Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV

Limitations to Treatment Safety and Efficacy

Cost Considerations and Antiretroviral Therapy

The clinical benefits, public health impact, and cost-effectiveness of HIV treatment have been well-established since the advent of combination antiretroviral therapy (ART),^1-6 and the expanded use of ART is one of the four pillars of the Ending the HIV Epidemic in the U.S. initiative.^7,8 However, HIV treatment with ART is costly. A 2015 study using 2012 health care expenditure data estimated that the discounted lifetime medical costs for an individual who acquires HIV at 35 years of age are $326,500 ($597,300 undiscounted), with 60% of the costs attributable to ART.⁹ The estimated total direct expenditure for HIV care and treatment between 2002 and 2011 was $10.7 billion annually, which is 800% to 900% higher than similar expenditures for other chronic conditions.¹⁰ Since the addition of the cost table in these guidelines in 2012,¹¹ the overall cost of brand-name, first-line antiretroviral (ARV) regimens increased by over 30% from 2012 to 2018,¹² which is 3.5 times higher than the rate of inflation for the same period. Total annual undiscounted spending on ARV drugs has more than doubled since 2010, reaching $22.5 billion in 2018.^13,14

This section provides guidance on cost considerations related to HIV clinical care. The cost of ART, especially out-of-pocket costs to the person with HIV, should be one of the many considerations in regimen selection, because such expenditures may directly affect adherence. Overall costs to the health care system, to insurers, and to society are also important, especially given the increasing number of people with HIV, rising drug costs, and increasing multimorbidity among people aging with HIV. Providers should make every effort to prevent costs from limiting HIV care.

Cost Sharing in the United States

Prescription drug pricing in the United States involves complex systems with varying requirements for mandatory and voluntary discounts, rebates, and reimbursement rates, and much of the pricing information is confidential. Prices can vary depending on the state, purchaser, type of public or private insurance coverage in use, and number of generic competitors to branded drugs (see Table 22b below). Additionally, provider-administered drugs and biologics, including those used in the management of HIV (e.g., intramuscular injections of long-acting cabotegravir plus rilpivirine [LA CAB/RPV]), are typically associated with product, administration, and/or office visit costs. Therefore, providers may find it difficult to navigate payer cost-containment practices, including formulary restrictions; prior authorization requirements; and cost-sharing arrangements, such as copayments (a fixed dollar amount per prescription), coinsurance (a fixed percentage of the prescription cost), and insurance deductible payments.

Out-of-pocket costs for people with HIV can be prohibitive, creating a barrier to the initiation and continuation of ART. Cost sharing results in higher rates of people not initiating ART, prescription abandonment at the pharmacy, decreased adherence, and more frequent drug discontinuation. In turn, these may lead to worse health outcomes and an increased use of the medical system, especially among people with chronic diseases.^15-20 Conversely, reducing out-of-pocket costs (e.g., through manufacturer copayment-assistance programs or by prescribing generic drugs instead of more costly brand-name products) has been associated with improved adherence.²¹ Given the clear association between out-of-pocket costs and the ability to pay for and adhere to medications, clinicians should minimize out-of-pocket drug-related expenses for people with HIV whenever possible. However, many of the cost-sharing arrangements that determine out-of-pocket costs are not transparent to clinicians or people with HIV at the time decisions on ART are made.

Maximum allowable copayments on prescription drugs covered by Medicaid can vary by family income, but they are usually nominal. For commercial insurers, cost sharing is generally subject to maximum payment rules under the Affordable Care Act (ACA). Manufacturer cost-sharing assistance programs are available for most brand-name ARV products but may be restricted by pharmacy and by state. Manufacturer copay assistance may also be subject to copay accumulator programs implemented by insurers’ pharmacy benefit managers, whereby manufacturer payments do not count toward a person’s deductible or out-of-pocket maximum.

Medicare Part D plan cost sharing can include deductibles and copayments or coinsurance, including out-of-pocket payments of up to 25% on prescription drugs, until total out-of-pocket spending reaches approximately $3,300 in 2024 and $2,000 in 2025.^22-25 Medicare Part B cost sharing on provider-administered drugs, such as LA CAB/RPV or ibalizumab-uiyk (IBA) infusions, can be up to 20% of all medication costs.²⁶ Low-income beneficiaries may qualify for subsidies to defray Part D cost-sharing payments or for the Qualified Medicare Beneficiary program to defray Part B cost-sharing payments. Beginning in 2025, Medicare Advantage and Part D plans will be required to offer beneficiaries an option to enroll in a Medicare Prescription Payment Plan authorized under the Inflation Reduction Act of 2022, allowing beneficiaries to pay out-of-pocket prescription drug costs in the form of capped monthly payments instead of a single payment in full at the pharmacy.²⁷ Manufacturer copay assistance programs may not be applied toward Medicare plan cost sharing, but assistance from independent foundations (e.g., Patient Access Network Foundation, Patient Advocate Foundation) may provide cost-sharing support if financial eligibility criteria are met.

