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HIV Treatment and Prevention Access: Drug Pricing and Cost Considerations

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HIV Treatment and Prevention Access: Drug Pricing and Cost Considerations
Tim Horn and David Evans
7/6/2018
UCSD HIV & Global Health Rounds

Published in: Health & Medicine
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HIV Treatment and Prevention Access: Drug Pricing and Cost Considerations

  1. 1. HIV Treatment and Prevention Access: Drug Pricing and Cost Considerations Tim Horn, Deputy Executive Director – HIV & HCV Programs Treatment Action Group, New York, NY David Evans, Interim Executive Director Project Inform, San Francisco
  2. 2. Organisation for Economic Cooperation and Development. https://data.oecd.org/healthres/pharmaceutical-spending.htm Pharma Spending: % of Health Spending (2015)
  3. 3. Organisation for Economic Cooperation and Development. https://data.oecd.org/healthres/pharmaceutical-spending.htm Health Spending: US$ Capita (2015)
  4. 4. Organisation for Economic Cooperation and Development. https://data.oecd.org/healthres/pharmaceutical-spending.htm Pharma Spending: US$ Capita (2015)
  5. 5. Per-Person Spending (2017) MedicaidACA Marketplace Plans Express Scripts. 2017 drug trend report. http://lab.express-scripts.com/lab/drug-trend-report/~/media/2b56ec26c9a04ec2bcca0e9bf1ea8ff1.ashx
  6. 6. The HIV (Treatment) Payer Patchwork • Employer-based plans • ACA Marketplace Plans • Medicaid/Medicare • Veterans Administration • Ryan White/ADAPs • Patient assistance programs & copay/coinsurance assistance
  7. 7. Why Drug Pricing Matters: Current View 74.50% 57.00% 55.00% 90% 80% DIAGNOSED LINKED WITHIN 1 MONTH RETAINED IN CARE VIRALLY SUPPRESSED HIV CARE CONTINUUM (2014) Achieved National Goals • Need to do better with finite resources • Evidence of payer resistance • Preference for older STRs; MTRs • 20% of plans only covering EFV/TDF/FTC; 15% of plans not covering any new (>2013) ARVs2 • Medicaid PDL restrictions on STRs • Highest coverage tiers/coinsurance amounts • Growing recognition of cost as structural barrier to HIV prevention care and PrEP 1. CDC. Monitoring selected national HIV prevention and care objectives by using HIV surveillance data United States and 6 dependent areas, 2015. 22(2). 2. NASTAD. Discriminatory Design: HIV Treatment in the Marketplace. 2016 July. https://www.nastad.org/blog/discriminatory-design-hiv-treatment-marketplace 1
  8. 8. Why Drug Pricing Matters: Future Worries • Ongoing efforts to repeal the ACA; possible risk to ARVs as protected drug class • Slow/no Medicaid expansion where it is needed most • Medicaid block grants, work requirements • 340B Drug Pricing Program in cross hairs • Rise of copay accumulators and other legal/statutory challenges to copay assistance programs • Increasing dependence on ADAP prescription drug coverage? • Political paradox • bipartisan aversion to high drug prices and doing something bold about them
  9. 9. About the 340B Drug Pricing Program PhRMA. 340B 101. 2017 Nov. https://www.phrma.org/report/340b-101. 340B Program permits eligible safety net providers “to stretch scarce Federal Resources as far as possible, reaching more eligible patients and providing more comprehensive services.” Case management Outreach Prevention education PrEP navigation, adherence, and support Treatment education Treatment adherence Legal services Housing services Nutrition services
