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While Gilead works on a “cure,” here are four things managed care executives need to know about the current state of HIV treatment
In August, Bloomberg reported that Gilead, “...is setting ambitious goals to vanquish two major viral scourges: HIV and hepatitis B. The biotech company dominates the HIV market, estimating that about 80% of new patients starting therapy are prescribed a Gilead drug.”
Gilead’s landmark drugs Harvoni and Sovaldi are curing patients of hepatitis C thereby validating their place in the world of value-based care. The value of a $94,500 course of Harvoni that cures hepatitis C versus a $577,000 liver transplant is easy to understand. However we anticipate real-world cure rates are not reaching the 96% to 99% levels the drugs tout in their advertisements based on tightly controlled clinical trials.
What does all of this mean for HIV and managed care executives? Is a “cure” for HIV nascent? What will that cost? And are currently available value-based therapies being utilized to prevent new HIV infections?
“An HIV patient today, with access to the right pharmaceuticals and a highly engaged medication management protocol, is more likely to die from old age than HIV. The medicine is that good.” A colleague at an HIV clinic with a major university hospital told me that earlier this year. Here are two points of evidence to support this claim.
First, according to work done by Curant Health for the 1917 Clinic at the University of Alabama Birmingham (a Ryan White Grantee), out of 157 HIV patients whose viral loads were not suppressed prior to enrollment in Curant’s medication management protocols, 103 have now achieved viral suppression. For HIV, “viral suppression” is the outcome standard by which HIV therapy is measured. HIV medications don’t (yet) eradicate the virus completely, which is where HIV treatment now differs from hepatitis C.
Second, a 2012 study published in the American Journal of Pharmacy Benefits, by Patrick Dunham and Jeffrey Karkula, showed that the number of patients on highly active antiretroviral therapies and a comprehensive medication management program whose viral loads improved to undetectable (or suppressed) levels increased from 28% to 66%. The same population of patients showed overall healthcare costs $3,000 less per patient per year than patients not on the medication management protocols.
The gains made in the care of HIV patients in the past 10 years have been phenomenal. New drugs for HIV treatment continue to effectively support viral suppression with fewer side effects, including liver damage. Add simplicity in dosing and increasing favorability in costs and the progress becomes even more remarkable. Nevertheless, there are significant gains yet to be made in the care continuum while we await a true cure or vaccination for HIV.
Consider this: the average lifetime cost to treat an HIV patient is estimated at around $368,000, according to the Centers for Disease Control and Prevention (CDC). The average cost to treat high-risk patients with Truvada (Gilead), as pre-exposure prophylaxis (PrEP) is $1,300 per month. A patient would have to engage in high-risk behavior for over 23 years to make treatment with PrEP more expensive than treatment with antiretroviral therapy (ART) after infection has already occurred.
And that’s just the cost of medication. When the cost of treating secondary HIV-related infections, hospital admissions, and other ancillary costs, it is clear that PrEP is more cost effective than ART; yet PrEP remains relatively unheard of outside infectious disease clinicians in urban areas. Even though PrEP prevents new HIV infections by 92% or more in patients who take it effectively, according to the CDC, and most insurance providers cover it, adoption of this therapy is soft. This is due in part to the absence of promotional assets assigned to PrEP given its relatively poor profit margins compared to other products. According to Gilead spokesperson Cara Miller as reported by Carline Chen for Bloomberg.com in February, “Gilead does not view PrEP as a commercial opportunity and is not conducting marketing activities around Truvada as PrEP.”
HIV medication cost doesn’t get the negative press that hepatitis C drugs do because annual HIV treatment costs are currently less than $25,000, according to the CDC. Yet HIV patients are commonly living 25 years or more. Based on my experience at industry conferences and other discussions with my colleagues, PBMs and health plans don’t “flag” pharmaceutical therapies unless they eclipse $100,000 or more per year. If a PBM or health plan was planning to manage an HIV patient long term, they would pay closer attention to prevention.
PBMs and health plans continue to consolidate, leaving patients with less choice among them. It is becoming more likely that payers will be managing more HIV patients for longer periods of time. Consolidation means they will be managing ever-increasing numbers of patients, along with their complex HIV treatment needs and potential complications because of long-term side effects of earlier HIV treatment with greater side effect implications including liver and cardiovascular damage. Managed care executives would be wise to ensure the entire continuum makes greater investments in HIV prevention while we await a cure.
There has been buzz around a cure or vaccine for HIV for 10 years or more. At the end of the day, while the HIV virus does not replicate as quickly as hepatitis C, it is a more complex virus. To date, there is no research or science to suggest that a true cure for HIV is eminent.
When science does create a cure for HIV, it likely will look very much like today’s cures for hepatitis C. Prices for the drugs will be astronomical. Yet they will bring cure rates at prices that are less than the cost of long term HIV treatment. While it is better to focus on prevention if a cure is so far off, the following will still be necessary when science achieves a cure for HIV:
1. Medication management programs proven to improve adherence and outcomes,
2. Patient access to the medications including prior authorization assistance and continuing support of the 340B drug pricing program, and
3. Patient education to mitigate side effects, a key component to improving adherence and outcomes for all chronically ill patients, especially those suffering from complicated infectious diseases.
Amy Hampton is HCV program director forCurant Health. Curant Health treats patients nationwide through its medication management protocols.