After several legal battles, the first pill for patients suffering from hepatitis C has been approved on Tuesday by federal health officials.

The medicine can treat all the main forms of hepatitis C and will make significant changes in the way doctors have prescribed this liver disease. Patients whose liver is damaged or not will have now access to the combination pill Epclusa from Gilead Sciences. Patients taking this new medicine approved by The Food and Drug Administration (FDA) would not need to use the other five pills doctors recommend for hepatitis C.

The Gilead’s company has won the national debate against patients associations, insurers, and politicians who claimed that the $1,000 hepatitis C pill- named Osvaldo- was too expensive. Image Credit: DDD Mag
The Gilead’s company has won the national debate against patients associations, insurers, and politicians who claimed that the $1,000 hepatitis C pill- named Osvaldo- was too expensive. Image Credit: DDD Mag

According to the Gilead, a single pill of Epclusa will cost $890, and the 12-week course treatment will cost $74.760, a price that is a little bit less than the company’s previous drug Harvoni which price was $1, 25 per pill.  According to IMS Health, Harvoni was also ranked as the top-selling prescription drug with $18 billion earnings around the world.

What is Gilead’s new pill for hepatitis C Epclusa?

Epclusa is a combination of Sovaldi with a new drug that attacks the liver-destroying virus through different mechanisms.  These new medicines can treat all types of hepatitis’ C.  According to clinical trial data reviewed by the FDA, at the end of the 12- week course treatment, patients will be 95 per cent cure from this disease.

The pill is prescribed with other medicines like ribavirin and antivirals. The FDA said that the most common side effects of Epclusa are headaches and fatigue.

2.7 million people have Hepatitis C in the U.S. Most of the people suffering from this disease at an early stage do not have symptoms. Therefore the virus can be inside in a person’s body for decades. When the disease is advanced, the most common symptoms are liver damage, yellowish skin, dark urine, and fatigue.

This new approval has brought joy and happiness to patients with hepatitis C that have to take other pills like Viekira Pak after their Medicaid had managed care plan refused to prescribe them access to this expensive pills because the stage of their illness was not advanced.

In 2014 more than 19,000 people died from Hepatitis C, according to the Centers for Disease Control and Prevention (CDC). Image Credit: Bioscience Technology
In 2014 more than 19,000 people died from Hepatitis C, according to the Centers for Disease Control and Prevention (CDC). Image Credit: Bioscience Technology

States and commercial insurers lift restrictions against expensive Hepatitis medication

With the Food and Drug’s Administration decision to allow sales of expensive hepatitis C drugs in all United States, some of the countries states and commercial insurers like Anthem Inc. and  United HealthCare have begun to lift all restrictions on companies like Gilead. Otherwise, they might probably face legal action.

However in some states like Massachusetts, the debate is still alive about the prices of Gilead Sciences’ pills Sovaldi, Harvoni and the recently approved Epclusa. Massachusetts is about to decide whether any patient suffering from hepatitis C can have access to this medicine by Medicaid, a state health program that offers limited, expensive drugs to people with advanced diseases only.

Massachusetts’s lawsuit that forced drug Markers Company to provide the state affordable prices for medications might be eradicated with this new FDA decision.

Nicholas Bagley -a professor of law at the University of Michigan- believes that are new restrictive policies coming and they will probably prevail in the lawsuits.

“These aren’t me-too drugs with marginal benefits:  they’re actual cures.  While their cost is a huge fiscal problem, states aren’t permitted under the law to restrict access to medically necessary therapies on the grounds that they cost too much.”

The problem with the Hepatitis C new drugs is that they can cure 90 per cent of the time the disease. Therefore, these pills can save a lot of lives in the United States, but since money is an important issue, it seems that only those who can afford the pricey medication will be able to live.

New York and Delaware has included these new pills in their Medicaid programs. In Washington, a federal judge announced that it was impossible for this state to withhold treatments from Medicaid patients with hepatitis C who were in the early stage of the disease and had not suffered severe symptoms.

Matt Silo, executive director of the National Association of Medicaid Directors, said: “We want to give these medications to everybody who needs them, but with the prices they’re commanding, something has to give. We’ve run out of escape valves.”

The problem with states is to compensate the price of $54,600 to $94,500 a 12-week course of treatment, for thousands of patients when a state health budget is just being offered to those patients who have severe complications.

Nevertheless, in March, the Department of Veterans Affairs said they would treat, in their health system, all people suffering from hepatitis C, regardless of the stage of the virus, this could help 130,000 veterans.

Source: Science