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Medicaid/HCV in Texas
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The Texas Health and Human Services Commission, which oversees Medicaid, had proposed a policy to allow the drug, Sovaldi, to be used mainly for sicker patients such as those whose hepatitis C had developed into advanced liver disease, according to state documents reviewed by Reuters.
The commission is revising its proposal and hopes to get board approval ahead of its August meeting so the treatment can be covered by the fall. If it is unable to do so, Medicaid patients are unlikely to be able to obtain the treatment through Medicaid until January, Goodman said.......http://www.texastribune.org/2014/05/26/new-drug-costs-complicate-access-inmates-poor/
Texas Prior Authorization Program Clinical Edit Criteria http://www.hhsc.state.tx.us/news/meetings/2014/DUR/0410/6e.pdf
Does the client have documented liver disease (fibrosis score 3/4 or
CTP class B/C*)?
[] Yes - Go to #12
[] No - Deny
Is the client showing signs of high risk behavior?
[] Yes - Deny
[] No - Go to #4
Criteria - Drug Utilization Review Board
http://www.txvendordrug.com/dur/board.shtml
Download the PDF here
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http://www.reuters.com/article/2014/04/11/us-usa-healthcare-hepatitisc-idUSBREA3A1BH20140411
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http://www.governing.com/topics/health-human-services/gov-hepatitis-coverage-solvaldi-lawsuits.html
Texas -- which is one of the three states yet to cover the drug -- is raising similar questions in a months-long review that could leave a final decision until the fall.
"Matt Salo, who heads the National Association of Medicaid Directors, said Oregon's restrictions might not hold up in court. As influential groups like the Centers for Disease Control and Prevention, Veterans Affairs and the FDA urge states to cover the drug without limitations, he said public health concerns could overwhelm arguments questioning the drug's effectiveness and cost.
"If this gets kind of couched as a public health crisis, as a push to eradicate a communicable disease, then I don't think Oregon's distinction makes a difference," he said.
What will become clearer is the need for some kind of federal policy solution, Salo argues. High-cost specialty drugs are a relatively new phenomenon arising with the decline of revenue from previously lucrative medications that now face steep competition from generic versions. The highest-profile lawsuit over state prior authorization rules has already been filed in Arkansas over coverage of a $300,000 cystic fibrosis medication. More are bound to come."
http://www.nytimes.com/2014/05/25/us/cost-of-new-drug-complicates-access-for-inmates-and-the-poor.html
AUSTIN AMERICAN-STATESMAN: Alam: Texas should reverse course on Sovaldi Hepatitis C drug
June 16 - Dr. Imtiaz Alam
More than 500 Medicaid Texans infected with the hepatitis C virus are currently being deprived of new, lifesaving biopharmaceuticals. While they wait patiently, the Texas Medicaid Drug Utilization Review Committee has decided to postpone its decision as to who will ultimately have access to this new treatment.
Texas, home to a relatively large number of hepatitis C patients, would have been the first major state to craft a policy. While we all idly wait, are we simply watching Emperor Nero play the fiddle while Rome burns?
http://www.mystatesman.com/news/news/opinion/alam-texas-should-reverse-course-on-sovaldi-hepati/ngL9W/
HOUSTON CHRONICLE: Could hepatitis C be eradicated?
June 27 - Kyrie O'Connor
http://www.chron.com/news/health/article/Could-hepatitisC-be-eradicated-5585365.php
Geneva Belt is looking at a future she never thought possible.
Belt, 55, is more than halfway through a 24-week course of treatment for the chronic liver disease hepatitis C. At the end of it, she will almost certainly be cured.
For Belt and thousands of others who have lived with this infection for decades, often enduring debilitating and ultimately unsuccessful treatments, the emergence of new drugs that can kill the virus quickly, with minimal side effects, is nothing short of miraculous.
"This medicine," she said, "really is awesome."
Hepatitis C, a liver disease that has been a decades-long scourge - and sometimes death sentence - is on the brink of becoming a highly curable infection.
Drugs that eliminated the virus in some cases have been available for about 15 years, but the course of treatment was much longer than Belt's present one, the side effects often miserable and the outcome highly uncertain.
The drugs, especially interferon, caused nausea, fatigue, depression and autoimmune symptoms in many patients. Some found the side effects so intolerable they stopped treatment. Some finished treatment only to see the virus re-emerge.
Drugs available now, and new drugs coming out around year's end, promise shorter courses with only pills, no injections - 12 weeks or perhaps even eight weeks - and minimal side effects, as well as higher success rates.
"By the end of the year it will probably not require interferon in the majority of cases," said Dr. F. Blaine Hollinger, professor of molecular biology and microbiology at Baylor College of Medicine.
An estimated 3.2 million Americans are infected with hepatitis C, but as many as 75 percent don't know they have the virus, so the total could be much higher. At least 12,600 people in the Houston area are infected, according to the American Liver Foundation. The virus often lies dormant for decades, eventually progressing to cirrhosis (scarring) of the liver and liver cancer.
Hepatitis C is the leading cause of liver transplants in the Western world.
