Health technology assessment


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Health technology assessment

  1. 1. Health Technology Assessment (HTA): a European perspective Report Links: FirstImpact: FDA approval of Aubagio Consensus Outlook: Multiple Sclerosis Therapy Trends: Multiple Sclerosis -- KOL Insight and Consensus Outlook Modules Pharmas Future Role in CME Therapy Trends: Rheumatoid Arthritis -- Consensus Outlook Module Therapy Trends: Rheumatoid Arthritis -- KOL Insight and Consensus Outlook Modules Therapy Trends: Rheumatoid Arthritis -- KOL Insight Module Pharma Reputations: Managing Perceptions Pharma sales force shape, size and structure — where next? Sampling: A key business driver in a multi-channel environment Inside China’s Healthcare Reforms: Opportunities for Multinational Pharma Effective Sales and Marketing Strategies for Orphan Drugs New Product Penetration: Understanding & Accelerating New Product Uptake Managing Investigator Initiated Research Therapy Trends: Alzheimers Disease - Breaking new ground in disease modification Therapy Trends: Multiple Sclerosis Branded Generics in South East Asia: Current and Future Opportunities Market Access: Communicating Value Stories to PayersThe bottom line: For payers facing tough financial crunches across Europe, Health TechnologyAssessment (HTA) is becoming increasingly important. Not only is HTA influencing reimbursement, it ishaving an impact on price and market access. And it’s not surprising. With greater scrutiny over theclinical and financial value of drugs, medical devices and procedures, HTA is increasingly being acceptedaround the world. The European situation is somewhat different: existing across multiple borders, the‘Europeanisation’ agenda of HTA has sparked debates about European-wide standards, the possibility ofa single agency governing HTA and the need for formalized cooperation. Report Overview In HealthTechnology Assessment (HTA): a European perspective, FirstWord examines the current role of HTA in
  2. 2. Europe, from its impact on reimbursement and pricing to market access. The report focuses on theexperiences of five European nations, reviewing the history of HTA and the key agencies in each. Writtenby an expert health economist and with insight from experts from NICE, EUnetHTA , the EMA and leadingpharmaceutical companies, the report reveals the problems, pitfalls and—most importantly—thepotential of a harmonized approach to HTA in Europe. Key features Detailed examination of the role ofHTA in European pricing, reimbursement and market access An overview of the role of HTA in Germany,France, Italy, Spain and the UK Country-by-country breakdown of key agencies Expert insight into the‘Europeanisation’ of HTA and its key challenges Review of the potential and pitfalls Key Benefits Fulloverview the role of HTA in Europe Insights from experts in the European Medicines Agency, theNational Institute for Health and Clinical Excellence and leading pharmaceutical companiesComprehensive references to key literature Key Questions Asked What role does HTA play in pricing,reimbursement and market access? What is the current state of play with HTA across Europe? Whatchanges are happening in HTA and what is their impact? Does one size fit all in terms of transferabilityand adaptability? What are the pitfalls, problems and potential of HTA in Europe? Who Should Read ThisReport Market Access directors & managers Health Economics professionals Pharmacoeconomicsprofessionals Health Outcomes / Outcomes Research professionals Health Technology Assessmentprofessionals Health Policy professionals Pricing & Reimbursement teams Government and regulatoryaffairs analysts Government and regulatory affairs analysts Key quotes “HTA is not the only game intown.” – Keiron Sparrowhawk of PriceSpective “There is the situation of the UK, where the whole pricingand reimbursement system is experiencing a change. The idea is to integrate the HTA system, particularlyNICE, into an overarching pricing system more explicitly, much more explicitly than at present.” – GünterHarms, Market Access & Public Affairs Director, Shire Human Genetic Therapies “There is a lot ofdifference in the governance across Europe, which ultimately leads to quality of HTA. An importantaspect is of course the independence of the assessment from the appraisal and ultimately the decisionon a certain price. Thats very, very different country by country and region by region.” – AnsgarHebborn, Global Head, Payer and HTA Programme Policy, Roche Expert Views Alicia Granados, MD.Senior Director Global HTA Strategy, GMA Genzyme Andrea Rappagliosi, Vice President EuropeanGovernment Affairs & Head of Brussels Office, GlaxoSmithKline Andrew Hobbs, Managing Director, PopeWoodhead and Associates Limited Ansgar Hebborn, Global Head, Payer and HTA Programme Policy,Roche Brian Lovatt, Chief Executive Officer, Vision Healthcare Clare McGrath, Senior Director HTA Policy,Pfizer David Grainger, Global Public Policy Director, Lilly Finn Børlum Kristensen, Director, EUnetHTASecretariat and Chair, EUnetHTA Executive Committee Günter Harms, Market Access & Public AffairsDirector, Shire Human Genetic Therapies Hans Georg Eichler, Senior Medical Officer, European MedicinesAgency Kalipso Chalkidou, Director of International Division, National Institute for Health and ClinicalExcellence Karen Facey, Evidence based health policy consultant and non-executive Director at NHSHealth Scotland, and Chair of the HTAi Interest Group for Patient/Citizen Involvement in HTA Mel Walker,Senior Director Value Expert Engagement & Collaborations, GlaxoSmithKline Rito Bergemann, MedicalDirector, HTA Strategy Global HEOR, Abbott Steven Flostrand, Principal, Pricing & Market Access, IMSHealth Ulf Staginnus, Head of Pricing & Health Economics Europe, Novartis and author Vivek Muthu, Chief Executive, Bazian Keiron Sparrowhawk, Partner,PriceSpectiveTable of Contents :
