TKI and standard dose | ICD10 category and incidence | Indication of TKI, and percentage of relevant ICD10 group | Eligibility in terms of pathology, and percentage of incident cases with this subtype | Eligibility in terms of stage of disease, a percentage of incident cases at this stage | Total number newly eligible for indication, per year | Total number newly eligible for TKI, per year | Total API requirement per year, in tonnes, to meet incident demand |
---|---|---|---|---|---|---|---|
Imatinib 400 mg QD | Leukaemia (C91–95), 351 965 | Chronic myeloid leukaemia, 12.3% | Philadelphia chromosome positive, 87.5% | NA, 100% | 37 880 | 47 999 | 7.0 |
Leukaemia (C91–95), 351 965 | Acute lymphoblastic leukaemia, 11.5% | Philadelphia chromosome positive, 25% | NA, 100% | 10 119 | |||
Erlotinib 150 mg QD for NSCLC, 100 mg QD for pancreatic cancer | Trachea, bronchus and lung (C33–34), 1 824 701 | Non-small cell lung cancer, 85% | Proportion of patients for whom EGFR status can be evaluated and are EGFR positive, 14.6% | Advanced/metastatic, 83.5% | 189 082 | 442 486 | 19.6 |
Pancreatic cancer, 337 872 | Pancreatic cancer, 100% | All, 100% | Advanced/metastatic, 75% | 253 404 | |||
Sorafenib 400 mg BID | Kidney cancer, 337 860 | Renal cell carcinoma, 85% | All, 100% | Advanced/metastatic, 71.5% | 205 334 | 443 734 | 129.6 |
Liver cancer, 782 451 | Hepatocellular carcinoma, 87.5% | All, 100% | Advanced/metastatic, 30% | 205 393 | |||
Thyroid cancer, 298 102 | Thyroid carcinoma, 95% | Iodine-refractory, 66.6% | Advanced/metastatic, 17.5% | 33 007 | |||
Lapatinib 1500 mg QD | Breast cancer, 1 671 149 | Breast cancer, 100% | HER-2 positive, 12.5% | Advanced/metastatic, 33.5% | 69 979 | 69 979 | 38.3 |
Gastrointestinal stromal tumour, for which imatinib and sunitinib are indicated treatments in some cases, has not been included, due to its relative rarity, and the fact that it spans multiple ICD10 categories. References for figures used in this table can be found in online supplementary appendix 4.
API, active pharmaceutical ingredient; BID, two times a day; EGFR, epidermal growth factor receptor; ICD, International Classification of Diseases; NA, not applicable; NSCLC, non-small cell lung cancer; QD, daily; TKI, tyrosine kinase inhibitor.