Penelitian ini bertujuan untuk menganalisis implikasi perbedaan pengaturan penggunaan obat trastuzumab pada pasien kanker payudara dalam program Jaminan Kesehatan Nasional (JKN) berdasarkan Peraturan Menteri Kesehatan Nomor 22 Tahun 2018 dan Keputusan Menteri Kesehatan Nomor HK.01.07/Menkes/2197/2023 tentang Formularium Nasional dalam praktik pelayanan kesehatan. Selain itu, penelitian ini bertujuan untuk mengkaji persepsi dokter dan apoteker terhadap perbedaan pengaturan tersebut serta implikasinya terhadap pemenuhan hak pasien kanker payudara dalam penyelenggaraan pelayanan kesehatan pada program JKN.
Penelitian ini merupakan penelitian hukum normatif empiris dengan pendekatan kualitatif dan bersifat deskriptif. Data sekunder diperoleh melalui studi dokumen terhadap peraturan perundang-undangan dan kebijakan terkait, sementara data primer diperoleh melalui wawancara mendalam dengan subyek penelitian. Penelitian dilakukan di Rumah Sakit Akademik Universitas Gadjah Mada. Analisis data dilakukan dengan metode analisis kualitatif dan penarikan kesimpulan secara deduktif.
Hasil penelitian menunjukkan bahwa: 1). perbedaan pengaturan penggunaan trastuzumab antara PMK No. 22 Tahun 2018 dan Formularium Nasional Tahun 2023 menimbulkan disharmonisasi regulasi yang berdampak pada ketidakpastian hukum dalam pelaksanaan pelayanan kesehatan. BPJS Kesehatan masih menggunakan PMK No. 22 Tahun 2018 sebagai dasar pembiayaan, sehingga penggunaan trastuzumab pada pasien kanker payudara stadium dini belum dapat dijamin melalui JKN meskipun telah tercantum dalam Formularium Nasional; 2). Kondisi ini menimbulkan dilema profesional bagi dokter dan apoteker, membatasi akses pasien terhadap terapi yang optimal, serta berpotensi mengurangi mutu dan keadilan dalam pelayanan kesehatan bagi peserta JKN.
This study aims to analyze the implications of differences in the regulation of trastuzumab use in breast cancer patients under the National Health Insurance (JKN) program based on Minister of Health Regulation No. 22 of 2018 and Minister of Health Decree No. HK.01.07/Menkes/2197/2023 concerning the National Formulary in health service practice. Additionally, this study aims to examine the perceptions of doctors and pharmacists regarding these differences in regulations and their implications for fulfilling the rights of breast cancer patients in the provision of health services under the National Health Insurance program.
This study is an empirical normative legal study with a qualitative and descriptive approach. Secondary data were obtained through document studies of relevant laws, regulations, and policies, while primary data were obtained through in-depth interviews with research subjects. The study was conducted at Gadjah Mada University Academic Hospital. Data analysis was performed using qualitative analysis methods and deductive reasoning.
The results of the study show that: 1) Differences in the regulations governing the use of trastuzumab between Minister of Health Regulation No. 22 of 2018 and the 2023 National Formulary have led to regulatory disharmony, resulting in legal uncertainty in the implementation of health services. The Social Security Administration Agency for Health still uses Minister of Health Regulation No. 22 of 2018 as the basis for financing, so that the use of trastuzumab in patients with early-stage breast cancer cannot be guaranteed through national health insurance, even though it is listed in the National Formulary; 2) This situation creates a professional dilemma for doctors and pharmacists, limits patient access to optimal therapy, and has the potential to reduce the quality and fairness of the National Health Insurance participants
Kata Kunci : Kanker Payudara, Disharmonisasi Regulasi, Formularium Nasional, Jaminan Kesehatan Nasional, Trastuzumab
