HCV Triple Threat

By Marcus Hopkins, Blogger

Here, at HEAL Blog, we’ve talked often about the cost of Gilead Science’s Sovaldi as a treatment regimen for patient either mono- or co-infected with the Hepatitis C Virus (HCV). Thanks in no small part to the introductory pricing of this and other HCV therapies, the discussion of pharmaceutical pricing is in the news, again, in a way that it hasn’t really been in nearly a decade.

This week, we’re focusing the spotlight on three points of interest involving Sovaldi and Gilead – the real world adherence rate of patients taking the current Sovaldi regimen, the likelihood that Gilead will be releasing a more costly (but, more effective) Sovaldi regimen in the coming months, and the recent deal struck between Gilead on seven drug manufacturers in India to produce a licensed generic version of Sovaldi to be marketed to low-income countries around the world.

As with any treatment regimen, adherence is the first priority in ensuring that the therapy works. One of the primary setbacks of prior HCV treatments was the difficulty patients had with tolerating the drugs; the general rule has been, “The more difficult to tolerate, the less likely patients are to adhere.”

Sovaldi

Sovaldi

Aside from the high SVR (cute rate), the main selling point of Sovaldi has been its tolerability – the side effects are minimal, and patient responses to the drug have been largely positive. That said, a recent analysis released by CVS seems to indicate that adherence levels are much higher than experienced during the trial phase.

8.1% of patients who first filled their Sovaldi prescriptions through CVS Caremark on or before May 15th, 2014, discontinued the use of the drug, compared to only 2% of patients during the clinical trial.

This is a considerable uptick in discontinuation, particularly given the ease with which it’s been shown tolerable by a majority of patients. While the CVS analysis doesn’t go so far as to specifically pinpoint any single reason for this increase, there are some interesting statistics that accompany their report:

Nearly 9% of patients who discontinued use of Sovaldi were treatment naïve, meaning that they had never taken medications to treat HCV prior to starting the regimen. Additionally, they found that those with less advanced HCV disease were markedly less likely to complete the regimen.

One of several reasons suggested for the discrepancy between adherence in the trial phase and in the real world is the lack of supervision and monitoring experienced by those patients in the clinical trial. This points to something that is often left out of the adherence conversation – the need for follow up and regular provider/patient interaction.

My own experience with HIV treatment has been somewhat anomalous, according to several of my doctors, over the years. The only question that I have been consistently asked at every appointment since I began treatment in 2007 has been, “Have you missed any doses?”

Since I began taking meds on November 19th, 2007, I have missed doses fewer than ten times, the majority of which have been due to lack of access to those medications, for one reason or another (either because I could not get my prescription filled, or I was physically unable to get to my medications). I have never willfully skipped a dose, nor have I ever even considered going off of meds.

I am, as many who know me will tell you, doggedly adherent to my medication regimen, and have little patience for those who do not take their own healthcare seriously. But, part of what has helped me to become that way is a strong support network, be that friends, family, or yes, even healthcare providers.

My current clinic, Positive Healthcare, based in Morgantown,WV, at Ruby Memorial Hospital, goes out of their way to ensure that every visit is worthwhile – at a typical visit, I meet with between four to five people, each of whom provide a different service, from physical and mental wellbeing, to medical treatment, to financial wellbeing.

This is atypical in the treatment world – few clinics I’ve attended can say that they treat the whole person, rather than just the disease, itself.

With HCV treatment, the paradigm should be the same. Whether mono- or co-infected, patients who have elected to undergo therapy for their virus should enjoy the same level of involvement from their providers, if only because the expense of undergoing treatment has no outpaced the average household income in this nation. Ensuring that these patients remain active participants in their own recovery is tantamount in order to guarantee that the money spent on these pills is not simply wasted.

At roughly $1,000 a pill, if patients begin to stray from adhering to the regimen, payers may become less incentivized to cover the cost (or the same percentage of the cost), particularly if a trend begins to develop. Why cover a costly treatment that people will not finish?

This segues nicely into the next point – Gilead plans to release a new Sovaldi regimen in October of this year (with a target release date of October 10th, 2014) that analysts believe may outstrip the cost of the current regimen.

