Printer Friendly Printed from http://www.researchandmarkets.com/reports/367705 Stakeholder Insight: Pricing and Reimbursement in Oncology - Do Payers Believe Oncology Drugs Offer Good Value? Description: The oncology market has shown remarkable growth in recent years, driven by the advent of targeted therapy and the high level of unmet needs in the disease, and it is poised for further expansion. While this will provide companies with opportunities, a key hurdle for novel cancer drugs will be the increasing pharmacoeconomic vigilance that prevails within cash-strapped healthcare systems. Scope of this title: - Overview of issues surrounding the sustainability of oncology drug pricing and reimbursement, supported by interviews with 23 key payer stakeholders - Review of processes involved in getting a new oncology drug approved for payment - Evaluation of the level of supporting clinical data, economic data or other value evidence used in the reimbursement decision-making process - Assessment of measures for cost-containment in oncology that have already been taken or are being planned for the future Highlights of this title: - FDA approval of innovative oncology drugs will guarantee patient access in the US and market uptake is dependent on clinicians perceptions of drug benefit rather than payer constraints. However, this is not the case in the EU where payers have a greater influence on prescribing decisions. - Drug developers need to be more proactive in initiating and integrating pharmacoeconomic studies concurrent with pivotal clinical trials. Manufacturers also need to shift payer focus away from drug acquisition cost, incorporating a more holistic approach to effectively communicate the value of their drugs. - Improvement in overall survival from randomized Phase III trials is deemed to be the most desirable outcome by payers. While other endpoints would be given consideration in reimbursement decision-making, payers were of the opinion that these endpoints would support an application based on improved overall survival, rather than as a substitute. Reasons to order your copy: - Evaluate what payer measures for cost-containment in oncology have already been taken or are being planned for the future - Maximize the chance of your drug gaining positive payer decisions by recognizing the influences on the reimbursement/funding decision-making process - Understand how the oncology pricing and reimbursement environment may evolve over the next five years Contents: ABOUT OUR HEALTHCARE 2 Nish Saini – Director of Oncology 2 Chapter 1. Executive summary 11 Our insight into the oncology drug reimbursement/funding decision-making process 11 Market penetration of novel cancer therapeutics challenged by increasing pharmacoeconomic vigilance 11 US market characterized by self-professed poor management of oncology drugs by Managed Care Organizations 12 More bureaucratic and centralized approach to drug reimbursement/funding decision-making prevails in the Europe 12 NICE blight hampering novel oncology drug uptake in the UK 14 Emphasis on pricing- rather than remibursement-control in Japan as regulatory approval virtually guarantees formulary inclusion 14 Independent health technology assessment bodies a rarity 15 Improvement in overall survival viewed as the optimal endpoint in supporting drug reimbursement funding/applications 15 Increased management of oncology drugs by payers viewed as inevitable 16 Chapter 2. Objectives, scope and coverage 18 Target Respondents 18 List of abbreviations 19 Chapter 3. Introduction 20 Market penetration of novel cancer therapeutics challenged by increasing pharmacoeconomic vigilance 20 Advances in cancer treatment outstripping available financial resources 20 The rising costs of cancer pharmacotherapy are often disproportionate to improvements in survival rates 21 Oncology is likely to be one of the first specialist disease areas to be targeted by the payer community 22 Improved pharmacoeconomic analysis will be required to communicate the ‘value’ of novel cancer treatments 23 Lack of flexibility in funding of new drugs in EU hospital settings has a major impact on patient access to innovative cancer drugs 23 Chapter 4. Dynamics of the reimbursement/ funding process 25 US market characterized by self-professed poor management of oncology drugs by Managed Care Organizations 25 Individual benefit design dictates which MCO committee makes formulary-inclusion decisions 27 Early delivery of clinical data to payer organizations is paramount to driving rapid and optimal market uptake 