The Institute for Clinical and Economic Review (ICER) has posted two Draft Scoping Documents outlining planned reviews of 1) three antiandrogen therapies for certain types of high risk prostate cancer, and 2) two therapies for hereditary transthyretin-related (hATTR) amyloidosis. The scoping documents will be open to public comment for three weeks until 5 p.m. EST April 2.
ICER’s report on treatments for high risk, non-metastatic, castration resistant prostate cancer is expected to include three antiandrogen therapies: enzalutamide (Xtandi, Astellas and Pfizer), abiraterone acetate (Zytiga, Janssen), and apalutamide (Erleada, Janssen).
The review of therapies for hATTR amyloidosis is expected to include inotersen (Ionis Pharmaceuticals, Inc.), an antisense oligonucleotide that interferes with transthyretin production in the liver, and patisiran (Alnylam Pharmaceuticals), which inhibits transthyretin through an RNA interference pathway. Both therapies are currently under review by the FDA, with approval decisions expected in July and August of 2018, respectively.
To read the full press release, click here.