- Email: [email protected]
Financial Policy Issues for HIV Pre-Exposure Prophylaxis
Financial Policy Issues for HIV Pre-Exposure Prophylaxis Cost and Access to Insurance Michael Horberg, MD, MAS, FACP, FIDSA, Brian Raymond, MPH
Introduction
T
he costs and access issues related to pre-exposure prophylaxis (PrEP) for HIV prevention have not been adequately explored in health services research or in health policy circles. The dearth of information about the fınancial aspects of PrEP is a reflection of the unsettled state of this recent HIV prevention strategy. The U.S. Food and Drug Administration (FDA) has approved a drug label change that brings the fırst antiretroviral combination medication to market for HIV prevention.1 Prior to this decision, there were anecdotal reports that the tenofovir– emtricitabine (TDF–FTC) combination pill Truvada® was already being prescribed and used “off label” as PrEP and that some insurers may have been willing to reimburse PrEP in limited circumstances.2 Although PrEP now has a small impact on HIV prevention, its near- to long-term implications could be profound. As healthcare leaders begin to deal with PrEP for mainstream prevention, fınancial policy issues will become increasingly important. This article highlights the practical aspects of cost and access to insurance related to PrEP for HIV prevention in the U.S. First, the cost drivers of PrEP for HIV prevention strategies are identifıed. Then, the factors that influence the availability of health insurance coverage for PrEP in the U.S. today are discussed. The conclusion includes key policy issues for healthcare leaders to consider going forward.
The Cost of Pre-Exposure Prophylaxis Understanding the cost of PrEP is essential to guide the use of antiretroviral therapy for HIV prevention. Although numerous cost studies of providing care for HIVinfected individuals have been conducted,3,4 few studies have examined the cost of prescribing antiretroviral medication to HIV-negative patients for HIV prevention.5,6 From the Mid-Atlantic Permanente Research Institute (Horberg), Rockville, Maryland; and Kaiser Permanente Institute for Health Policy (Raymond), Oakland, California Address correspondence to: Michael Horberg, MD, MAS, FACP, FIDSA, Mid-Atlantic Permanente Research Institute, 2101 East Jefferson Street, 3 West, Rockville MD 20852. E-mail: [email protected]. 0749-3797/$36.00 http://dx.doi.org/10.1016/j.amepre.2012.09.039
To build a comprehensive picture of the cost involved in PrEP, it is important to fırst identify the cost inputs of a PrEP preventive service package and the activities that go into providing those services. From the perspective of the healthcare payer, the total cost of PrEP takes in a broad range of inputs, including laboratory fees, professional fees, and other services, beyond the cost of prescription drugs (Table 1).
Antiretroviral Medication Antiretroviral drugs are the largest component of PrEP expenses. Daily dosing of PrEP is the only regimen shown effective in RCCTs; intermittent-use effıcacy is unknown. The average wholesale price for a standard dose of Truvada (300 mg tenofovir and 200 mg emtricitabine; one tablet once a day) is about $1425 monthly.8,9 Although the cost of antiretroviral drug therapy for HIV-positive patients is influenced by a number of potentially costsaving alternative treatment options, TDF–FTC is the only PrEP regimen proven to be effective for MSM and is still under patent in the U.S., where cheaper generics are therefore not available.
Laboratory Services Laboratory services are a leading cost driver for HIV care and will likely be an important cost component of PrEP, as well. The CDC’s interim guidance on PrEP recommends several screening lab tests before initiating PrEP; an HIV antibody test every 2–3 months (because PrEP is only partially effective, and frequent HIV testing is necessary for early detection of infection and potential emergence of drug-resistant variants if infected while taking the drug); sexually transmitted infection tests every 6 months; and checking blood urea nitrogen and serum creatinine 3 months after initiation and then yearly while on PrEP medication (assuming they are within normal limits and stable).7 Laboratory testing also is necessary to look for adverse effects and to ensure that those who experience serious side effects stop PrEP as quickly as possible, especially potential renal dysfunction.11 It can be estimated that the range of annual costs of laboratory services for PrEP users is $373.50 –$504.51, which includes the one-time screening before initiating PrEP.
© 2013 American Journal of Preventive Medicine • Published by Elsevier Inc.
