SWISS APPROVAL HEALTH CARE & MEDICAL TECHNOLOGY ASSESSMENT

Policy and Advocacy to shape regulation, that fosters a positive Pricing, Market Access and Business Development environment.

Aim to devise and execute effectively an intelligent strategy that will to shape a positive regulatory environment for pricing, market access and business development.

Such Policy and Advocacy, is based on thorough monitoring and understanding of the regulatory dynamics, analytical ability to assess regulatory and policy impact, establishment of strong partnerships with stakeholders, innovative thinking, and evidence-based policy recommendations and effective advocacy.

Our 5 Steps Process for Policy and Advocacy

Critical Client Task

  • Regulations: Monitor, analyse, understand and foresee evolving trends, standards and policies in marketing authorisation, Pricing and Reimbursement, Health Economics Outcomes Research, Health Technology Assessment, access, patient engagement, and advocacy.
  • Policy impact: Quantify impact and risks associated with policies and regulations for industry and for product portfolio and company business activities.
  • Stakeholders: Map important stakeholders, in academia, payers, Health Technology Assessment (HTA) bodies, providers, patient advocacy groups, Governments, understand and foresee their priorities, thinking, and market needs.
  • Market: Monitor, understand and predict and market size, structure, prevailing health and other technological trends, demand drivers and critical factors for business success.
  • Disease: Understand therapy market dynamics, therapeutic alternatives, management pathways, unmet medical and economic needs.

Services We Provide

  • Regulations: Pricing and Reimbursement, payer, HTA, market access landscape assessment, intelligence collection, trend analysis and insights, through desktop research, pricing stakeholder surveys, advisory boards, delphi panels and workshops.
  • Policy impact: Policy and regulation research & analysis, modelling, forecasting, impact analysis, risk analysis and mitigation, through workshops & advisory boards.
  • Stakeholders: Stakeholder mapping and segmentation studies, intelligence and insights development, analysis of needs and wants, through desktop research and reviews, surveys, advisory boards, and workshops;
  • Market: Market assessment, intelligence collection, trend analysis and insights, forecasting through desktop research, stakeholder surveys, advisory boards.
  • Disease: Rapid, targeted or systematic reviews of disease, market, Medical technology, guideline and patient management through desktop research, 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 technology, market access, evidence generation and brand plans.
  • Capacities: Assess internal organisational capacities, experience, gaps, and priorities at global, regional and national level and plan to cover any weakness and gaps.
  • Engagement: Engage with relevant stakeholders in pricing, reimbursement, health technology assessment, payer, governmental agencies, academia, professional associations, committees, and patient advocacy groups.

Services We Provide

  • Alignment: Provide cross functional alignment through workshops and facilitation; 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, undertake benchmarking and assess internal organisational capacities, to provide advice, training and support to cover gaps at different levels and functions.
  • Engagement: Identify and select stakeholders in relevant agencies and organisations, develop networks and engage effectively through scientific and advocacy events, research, and other relevant activities aiming to establish trusted relationships.

Critical Client Task

  • Strategy: Assess market dynamics, portfolio life cycle strategic plan and business priorities; Identifying policy priorities and objectives to overcome key barriers; Generate policies that shape favourable access and funding environments, and uptake of products.
  • Operations: Develop operational plan for managing and implementing policy; develop evidence generation, advocacy, and communication pan at supranational and national level .

Services We Provide

  • Strategy: Analytics, modelling and forecasting; Develop strategies and policy positions that address access barriers, support patient choice and ensure a sustainable pharmaceutical industry; Through research, advisory boards and technology committees.
  • Operations: Review, benchmarking and assess internal organisational capacities and provide advice, training and support; digital health business strategy; re-organisation plans; workshops and cross function alignment facilitation.

Critical Client Task

  • Build Value Evidence: Build evidence to demonstrate gaps and weakness, Pricing & Reimbursement, HTA, Market Access models and regulations; Generate evidence to support recommendations; Quantity potential value.
  • Communicate Value: Build strategy and tools to communicate policy recommendations value to stakeholders in convincingly meaningful, relevant, and customised manner to attain from them positive perceptions and decisions.

Services We Provide

  • Build Value Evidence: Policy and regulation research & analysis, modelling, forecasting, impact analysis, risk analysis and mitigation, through through desktop research and reviews, surveys, advisory boards, and workshops.
  • Communicate Value: Identify and select targets in relevant agencies and organisations; Develop engagement and communication plans; Engagement plans; Develop relevant networks and engage effectively through scientific and advocacy events and campaigns.

Critical Client Task

  • Infrastructure: Train, guide and support staff in negotiations with stakeholders and customer engagement; Develop corporate infrastructure and skills; Integrate access to functional domains.Facilitate cross-functional collaboration.
  • Impact Policy: Engage with stakeholders and communicate effectively to shape regulatory and policy environment with thought leadership work undertaken together with external partners to make it positive for company interests .

Services We Provide

  • 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.
  • Impact Policy: Support client engagement with stakeholders with tailor made advisory work, presentations, workshops, publications, and scientific, communication and advocacy events; identify and educating advocacy groups to inform policymakers; support communications and media relations activities.
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