Precision Therapy Assessments

Precision Therapy Assessments are comprehensive health technology assessments evaluating therapies, which target genes, proteins, and other molecules, or are guided by molecular testing, such as specialty drugs and gene therapies.

Used in conjunction with our Laboratory Insights database, these reports provide the critical evidence context for the use of genetic tests, including panel tests. These reports include the Hayes Rating to indicate the overall strength and direction of the body of evidence for the precision therapy.

Precision Therapy Assessments provide evidence-based support for the development of coverage policy, utilization management, and evidence-based clinical practices. Reports are reviewed annually up to 5 years post publication to determine if there is new literature or evidence that would impact a change in rating and warrant an updated report.

Lutetium Lu 177 Dotatate (Lutathera, Advanced Accelerator Applications USA Inc) for the Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Health Problem: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are a rare and heterogeneous group of neoplasms derived from neuroendocrine cells within the gastrointestinal tract and pancreas, where curative surgery options are limited. GEP-NETs are estimated to affect approximately 3 individuals per 100,000 people per year.

Tezacaftor-Ivacaftor (Symdeko) for Treatment of Cystic Fibrosis

Health Problem: Cystic fibrosis (CF) is an autosomal recessive genetic disease due to mutations in the cystic fibrosis transmembrane receptor (CFTR) gene. The basic defect results in poor chloride and bicarbonate transport, resulting in dehydration of secretions in the lungs, pancreas, and other organs. The bronchi and lungs are affected by r…

Lumacaftor-Ivacaftor (Orkambi) for Treatment of Cystic Fibrosis

Health Problem: Cystic fibrosis (CF) is an autosomal recessive genetic disease due to mutations in the cystic fibrosis transmembrane receptor (CFTR) gene. The basic defect results in poor chloride and bicarbonate transport resulting in dehydration of secretions in the lungs, pancreas, and other organs. The bronchi and lungs are affected by re…

Nusinersen (Spinraza; Biogen) for Spinal Muscular Atrophy

Health Problem: Spinal muscular atrophy (SMA) is a recessive genetic disorder characterized by progressive proximal muscle weakness and atrophy. SMA is predominantly caused by deletions or mutations of survival motor neuron (SMN) SMN-1, which leads to degeneration of alpha motor neurons of the spinal cord anterior horn cells. This affects the…

Atezolizumab (Tecentriq) for Non-Small Cell Lung Cancer

Health Problem: Lung cancer is the second most common form of cancer in men (after prostate cancer) and women (after breast cancer), accounting for approximately 14% of all new cancers. Non-small cell lung cancer (NSCLC) accounts for > 80% of all lung cancer cases, and it includes 2 major types: non-squamous, including adenocarcinoma, large-c…

Glucagon-Like Peptide-1 Receptor Agonists for the Treatment of Obesity in Women with Polycystic Ovary Syndrome

Health Problem: Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting 6% to 20% of women of reproductive age. It is characterized by oligoovulation (menstrual irregularity), hyperandrogenism (increased testosterone levels), and polycystic ovaries. Obesity is a common feature of PCOS, affecting approximately 40% to 80% of w…