Global Regulatory Consulting and Market Access Services
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Optimizing Time-to-Market for Biopharmaceuticals
Pricing
- Price comparator with existing therapies under local treatment frameworks to evaluate the effective cost of treatment over the full treatment lifecycle
- Focus on expected indication and therapeutic positioning
- Analysis of current treatment modalities and line of therapy
- KOL input on advantages and clinical benefits of the new therapy versus standard of care
- Risk assessment based on safety profile and adverse events
- Scientific evidence supporting product differentiation and value
Reimbursement
- Mapping of reimbursement policies across targeted markets
- Timeline and procedural guidance for securing reimbursement approvals
- Identification of primary launch markets based on reimbursement environment
- Strategic regulatory guidance for market entry and expansion
Market Overview
Market size
- Epidemiology of target patientsā group by literature review
- Local Epidemiology Study
Market Landscape
- Competitors
- Government policy: reimbursement and out-of-pocket market
- Treatment algorithm
- Local epidemiology data
- RWE review and analysis
Market research / KOL Analysis
- Price Sensitivity Analysis using analogs sourced from in-house proprietary data repository which is continuously updated
- Reference Pricing Mechanism Assessment their likely impact across markets
Commercial Team Alignment
Target patientsā profiles:
- Indication
- Positioning (in terms of treatment algorithm)
- Reference product identification
- Pricing proposal
- HEOR study scope and budget
Market access strategy:
- Scenario analysis and opportunities assessment
Market access strategy:
Internal stakeholdersā collaboration
External stakeholders:
- Stakeholders mapping according to the pre-identified key factors.
- Stakeholders networking plan (extra budget needed)
- Engagement meeting and visit
HEOR Study
Study preparation:
- Evidence synthesis/systematic reviews Study design
- Decision analysis modeling and simulation
- Health economic outcome analysis
- Budget impact, business case and return on investment analysis
- Risk sharing proposal
Study report and publication
Local Expertise, Delivered Globally with Pharma Wizard
- Diverse products experience across complex product categories and therapeutic areas
- Proven experience in market access and commercialization
- Health authority experience in navigating through complex, often ambiguous regulations
- Customer-focused, flexible services and solutions
- Flexible business model including project-based, managed services and FTE staffing model
- Hybrid-local-centralized support across safety functions
FAQS
What are key components of global Market Access Services?
The key components of Market Access include market research, market sizing (epidemiology, treatment algorithm, real world evidence assessment, key opinion leader analysis (KOL), target patient profile, reference product identification, pricing proposal, commercial team engagement, internal and external stakeholder engagement (prescribers, regulatory authorities, key opinion leaders etc), health economic outcome research (HEOR) and reporting.
How do you support Market Access across multiple countries?
Pharma Wizard has a highly experienced team of medical, market research, regulatory, and commercial experts with deep expertise across therapeutic areas and product categories, including new chemical entities and biologics. Our specialists have successfully supported the market entry of new therapies by leveraging real-world evidence, engaging key stakeholders in medical, scientific, and regulatory communities, and using data-backed benchmarking against approved therapies to ensure access to innovative biopharmaceuticals and drive commercial success for manufacturers.
What challenges do companies face in global Market Access and how do you address them?
Global biopharmaceutical companies often lack understanding of pricing and reimbursement regulations in new countries, lack access to key epidemiological and market data for market sizing and pricing analysis. Regional market access also requires sound knowledge and practical insights in preparing solid pricing proposals and application for reimbursement approvals; that in turn requires experience in successfully navigating local regulations and authorities.
How do you stay updated with global regulatory changes related to Market Access, Pricing & Reimbursement?
Pharma Wizardās central regulatory intelligence platform delivers comprehensive insights on market access, pricing, and reimbursement regulations across major global markets. In addition, our regional commercial and regulatory experts continuously monitor new regulations, guideline updates, notifications, and insights from health authorities, industry associations, and professional networks to ensure our strategies remain aligned with evolving requirements.
Still Have Questions ?
Specialized Regulatory Affairs Services Across Multiple Industries
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Expert Regulatory Services To Streamline Compliance
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