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Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

Limitations to Treatment Safety and Efficacy

Cost Considerations and Antiretroviral Therapy

(Last updated: July 14, 2016; last reviewed: July 14, 2016)

Although antiretroviral therapy (ART) is expensive (see Table 16 below), the cost-effectiveness of ART has been demonstrated in analyses of older1 and newer regimens,2,3 as well as for treatment-experienced patients with drug-resistant HIV.4 Given the recommendations for immediate initiation of lifelong treatment and the increasing number of patients taking ART, the Panel now introduces cost-related issues pertaining to medication adherence and cost-containment strategies, as discussed below.

Costs as They Relate to Adherence from a Patient Perspective

Cost sharing: Cost sharing is where the patient is responsible for some of the medication cost burden (usually accomplished via co-payments, co-insurance, or deductibles); these costs are often higher for branded medications than for generic medications. In one comprehensive review, increased patient cost sharing resulted in decreased medical adherence and more frequent drug discontinuation; for patients with chronic diseases, increased cost sharing was also associated with increased use of the medical system.5 Conversely, co-payment reductions, such as those that might be used to incentivize prescribing of generic drugs, have been associated with improved adherence in patients with chronic diseases.6 Whereas cost-sharing disproportionately affects low income patients, resources (e.g., the Ryan White AIDS Drug Assistance Program [ADAP]) are available to assist eligible patients with co-pays and deductibles. Given the clear association between out-of-pocket costs for patients with chronic diseases and the ability of those patients to pay for and adhere to medications, clinicians should minimize patients’ out-of-pocket drug-related expenses whenever possible.

Prior authorizations: As a cost-containment strategy, some programs require that clinicians obtain prior authorizations or permission before prescribing newer or more costly treatments rather than older or less expensive drugs. Although there are data demonstrating that prior authorizations do reduce spending, several studies have also shown that prior authorizations result in fewer prescriptions filled and increased non-adherence.7-9 Prior authorizations in HIV care specifically have been reported to cost over $40 each in provider personnel time (a hidden cost) and have substantially reduced timely access to medications.10

Generic ART: The impact of the availability of generic antiretroviral (ARV) drugs on selection of ART in the United States is unknown. Because U.S. patent laws currently limit the co-formulation of some generic alternatives to branded drugs, generic options may result in increased pill burden. To the extent that pill burden, rather than drug frequency, results in reduced adherence, generic ART could lead to decreased costs but at the potential expense of worsening virologic suppression rates and poorer clinical outcomes.11,12 Furthermore, prescribing the individual, less-expensive generic components of a branded co-formulated product rather than the branded product itself could, under some insurance plans, lead to higher copays—an out-of-pocket cost increase that may reduce medication adherence.

Potential Cost Containment Strategies from a Societal Perspective

Given resource constraints, it is important to maximize the use of resources without sacrificing clinical outcomes. Evidence-based revisions to these guidelines recommend tailored laboratory monitoring for patients with long-term virologic suppression on ART as one possible way to provide overall cost savings. Data suggest that continued CD4 monitoring yields no clinical benefit for patients whose viral loads are suppressed and CD4 counts exceed 200 cells/mm3 after 48 weeks of therapy.13 A reduction in laboratory use from biannual to annual CD4 monitoring could save ~$10 million per year in the United States14 (see the Laboratory Monitoring section). Although this is a small proportion of the overall costs associated with HIV care, such a strategy could reduce patients’ personal expenses if they have deductibles for laboratory tests. The present and future availability of generic formulations of certain ARV drugs, despite the potential caveats of increased pill burden and reduced adherence, offers other money-saving possibilities on a much greater scale. One analysis suggests the possibility of saving approximately $900 million nationally in the first year of switching from a branded fixed-dose combination product to a three-pill regimen containing generic efavirenz.3

