Nonalcoholic Steatohepatitis – Access & Reimbursement – Detailed, Expanded Analysis (US)
NASH is an increasingly prevalent disease characterized by excess lipid (steatosis) in the liver, resulting in inflammation and eventually liver fibrosis. Ensuing complications can include liver failure and hepatocellular carcinoma, which may necessitate liver transplantation. Consequently, the financial implications of NASH are ever-increasing. Despite a major unmet need, there are currently no drugs approved for NASH in any market; pharmacotherapy is limited to some use of off-label generic drugs, for which there is little evidence of benefit. However, there are now numerous agents in Phase II development or later, with the first launch of an approved agent expected in the next few years. With low diagnosis and treatment rates, novel NASH agents could be priced at a premium and consequently face significant market access challenges, as MCOs look to minimize the impact on their budgets.
QUESTIONS ANSWERED
- How do payers anticipate reimbursing emerging therapies for NASH (Intercept’s Ocaliva, Allergan’s cenicriviroc, Madrigal’s resmetirom, and Novo Nordisk’s semaglutide) if approved? What restrictions will they impose?
- What are physicians’ opinions on current the late-phase emerging therapies?
- How do payers reimburse current diagnostic tests, such as liver biopsy, in 2020? What role will diagnostic tests play in determining access to emerging therapies?
- What role do reimbursement, restriction, and patient cost play in physicians’ decisions to prescribe therapies for NASH?
PRODUCT DESCRIPTION
U.S. Access & Reimbursement provides integrated brand- and disease-level insight on reimbursement dynamics and the impact of U.S. payer policy on physician prescribing behavior in the market access environment, including up-to-date analysis of drug coverage and restriction policies and payer and prescriber perspectives on key marketed drugs and receptivity to emerging therapies.
GEOGRAPHY
United States
PRIMARY RESEARCH
- Survey of 97 hepatologists and gastroenterologists in the United States
- Survey of 30 U.S. managed care organization (MCO) pharmacy and medical directors (PDs/MDs)
KEY DRUGS COVERED
Ocaliva (obeticholic acid), cenicriviroc, resmetirom, pioglitazone, metformin, GLP-1 receptor agonists
CONTENT HIGHLIGHTS
- Reimbursement and contracting
- Access and prescribing
- Opportunities and challenges for emerging therapies
- Role of diagnostic tests
Rohit Bansal, M.S. (Pharm.), is an analyst on the Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders team at DRG, part of Clarivate. He has authored several reports on metabolic indications, chiefly dyslipidemia and nonalcoholic steatohepatitis (NASH). Prior to joining DRG, he worked in a consultancy assisting various pharmaceutical companies. He earned his master’s degree in pharmacoinformatics from the National Institute of Pharmaceutical Education and Research (NIPER) in India.