Antiretroviral Guidelines
US DHHS Guidelines with Australian commentary
Cost Considerations and Antiretroviral Therapy
Last Updated: December 18, 2019; Last Reviewed: December 18, 2019
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 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.
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 | |||||
|
300 mg tablet | 60 tablets | $150 to $482 | $502 to $603 | $43 |
|
300 mg tablet | 60 tablets | $559 | $670 | |
Emtricitabine | |||||
|
200 mg capsule | 30 capsules | $537 | $644 | N/A |
Lamivudine | |||||
|
300 mg tablet | 30 tablets | $75 to $343 | $324 to $430 | $51 |
|
300 mg tablet | 30 tablets | $416 | $499 | |
Tenofovir Disoproxil Fumarate | |||||
|
300 mg tablet | 30 tablets | $27 to $163 | $110 to $1,216 | $203 |
|
300 mg tablet | 30 tablets | $1,196 | $1,435 | |
Zidovudine | |||||
|
300 mg tablet | 60 tablets | $36 to $54 | $54 to $365 | $13 |
NRTI Combination Products | |||||
Abacavir/Lamivudine | |||||
|
600 mg/300 mg tablet | 30 tablets | $185 to $1,116 | $1,393 to $1,550 | $182 |
|
600 mg/300 mg tablet | 30 tablets | $1,292 | $1,550 | |
Tenofovir Alafenamide/Emtricitabine | |||||
|
25 mg/200 mg tablet | 30 tablets | $1,758 | $2,109 | N/A |
Tenofovir Disoproxil Fumarate/Emtricitabine | |||||
|
300 mg/200 mg tablet | 30 tablets | $1,676 | $2,011 | N/A |
Tenofovir Disoproxil Fumarate/Lamivudine | |||||
|
300 mg/300 mg tablet | 30 tablets | $1,005 | $1,207 | N/A |
|
300 mg/300 mg tablet | 30 tablets | $850 | $1,020 | N/A |
Zidovudine/Lamivudine | |||||
|
300 mg/150 mg tablet | 60 tablets | $134 to $578 | $878 to $932 | $123 |
|
300 mg/150 mg tablet | 60 tablets | $901 | $1,082 | |
Abacavir Sulfate/Zidovudine/Lamivudine | |||||
|
300 mg/300 mg/150 mg tablet | 60 tablets | $1,391 | $1,738 | Pending |
|
300 mg/300 mg/150 mg tablet | 60 tablets | $1,610 | $1,932 | |
NNRTIs | |||||
Efavirenz | |||||
|
600 mg tablet | 30 tablets | $894 to $980 | $1,073 to $1,117 | $768 |
|
600 mg tablet | 30 tablets | $981 | $1,177 | |
Doravirine | |||||
|
100 mg tablet | 30 tablets | $1,380 | $1,656 | N/A |
Etravirine | |||||
|
200 mg tablet | 60 tablets | $1,366 | $1,628 | N/A |
Nevirapine | |||||
|
200 mg tablet | 60 tablets | $10 to $45 | $648 to $651 | $65 |
|
200 mg tablet | 60 tablets | $906 | $1,087 | |
|
400 mg tablet | 30 tablets | $135 to $565 | $595 to $706 | $392 |
|
400 mg tablet | 30 tablets | $840 | $1,008 | |
Rilpivirine | |||||
|
25 mg tablet | 30 tablets | $1,115 | $1,338 | N/A |
PIs | |||||
Atazanavir | |||||
|
200 mg capsule | 60 capsules | $445 to $1,264 | $1,517 to $1,668 | $1,405 |
|
200 mg capsule | 60 capsules | $1,463 | $1,756 | |
|
300 mg capsule | 30 capsules | $445 to $1,252 | $1,502 to $1,652 | $1,032 |
|
300 mg capsule | 30 capsules | $1,449 | $1,739 | |
Atazanavir/Cobicistat | |||||
|
300/150 mg tablet | 30 tablets | $1,605 | $1,927 | N/A |
Darunavir | |||||
|
600 mg tablet | 60 tablets | $1,690 | $2,028 | N/A |
|