Am J Prev Med 2013;44(1S2):S125–S128 S125
Horberg and Raymond / Am J Prev Med 2013;44(1S2):S125–S128
S126
Table 1. PrEP cost inputs What’s included?7
Cost inputs
Annual cost ($)
Antiretroviral medication Daily doses of Truvada (TDF [300 mg] plus FTC [200 mg]) Laboratory services
17,125.088,9
Before initiating PrEP: HIV antibody test (CPT Code 86703)
19.43–26.2510
Confirm that calculated creatinine clearance is ⱖ60 mL per minute via Cockcroft-Gault formula (CPT Code 82575)
13.39–18.0910
Screen for hepatitis B infection and vaccinate against hepatitis B if susceptible (CPT Codes 86704, 86705, 06706, 87340)
63.58–85.9310
Screen for sexually transmitted infections (CPT Codes 102.91–139.0610 86592, 87491, 87590, 87591, and if positive test Subtotal ⫽ 199.31–269.33 result for syphilis 86780) Follow-up while PrEP medication is being taken: Every 2–3 months, perform an HIV antibody test (CPT Code 86703)
58.43–78.7510
Every 6 months, test for sexually transmitted infection 102.91–139.0610 12.85–17.3710 even if patient is asymptomatic (CPT Codes 86592, Subtotal ⫽ 174.19–235.18 87491, 87590, 87591, and if positive test result Total laboratory services ⫽ 373.50–504.51 for syphilis 86780) 3 months after initiation, then yearly while on PrEP medication, check blood urea nitrogen and serum creatinine (CPT Codes 82565, 85420) Professional services
Determine eligibility and confirm that patient is at substantial, ongoing high risk for acquiring HIV infection
102.95 (one initial visit/consultation)
Prescribe PrEP medication regimen Provide risk-reduction and PrEP medication-adherence counseling
206.91 (quarterly follow-up visits after initial visit/consultation)
Evaluate and support PrEP medication adherence at each follow-up visit, more often if inconsistent adherence is identified Every 2–3 months, assess risk behaviors and provide risk-reduction counseling
Total professional services ⫽ 309.86
CPT, Current Procedural Terminology; FTC, emtricitabine; PrEP, pre-exposure prophylaxis; TDF, tenofovir disoproxil fumarate
Professional Services The successful introduction of PrEP into clinical practice will require the services of a variety of medical professionals, including clinicians, HIV testing counselors, laboratory staff, clinical pharmacists, and behavioral interventionists.12 Medical screening is necessary to assess behavioral risks and determine eligibility of potential PrEP candidates. Potential candidates should be counseled by a clinician on the benefıts and potential risks of PrEP and to gain their commitment to adhere to the PrEP dosing regimen. All patients on antiretroviral treatment need ongoing access to a physician and other members of the HIV care team on a regular basis to identify and treat potential medication side effects. Clinical pharmacists may be needed to provide medication therapy evalua-
tions and recommendations to physicians and other healthcare professionals. Behavioral interventions that need to be incorporated into a PrEP care package include counseling to minimize risk compensation (the possibility that PrEP use might lead to greater frequency of high-risk sex practices because of PrEP users feeling more “protected”)13 and to evaluate and support PrEP medication adherence. The estimated annual cost of professional services for PrEP users will be approximately $310, which includes one initial physician consultation and quarterly follow-up physician offıce visits thereafter (Table 1). It should be noted that behavioral counseling on safer sex practices, including the appropriate use of condoms, is part of the usual standard of care for HIV prevention. The cost for www.ajpmonline.org
Horberg and Raymond / Am J Prev Med 2013;44(1S2):S125–S128
behavioral counseling would be similar to the professional fees noted here, albeit less frequent (often annually or less). The total cost of PrEP is estimated to be between $17,808 and $17,939 annually (per calculations in Table 1). Public-sector and group-plan pricing could differ. Additional services and nondelineated costs could add to total costs.
Adverse Drug Events The long-term safety of TDF–FTC in HIV-uninfected patients is not known. However, adverse events involving prescription drugs can be costly, and PrEP is not without health risks. Long-term use of TDF–FTC in HIV-positive patients has been associated with worsening of kidney function; Fanconi’s syndrome; lipodystrophy; lactic acidosis; bone loss (osteoporosis) without increased fracture rates; and an increased risk of coronary heart disease.7,14,15 However, many of these conditions also are associated with HIV infection itself, and so it is an outstanding question whether HIV-negative patients taking TDF–FTC will experience similar effects. The costs associated with the range of possible adverse events is diffıcult to estimate but should be considered.