  10. 10. Company Product Launch date Annual WAC at launch Current Annual WAC (July 2018) Total Change since launch Abbvie Norvir Jul-99 $534 $3,084 477% Kaletra Sep-00 $6,500 $12,288 89% BMS Sustiva Dec-98 $3,784 $14,120 273% Reyataz Dec-03 $7,949 $17,393 119% Evotaz Feb-15 $16,844 $19,266 14% Gilead Viread Nov-01 $3,917 $13,683 249% Truvada Aug-04 $7,810 $20,109 157% Atripla Jul-06 $13,811 $32,689 137% Biktarvy Feb-18 $35,349 $35,349 – Stribild Aug-12 $28,110 $37,080 32% Genvoya Nov-15 $31,362 $35,358 13% Odefsey Mar-16 $28,150 $32,169 14% Descovy Apr-16 $17,597 $20,109 14% Janssen Prezista Jul-06 $9,000 $18,968 111% Intelence Jan-08 $7,848 $15,553 98% Prezcobix Feb-15 $17,258 $21,680 26% Merck Isentress Oct-07 $9,720 $18,000 85% ViiV Epzicom Aug-04 $7,459 $15,500 108% Juluca Nov-17 $30,948 $30,948 – Tivicay Aug-13 $14,105 $19,891 41% Triumeq Aug-14 $26,488 $33,662 27%
  11. 11. Lower-cost ARVs • Branded Drugs: No Patent or FDA Exclusivity Protections • Efavirenz (EFV) 600/tenofovir disoproxil (TDF)/lamivudine (3TC), EFV 400/TDF/3TC, TDF/3TC • Potential generic competition, not interchangeable by pharmacies, copay assistance • Generic Drugs • abacavir, abacavir/3TC, atazanavir, didanosine, 3TC, nevirapine, ritonavir, stavudine, TDF • Six-month exclusivity periods possible; the more competition, the lower the price; no copay assistance • Branded Drugs: Patent and FDA Exclusivity Protections • Doravirine/TDF/3TC (July 2018), dolutegravir/3TC (2019) • Includes patented and off-patent drugs; lower launch prices (?); copay assistance likely
  12. 12. Recommended Initial Regimens for Most People with HIV Recommended regimens are those with demonstrated durable virologic efficacy, favorable tolerability and toxicity profiles, and ease of use. •INSTI + 2 NRTIs: BIC/TAF/FTC (AI) DTG/ABC/3TCa (AI)—if HLA-B*5701 negative •DTG + tenofovirb/FTCa (AI for both TAF/FTC and TDF/FTC) •EVG/c/tenofovirb/FTC (AI for both TAF/FTC and TDF/FTC) •RALc + tenofovirb/FTCa (AI for TDF/FTC, AII for TAF/FTC) Recommended Initial Regimens in Certain Clinical Situations These regimens are effective and tolerable, but have some disadvantages when compared with the regimens listed above, or have less supporting data from randomized clinical trials. However, in certain clinical situations, one of these regimens may be preferred (see Table 7 for examples). •Boosted PI + 2 NRTIs: (In general, boosted DRV is preferred over boosted ATV) (DRV/c or DRV/r) + tenofovirb/FTCa (AI for DRV/r and AII for DRV/c) •(ATV/c or ATV/r) + tenofovirb/FTCa (BI) •(DRV/c or DRV/r) + ABC/3TCa —if HLA-B*5701–negative (BII) •(ATV/c or ATV/r) + ABC/3TCa —if HLA-B*5701–negative and HIV RNA <100,000 copies/mL (CI for ATV/r and CIII for ATV/c) • NNRTI + 2 NRTIs: EFV + tenofovirb/FTCa (BI for EFV/TDF/FTC and BII for EFV + TAF/FTC) •RPV/tenofovirb/FTCa (BI)—if HIV RNA <100,000 copies/mL and CD4 >200 cells/mm3 • INSTI + 2 NRTIs: RALc + ABC/3TCa (CII)—if HLA-B*5701–negative and HIV RNA < 100,000 copies/mL • Regimens to Consider when ABC, TAF, and TDF Cannot be Used:d DRV/r + RAL (BID) (CI)—if HIV RNA <100,000 copies/mL and CD4 >200 cells/mm3 •LPV/r + 3TCa (BID)e (CI) HHS. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. 2017 October 17. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/0
  13. 13. Yes, but will they reduce costs?
