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Medicaids/ Feds Deny HCV Treatment to Poor/Disenfranchised, Those Most Affected by HCV-
 
 
  HCV Restrictions New Meeting Dec 18, 2014 by California Panel (CTAF) That Previously was the 1st to construct absurd restrictions .....the CTAF meeting in March 2014 was the 1st "kangaroo court" to restrict HCV treatment access, it appeared rigged as all these efforts are, they are not in the best interests of patients/marginalized patients and are opposite of the spirit of Medicaid & federally funded healthcare...they say - HCV treatment is too expensive...we can't treat everyone....we will construct restrictions that in affect deny access to drug users & treat only those with advanced disease...neglecting many facts including that $22 bill a year is spent on HIV domestically...$10 bill by medicaid+medicare.....the CTAF paper was the 1st to push for HCV treatment restrictions followed by several state medicaid's including Illinois, Oregon & Florida, now these states want to prevent access to "drug users", treat only patients with "advanced disease".......it appears clear these groups are mounting a gigantic misleading public/media campaign to deny patient treatment access with untruths & misleading information, please read onto thru this report to understand the dynamics....... a little research finds the CTAF to be associated with, to have people on Boards from, to receive funding support from insurance payers/medicaids yet their HCV paper released in March accused the HCV Guidelines panel members of having conflicts of interests....many on-target critical comments were submitted to their March hearing [http://ctaf.org/sites/default/files/u119/Public_comments_recd_Hep_C1.pdf] including by noted HCV experts, here are just a few excerpts. CTAF held this public hearing & in their Final Paper ignored critical public commentary from experts in the HCV field- [webcast: https://www.youtube.com/watch?v=e6-GcFxzdb4]......."CTAF and its parent appear to be dominated by the health insurance industry. The facts about this relationship should be made clear and transparent, including that of panel members whose business models are dependent on links to the insurance industry."......"The CTAF report significantly underestimates the full lifetime costs of treating chronic HCV. In addition, the CTAF analysis unduly discounts the value of initiating treatment at early stages of disease, thus reducing the human and economic costs of cirrhosis, liver cancer, liver transplants and deaths from HCV. A 2011 Henry Ford Foundation study of patients with end stage liver disease estimated their annual medical cost at $60,000.".........."The current battle over the price of Hep C treatments will go down just as the already fought battle over HIV drug prices did. Eventually we will realize that it is absolutely INHUMANE to offer state of the art curative treatment, with many benefits only to the wealthy, while the most affected populations suffer ongoing consequences"...........Sammy Saab, MD, said" The current model used by the committee to assess the pharmaeconominc benefits of sofosbuvir leaves much to be desired......"
 
Paul Pockos, MD, a noted researcher & expert said" Your conclusion that sofosbuvir is "low value" is clearly not based on data or science. There are a number of publications which demonstrate the cost of untreated hepatitis C and it exceeds the cost of treatment significantly, even at the cost of current regimens with SOF. As well, the QALY increment with SOF therapy is <50,000$/yr by any calculation used (Younossi Z, et al. J Hepatology Feb 2014). As a treating physician I can assure you that patients are no longer willing to fail first generation DAAs or PEG IFN and RBV before initiating treatment with SOF. Your conclusions are clearly based on inadequate or inaccurate information. Please reconsider.....Cami Graham, MD criticized questioned the authenticity of a number of statements by CTAF and said In conclusion, I suspect the cost-benefit, especially of sofosbuvir-containing regimens, has been underestimated in this draft report.......I am concerned that an overall negative report, such as this, will delay needed uptake in awareness and screening programs, thus limiting the immediate cost-benefit that would be possible if those who currently have more advanced fibrosis were treated.
 
..............the medicaid & private payers have been off on a public press/media blitz campaign to support their restrictions to new HCV treatment for patients, and apparently the public bit hook, line & sinker......
 
