January 09, 2020
The HIV treatment landscape has undergone an impressive transformation since the height of the AIDs epidemic in the mid-nineties. Antiretroviral therapies (ART) have led to a dramatic decline in the number of HIV- and AIDs-related deaths and are enabling patients to lead long, full lives. AIDs is no longer viewed as a terminal illness, but rather a manageable chronic condition, thanks to incredible advancements in modern medicine. According to the Centers for Disease Control and Prevention (CDC),
Strict adherence to antiretroviral therapies can even lead to an “undetectable” viral count, effectively rendering the disease no longer transmissible.1 Today, individuals have access to preventive antiviral agents, or preexposure prophylaxis (PrEP), that can significantly mitigate an individual’s risk of exposure.
Nevertheless, due to imperfect adherence to therapy and longer patient life span, new infections continue to occur.2 While the annual number of newly diagnosed HIV infections declined by 9% between 2010 and 2016, infections have increased among certain populations.3,4 Currently, there are more than 1.1 million people living with HIV in the United States.3 An estimated 87% of those living with HIV know of their infection; however, less than half of these patients have their virus under control.5 On the other hand, the remaining ~13% living with HIV (or roughly 1 in 7) are entirely unaware of their status.6 Nine in 10 new HIV infections come from patients not receiving proper HIV care. Many of these new cases could be averted through early diagnosis and appropriate ongoing treatment.7
With the rate of HIV diagnosis surpassing the rate of HIV- and AIDs-related deaths, and more people living with HIV now than ever before5, it has become an important priority of the Administration to halt the spread of HIV in its tracks. Furthermore, the U.S. Preventive Service Task Force (USPSTF) recently issued a new recommendation to place PrEP on the Affordable Care Act’s (ACA) preventive service coverage list, meaning that starting in 2020, non-grandfathered health plans will be required to cover PrEP, free of cost sharing (i.e. no copay, coinsurance or deductible).
Given the increasing number of HIV patients in the workforce, inconsistent treatment adherence, the rising of cost treatment and the recent USPSTF announcement, employers are focused on making coverage decisions and developing an effective employee communication strategy.
Assessing the Burden of Disease
Since 1981, 700,000+ lives have been lost to HIV.8 In 2017, 38,739 people received an HIV diagnosis in the United States and territories, with more than half of these cases occurring in the South. However, while the South has the highest number of people living with HIV, if population size is taken into account, the Northeast has the highest rate of people living with HIV. The majority of individuals who receive a diagnosis tend to live in urban metropolitan areas with populations of 500,00 or more.4
Of those diagnosed in 2017, men who have sex with men (MSM) was the largest transmission category (66%), followed by heterosexual contact (24%) and injection drug use (6%).9 African Americans accounted for 43% of all new HIV diagnoses in 2017, although they comprise only 13% of the U.S. population.
White and Hispanic/Latinos groups each accounted for 26% of all new HIV diagnoses in 2017. Transgender and nonbinary people are particularly impacted by the burden of HIV. According to a recent National Institutes of Health (NIH) estimate, 14% of transgender women and 2% of transgender men have HIV.10
These data points underscore the disproportionate impact that this disease has on certain populations and the need for targeted treatment and prevention efforts. Regardless of the incredible progress we’ve made to date in combating HIV, without proper intervention, another 400,000 Americans are projected to become infected over the next 10 years, despite available prevention tools. This is alarming, not only from a population health perspective but from a cost perspective as well. The total lifetime health care cost of an HIV-infected individual can be as high as $500,00.8 Currently the U.S. government spends $20 billion annually on HIV prevention and care measures.11
An Evolving Treatment Landscape
ART is the golden standard of treatment for HIV and consists of a combination of HIV medicines that are taken daily (“HIV treatment regimen”).12 These medications essentially work to prevent the HIV virus from multiplying to give the patient’s immune system a fighting chance. With the virus suppressed, the patient’s CD4 immune cells can recover and more appropriately fight off infections and certain HIV-related cancers.
