Economic modeling to evaluate the impact of chronic myeloid leukemia therapy management on the oncology care model in the US

Abstract

Objective: To develop an economic model to evaluate changes in healthcare costs driven by restricting usage of branded tyrosine kinase inhibitors (TKIs) through substitution with generic imatinib among chronic myeloid leukemia (CML) patients in a typical Oncology Care Model (OCM) practice, and examine the impact on Performance-Based Payment (PBP) eligibility. Methods: An Excel-based economic model of an OCM practice with 1,000 cancer patients during a 6-month episode of care was developed. Cancer types and proportions of patients treated in the practice were estimated from an OCM report. All-cause healthcare costs were obtained from published literature. It was assumed that if a practice restricts usage of branded TKIs for newly-diagnosed CML patients, 80% of the market share of branded imatinib and 50% of the market shares of 2 nd-gen TKIs would shift to generic imatinib. Among established TKI-treated patients, it was assumed that 80% of the market share of branded imatinib and no patients treated with 2 nd-gen TKIs would shift to the generic. Results: Four CML patients were estimated for a 1,000-cancer patient OCM practice with a total baseline healthcare cost of $51,345,812 during a 6-month episode. If the practice restricts usage of branded TKIs, the shift from 2 nd-gen TKIs to generic imatinib would reduce costs by $12,970, while shifting from branded to generic imatinib lowers costs by $25,250 during a 6-month episode. Minimum reductions of $3,013,832 in a one-sided risk model and $2,372,010 in a two-sided risk model are required for PBP eligibility; the shift from 2 nd-gen TKIs to generic imatinib would account for 0.4% and 0.5% of the savings required for a PBP, respectively. Conclusions: This analysis indicates that the potential cost reduction associated with restricting branded TKI usage among CML patients in an OCM setting will represent only a small proportion of the cost reduction needed for PBP eligibility.

Chronic Myeloid Leukemia Prognosis and Therapy: Criticisms and Perspectives

“…Several criticisms persist, and the most relevant one is the sustainability of long-term therapy with TKIs in terms of compliance, toxicity and costs [ 19 , 24 ].…”

“…Furthermore, considering that the cost of TKI therapy/year may range from 10,000 to 42,000 Euros, we can easily understand the huge amount of money that the National Healthcare Systems have to sustain for many years [ 24 ].…”

Current evidence on the efficacy and safety of generic imatinib in CML and the impact of generics on health care costs

“…42 There are some papers exploring the potential impact of generic imatinib use on health care costs among CML patients. [42][43][44][45][46][47] In 2015, just before the introduction of generic imatinib in the United States, Bloudek et al 43 developed a model for the estimation of reduced treatment costs with generic imatinib. Among a hypothetical 1 million members of commercial and Medicare plans, calculated numbers of patients receiving any TKIs in 1 year were 103 and 347 for commercial and Medicare plans, respectively.…”

“…A similar economic model of an oncology care model practice with 1000 cancer patients during a 6-month period was developed. 47 Four CML patients were estimated for that 1000-cancer patient oncology care model practice, and the changes in costs associated with substitution of branded imatinib and 2GTKIs (dasatinib and nilotinib) with generic imatinib in CML patients were analyzed. If the use of branded TKIs was restricted, in a 6-month episode, there would be a total reduction of $38 220 in health care costs, and $25 250 of this net cost reduction would come from a branded to generic imatinib shift.…”

“…If the use of branded TKIs was restricted, in a 6-month episode, there would be a total reduction of $38 220 in health care costs, and $25 250 of this net cost reduction would come from a branded to generic imatinib shift. 47 The first generic drug manufacturer to submit an abbreviated new drug application, which challenges to the patent of brand-name drug and meets certain regulatory and legal requirements may be eligible for a 180-day exclusivity. 48 During that period, the Hatch-Waxman Act gives temporary protection to the first generic manufacturer to sell the only generic in the market before the patent expiration of brand-name drug and other companies producing generic versions of the drug.…”