HTA Quarterly Spring 2018

England’s NICE and Scotland’s SMC are responsible for issuing appraisal guidance for reimbursement of new health technologies in their respective countries. While both agencies consider clinical and cost-effectiveness in their decisions, they have unique policies and procedures that may yield different outcomes. To better understand the similarities and differences in approaches to oncology decision making between NICE and SMC, Xcenda conducted an analysis of past appraisal decisions by the agencies to compare results.

Cell and gene therapies (CGTs) are a field of medicine that replace, manipulate, or engineer cells and/or genetic material to treat disease. Unlike traditional treatment options that may only target disease symptoms or slow progression of a disease, CGTs harness a patient’s own immune system to correct underlying disease-causing defects. The projected market size of this growing segment is vast, by some estimates, up to $50 billion USD by 2025. We examine the clinical and financial impact of these therapies by looking at comparators and past case studies.

Managed entry agreements (MEAs)—contractual agreements that allow market access for drugs by distributing the risk of uncertainty between the budget holder and the pharmaceutical, device, or diagnostics manufacturer—are used in many countries to control financial risk. MEAs are broadly divided into financial-based agreements and performance-based agreements. Currently, the former is more common due to its simplicity and familiarity, but the latter is becoming increasingly prevalent due to the drive for reimbursement agencies or budget holders to concurrently manage costs when making timely and appropriate coverage decisions. We take a look at these agreements and the implications for key stakeholders.