PHARMACOECONOMIC ANALYSIS OF USING SOLIFENACIN AND MODIFIED-RELEASE TAMSULOSIN FIXED DOSE COMBINATION FOR TREATMENT OF STORAGE SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA Avxentyev N 1 , Frolov M 2 1 Research Institute of Finance, Moscow, Russian Federation 2 Volgograd State Medical University of the Ministry of Health, Russian Federation and Interregional Association of Clinical Pharmacologists, Volgograd, Russia PUK 5 ISPOR 20th Annual European Congress, Glasgow, Scotland, November 4-8 2017 This study was funded by Astellas Pharma, Inc. BACKGROUND Out of 1.37 million men in Russia with prostate diseases, approximately 1 million have storage symptoms associated with benign prostatic hyperplasia (BPH). Most of them are eligible for α-blockers monotherapy, but approximately 25 % (250,000) experience insufficient response to it [1]. Modern guidelines [2, 3] suggest treating these patients with combination of α-blockers and muscarinic receptor antagonists that are available as free or fixed-dose combination (FDC), but only 14 % (35,400) eligible patients received this combination free of charge through government drug provision program in 2015 (see figure 1). OBJECTIVES The aim of the current study is to analyse the budget impact of 2 nd line FDC treatment in patients with storage symptoms associated with BPH, who do not respond to 1st line tamsulosin monotherapy in Russia. METHODS We considered three 2 nd line therapy scenarios: 1) FDC of solifenacin 6 mg + tamsulosin 0.4 mg modified-release tablets; 2) free combination of solifenacin (5 mg) and tamsulosin (0.4 mg modified release capsules, MRC); 3) free combination of solifenacin (5 mg) and tamsulosin (0.4 mg prolonged-release tablets, PRT). We employed 1-year (52 1-week cycles) Markov model of storage symptoms associated with BPH (figure 2), as proposed in Nazir et al (2015) [4]. Briefly, all patients start in “no response” health state and can switch to “response” during first 12 weeks. The other option, available starting week 12, is to switch to 3 rd line drug therapy. Patients on 2 nd and 3 rd therapy lines can discontinue treatment and wait for the surgery, or cope with storage symptoms and withdraw treatment. Finally, patients can die from any health state according to 65 y. o. men national mortality rate. Cost of resource use, including drugs (solifenacin, tamsolusin and tolterodine – the latter was used in combination with tamsolusin for 3 rd line treatment), GP visits and prostate resection were considered. Adverse events costs were not taken into account because most of them do not require special treatment and (or) lead to drug discontinuation [5]. RESULTS FDC drug was cost saving, as the annual cost was $384 per patient, which is $35 less than the free combination involving MRC and $195 less when using free combination involving PRT. The overall healthcare annual expenses of using the FDC drug was $96 million or $9 million less than free combination with MRC ($49 million less than free combination with PRT). Government reimbursement costs for FDC were $10 million or $1 million less when using free combination with MRC ($7 million less when using free combination with PRT). CONCLUSIONS Using the FDC drug for treatment of patients with storage symptoms associated with BPH is a cost-saving alternative to the free combination of solifenacin and tamsulosin. REFERENCES 1. LMMG New Medicine Recommendation. Vesomni for the treatment of Storage Symptoms associated with Benign Prostatic Hyperplasia. URL: http://www.lancsmmg.nhs.uk/wp-content/uploads/sites/3/2014/05/ MR140303-VESOMNI-CSU-New-Medicine-Review-Final-Recommendation-following-LMMG_ WEBSITE.pdf 2. National Clinical Guideline Centre. The management of lower urinary tract symptoms in men. National Clinical Guideline Center, 2015. https://www.nice.org.uk/guidance/cg97 3. Oelke M. et al. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. European urology. 2013; 64 (1): 118-140. 4. Nazir, Jameel, et al. Cost-effectiveness of a fixed-dose combination of solifenacin and oral controlled adsorption system formulation of tamsulosin in men with lower urinary tract symptoms associated with benign prostatic hyperplasia. BMC urology 15.1 (2015): 41. 5. van Kerrebroeck, Philip, et al. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomized controlled NEPTUNE trial. European urology 64.6 (2013): 1003-1012. Table 1. Per patient cost of treatment, dollar per patient per year FDC Free combination of solifenacin and tamsulosin MRC Free combination of solifenacin and tamsulosin PRT Drug cost 297.24 332.53 492.28 FDC 281.92 0.00 0.00 Tamsulosin MRC 0.00 129.72 0.00 Tamsulosin PRT 7.61 0.00 289.48 Solifenacin 0.00 195.09 195.09 Tolterodine 7.71 7.71 7.71 Inpatient care 74.89 74.89 74.89 Outpatient care 11.87 11.87 11.87 Total 384.00 419.29 579.04 Table 2. Total costs of treatment, million dollars per year FDC Free combination of solifenacin and tamsulosin MRC Free combination of solifenacin and tamsulosin PRT Drug cost 74 83 123 Tamsulosin + solifenacin 72 81 121 incl. government drug reimbursement program 10 11 17 Tolterodine 2 2 2 Medical services 22 22 22 Outpatient care 3 3 3 Inpatient care 19 19 19 Total 96 105 145 Figure 1. Patients disposition in Russia Figure 2. Treatment pathway