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HCV Guidelines Questionably Prioritize The Sickest To Be Treated, New Guidelines Section- "WHEN AND IN WHOM TO INITIATE HCV THERAPY" - commentary
  ".....last week Illinois state medicaid was the latest to announce what is perhaps the most severe restrictions following the week before Oregon's plan to restrict access which is also a harsh & punitive plan. The Illinois criteria for Sovaldi allow for treating only patients with the most advanced disease: Patient must have a metavir score of 4 or worse, AND the criteria exclude patients with evidence of substance abuse including alcohol, illicit drugs or prescription opoids) in the past 12 months.....Oregon's restrictions are similar..... miscarriage of justice, this insult to patients ...unamerican..... laws say state medicaid receive rebates/discounts & are supposed to provide unfettered access receive rebates/discounts."
Jules Levin, NATAP
Yesterday the HCV Guidelines panel held a conference call with the press/media & announced that HCV treatment is recommended but priority for treatment is recommended for the sickest patients including advanced fibrosis (F3), compensated cirrhosis (F4), liver transplant recipients, and patients with severe extra hepatic hepatitis C, with further details & their exact language below. Is this ok? I say no! Illinois just this past week & Oregon last week, their state medicaid's, announced intention to impose severely harsh & punitive restrictions to access to Sovaldi and presumably for new current HCV therapies. What will happen in the Fall when 5 new HCV therapies are FDA approved, we don't know yet. Why didn't the guidelines panel challenge these restrictions, why did they in essence say - ok if you are going to impose the restrictions we will provide guidelines that work with the restrictions. This provides cover to these state medicaids actions, and I question the legality of these restrictions imposed by the medicaids, see below a link I provide to the language in the Social Security Law Medicaid Rebate program, where it appears to say plainly medicaids get a discount or rebate from the manufacturer in return for providing access, there is no mention allowing states to impose their own new restrictions. The panel issued a great set of initial recommendations earlier this year on treatment and the panel includes many of the leading experts in HCV care, treatment & research. I understand & appreciate perhaps the panel feels they are trying to provide assistance in decision-making about treatment in the context of the current difficult situation, but this new recommendation lacks leadership & smacks of going along to get along too easily. The decision to treat & when & with what should be a decision between patient & clinician (doctor), I don't know of any other disease in the USA where patients are told to wait until they have advanced disease to be treated. Read the link below to the Social Security Law Medicaid Rebate program & see for yourself if these state medicaid restrictions are legal, I think the legality of these restrictions can & should be challenged. Congress & the White House should be brought to bear on this question, certainly the Social Security Administration & CMS, Medicare & Medicaid federal authorities should be asked about this. The state medicaids & the private/commercial insurance payers have been complaining about the price of the new HCV drugs. State medicaids receive by law a 23% discount or rebate, and the VA is receiving 44%, and if you read the link to the law below it says the rebate can't be more than 100%, so it appears negotiable to higher than 23%. The law appears to say that in return for the discount the state medicaid is to provide access to drugs, there is no mention of a right to impose arbitrary restrictions. In fact Illinois restrictions say not to treat one where there is evidence of substance abuse in the past 12 months, this is absurd because the highest transmission risk is injection drug use, so the Illinois restrictions don't want to treat the patient population most affected by HCV. The way the new section in the guidelines addresses this is by saying: "Treatment of individuals at high risk to transmit HCV to others (Table 2) may yield long-term future benefits from decreased transmission and a potential decrease in HCV disease prevalence."[table 2 is below in this report]. Oregon recommended similar restrictions including it is my understanding to prioritize HCV drugs approved before 2012 but not after 2012, where in the Social Security Law Medicaid Rebate Program does it permit for such arbitrary restrictions. The law says all FDA approved drugs are to be provided in return for a rebate from the manufacturer. The federal govt spends $22 billion a year on HIV care & treatment domestically, $5 bill on medicaid, and $4.5 billion for medicare, in HIV. Deaths due to HCV have surpassed HIV in recent years, in the USA. The federal govt has not responded to requests for adequate funding for HCV, their spending is paltry & what should be embarrassing, essentially a few million dollars on HCV. Congress & the White House have put window dressing on the problem, but they do not put essential funding into HCV to in any way address this problem in a serious way, they both throw rhetoric at the problem without real funding for an