Most sufferers are baby boomers born between 1945 and 1965. Experts urge anyone in that group to get tested. Some 15,000 Americans die each year of hepatitis C liver damage, more than die of HIV/AIDS, according to the American Liver Foundation.
Hepatitis C is passed via blood, not casual contact. Blood transfusions or organ transplants before 1992 (when blood began to be screened), use of injectable street drugs, sharing dirty needles, non-professional tattoos and similar practices are the most common means of transmission. Hepatitis C can be transmitted sexually, but this is uncommon.
The breakthroughs have come over the past few years in increments. "We're not going from 0 percent cured to 100 percent cured," as Hollinger puts it. They involve drugs that interrupt the life cycle of the virus that causes hepatitis C, known as protease and polymerase inhibitors. Treatments considered current as few as three years ago are now passe, said Dr. John Vierling, director of Baylor Liver Health. "The most recent drugs will be obsolete in a year," he said.
Even now, an oral-only protocol that offers a very good chance of a cure is available, according to Dr. Michael Fallon, a gastroenterologist at Memorial Hermann Hospital and director of the division of gastroenterology, hepatology and nutrition at the University of Texas Medical School - Houston.
"Theoretically, we can do it now if we can get insurance to pay for it," said Fallon. The combination of the drugs simeprevir and sofosbuvir, considered "off-label" but still often paid for by insurance, eliminates the virus in just 12 weeks in a large majority of cases of genotype 1 hepatitis C, by far the most prevalent type in the United States. Genotype 2, the second-most-prevalent type, can be cured in more than 95 percent of cases by a combination of sofosbuvir and ribavirin, said Vierling.
New drugs promise to be antivirals that a patient can take once a day, all in the same pill. Even interferon, an earlier treatment dreaded for its side effects, has a new incarnation, lambda interferon, with fewer drawbacks. This opens the door for patients who have tried earlier protocols and been disappointed.
Belt, for example, underwent treatment last year under an older drug regimen. The drugs left her so debilitated that she stopped treatment after seven months, knowing that better medications were in the offing. Now, taking sufosbuvir and ribavirin, Belt has no side effects, just a slight weakening of her immune system. Already she shows no trace of the virus in her body. If that's still true six months after her treatment at CHI St. Luke's -- Baylor St. Luke's Medical Center ends, she'll be declared cured.
Belt, who works at a family health center, was, many years ago, an intravenous drug user, which is almost certainly how she contracted hepatitis C. Now, clean and sober for more than two decades, happily married and a devoted mother and grandmother, she's glad to rid herself of the last vestige of that lifestyle. It was her daughter, who works at St. Luke's, who urged her to get treated.
"I want to give other people hope," she said.
The cost of the new drugs is a serious concern, however. Sofosbuvir, a polymerase inhibitor sold under the name Sovaldi, costs $1,000 a pill, meaning a 12-week course costs $84,000. A protease inhibitor called simeprevir, sold under the name Olysio, is slightly less expensive. No one knows what the upcoming drugs will cost.
"The hope is that more competition and more time in the free market" will bring the cost down eventually, said Fallon.
Who gets treated is also a matter of debate. "Do we have to treat everyone?" Hollinger asked rhetorically.
He leans toward not treating all infected people right away. Most sufferers take 30 to 50 years to develop cirrhosis. "About 60 percent have Stage 1 liver disease," he said, "so they're probably not going to die of it."
He's fine with such patients waiting a decade or so until the prices of drugs come down.
On the other side are those awaiting a liver transplant. They stand a good chance of reinfecting a new liver and developing cirrhosis within three to five years, he said. But if the virus is eliminated before transplant, or a patient with a new liver is treated, the patients' lifespans can increase. Treating someone to avoid an eventual transplant or eventual cancer makes sense, Hollinger said.
Fallon, however, believes in treating those who want treatment, regardless of the progression of the disease. "I tend to treat people who have the disease who want to be rid of the virus," he said. "Most patients want to be treated."
One population in limbo is those in prison and jail. In those institutions, hepatitis C infection can run as high as 30 percent, said Dr. Owen Murray, vice president for the University of Texas Medical Branch Offender Health Service. Guidelines for treating hepatitis C are in place, but not yet for the newer treatments. A committee appointed by the Legislature is expected to make a decision this fall about the new drugs.'
One person who has no doubts about treatment is J. Michael Trevino. The Houston lawyer and oil-and-gas industry consultant, 64, (whose wife, Ileana, is the CEO of the Memorial Hermann Foundation) contracted hepatitis C long before it even had a name, probably during his induction into the U.S. Army or in Vietnam during the war.
From September 2012 until September 2013 Trevino, under Fallon's guidance, underwent a grueling 48-week course of drugs to try to eliminate the virus from his body. He has happily deleted the names of his medications from his iPhone, but he doesn't mince words.
"They were total ass-kickers," he says. "They took my body for a real physical test." At times he was taking 17 to 19 pills a day. His blood platelet count went way down and his weight took a roller coaster ride. "I was tired and weak, and I didn't have any stamina," he said. In February, Trevino was declared cured.
His story, in shorter, easier terms, will be repeated many thousands of times in the next few years. "From a national or world public health perspective," said Murray, "an infectious disease could come close to being eradicated."
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