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In case you missed it- Viewpoint: New Expensive Treatments for Hepatitis C Infection

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This sort of Op-Ed piece in this coming week's JAMA sort of sums up the present and near future therapeutic landscape as well as attempting to address the pricing issues. I plucked out what I thought were the most important bits, but the full text is free at the JAMA Network site.

http://jama.jamanetwork.com/onlineFirst.aspx

(If, instead, you are looking for July 23/30 JAMA paper on the cure rates in co-infected folks that kind of made the news overnight, that link (also full free text) is here.)

Treatment of infection with hepatitis C virus (HCV) has changed substantially in the last 3 years, with new therapies now reaching cure rates (defined by sustained virologic response) higher than 95%. As little as 3 years ago, treatment involved an arduous course of pegylated interferon and ribavirin, which caused serious adverse effects in more than 80% of patients; less than 50% of patients could finish the treatment course.

In 2011, introduction of the first generation of protease inhibitors, particularly telaprevir and boceprevir, heralded change. ... However, these agents were much more expensive than standard therapy, at a cost of more than $80000 per course of therapy, and were associated with high levels of viral resistance ... if patients did not strictly adhere to therapy.

In 2014, the introduction of polymerase inhibitors set a new standard. The first in this class, sofosbuvir ... in patients with genotype 1 HCV. Sofosbuvir also can be combined with another new protease inhibitor, simeprevir, to treat patients in whom interferon-based therapy has failed. These regimens provide interferon-free treatment protocols that are shorter and well tolerated and have 80% to 95% cure rates. This fall, an oral combination of sofosbuvir and ledipasvir will be introduced ... and has been shown to reduce treatment to an 8-week course with cure rates of more than 95%. Now, a chronic disease that affects millions of Americans can be cured by well-tolerated oral medications.

The price of sofosbuvir is essentially $1,000 per pill, or $84,000 for a standard 12-week course. The fact that pricing in the United Kingdom for a similar regimen is $54,000, and perhaps as low as $900 in Egypt and other developing countries, indicates that the pricing in the United States is a purely financial decision by Gilead and has outraged many. Indeed, some pharmacy benefit managers are calling on their clients to boycott these products until alternatives are available late in 2014.

While a daily oral medication that costs $1000 per pill gains attention, the more important issue is the number of people eligible for treatment. With broader screening, the pool of eligible patients may be as high as 3 million in the United States alone. The simple math is that treatment of patients with HCV could add $200 to $300 per year to every insured American's health insurance premium for each of the next 5 years. Thus sofosbuvir is not really a per-unit cost outlier but is a "total cost" outlier ...

These costs will be especially burdensome over the next year. Presently, Gilead has a monopoly, and its investors expect it to make a profit during this period. However, it is anticipated that by December, another highly effective oral regimen will become available.

Given this context, how should costs be managed? In some state Medicaid programs, the new medications have not been added to the formulary, despite the new practice guidelines. Physicians for whom the drug is denied by the state are going to Gilead, and, by report, the company is quietly subsidizing the costs--there is an official assistance program offered by Gilead. 

... 

Some private insurers have added sofosbuvir to the formulary and are absorbing the costs but also are taking steps to ensure appropriate utilization by developing prior authorization programs based on practice guidelines. Some insurers are asking physicians to treat only patients who absolutely need therapy now.

The ultimate approach to cost will be lower prices, which will occur as more products create competition. However, it will likely entail narrower formularies, in which the physician choice of a particular medication is limited by the deals negotiated by insurers and pharmacy benefit managers.

Mike Barr is a board certified acupuncturist and herbalist and can be reached at Manhattan Acupuncture Associates, with offices at Columbus Circle and Flatiron. His expertise and interests include sports acupuncture, pain syndromes, liver health, immunological support, low energy, mood disorders, anxiety, insomnia, GI complaints, and herbal and acupuncture approaches to getting off/putting off prescription medications of unsatisfactory or unclear benefit, and in helping to manage the side-effects of other necessary and life-saving biomedical interventions. He has also been busy exploring the application of Chinese herbal therapies, and specific acupuncture protocols, for all aspects of sexual health and anti-senescence.

#####

For more on the business side of HCV drug development, as well as a bit of a look into the future of hep C rx, have a look at Matthew Herper's piece in Forbes magazine last month: Why Merck Just Spent $4B On New Drugs for Hepatitis C

Read about AbbVie's all oral, 3-in-1 combo regimen, expected in October at (and one state's efforts to play the two off one another for a 50% price reduction), among other places, Pharmalot.

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Comments on Mike Barr's blog entry "In case you missed it- Viewpoint: New Expensive Treatments for Hepatitis C Infection"

Hey Mike!
I'm sure this will seem absolutely ridiculous and break tons of gay male etiquette blog rules but, I d g a f because I'm pretty happy right now after stumbling upon your blog . I don't usually find myself perusing different resources on HIV/AIDS because I have become inured to the B S entrenched within. I had spent a good deal of my life both personally and professionally fighting through activism, and educating about ,the disease . I won't go into my C V because it's moot here . Every so often certain people , especially those whom I've lost either through demise ,or simply contact with , will almost permeate my mind . I live now mostly in AZ but I maintain an apartment in NY. One of the people who have popped into my head a lot over the last year for whatever reason is yourself . We spent hours and days and weeks manning the phones together at the act-up offices in the old AT&T bldg . You were one of the nicest people and I admired you very much. I won't go into how I feel about the decline of activism ; the apathy or the great void I feel at the enormity of loss. I am just so fucking happy to have seen your face on the blog and that you're still here . I hope you're happy and that life has been good to you in these past 20? + years .
(I really did have to write this and knew of no other way to possibly contact you . Apologies !)
Peace,
Quinn

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This page contains a single entry by Mike Barr published on July 20, 2014 10:56 PM.

Ear acupuncture helps manage the interferon side-effects of HCV treatment was the previous entry in this blog.

Half-Off Saturdays @ Turning Point Acupuncture is the next entry in this blog.

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