Market Access - Getting ready for Personalized Medicine!
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The document discusses the anticipated growth of the personalized medicine market, projecting it to reach $42 billion by 2015, up from $24 billion in 2009. It emphasizes the need for personalized medicine to adapt to new economic models, highlighting challenges in market access and reimbursement for diagnostic tests linked to treatments. Companies, particularly in the biopharmaceutical sector, must navigate complex partnerships and pricing strategies to maximize the potential of personalized medicine while ensuring patient access and understanding of value.
Market Access - Getting ready for Personalized Medicine!
- 1. Personalized Medicine How ready is the market for you and how ready are you for the market? Executive Insight AG. Company Snapshot Presentation.Our offering
- 2. Estimated Development of Personal Medicine Core Areas The future clearly lies in Personalized Medicine $ bn Total: $ 24bn Total: $ 42bn The Personalized Medicine Market Size is said to experience substantial growth in the next years - up to $ 42bn by 2015 (MDx tests and targeted 2 *Esoteric Lab Services or Tests involve testing for substances (e.g. biomarkers) which is usually not performed in a “routine clinical lab”. These Tests usually require specialized personnel and hardware therefore they are often outsourced from hospitals to research labs (e.g. part of big university clinics, specialized private labs etc.) Source: PwC 2012 +61% tests and targeted therapies) compared to $ 24 bn. in 2009
- 3. In principle, everyone stands to win Clearer basis for developing treatment guidelines Diagnostics: A more attractive business model built on value based pricing Higher efficacy & less side effects Pharma / Diagnostics Industry Pharma / Diagnostics Industry Policy Makers Policy Makers PatientPatient Pharma: From the outdated blockbuster model to niche-busters 3 Lower cost Right drugs for the right patients, especially for cancer Better balance between efficacy vs cost Better prediction of treatment outcome Payers/ Assessors Payers/ Assessors ProvidersProviders Prescribers/ Pathologist Prescribers/ Pathologist
- 4. Fearful that biopharmas use personalized medicine to disguise higher pricing Poor understanding of the difference between the prognostic vs predictive tests However, many Policy Makers and Payers/assessors are unwilling, unsure or unprepared to adapt 4 between the prognostic vs predictive tests Sceptical of unfamiliar clinical data evidence used to justify economic value, yet unable to propose alternatives
- 5. No holistic view of Rx and CDx (undermines the whole concept of personalized medicine) Rx assessment mechanisms blindly applied to CDx (eg.: same The current Market Access system is therefore unable to unleash the full value of CDx 5 blindly applied to CDx (eg.: same data requirements) Technology-based reimbursement criteria may not recognize the value of CDx
- 6. In turn, Biopharmas tread in uncharted waters in Market Access With different funding dynamics for CDx and Rx, how will unfunded CDx jeopardize MA of the Rx? Will the CDx linked to a Rx go through the reimbursement process together or separately? How will it affect the timeline? What new add-on funding opportunities exist for 6 What new add-on funding opportunities exist for combined Rx/CDx approaches? How should the CDx feed into the health economic data model? How can we enhance Market Access by combining the early access programs of both the Rx and CDx?
- 7. Biopharmas also face new challenging questions in developing a successful business model What is the best “distribution model” for promoting the CDx component and overcoming any local lab capacity hurdles? How can payer partnership program enhance Market Access of your Rx/CDx combination, if at all? 7 Access of your Rx/CDx combination, if at all? Which pricing option (combined or separate) for Rx/CDx in which markets give you a competitive edge?