"some payers (medicaid) are constructing unconscionable criteria to prevent access to treatment including Oregon & Illinois"......their press campaigns may be loaded with deceptive & misleading information they cite as evidence upon which to construct these unconscionable restrictions to HCV treatment......they cite the Sovaldi price as $84k in the press but medicaid's receive a 23% discount/rebate, the VA gets 44% under the& the Social Security Law Medicaid Rebate Section #1975 [http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Medicaid-Drug-Rebate-Program.html.......http://www.ssa.gov/OP_Home/ssact/title19/1927.htm] suggests the rebate is negotiable saying 'the rebate can't exceed 100%'; a medicaid, I believe Oregon, suggested they had the right to restrict use of HCV drugs approved after 2012,  and would provide HCV drugs approved before 2012, not after 2012, yet this law suggests the medicaid's do not have legal authority to create these harsh restrictions, the spirt or letter of the law says to me, here is exact language on Medicaid's website in the link above:
"The program requires a drug manufacturer to enter into, and have in effect, a national rebate agreement with the Secretary of the Department of Health and Human Services (HHS) in exchange for state Medicaid coverage of most of the manufacturer's drugs" this suggests that in return for a rebate the state medicaid is required to offer the drug, there is no language addressing that a medicaid can construct restrictions........only 70,000 patients have been treated so far this year nationally with Sovaldi yet each state medicaid claim's projected large expenditures that will break their budget for the year, do we know actually how much each medicaid spent on HCV treatment this year, are their projections, and let's not forget they were projections......often times their cost projections are based on the costs for treating all HCV-infected patients at once or many or most in the 1st year but reality is far from this, the system can treat only a small number of patients a year, this year so far only 70,000 have received Sovaldi, in the 1st year after the launch of telaprevir & boceprevir only 100,000 were treated, so these groups create an untruthful fear to the public about the costs......are they hyper-inflated as part of this media blitz campaign to win over public opinion, which they so far appear to have won, I SUGGEST - question their statements! ...nevertheless, perhaps its time for a new model to evaluate how to fund new innovative life-saving drug treatments in development for cancers & other serious life threatening diseases..... much more is being spent on HIV care & treatment, $22 billion a year is spent domestically on HIV, $4.5 bill by medicaid & $5 bill by medicare.....HIV treatment is lifetime, there is no cure for HIV, treatment is forever.......it costs $380,000 for ART for a patient over decades & $1 million for care & treatment....medicaids pay for this, why is this ok but not HCV care & treatment....some observers say the medicaid's are drawing the line here, on HCV, as a tactic with the public.....so they can create the same outcry regarding the coming of the new more expensive cancer & other serious diseases's drugs .....the legality of the restrictions by medicaids & these misdirected panels need to be challenged, a lawsuit might work, in fact Matt Salo from the national medicaid association said: one lawsuit could offer a cautionary tale......"any attempt to draw a line on an infectious disease will be met with a swift overturn in the courts", says Matt Salo, executive director of the National Association of Medicaid Directors.......http://www.yakimaherald.com/news/yhr/saturday/2363148-8/states-limit-medicaid-users-access-to-hepatitis-drug.......we need new models to evaluate new innovative drug treatments for sick patients....HCV is curable with 12 weeks therapy, HIV treatment is for lifetime & costs $400,000 to $1 million per patient over 20-40 year.......New Models for Healthcare Funding Needed - (08/06/14)
 
Next Public Meeting of CTAF to Examine Newest Treatments for Hepatitis C........will hold a public meeting on December 18, 2014 in Oakland, CA to assess the comparative effectiveness and value of multiple new, all-oral direct-acting antiviral agent (DAA) regimens for the treatment of hepatitis C. The review will cover treatments under review by the FDA, including those developed by Gilead Sciences, Inc. and AbbVie Inc., and possibly a third regimen developed by Bristol-Myers Squibb Co. CTAF examined the first two DAAs approved for treating hepatitis C (sofosbuvir and simeprevir) at its March 2014 meeting, and the December 2014 meeting will further help clinicians, patients, and policymakers understand the evolving evidence base on how best to treat hepatitis C. A policy roundtable discussion will focus on the issue of drug pricing and payment models for expensive drugs, of which the hepatitis C drugs are one example......http://www.icer-review.org/next-public-meeting-of-ctaf-to-examine-newest-treatments-for-hepatitis-c/ Some Payer Groups (medicaids-public/private-commercial) try to Hold Patients Hostage......Various countries & groups have made statements about Sovaldi on whether the drug is useful for patients, astonishingly the Oregon Paper said the sofosbuvir data is not good enough, the AASLD Guidelines were not good because they written by people with conflicts of interest & the FDA was wrong to NOT have comparator arms in Sovaldi studies. NOTHING could be further from the truth HCV Treatment Access/May 20, 2014- California Technology Assessment Forum (CTAF) Issues Final Report and Action Guides on New Treatments for Hepatitis C......http://www.natap.org/2014/HCV/062514_01.htm
 
California Technology Assessment Forum (CTAF) which is under the umbrella of ICER http://www.ctaf.org/- NEW DECEMBER meeting link where you can register to attend: http://www.ctaf.org/meetings/2014-12-18-000000......Objections CTAF raised: uncontrolled trials, low value of therapies relative to cost, HCV guidelines panel had "conflict of interests. INSTEAD they have a group, CTAF, evaluating HCV treatment, clearly none of them treat & have done HCV research, clearly controlled trials are unethical & unwieldy & unnecessary in this situation, the HCV guidelines panel recommendations earlier this year on treatments were stellar! one of the authors of the initial CTAF paper in March 2014 is Jeff Tice, MD who has developed cost-effectiveness analyses for the USPSTF, the group that is famous for creating biased medical statements about HCV screening & breast cancer....a look at the CTAF staff on their website finds a number on their Advisory Board with connections to the health insurance payers industry.....a look at the ICER, Institute of Clinical & Economic Review, Governance Board, finds several individuals from the insurance payer industry.
 
And the CTAF said: "It was noted that these guidelines do not attempt to address which patients should (or should not) be treated; nor do the guidelines include consideration of the costs of different treatment options", in response to this criticism, in my belief, the HCV Guidelines committee just announced their recommendation that prioritizing treatment for most advanced liver disease in light of the resource constraints is appropriate, which of course I criticized as caving in to these absurd restrictions to treatment by medicaid's.........
 