In summary, understanding HIV and ART-related costs in the United States is complicated because of the wide variability in medical coverage, accessibility, and expenses across regions, insurance plans, and pharmacies. In an effort to retain excellent clinical outcomes in an environment of cost-containment strategies, providers should remain informed of current insurance and payment structures, ART costs (see Table 16 below for estimates of drugs’ average wholesale prices), discounts among preferred pharmacies, and available generic ART options. Providers should work with patients and their case managers and social workers to understand their patients’ particular pharmacy benefit plans and potential financial barriers to filling their prescriptions. Additionally, providers should familiarize themselves with ARV affordability resources (such as ADAP and pharmaceutical company patient assistance programs for patients who qualify) and refer patients to such assistance if needed.

Table 16. Monthly Average Wholesale Priceb of Commonly Usedc Antiretroviral Drugs
ARV Drug
(Generic and Brand Names)
Strength Formulation Dosing Tablets, Capsules, or
mLs per Montha
AWPb
(Monthly)
Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Abacavir
  • Generic
300 mg tablet 2 tablets daily 60 tablets $602.66
  • Ziagen
300 mg tablet 2 tablets daily 60 tablets $670.37
  • Ziagen
20 mg/mL solution 30 mL daily 900 mL $660.86
Emtricitabine
  • Emtriva
200 mg capsules 1 capsule daily 30 capsules $643.82
  • Emtriva
10 mg/mL solution 24 mL daily 680 mL (28-day supply) $643.82
Lamivudine
  • Generic
300 mg tablet 1 tablet daily 30 tablets $283.89
  • Epivir
300 mg tablet 1 tablet daily 30 tablets $498.89
  • Epivir
10 mg/mL solution 30 mL daily 900 mL $498.90
Tenofovir Disoproxil Fumarate
  • Viread
300 mg tablet 1 tablet daily 30 tablets $1,197.32
Zidovudine
  • Generic
300 mg tablet 1 tablet twice daily 60 tablets $54.00–$360.97
NRTI Combination Products
Abacavir/Lamivudine
  • Epzicom
600/300 mg tablets 1 tablet daily 30 tablets $1,550.05
Tenofovir Alafenamide/Emtricitabine
  • Descovy
 25/200 mg tablet 1 tablet daily
30 tablets $1,759,73
Tenofovir Disoproxil Fumarate/Emtricitabine
  • Truvada
300/200 mg tablet 1 tablet daily 30 tablets $1,759.73
Zidovudine/Lamivudine
  • Generic
300/150 mg tablet 1 tablet twice daily 60 tablets $877.85
  • Combivir
300/150 mg tablet 1 tablet twice daily 60 tablets $1,081.70
Abacavir Sulfate/Zidovudine/Lamivudine
  • Generic
300/300/150 mg tablet 1 tablet twice daily 60 tablets $1,738.46
  • Trizivir
300/300/150 mg tablet 1 tablet twice daily 60 tablets $1,931.64
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Efavirenz
  • Sustiva
600 mg tablet 1 tablet daily 30 tablets $1,010.13
Etravirine
  • Intelence
200 mg tablet 1 tablet twice daily 60 tablets $1,308.06
Nevirapine
  • Generic
200 mg tablet 1 tablet twice daily 60 tablets $648.19