It is recommended that a patient initiate ART immediately upon diagnosis. CDC reports that consistent ART therapy can significantly lower the HIV viral load in the patient’s body to where it is undetectable, thus effectively removing the risk of sexual transmission.10 Despite these positive treatment results, many people living with HIV are not consistently adherent to treatment, and thus carry a virus left unchecked.2
There is a vast array of medications available to be taken as part of an HIV regimen, and they are grouped into seven different drug classes by the mode in which they fight the infection. Patients are usually placed on three medications from at least two different drug classes. Selection of these drugs depends largely on possible side effects and drug-to-drug interactions. Newer medication protocols carry far fewer side effects than those used in the past.10
Based on 2006 figures, the average annual cost per patient for ART was estimated to be $19,912, with the most popular drug combination (efavirenz/emtricitabine/tenofovir) carrying an average wholesale price tag of $2,253.88 for 30 tablets.13 By 2010, the average annual cost rose to $23,000.14 Today, with significant advancements in antiretroviral therapy, certain drugs on the market cost an HIV patient as much as $39,000 a year.15 As to be expected, overall treatment costs are higher for the sickest patients (CD4 cell counts below 50 cells/mm3) when factoring in inpatient care. Costs are projected to increase along with the aging HIV population.16
Research is underway to bring HIV treatment to the next level. The National Institute of Allergy and
Infectious Diseases has a goal of developing therapies that can be taken less frequently (e.g., once a week, once a month, or even less often). Such therapies would not only potentially improve patient adherence but would also likely be less toxic and more cost effective.
New therapies under development include:
- Long-acting drugs delivered via injections, patches and implants,
- Broadly neutralizing antibodies, which have fewer side effects, can last longer in the body and can stop a wide variety of HIV strains from infecting human cells; and
- Therapeutic vaccines, which would be administered to an HIV-infected patient to boost their immune system in response to future HIV attacks on CD4 cells, leading to sustained viral remission and eliminating the need for further therapy.17
There is also the possibility that HIV will be eradicated sooner than expected. Researchers from Temple University and the University of Nebraska Medical Center claim to have successfully eliminated the HIV virus from the DNA of infected mice using gene editing technology, offering hope for a potential cure in humans.18
The Role of PrEP in Ending the HIV Epidemic
Under the current Administration, The U.S. Department of Health and Human Services (HHS) has devised the Ending the HIV Epidemic: A Plan for America initiative to stamp out HIV in the United States within 10 years. The goal is a 75% reduction of new HIV infections in 5 years and a 90% reduction of new infections in 10 years.
Working with local communities, HHS will establish teams on the ground that will work tirelessly to
- Diagnose all HIV-infected individuals as early as possible;
- Treat the infection swiftly and effectively to achieve and sustain viral suppression;
- Protect high-risk individuals through proven prevention interventions, such as PrEP; and
- Respond rapidly to growing HIV clusters to prevent new infections.
The initiative will target 48 counties where transmission occurs most frequently, as well as Washington, DC, San Juan, Puerto Rico, and seven states where there is a high rural HIV burden. If program goals are achieved, a $100 billion reduction in HIV-related medical expenditures over the next decade is possible.
An important element of HHS’ four-pronged approach is that which focuses on protection, and pre-exposure prophylaxis (PrEP) as an integral piece of this strategy. PrEP involves taking anti-HIV medications before coming into contact with the virus in order to significantly mitigate an individual’s risk of infection.
