Untangling the Web of Antiretroviral Price Reductions Julia Hill Médecins Sans Frontières/Doctors Without Borders Access Advocacy Officer Gaborone, Botswana August 21, 2014 Overview • Context of ARV treatment today: focus on pricing • Cost of first-line, second-line, salvage regimens • Policies & strategies to overcome threats to access • Viral Load Monitoring • Pricing policies for “middle-income” countries • Intellectual Property Law Reform & Trade Negotiations • Access overview for important new drugs MSF Access Campaign MSF Overview: A Brief History • Independent International Medical Humanitarian Organisation • 1971: founded by French doctors & journalists • 1980s: MSF becomes international - operational centres throughout Europe - sections around the world • 1999: winner of Nobel Peace Prize -Access Campaign founded • 2013: 5 operational centres; 23 Associations. Int’l Office. Operating in over 60 countries MSF Access Campaign ARV Treatment Today: Where are we? • 12 million on ART today; 17 million more eligible based on CD4 500 • Early treatment reduces illness, death, transmission…but also creates new challenges: • Adherence challenges: can be improved through decentralisation strategies (task shifting); viral load monitoring; community-based ART support groups. (MSF: 91% ppl on ART with viral load <1000 copies/mL) • Stock outs, quality assurance, registration delays, weak health care systems can also limit access. • Medicine prices will have a significant impact on countries’ ability to scale up treatment; offer improved regimens—serious threats to affordability remain. MSF Access Campaign Prices of Different First-Line Regimens MSF Access Campaign Evolution in Price of First Line Regimens MSF Access Campaign Price Comparison of Treatment Regimens MSF Access Campaign Evolution in Price of Boosted Protease Inhibitors for Second-Line Regimens MSF Access Campaign Third-Line ARV Price Regimens MSF Access Campaign Viral Load Monitoring: Optimal ART & a strategy for cost saving • Necessary! • • • • Undetectable viral load keeps people healthy; stops transmission Monitors treatment efficacy: If effective, VL should be undetectable. Detect treatment failure: More sensitive and specific than CD4 Prevent drug resistance: can be used to initiate adherence counseling, help prevent drug resistance, preserve 1st line • Can trigger PMTCT interventions • Feasible! • Dried blood spots, pooling samples • Mobile health tech for results delivery • Financially viable! • Cost saving strategies (sample pooling) • Price per test can come down through increased transparency; pooled procurement; addressing IP barriers price MSF Access Campaign Tiered Pricing: a growing MIC challenge • Middle-Income Countries (MICs) home to ¾ of the world’s poor • Survey of 7,000 ARV purchases in developing countries, 2002-2007: • Tiered prices up to 500% more expensive than generic prices • Lack of price transparency; GNI determinant for price exacerbates problem 2013 Price Per Patient Per Year LPV/r as Component of Second-Line ARV Regimen MSF Access Campaign TRIPS Agreement, Doha, and IP Reform • Ability to overcome patent barriers increasingly important • India’s use of TRIPS flexibilities upheld—but feeling US/EU pressure • Other countries undergoing patent law reform: • South African policy aims to stop patent evergreening • Brazilian report looks to alternative innovation models • Some countries get better prices than others: • India utilised strict patentability criteria, oppositions • Thailand has pursued compulsory licenses • South African use of competition law to set precedent for VL MSF Access Campaign The Push-back: Voluntary Licenses, #Pharmagate & Trade Negotiations • Voluntary licenses outside MPP used to avoid compulsory licenses in countries like India—lack transparency of terms; limit price reductions from competition • Big Pharma scandal in South Africa recalls Nelson Mandela court case; illustrates challenges of IP reform • Trade agreements and ISDS sign countries up to TRIPS+ measures— limits use of TRIPS flexibilities MSF Access Campaign What does this mean for future availability of promising ARVs? MSF Access Campaign Darunavir (DRV) • Salvage therapy; future option for second-line? (dependent on supply and price) • Initial