Insurance Coverage for Pre-Exposure Prophylaxis Health insurance plans play an essential role in fınancing access to PrEP. As discussed above, medication costs alone for PrEP can exceed $17,000 per year,8,9 so health insurance will be a prerequisite for most PrEP candidates. However, drug-benefıt exclusions, cost-sharing, and medical-necessity criteria that govern health insurance policies can create substantial fınancial barriers for potential PrEP candidates. The degree to which public and private insurers will cover the use of antiretroviral drugs for HIV-negative patients is the most important fınancial policy issue for PrEP. Moreover, many individuals at greatest risk for HIV infection are currently uninsured or underinsured. In 2010, 49.9 million Americans were uninsured.16 The most-vulnerable uninsured Americans visit healthcare providers less frequently, are less likely to have the opportunity to have any medications prescribed, and face unmet prescription drug needs because of cost concerns.17 African Americans, Latinos, those of lower SES, Americans living in more-rural areas, and undocumented people living in the U.S. will be least likely to have access to PrEP through health insurance, without explicit intervention.18,19 It should be noted that Gilead Sciences, Inc., has developed a Truvada for PrEP Medication Assistance Program to assist in making PrEP more affordable for January 2013
S127
lower-income and underinsured/uninsured individuals.20 The impact of this assistance is uncertain.
Private Insurance Anecdotal information suggests that some private health insurers are willing to cover PrEP in the limited circumstances described by the CDC’s interim guidance,21 although no major health plan has made their PrEP-coverage policy public.2 If PrEP becomes more widespread among private insurers, coverage will likely vary by type of health plan. For example, nonprofıt health plans may be more likely to cover PrEP than for-profıt insurers. Health plans with low or no deductible will, by design, have a richer level of PrEP benefıts than high-deductible insurance plans available on the market. Self-insured healthcare plans often have more flexibility to limit their liability for health-benefıt costs and are not likely to be in the vanguard of PrEP implementation.
Public Insurance Pre-exposure prophylaxis is not a benefıt covered by Medicare or Medicaid (the principal insurer for HIV care in the U.S.). In addition, the Ryan White Care Act Part B HIV/AIDS drug assistance program only covers treatment for people who have HIV infection. Most states have recently experienced dramatic budget shortfalls and have implemented Medicaid cost-containment measures that may prevent them from extending coverage for PrEP any time soon.
Implications Going Forward Since the economic downturn of 2008, constrained fınancial resources have forced state and local HIV/AIDS treatment and prevention efforts to do much more with less. The fıscal reality is that the cost of providing PrEP to people at risk of HIV infection far exceeds current public funding capacity for HIV prevention. This is so at a time when many people already living with HIV do not have access to the medication or medical services they need.22 Three key issues related to fınancing of PrEP require monitoring. The FDA’s decision to approve the use of TDF–FTC as PrEP sets an important precedent and will likely affect TDF–FTC coverage decisions for PrEP by both private and public insurers. The Affordable Care Act, which will greatly expand access to insurance coverage for many uninsured Americans, will provide a potential platform for PrEP benefıt coverage. If PrEP were rated an A- or B-level preventive health service recommendation by the U.S. Preventive Services Task Force (USPSTF), that would lead to federal coverage of PrEP as a prevention strategy.23 At present, routine testing for HIV is still at the C level, so speculation of how the
S128
Horberg and Raymond / Am J Prev Med 2013;44(1S2):S125–S128
USPSTF will evaluate PrEP as a prevention strategy is diffıcult to determine. Without government drug assistance or generous private health insurance coverage, PrEP will be fınancially out of reach for most potential candidates. The longterm, out-of-pocket costs of PrEP can have an overwhelming effect on an individual’s fınancial well-being. At this time, there is no evidence that intermittent PrEP provides any protection against HIV infection, and the CDC interim guidance calls for uninterrupted daily dosing of TDF–FTC and ongoing support for adherence. Even with insurance, PrEP candidates will likely grapple with the personal fınancial trade-off of the out-of-pocket costs for PrEP versus that of consistent condom use only. The medical and public policy communities’ understanding of the effıcacy of PrEP is evolving, and clinical guidelines may change as new study data become available. Meanwhile, the practical aspects of cost and access to adequate insurance must remain at the top of the list of questions regarding the future of PrEP.
6.
7.
8. 9.
10.
11. 12.
13.
14.
