Novel anticoagulants achieve rapid market penetration despite higher costs

People with atrial fibrillation are five times more likely to suffer a stroke than the wider population and are often prescribed anticoagulants to reduce their elevated risk. Anticoagulants

prevent blood clots from forming when irregular heart rhythms caused by atrial fibrillation allow blood to pool in the heart.  Warfarin, an oral anticoagulant that was originally approved in

1954 and is widely available in generic form, was, until relatively recently, the standard treatment for stroke prevention in patients with atrial fibrillation.  In October 2010, novel oral

anticoagulants (or NOACs, marketed as Pradaxa, Xarelto and Eliquis) began entering the market as an alternative to warfarin. NOACs have a different mechanism of action and do not require

frequent monitoring or dose adjustments that warfarin does. By the end of 2014, just four years after the first of these novel oral anticoagulants received FDA approval for the prevention of

stroke among patients with nonvalvular atrial fibrillation, approximately 60 percent of patients taking daily oral anticoagulants for this purpose were using NOACs. Although it was not

until 2019, however, that sufficient evidence had accumulated to update the atrial fibrillation treatment guidelines to explicitly recommend NOACs as the preferred alternative to warfarin. 

Significantly, NOACs were priced substantially higher than existing therapies -- approximately 20 times more expensive. As a result, following the introduction of NOACs to the marketplace,

total annual per capita spending (i.e., out-of-pocket and plan paid amounts) on oral anticoagulants among newly treated atrial fibrillation patients increased dramatically—growing from a

couple hundred dollars per year to several thousand dollars per year for some patients. NOAC USAGE This study looks at commercially insured adults ages 50 to 64, and Medicare Advantage

enrollees ages 65 and older, with atrial fibrillation who filled a new prescription for an oral anticoagulant between 2010 and 2014. This period includes the final nine months before NOACs

began entering the market. Three NOACs entered the market during the study period: dabigatran (10/19/2010; sold as Pradaxa), rivaroxaban (11/04/2011; sold as Xarelto), and apixaban

(12/28/2012; sold as Eliquis).   During the nine months before NOACs began to enter the market, all index fills (the first time a new prescription is filled) were for warfarin. Over the

five-year study period, NOACs became more popular than warfarin, particularly among younger adults. By the end of 2014, NOACs accounted for 79 percent of index fills for adults ages 50 to 64

on commercial plans and 47 percent of index fills for Medicare Advantage enrollees ages 65 and older. NOAC COSTS Over the study period, annual out-of-pocket spending on oral anticoagulants

approximately tripled for commercial enrollees ages 50 to 64 and quintupled for Medicare Advantage enrollees ages 65 and older. This increase translated into an added out-of-pocket burden of

approximately $300 to $400 per year for patients who were adherent to their anticoagulant treatment.  These out-of-pocket spending increases, while substantial, were dwarfed by the

increases in annual plan spending on oral anticoagulants. Among adults ages 50 to 64 on commercial plans who adhered to their treatment, spending grew from $106 per patient per year to

$2,784 per patient per year. This represents a jump from 43 percent of the total cost of treatment to 86 percent of the total cost. Among adherent Medicare Advantage enrollees ages 65 and

older, plan spending grew from $104 per patient per year to $1,572 per patient per year—a jump from 53 percent of the total cost to 75 percent of the total cost. Indeed, health plans paid a

disproportionately large share of the additional expense for NOACs.  By the end of the study period, health plans were spending 15 to 25 times more per patient per year on anticoagulants

than they were before NOACs entered the market. Higher plan spending is typically passed on to consumers via higher premiums, higher deductibles, or higher out-of-pocket expenses for other

products and services. (The extent to which this burden was passed on to consumers could not be discerned from these data.)