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Oregon Medicaid Restricts HCV Therapy Access....A Symptom of a Failing Healthcare System That Denies Human Dignity & Life
 
 
  [from Jules: such harsh restrictions put patients at increased risk for liver cancer, HCC, hepatocellular carcinoma. Studies show that waiting to treat HCV until after a patient develops cirrhosis increases risk for HCC. Even if a patient achieves SVR, a sustained viral response, a cure, good & accepted medical practice requires if a patient had cirrhosis already when cured they will have to perform an MRI every 6 months for the rest of their lives & continued visits to their hepatitis specialist to be followed along with the MRI so at the very least the costs associated with this over a lifetime rival the cost of treatment. It is well established that the cost of NOT treating HCV is more expensive to the healthcare system than treating HCV, even UnitedHealthCare says so....."expenses can be expected to decrease over time as successfully treated patients avoid progressing to more severe forms of the disease"......http://www.natap.org/2014/HCV/062514_07.htm ......We need a new model to evaluate the utility of healthcare and innovative new therapies in the USA. The new HCV treatments are the first time in medical history that we can cure a virus, nonetheless with 12 weeks only of therapy with tolerable drug therapy. HIV is lifetime therapy & care entailing much greater costs to medicaid, commercial insures & healthcare compared to HCV. Innovative new therapies for serious life threatening diseases such as cancer are emerging, so we need a new model to evaluate healthcare in the USA, it is unethical to deprive patients life saving therapy. The federal government should be holding meetings & hearings on this issue. At this time we are cleft with the Wall treat model that evaluates the invest ability of a company - how much will it profit this quarter to make the stock increase. Private & public healthcare payers including medicaid's evaluate whether they can pay for new innovative life-saving expensive therapies based on their budget for the year, this HAS TO END. Federal, state & local govts need to figure out a way to devise a new model, perhaps that can actuarially address amortize costs differently, not for 1 year, but over a longer period of time, say 10-15 years. Plus we can find ways for cost saving rather than using sick patients as hostages, by diminishing the worth of an individual's life by simply saying NO we won't pay for your treatment that might save your life because my budget this year is too big. Let the states & the federal govt meet along with private & public payers and figure out a way to humanely address this issue, it doesn't only apply to HCV but to a host of serious life threatening diseases where research is investing quite a lot of resources to find life saving new therapies......http://thehealthcareblog.com/blog/2014/06/24/the-long-and-short-of-health-numbers/.........http://blogs.wsj.com/pharmalot/2014/06/24/what-impact-will-hepatitis-c-drugs-have-on-medical-costs-look-here/?KEYWORDS=hepatitis+c
 
An Oregon Medicaid committee on Thursday significantly scaled back access to an effective...... new drug used to treat hepatitis C......http://www.abc-7.com/story/26165081/oregon-medicaid-targets-expensive-hepatitis-drug......."Medicaid directors group said he worries about the potential for similar lawsuits over hepatitis C coverage guidelines"......several other state medicaid's are implementing similar restrictions...."is not an ethical and viable approach...."It's just horrendous....said Brian Edlin, at Weill Cornell Medical College/Institute for Infectious Disease Research at the National Development and Research Institutes......Illinois' Medicaid program is putting tight restrictions in place, including requiring patients to meet 25 criteria and get prior approval before the government program will pay for the new drug...http://www.nwherald.com/2014/07/30/illinois-medicaid-restricts-use-of-hepatitis-c-drug/at5ooiq/?page=2.........regarding Illinois restrictions: Dr. Steven Flamm of Northwestern University Feinberg School of Medicine said the constraints could eliminate all but 30 percent of the Medicaid patients he'd like to treat with Sovaldi. "It's going to ratchet down the numbers and lead to significant outrage in the community and among patients," said Flamm, who is involved in research and accepts consulting fees from several drug companies. The limit on early treatment is what bothers Dr. Nikunj Shah of Rush University Medical Center. He'd rather treat with Sovaldi before severe liver damage occurs. Treating earlier could prevent expensive liver transplants. "I think this would be much better investment of the money for the state," Shah said.
 
[the approach would reduce the state's costs from an estimated $168 million in the coming year to about $40 million...http://www.oregonlive.com/health/index.ssf/2014/07/oregon_moves_closer_to_limitin.html]
 
"Oregon's guidelines would allow the drug to be used only for patients with later stages of liver damage who have been drug-free for at least six months. The drug could only be prescribed by a liver or gastrointestinal specialist, which often requires months of waiting for an appointment."
 
Oregon took up the issue a day after Illinois' Medicaid program put in place tight restrictions on the use of the drug, including requiring patients to meet 25 criteria and get prior approval before the government program will pay. A separate Oregon panel could go even further next month, removing Sovaldi from the list of treatments covered under Medicaid and requiring doctors to make an individualized appeal to obtain the coverage. Oregon can take such a strong stance because of a federal waiver that allows the state to prioritize treatments for medical conditions based on their cost-effectiveness.
 