800 mg tablet | 30 tablets | $1,690 | $2,028 | N/A |
|
100 mg/mL suspension | 200 mL | $939 | $1,126 | N/A |
Darunavir/Cobicistat | |||||
|
800 mg/150 mg tablet | 30 tablets | $1,931 | $2,317 | N/A |
Lopinavir/Ritonavir | |||||
|
200 mg/50 mg tablet | 120 tablets | $1,024 | $1,229 | N/A |
Tipranavir | |||||
|
250 mg capsule | 120 capsules | $1,673 | $2,008 | N/A |
INSTIs | |||||
Dolutegravir | |||||
|
50 mg tablet | 30 tablets | $1,740 | $2,089 | N/A |
|
50 mg tablet | 60 tablets | $3,480 | $4,178 | N/A |
Raltegravir | |||||
|
400 mg tablet | 60 tablets | $1,574 | $1,889 | N/A |
|
600 mg tablet | 60 tablets | $1,574 | $1,889 | N/A |
Fusion Inhibitor | |||||
Enfuvirtide | |||||
|
90 mg injection kit | 60 doses (1 kit) | $3,586 | $4,303 | N/A |
CCR5 Antagonist | |||||
Maraviroc | |||||
|
150 mg tablet | 60 tablets | $1,556 | $1,867 | N/A |
|
300 mg tablet | 60 tablets | $1,556 | $1,867 | N/A |
|
300 mg tablet | 120 tablets | $3,112 | $3,734 | N/A |
CD4-Directed Post-Attachment Inhibitor | |||||
Ibalizumab-uiyk | |||||
|
200 mg vial | 8 vials | $9,080 | $10,896 | N/A |
Coformulated Combination Products as Single-Tablet Regimens | |||||
Bictegravir/Tenofovir Alafenamide/Emtricitabine | |||||
|
50 mg/25 mg/200 mg tablet | 30 tablets | $3,089 | $3,707 | N/A |
Darunavir/Cobicistat/Tenofovir Alafenamide/Emtricitabine | |||||
|
800 mg/150 mg/10 mg/200 mg tablet | 30 tablets | $3,722 | $4,466 | N/A |
Dolutegravir/Abacavir/Lamivudine | |||||
|
50 mg/600 mg/300 mg tablet | 30 tablets | $2,889 | $3,467 | N/A |
Dolutegravir/Lamivudine | |||||
|
50 mg/300 mg tablet | 30 tablets | $2,295 | $2,754 | N/A |
Dolutegravir/Rilpivirine | |||||
|
50 mg/25 mg tablet | 30 tablets | $2,707 | $3,249 | N/A |
Doravirine/Tenofovir Disoproxil Fumarate/Lamivudine | |||||
|
100 mg/300 mg/300 mg tablet | 30 tablets | $2,100 | $2,520 | N/A |
Efavirenz/Tenofovir Disoproxil Fumarate/Emtricitabine | |||||
|
600 mg/300 mg/200 mg tablet | 30 tablets | $2,858 | $3,429 | N/A |
Efavirenz/Tenofovir Disoproxil Fumarate/Lamivudine | |||||
|
600 mg/300 mg/150 mg tablet | 30 tablets | $1,634 | $1,961 | N/A |
|
400 mg/300 mg/150 mg tablet | 30 tablets | $1,634 | $1,961 | N/A |
Elvitegravir/Cobicistat/Tenofovir Alafenamide/Emtricitabine | |||||
|
150 mg/150 mg/10 mg/200 mg tablet | 30 tablets | $3,090 | $3,708 | N/A |
Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine | |||||
|
150 mg/150 mg/300 mg/200 mg tablet | 30 tablets | $3,241 | $3,889 | N/A |
Rilpivirine/Tenofovir Alafenamide/Emtricitabine | |||||
|
25 mg/25 mg/200 mg tablet | 30 tablets | $2,812 | $3,375 | N/A |
Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine | |||||
|
25 mg/300 mg/200 mg tablet | 30 tablets | $2,812 | $3,375 | N/A |
PK Enhancers (Boosters) | |||||
Cobicistat | |||||
|
150 mg tablet | 30 tablets | $230 | $277 | N/A |
Ritonavir | |||||
|
100 mg tablet | 30 tablets | $80 to $222 | $278 | $78 |
|
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 |