HCV Treatment, HIV Treatment: public & personal health denied - HCV Cost Burden - commentary - (08/11/14).......some payers (medicaid) are constructing unconscionable criteria to prevent access to treatment including Oregon & Illinois
 
Medicaid Restrictions, Opoid Replacement Therapy, African-Americans, Depression/Comorbidities....is this legal? A lawsuit- "swift overturn in courts" - (08/18/14)
 
Medicaids Restrictions Based on Misleading Information: African-Americans/ Opoid Replacement (Methadone) Users SVR Rates, comorbidities - (08/18/14)
 
"The relative paucity of evidence for genotype 1, treatment-experienced patients and for genotype 3 patients in particular were noted as the most significant needs for further evidence at this time."
 
Several CTAF
Panel members expressed strong opinions, however, that small, uncontrolled trials should not be the standard to which new treatments in this clinical area should be held going forward. The evidence was noted as being particularly limited for genotype 1, treatment-experienced patients, and for all genotype 3 patients......direct head-to-head trials or analyses of observational real-world data should be performed to buttress our understanding of the comparative clinical effectiveness of these drug regimens, particularly since new drug combination options are likely to be introduced over the next 1-2 years.............it is reasonable to consider prioritization of treatment by level of liver fibrosis.........For most patient subpopulations, the CTAF Panel found the new drug treatments for hepatitis C to represent a "low value" due to the magnitude of the potential impact on health care budgets of treating large numbers of patients with these high-priced drug regimens........The costs for initial treatment regimens including sofosbuvir or simeprevir are expected to range from a low of approximately $88,000 to a high exceeding $175,000 per patient
 
Specialty society clinical guidelines should be developed using best practices, including ratings of strength of evidence, transparency regarding the role of various organizations involved in guideline development, and full transparency regarding potential conflicts of interest of individual guideline committee members, with limits on the proportion of committee members who receive direct or indirect financial support from manufacturers......clinical guidelines for the treatment of hepatitis C developed by the American Association for the Study of Liver Diseases (AASLD), the Infectious Disease Society of America (IDSA), and the International Anti-Viral Society-USA.......A concern was raised regarding the difficulty in ascertaining the degree of drug industry support for the organizations involved in guideline development, and concern was also expressed that well over half of individual guideline committee members, including the committee chairmen, had either direct (e.g., consulting) and/or indirect support (for research) from the manufacturers of the new hepatitis C drugs
 
The goal of this technology assessment is to evaluate the comparative effectiveness and value of the new DAAs simeprevir and sofosbuvir in the treatment of chronic hepatitis C infection. There were no randomized or other studies that directly compared therapies based on simeprevir to those based on sofosbuvir or to the two first generation protease inhibitors boceprevir and telaprevir. We therefore performed a network meta-analysis to provide indirect evidence about the relative efficacy of the drug combinations available using currently FDA approved therapies.
 
All of the studies linking SVR to clinical outcomes are observational and thus may be subject to residual confounding. In addition, it is important to note that among patients with SVR, those with cirrhosis prior to treatment were still at risk for HCC during follow-up.80,81,83,88,89,93 Thus achieving an SVR24 will not prevent the complications of chronic HCV infection for all patients.
 
"the CTAF Panel voted that the two new drugs are likely superior in terms of clinical effectiveness for most patients and offer clinical benefits beyond current treatments. However, a majority of the CTAF Panel rated the new treatments as "low value" compared with older drugs due to the magnitude of the potential impact on health care budgets of treating large numbers of patients with these high-priced drug regimens.......consider prioritizing treatment with the new drugs for patients who need urgent treatment and are expected to benefit the most from immediate treatment."
 
"Even though the CTAF panel voted that the new drugs are likely superior in terms of clinical effectiveness for most patients and offer clinical benefits beyond current treatments, serious limitations in the evidence base remain"
 
"A majority of the CTAF Panel rated the new treatments as "low value" compared with older drugs due to the magnitude of the potential impact on health care budgets of treating large numbers of patients with these high-priced drug regimens"
 
"it is reasonable to consider prioritizing treatment with the new drugs for patients who need urgent treatment and have some evidence of liver fibrosis but do not have advanced liver disease"
 
Completed by:
Institute for Clinical and Economic Review

 
Download the PDF here

 
The Comparative Clinical Effectiveness and
Value of Simeprevir and Sofosbuvir in the
Treatment of Chronic Hepatitis C Infection
A Technology Assessment
Final Report
April 15, 2014
 
AUTHORS: Jeffrey A. Tice, MD
Associate Professor of Medicine
Division of General Internal Medicine
Department of Medicine
University of California San Francisco
Daniel A. Ollendorf, MPH, ARM
Chief Review Officer, Institute for Clinical and Economic Review Steven D. Pearson, MD, MSc, FRCP
President, Institute for Clinical and Economic Review
 
DATE OF
PUBLICATION: April 15, 2014

 
 
 
 
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