AIDS Drug Assistance Programs (ADAPs), through the Ryan White HIV/AIDS Program (RWHAP), make ARVs and other prescription drugs accessible to people with HIV who are underinsured and have limited financial resources. Furthermore, many ADAPs provide premium and cost-sharing assistance to eligible clients covered by Medicaid, commercial insurance plans, or Medicare.²⁸

Generic Antiretrovirals and Multi-Tablet Regimens

The U.S. health care system saved $408 billion in 2022 from using generic drugs and biosimilar products, including $130 billion in Medicare savings and $194 billion in savings for commercial insurers.²⁹

With substantial improvements in the long-term safety and effectiveness of contemporary ART, a number of regimens and regimen components in Tables 6a and 6b remain listed beyond their patent protection date and are or will be available as lower-cost generic options. In one study, the savings associated with a transition to a hypothetical lower-cost generic ART could potentially help cover the 20-year, $480 billion projected costs to reach national treatment targets.⁵

Some research informs the cost impact of using specific generic ARV regimens or regimen components. In a cost-effectiveness analysis conducted before the availability of integrase strand transfer inhibitors (INSTIs), the use of generic efavirenz (EFV) had an estimated savings of nearly $1 billion, and a regimen with generic EFV was very cost-effective.² Another study described a 25% reduction in both the wholesale acquisition cost (WAC)and federal supply schedule cost associated with switching from branded coformulated dolutegravir (DTG)/abacavir (ABC)/lamivudine (3TC) to branded DTG plus generic ABC and generic 3TC.^2,30

A number of generic options for ARV regimen components included in Tables 6a and 6b are commercially available. See Table 22b below for a summary of the costs associated with commonly used generic and proprietary ARV regimen components and coformulations.

There is keen interest in assessing the economic value of using newer, more expensive drugs compared with older, less expensive drugs that have established clinical safety and efficacy. One study investigated the cost-effectiveness of TDF-based versus tenofovir alafenamide (TAF)–based regimens.²² The study demonstrated that the similar efficacy—but slightly improved toxicity profile—of the TAF-based regimens would justify a $1,000 higher annual premium for the TAF-based regimens. The study further highlighted that once generic TDF becomes available at much lower costs, TAF-based regimens will remain cost-effective only if their annual cost is no more than $1,000 above that of generically available TDF-based regimens. Of note, generic TDF was approved in 2018.

The use of DTG plus generic 3TC for initial therapy has been evaluated in a cost-containment analysis. One study projected that if just 50% of people with newly diagnosed HIV initiated a two-pill regimen consisting of branded DTG plus generic 3TC, the cost savings would reach $550 million to $800 million over 5 years.³¹ If 25% of people with sustained viral suppression switched to branded DTG plus generic 3TC maintenance therapy, cost savings were projected to exceed $3 billion in just 5 years.³¹

Because all commercially available STRs are branded products, including those containing ARV components that are no longer patent protected, use of generics in the United States may necessitate modest increases in pill burden, but without changes in drug frequency. One study of Medicare Part D spending, which included expenditures for one ARV fixed-dose combination tablet (ABC/3TC), demonstrated that separating brand-name coformulated products into their generic components could have saved Medicare an estimated $2.7 billion from 2011 through 2016, and it highlighted this approach as a critical cost-containment measure.³² A benefit of STRs is that they eliminate the risk that one drug in the regimen will be temporarily or permanently discontinued because of prescribing error, unsynchronized refill schedules, or prohibitive out-of-pocket costs. Data to support or refute the superiority of once-daily STRs versus once-daily multi-tablet regimens, particularly based on virologic outcomes and especially following viral suppression, remain limited. One large observational cohort study demonstrated a small but statistically significant virologic efficacy benefit associated with STRs.³³ In this study, the time to treatment discontinuation was shorter for non-STRs than for STR once-daily regimens; however, this difference disappeared when modifications for regimen simplification were included in the analysis. On the other hand, observational data from Spain showed that coformulated DTG/ABC/3TC resulted in similar viral suppression compared to DTG plus ABC/3TC, both when used as an initial ARV regimen and when persons with viral suppression on STR were switched to the two-pill formulation as a cost-saving strategy.³⁴

Importantly, when the costs of brand-name drug products and generic ARV drugs are compared, savings associated with generic ARV drugs may vary when branded drugs are subject to discounts or rebates across public and private payer systems. Although generic drug products may be associated with societal cost savings and, specifically, savings for public payers, commercial insurers, and people with HIV with significant out-of-pocket pharmacy expenses, manufacturer copay assistance is not generally available to commercially insured individuals. In cases where manufacturer copay assistance may be available for a brand-name ARV product but not for the equivalent generic product, the generic drug prescription may paradoxically result in higher out-of-pocket costs.