infrastructure for screening, care & treatment & support services. The old ADAP Working Group back around 1997 was a model for a working group able to get funding for ADAP Perhaps, we need for HCV a similar type of model/Working Group in HCV, one similar in format but with different working principles & led by innovative strong thinking & actions with a good understanding of the dynamics of this situation. HIV had a Ryan White Care Act which HCV may not need but some federal programs are needed. HCV is not like HIV, its an easier problem in many ways, HCV is curable with limited duration therapy, only 12 weeks, without interferon now, with tolerable therapies, we should be celebrating the new discoveries in HCV drug treatment, the federal govt should want to help solve this problem. HCV can be eradicated in the USA with federal support. While HIV is lifetime therapy, treatment alone can cost $380,000 for a lifetime & $1 million for a lifetime for care, office visits, comorbidities, housing etc.
Yesterday's HCV Guidelines PRESS CONFERENCE, during the conference call yesterday this was said:
The latest addition, reporters were told, is a section on when - and in which patients - to initiate therapy......."From a clinical perspective, we are most concerned with those with severe liver disease,", Patients with advanced fibrosis or who have had a liver transplant are at the "highest need for urgent treatment," said Donald Jensen, MD, of the University of Chicago Medical Center, co-chair of an HCV guidelines panel organized by the Infectious Diseases Society of America (IDSA) and the American Association for the Study of Liver Diseases (AASLD), in collaboration with the International Antiviral Society-USA (IAS-USA) .......The advent of the novel direct-acting agents -- the first were approved in 2011 -- offers the possibility of eradicating the disease in a "very high percentage" of patients, Jensen said......"We hope that the cost issues will be sorted out in another venue," Jensen said, "but it's really patient-directed care that we're concerned about."......"We understand that the system is struggling because these medications are expensive.....and we need to provide some at least indirect guidance on who has the highest priority.", said Michael Saag, of the University of Alabama at Birmingham, the guidelines co-chair for IAS-USA.......One goal of the guidelines is to create a larger clinical workforce capable of treating patients with HCV, especially if that testing takes hold and a large number of people suddenly begin demanding treatment. "There aren't enough hepatologists in the United States to see all these patients," Saag said. "These guidelines will be able to help educate not only those who are very expert in the field about new and emerging treatment trends, but also to educate those who are perhaps new to the treatment of hepatitis C."......the guidelines are online and under constant revision, making them a "living document" that can cope with a rapidly changing field, said Saag.
Yesterday the HCV Guidelines (IDSA/AASLD) panel held a press/media conference call where they announced and discussed, took questions, regarding the release yesterday of their new section titled "WHEN AND IN WHOM TO INITIATE HCV THERAPY". Essentially as you can see they say "treatment is recommended for patients with HCV-infection"....."virologic cure is expected to benefit chronically infected persons"......."Limitations of workforce and societal resources may limit the feasibility of treating all patients", indirectly & I think underwhelmimg reference to recently announced harsh & punitive restrictions implemented by some insurance payers including state medicaid's Illinois & Oregon,........initiation of therapy should be prioritized first to those specific populations that will derive the most benefit or have the greatest impact on further HCV transmission. Others should be treated as resources allow [from Jules: really! As resources allow?, how about something stronger], treatment should be prioritized for patients with advanced liver disease". This announcement comes at a time when several state medicaids announced severe harsh & punitive restrictions to currently available new HCV drugs. Specifically last week Illinois state medicaid was the latest to announce what is perhaps the most severe restrictions following the week before Oregon's plan to restrict access which is also a harsh & punitive plan. The Illinois criteria for Sovaldi allow for treating only patients with the most advanced disease: Patient must have a metavir score of 4 or worse, AND the criteria exclude patients with evidence of substance abuse in the past 12 months: "The patient does not have evidence of substance abuse diagnosis or treatment (alcohol, illicit drugs or prescription opioids and other drugs listed on the schedule of controlled drugs maintained by the Drug Enforcement Administration) in the past 12 months".........Here is an interview with the Illinois Medicaid Medical Director where he says: "Why is it so bad to tell them they should be sober and take the drug in a dependable fashion? If someone is using a street drug such as heroin I can't be sure they are compliant taking Sovaldi. It's a total waste."- http://www.natap.org/2014/HCV/080814_07.htm. ATTACHED IS THE PDF- Sovaldi (Sofosbuvir)-HFS Criteria for Prior Approval Final: July 10, 2014.
