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Pricing & Reimbursement Assessment for an Epilepsy Drug
Task:
Assess the P&R landscape in anti-epileptics
Task:
Assess the P&R landscape in anti-epileptics
Client:
Market Access consultancy
Region:
The largest regional market
Treatment guidelines:
- Research of guidelines in the country available on each level: national, regional, and local.
- Building up a scheme of the patient's pathway within the targeted disease.
- Overview of recommendations in the general treatment guidelines.
- Analysis of whether current clinical practice was consistent with the guidelines in the country.
- Identification of the existing clinical practice (clinical standards).
Treatment infrastructure:
- Overview of the most essential treatment centers, KOLs, national KOLs, and experts in the country.
- Forming a list of potential HCPs and KOLs for the expert interview.
Deliverables:
- A roadmap for bringing an AED product into the country's market.
- A clear picture of the P&R environment in the country.
- Market and infrastructure research.
- Treatment guidelines and practices analysis.
Pricing analysis:
- Overview of actors that can participate on behalf of a Client (company representative / attorney-at-law / other) and timing.
- Examination of the rules for price-setting (for both original and generic drugs) in the country.
Epidemiology:
- Assessing the overall country's environment concerning epilepsy, its prevalence, incidence, and mortality.
- Estimation of the target population by funneling the total target patient population.
- Estimating the overall burden of the disease in the country.
- Identification of the unmet need in the targeted indication in the country.
Project areas:
- Market landscape analysis.
- Pricing & Reimbursement regulatory environment for anti-epileptics.
- Time and processes to achieve public funding in the country.
- Anti-epileptics treatment infrastructure overview.
- Understanding ways of early market entry.
- Timelining the P&R pathway process.
- Analysis of available public funding schemes.
Market analysis:
- Analysis of Marketing Authorization Holders of core competitive products in the market.
- Assessment of the availability of competitive products: drug programs, Early Access Programs, Named Patient Access, targeted import, etc.
- Analysis of reimbursement statuses of competitors.
- Costs analysis: cost per DDD (WHO), cost per most commonly used/prescribed doses.
- Pricing analysis: price per pack, public price per pack, EXW price per pack, patient discount per pack (if applicable), annual cost per patient, etc.
Reimbursement:
- Analysis of potentially available public funding schemes for medicines (in general) in the country.
- Identification of public funding options currently used for epilepsy drugs.
- Identification of whether the local market has centralized reimbursement decision-making and the process length (if available).
- Study of requirements for public funding and key decision-makers.
- Assessment of the existing HTA mechanism and guidelines in the country.
- Time from submission to favorable reimbursement decision.
- Review of reimbursement indication per each competitive product.
- Assessment of the level of competitive products being reimbursed.
- Study of the reimbursement modes in the country: pharmacy/drug program / other.
- Risk Sharing Schemes in the country availability analysis.
- Finding out all other possible reimbursement pathways (including e.g., innovative drug/device, other than a centralized reimbursement decision-making process).
- Identification of all components of the reimbursement process: what is required and what good to have (e.g., HTA report, local expert’s or patient organizations’ support), etc.
- Review of costs of submission in the country.
Project
leads
Yevgen Brovko
Co-founder, Market Access Partner (Pharmac/Biopharma, MedTech, Digital Health)
Anastasiia Maksymenko
Co-founder, Recruitment Partner (Pharma, Biotechnology, MedTech, Healthcare)
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