  14. 14. Savings from Generics: $253 Billion in 2016 Association for Accessible Medicines. 2017 Generic Drug Access and Savings in the U.S. Report. https://accessiblemeds.org/resources/blog/2017-generic-drug-access-and-savings-us-report $1.6 Trillion
  15. 15. Generics Cost Savings: HIV Walensky RP, et al. Economic savings versus health losses: the cost-effectiveness of generic antiretroviral therapy in the United States. Ann Intern Med. 2013 Jan 15;158(2):84-92. Martin EG, Schackman BR. Treating and Preventing HIV with Generic Drugs - Barriers in the United States. N Engl J Med. 2018 Jan 25;378(4):316-319.
  16. 16. Generics Average Wholesale Price (AWP) Wholesale Acquisition Cost (WAC) Average Manufacturer Price (AMP) Nonfederal Average Manufacturer Price (Non-FAMP) Federal Supply Schedule (FSS) Price Federal Ceiling Price Federal Ceiling; “Big 4” Price Best Price Medicaid Price340B Price Private sector prices Rebates to PBMs Copay assistance Other price concessions Unit rebate: 23.1% / 13% of AMP or AMP – Best Price plus CPI penalties 76% of non-FAMP minus additional discounts Supplemental rebates and discounts negotiated (including ADAPs) Supplemental discounts negotiated (VA and DoD) Negotiation on most-favored commercial customer price Drug Pricing: The Simple Version Federal Upper Limit State Maximum Allowable Cost
  17. 17. Generics Average Wholesale Price (AWP) Wholesale Acquisition Cost (WAC) Average Manufacturer Price (AMP) Nonfederal Average Manufacturer Price (Non-FAMP) Federal Supply Schedule (FSS) Price Federal Ceiling Price Federal Ceiling; “Big 4” Price Best Price Medicaid Price340B Price Private sector prices Rebates to PBMs Copay assistance Other price concessions Unit rebate: 23.1% / 13% of AMP or AMP – Best Price plus CPI penalties 76% of non-FAMP minus additional discounts Supplemental rebates and discounts negotiated (including ADAPs) Supplemental discounts negotiated (VA and DoD) Negotiation on most-favored commercial customer price ¯_(ツ)_/¯ Federal Upper Limit State Maximum Allowable Cost
  18. 18. ARV Regimen Retail Pharmacy Acquisition Cost Brand Name DTG + TDF/FTC or TAF/FTC $3,226/month ELV/CABO/TAF/FTC $2,944/month DTG/ABC/3TC $2,718/month Mixed (Brand plus Quasi-generic or Generic) DTG + TDF/3TC $2,603/month* RAL + ABC/3TC $1,620/month All Generic NVP + ABC/3TC $131 – $388/month National Average Drug Acquisition Cost (NADAC) database. https://data.medicaid.gov/Drug-Pricing-and- Payment/NADAC-National-Average-Drug-Acquisition-Cost-/a4y5-998d *NADAC data for TDF/3TC not available; based on WAC price.