patent expired 2013; subsequent patents licensed by US NIH to Tibotec (now Janssen/J&J) • Secondary patent applications filed by Tibotec—all rejected in India • 2010: NIH licensed DRV patent to Medicines Patent Pool, but Janssen patents aren’t in pool. • 2012: J&J—patents won’t be enforced in Sub-Saharan Africa (excludes MICs). FDC with Gilead’s cobicistat submitted to US FDA 2014. MSF Access Campaign Dolutegravir (DTG) • More effective in achieving virologic control compared to TDF/FTC/EFV—good candidate for first or second-line • Well-tolerated, effective, daily dose, high resistance barrier, pediatric potential • Patents granted or pending in many MICs; initial expires post-2026; secondary patents post-2029 • “Markush” claim inhibits R&D—opposed in India • MPP license with Viiv—67 royalty free low-income countries; tiered royalty structure for public market in six countries; excludes key MICs MSF Access Campaign Lopinavir/ritonavir (LPV/r)—paediatric • WHO-recommended 1st line treatment for children under 3; secondline for children receiving first line NNRTI • Preferred over nevirapine-based therapy; but LPV/r syrup has challenges: • Refrigeration required • Unpleasant taste • High alcohol content • New Cipla pellet formulation could offer benefits: can be mixed in food, heat stable, alcohol free, but not yet taste masked • Patents related to RTV also cover LPV/r pediatric combos MSF Access Campaign Raltegravir (RAL) • WHO indicates as third-line option • New class of drug, no apparent cross resistance with other ARV classes. Non-inferior to EFV in treatment-naïve, effective for treatmentexperienced. • BUT dosed twice daily, frequent AEs, doseadjusted for TB patients, not recommended for pregnant women • Merck quality-assured; Hetero submitted to US FDA • Initial patent runs from 2022-2025; India patent does not expire until 2022 • Not licensed to MPP; VLs with Emcure and Mylan for only 60 SSA/low-income countries—for export only. Limits generic competition in MICs 2013 Price Per Patient Per Year RAL MSF Access Campaign Tenofovir alafenamide (TAF) • Pro-drug of TDF—very effective with fewer side effects • Each pill can contain less of the active ingredient with same efficacy • Being trialled in phase III; co-formulated with FTC, elvitegravir, cobicistat • Should be registered as single drug for full flexibility in use • Initial Gilead patent runs until 2020-2024 (including in India). • Little known about price; generic competition will be limited until 2021 (when India patent expires—divisional patents also exist). • Gilead in negotiations with Indian generics; MPP MSF Access Campaign Call to Action • Access to lower ARV prices requires: • Increased price transparency from countries • Support for IP reform utilising TRIPS flexibilities in key countries (South Africa, India, Brazil) • Country advocacy for LDC extension on implementing TRIPS at WTO • Avoid TRIPS+ measures in bilateral or multilateral treaties • Viral load monitoring demands: • Purchasers increase price transparency, encourage competition, address IP • Funders support implementation of WHO guidelines • Cost reduction & feasible strategies be implemented (e.g. Dried Blood Spots) MSF Access Campaign Resources: ARV Pricing • Untangling the Web 17: https://www.msfaccess.org/utw17 • Medicines Patent Pool • Book: The Global Politics of Pharmaceutical Monopoly Power • Patent Opposition Database • Fix the Patent Laws (South African campaign) • Activist Guide to IP Reform • Equal Treatment on IP Reform MSF Access Campaign Resources: Undetectable • Report: Undetectable: How Viral Load Monitoring Can Improve HIV Treatment in Developing Countries • Issue Brief: HIV status? Undetectable • Issue Brief: How Low Can We Go? (Pricing of VL Testing) • Report: Putting HIV Treatment to the Test (Product Guide) • Issue Brief: Getting to Undetectable (5 country experiences) http://www.msfaccess.org @msf_access http://www.msf.org.za @msf_southafrica [email protected] @MSFJuliaHill @FixPatentLaw #PharmaGate MSF Access Campaign Extra Slides: Viral Load Monitoring MSF Access Campaign MSF Access Campaign MSF Access Campaign What does a VL test cost? MSF Access Campaign What are the Cost Drivers? MSF Access Campaign
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