SWISS APPROVAL HEALTH CARE & MEDICAL TECHNOLOGY ASSESSMENT

Value-based Market Access Strategy Development and Operationalisation Services

Aim to devise and execute effectively, an intelligent strategy that will attain swift, wide and unrestricted market access, based on robust data, synthesised with vigorous methodologies, to build compelling evidence, that will demonstrate to different decision makers, at International, National, Regional and Unit level, a convincingly meaningful, relevant and customised relative product value, for stakeholders.

The Market Access strategy is developed independently or in the context of innovative financial or outcome-based, risk-sharing, managed-entry schemes and agreements, so as to attain from them positive appraisals, reimbursement and coverage decisions.

Our 5 Steps Process for Market Access

Critical Client Task

  • Regulations: Monitor, Understand and Foresee Evolution of access landscape. Identify business data and evidential requirements, as well as any key company success factors at International, National, and Regional level.
  • Stakeholders: Map important stakeholders for P&R, access and HTA, understand and foresee their priorities, thinking, requirements, and needs at International, National and Regional level.
  • Competitors : Monitor, analyse and foresee competitor tactics; assess pricing competitive landscape; benchmark and assess strengths, weaknesses, opportunities and risks.
  • Policy: Monitor and foresee policy evolution, quantify policy impact; influence reimbursement and HTA policy practices and models together with external partners to influence and shape policy practice.
  • Disease: Understand therapy area and market dynamics, therapeutic alternatives, management pathways, unmet medical, health and payer needs, technology and epidemiology trends.

Services We Provide

  • Regulations:P&R, payer, HTA, market access landscape assessment, intelligence collection, trend analysis and insights, through desktop research, pricing stakeholder surveys, advisory boards, delphi panels and workshops.
  • Stakeholders: Stakeholder mapping studies, intelligence collection, insights, analysis of needs and wants, through desktop research and reviews, surveys, advisory boards, and workshops.
  • Competitors: Competition intelligence collection, benchmarking and analysis; insights; assessment of opportunities and risks through quantitative and qualitative research; risk mitigation analysis.
  • Policy: HTA, P&R, policy monitoring, analysis and insights; policy impact evaluation; partner to undertake thought leadership research and scientific activities, publications, presentations an advocacy.
  • Disease: Rapid, targeted or systematic reviews of disease, market, medical technology, guideline and patient management and assessments through desktop research, stakeholder surveys, advisory boards and workshops.

Critical Client Task

  • Alignment: Coordinate with other business functions, review and provide input into the development of the target product profile and the Regulatory, Medical, Market Access, Evidence Generation and business brand plans.
  • Capacities: Assess internal organisational capacities, experience, gaps, and priorities at global, International, National and Regional level, and plan to cover any limitations.
  • Engagement: Engage with important stakeholders in relevant pricing, reimbursement, health technology assessment, payer and governmental agencies, in academia, in professional associations, committees, and patient advocacy groups.

Services We Provide

  • Alignment: Provide cross functional and life cycle alignment through workshops; review and provide input into the development of the target product profile and the regulatory, medical, market access, evidence generation and brand plans.
  • Capacities: Review, benchmarking and assess internal organisational capacities and provide advice, training and support to cover areas gaps at different company levels and functions.
  • Engagement: Identify and select experts in relevant agencies and organisations, develop networks and engage effectively through scientific and advocacy meetings, research, campaigns and other relevant activities aiming to establish trusted relationships.

Critical Client Task

  • Strategy: Develop and test competitive positioning, value proposition and value messages, that resonate with payers and address their needs; Develop financial and outcome-based access scenarios; Draft market access strategy plan and receive feedback from other business functions.Cross function alignment facilitation.
  • Τactics: Develop operational plan for monitoring and supporting pricing and reimbursement negotiations at national and subnational (payer, regional, key account) level.

Services We Provide

  • Strategy: Positioning and value message testing for addressing P&R, HTA agency and payer needs; market access, value communication and stakeholder engagement and risk mitigation plan; financial and outcomes-based managed entry and risk sharing scenario plans; workshops and cross function alignment facilitation.
  • Τactics: National and key account segmentation and monitoring and develop of contractual arrangement and mitigation analyses plans and customer engagement and management plans.

Critical Client Task

  • Build Value Evidence: Build global customisable economic business models. Build value and formulary dossiers, in order to demonstrate unmet health and medical need, as well as product value and budget impact.
  • Innovative Contracting: Develop managed entry agreement or financial business agreement scenarios; Estimate their impact on value, budget and internal return; Plan activities for scenarios implementation, monitoring and revision.
  • Communicate Value: Build tools to communicate product value to decision makers in convincingly meaningful, relevant, and customised manner to attain from them positive appraisals, reimbursement and coverage decisions.

Services We Provide

  • Build Value Evidence: Build, review or locally customise health economic models (CEA, CMA, CUA, BI); data analytics, simulation and forecasting; targeted or systemic literature reviews and direct and indirect meta-analyses.
  • Innovative Contracting: Develop and measure internal and external impact of managed entry, risk sharing and financial business agreement scenarios; Testing and incorporation scenarios into economic models; Undertake implementation analyses and evaluation.
  • Communicate Value: Build, review or customise value dossiers, formulary dossiers and HTA reports; produce publications, presentations, abstracts; present to congresses; deliver interactive and customisable digital tools to communicate value and handle objections

Critical Client Task

  • Negotiation: Manage engagement and negotiations with national authorities and key accounts, to achieve best access. Manage Engagement to negotiate and implement innovative contracting schemes, throughout product lifecycle.
  • Infrastructure: Train, guide and support staff in reimbursement and HTA assessment negotiations with stakeholders; develop corporate infrastructure and skills; integrate access to functional domains.

Services We Provide

  • Negotiation: Support client submissions and negotiations with stakeholders with tailor made analytics, reports and models advisory work, presentations, internal workshops, and registry design for managed agreements and tenders.
  • Infrastructure: Undertake bespoke training on soft and technical skills development; give advice on organisational issues and capacity development; organise internal brainstorming and alignment workshops; facilitate cross-functional collaboration.
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