Monthly Archives: July 2014

Are HCV Price Wars Coming?

By: Marcus Hopkins, Blogger

Here at HEAL Blog, one of our primary concerns has been with the pricing of new HCV (Hepatitis C) treatments. As we’ve previously reported, the costs of both Sovaldi (Gilead) and Olysio (Janssen) have prompted both private insurance companies and Medicare to balk at the amount they’re expected to pay for treatment. The issue of pricing has gotten so much media attention that there was recently a Senate panel on the issue (specifically related to Sovaldi).

These prices offer a unique opportunity for AbbVie to enter the market with their own combination therapy (as-yet-unnamed), and potentially start a price war between manufacturers. While this may be good for both AbbVie and consumers, there are certain caveats that come with the company’s product:

In May of this year, AbbVie CEO Richard Gonzalez vowed not to enter a price war with Gilead and Janssen, stating that he would allow the “…attributes of [the] product [and] the performance [speak] for itself.”

Image of pennies stacked on top of each other.

While it’s true that AbbVie’s product has comparable “cure” rates with Sovaldi (hovering around the mid-90s, in terms of percentages), what it does not share is simplicity or tolerability.

Sovaldi is a single-dose daily medication, whereas as AbbVie’s combination therapy is a five-pill regimen taken over the course of a single day that includes the use of Norvir, an antiretroviral that can cause unwanted interactions with other drugs. This places extra pressure on patients who are less likely to comply with the treatment regimen if they feel that it is a hassle to do so.

Additionally, they may soon have to compete with Gilead, yet again, with Sovaldi’s second iteration – a dual-drug combo that shows promise of an eight-week treatment period, rather than the single pill’s twelve-week period.

It is difficult to fathom that AbbVie’s product, regardless of its efficacy, will be able to stand on its own merits alone without a significant reduction in price when compared to Sovaldi. If CEO Gonzalez remains true to his word, it is unlikely that AbbVie will be able to make any significant headway in the treatment market.

Treatment regimens aside, one of the primary issues facing AbbVie is the reality that they are entering a market that is all but saturated with marketing on behalf of Gilead and Janssen. As someone who has worked in event planning, whenever there’s a competing event, he who gets his marketing out, first, is the one who wins the day.

Right now, the first word in HCV treatment is “Sovaldi,” and without a memorable drug name and marketing campaign, that word is unlikely to change to “As-Yet-Unnamed AbbVie HCV Treatment.”

There is, however, some hope – if consumers, activists, medical professionals, and advocates can place enough pressure on AbbVie to compete with Sovaldi and Olysio on the pricing front, they may be able to penetrate the very lucrative HCV market. Offering a treatment regimen that, although more complicated than its rivals offers similar cure rates, at a significantly lower price point could allow AbbVie to turn the tide in its favor. The net benefit, however, is likely to better serve AbbVie and insurance providers, rather than the consumer.

This, however, is the game we play in the advocacy arena – even though a lower price will be “better,” when will “better” become “affordable?” With these drugs being so new, it is unlikely that affordability will be a concept coming to a consumer near you.

Much of the problem associated with pharmaceutical pricing comes from the fact that it is currently illegal for Medicare, the party who will likely end up enduring the brunt of these HCV prices (given the average age of HCV patients), to enter price negotiations with pharmaceutical companies. Allowing this program to do so would no doubt have a highly beneficial result for consumers; as such, Big Pharma has gone well out of its way to ensure that this will likely never come to pass.

This leave us in the lurch, hoping against hope that AbbVie’s Gonzalez will relent and enter into a pricing war. Whether or not this comes to pass, however, has yet to be seen.

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.

Portions of this article are informed by Crain’s Chicago Business authors, Andrew L. Wang and Joe Cahill. Links to their original articles are listed below:

http://www.chicagobusiness.com/article/20140510/ISSUE01/305109990/abbvies-84000-question

http://www.chicagobusiness.com/article/20140516/BLOGS10/140519840/why-abbvie-needs-to-rethink-the-price-of-its-hepatitis-c-drug

 

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Boehringer Ingelheim Exits HCV Space

By: Marcus Hopkins, Blogger

We’ve spoken several times about the new HCV medications making their ways into the marketplace, but what happens when one of these new treatments simply doesn’t pan out for the company that manufactures them?

