50%. Those 20% patients are then potentially affected by a prescription for pembrolizumab.
- ▪
- In the 2nd line, in its opinion, the HAS estimates that among the patients treated in the first line, only 40% of patients will be eligible for a new treatment. However, with regard to treatment with ICI, which is theoretically better tolerated than treatment with chemotherapy, it is assumed that 50% of patients will be eligible for second-line treatment. In addition, we assume that patients who received first-line treatment with ICI will not be eligible for a new immunotherapy treatment even if there are no data on the prescription of ICI in the 2nd line. Finally, among the patients still to be treated in the 2nd line, the number of patients likely to benefit from nivolumab and/or pembrolizumab is estimated at 100% due to the fact that nivolumab prescription does not depend on PD-L1 status.
2.5. Evolution of the Analysis Population between 2018 and 2019
2.6. Cost of Nivolumab and Pembrolizumab
2.7. Patients’ Weight
2.8. Duration of Treatment
2.9. Scenarios
2.10. Sensitivity Analyses
3. Results
4. Discussion
Comparison with the Literature
- ▪
- For the largest centers, regroup patients receiving nivolumab visits over a few targeted days each week in order to be able to use the rest of each vial for the next patient.
- ▪
- In centers with a smaller volume of patients, the use of dose standardization (dose-banding) up to a maximum dose is proposed. In the PGTM model, the standard doses are rounded to the nearest 20 mg, unless this exceeds 5% of the difference from the dose he or she would have received based on his or her weight (3 mg/kg), in which case, they increase to the higher dose (rounded up to the next 20 mg), up to a maximum of 240 mg.
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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Year | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 |
---|---|---|---|---|---|---|---|
Number of patients | 6981 | 7036 | 7207 | 7351 | 7574 | 7449 | 7642 |
Growth rates | +0.8% | +2.4% | +2.0% | +3.0% | −1.7% | 2.6% |
Pembrolizumab | Nivolumab | |
---|---|---|
2018 (PMSI data) | ||
Avicenne Hospital | 20 | 84 |
Ile-de-France | 261 | 1876 |
2019 (projection after application of population change rate) | ||
Avicenne Hospital | 20 * | 85 * |
Ile-de-France | 265 * | 1904 * |
Posology A | Weight (kg) B | Total (mg) C = A × B | Price (All Taxes Included)/mg D | Cost per Administration C × D | Number of Cycles E | Treatment Cost per Patient (C × D) × E |
---|---|---|---|---|---|---|
Pembrolizumab | ||||||
2 mg/kg | 68 | 136 | €26.84 * | €3650 | 10.5 | €38,325 |
200 mg | 68 | 200 | €26.84 * | €5368 | 10.5 | €56,364 |
Posology A | Weight (kg) B | Total (mg) C = A × B | Price (All Taxes Included)/mg D | Cost per Administration C × D | Number of Cycles E | Treatment Cost per Patient (C × D) × E |
---|---|---|---|---|---|---|
Nivolumab | ||||||
3 mg/kg | 68 | 204 | €10.58 * | €2158 | 8.5 | €18,343 |
240 mg | 68 | 240 | €10.58 * | €2539 | 8.5 | €21,582 |
Pembrolizumab | ||||||
2 mg/kg | 68 | 136 | €26.84 * | €3650 | 4.9 | €17,885 |
200 mg | 68 | 200 | €26.84 * | €5368 | 4.9 | €26,303 |
ICI | Nivolumab | Pembrolizumab | |
---|---|---|---|
1st Line | 2nd Line | ||
Cost of Weight-based dose | €18,343 | €38,325 | €17,885 |
Cost of fixed dose | €21,582 | €56,364 | €26,303 |
Additional treatment cost per year and per patient | €3239 | €18,039 | €8418 |
Nivolumab | 2018 | 2019 | |
---|---|---|---|
Low Hypothesis | High Hypothesis | ||
Avicenne Hospital | €272,076 | €277,032 | €152,215 |
Ile-de-France | €6,076,364 | €5,948,192 | €3,268,238 |
Pembrolizumab (1st line + 2nd line) | 2018 | 2019 | |
Low hypothesis | High hypothesis | ||
Avicenne Hospital | €278,039 | €279,937 | €604,329 |
Ile-de-France | €3,628,414 | €4,252,835 | €11,217,904 |
Nivolumab + Pembrolizumab | 2018 | 2019 | |
---|---|---|---|
Low Hypothesis | High Hypothesis | ||
Avicenne Hospital | €550,115 | €556,969 | €756,544 |
Ile-de-France | €9,704,778 | €10,201,027 | €14,486,141 |
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Monirul, S.; Rigal, M.; Chouahnia, K.; Le Jouan, M.; Apparuit, M.; Paix, A.; Jacolot, A.; Zelek, L.; Duchemann, B. Budget Impact Analysis of Fixed Dose Versus Weight-Based Dosing Regimen of Nivolumab and Pembrolizumab in the Treatment of Non-Small Cell Lung Cancer. Vaccines 2020, 8, 730. https://doi.org/10.3390/vaccines8040730
Monirul S, Rigal M, Chouahnia K, Le Jouan M, Apparuit M, Paix A, Jacolot A, Zelek L, Duchemann B. Budget Impact Analysis of Fixed Dose Versus Weight-Based Dosing Regimen of Nivolumab and Pembrolizumab in the Treatment of Non-Small Cell Lung Cancer. Vaccines. 2020; 8(4):730. https://doi.org/10.3390/vaccines8040730
Chicago/Turabian StyleMonirul, Sanjana, Marthe Rigal, Kader Chouahnia, Mélisande Le Jouan, Maxime Apparuit, Adrien Paix, Anne Jacolot, Laurent Zelek, and Boris Duchemann. 2020. "Budget Impact Analysis of Fixed Dose Versus Weight-Based Dosing Regimen of Nivolumab and Pembrolizumab in the Treatment of Non-Small Cell Lung Cancer" Vaccines 8, no. 4: 730. https://doi.org/10.3390/vaccines8040730