Trends in First-Year Utilization

Drug Trends Costs of HIV Medications

Anthony Palmieri, RPh, PharmD, MBA; Lisa Mostovoy, PharmD, MBA; Osayi Akinbosoye, PhD, PAHM; John A. Szychowski, AAS, BS; Marina L. Sehman, RPh, PharmD; and Olga S. Matlin, PhD

he prevention and treatment of human immu- of various treatment options. Recent approval of preven- nodefi ciency virus (HIV) is a topic of interest tive therapy and an over-the-counter HIV test may further T among many in public health and managed care. increase the costs of HIV-related therapy. To establish The Centers for Disease Control and Prevention (CDC) the baseline costs which prescription drug plan sponsors estimates that as of 2008, approximately 1.2 million peo- have been incurring prior to these approvals, this study ple in the United States were living with HIV infection; 1 examines the recent trends in 1-year costs of HIV ART in 5 are undiagnosed.1 The annual number of new HIV therapy in therapy-naïve patients. infections has remained relatively stable recently, with roughly 50,000 Americans newly diagnosed with the dis- METHODS ease each year.2 Of the HIV diagnoses made in 2008, the The purpose of this study was to measure costs and de- CDC calculated that 1 in 3 (33%) were late, often made mographic characteristics associated with new HIV therapy after the development of AIDS.1 Progression of HIV in- initiators in a nationally representative population sample fection to acquired immune defi ciency syndrome (AIDS) over a 4-year period and to determine factors associated can be delayed—often for many years—by using various with changing prescription costs over time. A retrospec- combinations of currently approved antiretroviral therapy tive, longitudinal study was conducted on prescription (ART). Frequently, these expensive ART medications claims data from CVS Caremark from July 1, 2006, to June comprise a high portion of the total pharmacy costs for 30, 2012. HIV therapy utilizers were identifi ed based on prescription drug plan sponsors. an index fi ll in the period between January 1, 2007, and The main goal of HIV ART is to reduce morbidity and June 30, 2011. To be included in the study, patients had mortality associated with the disease via the inhibition of to be continuously eligible for pharmacy benefi ts for at HIV replication, which keeps the viral load below detect- least 18 months (6 months prior to the index fi ll and 12 able levels and allows immune reconstitution to begin.3 months after the index fi ll). A patient was considered There are a number of HIV drug-treatment protocols with therapy-naïve at index fi ll if there was no HIV medication varying degrees of complexity and cost; in fact, there are prescription fi lled within 6 months prior to the index fi ll of over 20 approved antiretroviral (ARV) medications in 6 an HIV medication. Study outcomes were measured over therapeutic classes that are available to design combina- 12 months from the index fi ll and included total costs of tion ART regimens.4 These 6 HIV ARV classes include HIV therapy (plan-paid plus member out-of-pocket cost) nucleoside/nucleotide reverse transcriptase inhibitors per 1-day supply of medication. Patient characteristics, (NRTIs), non-nucleoside reverse transcriptase inhibitors including gender, age, region of residence, and Census- (NNRTIs), protease inhibitors (PIs), fusion inhibitors based income and college education in the zip code, as (FIs), CCR5 antagonists, and integrase strand transfer in- a proxy for socioeconomic status, were also measured. A hibitors (INSTIs).4,5 Combination therapy with multiple- linear regression model of total costs was constructed to class drugs is the standard of care, and treatment-naïve evaluate the impact of demographic covariates on drug patients require at least 3 active agents. HIV therapy se- costs during the fi rst year of utilization. Descriptive and lection must be done on a patient-specifi c basis based on ANOVA analyses were conducted using SAS Version 9.1 factors such as comorbid conditions, concomitant medi- with SAS/STAT. HIV medications were determined using a cations, and potential barriers to adherence. Medi-Span indicator for HIV therapy. The cost of HIV treatment depends on multiple fac- tors, including infection and diagnosis rates, the lifespan RESULTS of patients with the disease, and costs and availability There were a total of 86,455 new initiators over the

228 The American Journal of Pharmacy Benefi ts • September/October 2012 www.ajpblive.com First-Year Utilization Costs of HIV Medications

