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

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Limitations to Treatment Safety and Efficacy

Cost Considerations and Antiretroviral Therapy

Last Updated: December 18, 2019; Last Reviewed: December 18, 2019

Table 19a. Insurance and Health Program Prescription Drug Pricing and Access
Insurance/Health Program Prescription Drug Pricing and Access
Medicaid Drug manufacturers must participate in MDRP for their drugs to be covered by Medicaid and under Medicare Part B.

Manufacturers are required to pay Medicaid programs a rebate of at least 23.1% of the average price paid to manufacturers by wholesalers (AMP) for most brand-name drugs sold to retail pharmacies (13% for generics). Manufacturers pay additional rebates if this confidential AMP increases faster than the CPI-U rate of inflation.

States are permitted to require “nominal” cost-sharing for medical and pharmacy benefits for some beneficiaries though many elect not to do so. States can obtain a waiver to allow them to apply higher cost-sharing.
Medicare ARVs are one of six “protected drug classes” under Medicare Part D. Part D plans must provide access to all, or substantially all, FDA-approved ARVs. Part D plan sponsors, or PBMs on their behalf, negotiate rebates on outpatient drugs with manufacturers; the extent of rebating is unclear.

Most physician-administered drugs and biologics are covered under Medicare Part B at a set cost: ASP plus 6%. This pricing mechanism controls spending by narrowing the spread between what is actually paid for the drug and what is actually billed to Medicare.

Premiums and cost-sharing payments may be significant for both services and prescription drugs; there is no cap on out-of-pocket spending under Part A (hospital care) and Part B.

Some subsidies and supplemental coverage are offered for low-income beneficiaries. Manufacturer copay assistance programs cannot be applied to Part B or Part D cost sharing; cost sharing support is available from ADAPs, foundations, and other sources, based on financial eligibility criteria.
Commercial Insurance Private insurance plans, or PBMs on their behalf, negotiate rebates on inpatient and outpatient drugs with manufacturers; the extent of rebating is unclear.

Formulary restrictions and utilization management (prior authorization, step therapy, higher cost sharing) are possible as cost-containment measures.

Cost sharing can be highly variable. Manufacturer copay assistance programs can be applied in most cases but may not count toward annual Affordable Care Act cost sharing limits; cost sharing support is also available from ADAPs, foundations, and other sources based on financial eligibility criteria.
ADAPs Significant discounting on most ARVs negotiated by the ADAP Crisis Task Force is allowed under the 340B Drug Pricing Program.

There is usually no cost sharing for ADAP clients who are uninsured. ADAP can assist with commercial or public insurance out-of-pocket costs.
Veterans Affairs The FCP is the maximum price manufacturers may charge the four largest federal purchasers of pharmaceuticals (the “Big Four”): The Department of Veterans Affairs, the Department of Defense, the Public Health Service (including the Indian Health Service), and the Coast Guard. The FCP of a drug includes a 24% discount on a drug’s average price paid by non-federal purchasers. Additional discounts may be applied if non-federal purchase prices increase faster than the CPI-U inflation rate.

Big Four prices may be 40% to 50% below list prices. VA may negotiate further price reductions.

Prescription drug cost sharing is generally nominal; medications are not withheld from those who cannot afford cost sharing expenses.
Community Health Centers Many community health centers are enrolled in the 340B Drug Pricing Program, which allows for discounted drug purchasing using the MDRP formula.

Discounts start at 23.1% off AMP, with additional discounts if the AMP increases faster than the CPI-U rate of inflation.

Cost-sharing in community health centers is first driven by payer source. For clients who are uninsured, cost-sharing, if required, is typically based on a sliding fee scale.
Key: ADAP = AIDS Drug Assistance Programs; AMP = average manufacturer price; ARV = antiretroviral; ASP = average sales price; CPI-U = consumer price index-urban; FCP = Federal Ceiling Price; FDA = Food and Drug Administration; MDRP = Medicaid Drug Rebate Program; PBM = pharmacy benefits manager; VA = Veterans Affairs

Table 19b. Monthly Average Prices of Commonly Used Antiretroviral Drugs

Table 19b includes three benchmark prices, rounded to the nearest dollar, for commonly used ARV drugsa as a general reference for health care providers when considering the cost of HIV treatment. Health care providers should contact patients’ pharmacies or payers regarding actual prices, comparative cost savings, formulary restrictions, and patient cost-sharing requirements.