This question was recently answer, by Boehringer Ingelheim (BI), who, in a statement released on June 18th, have decided not to move forward with any approvals or market considerations for their HCV protease inhibitor, faldaprevir.

LOGO: Boehringer-Ingelheim

BI reached this decision at a key moment in the rapid development of new, easier to tolerate HCV treatments – regimens are switching over to all-oral treatments with fewer side effects and high SVR (cure) rates.

Faldaprevir must be used in conjunction with interferon, making it far more difficult for patients to tolerate (and thus, more likely to either stop or forego treatments, altogether). Additionally, this drug requires a longer length of therapy than the newer regimens (primarily Olysio and Sovaldi), and has a lower SVR rate that these treatments, as well.

Since their June 18th press release, BI has decided to halt any further developments involving faldaprevir, and have withdrawn all pending marketing applications. Furthermore, they have gone further to say that they will most likely not be reentering this field, and will be moving forward by refocusing their efforts on numerous promising development projects in immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology.

One of the things that’s interesting about this development is that it has not really sent any ripples throughout the HCV community. Granted, there is some disappointment that patients will now have fewer options when choose a treatment regimen, but, to what degree, honestly, will that make a difference?

This is a question I get a lot – “How does this affect me?”

The people who will take the biggest hit from BI’s withdrawal from the HCV field are those whose incomes relied on Boehringer Ingelheim for some portion of their funding in order to meet the needs of their patients, inform medical professionals of new developments, and/or provide information to educators who will pass on this information to patients and medical professionals.

But, for most patients, will the BI departure really matter to current and future HCV patients? Likely not. The new regimens out on the market, today, are far easier to tolerate, have a higher cure rate, and a shorter length of treatment, all of which bode well for the patients.

In this case, BI seems to have made a smart decision, both for patients and for their bottom line. Mind you, it’s a little disheartening to see that they’ve virtually cut themselves out of this burgeoning market, altogether, by completely shutting down all HCV development, which I must say is a bit surprising – most companies would reassess their product’s viability, and if it’s not up to snuff, work on a new product that will address the issues posed by the initial output.

This process, however, is a very costly, and often unsuccessful venture. In the meantime, we, here at HEAL Blog, look forward to the new developments in the HCV arena, and wish BI the best in their refocused efforts.

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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HCV, HIV & Questions about PrEP

By: Marcus Hopkins, Blogger

In one of my recent pieces for HEAL Blog, I addressed the issue of transmission of HCV (Hepatitis C Virus) through sexual contact. A colleague and former professor of mine from East Tennessee State University reminded me that conventional wisdom tells us that “…HCV in inefficiently spread through sexual contact.”

For the most part, this holds true – for most people, HCV is inefficiently transmitted through sexual contact. Here at HEAL Blog, however, we are primarily concerned with HIV/HCV co-infection, and for patients who are currently living with HIV-infection, conventional wisdom may not hold true.

In a piece published on June 24th, 2014, for Healthline, News, David Heitz brings to the fore a study released in 2011 (Fierer, Daniel S., et al.) that suggests that HIV-infected MSM (Men who have Sex with Men) are more likely to transmit HCV through sexual intercourse than those who fall outside of those demographics.

While sexual transmission of HCV is generally rare, concurrent HIV infection results in increased HCV RNA levels, which is thought to increase the infectiousness of HCV acquired through sexual contact. Unprotected penetrative anal intercourse can often involve tearing of soft tissue within the body cavity, which allows the virus easier access to direct contact with the blood.

