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New Federal HCV Policy Direction Needed....'find new champions in White House, Congress, funding for screening, open access to treatment'
  Jules Levin, NATAP
A new direction in advocacy must be forged. Clearly these are difficult times with Congress & the federal govt facing many domestic & global issues including the economy. I receive calls & emails regularly every day from patients all over the USA: "I have been denied access to HCV treatment", "what are the advocates in DC doing". We are responsible to them! The key goals we want to accomplish in HCV are: Funding for Screening/linkage to care & eliminating barriers to access to treatment. There are many laudatory additional needs to address but large-scale funding for screening programs & for open treatment access are the main goals. We want $100 million to begin with for screening/linkage & we want to eliminate any barriers to treatment access. There are a number of ideas for programs to implement a $100 million screening program which I outline below. And there are a number of ideas I outline below to address the access issue including considering "new models" to fund new innovative life-saving drug therapies. And there are numerous ways to distribute $100 Mill in screening funding for locally based implementation. There is no disease in the US that has these undue harsh illegal, discriminatory restrictive barriers to treatment access.
We have reached an unacceptable new pinnacle this week with major commercial payers denying treatment access, United HealthCare not only required F3 but denied access to drug & alcohol users and used the AASLD/IDSA/ISA-USA Guidelines to support their position & they are a among numerous commercial payers doing this & the numbers will grow of payers doing this. This will NOT STOP, its getting worse:
UnitedHealthCare - F3/F4 - AASLD/IDSA Guidance - (10/31/14)
Harvoni Criteria Anthem/Express Scripts - (10/24/14)
What we have now in HCV is like not treating heart disease until one almost has a heart attack, or not treating diabetes until one has frank diabetes, not treating pre-diabetes. This is about the payers, commercial & public, who think they can push us & patients around, who are succeeding in pushing us & our patients around, UNACCEPTABLE.
It is time HCV advocates adjust course to include & focus on a new direction in policy advocacy. We need to meet with the White House and begin to meet with new Congressional members. The Bill and the caucus have been a focus for years. When I started my effort to get HCV & HBV into the Ryan White Care Act in 2000, efforts began to introduce the HCV Bill so it has been 13 years that the Bill has been before Congress, without it moving. The HCV Caucus as well have not come through for us, it is 10+ years. If they were going to do move this Bill they would have done it already, they benefit quite a lot from associating with us regarding this Bill & yet the Bill has not been introduced nor passed.
Thousands of patients are being denied treatment access to the new HCV drugs, we have an obligation & responsibility to them to make our best efforts & not waste our resources, our efforts & time in Wash DC. They are our constituents, we answer to them.
What To Do
We must begin two efforts. Start a new dialogue with the White House & start a new effort in Congress to find new champions. I wrote the language with Congressional staffer help on HCV & HBV that is in the re-authorized 2006 Ryan White Care Act [http://www.natap.org/2008/HBV/032508_05.htm] which was expanded in the subsequently approved Ryan White Care Act. I was able to accomplish this by finding "champions" in Congress, that means finding House/Senate member & offices willing to put into legislation & implement putting hepatitis into law, a champion believes in your cause and is willing to MAKE IT HAPPEN. The current so-called HCV Caucus has failed us, we need to find true champions. A champion is willing to use their "capital" to put your issue into law, they put themselves on the line for your idea, clearly the current caucus has not been willing to do this after 10+ years.
So, we need to begin an effort in Congress by selecting new offices & members to meet with. We might have some ideas of offices that might be friendly to our cause, we can begin with them, but you never know who you will find that might support your effort. Our new effort must be bi-partisan. We need to meet with Republicans & Democrats.
My effort initially in 2000 found Senate Republicans to be more supportive to get HCV & HBV into the Ryan White Care Act, later, about 2 years later the Democrats who were HIV leaders in the Senate came on board full strength along with Republican leaders in HIV in the Senate. The first supporter I had was the Republican Leader in the Senate at that time. I held the 1st HCV Briefing in Congress cosponsored by a few key House & Senate member's offices, and continued to hold Briefings in Congress over several years. In the last few years before the language was introduced to the floor for passage along with the Care Act key Senate Republican & Democratic leaders designed & led my HCV Briefings to bring their colleagues along to support the effort of getting HCV & HBV into the Care Act. These were champions who wanted to get this done, who realized this was right & they took the lead upon themselves to make it happen, thats what real champions do, not like this current "caucus".
I met with very high HHS officials & with key White House leaders, at the time it was during the Bush Administration.
Another key point to make is "messaging". One must be very facile with HCV & the key elements of the disease that explain the affects on society & the underclasses affected & how it affects them . When you are sitting with key White House & Senate members the key is effective "messaging", that is the capacity to make your case to convince them they want to support you, that is the ability to verbally explain the key issues & why they are important, who this problem affects, disproportionately affected patient communities, disparities in care, why this problem is so important to these patient communities & to the US health & why it is cost effective to do this & why we need their support. That is why lobbyists get big money, because they can deliver "effective messaging". It is a skill not easily attainable to walk into a Senate office & be able in 5 minutes, often thats all you have with a Senator, and convince them, pursuade them why they need to take on this issue, why they need to spend their political capital on your issue. This is not easy. It require a certain professionalism & experience & prior success to do this.
The power to get things done in Wash DC lives with Congress & the White House. HHS & agency administration heads work for the President & so unless the White House wants to move something HHS will not do it. There are certain less major supportive efforts that HHS can implement & that agencies can do on their own, so we should continue to meet with key agencies to try to get them to support spending in screening/linkage efforts but the big money comes from Congress and or the White House.
