Characteristics and Cost of Unscheduled Hospitalizations in Patients Treated with New Oral Anticancer Drugs in Germany: Evidence from the Randomized AMBORA Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Patients
2.2. Data Collection
2.3. Assessment of Drug-Related Problems
2.4. Assessment of Hospitalizations
2.5. Economic Data Collection and Analysis
2.6. Data Analysis SHI Collective (AOK Bayern)
2.7. Estimating the Potential Savings of Direct Hospital Cost by an Intensified Care Program as Provided in AMBORA
2.8. Statistical Analysis
3. Results
3.1. Patients within AMBORA
3.1.1. Characteristics of Hospitalizations within AMBORA
3.1.2. Oral Anticancer Drugs Associated with Hospitalizations in AMBORA
3.1.3. Adverse Drug Reactions Associated with Hospitalizations in AMBORA
3.2. Characteristics of Hospitalizations within the SHI Collective
3.3. Cost of OAT-Related Hospitalizations within AMBORA
3.4. Potential Savings within the SHI Collective
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic | No. (%) Total (n = 18) |
---|---|
Age, years (mean, range) | 67.8 (47–91) |
Female sex | 11 (61.1) |
Cancer type | |
Solid tumors | |
Breast | 3 (16.7) |
Soft tissue sarcoma | 3 (16.7) |
Small intestine | 2 (11.1) |
Others * | 4 (22.2) |
Hematologic malignancies | |
Acute myeloid leukemia | 2 (11.1) |
Mantle cell lymphoma | 2 (11.1) |
Multiple myeloma | 2 (11.1) |
ECOG performance status | |
0 | 4 (22.2) |
1 | 11 (61.1) |
2 | 2 (11.1) |
3 | 1 (5.6) |
Number of drugs + (median, range) | 9 (3–24) |
Oral anticancer drug | |
Protein kinase inhibitors | 13 (72.2) |
Pazopanib | 3 (16.7) |
Everolimus | 2 (11.1) |
Ibrutinib | 2 (11.1) |
Palbociclib | 2 (11.1) |
Cabozantinib | 1 (5.6) |
Lenvatinib | 1 (5.6) |
Midostaurin | 1 (5.6) |
Ribociclib | 1 (5.6) |
Antineoplastic agents | 3 (16.7) |
Niraparib | 1 (5.6) |
Tegafur, gimeracil, oteracil | 1 (5.6) |
Venetoclax | 1 (5.6) |
Immunomodulators | 2 (11.1) |
Lenalidomide | 2 (11.1) |
CTCAE Term | No. (%) Total (n = 18 Patients) | |
---|---|---|
Any Grade | Grade ≥ 3 | |
Total | 55 (100) | 41 (74.5) |
Blood count disorders | 19 (34.5) | 19 (46.3) |
Lymphocyte count decreased | 6 (10.9) | 6 (14.6) |
Neutrophil count decreased | 5 (9.1) | 5 (12.2) |
White blood cells decreased | 5 (9.1) | 5 (12.2) |
Anemia | 2 (3.6) | 2 (4.9) |
Platelet count decreased | 1 (1.8) | 1 (2.4) |
Gastrointestinal disorders | 17 (30.9) | 5 (12.2) |
Nausea | 3 (5.5) | 1 (2.4) |
Anorexia | 2 (3.6) | 0 (0) |
Diarrhea | 2 (3.6) | 1 (2.4) |
Mucositis oral | 2 (3.6) | 1 (2.4) |
Vomiting | 2 (3.6) | 1 (2.4) |
Anal mucositis | 1 (1.8) | 0 (0) |
Bloating | 1 (1.8) | 0 (0) |
Constipation | 1 (1.8) | 1 (2.4) |
Dysgeusia | 1 (1.8) | 0 (0) |
Gastroesophageal reflux disease | 1 (1.8) | 0 (0) |
Laryngeal mucositis | 1 (1.8) | 0 (0) |
Cardiovascular and lung disorders | 6 (10.9) | 6 (14.6) |
Dyspnea | 2 (3.6) | 2 (4.9) |
Hypertension | 2 (3.6) | 2 (4.9) |
Pleural effusion | 1 (1.8) | 1 (2.4) |
Pulmonary fibrosis | 1 (1.8) | 1 (2.4) |
Infections | 5 (9.1) | 4 (9.8) |
Anorectal infection | 1 (1.8) | 1 (2.4) |
Bronchial infection | 1 (1.8) | 1 (2.4) |
Fever | 1 (1.8) | 0 (0) |
Infections, other | 1 (1.8) | 1 (2.4) |
Sepsis | 1 (1.8) | 1 (2.4) |
Bleeding disorders | 3 (5.4) | 2 (4.9) |
Hematoma | 1 (1.8) | 1 (2.4) |
Lower gastrointestinal hemorrhage | 1 (1.8) | 1 (2.4) |
Oral hemorrhage # | 1 (1.8) | 0 (0) |
Organ failure | 2 (3.6) | 2 (4.9) |
Heart failure | 1 (1.8) | 1 (2.4) |
Hepatic failure | 1 (1.8) | 1 (2.4) |
