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International Approaches to Comparative Effectiveness Research

Written By: Jason Shafrin - Jun• 18•12

Comparative Effectiveness Research (CER) aims to determine whether a drug or medical procedure’s are more cost-effective than alternative treatments and/or none at all.  Although the U.S. is not known as a leader in CER research (in part because public health insurance bodies such as Medicare do not take CER evidence into account when making coverage decisions), the American Recovery and Reinvestment Act (ARRA) recently allocated $1.1 billion to advance CER in the U.S.  Healthcare Reform (i.e., the ACA) also established the Patient-Centered Outcomes Research Institute (PCORI), which is a non-profit body aiming to fund and evaluate CER studies.

Despite these advances in the U.S., Europe leads the way in terms of implementing CER systems.  Today, I review a Commonwealth Fund study that examines the use of CER in six countries (Denmark, England, France, Germany, the Netherlands and Sweden.)  More information after the jump:

Decisions based on CER fall into two categories: assessment and appraisal. First, one must assess the drug’s absolute benefits, the drug’s benefits relative to other drugs, and the drugs cost. The second stage, appraisal, takes this evidence and determines coverage and pricing decisions.

In countries with advisory bodies (France, Germany, the Netherlands), the Ministry of Health oversees the assessment process or sets priorities for assessment to some degree. The bodies can also
be categorized as those that “produce” CER (England, Germany, Sweden)—that is, they conduct evidence synthesis, economic modeling, and other studies—and those that mainly “use” existing CER, typically submitted from manufacturers, to make coverage recommendations or decisions (Denmark, France, the Netherlands).

Probably the most well-known CER organization is England’s National Institute for Health and Clinical Excellence (NICE), which coordinates independent review conducted by academic research centers. A summary of the Key Drug Review and Decision-Making Bodies in Denmark, England, France, Germany, Netherlands, and Sweden can be found here.

Stakeholders are involved in the CER process in all countries. For instance, “For example, NICE in England has established a Citizens Council to gather public perspectives on key social and ethical issues, such as whether age and disease severity should be taken into account when NICE makes decisions about treatment availability and use….In all six countries, manufactures are involved prior to the assessment process, when they submit a dossier of evidence to the review body.”

How do countries use CER evidence?

In all these countries, a drug’s relative therapeutic benefit is the most important criterion in determining coverage status, followed by cost-effectiveness, which is measured using cost per quality-adjusted life year (QALY) ratios. Cost-effectiveness is particularly important for drugs that have new indications, are expensive, are expected to be widely used, or whose benefits differ by indication or patient subgroup. England, Germany, the Netherlands, and Sweden explicitly use cost-effectiveness in coverage decision-making, whereas its role in the review process is not always clear in Denmark and France.

Certain countries also base drug prices on market share and drug cost.

“England, France, the Netherlands, and Sweden have introduced risk-sharing agreements and coverage with evidence development (CED) schemes with manufacturers. Risk-sharing agreements allow coverage based on meeting certain, specified conditions, such as cost, volume, market share, and costeffectiveness targets. If the conditions are not met, then coverage may be withdrawn or the drug’s price reduced. For example, after NICE controversially recommended against the use of various products for multiple sclerosis, the government established a risk-sharing scheme with manufacturers to supply these treatments on the NHS.”

Other countries, such as Sweden, use value-based pricing (VBP). VBP bases coverage and pricing decisions based on drug cost-effectiveness. France uses CER evidence to determine the amount the copayment the patient pays for a drug.

Most countries also reevaluate drugs after they have been put into practices to determine whether the drug still represents a good value and that the drug has not become obsolete.


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