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Tuesday, January 12, 2010

Brits Not NICE to Dronedarone


The British National Institute for Clinical Excellence (NICE) has made a preliminary determination NOT to cover the new antiarrhythmic drug dronedarone (Multaq, Sanofi-Aventis) for British patients with atrial fibrillation (AF). Instead, NICE implies, patients should continue receiving amiodarone (Cordarone, Pacerone), which is more effective and cheaper.

Amiodarone is the most effective antiarrhythmic drug (drug that is supposed to stabilize the heart rhythm) available, but it unfortunately produces a bizarre array of side effects that are common, often dangerous or disabling, and difficult to treat. A suitable "replacement" for amiodarone has long been sought.
Amiodarone: A Uniquely Toxic Drug
Amiodarone's Strange History

For a long time, it was hoped that dronedarone (a compound related to amiodarone) would be that perfect replacement. It is not. While it appears to have much less toxicity than amiodarone, it is not as effective in treating AF.
Dronedarone Drug Information

And indeed, this was the very logic used by NICE to deny approval for dronedarone -- it is not as effective as amiodarone, and it is much more expensive. So it will not be made available for British patients.

DrRich Comments:

The dronedarone/NICE story illustrates how panels of "clinical excellence" (like NICE, or like the panels apparently being established in the United States under pending healthcare reforms), even when they strictly follow the results of randomized clinical trials, can make decisions that seem reasonable on the surface but ultimately are harmful to patients.

Consider that while the effectiveness of dronedarone in treating AF (effective in approximately 30% to 40% of patients) is substantially less than for amiodarone (which is effective in approximately 50% to 60%), this still means that a substantial minority of patients could potentially be treated effectively with dronedarone. So, for instance, if patients with AF were given a trial of dronedarone, potentially up to 40% of them could be spared exposure to the extravagant toxicity of amiodarone.

But because randomized trials tell us that, in a large population of patients, the average response to dronedarone is significantly lower than the average response to amiodarone, no patients (in Britain, at least) will have the opportunity to try dronedarone.

To my mind, this example succinctly illustrates a key problem with how our bureaucrats propose to use panels of experts. Such panels can be of immense help in providing guidance to clinicians. But when bureaucrats insist on converting such recommendations into strict, "up or down" coverage decisions, individual patients will lose their opportunity to receive the kind of individualized care most of us value -- care given by our chosen doctors, who judiciously apply expert-generated clinical guidelines, while still taking our individual circumstances into account.


National Institute of Health and Clinical Excellence. Atrial fibrillation - dronedarone: appraisal consultation document. http://www.nice.org.uk/guidance/index.jsp?action=articleo=46768 Accessed January 7, 2009.

Brits Not NICE to Dronedarone originally appeared on About.com Heart Disease on Monday, January 11th, 2010 at 07:21:31.

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