28 Medicare Modernization Act (MMA) introduces defined time line for formulary-inclusion decisions 28 Procedural aspects of formulary-inclusion decision-making appear standardized across interviewed MCOs 29 Procedure unchanged for second- and third-generation therapies 31 Negative formulary-inclusion decisions have minimal impact on patient access to novel oncology therapeutics 31 Payers attempt to rationalize oncologists’ prescribing behavior through innovative approaches 33 Japan: centralized agency controlling relatively efficient healthcare system 35 Key stakeholders within the MHLW 35 Pricing rather than reimbursement control in Japan since formulary inclusion is virtually guaranteed by regulatory approval 36 Transparency increased with the NHI Pricing Organization 37 Rewarding innovation with price premium 39 Cost accounting method for drugs without comparators 41 Biennial price cuts to contain healthcare costs 42 Increasing importance of pharmacoeconomic data 43 Novel drugs are subject to reassessment due to changes in circumstances 43 France: multi-step pricing and reimbursement decision-making process can delay access to innovative oncology drugs 44 Evaluation of therapeutic benefit by Transparency Commission is crucial to facilitating market access and optimizing manufacturer reimbursement 44 Different agencies have responsibility for pharmacoeconomic and clinical evaluations 47 Hospital formulary-inclusion decisions rely heavily on Transparency Commission evaluation 48 ‘ATU’ system provides a mechanism for temporary authorization of innovative cancer drugs that would otherwise be delayed by lengthy decision-making processes 50 Recently-mandated reference pricing system for multi-source drugs will have little if any impact on innovative oncology treatments 51 Recent pricing and reimbursement reforms attempt to encourage innovation of drugs 51 Germany: reference pricing system threatens revenue potential for second- and subsequent-generation oncology drugs 53 Patient access to approved innovative cancer drugs relatively unhindered 53 Within Germany’s reference pricing system, decisions regarding innovative products are relatively uncomplicated 54 Increased cost-containment measures are likely to impact on favorable drug prices for oncology drugs administered in hospitals 56 Italy: single agency responsible for all aspects of drug approval, pharmacovigilance, pricing and reimbursement 57 Regulation of centralized decision-making at local level is particularly relevant for oncology drugs 57 Dynamics of application procedure and structure of AIFA facilitates expeditious decision-making for innovative drugs 58 Elements beyond clinical and pharmacoeconomic data may influence pricing decisions 60 Negative decisions regarding oncology therapeutics are rare 60 Unique reference pricing systems can significantly challenge market penetration for second- and third-generation drugs 61 Re-evaluation of manufacturer reimbursement levels every two years effectively penalizes success 62 Spain is one of the most efficient EU nations in facilitating access to new cancer drugs 64 Ease of access to innovative cancer drugs in Spain is evidenced by Karolinska Institute report 64 Drug developers and suppliers bear the burden for cost-containment efforts 64 Despite rigorous appraisal process by Directorate of Pharmacy and Healthcare Products, market access is virtually guaranteed following AEMPS approval 66 Autonomous communities (ACs) make efforts to rationalize regional drug use 68 Pricing determinations for reimbursable prescription drugs performed by specialized agency 69 UK: favorable pricing structures are countered by poor and discrepant access to novel cancer treatments across country 71 Cancer networks are responsible for implementing and delivering NHS cancer services 71 NICE serves as a ‘gatekeeper’ in managing universal access to novel treatments 73 Complex funding system for oncology drugs, with procedural variation among geographic regions 74 Funding decision-making triggered at request of local specialists rather than automatically following drug approval 75 Payers will not routinely consider funding unlicensed drugs or off-label use of licensed drugs 76 Constitution of funding decision-making group somewhat variable 78 Clinical and pharmacoeconomic (PE) data evaluation is rigorous, sourcing information from multiple sites 79 Inefficiency of financial arrangements and weak clinical evidence perceived as ‘bottlenecks’ to the decision-making process 79 Process and decision-making for entry and evaluation of