  • Viramune
200 mg tablet 1 tablet twice daily 60 tablets $912.86
  • Viramune XR
400 mg tablet 1 tablet daily 30 tablets $846.66
Rilpivirine
  • Edurant
25 mg tablet 1 tablet daily 30 tablets $1,075.15
Protease Inhibitors (PIs)
Atazanavir
  • Reyataz
200 mg capsule
2 capsules daily 60 capsules $1,656.52
  • Reyataz
300 mg capsuled 1 capsule daily  30 capsules $1,640.86
Atazanavir/Cobicistat
  • Evotaz
300/150 mg tablet 1 tablet daily 30 tablets $1,817.51
Darunavir
  • Prezista
600 mg tablete 1 tablet twice daily 60 tablets $1,629.06
  • Prezista
800 mg tabletd 1 tablet daily  30 tablets $1,629.06
  • Prezista
100 mg/mL suspensione 8 mL daily
6 mL twice daily
240 mL
360 mL
$1,086.05
$1,629.07
Darunavir/Cobicistat
  • Prezcobix
800/150 mg tablet 1 tablet daily 30 tablets $1,862.12
Lopinavir/Ritonavir
  • Kaletra
200/50 mg tablet 2 tablets twice daily
or
4 tablets once daily
120 tablets $1,106.29
  • Kaletra
80/20 mg per mL solution 5 mL twice daily 300 mL $1,037.14
Tipranavir
  • Aptivus
250 mg capsulee 2 capsules twice daily 120 capsules $1,685.59
Integrase Strand Transfer Inhibitors (INSTIs)
Dolutegravir
  • Tivicay
50 mg tablet
1 tablet once daily
30 tablets $1,707.26
  • Tivicay
50 mg tablet
1 tablet twice daily
60 tablets $3,414.52
Elvitegravir
  • Vitekta
85 mg tablet 1 tablet daily 30 tablets $1,445.34
  • Vitekta
150 mg tablet 1 tablet daily 30 tablets $1,445.34
Raltegravir
  • Isentress
400 mg tablet 1 tablet twice daily 60 tablets $1,545.07
Fusion Inhibitor
Enfuviritide
  • Fuzeon
90 mg injection kit 1 injection twice daily 60 doses (1 kit) $4,097.78
CCR5 Antagonist
Maraviroc
  • Selzentry
150 mg tablet 1 tablet twice daily 60 tablets $1,296.77
  • Selzentry
300 mg tablet 1 tablet twice daily 60 tablets $1,296.77
  • Selzentry
300 mg tablet 2 tablets twice daily
120 tablets $2,593.54
Co-Formulated Combination Products as Single Tablet Regimens
Dolutegravir/Abacavir/Lamivudine
  • Triumeq
50/600/300 mg tablet 1 tablet daily 30 tablets $2,889.22
Efavirenz/Tenofovir Disoproxil Fumarate/Emtricitabine
  • Atripla
600/300/200 mg tablet 1 tablet daily 30 tablets $2,869.86
Elvitegravir/Cobicistat/Tenofovir Alafenamide/Emtricitabine
  • Genvoya
150/150/10/200 mg tablet 1 tablet daily
30 tablets $3,093.19
Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine
  • Stribild
150/150/300/200 mg tablet 1 tablet daily 30 tablets $3,244.76
Rilpivirine/Tenofovir Alafenamide/Emtricitabine
  • Odefsey
25/25/200 mg tablet 1 tablet daily 30 tablets $2,815.04
Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine
  • Complera
25/300/200 mg tablet 1 tablet daily 30 tablets $2,815.04
Pharmacokinetic Enhancers (Boosters)
Cobicistat
  • Tybost
150 mg tablet 1 tablet daily 30 tablets $230.90
Ritonavir: Total daily dose depends on the dose of the concomitant PI (100 mg once or twice daily, or 200 mg twice daily)
  • Norvir

