The use of antiretroviral therapies (ART) to combat human immunodeficiency virus (HIV) is one the great success stories of modern medicine. In short, ART drugs have the power to transform HIV from a nearly-always fatal infection into a more manageable, chronic disease.1 According to the United Nations, the increased use of ART has been the primary reason for a 48% decline in deaths from AIDS-related causes on a global basis from 2005 to 2016.2
Effective use of antiretrovirals requires carefully tailored medication regimens and attention to adherence. The resources and deep clinical expertise of OptumRx helps ensures the best health outcomes for people with HIV while simultaneously addressing total cost of care.– Savitha Vivian, OptumRx Vice President of Clinical Services
While ART has resulted in a dramatic decline in mortality, treating HIV infection requires life-long ART and therefore payers face significant costs related to both the medication and treating co-morbidities that impact patients with HIV. In the U.S., spending on HIV antiviral medications is ranked the 4th highest disease class by spend, trailing inflammatory conditions, diabetes, and oncology.3
This article will explore how the use of ART drives plan sponsor costs in the HIV space.
HIV cost drivers
When someone acquires HIV infection, the virus begins to attack white blood cells which are vital to helping the immune system fight infection and disease. Therefore, people living with HIV who are not treated with ART are likely to acquire opportunistic infections over time. In addition, people living with HIV have higher rates of additional medical conditions such as hepatitis C infection, cardiovascular disease, kidney disease, liver disease and certain types of cancer.4
These additional conditions bring higher medical costs. In one study, adult HIV patients with chronic kidney disease and cardiovascular disease had significantly higher health care utilization and costs. Average incremental costs per person per month ranged from $1403 to $2655 higher among a commercial population compared to people without HIV. 5
AIDS (acquired immune deficiency syndrome) is the most advanced stage of HIV infection and indicates that a patient has a life-threatening infection or cancer. However, advancing to AIDS is unlikely with the use of ART medications.
ART enters the frame
The first ART medication received approval from the U.S. Food and Drug Administration in 1987. There are now more than 25 ART drugs approved to treat HIV. These drugs are divided into 6 distinct classes based on their mechanism of action.
There are at least three basic features of ART medications that are critical to understanding how they currently affect the payer landscape. These features are:
- First, all types of ART work to suppress the virus rather than eliminate it. The goal in treatment is for the ART drugs to suppress the virus to levels undetectable in blood tests.
- Second, drugs from different therapy classes are commonly taken together to achieve combination antiretroviral therapy (cART).
- The third key feature of ART therapies is that these regimens can be complex. For example, someone may be required to take a combination of pills, several times per day, with or without certain kinds of food. Thankfully, the latest generation of ART is simpler to take and many medications require just 1 or 2 tablets per day. 6
“The development and expanded use of antiretrovirals has greatly increased the life expectancy and quality of life of people living with HIV,” says Savitha Vivian, VP of Clinical Services for OptumRx. “These medicines are often taken in combination and their effective use requires carefully tailored medication regimens and attention to adherence. The resources and deep clinical expertise of OptumRx helps ensures the best health outcomes for people with HIV while simultaneously addressing total cost of care.”
Spending shifts to prevention
While combination ART is effective, the best way to treat HIV infection is to prevent infection from occurring in the first place.
The most immediate development in HIV prevention efforts is the shift to using pre-exposure prophylaxis (PrEP) in individuals who are at high risk of HIV infection. PrEP can be an effective way to prevent HIV transmission, provided it is taken regularly and prior to possible exposure.
Currently, the only approved PrEP therapy is Truvada®, which was first approved in 2004 as an HIV treatment. Truvada was granted FDA approval to be used as PREP in 2012.7
Since then, utilization of and spending on Truvada, which has a list price of approximately $2,000 per month, has continued to increase.8 For example, OptumRx clients have seen spending on Truvada rise 77% from 2016-2018 on a PMPM basis.3 In fact, Truvada now accounts for 25% of market share across the HIV class.3
Yet, considering the great cost of treating HIV infections once established, increased spending on PrEP seems an entirely sensible means of cost avoidance. The Centers for Disease Control and Prevention estimates that for every HIV infection that is prevented, $360,000 is saved in the cost of providing future HIV treatment.9
New options for PrEP are now in development and will soon bring competition to the PrEP market. In addition to newer brand options, Truvada will have a generic equivalent available in the U.S. in 2021, and this additional competition brings the prospect of lower costs.10
Other developments to watch include the recent availability of a new type of ART to help people with multidrug-resistant HIV infections.11 Additionally, an injectable formulation of cART, which offers the prospect of longer-lasting treatment intervals than oral versions, is currently exhibiting promise in clinical trials.12
Looking further ahead, there is also cautious optimism that longstanding efforts to develop an HIV vaccine will eventually yield enduring protection from HIV. Until then, prevention and treatment with current ART drugs will remain the best means of treating and stopping the spread of HIV.
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1. Lancet. “The End of AIDS: HIV Infection as a Chronic Disease.” Accessed at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4058441/
2. Joint United Nations Program on HIV/AIDS. “Ending AIDS.” Accessed at: http://www.unaids.org/sites/default/files/media_asset/Global_AIDS_update_2017_en.pdf
3. Optum internal data
4. U.S. National Library of Medicine. “HIV-Related Conditions.” Accessed at: https://aids.nlm.nih.gov/topic/1092/hiv-related-conditions/2136/basics:-hiv-related-conditions
5. Current Medical Research and Opinion. Healthcare utilization and direct costs of non-infectious comorbidities in HIV-infected patients in the USA. Accessed at: https://www.tandfonline.com/doi/abs/10.1080/03007995.2017.1383889?journalCode=icmo20
6. U.S. Department of Health and Human Services. “Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV.” Accessed at: https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/0
7. Food and Drug Administration. “FDA approves first drug for reducing the risk of sexually acquired HIV infection.” Accessed at: https://aidsinfo.nih.gov/news/1254/fda-approves-first-drug-for-reducing-the-risk-of-sexually-acquired-hiv-infection
8. NPR. “Rising Cost Of PrEP To Prevent HIV Infection Pushes It Out Of Reach For Many.” Accessed at: https://www.npr.org/sections/health-shots/2018/06/30/624045995/rising-cost-of-prep-a-pill-that-prevents-hiv-pushes-it-out-of-reach-for-many
9. Centers for Disease Control and Prevention. “HIV Prevention Works.” Accessed at: https://www.cdc.gov/hiv/policies/hip/works.html
10. Gilead. “Gilead Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Once-Daily Descovy® for HIV Pre-Exposure Prophylaxis.” Accessed at: https://www.gilead.com/news-and-press/press-room/press-releases/2019/4/gilead-submits-supplemental-new-drug-application-to-us-food-and-drug-administration-for-oncedaily-descovy-for-hiv-preexposure-prophylaxis
11. Food and Drug Administration. “FDA approves new HIV treatment for patients who have limited treatment options.” Accessed at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm599657.htm
12. The Financial Times. “Monthly jab for HIV treatment passes late-stage trials.” Accessed at: https://www.ft.com/content/f0a7068e-40cf-11e9-9bee-efab61506f44
STATEMENT REGARDING FINANCIAL INFLUENCE:
This article is directed solely to its intended audience about important developments affecting the pharmacy benefits business. It is not intended to promote the use of any drug mentioned in the article and neither the author nor OptumRx has accepted any form of compensation for the preparation or distribution of this article.