Compared To US Practice, Evidence-Based Reviews In Europe Appear To Lead To Lower Prices For Some Drugs

Abstract

In Europe drug reimbursement decisions often weigh how new drugs perform relative to those already on the market and how costeffective they are relative to certain metrics. In the United States such comparative-effectiveness and cost-effectiveness evidence is rarely considered. Which approach allows patients greater access to drugs? In 2000-11 forty-one oncology drugs were approved for use in the United States and thirty-one were approved in Europe. We compared patients' access to the twenty-nine cancer drugs introduced into the health care systems of the United States and four European countries. Relative to the approach used in the US Medicare program in particular, the European evidence-based approach appears to have led to reduced prices for those drugs deemed worthy of approval and reimbursement. The result is improved affordability for payers and increased access for patients to those drugs that were available. The United States lacks a systematic approach to assessing such evidence in the coverage decision-making process, which may prove inadequate for controlling costs, improving outcomes, and reducing inequities in access to care.

OECD Health Statistics

“…54 Part D plans had less success at controlling price infl ation for branded and innovative drugs, partly due to the lack of a systematic approach to assessing comparative eff ectiveness and cost-eff ectiveness. 55,56 Other high-spending countries were subject to similar infl ationary pressures linked with technological innovation in the pharmaceutical sector, but not to the pressures generated by expansions of coverage. Despite this, and despite a broader availability of incisive costcontrol approaches in more centralised systems, the expenditure outcomes were not substantially diff erent from those reported in the USA.…”

Are payers treating orphan drugs differently?

“…This shift was designed to control prescription utilization and spending ( 8 ). Co-insurance percentages have on average risen from 15 to 28% in the past decade ( 9 , 10 ). Given the level of prices of many orphan drugs, this represents a significant shift of the cost burden onto the patient.…”

“…Given the level of prices of many orphan drugs, this represents a significant shift of the cost burden onto the patient. Also, in therapeutic classes with multiple orphan options, such as colorectal cancer and chronic myeloid leukemia, US payers are differentiating among orphan drugs by granting preferred formulary status to certain drugs and non-preferred status to others ( 10 ). Furthermore, payers are adding prior authorization to many orphan drugs as a condition of reimbursement, or requiring clinical diagnostic tests prior to prescribing.…”

Is the increasing cost of treating rare diseases sustainable?

“…This shift was designed to control prescription utilization and spending [9]. Co-insurance percentages have risen, on average, from about 15 to 28% in the past 10 years [10,11]. Given the level of prices of many orphan drugs, this represents a significant shift of the cost burden onto the patient.…”

“…Also, in therapeutic classes with multiple options, such as colorectal cancer and chronic myeloid leukemia, US payers are granting preferred formulary status to certain drugs. In other cases, payers are adding prior authorization as a condition prior to reimbursement, or requesting clinical diagnostic tests prior to prescribing [11]. In Europe, orphan drug prices are under substantial pressure from health authorities.…”