Including the cost of accompanying drugs in the current therapy, the costs average around $95k for twelve months of treatment; analysts are predicting that the new combo regimen will start at $95k-$100k.

Mind you, this is the same company whose introductory prices caused such an outcry from Medicare, Medicaid, and insurance providers that Senate panels were held to address the issue. With that in mind, some analysts believe that Gilead, wary of causing any further furor over pricing, may opt instead to come out with a “more affordable” price in order to put forth the image that they understand the financial limitations at hand.

While the new regimen touts even higher SVR rates than the current one, what incentive will either providers or payers have to prescribe the new option over the old? Will patients, providers, or payers choose only marginally greater efficacy over marginally greater affordability?

This is a conundrum in which many find themselves, and several providers to whom I’ve spoken have, on the condition of anonymity, stated that they are holding back on treatment for as long as possible in the hopes that a more affordable, yet equally effective treatment option arises.

That revelation was, for me, a troubling one. As an advocate for a “hit ‘em sooner, and hit ‘em hard” approach to the treatment; and yet, despite my reservations about their approach, I understand that they have not only the physical wellbeing, but the financial wellbeing of their patients in mind.

The Medicaid-age horror stories have rung loud and clear for well over a decade – the choice between food or meds – and while these stories are largely anecdotal, it is situations and prices like these that may prompt providers to consider holding off on treatment in the hope that a better option arises.

Part of the problem with this approach, however, is that there are programs out there that offer assistance to lower-income, uninsured, or underinsured patients, but the people who should know about them often don’t. (For further discussion on this topic, please see our last entry to HEAL Blog.)

The prospect that the next regimen could potentially bypass the $100k mark has many patient advocates and payers worried that this could start a dangerous trend amongst pharmaceutical companies. If payers demonstrate a willingness to pay for top-dollar regimens on a wide scale, will that serve as a green light for the rest of Big Pharma to follow suit?

This type of “Slippery Slope” argument is often regarded as fear mongering within the pharmaceutical world, but other examples of this, as it relates to healthcare and medical treatment, have shown that it is a distinct possibility.

With the threat of more expensive treatments looming, advocates, patients, providers, and payers, alike, were not shy in expressing their criticisms over Gilead’s recent deal struck with Indian drug manufacturers that licensed a generic version of Sovaldi to be marketed to low-income countries at around $300/month.

With the average regimen being three months, this comes in at roughly 1.03% of the cost of treatment in the United States. That figure has many people up in arms, and many argue that this is justified. “Why,” they ask, “should Americans be expected to foot the $87,000 bill while others pay pennies on the dollar?”

This issue is one that had plagued the HIV community for well over a decade. It is no small bone of contention amongst activists and advocates that generic HIV medications are made available in other countries at literally pennies on the dollar, while American patients (or whomever picks up the tab) are expected to pay sums of money that, were they paid entirely out of pocket, would bankrupt most Americans in under five years.

That Gilead would make such a public deal with these Indian manufacturers speaks to this issue in a way that has many up in arms. As we’ve discussed before, how medications are priced is a very complicated formula, little of which is transparent, either to consumers or insurers. To be fair, the pricing formula of virtually every aspect of healthcare in the United States is nebulous, at best, despite itemized bills that list a fee for literally every item in a given visit, but provide no information as to how those goods and services came to be so expensive.

Is there a short-term answer? Unfortunately, no.

Realistically speaking, the price of medications in the United States is going to remain high, as will the cost of treatment, until we find some sort of stabilized structure that standardizes the costs of healthcare goods and services; this is also unlikely to occur, as there is simply too much profit to be made from keeping the formulae so complex that it cannot be easily broken down into component parts, and no one who is receiving the money has any motivation to do so.

We are going to be entering an interesting phase in the HIV/HCV co-infection community, with new treatments and drugs being offered on a regular basis, which means that many of the issues that we’ve discussed in this piece will likely not only become more complex, but more prevalent. It is vitally important that we continue to bring these issues to light, and find ways to deal with them, before we become so mired in minutiae that we are unable to focus on the bigger picture.

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.

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