(1) meet with key selected White House officials,
(2) meet with new Senate & House members to find "real" new "champions" for our cause & to forge an effort to secure $100 million for HCV screening/linkage programs. & to eliminate treatment access criteria.
Treatment Access & New Models to Evaluate New Life-Saving Drugs
We have an impossible situation now, that patients have to wait until they have F3, cirrhosis, to be treated, liver cancer (HCC) can develop & starts to develop before F3. This is unacceptable. We must change this. The current situation is very fluid & might change & improve but we must plan for the current situation continuing & if things improve great. There is no science to their criteria, medicaid & commercial payers. They base their restrictions on false statements, Medicaid officials claim the new HCV drugs have not been studied in African-Americans, people with a history of substance abuse so "how do they know it works in these patients & why should we pay for this if there is no evidence it works", this is what the Illinois Medicaid Director said [http://natap.org/2014/HCV/080814_07.htm]; we know this is not true, there IS data in these patient populations showing the SVR rates are the same, here is the data: http://www.natap.org/2014/HCV/081814_01.htm The medicaid officials know what they are doing 'would likely not hold up in court if challenged': "Matt Salo, who heads the National Association of Medicaid Directors, said Oregon's restrictions might not hold up in court"
Medicaids & commercial payers launched earlier in 2014 a PR campaign to persuade the public & Congress that they could not pay for these new drugs. They mischaracterized the issues & misled everyone, they have lied to the American public. Let's not forget this is a big industry that pushes big money into donations to politicians & there is for them a lot of money at stake. These payer groups control access & get paid big money to save public & private payers money, they have a vested interest in denying access, to constructing restrictions that save their clients - medicaid, commercial payers - big money. We are fighting this. Right now they are winning, they convinced certain politicians in the Senate to support them. We must fight this difficult foe & this situation. Initially in early 2014 they highlighted $84k without mentioning they received at least a 23% rebate & the VA gets 44%. Their cost projections in early 2014 for the year were not based in reality and of course the cost projections were based on unrealistic projections of how many patients would be treated. For example, in NYS at the NYS Hearing on Sovaldi Criteria NYS Sept 18 state officials said 58,000 on medicaid had HCV but it appears now only 3,500 patients were treated this year. I believe they are using HCV as a test case to see how far they can go, before new innovative & more expensive new drugs for other diseases are available.
WHAT is good enough for these payers? The VA gets a 44% discount, the state medicaid programs CAN negotiate more than 23% rebates. So is $45,000 for a one-time upfront cost to cure a serious disease, HCV, acceptable? HIV therapy HAART, costs $14,000 per year forever, in perpetuity, so after 5 years thats $70k, that is more than medicaid has to pay for Sovaldi or Harvoni. Don't forget behind closed doors commercial payers also negotiate the real price they will pay to drug makers. These payers are public companies with billions of dollars at stake with obligations to their shareholders & to meet quarterly earnings & to boost their share prices on Wall Street. After 30 years on HAART the bill is $500,000 for those drugs alone & with other costs - labs, doctor visits etc, the bill is $1 million. So why are the payers complaining about HCV? Because they can get away with it. They are a powerful wealthy donor in Wash DC, in Congress. Because we need another solution "A New MODEL" to evaluate & pay for new life saving therapies & because they, the payers can get away with this, they have up to now, we need to change this. I question whether any big price discount will be acceptable to payers now, they have a head of steam going & are getting away with it so why should they agree to $40,000, THEY WANT TO SEE how far they can go with this & the hell with patients' needs!
The federal govt spends $22 billion a year, every year on HIV, $5 bill a year in perpetuity on medicaid & $4.5 Bill every year on medicare, so why do the payers & the feds do this & but refuse a must less costly HCV treatment that would cure a deathly health epidemic disease, HCV? The payers JUST do not want to spend the money on HCV & we let them get away with this.
In 1996 when HIV protease inhibitors were launched a similar battle ensued with payers. This receded after 2 years. For 5 years IDUs were not "treatable", this too changed.
New Models
There are many new ideas to provide open access, to pay for the costs:
- federal loans to the state medicaid programs, or
- the feds could provide outright funding to help medicaid pay for the drugs
- amortization, like a mortgage, of the costs by the payers themselves
- the feds could sell bonds to pay for "new innovative life-saving drugs
Here is an article by an expert in this field:
Implementing $100 Mill for Screening/Linkage
There are many ways to implement a large national program for screening, here are some ideas:
- funding directly to state & municipalities & Depts of Health
- funding to an HCV Council in 10 major cities, to start. This Council like with the Ryan White Care Act model could be composed of DOHs, community groups & local hospitals & stakeholders who receive a direct HCV screening grant & they implement it in their region
- HHS & CDC grants to local stakeholders & coalitions
Do you have ideas? There are many ways to do this.
We have limited ourselves to asking only for CDC to receive the funding, for them to distribute funds. There are many ways to do this.
We as advocates represent the needs & concerns of patients, that is who we work for. We cannot waste our time anymore, thousands of patients are being denied access to treatment, this has hit a pinnacle with key commercial payers denying access unless a patient has cirrhosis, F3.
We need to forge a new direction:
(1) meet with key selected White House officials,
(2) meet with new Senate & House members to find "real" new "champions"
for our cause & to forge an effort to secure $100 million for HCV screening/linkage programs. & to eliminate treatment access criteria.
We need new models for distributing the $100 Mill in screening program funding !!!!
We should discuss with lawmakers in Wash DC new models to fund humane treatment access, no restrictions.
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