IOM workshop on The Global Supply Chain for Second-Line Drugs for MDR-TB

Transcription

1 Session 3: SLD Financing Issues IOM workshop on The Global Supply Chain for Second-Line Drugs for MDR-TB Keck Center Washington D.C. 31 July 2012 Michael E. Kimerling Global Health Program Seattle

2 Primary challenges to the SLD IQA supply and pricing barriers Our collective inability to consolidate demand and deliver treatments in a predictable and timely fashion so that volumes can grow sufficiently How to work more efficiently and effectively among stakeholders and funders to stimulate price competition, leveraging each group s mandate and strengths.

3 Understanding the realities, barriers and possible interventions

4 New tools are mandatory but inadequate: integrated delivery systems The right Diagnostics Laboratory infrastructure investment boost in 2006 after XDR Global Task Force meeting Tipping point in with molecular tools (price remains a concern) Role of future POC diagnostics TBD but an R/D priority Need for rapid DST testing for new/old drugs urgently needed Affordable SLD supply Present: old drugs; all generics; limited IQA supply; high prices Future: new drugs and regimens; shortened therapy for both DS and DR-TB; pricing unknown Demand and Delivery Complex patient management systems Over-fragmentation of SLDs created by multiple and non-standardized regimens; use of PQ and non-pq drugs Resulting inability to forecast true demand that can be delivered Lack of country ownership, though progress made since the 2009 Beijing MDR meeting Financing and financial tradeoffs as part of each component

5 March 2011 *Prices for FQs not shown but dropping due to introduction of generics

6 Despite increasing volumes, key SLD prices have increased or flat-lined over the last 5 years 1,2,3 [1] Source: GFATM PQR transaction data, Accessed 19 July [2] Global average product price estimated as: total $ cost of orders placed by all countries, divided by the total # of units (i.e. tablets, vials, or grams in the case of the PAS products) ordered in a given year. The year is defined by the purchase order date. [3] Approximately 70 records (totaling approximately 12M USD) out of 800 were omitted because of insufficient data and pending verification from GFATM.

7 Cost per patient for MDR treatment (Fitzpatrick and Floyd, Pharmacoeconomics 2012)

8 Market fragmentation: high degree of variation between standard MDR regimens used by country programs (patient-months of treatment)* Data source: WHO Stop TB Department * Weighted averages used for countries using multiple standard regimens

9 Global TB Drug Pipeline Discovery 1 Preclinical Development Clinical Development Lead Optimization Preclinical Development GLP Tox. Phase I Phase II Phase III Diarylquinoline DprE Inhibitors GyrB inhibitors InhA Inhibitors LeuRS Inhibitors MGyrX1 inhibitors Mycobacterial Gyrase Inhibitors Pyrazinamide Analogs Riminophenazines Ruthenium (II) complexes Spectinamides Translocase-1 Inhibitors CPZEN-45 DC-159a Q201 SQ609 SQ641 BTZ043 TBA-354 AZD5847 Bedaquiline (TMC-207) Linezolid Novel Regimens 2 PA-824 Rifapentine SQ-109 Sutezolid (PNU ) Delamanid (OPC-67683) Gatifloxacin Moxifloxacin Rifapentine Chemical classes: fluoroquinolone, rifamycin, oxazolidinone, nitroimidazole, diarylquinoline, benzothiazinone 1 Ongoing projects without a lead compound series can be viewed at 2 Combination regimens: first clinical trial (NC001) of a novel TB drug regimen testing the three drug combination of PA-824, moxifloxacin, and pyrazinamide was initiated November 2010 and completed in 2011 with promising results. The second clinical trial (NC002) of this regimen was launched in March 2012 and will test the efficacy of the regimen in drug-sensitive and multidrug-resistant patients. The third clinical trial (NC003) will evaluate PA-824, TMC-207, pyrazinamide and clofazimine in combinations and is scheduled to begin September Updated: June 18, 2012

10 COMMODITY EXPENDITURE & FUNDING, 2011 (GDF data) Funding Source CIDA TB Reach Unspecified (CIDA/USAID) Consumables FLD s SLD s Expand TB TB Reach Total $4,089,042 $2,066,910 $6,155,952 $12,576,062 $12,576,062 DFID $9,958,394 $9,958,394 KNCV $46,896 $ 127,203 $35,026 $209,129 MSF $2,444 $1,898,322 $1,900,766 Novartis $3,468,206 $3,468,206 Other $3,110,618 $ 757,297 $3,867,915 Government $2,854,658 $ 2,701,339 $5,555,997 WHO $24,226 $190,724 $ 58,130 $19,342 $292,422 GFATM $23,099,434 $63,204,294 $86,303,728 UNITAID $1,222,757* $16,537,022 $6,437,753 $23,097,532 TOTAL $4,160,163 $56,483,298 $85,283,607 $6,437,753 $2,121,278 $154,486,099