- 8. Personalized Medicine This is where ExecutiveInsight comes in… Executive Insight AG. Company Snapshot Presentation.Our offering
- 9. Executive Insight can undertake a rigorous review of your Pricing and Reimbursement Strategy P&R pathway & evidence requirements Best Market Access option Diagnostic Test G-BA • Test for early detection §§§ 92; 25;26 SGB-V Kap. 2 § 10 VO-GBA • Real innovation: Kap 2 § 2 (1) VO-GBA - Either: not included in the EBM in any way - Or: significant change orunderlying technology Benefitattributed (+ / -) Potential for benefitrecognized Coverage with evidence development § 137e Performs benefit assessment §§ 135;137c Decision §§§ 92;25; 26 SGB-V Kap. 2 § 10 VO-GBA G-BA consults BA on significance of innovation Kap. 2 § 2 (2) VO-GBA • Technology already (‘somewhat’) included in EBM through (generic coding, or code for highly similar procedure) Performs HTA assessment (if required by the BA) Anlage 22 Kap. 32 EBM Decides on entry of new code and EBM point value § 87, SGB-V LEGEND: Actions Requirements Requirements test early detection Legal basis Institution or Decision Bewertungs- ausschuss AG Labor Align expectations with external and internal stakeholders Needs of 9 Enable optimal use of resources Develop win-win value propositions for key stakeholders Needs of the network of stakeholders Link Strength 1 2 3 4 MarketAccess Medical Experts Interviewscoveringallrelevantclinicianandpayersforthe in-andoutpatientsetting LeverageExecutive Insightexpertnetwork Stakeholder Payers KOLs National Regional Hospital Clinicians Pathologist Number of interviews 7x 2x 5x 7 2x
- 10. ...set up a winning sustainable Business Model Payer partnershipDistribution mix Pricing models Performance based agreements (PBS) 10 Assess feasbility of testing clusters for faster patient access and uptake Explore schemes which can increase chance of targeted prescription (eg: introduction of eligibility quality assurance) Propose models that reflect new customer needs and value perception (combined or separate offerings) Value added agreements (VAA) Financial based agreements (FBA)
- 11. ... and help you prepare efficiently for successful launch Early access programs Pre-launch activity roadmap 11 Develop CUP, NPP and ROK for faster patient access and uptake Highlight critical success factors that ensure optimal and timely preparation for launch
- 12. Do not use personalized medicine as a disguise for pure market expansion Reach out to a truly eligible patients through quality management programs We pursue the true spirit of releasing the full value of Personalized Medicine A true personalized medicine approach 12 Do not circumvent standard Market Access options to accelerate reimbursement Help to shape the system so that fast access becomes possible through standard processes Acceleration instead of circumvention
- 13. We bring to your projects our unique set of expertise in Personalized Medicine Medical experts with the in-depth understanding of patient pathways to evaluate and propose MA options AG Labor KBV / GKV-SV Ärztliche Berufsverb. Med. Fachgesellsch. Herstellerverbände Dürfen einen Antrag auf Aufnahme in den EBM stellen Datenanforderungen (außer Antrag kommt von KBV / GKV-SV) sind wie folgt: - Beleg des medizinischen Nutzens durch klinische Studiendaten (ggf.vergleichende Studien zu etablierten Parametern;insbesondere wenn diese ein Substitutions- /Verbesserungspotential aufzeigen - Angaben zu Kosten und Patientenvolumenentwicklung ‚BudgetImpact‘ Rein administratives Institut (Kopf dahinter ist das COC-L) Bestehend aus 7 KBV und 7 Antrag COC-L Beratung / HTA Das Kompetenzzentrum Labor (COC wird fastausnahmslos bei jedem Antrag involviertund ist im Endeffekt fast gänzlich für die Empfehlung des AG Labor verantwortlich P&R country experts with experienced in P&R pathways and evidence requirements or MDx lab OP-Präparat or MDx-lab* OP-Präparat or >90% <10% Ambulant Stationär Histologie- lab Biopsie (Durch dieadjuvanteIndikation wird die Genmutationsanalyse andem OP-Präparat vorgenommen werden) DRG >95% EBM EBM~70% DRG / Drittmittel (Nur in „late stage“ Fällen initiiert das KH die Therapie) (ZE könnendenAnteil der stationären Behandlungen erhöhen) ~30% or MDx lab OP-Präparat or MDx-lab* OP-Präparat or >90% <10% Ambulant Stationär Histologie- lab Biopsie (Durch dieadjuvanteIndikation wird die Genmutationsanalyse andem OP-Präparat vorgenommen werden) DRG >95% EBM EBM~70% DRG / Drittmittel (Nur in „late stage“ Fällen initiiert das KH die Therapie) (ZE könnendenAnteil der stationären Behandlungen erhöhen) ~30% 13 Bestehend aus 7 KBV und 7 GKV-SV Vertretern MDS / MDK Der MDK / MDS hätte die Möglichkeitdiese HTA Kompetenz aufzubauen,hat sich bisher aber noch nicht in diese Richtung positioniert Bewertungs- ausschuss Vorbereitung / Empfehlung Entscheidung über Aufnahme Entscheidung über Punktewert(Bazar artige Verhandlung) Nein Ja or Zeit / Krankheitsentwicklung I II III IVStage: (Platin Chemotherapie) (MAGE-A3) (Xalkori) (Iressa) EBM DRG (+ZE) (Platin Chemotherapie +Avastin) (Tarceva) or Zeit / Krankheitsentwicklung I II III IVStage: (Platin Chemotherapie) (MAGE-A3) (Xalkori) (Iressa) EBM DRG (+ZE) (Platin Chemotherapie +Avastin) (Tarceva) “You get access to a senior consulting team who have deep competency and experience in their respective areas.” Global Top 3 Pharma, Specialty Care Excellence “…they're working with you and not just putting a lot of junior people in the projects to learn and be trained” “they came across as more knowledgeable and more experienced”