Table 1. Selected Demographics of HIV Initiators (2008-June 2012) Characteristic 2008 2009 2010 2011 2012 Total Age, mean (SE) 45.20 (0.08) 45.50 (0.07) 45.66 (0.07) 45.30 (0.07) 45.69 (0.22) 45.47 (0.10) Age Category, n (%) <18 y 58 (0.4) 75 (0.39) 117 (0.47) 167 (0.68) 9 (0.32) 426 (0.49) 18-34 y 1617 (11.12) 2542 (13.09) 3564 (14.17) 3903 (15.87) 484 (17.35) 12,110 (14) 35-44 y 5950 (40.93) 7046 (36.28) 8480 (33.72) 7970 (32.4) 772 (27.68) 30,218 (34.94) 45-54 y 5119 (35.21) 6776 (34.89) 9195 (36.56) 8764 (35.63) 1015 (36.39) 30,869 (35.69) 55-64 y 1557 (10.71) 2383 (12.27) 2846 (11.32) 2903 (11.8) 430 (15.42) 10,119 (11.7) 65-74 y 207 (1.42) 515 (2.65) 748 (2.97) 674 (2.74) 53 (1.9) 2197 (2.54) 75+ y 29 (0.2) 83 (0.43) 200 (0.8) 218 (0.89) 26 (0.93) 556 (0.64) Gender, n (%) Female 3587 (24.67) 5061 (26.06) 6245 (24.83) 6066 (24.66) 652 (23.38) 21,611 (24.99) Male 10,950 (75.33) 14,359(73.94) 18,905 (75.17) 18,533 (75.34) 2137 (76.62) 64,884 (75.01) Median Annual Household Income Category, n (%) <$35,000 4997 (35.59) 6414 (34.18) 8677 (36.12) 8268 (34.96) 889 (32.72) 29,245 (35.15) $35,001- $55,000 6632 (47.23) 8670 (46.21) 10,446 (43.48) 10,398 (43.97) 1250 (46.01) 37,396 (44.95) >$55,000 2412 (17.18) 3680 (19.61) 4903 (20.41) 4981 (21.06) 578 (21.27) 16,554 (19.9) Percent College Educated in Zip Code, n (%) <8% 4750 (20.2) 5167(18.38) 6824 (20.12) 5961 (18.9) 705 (19.19) 23,407 (19.38) 8%-20% 12,300 (52.31) 15,066 (53.6) 16,588 (48.9) 15,524 (49.22) 1768 (48.14) 61,246 (50.72) >20% 6463 (27.49) 7873 (28.01) 10,511 (30.98) 10,053 (31.88) 1200 (32.67) 36,100 (29.9) Region of Residence, n (%) Midwest 3621 (14.85) 3489 (12.06) 3633 (10.45) 3227 (9.97) 367 (9.84) 14,337 (11.54) Northeast 6872 (28.19) 7518 (25.98) 7890 (22.69) 6863 (21.2) 721 (19.33) 29,864 (24.04) South 11,025 (45.23) 12,651 (43.71) 15,687 (45.1) 15,476 (47.8) 1921 (51.5) 56,760 (45.7) West 2859 (11.73) 5284 (18.26) 7569 (21.76) 6813 (21.04) 721 (19.33) 23,246 (18.72) SE indicates standard error. Source: CVS Caremark electronic claims data. study period, with an average of 17,291 per year. Annual to $33.29 by mid-2012 (Figure). Despite total cost in- demographic characteristics of HIV therapy initiators are creases, patient out-of-pocket spend has remained stable presented in Table 1, with the 2012 statistics refl ecting the at approximately 7% of the total cost. Additionally, some mid-year measures. While the age of new therapy initia- therapies have seen substantial infl ation in cost per day’s tors over the 4.5 years of the study remained relatively supply over the study time period (Table 2), especially stable at approximately 45 years, there was a relative de- when compared with the United States general infl ation crease in initiatiors in the 35 to 44 year age groups, with trend of 6% between 2008 and mid-2012, and even the relative increases in every other age group. The majority prescription medications infl ation trend of 16% during the of HIV therapy initiators were male (75.01%). For most same time period. new HIV therapy initiators, the median annual household Of several different combinations of ART started by income was $35,001 to $55,000 (44.95%), with 50.72% of new initiators over the entire study period, Atripla was the new initiators living in a zip code where only 8% to 20% predominant triple therapy HIV medication utilized solely of the population was college-educated. The majority of (utilized by 27.7% of new initiators by mid-2012), whereas HIV therapy initiators lived in the southern part of the Truvada was the predominant double therapy medication United States (45.7%). utilized in combination with other medication(s) (Table 3). The average total cost per day of HIV ART therapy in There were signifi cant demographic differences in to- the fi rst year post-initiation has risen from $26.48 in 2008 tal costs across groups over the study period. Patients

www.ajpblive.com Vol. 4, No. 5 • The American Journal of Pharmacy Benefi ts 229 I Palmieri • Mostovoy • Akinbosoye • Szychowski