Publication of this article was supported by the CDC through the Association for Prevention Teaching and Research (CDCAPTR) Cooperative Agreement number 11-NCHHSTP-01. No fınancial disclosures were reported by the authors of this paper.
15.
16.
17.
References 1. U.S. Food and Drug Administration (FDA). FDA approves fırst drug for reducing the risk of sexually acquired HIV infection. Silver Spring MD: FDA, 2012. 2. Hazelton P. Financing and delivery mechanisms to increase pre-exposure prophylaxis (PrEP) access in populations at high-risk of HIV infection, a paper prepared for the Advanced Policy Analysis for the Goldman School of Public Policy from the University of California, Berkeley. Berkeley CA: University of California, 2011. 3. Gebo KA, Fleishman JA, Conviser R, et al. Contemporary costs of HIV healthcare in the HAART era. AIDS 2010;24(17):2705–15. 4. Meenan R, O’Keeffe Rosetti M, Kimes T, et al. Abstract TUPE0236; Excess prevalence-based costs of multiple HAART switches among HIV⫹ patients in a U.S. health maintenance organization. Proceedings of the XVII International AIDS Conference; 2008 Aug 3– 8; Mexico City, Mexico. 5. Desai K, Sansom SL, Ackers ML, et al. Modeling the impact of HIV chemoprophylaxis strategies among men who have sex with men in the
18.
19.
20. 21.
22. 23.
U.S.: HIV infections prevented and cost-effectiveness. AIDS 2008; 22(14):1829 –39. Paltiel AD, Freedberg KA, Scott CA, et al. HIV preexposure prophylaxis in the U.S.: impact on lifetime infection risk, clinical outcomes, and cost-effectiveness. Clin Infect Dis 2009;48(6):806 –15. CDC. Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep 2011;60(3):65– 8. The Body. Test Positive Aware Network. Cost of Truvada. 2011. www.thebody.com/content/art1331.html. Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Washington DC: DHHS, 2012:1–128. Center for Medicare & Medicaid Services (CMMS), DHHS. CMS 2012 clinical diagnostic laboratory fee schedule. Washington DC: CMMS, 2012. CDC. CDC HIV/AIDS facts, Q&A: CDC’s clinical studies of preexposure prophylaxis for HIV prevention. Atlanta GA: DHHS, 2009. Underhill K, Operario D, Skeer M, Mimiaga M, Mayer K. Packaging PrEP to prevent HIV: an integrated framework to plan for pre-exposure prophylaxis implementation in clinical practice. J Acquir Immune Defıc Syndr 2010;55(1):8 –13. AIDS Vaccine Advocacy Coalition (AVAC). Summary from the AVAC Think Tank on PrEP Financing in the U.S.; 2009 Jan 14; San Francisco CA. Liu AY, Vittinghoff E, Sellmeyer DE, et al. Bone mineral density in HIV-negative men participating in a tenofovir pre-exposure prophylaxis randomized clinical trial in San Francisco. PLoS One 2011; 6(8):e23688. Yazdanpanah Y. Costs associated with combination antiretroviral therapy in HIV-infected patients. J Antimicrob Chemother 2004; 53(4):558 – 61. The Henry J. Kaiser Family Foundation. Kaiser Commission on Medicaid and the Uninsured: key facts. Washington DC: The Henry J. Kaiser Family Foundation, 2011. Boukus ER, Carrier ER. Americans’ access to prescription drugs stabilizes, 2007–2010. Track Rep 2011;(27):1–5. Szekeres G, Coates T, Frost S, Leibowitz A, Shoptaw S. Anticipating the effıcacy of HIV pre-exposure prophylaxis (PrEP) and the needs of at-risk Californians. Los Angeles CA: University of California Los Angeles, 2004. Heckman TG, Somlai AM, Peters J, et al. Barriers to care among persons living with HIV/AIDS in urban and rural areas. AIDS Care 1998;10(3):365–75. Gilead Sciences Inc. Truvada Medication Assistance Program. 2012. www.gilead.com/truvada_assistance_program. Horberg M. PrEP: access and cost from private sector payor. International Association of Physicians in AIDS Care, ed. TasP PrEP Evidence Summit 2012: controlling the HIV pandemic with antiretrovirals: treatment as prevention and pre-exposure prophylaxis. London, UK, 2012. The White House Offıce of National AIDS Policy. National HIV/AIDS strategy for the U.S. Washington DC: ONAP, 2010. One Hundred Eleventh Congress of the U.S. The Patient Protection and Affordable Care Act. U.S.; 2010: 1–906.
