By: Marcus J. Hopkins, Blogger
This past week, I was privileged to attend the National Strategy for the Elimination of Hepatitis B and C at the National Academies in Washington, DC. This was he third such strategizing meeting in which a panel of well-regarded specialists gather information from various state, Federal, private, and advocacy organizations in an effort to devise a workable and feasible national strategy recommendation for confronting the nation’s deadliest health condition. For two days, testimonies are heard from a wide variety of sources who speak to the roles their organization plays or has played in the fight against Viral Hepatitis.
As a policy vs. reality wonk, I find these meetings to be of the most use for advocates, even if they are not necessarily aware of its existence. It is at these types of events that we hear how the fights are going on the ground, rather than simply looking at a set of national statistics that may not tell the whole story.
I gleaned from this meeting several pages of notes, but was really intrigued by three moments in the conversations, about each of which I could write dozens of pages: (1) Hepatitis advocates, while fewer in number than their HIV-related advocacy peers, face a dearth of materials, research, and statistical data to use in their advocacy efforts; (2) the Centers for Disease Control & Prevention (CDC) has only 30 states that report data for both HBV and HCV, and openly admits that there are neither resources, nor reliable reporting datasets to create the resources that advocates need; (3) Gilead’s justification for the high price tags on their HCV drugs is surprisingly well-reasoned and convincing, but using their argument may do little to assuage the concerns of cash-strapped states when considering their pharmacy budgets.
Perhaps the most telling, yet largely overlooked, statements in the meeting was made by Ryan Clary of the National Viral Hepatitis Roundtable: to paraphrase what he said, it is increasingly difficult to make a convincing, evidence-based argument to legislator and budget committees about the dire need to provide additional funds for Hepatitis C without the adequate tools available to do so. While advocates and organizations can make impassioned pleas, relying solely upon “…what we know in our guts to be true,” without reliable, comprehensive, and timely data related to HCV incidence, prevalence, and mortality rates, we are truly unable to make arguments that can be backed up by peer-reviewed or official statistics.
We at HEAL Blog have been sounding this trumpet for the past year, after nine months of largely fruitless efforts to get reliable monthly reporting from individual states. The CDC has STILL not made any real effort to define the reporting standards or requirements (to the contrary of Dr. John Ward’s response that “…definition [wasn’t] really the problem) for the states in the same manner they did with HIV over twenty years ago; the problem, according to Dr. Ward is that there are simply no resources to expend or allocate to require regular national reporting.
It segues nicely into the second moment – only 30 states currently report data for both HBV and HCV, and even with those states, there is little consistency between them. With only 3/5 of U.S. states reporting inconsistently, the CDC must rely heavily on mathematical modeling, rather than on verifiable data. How can advocates be expected to effectively convince legislatures and budget committees without sufficient data to do so; if Hepatitis is such a pressing threat, according to the CDC’s own admittedly insufficient data, why does the virus receive literally a fraction of the funding enjoyed by HIV? While the CDC does not control the budgeting process, it seems that it would be incumbent upon the CDC to force the issue by requiring states to at the very least collect and report data, even if they don’t have the funds to track patients through the treatment cascade.
Finally, Gilead, the maker of Sovaldi and Harvoni, made a very compelling argument in an effort to justify the high cost of their HCV drugs: Curing HCV with Harvoni can be accomplished in a single quarter, as opposed to MS (2.41 years), Cancer (3.28), and Rheumatoid Arthritis (4.55); as such, the price per for achieving a Sustained Virologic Response (SVR, or “cure”) is comparable to those chronic conditions, with the only difference being that the price is up front, rather than apportioned over time. Additionally, the price per SVR has dropped considerably when taking into account the high failure and non-adherence rates for the older, less easily tolerated HCV therapies – essentially, with the new Direct Acting Agents (DAAs) for HCV, fewer patients fail to complete the regimen, the regimen has a 95-98% SVR rate, meaning fewer patients have to repeat the regimen it fails, and the regimens are one-a-day pills, making it easier for patients to remain compliant with the regimen.
While these arguments are very well-reasoned, it’s unlikely that states already facing budgetary shortfalls will be able to afford the cost of treating all HCV patients on their respective Medicaid rosters, regardless of the cost-effectiveness at hand. Plainly put, American politicians are rarely “long-term thinkers,” when it comes to budget issues. No matter how many times you argue that spending a lot of money in the present will save money in the future, the current atmosphere of “WE MUST CUT SPENDING, AT ANY COST!!!” simply doesn’t allow for high, one-time expenses. With a starting point of “Slash and Burn” economics, it is unlikely that Gilead’s argument will hold much weight with anxious legislators who campaign on lower spending.
The National Strategy meeting was a fantastic learning experience, and hearing from industry, government, and medical professionals about the state of HCV treatment and funding in the U.S. was both heartening and somewhat temporarily bleak, in terms of short-term affordability. In all honesty, there will likely be little movement until after the elections on November 8th, the outcome of which may fundamentally shift the prospects of funding, entirely. Ultimately, we still remain in a holding pattern, but the National Strategy committee members are doing phenomenal work in reaching a well-reasoned and realistic eradication strategy.
Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.