- 14. We take a front seat in shaping Personalized Medicine policies Member of standing panel of 10 payers and 5 policy makers from major European Publish articles on early access programs and payer partnerships programs (‘innovative contracting’) 14 5 policy makers from major European markets, competent in all questions related to Personalized Medicine Track Record Developed pricing models for 5 major Rx/CDx solutions Accompanied PPP’s from initial discussions between Payers and Pharma to successful PPP implementation Established test cluster pilots successfully in major EU markets
- 15. Finally, our client-partners seem to like the way we work with them Open Collaboration Creative Pragmatism • We challenge constructively • Before going into new solutions, we leverage and maximize our customer internal knowledge, expertise and competences • We develop an approach based on our experience with what works and what doesn’t • We provide actionable recommendations Uncovering your true needs by embedding ourselves in your team knowledge, expertise and competences “they made my priorities their priorities, they really did” “the collaboration and flexibility is a real strengths of theirs” “they are very good at being a critical friend“ “they have a pragmatic view of how things actually get implemented and executed once you develop the strategy “ “merging within the team culture and acting as a part of the team” • We provide actionable recommendations that remain valid after we leave “they have just delivered very strong results consistently” “fantastic brains and innovation that they have “they do generate a chemistry match between themselves and the customer
- 16. Your contact persons: If you want support in defining your plans and can identify with our thinking, contact us Andrea Sobrio Mobile: +41 79 456 87 16 [email protected] Klarissa Hoday Mobile: +41 79 446 93 79 16 Company address: Mobile: +41 79 446 93 79 [email protected] 16 Executive Insight AG Metallstrasse 9 CH-6304 Zug Tel. +41 (0)41 710 71 63 www.executiveinsight.ch [email protected]
- 17. Appendices – About Executive Insight 17
- 18. Our place in the industry – consistent thought leadership 2000 2004 2007 2011 Move from block busters to niche products Increasingly complex and intertwined environment Emerging power of payers Value expectations along the whole patient pathway Our flagship methodologies provided timely answers to the most challenging issues Regionally based Business Model for Narrow indication products Network Based Commercialization Payer Engagement and Contracting Beyond the Pill Networked Healthcare Series Journal of Medical Marketing Organisational Polygamy Pharmaceutical Executive Check out our website for all related publication and TL on the topics www.executiveinsight.ch/publications Beyond The Pill: More than Just a Slogan Farmafocus Innovative Contracting Pharmaceutical Executive
- 19. Our team - a unique mix of industry, consulting and medical backgrounds Interdisciplinary team of 20 professionals Meet some of our experts here: (see the entire team online) CONSULTING EXPERTS INDUSTRY EXPERTS MEDICAL EXPERTS Suzan Esslinger • Theoretical medicine, PhD in Molecular Biology Andrea Sobrio • > 10 years healthcare consulting experience Eric Janvier • > 17 years pharma industry experience Cover the EU big 5 languages (English, German, French, Italian, Spanish) and beyond (e.g. Chinese) PhD in Molecular Biology • Expert for Medical Info., Education & Regulatory Sandra Schoenes • Medical doctor • General and orthopaedic surgeon consulting experience • Focus: Market Access, Commercial Models Meike Wenzel • > 10 years healthcare consulting experience • Focus: Sales, Customer & Market Insights Marc Pesse • > 10 years healthcare consulting experience • Focus: Network Mapping & Mgt. industry experience • Finance & Business Development Wendy van der Lubbe • > 7 years pharma industry experience • Product Mgt. & Medical Affairs Francesca Boggio • > 3 years medical device industry • > 8 years consulting • Strategic marketing Dr. Morteza Yazdani • PhD in Neuroscience • Diploma in Biotechnology
- 20. Our services MARKET ACCESS We support our clients in in-depth understanding of the HC environment and the design of solutions that meet payers REGULATORY We support you with building a regulatory strategy to successfully accompany your product through its MARKETING We support our clients in developing a compelling value proposition that goes beyond the product to ensure “value beyond SALES We help you find the right balance between adding true value to customer interactions and realising that meet payers objectives and needs product through its entire life cycle to ensure “value beyond the pill” and realising efficiencies CUSTOMER & MARKET INSIGHTS We offer innovative methods for generating fresh customer insights
- 21. Our clients