11 Overview of BMGF TB Strategy Initiatives, 2012 Goal: Accelerate decline in TB incidence, focusing on interventions that reduce transmission 1 Vaccines Discover and develop new vaccines 2 Drugs Discover and develop new drug regimens Diagnostics Innovation in TB control systems Global access/market dynamics Discover and develop point of care diagnostics & next generation molecular tools Emerging Delivery strategy Generate evidence of impact for tools at country level; Combine and evaluate innovations (tools and systems) in our focus countries, including engagement with private and hospital sectors; Advocate for scale-up of successful systems innovation Support cost reduction strategies for new and current tools. Work with global finance partners and supply mechanisms to support introduction and scale-up of innovation in focus countries and in Rest of World; 6 Advocacy Mobilize resources and political support for TB R&D; Maximize commitments for TB control by GFATM, UNITAID and others; Develop rigorous analytics & approaches to ensure support from appropriate normative agencies. August 7, Bill & Melinda Gates Foundation 1

12 Three factors have inflated non-essential elements of price (CHAI analysis and report, Dec 2011) Premium charged due to lack of competition Monop oly premiu m Cost of subscale mfg Inefficiency costs due to low volumes Premium charged due to perceived market risks Risk premiu m True cost of mfg Costs of raw materials, labor, etc The two keys to breaking this cycle are growing volumes and facilitating effective competition

13 Potential BMGF supported financial interventions to facilitate competition: Program Related Investments (PRIs) Direct investment, or Loan Volume guarantee Premium charged due to lack of competition Monop oly premiu m Cost of subscale mfg Inefficiency costs due to low volumes Premium charged due to perceived market risks Risk premiu m True cost of mfg Costs of raw materials, labor, etc Volume guarantee The two keys to breaking this cycle are growing volumes and facilitating effective competition

14 GOALS OUTCOMES WORKSTREAM SLDAII Vision and Goals Vision: All people with MDR-TB are able to access affordable, quality-assured treatment within a sustainable MDR-TB drug market Increased Affordability of IQA SLDs Increased Supply of IQA SLDs Greater Operational Efficiency Credible capacity plan to deliver against projected demand Adequate volume from qualified suppliers Regular process for operational forecasting Increased manufacturer confidence Documentation and diagnosis of global supply chain Prioritization of top issues Improvement plans developed and implemented Allocation of funds for additional purchase of PQ MDR drugs by key treatment pgms Larger, more viable market for IQA drugs Sustainably reduced prices and improved availability for key SLDs Formal report with evidence to support local adoption of IQA standards Improved local understanding of IQA public health benefits Increased availability and demand for IQA drugs Proven examples of public-private collaboration in MDR-TB in India and other target geographies Technical assistance plans Increased demand for IQA SLDs through new treatment channels 1 Manufacturer Scale-Up 1.5 Operational Forecasts 2 Supply Chain Diagnosis 3 Financing Mechanisms 4 IQA Recommendation 5 Private Sector Engagement Note: Arrows represent connection between workstreams to different goals. 14

15 SLDAII Context The Second-Line Drug Access Improvement Initiative fills an important niche in the current environment, yet progress has been limited Q3 Lille Meeting: Stakeholders met and reviewed the current SLD market and opportunities to focus efforts in India Developed a workplan for 2012, focusing on demand- and supply-side objectives Responsibilities for workstreams assigned to different stakeholders London Meeting: SLDAII group lead identified, Operations Team put into place Initiative charter developed Report out and discussion on all workstreams Identified priority next steps Targeted UNITAID LOI as a near-term win to maintain momentum Q4 Q1 Q2 Q3 Delhi Meeting: Initial convening of stakeholders in New Delhi Highlighted key challenges to secure and increase global TB drug supply in the public sector Shared experiences on India Generated ideas around collaboration to enhance TB drug procurement and quality assurance Developed an initial set of priorities BMGF Washington DC Meeting: Meeting participants discussed individual organizations contributions towards addressing challenges in the MDR-TB drug market, also highlighting the work of the Stakeholder Group CHAI analysis presented on improving the price and availability of key MDR-TB drugs, highlighting five key levers for action UNITAID LoI Process (GDF-led): Key workstream leads involved in developing analysis and potential LoI content Operations support for planning and writing process contribute Geneva meeting to discuss content of LOI Progress has slowed significantly since the completion of the UNITAID LOI, and we are in the process of exploring new projects or workstreams for SLDAII 15

16 Moving forward Move from writing documents to writing business plans based on sound analysis and risk assessment of various scenarios Move from identifying barriers why we cannot do something to creating innovative solutions (SLD issues distinct from FLDs) Move from talk of partnership to becoming real partners: what skill sets are lacking, who can best provide them and how to best engage those with them? Move from talking primarily amongst ourselves in the public sector to learning the language and needs of the private sector, and to adapt to a changing market Establish a set of principles that uninterrupted access to quality assured medicines that are optimally formulated at an affordable price is our common goal Work urgently and systematically

17 But, a better way to do it?