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, as these are multiple-source products with variable list prices. With increasing competition, actual transactional prices of generic drugs among wholesalers and pharmacies decrease substantially. 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 include variable price concessions along supply and payment chains, including discounts and rebates to wholesalers, pharmacies, federal purchasers (e.g., the Veterans’ Administration), pharmacy benefit managers (PBMs), 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 prices are assigned to generic products with three or more therapeutically and pharmaceutically equivalent products, as determined by the Food and Drug Administration. This federally established price 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); commercial insurers set their own reimbursement upper limits with pharmacies. Whereas 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 the table below, the FUL for a drug is described as “pending” if a generic drug currently lacks the competition required to trigger a FUL.

Table 19b. Monthly Average Prices of Commonly Used Antiretroviral Drugs
ARV Drug (Generic and Brand Names) Strength, Formulation Tablets, Capsules, or mLs per Month WAC (Monthly)b AWP (Monthly)b FUL (As of Oct. 31, 2019)c
NRTIs
Abacavir
  • Generic
300 mg tablet 60 tablets $150 to $482 $502 to $603 $43
  • Ziagen
300 mg tablet 60 tablets $559 $670
Emtricitabine
  • Emtriva
200 mg capsule 30 capsules $537 $644 N/A
Lamivudine
  • Generic
300 mg tablet 30 tablets $75 to $343 $324 to $430 $51
  • Epivir
300 mg tablet 30 tablets $416 $499
Tenofovir Disoproxil Fumarate
  • Generic
300 mg tablet 30 tablets $27 to $163 $110 to $1,216 $203
  • Viread
300 mg tablet 30 tablets $1,196 $1,435
Zidovudine
  • Generic
300 mg tablet 60 tablets $36 to $54 $54 to $365 $13
NRTI Combination Products
Abacavir/Lamivudine
  • Generic
600 mg/300 mg tablet 30 tablets $185 to $1,116 $1,393 to $1,550 $182
  • Epzicom
600 mg/300 mg tablet 30 tablets $1,292 $1,550
Tenofovir Alafenamide/Emtricitabine
  • Descovy
25 mg/200 mg tablet 30 tablets $1,758 $2,109 N/A
Tenofovir Disoproxil Fumarate/Emtricitabine
  • Truvada
300 mg/200 mg tablet 30 tablets $1,676 $2,011 N/A
Tenofovir Disoproxil Fumarate/Lamivudine
  • Cimduo
300 mg/300 mg tablet 30 tablets $1,005 $1,207 N/A
  • Temixys
300 mg/300 mg tablet 30 tablets $850 $1,020 N/A
Zidovudine/Lamivudine
  • Generic
300 mg/150 mg tablet 60 tablets $134 to $578 $878 to $932 $123
  • Combivir
300 mg/150 mg tablet 60 tablets $901 $1,082
Abacavir Sulfate/Zidovudine/Lamivudine
  • Generic
300 mg/300 mg/150 mg tablet 60 tablets $1,391 $1,738 Pending
  • Trizivir
300 mg/300 mg/150 mg tablet 60 tablets $1,610 $1,932
NNRTIs
Efavirenz
  • Generic
600 mg tablet 30 tablets $894 to $980 $1,073 to $1,117 $768
  • Sustiva
600 mg tablet 30 tablets $981 $1,177
Doravirine
  • Pifeltro
100 mg tablet 30 tablets $1,380 $1,656 N/A
Etravirine
  • Intelence
200 mg tablet 60 tablets $1,366 $1,628 N/A
Nevirapine
  • Generic
200 mg tablet 60 tablets $10 to $45 $648 to $651 $65
  • Viramune
200 mg tablet 60 tablets $906 $1,087
  • Generic XR
400 mg tablet 30 tablets $135 to $565 $595 to $706 $392
  • Viramune XR
400 mg tablet 30 tablets $840 $1,008
Rilpivirine
  • Edurant
25 mg tablet 30 tablets $1,115 $1,338 N/A
PIs
Atazanavir
  • Generic
200 mg capsule 60 capsules $445 to $1,264 $1,517 to $1,668 $1,405
  • Reyataz
200 mg capsule 60 capsules $1,463 $1,756
  • Generic
300 mg capsule 30 capsules $445 to $1,252 $1,502 to $1,652 $1,032
  • Reyataz
300 mg capsule 30 capsules $1,449 $1,739
Atazanavir/Cobicistat
  • Evotaz
300/150 mg tablet 30 tablets $1,605 $1,927 N/A
Darunavir
  • Prezista