Download the PDF here
These severe restrictions are occurring in some states not all, NYS & many other state medicaid's are covering the new HCV drugs available now, and bear in mind in the Fall - Oct/Nov - it's expected the FDA will approve several new HCV medications & regimens eliminating the need for interferon at all - Gilead's fixed dose combination Sovaldi/Ledipasvir, Abbvie's 3D regimen, BMS' daclatasvir and asunaprevir, and Janssen's supplemental IND request for simeprevir+sofosbuvir. These combinations, without interferon provide with 12 weeks therapy in general up to a 100% cure rate. It remains to be seen what the public & private payers will do regarding coverage after the FDA approves these medications.
Now, the law requires state medicaid's to provide these therapies & all drugs FDA approved, and in return state medicaid's receive a 23% or greater discount. The VA receives currently a 44% discount and by my reading of the federal regulations, Medicaid Rebate. Social Security Laws, the discounts are negotiable & the law says the discount, they call it a rebate, can't go beyond 100%. So, is it legal for the states to impose these restrictions, here is link to the language in the law, read for yourself, to me the laws say state medicaid receive rebates/discounts & are supposed to provide unfettered access receive rebates/discounts. Last week Oregon said they plan to allow access only to FDA drugs approved for HCV before 2012, Dec I think is the month, but not after that. The law doesn't say that a state Medicaid can do that. These restrictions sound illegal. As well, in order to make their case Oregon authorities questioned the effectiveness of Sovaldi, thus questioning all the new oral drugs, they accused the HCV Guidelines committee of having a conflict of interest, and they said the FDA approval to allow the companies to conduct their studies without a comparator arm undermines the outcome of the studies, in other words Oregon says the studies should have randomized study patients to either the new drug or regimen vs the old standard of care which would have been telaprevir or boceprevir +Peg/Rbv, which the FDA said the companies should NOT do because it was not appropriate to do that, for several good reasons that everyone agreed were very appropriate. The HCV guidelines panel did a great job in their initial guidelines which came out earlier this year http://www.hcvguidelines.org/, the panel are widely recognized experts with long standing records in HCV research, care & treatment, and their recommendations were well received. This new recommendation to prioritize the sickest patients (F3/F4) is to me very questionable. It sends the wrong message. In the face of such harsh restrictions they should challenge state medicaids on the restrictions rather than merely going along with this miscarriage of justice, this insult to patients.
Section 1927 of the Social Security Act (actual text of the law establishing the Medicaid drug rebate program):
Here is language from their new section: "Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure; virologic cure is expected to benefit chronically infected persons. Limitations of workforce and societal resources may limit the feasibility of treating all patients within a short period of time. Therefore, when such limitations exist, initiation of therapy should be prioritized first to those specific populations that will derive the most benefit or have the greatest impact on further HCV transmission. Others should be treated as resources allow."