www.ajpmonline.org
Introduction
T
he costs and access issues related to pre-exposure prophylaxis (PrEP) for HIV prevention have not been adequately explored in health services research or in health policy circles. The dearth of information about the fınancial aspects of PrEP is a reflection of the unsettled state of this recent HIV prevention strategy. The U.S. Food and Drug Administration (FDA) has approved a drug label change that brings the fırst antiretroviral combination medication to market for HIV prevention.1 Prior to this decision, there were anecdotal reports that the tenofovir– emtricitabine (TDF–FTC) combination pill Truvada® was already being prescribed and used “off label” as PrEP and that some insurers may have been willing to reimburse PrEP in limited circumstances.2 Although PrEP now has a small impact on HIV prevention, its near- to long-term implications could be profound. As healthcare leaders begin to deal with PrEP for mainstream prevention, fınancial policy issues will become increasingly important. This article highlights the practical aspects of cost and access to insurance related to PrEP for HIV prevention in the U.S. First, the cost drivers of PrEP for HIV prevention strategies are identifıed. Then, the factors that influence the availability of health insurance coverage for PrEP in the U.S. today are discussed. The conclusion includes key policy issues for healthcare leaders to consider going forward.
The Cost of Pre-Exposure Prophylaxis Understanding the cost of PrEP is essential to guide the use of antiretroviral therapy for HIV prevention. Although numerous cost studies of providing care for HIVinfected individuals have been conducted,3,4 few studies have examined the cost of prescribing antiretroviral medication to HIV-negative patients for HIV prevention.5,6 From the Mid-Atlantic Permanente Research Institute (Horberg), Rockville, Maryland; and Kaiser Permanente Institute for Health Policy (Raymond), Oakland, California Address correspondence to: Michael Horberg, MD, MAS, FACP, FIDSA, Mid-Atlantic Permanente Research Institute, 2101 East Jefferson Street, 3 West, Rockville MD 20852. E-mail: [email protected]. 0749-3797/$36.00 http://dx.doi.org/10.1016/j.amepre.2012.09.039
To build a comprehensive picture of the cost involved in PrEP, it is important to fırst identify the cost inputs of a PrEP preventive service package and the activities that go into providing those services. From the perspective of the healthcare payer, the total cost of PrEP takes in a broad range of inputs, including laboratory fees, professional fees, and other services, beyond the cost of prescription drugs (Table 1).
Antiretroviral Medication Antiretroviral drugs are the largest component of PrEP expenses. Daily dosing of PrEP is the only regimen shown effective in RCCTs; intermittent-use effıcacy is unknown. The average wholesale price for a standard dose of Truvada (300 mg tenofovir and 200 mg emtricitabine; one tablet once a day) is about $1425 monthly.8,9 Although the cost of antiretroviral drug therapy for HIV-positive patients is influenced by a number of potentially costsaving alternative treatment options, TDF–FTC is the only PrEP regimen proven to be effective for MSM and is still under patent in the U.S., where cheaper generics are therefore not available.
Laboratory Services Laboratory services are a leading cost driver for HIV care and will likely be an important cost component of PrEP, as well. The CDC’s interim guidance on PrEP recommends several screening lab tests before initiating PrEP; an HIV antibody test every 2–3 months (because PrEP is only partially effective, and frequent HIV testing is necessary for early detection of infection and potential emergence of drug-resistant variants if infected while taking the drug); sexually transmitted infection tests every 6 months; and checking blood urea nitrogen and serum creatinine 3 months after initiation and then yearly while on PrEP medication (assuming they are within normal limits and stable).7 Laboratory testing also is necessary to look for adverse effects and to ensure that those who experience serious side effects stop PrEP as quickly as possible, especially potential renal dysfunction.11 It can be estimated that the range of annual costs of laboratory services for PrEP users is $373.50 –$504.51, which includes the one-time screening before initiating PrEP.
© 2013 American Journal of Preventive Medicine • Published by Elsevier Inc.
