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Cost of NOT Treating HCV
  The article below published today and many articles like this herald the costs associated with treating HCV. This new article report NYS Medicaid spent $185 mill in the 2nd quarter of 2015 on HCV drugs. What they don't discuss is WHAT iS THE COST OF NOT TREATiNG HCV and what are the long term outcomes and benefits for treating ALL. At the November 2015 NYS Durb meeting, NYS officials said 57,000 in NYS Medicaid have HCV. Drug costs have declined by 50% so at the price of $50,000 that works out to $2.15 Billion total drug costs to treat all patients. The total healthcare savings over the next 30 years by treating all these patients outstrips the $2 billion. Right now NYS Medicaid imposes the harsh restriction that only patients with cirrhosis can be treated. Performing an MRi (see explanation below) for each of these patients forever every 6 months totals $171 million. This study published recently in Health Affairs [http://www.natap.org/2015/HCV/101515_01.htm] found TREATiNG ALL patients provides the best value to society: "Treat all: Using the latest drugs, this approach would have the greatest social value, generating up to $1.2 billion in QALYs and saving up to $139 billion in medical costs over a 50-year span. Cases would drop to 1,400 in 50 years, but up-front treatment costs would exceed $150 billion". Many cost-effectiveness studies have been published and reported at this years AASLD showing it is less expensive in terms of total healthcare costs to pay up front the one-time cost than to delay or not treat. in addition, work productivity has also been the subject of many studies, here is just one such study conducting an analysis and finding costs due to work productivity impairment in the USA is $7.1 Bill and the savings amount to $2.7 Billion each year in the USA upon achieving an SVR [http://www.natap.org/2015/DDW/DDW_17.htm].
Patients with HCV can develop what is called extra-hepatic manifestations: cancers, cardiovascular disease. Studies have found once HCV is cured these other diseases can be prevented or at least the risk for developing them is reduced [http://www.natap.org/2015/HCV/091815_03.htm] [http://www.natap.org/2015/iAS/iAS_105.htm].
This study from the CDC [http://www.natap.org/2015/HCV/102015_03.htm] found that the risk for hepatic decompensation or HCC quadruples if treatment is delayed from F0-2, early disease, to cirrhosis: from 8% to 37%:
CDC CHeCS Study Reports - Risk for Liver Decompensation is 8.1% for F0/1-2: "Our study provides timely data for understanding the implications in the United States if HCV treatment is delayed in certain patient groups as a national debate is ongoing regarding restrictive policies for access to newer HCV therapies
[13]. Our risk estimates in patients with early stages of liver disease are important for cost-effectiveness analyses and policy decisions about timing of treatment [20].......patients staged at F3 and F4 at baseline were treated for HCV, sometimes with >1 attempt, an overall 19.6% of F3 patients and 37.2% of F4 patients went on to experience hepatic decompensation or HCC within 5 year.....in F4 patients, the 1-year progression rate to HCC was 4.8% and to hepatic decompensation was 13.4%. "Decompensation [included] conditions of hepatic encephalopathy, esophageal varices with bleeding, ascites, or hepatorenal syndrome were defined as the first occurrence of iCD-9 diagnosis or CPT codes in following groups: hepatic encephalopathy (572.2), portal hypertension (572.3, 37140, 37160, 37180, 37181, 37182, 37183), esophageal varices with bleeding (456.0, 456.20, 42.91, 44.91, 96.06, 43204, 43205, 43243, 43244, 43400, 43401), ascites (789.5, 789.59, 54.91, 49080, 49081), or liver failure with hepatorenal syndrome.
AND this study found patients develop more comorbidities the longer they delay HCV treatment:
"The proportions of patients who had comorbidities, abnormal liver and renal function tests, and low platelets grew with increasing fibrosis stage, and in the F4 group, only about half (55.9%) did not have any Charlson comorbidity diagnosed (Table 1)."
From Jules: the Charleston index for comorbidities they used includes not only renal & liver diseases but also heart disease, cerebrovascular disease, diabetes, dementia, peripheral vascular disease.
it is this type of article below and information that misleads the public.
