Pharmacoeconomic and clinical implications of sequential therapy for metastatic renal cell carcinoma patients in Central and Eastern Europe

Figures & data

Table 1. Reimbursement of drugs for the treatment of mRCC in any line of therapy.

Country (n)	Reimbursed mRCC treatments
	Axitinib	Bevacizumab	Everolimus	IFN-α	IL-2	Pazopanib	Sorafenib	Sunitinib	Temsirolimus
Belarus (n = 2)	–	✓	✓	✓	✓	✓	✓	✓	✓
Bosnia and Herzegovina (n = 1)	–	–	✓	–	–	–	–	✓	–
Bulgaria* (n = 3)	✓	✓	✓	✓	–	✓	✓	✓	✓
Croatia (n = 2)	✓	–	✓		–	✓	✓	✓	✓
Czech Republic (n = 5)*	✓	✓	✓	✓	✓	✓	✓	✓	✓
Estonia (n = 3)	✓	✓	–	✓	–	✓	✓	✓	✓
Hungary* (n = 3)	✓	–	✓	✓	–	✓	✓	✓	✓
Kazakhstan* (n = 2)	–	✓	✓	✓	✓	✓	✓	✓	–
Latvia (n = 1)	–	–	–	✓	–	✓	–	–	–
Poland (n = 4)	✓	–	✓	✓	–	✓	✓	✓	–
Romania* (n = 2)	–	✓	–	✓	–	–	✓	✓	✓
Serbia (n = 1)*	–	–	–	–	–	–	–	✓*	–
Slovakia (n = 4)*^,‡	–^§	–	✓	✓	–	✓	✓	✓	✓
Slovenia (n = 2)	–	✓	✓	✓	–	✓	✓	✓	✓
Turkey (n = 5)	✓	–	✓	✓	✓	✓	✓	✓	✓

*Specific restrictions apply, including duration of previous lines of therapy (see Section 3.2 and Table 2).

^‡The use of all drugs for the treatment of mRCC must be discussed with the HIC representative and approval for the reimbursement of treatment obtained every 3 months.

^§Treatment costs are covered for a limited number of patients based on individual agreements with HICs.

HIC: Health insurance company; mRCC: Metastatic renal cell carcinoma.

Table 2. Restrictions on the reimbursement of everolimus, axitinib and sorafenib in second line (beyond regulatory approval).

		Belarus		Bosnia and Herzegovina	Bulgaria*		Croatia^‡		Czech Republic			Estonia		Hungary			Kazakhstan		Poland			Romania	Slovakia			Slovenia			Turkey
Drugs reimbursed in second line		E	S	E	E	S	E	S	A	E	S	A	S	A	E	S	E	S	A	E	S	S	A	E	S	E		S	A	E	S
Restrictions	Specific subpopulations only	✓	✓	✓	–	✓	–	–	✓	–	✓**	✓	✓	–	–	–	–	–	✓	✓	✓	–	✓^##	–	✓***	–	–		–	–	–
	Prior cytokine treatment required	–	–	–	–	–	–	–	–	–	✓	–	✓	–	–	✓	✓	–	–	–	✓^¶¶	✓	–	–	✓	–	–		✓	–	✓
	Good-/ intermediate-prognosis patients only	✓	✓	–	✓	✓	✓	✓	✓^§	–	✓^§	✓	✓	✓	✓	✓	✓	–	–	✓	–	–	–	–	–	–	–		–	–	–
	Based on first-line agent used	–	–	–	✓	✓	✓	–	✓	✓^#	✓^‡‡	–	✓	✓	✓	✓	✓	–	✓^§§	✓^§§	✓	–	–	✓	–	–	–		✓	✓	–
	Based on response to first-line therapy	–	–	–	–	–	–	–	✓	✓	✓	✓	–	✓	–	–	–	–	–	–	–	–	–	–	✓	✓	✓		✓	–	–
	Other restrictions	✓	–	–	–	–	✓	✓	✓^¶	✓	✓	–	✓	–	–	–	–	–	✓	✓	–	–	–	✓	✓	–	–		–	✓	–

*Expected reimbursement Q1 2015 for second line after progression with TKI therapy.

^‡Everolimus, restrictions: no brain metastases; AST and ALT < 5 times upper limit of normal, creatinine clearance ≥30 mL/min; sorafenib, restrictions: no brain metastases.

^§Axitinib and sorafenib only reimbursed in patients with ECOG performance status of 0 or 1 and no CNS metastases.

^¶Axitinib reimbursed only following treatment with sunitinib.

^#Everolimus reimbursed only following TKI therapy.

**Sorafenib reimbursed only following cytokine treatment if the patient is intolerant to sunitinib.

^‡‡Sorafenib reimbursed only following treatment with cytokines.

^§§Axitinib and everolimus reimbursed only following targeted treatment.

^¶¶Sorafenib reimbursed only after IFN.

^##Treatment costs are covered for a limited number of patients based on individual agreements with HICs.

***Officially only reimbursed after cytokines, but often approved by HIC representatives following targeted therapy because of decreasing use of cytokines.

A: Axitinib; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; E, Everolimus; ECOG: Eastern Cooperative Oncology Group; HIC: Health insurance company; S: Sorafenib; TKI: Tyrosine kinase inhibitor.

Table 3. Reimbursement for targeted agents for patients with mRCC in Russia.

	Essential drug program (ONLS)/additional medical supplies program (DLO)	OMI program	Regional reimbursement on patient request to the regional Ministry of Health
Axitinib	–	–	✓
Bevacizumab	✓	In some regions	✓
Everolimus	–	In some regions	✓
Pazopanib	–	In some regions	✓
Sorafenib	–	In some regions	–
Sunitinib	–	In some regions	✓
Temsirolimus	–	In some regions	–

OMI: Outpatient–inpatient; ONLS: Essential drug coverage program; mRCC: Metastatic renal cell carcinoma.