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Accelerating access for optimized regimens
Carmen Pérez Casas HIV Technical Manager Strategy & Results UNITAID I would like to describe today expected changes in the market for next years, as well as main drivers to ensure that access to emerging promising regimens is possible without unnecessary delays. November 2015, Harare
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Key facts on HIV treatments
HIV is a chronic condition with life-long treatment Large market and growing ($1.44 billion in LMICs in 2014) Complexity and vulnerability of current treatments Resistance to antiretrovirals is a major threat 1 HIV is a chronic condition as there is no cure yet. As things stand today, every person starting treatment, might need to remain on it throughout their lifetime, while life expectancy, thanks to ART, is almost reaching normal levels for those on efficient treatment. Implying an increasing cumulative number of people on ART . In addition, with the recent WHO eligibility criteria review, the total number of people to eventually on treatment is the total number of people living with HIV. 2 The market for ARVs in low- and middle-income countries is large and continues to grow (specially for first-line, not so big for second-line or for peds). By mid-2014, approximate market value of $1.44 billion in LMICS 3. However, treatment is still complex to use, not robust enough with resistance becoming a major threat to future gains, with reports of over 10% of resistance in some African countries. 4. So we need to consider the opportunities to optimize regimens with formulations that offer both clinical and cost-saving benefits and could enable LMICS to reach the ambitious targets to treat everybody in need. Opportunities to optimize regimens potential for clinical improvements & cost savings
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Accelerate current efforts
HIV global targets are technically feasible with innovative approaches and commodities Accelerate current efforts Accelerate uptake of innovation There is consensus that goals are technically feasible, but not if we continue with current pace let me share a quote from WHO draft HIV Strategy: “Business as usual’ will see the HIV response lose steam and slide back. It is time to move into ‘fast-track’ mode, to accelerate current efforts and to seek innovations that can change the trajectory of the response. In fact HIV has always been about innovation, contrary to other diseases like Malaria or TB Innovations in the past have transformed HIV/AIDS from a fatal illness, to a chronic condition that n be managed for most people with one pill a day. But are all populations getting access to innovations at same speed? What is the impact of delaying access to innovation?
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Game-changers that could accelerate the pace of change…
Select examples – not exhaustive 2015 2016 2017 DTG and TAF-combos in high-income countries New LPV/r pellets Nanoparticles- ARVs Cabotegravir, rilpirivine long acting. Multipurpose prevention tools Long-acting PrEP TAF/FTC approval BN Antibodies; New ARVs classes. DTG for infants DTG for children ARVs for resistant strains Need to understand the landscape to anticipate and prepare for potential game-changers There is a lot going on here, and there are a lot of moving pieces, with the use of ARVs not only for treatment (in red) but also for prevention (in green) the landscape of treatment and prevention (in is merging. IN addition to current emerging products, like DTG or TAF for adults, we are very much looking forward news on technical solutions to decrease doses (nanoparticles), new delivery systems (long acting formulations that can drastically change the way we manage treatment, and new ARVs useful in resistance) Regarding children , alrady expalined before by Nandita, pipeline is slower… TAF: US approved Quad earlier this month (FDC with EVG, COBI, FTC and TAF) TDF/FTC Q3 2016 Single alone : Not, only for HCV Emphasize that we believe for certain areas we can anticipate the pipeline, for eg, DTG in children: what can we do to make it happen earlier? Changes expected from 2020+: Vaccine … or gene therapy for a cure Children Adults Prevention Source: UNITAID landscape analyses
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Approvals, licenses and uptake: TDF-first-line ART case study
$ 9 years UNITAID/ CHAI project ($305m) WHO initial 2002 ART guideline WHO 2006 AZT or TDF preferred WHO 2010 AZT or TDF preferred, FDC WHO 2013 TDF +XTC + EFV FDC preferred But let’s look now at the recent past, In a group formed by WHO/GF/MPP and UNITAID we have been examining in more detail the time and drivers that led to uptake for the TDF triple therapy only 9 years after it was approved by US FDA. Market incentives (such as the CHAI/UNITAID project in 2007), And availability of Q-A products, as assessed by WHO PQ or US FDA addressing IP barriers, as through (UNITAID-funded MPP) Enabled WHO Recommendations to include the regimen as the preferred one in 2013, US approval of the proiginat9 years after US approval of the originator, , and GF, PEPFAR and countries bulk procurement and scale-up. Leading to further price decreasing MPP license TDF/FTC/EFV approval July 2006 TDF/3TC/EFV approval Mar 2009 Global Fund /PEPFAR/countries bulk procurement TDF FDA approval Oct 2001 Source: GF/UNITAID/MPP/WHO Emerging ARTs group
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Where can we act to accelerate access to innovation?
