By October 10, U.S. health regulators will decide whether to approve a new drug by Gilead Sciences that combines Sovaldi (sofosbuvir) with the drug ledipasvir. The combo has been shown to cure up to 99 percent of hepatitis C virus (HCV) patients without the need of other drugs, such as ribavirin and interferon.

However, the new all-oral therapy is also set to be the most expensive hep C drug ever, Reuters reports. Market analysts predict higher pricing than Sovaldi’s $84,000 per-treatment cost.

Gilead has not yet revealed the exact cost, but financial experts predict pricing between $85,000 and $100,000 per patient.

Critics claim that the cost of treating the more than 3 million Americans living with HCV could reach hundreds of billions of dollars without a discount. They stress that adding an even more expensive drug could make matters worse.

Gilead argues that since the new combo pill takes a shorter time to treat patients—eight weeks compared to 12 weeks with Sovaldi alone—and is even more effective than existing next-generation therapies, it will ultimately save the system money.

For example, the shorter treatment time could potentially cut per-patient costs by mitigating their risk of re-treatment and by preventing expensive complications from untreated HCV, such as cirrhosis, liver cancer and organ transplants.

Gilead is expected to make nearly $12 billion on hepatitis C drugs worldwide in 2014 alone, an unprecedented profit for any drug in its first year on the market.