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 이성욱 ( 2014-10-14 12:44:25 , Hit : 1857
 Harvoni, a Hepatitis C Drug From Gilead, Wins F.D.A. Approval

By ANDREW POLLACKOCT. 10, 2014


The first complete treatment for hepatitis C that requires taking only a once-a-day pill won approval Friday from the Food and Drug Administration.

The drug, called Harvoni from Gilead Sciences, could shorten the duration of treatment and provide the first all-oral regimen for many patients.

The new drug also appears to be a bit less expensive for some patients than Gilead’s existing blockbuster hepatitis C drug, Sovaldi, which has become the poster child for those complaining that the cost of medicines is out of control.

Sovaldi costs $1,000 a pill, or $84,000 for a typical 12-week course of treatment, but it must be used with other drugs. Harvoni is even more expensive at $1,125 a pill, or $94,500 for a 12-week course of treatment. But that is roughly in line with the total cost for Sovaldi and the drugs used with it. Many patients will be able to take Harvoni for only eight weeks, at a cost of about $63,000.

This will probably not mollify insurance companies and Medicaid programs, many of which are restricting the use of Sovaldi to the most seriously ill patients.

Photo


  
Harvoni may shorten  treatment for hepatitis C. Credit Gilead Sciences  

“They are not prepared to cover the cost even at $63,000,” said Dr. Steven Miller, the chief medical officer of Express Scripts, which manages pharmacy benefits for employers and insurance companies. “Their budgets just are not going to be able to tolerate it.”

He said the patients eligible for the shorter regimen are also the ones least in need of treatment.

But some patient advocates hope the pricing will persuade payers to relax their restrictions.

“We’re talking about a much lower cost to Medicaid for a substantial number of people, and to me that’s a game changer,” said Ryan Clary, executive director of the National Viral Hepatitis Roundtable, a coalition of organizations that receives some funding from drug companies.

Gilead defended the price. “We believe the price of Harvoni reflects the value of the medicine,” it said in a statement. “Unlike long-term or indefinite treatments for other chronic diseases, Harvoni offers a cure at a price that will significantly reduce hepatitis C treatment costs now and deliver significant health care savings to the health care system over the long term.”



Harvoni is a combination of sofosbuvir, the ingredient in Sovaldi, and a new medicine from Gilead called ledipasvir, which is not available as a stand-alone product. The two drugs attack the virus in different ways.

By combining drugs into a single pill, Gilead is repeating the strategy it used to become the leading supplier of drugs for H.I.V. Its drug Atripla, which combines three medicines, was the first once-a-day complete treatment for that disease.

Gilead estimates that over the long run as many as half of the patients might be able to receive only eight weeks of treatment.

Three million to four million Americans are infected with hepatitis C, which can gradually damage the liver. Harvoni’s approval is only for the main subtype of hepatitis, called genotype 1, which accounts for about 70 percent of the cases in the United States.

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In clinical trials, more than 90 percent of the patients treated with Harvoni had no detectable virus in their blood 12 weeks after treatment ended. Doctors say that is considered an effective cure.

Sovaldi, which was approved in December, has already made a huge difference for patients, reducing the duration of treatment to 12 weeks from 24 or 48 weeks, increasing the cure rate and reducing side effects.

But Sovaldi is not supposed to be used by itself. Patients with genotype 1 are supposed to also take the older hepatitis C drugs, alpha interferon and ribavirin. Interferon in particular, which is given as a weekly injection, can have debilitating side effects such as flulike symptoms and depression.

In practice, many doctors this year have been avoiding the use of interferon by prescribing Sovaldi with another new pill, Johnson & Johnson’s Olysio. That combination has not been approved by the F.D.A. and costs about $150,000.

Compared with that off-label combination, Harvoni is far less expensive, which could mean lower sales for Johnson & Johnson’s drug.

It is not so much the price per patient of Sovaldi but the total cost that has insurers and Medicaid programs worried. Sales of Sovaldi in the first half of the year were nearly $6 billion, almost all of it in the United States, shattering the record for first-year sales of any drug.

“Ironically, if this drug were not a breakthrough drug, people would not object to it because so many people would not be standing in line,” said Ed Schoonveld, a principal at ZS Associates, a consultant to drug companies.

Caught off guard by the surge in demand, many insurers and state Medicaid programs have started to restrict the use of Sovaldi to patients who have more advanced liver disease. Some are requiring patients to demonstrate they have not abused alcohol or illicit drugs in a number of months.

Some advocacy groups, led by the National Viral Hepatitis Roundtable, sent a letter last month to Sylvia Mathews Burwell, the secretary of health and human services, saying that such restrictions were “discriminatory and violate the spirit and the intent of the Affordable Care Act.”

It can take 20 years or more for hepatitis C to cause noticeable cirrhosis or liver cancer. Many people infected with the virus never suffer noticeable liver damage.

That is why in many cases it can be acceptable for patients without advanced liver damage to delay treatment. Many patients, on advice from their doctors, have been delaying treatment until Harvoni became available.

Gilead and some doctors make the case that even if liver damage is not serious, people with a chronic virus infection can have various other health problems, including an increased risk of heart attack. Treating the disease early is better, they argue, because it avoids liver damage to begin with.

“The sooner you cure them, the more likely you are to have better long-term outcomes for these patients,” John F. Milligan, president and chief operating officer of Gilead, said at the Morgan Stanley health care conference last month.

Gilead recently agreed to allow several generic drug manufacturers in India to make and sell much less expensive copies of Sovaldi in about 90 poorer countries. That agreement also applies to Harvoni.

Analysts think the introduction of Harvoni will keep Gilead in the lead in the market for hepatitis C treatments. Just this week, Bristol-Myers Squibb said it would essentially give up for now on fielding its own combination treatment, a tacit acknowledgment that its regimen would not be competitive.

The competition for Gilead is expected from AbbVie, which could receive F.D.A. approval for its combination regimen by the end of this year. Insurers hope to play Gilead and AbbVie against each other to obtain lower prices, but it is not clear that will work.







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