600 mg tablet 60 tablets $1,690 $2,028 N/A
  • Prezista
800 mg tablet 30 tablets $1,690 $2,028 N/A
  • Prezista
100 mg/mL suspension 200 mL $939 $1,126 N/A
Darunavir/Cobicistat
  • Prezcobix
800 mg/150 mg tablet 30 tablets $1,931 $2,317 N/A
Lopinavir/Ritonavir
  • Kaletra
200 mg/50 mg tablet 120 tablets $1,024 $1,229 N/A
Tipranavir
  • Aptivus
250 mg capsule 120 capsules $1,673 $2,008 N/A
INSTIs
Dolutegravir
  • Tivicay
50 mg tablet 30 tablets $1,740 $2,089 N/A
  • Tivicay
50 mg tablet 60 tablets $3,480 $4,178 N/A
Raltegravir
  • Isentress
400 mg tablet 60 tablets $1,574 $1,889 N/A
  • Isentress HD
600 mg tablet 60 tablets $1,574 $1,889 N/A
Fusion Inhibitor
Enfuvirtide
  • Fuzeon
90 mg injection kit 60 doses (1 kit) $3,586 $4,303 N/A
CCR5 Antagonist
Maraviroc
  • Selzentry
150 mg tablet 60 tablets $1,556 $1,867 N/A
  • Selzentry
300 mg tablet 60 tablets $1,556 $1,867 N/A
  • Selzentry
300 mg tablet 120 tablets $3,112 $3,734 N/A
CD4-Directed Post-Attachment Inhibitor
Ibalizumab-uiyk
  • Trogarzo
200 mg vial 8 vials $9,080 $10,896 N/A
Coformulated Combination Products as Single-Tablet Regimens
Bictegravir/Tenofovir Alafenamide/Emtricitabine
  • Biktarvy
50 mg/25 mg/200 mg tablet 30 tablets $3,089 $3,707 N/A
Darunavir/Cobicistat/Tenofovir Alafenamide/Emtricitabine
  • Symtuza
800 mg/150 mg/10 mg/200 mg tablet 30 tablets $3,722 $4,466 N/A
Dolutegravir/Abacavir/Lamivudine
  • Triumeq
50 mg/600 mg/300 mg tablet 30 tablets $2,889 $3,467 N/A
Dolutegravir/Lamivudine
  • Dovato
50 mg/300 mg tablet 30 tablets $2,295 $2,754 N/A
Dolutegravir/Rilpivirine
  • Juluca
50 mg/25 mg tablet 30 tablets $2,707 $3,249 N/A
Doravirine/Tenofovir Disoproxil Fumarate/Lamivudine
  • Delstrigo
100 mg/300 mg/300 mg tablet 30 tablets $2,100 $2,520 N/A
Efavirenz/Tenofovir Disoproxil Fumarate/Emtricitabine
  • Atripla
600 mg/300 mg/200 mg tablet 30 tablets $2,858 $3,429 N/A
Efavirenz/Tenofovir Disoproxil Fumarate/Lamivudine
  • Symfi
600 mg/300 mg/150 mg tablet 30 tablets $1,634 $1,961 N/A
  • Symfi Lo
400 mg/300 mg/150 mg tablet 30 tablets $1,634 $1,961 N/A
Elvitegravir/Cobicistat/Tenofovir Alafenamide/Emtricitabine
  • Genvoya
150 mg/150 mg/10 mg/200 mg tablet 30 tablets $3,090 $3,708 N/A
Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine
  • Stribild
150 mg/150 mg/300 mg/200 mg tablet 30 tablets $3,241 $3,889 N/A
Rilpivirine/Tenofovir Alafenamide/Emtricitabine
  • Odefsey
25 mg/25 mg/200 mg tablet 30 tablets $2,812 $3,375 N/A
Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine
  • Complera
25 mg/300 mg/200 mg tablet 30 tablets $2,812 $3,375 N/A
PK Enhancers (Boosters)
Cobicistat
  • Tybost
150 mg tablet 30 tablets $230 $277 N/A
Ritonavir
  • Generic
100 mg tablet 30 tablets $80 to $222 $278 $78
  • Norvir
100 mg tablet 30 tablets $257 $309
a The following less commonly used ARV drugs are not included in this table: DLV, ddI, FPV, IDV, NFV, SQV, and d4T.

b Source: Micromedex Red Book [database]. IBM Watson Health. 2019. Available at: https://www.micromedexsolutions.com

c Source: Federal Upper Limits–October 2019 [database]. Medicare & Medicaid Services. 2019. Available at: https://www.medicaid.gov/medicaid/prescription-drugs/pharmacy-pricing/index.html.

Key: ARV = antiretroviral; AWP = average wholesale price; CD4 = CD4 T lymphocyte; d4t = stavudine; ddI = didanosine; DLV = delavirdine; FPV = fosamprenavir; FUL = federal upper limit; HD = high dose; IDV = indinavir; INSTI = integrase strand transfer inhibitor; N/A = not applicable; NFV = nelfinavir; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; PI = protease inhibitor; PK = pharmacokinetic; SQV = saquinavir; WAC = wholesale acquisition cost; XR = extended release

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