Costs and Cost-Effectiveness of ARV Regimens for Highly Treatment-Experienced People With Multidrug-Resistant HIV

For people with multidrug-resistant (MDR) HIV, an ARV regimen that includes intravenous IBA, subcutaneous lenacapavir, or oral fostemsavir can be effective in achieving viral suppression, but with high associated costs. Two cost-effectiveness analyses using independent simulation models have demonstrated that IBA-containing ARV regimens would substantially improve survival for people with MDR HIV but at a high cost per quality-adjusted life-year, given the high cost of IBA. However, the overall budget impact of such regimens would be relatively small, given the limited number of people for whom IBA would be necessary.^35,36

Laboratory Services

In the context of lifelong ART, the amount of money saved by performing infrequent or one-time tests (e.g., genotypes, serologies) is modest, even for expensive tests. Even so, judicious use of laboratory testing, without compromising individual care, can still be an important way to reduce costs. For people with deductibles for laboratory tests, decreasing the use of tests with limited clinical value could reduce costs and improve adherence to a care plan. Several studies have examined the value of laboratory services in HIV care. One cost analysis study suggested that there may be no clinical benefit to continuing CD4 T lymphocyte (CD4) cell monitoring in people with suppressed viral loads and CD4 counts >200 cells/mm³ after 48 weeks of therapy.¹⁹ In the United States, reducing biannual CD4 monitoring to annual monitoring could save approximately $10 million per year.³⁷ Another study reviewed the records of 429 hospitalizations for 274 people with HIV at a single site during a 6‑month period. The inpatient chart review demonstrated that 45% of ordered laboratory tests were not indicated, including hepatitis serologies, other serologies, and cytomegalovirus polymerase chain reaction tests. During this 6-month period, the estimated cost of excess and inappropriate laboratory testing totaled between $14,000 and $92,000.³⁸

Cost-effectiveness analyses from 2001 and 2005 demonstrated the value of genotypic resistance testing in people who are ART-experienced and ART-naive and supported the recommendation by the Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) to perform resistance testing before ART initiation and at time of virologic failure.^39,40 More recent cost-effectiveness analyses have revisited the value of baseline, pre-treatment genotype testing in the setting of INSTI plus two-nucleoside reverse transcriptase inhibitor (NRTI) regimens. One modeling study suggested that INSTI-specific genotype testing before initiation of a regimen including DTG plus two NRTIs was not cost-effective and may lead to underutilization of INSTIs; the results highlighted that some people with minor INSTI resistance mutations would still become virologically suppressed on a DTG-based regimen.⁴¹ A second modeling study found that standard (NRTI, non-nucleoside reverse transcriptase inhibitor, protease inhibitor) genotype testing before ART initiation was also not cost-effective, because it may have little impact on outcomes given the use of regimens including an INSTI plus two NRTIs in first-line treatment.⁴² Both of these modeling studies assessed the use of genotype testing only for decision-making for initial ART and presumed that such testing would be available for use at the time of first-line failure. The results of these modeling studies suggest that additional clinical research is needed to define the role of genotypic resistance testing before initiation of a regimen including an INSTI plus two NRTIs. Importantly, these modeling data do not apply to the initiation of two-drug ARV regimens (e.g., DTG plus 3TC) or to people who have received cabotegravir (CAB) as pre-exposure prophylaxis (PrEP), which are both being prescribed increasingly in clinical practice. It should be noted that the Panel continues to recommend baseline testing for clinically relevant protease and reverse transcriptase mutations for most people, with additional genotypic resistance testing for integrase mutations for individuals with a history of CAB use for PrEP (see Drug-Resistance Testing).