Other adverse drug reactions | 3 (5.5) | 3 (7.3) |
Fatigue | 1 (1.8) | 1 (2.4) |
Hypokalemia | 1 (1.8) | 1 (2.4) |
Retinal detachment | 1 (1.8) | 1 (2.4) |
OAT * | No. | Hospitalization Rate, Normalized by Prescription Numbers (%) | |
---|---|---|---|
First Prescriptions | Emergency Hospitalizations | ||
Total (n = 8102) | Total (n = 2761) | 34.1 | |
KINASE INHIBITORS | 4333 | 1536 | 35.4 |
CDK4/6 inhibitors | 1058 | 255 | 24.1 |
Palbociclib | 776 | 167 | 21.5 |
Ribociclib | 229 | 69 | 30.1 |
Abemaciclib | 53 | 19 | 35.8 |
VEGFR inhibitors | 1016 | 509 | 50.1 |
Sorafenib | 191 | 100 | 52.4 |
Sunitinib | 170 | 83 | 48.8 |
Cabozantinib | 159 | 71 | 44.7 |
Other VEGFR inhibitors | 496 | 255 | 51.4 |
BCR-ABL inhibitors | 388 | 84 | 21.6 |
Imatinib | 197 | 47 | 23.9 |
Dasatinib | 79 | 17 | 21.5 |
Nilotinib | 74 | 14 | 18.9 |
Other BCR-ABL inhibitors | 38 | 6 | 15.8 |
EGFR inhibitors | 325 | 129 | 39.7 |
Osimertinib | 165 | 57 | 34.5 |
Afatinib | 84 | 41 | 48.8 |
Erlotinib | 49 | 27 | 55.1 |
Other EGFR inhibitors | 27 | 4 | 14.8 |
BRAF inhibitors | 250 | 109 | 43.6 |
Dabrafenib | 182 | 84 | 46.2 |
Vemurafenib | 38 | 12 | 31.6 |
Encorafenib | 30 | 13 | 43.3 |
MEK inhibitors | 241 | 110 | 45.6 |
Trametinib | 186 | 88 | 47.3 |
Binimetinib | 33 | 15 | 45.5 |
Cobimetinib | 22 | 7 | 31.8 |
ALK inhibitors | 153 | 61 | 39.9 |
Alectinib | 71 | 16 | 22.5 |
Crizotinib | 44 | 19 | 43.2 |
Lorlatinib | 15 | 11 | 73.3 |
Other ALK inhibitors | 23 | 15 | 65.2 |
Other kinase inhibitors | 902 | 279 | 30.9 |
Ibrutinib | 369 | 120 | 32.5 |
Ruxolitinib | 265 | 60 | 22.6 |
Everolimus | 174 | 69 | 39.7 |
Other kinase inhibitors | 94 | 30 | 31.9 |
HORMONE ANTAGONISTS | 1733 | 495 | 28.6 |
Abiraterone | 1048 | 291 | 27.8 |
Enzalutamide | 652 | 197 | 30.2 |
Apalutamide | 33 | 7 | 21.2 |
ANTI-NEOPLASTIC DRUGS | 1343 | 481 | 35.8 |
Antimetabolites | 262 | 123 | 46.9 |
Trifluridine | 256 | 122 | 47.7 |
Tegafur, gimeracil, oteracil | 6 | 1 | 16.7 |
PARP inhibitors | 220 | 51 | 23.2 |
Olaparib | 128 | 35 | 27.3 |
Niraparib | 87 | 14 | 16.1 |
Rucaparib | 5 | 2 | 40.0 |
Other anti-neoplastic drugs | 861 | 307 | 35.7 |
Temozolomide | 465 | 168 | 36.1 |
Anagrelide | 139 | 22 | 15.8 |
Venetoclax | 117 | 69 | 59.0 |
Other anti-neoplastic drugs | 140 | 48 | 34.3 |
IMMUNOMODULATORS | 693 | 249 | 35.9 |
Lenalidomide | 569 | 181 | 31.8 |
Pomalidomide | 107 | 57 | 53.3 |
Thalidomide | 17 | 11 | 64.7 |
Patient Characteristics | G-DRG Data | |||||
---|---|---|---|---|---|---|
Patient ID | OAT | Type of Adverse Drug Reaction(s) Related to Hospitalization | Length of Stay (Days) | G-DRG Code | G-DRG Name | G-DRG cost (EUR) |
Intervention Group | ||||||
1 | Palbociclib | Blood count disorder | 1 | Q63B | Aplastic anemia | 1176 |
2 | Ibrutinib | Bleeding disorder | 16 | R61A | Lymphoma and non-acute leukemia with sepsis or a certain complicating constellation | 17,024 |
3 | Lenali-domide | Infection, blood count disorders | 8 | I66B | Other connective tissue disorders | 7023 |
Total | 25,223 | |||||
Control group | ||||||
4 * | Niraparib | Gastrointestinal disorders | 3 | G67A | Esophagitis, gastroenteritis, gastrointestinal hemorrhage, ulcer disease, and various diseases of the digestive organs | 2500 |
Other disorders (hypokalemia) | 2 | L71Z | Renal failure | 1621 | ||
5 | Pazopanib | Other disorders (retinal detachment) | 9 | C03B | Interventions on the retina with pars plana vitrectomy, with extracapsular extraction of the lens (ECCE) | 4008 |
6 | Lenali-domide | Lung disorders | 9 | E74Z | Interstitial lung disease | 2834 |