Am J Prev Med 2013;44(1S2):S125–S128 S125
Horberg and Raymond / Am J Prev Med 2013;44(1S2):S125–S128
S126
Table 1. PrEP cost inputs What’s included?7
Cost inputs
Annual cost ($)
Antiretroviral medication Daily doses of Truvada (TDF [300 mg] plus FTC [200 mg]) Laboratory services
17,125.088,9
Before initiating PrEP: HIV antibody test (CPT Code 86703)
19.43–26.2510
Confirm that calculated creatinine clearance is ⱖ60 mL per minute via Cockcroft-Gault formula (CPT Code 82575)
13.39–18.0910
Screen for hepatitis B infection and vaccinate against hepatitis B if susceptible (CPT Codes 86704, 86705, 06706, 87340)
63.58–85.9310
Screen for sexually transmitted infections (CPT Codes 102.91–139.0610 86592, 87491, 87590, 87591, and if positive test Subtotal ⫽ 199.31–269.33 result for syphilis 86780) Follow-up while PrEP medication is being taken: Every 2–3 months, perform an HIV antibody test (CPT Code 86703)
58.43–78.7510
Every 6 months, test for sexually transmitted infection 102.91–139.0610 12.85–17.3710 even if patient is asymptomatic (CPT Codes 86592, Subtotal ⫽ 174.19–235.18 87491, 87590, 87591, and if positive test result Total laboratory services ⫽ 373.50–504.51 for syphilis 86780) 3 months after initiation, then yearly while on PrEP medication, check blood urea nitrogen and serum creatinine (CPT Codes 82565, 85420) Professional services
Determine eligibility and confirm that patient is at substantial, ongoing high risk for acquiring HIV infection
102.95 (one initial visit/consultation)
Prescribe PrEP medication regimen Provide risk-reduction and PrEP medication-adherence counseling
206.91 (quarterly follow-up visits after initial visit/consultation)
Evaluate and support PrEP medication adherence at each follow-up visit, more often if inconsistent adherence is identified Every 2–3 months, assess risk behaviors and provide risk-reduction counseling
Total professional services ⫽ 309.86
CPT, Current Procedural Terminology; FTC, emtricitabine; PrEP, pre-exposure prophylaxis; TDF, tenofovir disoproxil fumarate
Professional Services The successful introduction of PrEP into clinical practice will require the services of a variety of medical professionals, including clinicians, HIV testing counselors, laboratory staff, clinical pharmacists, and behavioral interventionists.12 Medical screening is necessary to assess behavioral risks and determine eligibility of potential PrEP candidates. Potential candidates should be counseled by a clinician on the benefıts and potential risks of PrEP and to gain their commitment to adhere to the PrEP dosing regimen. All patients on antiretroviral treatment need ongoing access to a physician and other members of the HIV care team on a regular basis to identify and treat potential medication side effects. Clinical pharmacists may be needed to provide medication therapy evalua-
tions and recommendations to physicians and other healthcare professionals. Behavioral interventions that need to be incorporated into a PrEP care package include counseling to minimize risk compensation (the possibility that PrEP use might lead to greater frequency of high-risk sex practices because of PrEP users feeling more “protected”)13 and to evaluate and support PrEP medication adherence. The estimated annual cost of professional services for PrEP users will be approximately $310, which includes one initial physician consultation and quarterly follow-up physician offıce visits thereafter (Table 1). It should be noted that behavioral counseling on safer sex practices, including the appropriate use of condoms, is part of the usual standard of care for HIV prevention. The cost for www.ajpmonline.org
Horberg and Raymond / Am J Prev Med 2013;44(1S2):S125–S128
behavioral counseling would be similar to the professional fees noted here, albeit less frequent (often annually or less). The total cost of PrEP is estimated to be between $17,808 and $17,939 annually (per calculations in Table 1). Public-sector and group-plan pricing could differ. Additional services and nondelineated costs could add to total costs.
Adverse Drug Events The long-term safety of TDF–FTC in HIV-uninfected patients is not known. However, adverse events involving prescription drugs can be costly, and PrEP is not without health risks. Long-term use of TDF–FTC in HIV-positive patients has been associated with worsening of kidney function; Fanconi’s syndrome; lipodystrophy; lactic acidosis; bone loss (osteoporosis) without increased fracture rates; and an increased risk of coronary heart disease.7,14,15 However, many of these conditions also are associated with HIV infection itself, and so it is an outstanding question whether HIV-negative patients taking TDF–FTC will experience similar effects. The costs associated with the range of possible adverse events is diffıcult to estimate but should be considered.