Yes Medicaid may have spent $185 mill in the 2nd QTR of 2015 on HCV drugs, and if you multiply times 4 that equals about $740 mill for a year although apparently treatment numbers appear to be decreasing as the year wears on, so perhaps its lower. But this is a CURE, so once a patient is treated and CURED healthcare costs are essentially eliminated. HCV is not like HiV, which are compared by the article below, you can't compare them. The US federal government spends $10 BiLLiON each and every year forever for domestic medicaid & medicare on HiV. if one year of HiV drugs costs about $15,000 after 30 years that is almost $500,000 not to mention associated healthcare costs that would include rotor visits, labs, associated healthcare costs like the costs of treating comorbidities and the drugs and hospitalizations associated with a cormorbidity caused by HiV like bone disease or kidney disease. i see a heart specialist and a kidney specialist and have for many years and i fill prescriptions associated with kidney disease which is caused by HiV or HiV ARTs. SO, once a patient is cured of HCV that iS iT, the disease is in theory GONE. BUT most important in the context of this discussion is that NYS MEDiCAiD as other Medicaids restrict access to HCV drugs so only patients with advanced disease, who have cirrhosis can get these drugs. Patients with earlier disease are restricted or prevented from getting access, as both Medicaid & Commercial insurers are imposing these harmful restrictions, harmful to patients and society. Delaying therapy until cirrhosis is self-defeating. Once a patient develops advanced disease they are less likely to regress their liver disease. That is, when a patient is cured liver disease can and usually regresses back towards normal iF TREATED BEFORE CiRRHOSiS. Once cirrhosis develops the capacity for regression is reduced, many studies recently have shown this. At this year's AASLD in November in San Francisco study investigators reported regression of liver disease for 69% of patients cured when they had F3-4 stage liver disease but only 55% regressed if they were treated when they had cirrhosis already http://www.natap.org/2015/AASLD/AASLD_71.htm. This study received quite a lot of attention at the AASLD meeting. Once any patient has cirrhosis despite being cured they have an increased risk for developing HCC, liver dance (hepatolcelluar carcinoma). The standard of care for this patients is despite a cure forever they must do an MRi every 6 months to check for HCC, an MiRi costs $1500-2000, that equals $90,000 to $120,00 after 30 years, not to mention doctor visits and lab costs. in addition once a patient is cured there are benefits in work productivity, contributions to society. The best time to treat TO PREVENT LiVER CANCER is in the earliest stages of liver disease, F-0/1/2, the earlier the better.
Here are other studies reported this year finding similarly:
This study at AASLD found that the risk of developing liver cancer (HCC) was 0.327% among people with HCV but the real news even after a patient achieves a cure (SVR) if that patient delayed treatment until after they developed cirrhosis the risk was 4.55 fold higher. Cirrhosis is a predictor of developing liver cancer. But don't get too alarmed because even if a patient has cirrhosis and then achieve an SVR the overall risk of developing liver cancer is low: this study found the risk 8 years after achieving SVR was 8.5%, but if the patient achieved SR when the patient had bridging fibrosis the risk was only 1.8% http://www.natap.org/2013/AASLD/AASLD_39.htm
This study - http://www.natap.org/2015/HCV/102015_03.htm - reports amongHCV-infected with very early disease, no fibrosis (F1) or very little (F2) fibrosis the risk HCC or decompensated cirrhosis is 2.3% but doubles to 4.7% by the time patients reach the next stage of liver disease (F2), but of note once the patient gets to F3 which is the beginning stages of cirrhosis the risk triples as 19.6% of patients develop hepatic decompensation or hepatocellular carcinoma (liver cancer, HCC), and for patients who are F4, cirrhosis the risk doubles again to 37.2% for developing decompensated liver disease or HCC; decompensated liver disease is when serious complications of liver disease occurs and the liver is no longer able to function well. Finally for today's report several important studies reported this year found if a patient achieves SVR after cirrhosis has developed the chance of seeing regression of the liver disease (improved liver fibrosis is much less, one study in HiV-coinfected patients - http://www.natap.org/2015/iAS/iAS_55.htm - reported 45% of these patients did not achieve fibrosis regression and had increased death rates. Another study in HCV-moninfected patients found 96% with earlier disease F2 had fibrosis regression but 71% with F4 achieved fibrosis regression. And another study found HCV disease moves more quickly than many think. Although it is traditionally thought that it takes 20-30 years for most HCV-infected to reach cirrhosis, this is not true for everyone. "Our study shows that fibrosis progression after HCV infection starts early and that a substantial proportion of HCV-infected persons develop significant fibrosis or cirrhosis within the first 5 to 10 years of infection". This study - http://www.natap.org/2014/HCV/121214_01.htm - reported: FiB-4 scores (a bloodiest that measures fibrosis) doubled in the first 4 years after HCV-infection and more than 18% of them developed cirrhosis within 10 years after infection, our data would suggest treating early.....At 5 years after HCV-fection, more than 15% of HCV+ persons had a diagnosis of cirrhosis,...."Our study and after 10 years following HCV-infection 18.4% of patient developed cirrhosis.