Figure. Average Total Costs of HIV Therapy for New Initiators 2008 to June 2012

34.00

32.00 $2.40

Average copay/day

30.00 Average paid amount/day $2.30

$2.05 28.00 $2.04 $

26.00 $2.19 $30.89

$28.20 24.00 $27.18 $26.24

22.00 $24.29

20.00 2008 2009 2010 2011 2012 younger than 65 years had higher costs compared with Preventive Therapy patients 65 years and older. Patients in the West incurred In July 2012, the US Food and Drug Administration lower costs compared with patients residing in other (FDA) granted supplemental approval to Truvada (emtric- geographic areas. Gender and socioeconomic status itabine/tenofovir) as the fi rst pharmaceutical approved to were not signifi cant predictors of therapy costs (Table 4). reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage DISCUSSION in sexual activity with HIV-infected partners. Truvada, This study found signifi cant increases in the cost of taken daily, is to be used for pre-exposure prophylaxis ART therapy over the last several years for therapy initia- (PrEP) in combination with safer sex practices to reduce tors, and signifi cant increases in costs of individual thera- the risk of sexually acquired HIV infection in adults at pies, which are part of complex treatment regimens. In high risk. Truvada has been available since 2004 for use addition to demographic and drug costs drivers of HIV in combination with other antiretroviral agents for the treatment costs, recent developments will impact the cost treatment of HIV-infected adults and children 12 years or of HIV therapy. older.6 Truvada’s existing boxed warning was revised to

Table 2. Annual Trends in Costs per Day’s Supply for Most Commonly Utilized Medications (2008 to June 2012) Percent Infl ation Percent Infl ation Percent Infl ation Percent Infl ation Overall Cost Increase Medication (2008-2009) (2009-2010) (2010-2011) (2011-2012) (2008-June 2012) Atripla 6.0 5.4 2.7 12.6 29.2 Isentress 8.3 3.1 3.7 7.3 24.3 Kaletra 4.6 5.4 2.2 4.6 17.8 Norvir 5.4 4.3 3.0 4.7 18.5 Reyataz 4.7 5.2 4.5 4.2 19.9 Truvada 6.0 6.1 3.7 8.9 27.0 Source: CVS Caremark electronic claims data.

230 The American Journal of Pharmacy Benefi ts • September/October 2012 www.ajpblive.com First-Year Utilization Costs of HIV Medications state that PrEP must only be used in individuals who are Table 3. Percent of Initiators of the Top 3 Most Commonly confi rmed to be HIV negative prior to prescribing and Utilized Therapy Combinations (2008 to June 2012) who test negative for the infection at least every 3 months Atripla only 3 18.7% during PrEP use. The drug is contraindicated for PrEP in 2008 Norvir + Reyataz + Truvada 4 7.2% individuals with unknown or positive HIV status.7 Kaletra + Truvada 4 5.2% Although the added indication for Truvada was rec- Atripla only 3 24.2% ognized by most as a victory in the fi ght against HIV/ 2009 Norvir + Reyataz + Truvada 4 8.7% AIDS, concerns have been raised due to nonadherence, Kaletra + Truvada 4 4.3% improper use by those already infected by HIV (which Atripla only 3 24.2% could lead to viral resistance), signifi cantly increased 2010 Norvir + Reyataz + Truvada 4 8.7% medication cost in an otherwise healthy population, and Isentress + Truvada 3 4.3% increased risky behavior due to behavioral compensa- Atripla only 3 24.9% tion (eg, the idea of being “bulletproof” may infl uence individuals to engage in sexual practices such as aban- 2011 Norvir + Reyataz + Truvada 4 8.7% doning the use of condoms, which are a cornerstone of Isentress +Truvada 3 5.2% HIV prevention).8 Atripla only 3 27.7% The new indication of Truvada for prophylactic use 2012 Norvir + Reyataz + Truvada 4 7.5% will likely be expensive. The AIDS Healthcare Founda- Isentress + Truvada 3 6.6% tion recently estimated the cost of a year’s supply of Tru- Source: CVS Caremark electronic claims data. vada to be $14,130.9 However, the lifetime treatment cost of an HIV infection can be used as a measure of the value HIV Testing in averting a single infection. Currently, the lifetime treat- Detection of HIV is critically important in controlling ment cost of an HIV infection is estimated at $379,668 transmission of the virus because treating patients with (in 2010 dollars); therefore a prevention intervention is the appropriate anti-retroviral therapy can lower trans- deemed cost-saving if its cost-effectiveness ratio is less mission person to person by as much as 96%.11 Home than $379,668 per infection averted.10 medical tests are popular with consumers because of

