AS, hainews.id – Badan Pengawas Obat dan Makanan Amerika Serikat (FDA) menyutujui obat Leqembi sebagai pengobatan bagi penderita tahap ringan dan awal Alzheimer pada Jumat (6/1/2023).
Persetujuan ini dikeluarkan tidak lama setelah badan pengawas itu dikritik keras karena telah memberikan izin penggunaan bagi jenis obat Alzheimer lainnya, yakni Aduhelm. Mereka dikritik karena telah mengeluarkan izin meskipun hasil uji coba produk menunjukkan bahwa pengobatan antibodi monoklonal berisiko menimbulkan pembengkakan dan pendarahan otak.
Kedua obat tersebut dikabarkan telah disetujui oleh FDA melalui proses yang dipercepat. Hal ini memungkinkan adanya kebutuhan yang tidak terpenuhi meski obat telah memperoleh izin.
Kendati demkikian, FDA menilai bahwa peluncuran Leqembi dan Aduhelm justru menjadi bukti kemajuan penting dari proses pengobatan yang bisa diterima oleh para penderita Alzheimer.
“[Kedua obat] mewakili kemajuan penting dalam perjuangan berkelanjutan untuk mengobati penyakit Alzheimer secara efektif”, terang FDA.
Perwakilan Pusat Evaluasi dan Penelitian Obat FDA Billy Dunn menyebut, tidak hanya untuk mengobata gejala Alzheimer, Leqembi juga akan menjadi jenis terapi terbaru yang berfungsi untuk menargetkan dan mempengaruhi proses penyakit yang mendasari Alzheimer.
Berdasarkan data uji coba Leqembi pada September 2022, obat ini disebutkan dapat memperlambat penurunan kognitif penderita Alzheimer hingga 27 persen.
Namun, menurut data uji coba lengkap yang diterbitkan dalam New England Journal of Medicine, pemberian obat bagi penderita Alzheimer mampu menimbulkan gejala efek samping termasuk pendarahan otak dan pembengkakan. Dari total 1.800 orang yang mengikuti uji coba fase ketiga, 17,3 persen di antaranya dipastikan mengalami pendarahan otak dan 12,6 persen lainnya mengalami pembengkakan otak.
Biaya Tinggi
Biogen dan Eisai ternyata sempat berupaya memasarkan produk Aduhelm ke pasaran. Namun, terjadi kontrovensi mengenai tingkat efektivitas Aduhelm dan persetujuannya pada 2021 telah menyebabkan pengunduran diri dari pejabat tinggi FDA.
Investigasi kongres AS menuturkan, proses persetujuan yang dipercepat untuk Aduhelm menunjukkan bahwa tahapan tersebut penuh dengan tidak kebeneran. Selain itu, Biogen juga mematok harga yang cukup tinggi untuk sebuah obat, yakni sekitar US$56.000 per tahun.
“Harga tinggi yang tidak dapat dibenarkan,” demikian tertulis dalam Laporan Kongres AS.
Senada dengan Aduhelm, produk Leqembi ternyata juga akan dipasarkan dengan harga yang cukup tinggi, yakni US$26.500 per tahun. Hingga 2026, sebanyak 100.000 orang Amerika diperkirakan telah menerima obat Alzheimer tersebut.
Meski demikian, biayanya yang sangat tinggi itu ternyata mendapat kritik dari sejumlah pihak, salah satunya adalah CEO Asosiasi Alzheimer Joanne Pike. Dia mengatakan bahwa harga yang sangat tinggi itu membuat kedua obat tersebut tidak dapat dijangkau oleh mayoritas masyarakat AS. Terutama jika biaya pengobatan mereka ditanggung oleh Mediacare, program asuransi kesehatan pemerintah untuk orang tua.
“Orang yang hidup dengan penyakit mematikan ini hari ini tidak punya waktu untuk menunggu obat atau penyembuhan ajaib,” ucap Pike.
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