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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:May 01, 2014; last reviewed:May 01, 2014)

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.

Click here to view this table as an image 

Table 16: Monthly Average Wholesale Pricea of Antiretroviral Drugs
ARV Drug
(Generic and Brand Names)
 Strength Dosing Tablets/Capsules/
mLs per Month
AWPa
(Monthly)
Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Abacavir
  • Generic
300 mg tab 2 tabs daily 60 tabs $602.66
  • Ziagen
300 mg tab 2 tabs daily 60 tabs $670.30
  • Ziagen
20 mg/mL soln 30 mL daily 900 mL $660.86
Didanosine Delayed-Release
  • Generic
400 mg cap 1 cap daily 30 caps $368.72
  • Videx EC
400 mg cap 1 cap daily 30 caps $515.84
Emtricitabine
  • Emtriva
200 mg cap 1 cap daily 30 tabs $602.27
  • Emtriva
10 mg/mL soln 24 mL daily 680 mL (28-day supply) $568.88
Lamivudine
  • Generic
300 mg tab 1 tab daily 30 tabs $429.66
  • Epivir
300 mg tab 1 tab daily 30 tabs $498.89
  • Epivir
10 mg/mL soln 30 mL daily 900 mL $498.90
Stavudine
  • Generic
40 mg cap 1 cap twice daily 60 caps $410.70
  • Zerit
40 mg cap 1 cap twice daily 60 caps $553.12
Tenofovir
  • Viread
300 mg tab 1 tab daily 30 tabs $1,047.73
Zidovudine
  • Generic
300 mg tab 1 tab twice daily 60 tabs $360.97
  • Retrovir
300 mg tab 1 tab twice daily 60 tabs $476.70
NRTI Combination Products
Abacavir/Lamivudine
  • Epzicom
600/300 mg tab 1 tab daily 30 tabs $1,239.41
Tenofovir Disoproxil Fumarate/Emtricitabine
  • Truvada
300/150 mg tab 1 tab daily 30 tabs $1,539.90
Zidovudine/Lamivudine
  • Generic
300/150 mg tab 1 tab twice daily 60 tabs $931.61
  • Combivir
300/150 mg tab 1 tab twice daily 60 tabs $1,081.70
Abacavir Sulfate/Zidovudine/Lamivudine
  • Generic
300/300/150 mg tab 1 tab twice daily 60 tabs $1,738.46
 
  • Trizivir
300/300/150 mg tab  1 tab twice daily   60 tabs $1,931.64 
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Efavirenz
  • Sustiva
600 mg tab 1 tab daily 30 tabs $862.14
Etravirine
  • Intelence
200 mg tab 1 tab twice daily 60 tabs $1,123.52
Nevirapine
  • Generic
200 mg tab 1 tab twice daily 60 tabs $650.05
  • Viramune
200 mg tab 1 tab twice daily 60 tabs $812.45
  • Viramune XR (nevirapine extended release)
400 mg tab 1 tab daily 30 tabs $753.52
Rilpivirine
  • Endurant
25 mg tab 1 tab daily 30 tabs $923.47
Protease Inhibitors (PIs)
Atazanavir
  • Reyataz
150 mg capb 2 caps daily 60 caps $1,422.83
  • Reyataz
200 mg cap  2 caps daily   60 caps $1,422.83
  • Reyataz
300 mg capb  1 cap daily 30 caps  $1,409.39 
Darunavir
  • Prezista
600 mg tabb 1 tab twice daily 60 tabs  $1,399.25
 
  • Prezista
 800 mg tabb  1 tab daily  30 tabs $1,399.25
  • Prezista
100 mg/mL soln 8 mL daily
6 mL twice daily
240 mL
360 mL
 $932.83
$1,399.25
Fosamprenavir
  • Lexiva
700 mg tab  2 tabs twice daily  120 tabs  $2,088.40
  • Lexiva
700 mg tab 1 tab twice dailyb 60 tabs  $1,044.20
  • Lexiva
700 mg tab  2 tabs once dailyb  60 tabs $1,044.20
Lopinavir/Ritonavir
  • Kaletra
200 mg/50 mg tab  2 tabs twice daily
or
4 tabs once daily 
120 tabs  $977.22
  • Kaletra
80 mg/20 mg per mL soln   5 mL twice daily 300 mL  $916.13
Ritonavir
Total Daily Dose Depends On Concomitant PI
  • Norvir
100 mg tab  1 tab once daily  30 tabs $308.60
  • Norvir
100 mg tab 1 tab twice daily 60 tabs $617.20 
  • Norvir
100 mg tab 2 tabs twice daily  120 tabs $1,234.40
Saquinavir
  • Invirase
500 mg tabb 2 tabs twice daily  120 tabs $1,177.58
Tipranavir
  • Aptivus
250 mg capb  2 caps twice daily 120 caps  $1,500.17 
Integrase Strand Transfer Inhibitors (INSTIs)
Please refer to Co-formulated Combination Antiretroviral Drugs for cost of elvitegravir/cobicistat/tenofovir/emtricitabine (Stribild)
Dolutegravir
  • Tivicay
50 mg tab
1 tab once daily
30 tabs $1,410.48
  • Tivicay
50 mg tab
1 tab twice daily
60 tabs $2,820.96
Raltegravir
  • Isentress
400 mg tab 1 tab twice daily 60 tabs $1,352.05
Fusion Inhibitor
Enfuviritide
  • Fuzeon
90 mg injection kit 1 injection twice daily 60 doses
(1 kit)
$3,513.49
CCR5 Antagonist
Maraviroc
  • Selzentry
150 mg tab 1 tab twice daily 60 tabs $1,297.62
  • Selzentry
 300 mg tab   1 tab twice daily    60 tabs  $1,297.62
  • Selzentry
300 mg tab   2 tabs twice daily 
 120 tabs $2,595.24 
Co-formulated Combination Products as Complete Antiretroviral Regimens
Efavirenz/Tenofovir Disoproxil Fumarate/Emtricitabine
  • Atripla
600/300/200 mg tab 1 tab daily 30 tabs $2,402.04
Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine
  • Complera
25/300/200 mg tab 1 tab daily 30 tabs $2,463.37
Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine
  • Stribild
150/150/300/200 mg tab  1 tab daily  30 tabs  $2,948.70 
AWP = Average Wholesale Price. Note that this price may not represent the pharmacy acquisition price or the price paid by consumers. 
Source: Red Book Online. Available at http://aapredbook.aappublications.org. Accessed January 2014

b Should be used in combination with ritonavir. Please refer to Appendix B, Table 3 for ritonavir doses.

Key to Abbreviations: cap = capsule; EC = enteric coated; soln = solution; AWP = average wholesale price; tab = tablet; 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.
  5. Goldman DP, Joyce GF, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA. 2007;298(1):61-69. Available at http://www.ncbi.nlm.nih.gov/pubmed/17609491.
  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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