Tom Burns, director of pharmacy programs at the Oregon Health Authority, said it's impossible to know how many patients will make it over the hurdles officials are establishing.
 
Hepatitis develops slowly over years or decades. Oregon officials say that while they wait for the price to drop or for new treatments to come on the market, they want the drug available only to those who face imminent severe liver problems.
 
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From Yesterday's News:
 
Some Medicaids Restrict Sovaldi Access...to sickest patients, only with Cirrhosis...."not an ethical and viable approach....horrendous"....Arkansas
patients suffering from cystic fibrosis filed a lawsuit last month claiming the state refused to cover a $300,000 drug because of its cost......Salo of the Medicaid directors group said he worries about the potential for similar lawsuits over hepatitis C coverage guidelines.
 
Doctors who have seen Sovaldi wipe out the virus find the rules too restrictive. Dr. Steven Flamm of Northwestern University Feinberg School of Medicine said the constraints could eliminate all but 30 percent of the Medicaid patients he'd like to treat with Sovaldi.
 
"It's going to ratchet down the numbers and lead to significant outrage in the community and among patients," said Flamm, who is involved in research and accepts consulting fees from several drug companies.
 
The limit on early treatment is what bothers Dr. Nikunj Shah of Rush University Medical Center. He'd rather treat with Sovaldi before severe liver damage occurs. Treating earlier could prevent expensive liver transplants. "I think this would be much better investment of the money for the state," Shah said. By the end of 2014, half of Illinois Medicaid patients will be covered by a managed care plan. The private insurers with Medicaid contracts are writing their own Sovaldi rules. Illinois has agreed to pay the managed care plans more to account for the new drug, but not by as much as the plans would like. "The medical world is a dynamic one and we would like a universal solution to fit the needs of health plans, the state and consumers," said Samantha Olds of the Illinois Association of Medicaid Health Plans, which represents nine health insurers with state contracts.
 
In contrast to Medicaid, people with private insurance have out-of-pocket costs such as copays, which get them thinking critically about whether a drug is worth it, Goyal said. Medicaid patients pay nothing. The cost falls on taxpayers, leaving governments to make the call.
 
Diana Sylvestre, who founded an Oakland clinic treating hepatitis C patients, said new Sovaldi guidelines from California's Medicaid program appear overly burdensome....."The new policies are going to further restrict access to care for thousands of patients on the basis of no evidence," said Sylvestre.......http://www.washingtonpost.com/blogs/wonkblog/wp/2014/07/24/the-drug-thats-forcing-americas-most-important-and-uncomfortable-health-care-debate/
 
[Matt], Salo expects that states will have to choose which patients are sick enough to receive treatment. Should it be patients with stage-four liver damage? Stage three? And if a line is drawn, and states refuse treatment to some until their liver is in worse shape, is it ethical? "I think rationing, which is what people are talking about doing, is not an ethical and viable approach," said Brian Edlin, an associate professor of public health and medicine at Weill Cornell Medical College and a senior principal investigator at the Institute for Infectious Disease Research at the National Development and Research Institutes.
 
Imagine, he said, telling people they have an infection but they have to wait until their liver is really shot before they can be treated....."That, to me, is, I don't know the word to describe it," he said. "It's just horrendous."
 
Oregon's current coverage policy for Sovaldi usually requires that patients have significant liver scarring, or what's known as stage-three or stage-four fibrosis. On July 31, an advisory committee of physicians will consider a recommendation by Oregon Medicaid staff to narrow the eligibility criteria to include only patients with stage-four fibrosis, the point at which liver damage starts to become irreversible, or cirrhosis, Burns says.....http://blogs.wsj.com/pharmalot/2014/07/17/oregon-to-pharma-lets-make-a-deal-on-hepatitis-c-drugs/
 
Oregon and several other states are looking to limit who has access to the drug that nearly everyone acknowledges is a revolutionary treatment for the disease affecting more than 3 million Americans......."We recognize that there are those patients who must be treated, and we're going to treat them," said Burns, director of pharmaceutical purchasing at the Oregon Health Authority, which oversees the state's Medicaid program. "But the vast majority can wait while we figure out a policy that doesn't bankrupt this state.".......Three Arkansas patients suffering from cystic fibrosis filed a lawsuit last month claiming the state refused to cover a $300,000 drug because of its cost. Salo of the Medicaid directors group said he worries about the potential for similar lawsuits over hepatitis C coverage guidelines.
 
The big unknown is whether a new round of hepatitis C treatments expected to hit the market in the next couple of years will come in at a lower cost or if they'll be as effective as Sovaldi.....Diana Sylvestre, who founded an Oakland clinic treating hepatitis C patients, said new Sovaldi guidelines from California's Medicaid program appear overly burdensome....."The new policies are going to further restrict access to care for thousands of patients on the basis of no evidence," said Sylvestre.......http://www.washingtonpost.com/blogs/wonkblog/wp/2014/07/24/the-drug-thats-forcing-americas-most-important-and-uncomfortable-health-care-debate/
 
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