The high cost of hepatitis C virus (HCV) drugs has caused significant financial strain for patients and the health care system. These drugs cost as much as $95,000 for a 12-week treatment, but carry a 90% or better cure rate, which many believe justifies the cost.

While some insurers have implemented cost containment strategies to prevent early stage patients from receiving the treatment, lawsuits have been filed challenging the ethics of these practices.

Lawmakers are now struggling to create legislation that will provide these patients with the treatments they need, but a majority of proposals do not gain traction, according to a report published by Mediware.

Sofosbuvir (Sovaldi) received FDA approval in 2013, and was the first drug deemed safe and effective without interferon. It was also the first approved curative treatment for HCV.

No previous treatments resulted in a sustained virologic response, which made sofosbuvir a highly sought-after drug. Gilead Sciences priced the treatment at $1000 per pill, making the total cost of the treatment $84,000.

Gilead then combined sofosbuvir with a new drug, ledipasvir, to create the even more effective combination treatment, Harvoni. Harvoni’s total treatment cost is $94,500 for a 12-week regimen.

If CDC estimates are correct and 3.5 million Americans have HCV, then treatment with Harvoni would cost payers $331 billion, which was more than total drug spending in 2013, according to the report.

Although most other specialty drugs only treat a small number of patients, HCV drugs treat a large patient population, and provide manufacturers with opportunities to generate significant revenue.

Interestingly, sofosbuvir only costs $900 in Egypt, and $55,000 in Canada, substantially less than the cost in the United States. This has caused some lawmakers to accuse Gilead of price gouging, and limiting access to effective treatments, according to the report.

The report notes that: “Patients who do not receive treatment for HCV are more likely to develop liver cancer and type 2 diabetes, experience plaque build-up in the arteries, and have an increased risk of stroke.”

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