Insurance Coverage for Pre-Exposure Prophylaxis Health insurance plans play an essential role in fınancing access to PrEP. As discussed above, medication costs alone for PrEP can exceed $17,000 per year,8,9 so health insurance will be a prerequisite for most PrEP candidates. However, drug-benefıt exclusions, cost-sharing, and medical-necessity criteria that govern health insurance policies can create substantial fınancial barriers for potential PrEP candidates. The degree to which public and private insurers will cover the use of antiretroviral drugs for HIV-negative patients is the most important fınancial policy issue for PrEP. Moreover, many individuals at greatest risk for HIV infection are currently uninsured or underinsured. In 2010, 49.9 million Americans were uninsured.16 The most-vulnerable uninsured Americans visit healthcare providers less frequently, are less likely to have the opportunity to have any medications prescribed, and face unmet prescription drug needs because of cost concerns.17 African Americans, Latinos, those of lower SES, Americans living in more-rural areas, and undocumented people living in the U.S. will be least likely to have access to PrEP through health insurance, without explicit intervention.18,19 It should be noted that Gilead Sciences, Inc., has developed a Truvada for PrEP Medication Assistance Program to assist in making PrEP more affordable for January 2013
S127
lower-income and underinsured/uninsured individuals.20 The impact of this assistance is uncertain.
Private Insurance Anecdotal information suggests that some private health insurers are willing to cover PrEP in the limited circumstances described by the CDC’s interim guidance,21 although no major health plan has made their PrEP-coverage policy public.2 If PrEP becomes more widespread among private insurers, coverage will likely vary by type of health plan. For example, nonprofıt health plans may be more likely to cover PrEP than for-profıt insurers. Health plans with low or no deductible will, by design, have a richer level of PrEP benefıts than high-deductible insurance plans available on the market. Self-insured healthcare plans often have more flexibility to limit their liability for health-benefıt costs and are not likely to be in the vanguard of PrEP implementation.
Public Insurance Pre-exposure prophylaxis is not a benefıt covered by Medicare or Medicaid (the principal insurer for HIV care in the U.S.). In addition, the Ryan White Care Act Part B HIV/AIDS drug assistance program only covers treatment for people who have HIV infection. Most states have recently experienced dramatic budget shortfalls and have implemented Medicaid cost-containment measures that may prevent them from extending coverage for PrEP any time soon.
Implications Going Forward Since the economic downturn of 2008, constrained fınancial resources have forced state and local HIV/AIDS treatment and prevention efforts to do much more with less. The fıscal reality is that the cost of providing PrEP to people at risk of HIV infection far exceeds current public funding capacity for HIV prevention. This is so at a time when many people already living with HIV do not have access to the medication or medical services they need.22 Three key issues related to fınancing of PrEP require monitoring. The FDA’s decision to approve the use of TDF–FTC as PrEP sets an important precedent and will likely affect TDF–FTC coverage decisions for PrEP by both private and public insurers. The Affordable Care Act, which will greatly expand access to insurance coverage for many uninsured Americans, will provide a potential platform for PrEP benefıt coverage. If PrEP were rated an A- or B-level preventive health service recommendation by the U.S. Preventive Services Task Force (USPSTF), that would lead to federal coverage of PrEP as a prevention strategy.23 At present, routine testing for HIV is still at the C level, so speculation of how the
S128
Horberg and Raymond / Am J Prev Med 2013;44(1S2):S125–S128
USPSTF will evaluate PrEP as a prevention strategy is diffıcult to determine. Without government drug assistance or generous private health insurance coverage, PrEP will be fınancially out of reach for most potential candidates. The longterm, out-of-pocket costs of PrEP can have an overwhelming effect on an individual’s fınancial well-being. At this time, there is no evidence that intermittent PrEP provides any protection against HIV infection, and the CDC interim guidance calls for uninterrupted daily dosing of TDF–FTC and ongoing support for adherence. Even with insurance, PrEP candidates will likely grapple with the personal fınancial trade-off of the out-of-pocket costs for PrEP versus that of consistent condom use only. The medical and public policy communities’ understanding of the effıcacy of PrEP is evolving, and clinical guidelines may change as new study data become available. Meanwhile, the practical aspects of cost and access to adequate insurance must remain at the top of the list of questions regarding the future of PrEP.
6.
7.
8. 9.
10.
11. 12.
13.
14.
Publication of this article was supported by the CDC through the Association for Prevention Teaching and Research (CDCAPTR) Cooperative Agreement number 11-NCHHSTP-01. No fınancial disclosures were reported by the authors of this paper.