There are, however, some caveats to this study that should, in the effort of doing due diligence, be disclosed:

  1. This report suggests high-risk sexual behavior as a cause of HCV infection in New York City. In this instance, the term “high-risk” included unprotected receptive anal intercourse with ejaculation.
  2. Additionally, another key factor in these infections was the use of methamphetamine as the most important predictor of infection, meaning that the use of this drug, while not directly responsible for the infection, played a likely role in the subjects’ proclivity to engage in high-risk sexual behavior.

Those within the LGBT community have spent much of the last decade temporizing about the burgeoning meth usage crisis we face. It is no accident that, as meth usage increases, so does the incidence of new HIV infections and accompanying STDs/STIs. What this study suggests is that, in addition to Syphilis, HAV/HBV, and other curable infections, HCV, once thought to be almost exclusively the result of injection drug usage or blood transfusion, should now be considered of equal import in our educational and prevention efforts.

This having been stated, there seems no better time than to bring the reality of PrEP (Pre-Exposure Prophylaxis – Truvada) into the conversation.

PrEP has been making waves in the LGBT and HIV community for much of the past year, in no small part due to virulent opposition on the part of AHF (AIDS Healthcare Foundation) founder, Michael Weinstein.

Without delving into the micro-political issues that surround the controversy, there are several arguments being made with which I take issue:

  1. Mr. Weinstein’s suggestion that reliance on Truvada as an HIV prevention method will essentially reduce it to a “party drug” is likely irrelevant to the discussion, as is the accompanying outcry on behalf of his opponents. Given current condom usage statistics that suggest a mere 15% of MSM consistently and correctly use condoms while having sex, it seems to me that any sort of prophylaxis against HIV would be welcome to the fight. What should have been disregarded as nonsense was instead met with outrage, and revealed what I consider to be a sore subject in the HIV infection world – that “party drugs,” such as methamphetamine, frequently play a role in new infections.
  2. On the other side of the argument, it seems as if the proponents of PrEP are going out of their way to treat Truvada as a panacea that is certain to stop the progression of HIV. While the studies suggest that Truvada does a great deal (and a great job) of prevention transmission (is consistently and correctly used), what Truvada does not stem is the spread of other STDs/STIs – HCV, for example.
  3. When condoms are introduced into the conversation, proponents of PrEP are quick to mention that the FDA has never approved condoms for anal intercourse. This assertion, while true, seems ironic, given the effort into which these very same advocates once put into being vociferous adherents to the “You Must Use Condoms, Every Time” message that was, and continues to be, pushed onto the American populace over the past thirty years.

Part of what is so infuriating about this continuing debate is the alacrity with which members of the MSM HIV community have cottoned to PrEP as the Holy Grail of HIV prevention. Several message boards and social media information pages are filled with fantastic information about how PrEP works to stop the spread of HIV, but a consistent theme I have noticed while reading these posts is the tendency of these HIV advocates and educators to all put pillory commenters who have the temerity to rightly suggest that other diseases are of equal importance, and that Truvada does nothing to prevent their spread.

Image of opened condom wrapper with blue pill falling out (resembling Truvada pill)

Source: HERE MEDIA INC. ALL RIGHTS RESERVED

Arguments on these threads can be fierce, and often very quickly devolve into ad hominem attacks, where advocates accuse people of being “…in league with Weinstein” (that is a direct quote), and even worse, “part of the problem.”

This leads me to beg the question – “What is the problem?

As an advocate and educator whose goal is to spread scientifically accurate information about how STDs/STIs are spread, it is important to me that I realize that HIV isn’t the only game in town – my students and lecture attendees expect for me to paint them a realistic picture of the risks associated with high-risk sexual behavior. To suggest that, because PrEP shows promising results in preventing the spread of HIV, condoms are no longer necessary is a fool’s errand.

Studies such as the Fierer study further show the need for continued adherence to the condom regimen, regardless of whether or not the FDA has approved their usage for anal intercourse. While PrEP may go a long way in fighting the HIV epidemic, we must remain vigilant in our efforts to stem the tide of other viruses, as well.

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.

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