Table 4. Impact of Demographic Factors on Average Total Cost per Day’s Supply of Medication Demographic Characteristics Estimate P Female gender 0.04 .55 Age, compared with 75+ <18 y 2.91 <.0001a 18-34 y 3.06 <.0001a 35-44 y 2.53 <.0001a 45-54 y 2.36 <.0001a 55-64 y 1.34 .01a 65-74 y 0.54 .31 Median household income, compared with $55K+ <$35,000 0.08 .46 $35,001- $55,000 0.20 .02a Percent college educated in zip code, compared with 20%+ <8% 0.07 .50 8%-20% -0.14 .05a Region, compared with West Midwest 1.46 <.0001a Northeast 2.06 <.0001a South 1.50 <.0001a aDenotes statistical signifi cance at the 5% level.

www.ajpblive.com Vol. 4, No. 5 • The American Journal of Pharmacy Benefi ts 231 I Palmieri • Mostovoy • Akinbosoye • Szychowski their convenience and the privacy they provide. In July Concerns Surrounding the Test 2012, the FDA approved OraSure Technologies’ Ora “We shouldn’t let the perfect be the enemy of the good,” Quick ADVANCE Rapid HIV-1/2 Antibody Test as the fi rst a statement from an FDA advisory committee member, such OTC product for consumers to determine their HIV Dr Brooks Jackson, gets to the heart of one of the more status in the privacy of their own home via the collection controversial issues with the in-home test: the high rate of of an oral fl uid sample. The usability of the test is on par false negative results that could lead to recklessness and with the ease of home pregnancy tests and is seen as an endangering of sexual partners. In addition to this high important step in the normalization of a disease that has rate of false negative outcomes, several other issues have historically been stigmatized within the community.12 been raised regarding the approval of this test. The test is able to detect antibodies to HIV-1 and HIV-2 One of the main concerns involves the lack of full in 20 minutes. OraQuick does not use saliva, but rather comprehension surrounding the results and the limita- absorbs antibodies directly from the blood vessels in the tions of a screening test, such as the length and meaning mucous membranes of the mouth; it detects antibodies for of the “window period”—denoting the time for a mea- HIV, not the virus itself.13 surable antibody response from recent exposure. This According to Phase III data presented by OraSure timeline may take up to 90 days in certain patients to and reviewed by the FDA that represent a more real- reach detectable levels and could therefore lead to inac- world scenario, OraQuick has about a 92.9% sensitivity curate interpretation of HIV status.16 This is particularly (the percentage of users with HIV in whom the virus was important because most people are most infectious right correctly detected) rate, or 1 false negative result per 12 after they are fi rst exposed to the HIV virus and more tests—as well as 99.98% specifi city (the percent of pa- than half of HIV transmissions are believed to pass from tients correctly identifi ed as not being infected with HIV), an infected person to a new victim during the infected or 1 false-positive result in every 5000 tests.14 person’s fi rst 60 to 90 days of exposure.17 The OraQuick ADVANCE Rapid HIV-1/2 antibody test Additionally, the lack of live counseling raises the po- was originally approved as a rapid antibody test for use tential for adverse outcomes if the user obtains an unex- with fi ngerstick whole blood specimens in 2002. In June pected result without concurrent live support and context. 2004, OraSure obtained approval for use of the test with Furthermore, the inability to reach individuals testing at oral fl uid and since that time over 20 million units have home for medical follow-up, partner notifi cation, and been used for HIV testing in this country. The FDA’s ap- public health reporting represent further downside to the proval of the OTC antibody test included a requirement use of the test in the home setting.14 that a call center for consumers to access be made avail- In the immediate wake of its approval, OraSure has able 24 hours a day, 7 days a week. The support center priced the OraQuick test at $34.00, available directly for the OTC test will be operated by full-time dedicated from the manufacturer via its website.18 It remains to be representatives with bilingual capability (English and seen if this price point will be a barrier to use for patients Spanish) that have undergone 120 hours of training to who should properly be self-testing at intervals several ensure the highest standards of support. OraSure’s launch times during the year, which is the recommended inter- plan for the test also included extensive pharmacist and val for some high-risk groups. Therefore the pricing of physician education tools to ensure they are aware of not the OTC version may be as critical to the overall public only how the test works, but of all the support services health impact as the test itself.14 OraQuick is expected to available to their customers.15 be launched for retail sale in October.19 There is a push Many experts believe that the approval and use of for HIV testing to be paid for by third party payers. With this home test for HIV represents a positive step for- implementation of the Affordable Care Act, coverage of ward in controlling a 30-year-old epidemic.12 Certainly, HIV testing has already expanded and will greatly increase any process that can provide rapid results, especially to in the future. the population unaware of their infected status, would Another issue with the test involves consumers who be seen as an important component of controlling the were involved in the HIV vaccine trials. According to the spread of the disease. In fact, 41% of pivotal study investigators from the study, over 40% of the participants participants for the home test found to be HIV posi- developed antibodies to the vaccine, which would cross- tive reported they had never before been tested and react with the in-home test and cause a falsely positive likely would not have been tested without the OTC outcome. Therefore vaccine trial participants need to be self-testing option.8 made aware of this issue with using the OTC product.14