these 2 studies at iAS (intl AiDS Conference-8/2015) finding that despite an SVR if the patient already had cirrhosis the risk for disease & death persists: in 1 study of patients with cirrhosis who achieved SVR 71% achieved fibrosis regression vs 96% treated with F2 & 87% treated at F3 [http://www.natap.org/2015/iAS/iAS_111.htm].....in the 2nd study at iAS this summer this study was conducted with Peg/Rbv [http://www.natap.org/2015/iAS/iAS_55.htm], in patients had cirrhosis - more patients with less advanced disease achieved SVR - "45% of HiV coinfected patients with cirrhosis who achieved SVR did not achieve fibrosis regression (FR) & 32% of them died vs 17% who died who did achieve fibrosis regression (p=0.01) and 11% with SVR but without FR experienced liver-related complication vs 4% who had SVR but FR (F=0.2) and 16% with SVR but without FR experienced hospital admission vs 9% with SVR but without FR....and "Fibrosis regression cut the overall death risk 64% and and the liver-related death risk 85%".....in the SVR group, 4 of 23 with fibrosis regression died, compared with 6 of 19 without regression (17% versus 32%, P = 0.01).......in the SVR group, 4 of 23 with fibrosis regression died, compared with 6 of 19 without regression (17% versus 32%, P = 0.01). Mortality with versus without regression was 2.45 versus 5.36 per 100 person-years. One person with fibrosis regression and 3 without regression had a liver-related death (4% versus 16%, incidence 0.61 versus 2.68, P = 0.01). Liver-related complications and hospital admissions also proved less frequent in the group with fibrosis regression, but not significantly so.
New York Medicaid spending soars on Hep C drugs
By Dan Goldberg 5:39 a.m. | Dec. 14, 2015
New York State's Medicaid program spent nearly $185 million on hepatitis C drugs during the second quarter of 2015, accounting for more than 6 percent of all drug spending.
That's up nearly 50 percent from the $124 million the state's insurance program for low-income New Yorkers spent during the first three months of the year, according to data released by the Centers for Medicare and Medicaid Services. Drug prices have become the focus of national outrage, with presidential candidates from both sides of the aisle and a bipartisan group of lawmakers criticizing pharmaceutical companies for the exorbitant prices of new drugs, and exponential price increases for existing drugs.
Most of the spending - $145 million - went to Harvoni, a drug made by Gilead Sciences that came on line at the end of 2014. it was, by far, the costliest drug in the Medicaid program.
Harvoni can cure patients of hepatitis C, which had previously been a chronic infection that could cause liver failure.
The sticker price is more than $90,000 for one course of treatment, but Medicaid officials negotiate large rebates that can reduce the cost by more than 50 percent.
Even with these discounts, New York's Medicaid program spent nearly three times as much on Harvoni as it did on the second-most expensive drug, Truvada, a pill that prevents HiV infection.
The state's Medicaid spending is on top of the $415 million New York seniors spent on hepatitis C drugs via the Medicare program through the first six months of the year, and while long-term benefits may outweigh the short-term costs, politicians and public health officials are discouraged at what appears to be the unending pursuit of profit.
A recent Senate report accused Gilead of trying to maximize its revenue even though company officials knew a lower price would allow more people to receive the life-changing drug.
Gilead "respectfully disagreed" with the report's conclusions.
Treating the disease, which effects more than 200,000 New Yorkers, according to the state health department, could save taxpayers billions over the long term because there will be less need for liver transplants and maintenance medications.
Yet the immediate expense is what has New York officials, and Medicaid directors across the country, worried, and has forced at least two dozen states, including New York, to ration care to only the sickest patients.
The state and federal government split the cost of New York's Medicaid program, which restricts Harvoni and Sovaldi - another drug also made by Gilead - to only the sickest patients.
in the near term, taxpayers are likely to be on the hook for an even greater figure as baby boomers, soon to age on to Medicare, learn they have hepatitis C, a virus that is contracted through contaminated blood but can lay dormant for decades.

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