An International Review of Health Technology Assessment Approaches to Prescription Drugs and Their Ethical Principles

Abstract

Health technology assessment (HTA) organizations assess the economic value and make recommendations about reimbursement or coverage of prescription drugs and other health care products. The findings are then used by governments or other health insurers to negotiate prices, structure budgets, and decide whether to finance access to a drug or product. HTA is an important tool to control health care costs and determine the distribution of resources in society.

Most high-income countries around the world use HTA as part of a negotiation process to establish drug prices, with the notable exception of the US. While many high-income countries have experienced increases in prescription drug spending in the past decade, due to both increased volume and prices, rising health care costs and prescription drug prices in the US far exceed any other setting. In response, the current US presidential administration and leading Congressional bills seek to rein in spending and excessive drug prices by linking US drug prices to those paid by other countries.4 In 2019, House bill H.R.3 — the Elijah E. Cummings Lower Drug Costs Now Act — proposed pricing some of the most expensive drugs for Medicare and Medicaid Advantage at negotiated prices that may not exceed 120% of the average price in Australia, Canada, France, Germany, Japan, and the UK, each of which uses HTA to negotiate prices for the country. H.R. 3 would also require negotiation for prices below the maximum level taking into consideration costs of drug development and production and information on the comparative effectiveness of the new drug. The methods for this assessment have not been specified yet; other policy proposals may supplant H.R. 3, and so there is an opportunity to learn from the international example and shape the methods based on social and cultural values.

While HTA is an empirical process using economic and clinical evidence to arrive at a cost-effectiveness valuation of a drug, HTA is also fundamentally political; though grounded in evidence and validated modelling methods, the findings and recommendations reflect the political and social values of a country. Though there are objections to HTA as an approach to determining coverage, its use in many countries signals a broad acceptance of a health economics approach to evaluating the value of drugs, so this paper focuses on HTA approaches. There are two key dimensions of every HTA organization that raise potential ethical concerns. The first is how HTA functions to generate the quantitative findings of cost-effectiveness. For example, some HTA bodies may choose to integrate modifications to the economic evaluation methods that change cost or effectiveness thresholds for a particular patient population, such as drugs treating rare diseases. Such adjustments have important implications for patient access.