Tesis

Analisa Efektivitas dan Biaya Dual Anti Platelet Ticagrelor – Aspirin Dibandingkan Klopidogrel – Aspirin Pada Pasien Sindrom Koroner Akut Di RSUPN Cipto Mangunkusumo Periode 2014 – 2016 = Cost Effectiveness Analysis Dual Anti Platelet Ticagrelor – Aspirin Versus Clopidogrel – Aspirin in Patients With Acute Coronary Syndrome in dr Cipto Mangunkusumo Hospital during 2014 – 2016.

Pendahuluan: Jumlah pasien Sindrom Koroner Akut (SKA) semakin meningkat dari tahun ke tahun. Ticagrelor merupakan penghambat P2Y12 dengan onset cepat dan efek hambatan platelet lebih besar dibandingkan klopidogrel, namun memiliki masalah meningkatnya efek samping perdarahan mayor, efek samping lain, dan biaya yang lebih mahal. Penelitian ini bertujuan melakukan evaluasi efektifitas, keamanan, dan cost effectiveness analysis ticagrelor dibandingkan klopidogrel add on aspirin pada pasien SKA sejak tahun 2014-2016 di RSUPN Cipto Mangunkusumo. Metode: Penelitian ini menggunakan design kohort retrospektif. Rekam medis dari pasien SKA yang pertama kali didiagnosa dan diterapi dengan klopidogrel dan pasien SKA yang pertama kali didiagnosa dan diterapi dengan ticagrelor dimasukkan kedalam kriteria inklusi. Outcome efektivitas adalah insiden major adverse cardiovascular events (MACE) yang dapat dicegah dalam 3, 6, 9, dan 12 bulan. Outcome safety adalah insiden efek samping yang timbul dalam 3 bulan.Outcome biaya dinilai dengan cost effectiveness analysis (CEA). Data untuk CEA disajikan dalam bentuk incremental cost effectiveness ratio (ICER). Untuk menilai ketidakpastian data (uncertainty) digunakan analisa sensitivitas satu arah. Hasil: Rekam medis dari 123 pasien klopidogrel-aspirin dan 57 pasien ticagrelor-aspirin berhasil dievaluasi. Trend pemakaian ticagrelor semakin meningkat sejak tahun 2014 sampai dengan 2016, sedangkan klopidogrel semakin menurun. Outcome efektivitas adalah MACE yang dapat dicegah dalam 3 bulan. Dalam 3 bulan MACE terjadi pada 15.8% pasien di kelompok ticagrelor dan 31.7% pasien di kelompok klopidogrel (RR; 0,498, 95% CI; 0,259 –0,957, P = 0,039). Tidak ada perbedaan signifikan pada bulan ke 6,9, dan 12. Ticagrelor memiliki efek samping perdarahan mayor (melena) lebih tinggi dibanding klopidogrel (5,3% vs 1,62%, P = 0,681), terutama pada pasien geriatri. ICER = Rp 279.438,87., dengan pengertian diperlukan tambahan biaya Rp 279.438,87., untuk setiap insiden MACE yang dapat dihindari dalam 3 bulan jika digunakan ticagrelor sebagai DAPT. ICER tersebut dianggap cost effective karena berada dibawah 1 GDP (Gross Domestic Product) Indonesia tahun 2016, yaitu $3603 (Rp 49.000.800). Kesimpulan: Ticagrelor-aspirin lebih efektif dan lebih cost-effective dalam mencegah MACE dalam 3 bulan dibandingkan klopidogrel-aspirin pada pasien SKA. Masih diperlukan penelitian prospektif lanjutan dengan jumlah besar terutama pada pasien geriatri dengan SKA.
Kata Kunci: Ticagrelor, Klopidogrel, Dual Antiplatelet Therapy, Cost Effectiveness Analysis


Introduction: The enormous number of acute coronary syndrome (ACS) cases make it important to evaluate the economic burden of this illness. Ticagrelor is a P2Y12 inhibitor with pronounced platelet inhibition effect and more rapid onset compared to clopidogrel, with disadvantages of higher price and major bleeding adverse effects. This study aimed to evaluate effectiveness, safety, and cost-effectiveness analysis of dual antiplatelet aspirin-ticagrelor compared with aspirin-clopidogrel at ACS patients in Cipto Mangunkusumo Hospital during 2014-2016 Methods: This is a retrospective cohort study from data records of ACS patient treated in Cipto Mangunkusumo Hospital between 2014-2016 period. ACS patients diagnosed and treated for the first time with aspirin-clopidogrel and patients diagnosed and treated for the first time with aspirin-ticagrelor were included. Effectiveness outcome were the occurence of major adverse cardiovascular events (MACE) successfully avoided within 3, 6, 9, and 12 months of antiplatelet treatment. Safety outcome were the insidence of adverse drug reactions within 3 months. Cost outcome were determined with cost effectiveness analysis (CEA). Data for CEA calculation were presented as Incremental Cost Effectiveness Ratio (ICER). One way sensitivity analysis were performed to evaluate data uncertainty. Results: A total of 123 data records of ACS patients treated with aspirin-clopidogrel and 57 with aspirin-ticagrelor were evaluated. Trend for antiplatelet prescription showed that ticagrelor prescription increased since 2014 until 2016, while clopidogrel decreased. Within the first three months, the MACE rate was 15.8% in ticagrelor group and 31.7% in clopidogrel group (RR; 0,498, 95% CI; 0,259 – 0,957, P = 0,039). There were no significant differences of MACE between groups after 6, 9, and 12 months treatment. Ticagrelor had unsignificant major bleeding (melena) higher than clopidogrel (5,3% vs 1,62%, P = 0,681), especially in geriatric patients. ICER value was IDR 279.438,87, indicating additional cost needed for every MACE incidence successfully avoided within 3 month if aspirinticagrelor was used. ICER under 1 Indonesian GDP (Gross Domestic Product) in 2016 ($3603, equal to IDR 49.000.800) is considered cost effective. Conclusions: Ticagrelor-aspirin is a clinically superior and cost-effective option for MACE prevention among ACS patients especially during the first three months antiplatelet treatment. Further prospective rearch with higher number especially in geriatric patients with ACS is still needed.
Keywords: Ticagrelor, Klopidogrel, Dual Antiplatelet Therapy, Cost Effectiveness Analysis