Costs and Cost-Effectiveness of Comprehensive HIV Care

Comprehensive person-centered HIV care offers substantial clinical benefits.⁴³ Such programs include integration of social service needs and services for mental health, substance use disorders, sexual health, and age-associated multimorbidity (see Substance Use Disorders and HIV, Transgender People With HIV, Adherence to the Continuum of Care, and HIV and the Older Person). Integrated services can improve engagement in care and virologic suppression among people with HIV, but they require investment and resources. Several cost-effectiveness analyses have demonstrated that integrated care programs can offer excellent value, especially if delivered to people at increased risk of disengagement in care.^44-46

Health care access in the United States can be inequitable and limited, depending on location and income. Although the ACA has substantially improved access to HIV clinical services in many regions of the United States since 2010, an estimated 36% of people with HIV in the United States live in the 11 states that had not expanded Medicaid in accordance with the ACA as of August 2020.²⁸

The RWHAP provides a critical source of outpatient HIV clinical care for people with HIV who have low income and remain uninsured or underinsured under the ACA, or who require wraparound support.²⁸ A recent cost-effectiveness analysis underscored the value of this safety net program and projected its clinical and cost impact over 50 years. Given higher rates of virologic suppression among people with HIV attending RWHAP clinics (compared with estimated virologic suppression in the absence of such supports), the analysis projects fewer HIV incident infections and longer life expectancy and demonstrates the cost-effectiveness of RWHAP.⁴⁷ However, because RWHAP is focused on HIV care and support services, people with HIV who have other important outpatient and inpatient health needs may experience underdiagnosis and undertreatment if they cannot pay the out-of-pocket costs of clinical care.

Comprehensive HIV care and treatment often require navigating a complex, dynamic patchwork of service delivery, and both payer and financing mechanisms. Provider awareness of this patchwork, including the array of services available to people with HIV eligible for RWHAP, is therefore essential to maximizing clinical outcomes.

Conclusion

Ideally, costs should not drive clinical care, yet they are a factor in contemporary health care. Because regimen costs may affect the ability of people with HIV to afford and adhere to therapy, understanding ART-related costs in the United States is increasingly important. Providers play a key role in ensuring optimal care while working to both (1) minimize costs for ARV drugs and avoid or minimize unnecessary laboratory monitoring and (2) retain excellent clinical outcomes in an environment of cost-containment strategies, including formulary restrictions, utilization management (e.g., prior authorization), and cost-sharing. Therefore, providers should remain informed of current insurance and payment structures, ART costs (see Table 22b below for estimates of average drug prices), out-of-pocket expenditure requirements, and available generic ARV options. Providers should work with people with HIV and their pharmacists, social workers, case managers, and peer navigators to understand the medication benefits and any potential financial barriers to prescription fulfillment and full adherence for each person with HIV. This information will help providers identify treatment options that are safe, effective, and affordable. Engaging people with HIV in discussion about cost constraints during regimen selection will likely facilitate adherence. Additionally, providers should familiarize themselves with ARV affordability resources (such as ADAP and pharmaceutical company assistance programs for people who qualify) and refer them to such assistance if needed. Similarly, providers should help people with HIV to find comprehensive clinical care coverage when available and consider opportunities to integrate care when feasible.

Table 22b. Monthly Average Prices of Commonly Used Antiretroviral Drugs

Table 22b includes three benchmark prices, rounded to the nearest dollar, for commonly used antiretroviral (ARV) drugs^a as a general reference for health care providers when considering the cost of HIV treatment. Health care providers should contact pharmacies or payers regarding actual prices, comparative cost savings, formulary restrictions, and cost-sharing requirements. The wholesale acquisition cost (WAC) is the list price published by manufacturers for prescription drugs or biologics sold to wholesalers. The WAC price approximates what retail pharmacies pay wholesalers for single-source (e.g., brand-name) drugs. There is a range of WAC prices for generic ARV drugs because these are multiple-source products with variable list prices. With increasing competition, actual transactional prices of generic drugs decrease substantially among wholesalers and pharmacies. Average wholesale price (AWP) has historically been used as the basis for setting public (e.g., Medicaid) and private (e.g., commercial insurer) reimbursement rates for pharmacies. Neither WAC nor AWP includes variable price concessions along supply and payment chains, including discounts and rebates to wholesalers, pharmacies, federal purchasers (e.g., the Department of Veterans Affairs), pharmacy benefit managers, commercial insurers, Medicaid, 340B pharmacies, and AIDS Drug Assistance Programs. The availability of these discounts and rebates depends on product demand, market competition, and WAC price increases set by manufacturers. Maximum Medicaid payment rates are assigned to generic products with three or more therapeutically and pharmaceutically equivalent products, as determined by the U.S. Food and Drug Administration. This federally established pharmacy reimbursement limit is the federal upper limit (FUL). Federal Medicaid will reimburse state Medicaid programs up to this limit for multiple-source drugs (plus the dispensing fee); states may set their own state maximum allowable costs and commercial insurers set their own reimbursement upper limits with pharmacies. While WACs and AWPs are generally set annually, FULs are adjusted on a monthly basis, particularly for multiple-source drugs with fluctuating pharmacy acquisition costs. In this table, the FUL for a drug is described as “pending” if a generic drug currently lacks the required competition.

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