232 The American Journal of Pharmacy Benefi ts • September/October 2012 www.ajpblive.com First-Year Utilization Costs of HIV Medications

Despite some serious and valid concerns, the FDA con- With respect to generic HIV drugs, several moderately cluded that if just 1% of Americans use the test, OraQuick used products have come to market in the last year. Most could identify up to 45,000 previously undetected HIV- recently, abacavir (generic Ziagen) launched in June positive people and prevent close to 4000 new infections 2012. Generic versions of Viramune (nevirapine) tablets each year. So it basically comes down to a risk/benefi t for and oral suspension became available on the market in the individual versus the community as a whole—the risk May 2012. Epivir (lamivudine) and Combivir (/ for the 1 in 12 false negative individuals versus the soci- lamivudine) both became available generically in late etal benefi ts from the projected thousands of consumers December 2011. These products join a number of other who are identifi ed as HIV positive and can obtain earlier generic HIV treatments. The next product expected to treatment and prevent further transmission.14 launch generically in the near term is nelfi navir (generic Viracept), projected to launch sometime in Q2 2014.21 HIV: Selected Drugs in the Pipeline There are reportedly 60 new drugs currently in de- CONCLUSIONS velopment for the treatment of HIV. Selected products Over the past decade, there has been a signifi cant im- anticipated to come to market in the near future include: provement in access to HIV testing and care, streamlined therapy options, and a reduction in the societal stigma • Quad. In May 2012, the FDA’s Antiviral Drugs associated with the disease.11 This has led to the recent Advisory Committee voted in favor of Gilead milestone fi rst-time approvals of an OTC in-home HIV Sciences’ Quad (elvitegravir/cobicistat/emtricit- test (OraQuick)23 and the fi rst drug indicated to prevent abine/tenofovir) fi xed-dose 4-drug-in-1 HIV pill HIV infection in a healthy population (Truvada).6 Histori- for treatment-naïve adults despite renal toxicity cally, motivating people to test for HIV has been prob- concerns.20 Quad has shown similar effi cacy as lematic due to a perceived loss of confi dentiality, lack Atripla and while nausea was more signifi cant of privacy, and fear of visibility in public settings. The with Quad, dizziness, abnormal dreams, insom- OraQuick test may help identify patients sooner, mak- nia, and rash were signifi cantly more frequent ing them less likely to transmit the infection to others with Atripla.21 and enabling them to receive treatment earlier. Similarly, • Elvitegravir. Part of the Quad combination prod- Truvada has the potential to be a powerful tool for many uct, stand-alone elvitegravir could open up the individuals and couples struggling to remain HIV-free. integrase-inhibitor market. In a study submitted in Analysis of historical pharmacy claims for therapy support of approval the single-agent, once-daily initiators found a 26% increase, from $26.48 in 2008 to elvitegravir proved comparable to Merck’s twice- $33.29 by mid-2012, in average daily cost of medication. daily blockbuster Isentress, the only commer- The increases well outpaced prescription medication’s cially available integrase inhibitor. Approved for infl ation trend of 16% during the same time. both treatment-experienced and treatment-naïve HIV ART will continue to be a signifi cant challenge patients, Isentress brought in sales of almost $1.4 in terms of prescription drug cost for prescription drug billion in 2011, up 25% from the previous year. plan sponsors. For many payers, this class will have a In spite of the market success to date, attempts at noticeable impact on trend. Factors that play a role in the making a once-daily version of Isentress have not size of this impact include: price, the new drug pipeline, been successful, which could jeopardize future additional testing opportunity translating to more diag- growth.22 nosis, and prophylactic use of Truvada. With approval • Cobicistat. One of the more interesting drugs in of Truvada for PrEP, HIV has emerged from being a top- the pipeline, cobicistat has no direct effect on HIV spend chronic, complex condition to being a preven- itself. Cobicistat (, Phase II) is for tatable condition which now, more than ever, requires the treatment of HIV infection in combination with hands-on management by specially trained clinicians. other antiretroviral agents. The product is called a By layering on top of this an OTC self-use diagnostic pharmacokinetic enhancer or “booster” drug that tool and an increase in therapeutic options, there is cre- makes other products, especially protease inhibi- ated a critical need for accessible clinical management: tors, last longer in the patient’s bloodstream. Also a need for clinicians who understand the complexity of part of Gilead’s Quad combination pill, Cobicistat’s the disease, the importance of adherence, the difference projected launch timeline is Q1 2013.21 between therapeutic and preventive treatment, and the