second- and third-generation products variable 80 Manufacturers at the mercy of payers suffering “NICE blight” 81 Chapter 5. Required levels of clinical and economic evidence 83 Independent health technology assessment bodies a rarity 83 Increased emphasis on contextualizing the clinical benefit derived from novel oncology drugs in relation to other therapeutic areas 85 Greater acceptance among US payers of positive supporting data derived solely from Phase II trials 85 French approach places onus on marketing company to fully disclose all supporting clinical and pharmacoeconomic data 86 German and Italian payers less rigorous in their appraisal of the clinical value of novel oncology therapeutics already approved by EMEA 87 Japanese payers primarily focus is on level of reimbursement rather than formulary inclusion decision-making 88 Improvement in overall survival viewed as the optimal endpoint in supporting drug reimbursement funding/applications 88 US payers more pragmatic in their consideration of endpoint designation 89 European payers reticent in quantifying the relative increase in specific endpoints that would justify drug reimbursement/funding 90 US payers more forthcoming in quantifying desired improvements in clinical benefit 91 Automatic listing in Japan but endpoints significantly influence pricing based on prescribed formula 92 Payers generally feel underserved in terms of the provision of pharmacoeconomic information from manufacturers. 92 Discipline of pharmacoeconomics is in its relative infancy, with payers feeling unable to interpret complex information 93 UK payers most familiar with QALY concept, an integral component of the NICE appraisal process 95 Raising awareness of cost-effectiveness in Germany 95 Independent pharmacoeconomic evaluations seen as preferential 96 Pharmaceutical companies needs to shift payer focus away from solely drug acquisition costs 96 Disparate opinions about influence of budget impact on decision making 96 Heightened awareness among French payers with regard to off-label use 98 Discrepant opinions among EU and US payers regarding relative importance of criteria for reimbursement/funding decisions 99 EU payers interviewed placed a greater emphasis on cost-effectiveness than their US counterparts 101 Beyond persuasive clinical and pharmacoeconomic data, other influences may impact on the decision process 102 UK payers misplaced in their denial that payer advocacy or media attention have any influence on funding decisions? 102 Early engagement of patient advocacy groups a valid and effective strategy 103 Distribution channels and patient/caregiver education seen as important ‘service elements’ influential to US payers 103 Chapter 6. Future cost-containment measures 105 US payers believe they have little option other than to increase their management of oncology drugs 105 US payers believe reduced profiteering among oncologists with regard to drug acquisition is essential 106 Community oncologists argue that MMA legislation will significantly impact service provision 107 Concern that financing of MMA may result in future implementation of price controls 108 Pre-emptive move by pharmaceutical companies 108 Impact of MMA will inevitably extend beyond Medicare patients 109 Numerous other cost-containment measures envisaged in US 109 Greater shift of cost-pressures to insureds not met with universal payer enthusiam 110 European payers’ favorable attitudes to innovative oncology drugs starting to wane 112 An increased emphasis on disease prevention and drug reimbursement based on treatment outcomes postulated 113 Risk-sharing model for pricing 113 Uniqueness of UK-specific measures reflect complexity of drug funding system 114 No urgency among Japanese payers 116 Chapter 7. Hypothetical scenarios 118 Scenario one: Payer attitudes to a novel high-cost oncology drug with debatable clinical benefit 118 Scenario two: Value of second-generation oncology drugs with reduced toxicity accompanied by non-inferiority 122 Chapter 8. Appendix 125 Contributing experts 125 US Payer Transcripts 127 Japan Payer Transcripts 222 France Payer Transcripts 254 Germany Payer Transcripts 268 Italian Payer Transcript 290 Spain Payer Transcripts 299 UK Payer Transcripts 321 List of abbreviations 369 Bibliography 372 Research methodology 372 Disclaimer 373 Ordering: Order Online - visit http://www.researchandmarkets.com/reports/367705 Order by Fax - using the order form below Order By Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. 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