First PI-based single-tablet regimen debuts in the United States at record-high price

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July 23, 2018 – The Fair Pricing Coalition (FPC), an ad hoc coalition of HIV and hepatitis C virus (HCV) activists, today expressed its strong dissatisfaction with Janssen Therapeutics over its launch price for Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide). At a wholesale acquisition cost (WAC) of $41,784 a year, Janssen has set a record-high price for single-tablet antiretroviral regimens (STRs), ignoring the need for cost containment in HIV care and defying a groundswell of public and governmental demands for lower prescription drug prices.
 

“Symtuza is a useful addition to the HIV treatment toolbox for people living with HIV requiring a protease inhibitor and single-tablet dosing,” said FPC Chair Tim Horn. “However, the unprecedented price is very difficult to swallow. Symtuza is roughly $4,700 to $6,400 more than the current WAC prices for Stribild, Genvoya, and Biktarvy, until now the most expensive STRs on the market. We understand that Janssen isn’t charging any more than the components included in Symtuza, specifically Prezista (darunavir), Tybost (cobicistat), and Descovy (emtricitabine/tenofovir alafenamide), but the original development costs of these components have already been recovered many times over.

 

Janssen missed the opportunity to introduce both an easier-to-take and less costly version of antiretrovirals that have all been available for some time now, which is unfortunate.”

 

When in doubt about STR research and development investments, FPC does advocate for parity pricing with the individual components – but with a very important stipulation.  “We urge companies to factor out the egregious annual price increases taken on the components over the years and focus instead on what the component prices should be, based on either standard or medical inflation rates,” said FPC member Paul Arons. “We’re being punished twice – by price increases on older drugs that have snowballed compared to actual inflation rates, and on new drug products with prices based on these bloated benchmarks.”

 

Had prices of Symtuza’s component drugs risen only 28.8%, in line with the medical inflation rate over the years during which most of them were launched, the maximum price should have been $30,394 – $12,390 less than Janssen’s WAC. And with overall U.S. inflation, the WAC could reasonably have been 16.6% higher, or as low as $27,508. Having shared such calculations with Janssen, the Fair Pricing Coalition considers the company’s pricing decision especially regrettable.

 

The Symtuza launch price is particularly problematic in the context of comparable generic and quasi-generic drugs becoming widely available in the U.S. For example, the darunavir in Symtuza is one of two protease inhibitors (the other being atazanavir, which is now available as a stand-alone generic) classified as components of “Recommended Initial Regimens in Certain Clinical Situations” in the Department of Health and Human Services’ Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV, meaning they are not among the primary initial regimens. That means Symtuza is likely to have a more limited market than a drug that is listed in the guidelines for more widespread use. Common sense would dictate that Janssen would assign a lower price to a drug like Symtuza that is less clinically important.

Other components of Symtuza have generic or quasi-generic equivalents. “Using current and anticipated generic drug prices as a benchmark, a minimal fair price for Symtuza should have been below $10,000 annually,” said Horn. “Symtuza’s launch price goes to show that fairness rules aren’t being applied to newer HIV drug products with marginal advantages over older offerings, which is, at best, a shame, and at worst, a genuine threat to our stretched-thin systems of HIV care coverage.”

“We take some solace at the news Janssen has increased its copay assistance limit to $10,500,” said FPC member John Peller. However, the maximum eligibility for full indigent coverage under the Johnson & Johnson Patient Assistance Foundation remains at only 300% of the Federal Poverty Level – 40% short of the current pharmaceutical standard. Thus, the cost of Symtuza for a person living with HIV who earns just above that level could be as much as a full year’s income. “To what extent Janssen’s financial support programs defray out-of-pocket costs, particularly for such high-priced HIV drug products in an era of copay accumulators and an upswing in public and private policy attacks on products intended to defray patient costs, remains to be seen,” Peller added.