This prevention strategy is currently an underutilized, yet highly effective, prevention tool. It is estimated that more than one million high-risk individuals might benefit from PrEP; however, only about 10% who could benefit from PrEP are actually using it. Despite these statistics, awareness is on the rise – The use of PrEP among MSM at high risk increased from 6% to 35% between 2014 and 2017.20
While the U.S. Food and Drug Administration (FDA) approved Truvada (Gilead) for PrEP use back in 2012, the therapy has recently taken center stage, both in direct-to-consumer advertising and as part of President Donald Trump’s initiative to end the HIV epidemic in America. Truvada for PrEP works to block the HIV reverse transcriptase enzyme in the body, and thus the ability of HIV to replicate. This oral pill is taken once daily at the same time each day, with or without food. It is a relatively low-effort regimen with low rates of side effects and huge benefits. It is extremely important, however, that the pill be taken every day as directed, otherwise, the level of protection against HIV wanes. When an HIV-negative individual is strongly adherent to the medication regimen, Truvada for PrEP lowers HIV risk by 92%-99%. The iPrEx study found that PrEP is 99% protective for people who take 7 pills per week, and that the level of protection wanes to 96% at 4 pills per week and to 76% at 2 pills per week. Importantly, when initiating PrEP, it takes at least 7 days to reach high levels of protection against HIV infection. When stopping the use of PrEP, individuals should continue using for 4 weeks after exposure.21
Though PrEP costs nearly $2,000 for a 30-day supply, the potential alternative is a lifetime HIV treatment cost of $500,000.8 PrEP is not intended to be taken for the duration of a patient’s life, but rather only during the timeframe when a patient is most at risk. It has been found to be highly cost-effective, especially in concentrated epidemic settings. For example, in a cost-effectiveness analysis of PrEP among Los Angeles County MSM, PrEP was shown to be cost-effective at $27,863 per quality adjusted life year (QALY) relative to the status quo (testing with treatment initiation at a CD4 cell count less than or equal to 500 cells per micro liter).22 In another study that estimated the cost effectiveness of PrEP over 40 years in Germany, short-term investments in PrEP were predicted to result in long-term cost savings. Indeed, while PrEP was shown to potentially raise costs by as much as $171 million during the first 10 years, Germany could be looking at a total savings of $5.8 billion by 2058.23
Gilead Sciences came to an agreement with Teva Pharmaceuticals to allowing them to launch a generic version of Truvada earlier than expected, which will undoubtedly help alleviate some of the cost burden of PrEP.24 Gilead has also announced that it will be donating up to 2.4 million bottles of Truvada to the CDC annually for use by uninsured Americans at high risk for HIV. This medication donation marks the largest ever in the United States and will continue until 2030, at which point the donation will transition to their newer medication – Descovy.25
In a number of years, we’ll likely see a wider array of PrEP options available on the market, as there are a number of clinical trials currently underway to assess whether other anti-HIV drugs are effective for prevention.21
The United States Secretary of Health and Human Services, Alex Azar has stated that we now have the tools and leadership to capitalize on a “historic opportunity…to solve one of the greatest public health challenges of our time.”26 The stage has been set for employers to answer the call to action.
Perhaps the most immediate employer conversations will revolve around the recent USPSTF recommendation. An A-rating for PrEP essentially means that there is high certainty that its net benefit is substantial and, therefore, that it should be offered with effective antiretroviral therapy to individuals who are at high risk of HIV infection. It also means that non-grandfathered group health plans now must cover this option, without cost sharing (i.e., no copay, coinsurance, or deductible), effective for plan years beginning on or after June 11, 2020 (January 1, 2021 for calendar year plans). The ACA requires that non-grandfathered group health plans cover, without cost sharing, all preventive services with an A or B rating from the USPSTF.
This recommendation has undoubtedly shown a bright spotlight on Truvada while raising a number of questions for employers.
Who does this USPSTF recommendation apply to?
All individuals who are not infected with HIV who are at high risk of contracting the infection. The following individuals should be considered for PrEP:
- MSM who are sexually active and either 1) have a sex partner living with HIV, 2) have had a recent sexually transmitted infection (STI) with syphilis, gonorrhea or chlamydia or 3) use condoms inconsistently.
- Heterosexual individuals who are sexually active and either 1) have a sex partner living with HIV, 2) have had a recent STI with syphilis or gonorrhea, or 3) inconsistent condom use with a partner whose HIV status is unknown and who is at high risk (i.e., bisexual, injection drug-user).
- Individuals who inject drugs and either 1) share drug injection equipment or 2) are at risk of becoming infected with HIV through sexual contact.
All individuals being considered for PrEP must have a recently documented negative HIV test.27
What does it mean from a plan design perspective?
The Business Group’s 2019 Large Employers’ Health Care Strategy and Plan Design Survey revealed that 38% of large employers have implemented at least four tiers in their pharmacy plan design, with greater cost sharing for high cost drugs like Truvada. Now that Truvada has received the “A” recommendation, employers will soon be required to cover it at no out-of-pocket (OOP) costs for employees. For employers that currently provide coverage for PrEP pre-deductible via a preventive drug list, the impact on cost and employee OOP will be less pronounced, but potentially still significant, depending on their plan design.
The HIV/AIDS drug category recently experienced yet another shake-up when Express Scripts excluded seven HIV medicines from its formulary. This move enraged AIDS advocacy groups, who fear that these exclusions may harm patients. Express Scripts (ESI), however, maintains its position on grounds of clinical evidence and the fact that there are less expensive alternatives available on the market.28
What will this do to my costs?