15.
16.
17.
References 1. U.S. Food and Drug Administration (FDA). FDA approves fırst drug for reducing the risk of sexually acquired HIV infection. Silver Spring MD: FDA, 2012. 2. Hazelton P. Financing and delivery mechanisms to increase pre-exposure prophylaxis (PrEP) access in populations at high-risk of HIV infection, a paper prepared for the Advanced Policy Analysis for the Goldman School of Public Policy from the University of California, Berkeley. Berkeley CA: University of California, 2011. 3. Gebo KA, Fleishman JA, Conviser R, et al. Contemporary costs of HIV healthcare in the HAART era. AIDS 2010;24(17):2705–15. 4. Meenan R, O’Keeffe Rosetti M, Kimes T, et al. Abstract TUPE0236; Excess prevalence-based costs of multiple HAART switches among HIV⫹ patients in a U.S. health maintenance organization. Proceedings of the XVII International AIDS Conference; 2008 Aug 3– 8; Mexico City, Mexico. 5. Desai K, Sansom SL, Ackers ML, et al. Modeling the impact of HIV chemoprophylaxis strategies among men who have sex with men in the
18.
19.
20. 21.
22. 23.
U.S.: HIV infections prevented and cost-effectiveness. AIDS 2008; 22(14):1829 –39. Paltiel AD, Freedberg KA, Scott CA, et al. HIV preexposure prophylaxis in the U.S.: impact on lifetime infection risk, clinical outcomes, and cost-effectiveness. Clin Infect Dis 2009;48(6):806 –15. CDC. Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep 2011;60(3):65– 8. The Body. Test Positive Aware Network. Cost of Truvada. 2011. www.thebody.com/content/art1331.html. Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Washington DC: DHHS, 2012:1–128. Center for Medicare & Medicaid Services (CMMS), DHHS. CMS 2012 clinical diagnostic laboratory fee schedule. Washington DC: CMMS, 2012. CDC. CDC HIV/AIDS facts, Q&A: CDC’s clinical studies of preexposure prophylaxis for HIV prevention. Atlanta GA: DHHS, 2009. Underhill K, Operario D, Skeer M, Mimiaga M, Mayer K. Packaging PrEP to prevent HIV: an integrated framework to plan for pre-exposure prophylaxis implementation in clinical practice. J Acquir Immune Defıc Syndr 2010;55(1):8 –13. AIDS Vaccine Advocacy Coalition (AVAC). Summary from the AVAC Think Tank on PrEP Financing in the U.S.; 2009 Jan 14; San Francisco CA. Liu AY, Vittinghoff E, Sellmeyer DE, et al. Bone mineral density in HIV-negative men participating in a tenofovir pre-exposure prophylaxis randomized clinical trial in San Francisco. PLoS One 2011; 6(8):e23688. Yazdanpanah Y. Costs associated with combination antiretroviral therapy in HIV-infected patients. J Antimicrob Chemother 2004; 53(4):558 – 61. The Henry J. Kaiser Family Foundation. Kaiser Commission on Medicaid and the Uninsured: key facts. Washington DC: The Henry J. Kaiser Family Foundation, 2011. Boukus ER, Carrier ER. Americans’ access to prescription drugs stabilizes, 2007–2010. Track Rep 2011;(27):1–5. Szekeres G, Coates T, Frost S, Leibowitz A, Shoptaw S. Anticipating the effıcacy of HIV pre-exposure prophylaxis (PrEP) and the needs of at-risk Californians. Los Angeles CA: University of California Los Angeles, 2004. Heckman TG, Somlai AM, Peters J, et al. Barriers to care among persons living with HIV/AIDS in urban and rural areas. AIDS Care 1998;10(3):365–75. Gilead Sciences Inc. Truvada Medication Assistance Program. 2012. www.gilead.com/truvada_assistance_program. Horberg M. PrEP: access and cost from private sector payor. International Association of Physicians in AIDS Care, ed. TasP PrEP Evidence Summit 2012: controlling the HIV pandemic with antiretrovirals: treatment as prevention and pre-exposure prophylaxis. London, UK, 2012. The White House Offıce of National AIDS Policy. National HIV/AIDS strategy for the U.S. Washington DC: ONAP, 2010. One Hundred Eleventh Congress of the U.S. The Patient Protection and Affordable Care Act. U.S.; 2010: 1–906.
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