  19. 19. Truvada ($54*) Cimduo ($33.50*) ABC/3TC ($4.00*) URA: 23.1% + CPI Penalty: ~51% (TDF/FTC) URA: 13% Medicaid/340B (~$14.00) Medicaid/340B (~$25.00) URA: 23.1% *WAC **NADAC Beyond benchmark prices 5/18 FUL ($6.86) Commercial Plans Commercial Plans Commercial Plans voluntary discount/rebate (TAF/FTC) Descovy ($54*) Federal Supply Schedule $34.00 6/18 FSS ($7.71)
  20. 20. Lower-Cost ARVs: Market Forces Rule • Unique to HIV care: limited demand among patients and providers • Payers and the power of “NO” • Utilization management • Less contentious • Preferences for EFV/TDF/3TC over EFV/TDF/FTC; TDF/3TC over TDF/FTC (for Tx) • Switches from branded ATZ, RTV, ABC/3TC, etc. to generic equivalents • Copay challenge here; switches to products with assistance • More contentious • Step therapy: e.g., DTG plus TDF/3TC or ABC/3TC, switch to BIC/TAF/FTC with renal/bone/adherence needs • Difficulty of implementing population-level cost-containment measures in the face of individualized treatment needs
  21. 21. Patient & Provider Choice: The Big Questions • Is TAF preferable to TDF for all PLWHIV? • TAF more favorable effects on renal markers and BMD, but TDF still a Guidelines-recommended component of initial regimens for most people with HIV based on well-established safety and efficacy • Are QD STRs preferable to QD MTRs for all PLWHIV? • STRs are easier to use with fewer monthly copays, but data supporting or refuting superiority are limited; STRs and MTRs among Guidelines- recommended initial regimens for most people with HIV
  22. 22. Conclusion I: Era of ARV Drug Cost Considerations is Here • Generics and quasi-generics can potentially increase competition and lead to lower prices for purchasers and payors • Some payors will likely benefit more than others • Providers and patients should discuss pricing and access, along with efficacy, safety, and ease of administration • Increased payor regulation of formularies possible • Need strong guidelines addressing when this is acceptable or unacceptable
  23. 23. Conclusion II: Who Benefits? • No clear pathway for reinvesting cost savings in HIV prevention and care • Patient considerations: formulary restrictions, generic drug copays (vs. brand-name product copay assistance) • FQHC/340B: high drug costs = revenues for HIV services; reduced drug costs = fewer HIV services? • Must still recognize societal benefits of lower prescription drug prices
  24. 24. Generics and Access A California Case Study
  25. 25. Generics, Co-Copays and PrEP – Oh My! • Copayment Protections Become Law in 2015 • California legislature passes AB 339 in 2015, ensuring that consumer co-payments may not exceed $250 for a 30-day supply. • AB 339 also prohibits insurers from routinely place specialty drugs on higher tiers. • A hard fought battle with insurers, which strangely aligned us with pharma, but we ultimately prevailed. • However…the statute expires in 2019.
  26. 26. HIV STRs Protected From CA Generics Law • A second bill, AB265, signed into law in 2017, prohibits drug manufacturers from offering rebates or copayment assistance if a medically equivalent generic drug is available. • But…we got a carve out for HIV, the only disease carved out, which reads: • A single-tablet drug regimen for treatment or prevention of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) that is as effective as a multitablet regimen, unless, consistent with clinical guidelines and peer-reviewed scientific and medical literature, the multitablet regimen is clinically equally effective or more effective and is more likely to result in adherence to the drug regimen.
  27. 27. HIV in the Crosshairs • In both bills, arguments heavily carried by HIV advocates. • Both laws were imperfect, but if we hadn’t carved out HIV, people would have been harmed, • But now we’ve got a target on our backs. • This is now playing out with SB 2010. It makes co-pay protections permanent, and explicitly protects HIV prevention medications. • Not surprisingly, insurers hate the bill, but they are really coming after the provision on PrEP.
  28. 28. Insurer Objections to Protections for PrEP • With generic TDF now available, insurers argue that a two pill PrEP regimen (e.g. generic TDF + brand FTC) will be just as good as branded Truvada, but much less expensive. • Insurers argue that the new law will encourage companies like Gilead to escalate drug prices out of control. • These can be reasonable arguments given skyrocketing drug prices, but who is more trustworthy with people’s lives: pharma or insurers? • When confronted with he argument that generic TDF + FTC may not be significantly cheaper under many circumstances, at least one payer suggested generic TDF + 3TC as an alternative.
  29. 29. So…which of the following is true?  Generics can drive down health care costs  Generics are almost always less expensive than brand drugs  The availability of generic drugs won’t diminish access to brand drugs when they are truly needed.  Explicitly protecting people living with or at risk for HIV from bad laws is a good thing.  All of the above  None of the above

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