100 mg tablet 1 tablet once daily 30 tablets $308.60
80 mg/mL solution 100 mg daily 37.5 mL (of a 240 mL bottle) $270.04
a Represents 30 days or as specified.
b AWP = average wholesale price. Note that the AWP may not represent the pharmacy acquisition price or the price paid by consumers. 
Source: http://www.micromedexsolutions.com/. Accessed April 2016.
c The following less commonly used ARV drugs are not included in this table: delavirdine, didanosine, fosamprenavir, indinavir, nelfinavir, saquinavir, and stavudine.
d Should be used in combination with ritonavir or cobicistat. Please refer to Appendix B, Table 3 for ritonavir doses.
e Should be used in combination with ritonavir. Please refer to Appendix B, Table 3 for ritonavir doses.

Key to Abbreviations: ARV = antiretroviral; EC = enteric coated; XR = extended release

References

  1. Freedberg KA, Losina E, Weinstein MC, et al. The cost effectiveness of combination antiretroviral therapy for HIV disease. N Engl J Med. 2001;344(11):824-831. Available at http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11248160.
  2. Mauskopf J, Brogan AJ, Talbird SE, Martin S. Cost-effectiveness of combination therapy with etravirine in treatment-experienced adults with HIV-1 infection. AIDS. 2012;26(3):355-364. Available at http://www.ncbi.nlm.nih.gov/pubmed/22089378.
  3. Walensky RP, Sax PE, Nakamura YM, et al. Economic savings versus health losses: the cost-effectiveness of generic antiretroviral therapy in the United States. Ann Intern Med. 2013;158(2):84-92. Available at http://www.ncbi.nlm.nih.gov/pubmed/23318310.
  4. Bayoumi AM, Barnett PG, Joyce VR, et al. Cost-effectiveness of newer antiretroviral drugs in treatment-experienced patients with multidrug-resistant HIV disease. J Acquir Immune Defic Syndr. 2013;64(4):382-391. Available at http://www.ncbi.nlm.nih.gov/pubmed/24129369.
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  6. Maciejewski ML, Farley JF, Parker J, Wansink D. Copayment reductions generate greater medication adherence in targeted patients. Health Affair. 2010;29(11):2002-2008. Available at http://www.ncbi.nlm.nih.gov/pubmed/21041739.
  7. Abdelgawad T, Egbuonu-Davis L. Preferred drug lists and Medicaid prescriptions. PharmacoEconomics. 2006;24 Suppl 3:55-63. Available at http://www.ncbi.nlm.nih.gov/pubmed/17266388.
  8. Ridley DB, Axelsen KJ. Impact of Medicaid preferred drug lists on therapeutic adherence. PharmacoEconomics. 2006;24 Suppl 3:65-78. Available at http://www.ncbi.nlm.nih.gov/pubmed/17266389.
  9. Wilson J, Axelsen K, Tang S. Medicaid prescription drug access restrictions: exploring the effect on patient persistence with hypertension medications. Am J Manag Care. 2005;11 Spec No:SP27-34. Available at http://www.ncbi.nlm.nih.gov/pubmed/15700907.
  10. Raper JL, Willig JH, Lin HY, et al. Uncompensated medical provider costs associated with prior authorization for prescription medications in an HIV clinic. Clin Infect Dis. 2010;51(6):718-724. Available at http://www.ncbi.nlm.nih.gov/pubmed/20695800.
  11. Hanna DB, Hessol NA, Golub ET, et al. Increase in Single-Tablet Regimen Use and Associated Improvements in Adherence-Related Outcomes in Hiv-Infected Women. J Acquir Immune Defic Syndr. 2013. Available at http://www.ncbi.nlm.nih.gov/pubmed/24326606.
  12. Nachega JB, Parienti JJ, Uthman OA, et al. Lower Pill Burden and Once-daily Dosing Antiretroviral Treatment Regimens for HIV Infection: A Meta-Analysis of Randomized Controlled Trials. Clin Infect Dis. 2014. Available at http://www.ncbi.nlm.nih.gov/pubmed/24457345.
  13. Girard PM, Nelson M, Mohammed P, Hill A, van Delft Y, Moecklinghoff C. Can we stop CD4 testing in patients with HIV-1 RNA suppression on antiretroviral treatment? Analysis of the ARTEMIS trial. AIDS. 2013. Available at http://www.ncbi.nlm.nih.gov/pubmed/23842127.
  14. Hyle EP, Sax PE, Walensky RP. Potential Savings by Reduced CD4 Monitoring in Stable Patients With HIV Receiving Antiretroviral Therapy. JAMA Intern Med. 2013. Available at http://www.ncbi.nlm.nih.gov/pubmed/23978894.

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