Here are their recommendations-




Here is IDSA statement on HCV drug pricing.......http://www.idsociety.org/Hepatitis_C_Antivirals_Statement/
IDSA Statement on Hepatitis C Antivirals
The Infectious Diseases Society of America (IDSA) is encouraged by the recent development of direct-acting antivirals for the treatment of hepatitis C virus (HCV). With an estimated 3 to 4 million Americans infected with HCV, the potential for cure offered by these new drugs for a majority of patients with HCV represents a significant medical advancement.
There are many factors that impact an individual patient's access to care - availability of and access to appropriate health care practitioners, insurance benefit design (including drug coverage and cost-sharing), and drug affordability. IDSA recognizes the substantial investment in research and development required to bring new, effective drugs to patients. We are, however, concerned that pricing of new drugs may put such therapy out of reach for many patients who are most in need of these life-saving drugs. IDSA is hopeful that the various stakeholders can work together to maximize patient access to optimal care.


Hepatitis C Treatment: Guidance on When and in Whom to Initiate Therapy Published Today Online
When and in Whom to Initiate HCV Therapy, the newest section of the HCV Guidance website, was published today by the AASLD/IDSA/IAS-USA.
The Panel of the AASLD/IDSA/IAS-USA Guidance recommends that everyone with HCV infection be treated. Owing to limitations of the capacity within the health system and the availability of resources, treatment might be prioritized to patients who are most likely to benefit from more immediate treatment (including those with advanced fibrosis or compensated cirrhosis, or who have had liver transplants) or whose treatment is most likely to reduce onward HCV transmission. Attainment of a sustained virologic response (SVR; virologic cure) in these patients likely will result in an overall decrease in HCV disease prevalence.
A link to access the new section can be found on the IAS-USA website.
This is the press release the HCV Guidelines-AASLD/IDSA panel put out this morning, Aug 11 2014:
HCV Treatment Recommendations Now Includes
Information on Prioritizing Patients Under Limited Resources

The American Association for the Study of Liver Disease (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society-USA (IAS-USA), today released the latest section of their website, www.hcvguidance.org, which assists clinicians treating patients with hepatitis C virus (HCV). The new section is titled, "When and in Whom to Initiate HCV Therapy."
It is estimated that between 3 and 4 million Americans are infected with HCV and have chronic liver disease as a result. Recent direct-acting antivirals are extremely effective in treating the virus and hold great potential for cure. However, limitations of workforce and societal resources may limit the feasibility of treating all patients within a short period of time.
With the addition of the new section, www.hcvguidance.org now offers clinicians information on how to prioritize treatment for those patients who will derive the most benefit or will have the greatest impact on limiting further HCV transmission. Highest priority should be given to patients with advanced fibrosis with compensated cirrhosis and liver transplant recipients and high priority given to patients at high risk for liver-related complications and severe extra-hepatic HCV complications. The guidance provides further detailed information on additional conditions that warrant prioritization of treatment.
The website, developed by a panel of 27 liver disease and infectious diseases specialists and a patient advocate, provides recommendations based on the latest evidence and on consensus of the panelists. It will be updated regularly to keep pace with improved diagnostic tools and new drug options as they become available.
"The benefits of curing HCV are clear from the standpoint of individual patients as well as that of the health and welfare of our society. This new guidance will help clinicians determine the best course of therapy for each patient given their unique condition," said Barbara Murray, MD, president of IDSA.
The three organizations will continue to work together to provide future sections of the guidance website as well as timely updates. The next two sections are underway and cover monitoring patients following treatment and management of acute HCV infection.
"New therapies recently approved by the FDA and those that are in the pipeline and will reach market soon will completely change the landscape for patients with hepatitis C," said Steven Echard, AASLD chief executive officer. "We have filled a void in providing reputable and timely information to healthcare providers and their patients by addressing whom to treat and when, as well as identifying patients that are in immediate need of treatment and those who can safely wait for the next generation of drugs."

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