The Express Scripts 2018 Drug Trend Report defines HIV as the fifth most costly drug therapy class for commercial plans, behind inflammatory conditions, diabetes, oncology and multiple sclerosis. The recent “A” rating given to PrEP will likely trigger an increase in cost to the employer plan in the short term. However, generics may help to lessen this initial burden.
Behavioral Health Considerations
Eradicating HIV also means addressing the social factors that are so deeply entwined in the epidemic, including discrimination, stigma and homophobia.5 HIV-related stigma and discrimination all too often prevent individuals from learning their HIV status, and thus can inadvertently fuel the spread of disease. This reality only underscores the importance of combatting HIV stigma and dispelling the myths in order to prevent the spread of infection.29
Employers should consider the historic behavioral health ramifications of HIV/AIDS and new ways to tap into this domain to help stamp out stigma along with the disease itself. Just like other serious chronic conditions, HIV places an incredible burden on an individual’s mental health, with cultural sensitivities and financial insecurity at play. Interestingly, the PrEP pill, in and of itself, may have a positive behavioral health impact on an individual living with HIV. A recent 2019 study demonstrated lower rates of sexual anxiety among men who routinely take the pill. This finding reveals that PrEP might actually offer psychological benefits to gay and bisexual men who are extremely fearful of contracting HIV.30
The momentum from the Administration combined with the recent USPSTF A-rating opens the door for additional conversation about HIV/AIDs treatment and prevention. This, in turn, invites a more productive dialogue surrounding stigma and behavioral health efforts.
Next Steps to Consider
- Develop an HIV communication strategy for your entire employee population and couple it with a more targeted approach to better reach those at risk. The intent is to “normalize” speaking about the disease, simplify communications and make patients, and/or those at risk, feel less isolated.
- Incorporate HIV testing as well as PrEP communication campaigns into worksite well-being activities.
- Integrate a message about stigma across all behavioral health activity.
- Partner with health systems that have experience serving HIV/AIDs patients and have well established programs to ensure proper medication adherence.
- Ask your health plan to assess network coverage for facilities that are culturally competent in prescribing and monitoring the use of PrEP.
- Ask your pharmacy benefit manager (PBM) to estimate the impact that the “A” rating will have on your plan costs and utilization. This should incorporate potential market entry of generic competitors to Truvada in 2021/2022.
- Before implementing a copay accumulator program, evaluate the level of copay assistance being received by your members affected by HIV and the impact that this assistance may have on adherence.
- Truvada is a specialty medication and therefore, for some employers, may be restricted to mail-only pharmacy. In light of privacy concerns, consider allowing retail distribution of Truvada.
- Partner with employer resource groups to ensure culturally sensitive communications to the LGBTQ community and consider them allies in your quest to increase awareness about prevention, testing and medication adherence.
- Ensure that your existing resources such as care management and navigation teams are equipped with appropriate information on best sites of care for HIV/AIDs services and are able to integrate behavioral health support for these patients.
HIV has undoubtedly made its mark on this country and across the globe, infecting more than 70 million people worldwide and claiming 35 million lives since the start of the epidemic in the 1980s.31 Despite all the progress that has been made, there is still much to do. With expanded access to treatment and prevention tools like PrEP, a remarkably innovative drug pipeline and a strong government focus on crushing this epidemic, it is an opportune time for employers to take a fresh look at ways they can help in the quest to eradicate the disease.
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- 11 | HIV.gov. What is ‘ending the HIV epidemic: A plan for America’? 2019. https://www.hiv.gov/federalresponse/ending-the-hiv-epidemic/overview. Accessed July 26, 2019.
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- 13 | Solem CT, Snedecor SJ, Khachatryan A, et al. Cost of treatment in a US commercially insured, HIV-1 infected population. PLoS One. 2014;9(5). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4035292/. Accessed July 26, 2019.
- 14 | Centers for Disease Control and Prevention. HIV cost-effectiveness. 2017. https://www.cdc.gov/hiv/programresources/guidance/costeffectiveness/index.html. Accessed July 26, 2019.
- 15 | Rosenberg T. HIV drugs cost $75 in Africa, $39,000 in the U.S. Does it matter? The New York Times. 2018. https://www.nytimes.com/2018/09/18/opinion/pricing-hiv-drugs-america.html. Accessed July 26, 2019.