Uptake delayed Patents Lack of clinical data Delayed submission for approval Delayed inclusion in Guidelines Lack of adapted formulation Limited demand High prices For emerging products, manufacturers typically delay investing to improve formulations due to limited early demand; in a dangerous circle, without demand, prices remain very high, unrelated to cost of production, competition does not take place, specially oif tehre are patents, and there is no interest on gathering necessary clincial data for approval and recommendations in WHO gx and country Gx., which in turn closes the vicious circle impeding the potentially better-adapted regimen to be uptaken For example, the WHO 2013 treatment guidelines acknowledged that, even though it was in wide use in high-income settings, " two key factors precluded DRV/r as the preferred option for second-line regimens, its high cost and it not being available as a heat-stable fixed-dose combination”.
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Where can we act to accelerate access to innovation?
Support evidence-gathering to enable recommendations Address IP for optimized combination regimens Boost key products development, optimization and launch Prepare for smooth product introduction and transition
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Evidence-gathering to enable recommendations
1 Evidence-gathering to enable recommendations Unaddressed research questions hinder uptake and cause long delays Populations in low and middle-income unrepresented in trials by originator companies for registration in high-income markets (e.g. Asian-African population, women of child bearing age, children, coinfections) Potentially promising combinations not targeted Accelerate research for priority products and regimens Focused funding to potential trial implementers
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Address IP for optimized combination regimens
2 Address IP for optimized combination regimens Patents affecting priority products and combinations Newer ARVs are normally subject to wider patent protection than older products, and in an increasing number of countries Patents for new products available in key producing countries (APIs, finished products ) like India, and China Potential challenges for generic competition, price reductions, development of combinations Support measures to enable product development and competition in affected countries
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Pipeline products: patents and licenses
2 Patent in India Patent in China Voluntary licenses COBICISTAT Pending Granted Yes DOLUTEGRAVIR TAF ELVITEGRAVIR RILPIVIRINE Yes Yes Source: MPP
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Example: licences to MPP and manufacturing partners
2 Example: licences to MPP and manufacturing partners TAF Dolutegravir
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Boost key products development, optimization and launch
3 Boost key products development, optimization and launch Uncertainties on potential market size disincentive manufacturers With short lifecycle for products, lack of incentive to invest in existing product optimization and production-cost reduction strategies Lack of clear projections for new products to inform product planning decision Coordinate communications and projections among key stakeholders, including manufacturers Establish incentives mechanisms Facilitate prequalification
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Priority formulations: reducing expected timelines
3 Priority formulations: reducing expected timelines Expected regulatory filing by first generic companies Potential price at launch TDF/XTC/EFV 400 Q1 2016 99$ ppy DTG May 2015 Aurobindo 44$ ppy TDF/XTC/DTG Q3 2016 Similar as TDF/XTC/EFV (110$) TAF/FTC (Q originator) Decreased expected TAF/XTC/DTG Q2- 2018 DRV/r Source: Announcement 30 Nov 2015 on 3 agreements
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Prepare for smooth product introduction and transition
4 Prepare for smooth product introduction and transition Unplanned transition leads to supply disruptions Manufacturers and countries : lack of information on forthcoming product launch and potential switching policies Specific programmatic challenges with new formulations types (pellets, long-term formulations) Prepare for transition and introduction : clinical awareness, national guidelines, EML, PSM, … Support catalytic introduction in early-adopter countries Support dissemination of robust projections
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Partnerships to accelerate access to innovation for LMICs
Upstream R&D and innovation PDPs Private sector Academia Normative, guidance, quality , advocacy Civil society NGOs Delivery, availability Countries NGOs Civil society Downstream
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