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

2. 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

3. Organisation for Economic Cooperation and Development. https://data.oecd.org/healthres/pharmaceutical-spending.htm
Pharma Spending: % of Health Spending (2015)

4. Organisation for Economic Cooperation and Development. https://data.oecd.org/healthres/pharmaceutical-spending.htm
Health Spending: US$ Capita (2015)

5. Organisation for Economic Cooperation and Development. https://data.oecd.org/healthres/pharmaceutical-spending.htm
Pharma Spending: US$ Capita (2015)

6. 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

7. The HIV (Treatment) Payer Patchwork
• Employer-based plans
• ACA Marketplace Plans
• Medicaid/Medicare
• Veterans Administration
• Ryan White/ADAPs
• Patient assistance programs &
copay/coinsurance assistance

8. 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

9. 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

10. 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

11. 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%

12. 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

13. 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

14. Yes, but will they reduce costs?

15. 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

16. 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.

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
Drug Pricing: The Simple Version
Federal Upper Limit
State Maximum
Allowable Cost

18. 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

19. 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.

20. 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)

21. 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

22. 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

23. 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

24. 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

25. Generics and Access
A California Case Study

26. 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.

27. 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.

28. 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.

29. 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.

30. 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