  3. 3. Executive summaryBiosimilar drugs in EuropeWhat are biosimilars?Generics and biosimilars – similarities and differencesBiosimilars available so far in EuropeThe market opportunities for biosimilars in EuropeThe biologics patent cliff will have an impact on the marketMarket types for biosimilars will differ across EuropeGeographic markets for biosimilars will vary across EuropeIn Italy, prescriptions are fulfilled by brandIn France and Spain, drugs are discounted to targetsIn the UK, biosimilar uptake is driven by NICEIn Germany, biosimilars uptake is good but varies by drug typeBiosimilar uptake will vary by molecule and indication across EuropeEpoetin uptake may have been slowed by immunogenicity issuesFilgrastim uptake has been faster in EuropeBiosimilar use is likely to vary between chronic and episodic treatmentThere may be a resistance to switching patients on established treatmentsHospital physicians may be more likely to use biosimilars than primary care physiciansBiosimilars will have an impact in cost-sensitive marketsThe paediatric population may be reluctant to take up biosimilarsThe challenges for biosimilars in EuropeThe biosimilars challenge: Gaining approval in EuropeThe EU regulatory process for biosimilarsBiosimilar regulations will be a steep learning curveWill regulations be fair and balanced on all points?The biosimilars challenge: Overcoming development and manufacturing hurdlesBiologics are highly variable by natureVariations can cause issues with immunogenicityThe biosimilars challenge: Overcoming patent hurdlesThe biosimilars challenge: Gaining stakeholder trustPayers can be a major driver for biosimilars uptakePhysicians will be key gatekeepers for biologics and biosimilarsPatients may be cautious about biosimilarsThe defensive position: Originator companies will try to limit biosimilar uptakeLifecycle management can maintain market shareLack of automatic substitution will protect originator drugsExclusivity provisions and patents will protect originator drugsOriginator companies can exploit loyalty to maintain market shareFocusing on quality, safety and efficacy claims can maintain loyaltyUsing marketing, sales and healthcare professional training to attract and keep market shareProtecting the market through degree of similarity – is a biosimilar really similar?Competitive pricing and rebate agreements will keep cost-sensitive customersThe offensive position: breaking into a new market
  4. 4. Pricing is the key differentiator for biosimilars Knowing the market will help gain market share Information and education: defending biosimilars against the naysayers Sales, marketing and account management: Market share through talking to the payers Education for healthcare professionals: Market share through talking to the physicians Gaining market share by adding value: Devices and formulations Making the biosimilar easier to use: Devices Making the biosimilar easier to handle: formulations Protecting biosimilars through patentsThe company landscape: Opportunities for companies in biosimilars Generics companies will be key playersCollaboration and licensing in the biosimilars market Collaborations between generics companies – bringing together development and marketing Collaborations between generic and originator companies combines know-how and manufacturingcapabilities Geographic collaborations allows access to wider markets Looking into biosimilars deal data Biosimilar deals by volume Biosimilar deals by value Biosimilar deals by type Biosimilar deals by indication Biosimilar deals: Deal case studies Biopharma company signs agreement to access biosimilars Generics company signs agreement to fill pipelineWhat’s next for biosimilars in Europe? Monoclonal antibodies will be a dramatic entry to the biosimilars market Biobetters could ‘follow-on’ from biosimilars Biobetters will follow a different route of approval The US: Changing the biosimilars environmentConclusionAcknowledgementsBibliographyRelated Keywords : Market, Research, Report, Business, Industry, Information, Automotive, Banking, Finance, Food,Beverages, Technology, Biomass, Books, Conference, Company Profiles, CountryFor More details about above & other Reports plz contact :PranaliAarkstore.comContact: Marketing teamMob.No.918149852585Email: , discount@aarkstore.comURL: http://www.aarkstore.com
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