- 16 | Carter M. HIV treatment is costly, especially for the sickest patients. NAM. 2010. http://www.aidsmap. com/news/sep-2010/hiv-treatment-costly-especially-sickest-patients. Accessed July 26, 2019.
- 17 | National Institute of Allergy and Infectious Diseases. Future directions for HIV treatment research. 2018. https://www.niaid.nih.gov/diseases-conditions/future-hiv-treatment. Accessed July 26, 2019.
- 18 | Dash PK, Kaminski R, Gendelman HE, et al. Sequential LASER ART and CRISPR treatments eliminate HIV-1 in a subset of infected humanized mice. Nature Communications. 2019;10(2753). https://www. nature.com/articles/s41467-019-10366-y#Abs1. Accessed August 8, 2019.
- 19 | Centers for Disease Control and Prevention. First year geographic focus: Ending the HIV Epidemic: A Plan for America. https://www.cdc.gov/endhiv/docs/Ending-HIV-geographic-focus-508.pdf. Accessed July 26, 2019.
- 20 | Centers for Disease Control and Prevention. CDC HIV prevention progress report, 2019. https://www. cdc.gov/hiv/pdf/policies/progressreports/cdc-hiv-preventionprogressreport.pdf. Accessed July 26, 2019.
- 21 | San Francisco AIDS Foundation. Prep: The basics. prepfacts.org. https://prepfacts.org/prep/the-basics/. Accessed July 26, 2019.
- 22 | Drabo EF Hay, JW Vardavas, R Wagner, ZR Sood, N. A cost-effectiveness analysis of preexposure prophylaxis for the prevention of HIV among Los Angeles County men who have sex with men. Clinical Infectious Diseases. 2016;63(11). https://academic.oup.com/cid/article/63/11/1495/2526220. Accessed July 26, 2019.
- 23 | Stephens W. Estimating the cost-effectiveness of PrEP over 40 years. AJMC. 2019. https://www.ajmc. com/newsroom/estimating-the-costeffectiveness-of-prep-over-40-years. Accessed July 26, 2019.
- 24 | Fitzsimons T. Generic HIV prevention drug coming in 2020, Gilead says. NBC News. May 8, 2019. https://www.nbcnews.com/feature/nbc-out/generic-hiv-prevention-drug-coming-2020-gilead-saysn1003391. Accessed July 26, 2019.
- 25 | Gilead. Gilead Sciences to provide free Truvada for PrEP to support U.S. initiative to end the HIV epidemic. May 9, 2019. https://www.gilead.com/news-and-press/press-room/press-releases/2019/5/gileadsciences-to-provide-free-truvada-for-prep-to-support-us-initiative-to-end-the-hiv-epidemic. Accessed July 26, 2019.
- 26 | NPR. How HHS Secretary reconciles proposed Medicaid cuts, stopping the spread of HIV. NPR transcript. April 8, 2019. https://www.npr.org/templates/transcript/transcript.php?storyId=711020181. Accessed July 26, 2019.
- 27 | U.S. Preventive Services Task Force. Draft recommendation statement: Prevention of human immunodeficiency virus (HIV) infection: Preexposure prophylaxis. 2018. https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/prevention-of-human-immunodeficiencyvirus-hiv-infection-pre-exposure-prophylaxis. Accessed July 26, 2019.
- 28 | Silverman E. AIDS groups criticize Express Scripts for excluding several HIV medications. STAT: Pharmalot. June 6, 2019. https://www.statnews.com/pharmalot/2019/06/06/ aids-hiv-express-scripts-formularies/?. Accessed July 26, 2019.
- 29 | HIV.gov. Activities combatting HIV stigma and discrimination. 2017. https://www.hiv.gov/federal-response/federal-activities-agencies/activities-combating-hiv-stigma-and-discrimination. Accessed July 26, 2019.
- 30 | Rosenberg J. PrEP may offer psychological benefits to gay, bisexual men at risk for HIV. 2019. AJMC. https://www.ajmc.com/newsroom/prep-may-offer-psychological-benefits-to-gay-bisexual-men-at-riskfor-hiv. Accessed July 26, 2019.
- 31 | World Health Organization. Global health observatory data (GHO): HIV/AIDS. https://www.who.int/ gho/hiv/en/. Accessed July 26, 2019.