www.ajpblive.com Vol. 4, No. 5 • The American Journal of Pharmacy Benefi ts 233 I Palmieri • Mostovoy • Akinbosoye • Szychowski necessity of frequent HIV testing. Clinical guidance and Truvada for reducing the risk of acquiring HIV. http://investors.gilead.com/phoenix .zhtml?c=69964&p=irol-newsArticle&id=1715013. Published July 16, 2012. management will be keys in the future success of HIV Accessed July 17, 2012. prevention. 9. Marcus A, McKay B. Fight over use of HIV drugs. The Wall Street Journal. Published March 7, 2012. Author Affi liations: From the Division of Enterprise Analytics (JAS, 10. Centers for Disease Control and Prevention. HIV cost-effectiveness. http:// MLS, OA, OSM), CVS Caremark, Scottsdale, AZ, and Northbrook, IL; www.cdc.gov/hiv/topics/preventionprograms/ce/index.htm. Published 5, 2012. Clinical Sales and Account Services (AP, LM), CVS Caremark, Scottsdale, Accessed July 12, 2012. AZ, and Philadelphia, PA. 11. Aggleton P, Wood K, Malcolm A, Parker R; UNAIDS. HIV-related stigma, dis- Funding Source: None reported. crimination and human rights violations: case studies of successful programmes. Author Disclosures: The authors (AP, LM, OA, JAS, MLS, OSM) UNAIDS Best Practice Collection. http://data.unaids.org/publications/irc-pub06/ report no relationship or fi nancial interest with any entity that would jc999-humrightsviol_en.pdf. Published 2005. Accessed July 16, 2012. pose a confl ict of interest with the subject matter of this article. The con- 12. McNeil DG, Rapid H.I.V. home test wins federal approval. The New York Times. tent is solely the responsibility of the authors and does not necessarily Published July 3, 2012. represent the offi cial views of CVS Caremark. 13. OraSure Technologies, Inc. The OraQuick ADVANCE rapid HIV-1/2 antibody Address correspondence to: John A. Szychowski, AAS, BS, CVS test detects antibodies to HIV-1 and HIV-2 in 20 minutes. http://www.orasure Caremark, 9501 E Shea Blvd MC 034, Scottsdale, AZ 85260. E-mail: John. .com/products-infectious/products-infectious-oraquick.asp. Published May 7, [email protected]. 2009. Accessed July 22, 2012. 14. Judy Stone. Over-the-counter OraQuick HIV test: what does this mean for REFERENCES you? Scientifi c American Blog. http://blogs.scientifi camerican.com/molecules-to- 1. Centers for Disease Control and Prevention (CDC). Results of the Expanded HIV medicine/2012/07/09/over-the-counter-oraquick--test-what-does-this-mean- Testing Initiative–25 jurisdictions, United States, 2007-2010. MMWR Morb Mortal for-you/. Published July 9, 2012. Accessed July 21, 2012. Wkly Rep. 2011;60(24):805-810. 15. OraSure Technologies, Inc. Final Advisory Committee Briefi ng Materials: 2. Centers for Disease Control and Prevention. National Center for HIV/AIDS, Viral Available for Public Release: Blood Products Advisory Committee Briefi ng Docu- Hepatitis, STD, and TB Prevention. HIV in the United States: at a glance, National ment. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting- Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. http://www.cdc. Materials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ gov/hiv/resources/factsheets/us.htm. Published March 2012. Accessed July 22, UCM303652.pdf. Published May 15, 2012. Accessed July 22, 2012. 2012. Publication CS231128. 16. OraQuick Advance Rapid HIV-1/2 Antibody Test Package Insert. http://www 3. American Public Health Association. Adherence to HIV treatment regimens: rec- .orasure.com. Accessed July 21, 2012. ommendations for best practices. http://www.apha.org/NR/rdonlyres/1F7F3BD1- BE3D-440E-B2F4-16E5EC6C4DBE/0/Best_Practices_new.pdf. Published June 17. Parloff R. The quiet scandal of the HIV home test kit. http://features.blogs 2004. Accessed July 10, 2012. .fortune.cnn.com/2012/07/09/oraquick-hiv-test/. Published July 9, 2012. Ac- cessed July 22, 2012. 4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Department of Health and Human Services. AIDSinfo. Guidelines for the use of antiretroviral 18. OraQuick HIV Test. http://oraquickhivtests.com/. Published 2011. Accessed agents in HIV-1-infected adults and adolescents. http://aidsinfo.nih.gov/con- July 23, 2012. tentfi les/lvguidelines/AdultandAdolescentGL.pdf. Published March 27, 2012. 19. Soper S. FDA approves OraSure at-home HIV test. The Morning Call. http:// Accessed June 25, 2012. articles.mcall.com/2012-07-03/business/mc-oraquick-hiv-test-ap- 5. Bookstaver PB. HIV infection and AIDS. In: American College of Clinical Phar- proved-20120703_1_orasure-ceo-douglas-michels-oraquick-in-home-hiv-test- macy. PSAP. 7th ed. Lenexa, KS: American College of Clinical Pharmacy; 2012: orasure-technologies. Published July 3, 2012. Accessed July 31, 2012. 7-25. 20. Sutter S, Gilead’s quad makes it through FDA panel review despite renal 6. U.S. Food and Drug Administration. FDA approves fi rst drug for reducing safety concerns. The Pink Sheet. 2012;74(20). the risk of sexually acquired HIV infection [press release]. http://www.fda.gov/ 21. CVS Caremark Specialty Product Evaluation Worksheet. June 2012. NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm. Published July 22. Hayes E. Gilead fi les once-daily integrase inhibitor Elvitegravir with FDA. The 16, 2012. Accessed July 22, 2012. Pink Sheet Daily. June 28, 2012. 7. Sutter S. FDA approves truvada for PrEP with bolstered labeling but no 23. Walker EP. Home HIV Test Wins FDA Nod. MedPage Today. http://www restricted distribution. The Pink Sheet Daily. Published July 16, 2012. .medpagetoday.com/HIVAIDS/HIVAIDS/33610. Published July 3, 2012. Accessed 8. Gilead Sciences, Inc. US Food and Drug Administration approves Gilead’s July 22, 2012.

234 The American Journal of Pharmacy Benefi ts • September/October 2012 www.ajpblive.com