2011_个体化用药_基因检测_-_医保政策(现实障碍和解决之道).pdf
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1、Reimbursement for Personalized Medicine Diagnostics: Current Limitations and Evolving Strategies Kristin Pothier, Partner Gary Gustavsen, Manager Health Advances, LLC 9 Riverside Road Weston, Massachusetts 02493 USA tel: +1 781.647.3435 fax: +1 781.392.1484 CONFIDENTIAL June 27, 2011 Reimbursement
2、Workshop CONFIDENTIAL June 27, 2011 1 Agenda 8:30-8:45 Introductions 8:45-9:15 Health Advances Personalized Medicine Overview 9:15-10:15 Reimbursement Landscape Overview 10:15-11:15 Breakout Sessions 11:15-11:30 Summary and Wrap-up Reimbursement Workshop CONFIDENTIAL June 27, 2011 2 Agenda Health Ad
3、vances Introduction Reimbursement Landscape Limitations Real-World Impact Proposed Solutions Breakout Sessions Summary and Wrap-up Reimbursement Workshop CONFIDENTIAL June 27, 2011 3 Strategy Consulting for Industry Leaders: Diagnostics and Life Sciences Practice Turn technological insight, clinical
4、 understanding, market knowledge and competitive intelligence into compelling commercial and clinical development strategies Efficiently gather market data from providers, patients and payers employing a large, established, international network of experts to provide a robust fact base Management te
5、am of five partners and five vice presidents, each with their own expertise and practice areas Leverage 65 professionals in Boston and San Francisco to detect patterns, evaluate strategic trade-offs, and present logical alternatives Integrate therapeutics, devices and diagnostics into a comprehensiv
6、e industry perspective Build consensus among management teams for recommended actions Market assessment Product strategy Portfolio prioritization Business and corporate development Pricing and reimbursement Diligence and M Heightens Companys Focus on Tests for Cancer Drug Personalization Life Techno
7、logies and Ignite Institute Partner to Create Largest NGS Facility in North America SureGene and Medco Enter Collaboration to Evaluate the Ability of Genetic Biomarkers to Enhance Drug Selection for Serious Mental Health Illnesses. bioMerieux and GSK Sign Theranostics Agreement to Develop Predictive
8、 Test for Selecting Breast Cancer Treatment Nestle Buys Prometheus Laboratories to Expand in Health On-Q-ity Announces Strategic Alliance with LabCorp Reimbursement Workshop CONFIDENTIAL June 27, 2011 9 A Personalized Approach Personalized Medicine The right treatment for the right patient at the ri
9、ght time Factors Driving Need for Personalized Medicine Aging population More complex diseases Desire to control costs Desire to provide better treatment with fewer side effects Source: Health Advances analysis. Reimbursement Workshop CONFIDENTIAL June 27, 2011 10 0100,000200,000 Non-Hodgkin Lymphom
10、a Melanoma Urinary Bladder Colorectal Breast Prostate Lung and Bronchus Number of Patients per Year 2010 US Incidence 2010 US Deaths Continued Unmet Needs in Cancer Care The investment in cancer biomarkers and drug development has only begun to address this family of diseases. 2010 US Cancer Inciden
11、ce and Deaths Highest Incidence Source: Health Advances analysis, American Cancer Society Cancer Facts and Figures, SEER Cancer Statistics. 0% 25% 50% 75% 100% 1975198519952005 5 Year Survival Rate Year Prostate Melanoma Breast Colorectal Ovary Stomach Esophagus Lung Liver Pancreas US Cancer 5 Year
12、Survival Rates Progression Over Time Reimbursement Workshop CONFIDENTIAL June 27, 2011 11 DX and TX Paradigms Becoming More Complex Observation Stage IV/ Metastatic Breast Cancer Chemo +/- Targeted Therapy Progression Herceptin +/or Tykerb +/or Chemo Recurrence Neoadjuvant Stage I,II and III Surgica
13、l Resection Hormonal treatment alone or in combo PI3K inhibitors +/or Akt inhibitors MET inhibitors IGF-1 inhibitors +/or +/or +/or Herceptin Tykerb Avastin* +/or +/or HER3 inhibitors VEGF TKIs EGFR inhibitors +/or +/or +/or PARP inhibitors mTOR inhibitors +/or +/or HSP inhibitors HDAC inhibitors +/
14、or +/or * On December 16, 2010 the FDA notified Genentech of its Proposal to Withdraw Marketing Approval of Avastin in breast cancer. Note: Graphic depicts current approved targeted agents plus Phase III and Phase II agents. Source: Health Advances interviews and analysis, NCCN, PharmaProjects. As t
15、he number of targeted therapies continues to grow, physicians will need biomarkers and methods of measuring these biomarkers (i.e. diagnostics) to guide effective treatment. Reimbursement Workshop CONFIDENTIAL June 27, 2011 12 Oncology Clinical Development Pipeline PM Drivers: Biomarkers in Oncology
16、 The increase in complex targeted drugs in the pipeline is driving the need for novel biomarkers aimed at identifying patients expressing a given target. Note: Targeted therapies are defined as affecting specific molecular targets such as EGFR, HER-2, BRAF, etc. Non-targeted therapies include tradit
17、ional chemotherapeutic agents, hormonal therapies, cell based therapies, non-specific anti-apoptotic therapies, and general immunomodulatory therapies. Source: Health Advances analysis, Pharmaprojects. Complex signaling mechanisms Simple targeted therapies Co-developed combinations Single agents Wid
18、espread advanced biomarker use Moderate biomarker use Future Today 0% 25% 50% 75% 100% LaunchedPhase IIIPhase IIPhase I Percent of Compounds Non-Targeted Targeted 14% 36% 37% 45% Reimbursement Workshop CONFIDENTIAL June 27, 2011 13 Crizotinib With only three years separating Phase I and Phase III in
19、itiation, the development of crizotinib highlights the importance of incorporating molecular profiling within early- phase trials and the role of partnering for commercialization. Source: Windhover SIS, company press releases, ASCO abstracts, Health Advances analysis. Crizotinib First Synthesized PF
20、-02341066 first synthesized as a small molecule inhibitor of cMET and ALK Phase I Initiated Originally focused on tumors with cMET activation Phase I Recruitment Expansion After the key NSCLC report during the dose escalation phase, lung cancer patients with proven ALK gene rearranged tumors were al
21、so recruited Impressive Phase I Data at ASCO In 76 heavily pretreated ALK+ NSCLC patients 64% objective response rate Companion Dx Deal with Abbott Deal with Abbott to develop FISH-based companion Dx to detect ALK gene rearrangements ALK in NSCLC Reported Report of ALK gene rearrangements occurring
22、in NSCLC Phase III Initiated 318 ALK+ NSCLC patients Pfizer, Abbott Plan Filing Pfizer, Abbott plan parallel filing for FDA approval of crizotinib and FISH test 2006 2009 2007 2005 2010 2008 2011 Reimbursement Workshop CONFIDENTIAL June 27, 2011 14 Personalized Medicine Applications: Oncology Person
23、alized medicine has impacted the management of oncology across the continuum of care. Source: Health Advances analysis. Description Diagnostic tests to complement traditional risk factors Applied to high-risk patients to identify disease early Used for definitive diagnosis and general cancer typing
24、Assess severity and/or risk of recurrence Inform adjuvant chemo decision Used to predict efficacy or safety response to specific treatments Recurrence monitoring Monitoring for treatment efficacy Test Examples BRACAnalysis COLARIS MELARIS deCODE Prostate Cancer PreGen-Plus EarlyCDT- Lung CancerTYPE
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