7 * | Lenvatinib | Cardiovascular disorder | 2 | F67D | Hypertension without a complicated diagnosis | 1808 |
Bleeding disorder | 8 | D13B | Small operations on the nose, ears, mouth and throat without complicating the diagnosis | 2180 | ||
8 | Tegafur, gimeracil, oteracil | Gastrointestinal disorders | 9 | G60B | Malignant growth of the digestive organs | 2075 |
9 | Everolimus | Infection, gastrointestinal disorder | 2 | G71Z | Other moderately severe diseases of the digestive organs | 1990 |
10 | Cabozan-tinib | Organ failure | 9 | H61A | Malignant neoplasm of the hepatobiliary system and pancreas | 6409 |
11 | Ribociclib | Blood count disorders | 1 | J62B | Malignant neoplasms of the breast | 1491 |
12 | Palbociclib | Blood count disorders | 3 | Q60C | Diseases of the reticuloendothelial system, immune system and coagulation disorders with complex diagnosis | 2840 |
13 | Ibrutinib | Organ failure, lung disorders | 10 | R03Z | Lymphoma and leukemia with a specific OR procedure | 26,389 |
14 | Venetoclax | Infection, blood count disorders, gastrointestinal disorders | 12 | R60C | Acute myeloid leukemia with int. chemotherapy | 12,817 |
15 | Midostaurin | Infection, blood count disorders, gastrointestinal disorders | 9 | R60E | Acute myeloid leukemia with moderately complex chemotherapy | 5816 |
16 | Everolimus | Infection, blood count disorder | 2 | T60F | Sepsis, died <5 days after admission | 1951 |
17 | Pazopanib | Cardiovascular disorder | 1 | X62Z | Poisoning/Toxic Effects of Drugs, Medicines and Other Substances | 957 |
18 | Pazopanib | Gastrointestinal disorders, other disorders (fatigue) | 3 | G67A | Esophagitis, gastroenteritis, gastrointestinal hemorrhage, ulcer disease, and various diseases of the digestive organs | 2815 |
Total | 80,501 | |||||
Mean per patient ± SD | 6.0 ± 4.3 | 5873 ± 6612 |
Number of Patients | Absolute Risk (%) | |||
---|---|---|---|---|
OAT-Related Hospitalization | No OAT-Related Hospitalization | Total | ||
AMBORA collective | ||||
Intervention group Intensified pharmacological/ pharmaceutical care program | 3 | 95 | 98 | 3.06 |
Control group Standard of care | 15 | 89 | 104 | 14.42 |
SHI collective AOK Bayern | ||||
Scenario 1 Standard of care for all patients | 1025 | 6081 | 7106 | 14.42 |
Scenario 2 Intensified pharmacological/pharmaceutical care program for all patients | 217 | 6889 | 7106 | 3.06 |
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Dürr, P.; Meier, F.; Schlichtig, K.; Schramm, A.; Schötz, L.; Fromm, M.F.; Dörje, F. Characteristics and Cost of Unscheduled Hospitalizations in Patients Treated with New Oral Anticancer Drugs in Germany: Evidence from the Randomized AMBORA Trial. J. Clin. Med. 2022, 11, 6392. https://doi.org/10.3390/jcm11216392
Dürr P, Meier F, Schlichtig K, Schramm A, Schötz L, Fromm MF, Dörje F. Characteristics and Cost of Unscheduled Hospitalizations in Patients Treated with New Oral Anticancer Drugs in Germany: Evidence from the Randomized AMBORA Trial. Journal of Clinical Medicine. 2022; 11(21):6392. https://doi.org/10.3390/jcm11216392
Chicago/Turabian StyleDürr, Pauline, Florian Meier, Katja Schlichtig, Anja Schramm, Lukas Schötz, Martin F. Fromm, and Frank Dörje. 2022. "Characteristics and Cost of Unscheduled Hospitalizations in Patients Treated with New Oral Anticancer Drugs in Germany: Evidence from the Randomized AMBORA Trial" Journal of Clinical Medicine 11, no. 21: 6392. https://doi.org/10.3390/jcm11216392