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Pricing & Reimbursement Assessment for an Epilepsy Drug

To assess the pricing & reimbursement environment in the anti-epileptic therapeutic area in one CIS market
To assess the pricing & reimbursement environment in the anti-epileptic therapeutic area in one CIS market
Market Access consultancy
One of the biggest CIS market
Guidelines study:
  • Research of guidelines in the country available on each level: national, regional, local.
  • Building-up a scheme of patient's pathway within the targeted disease.
  • Overview of recommendations in the general treatment guidelines.
  • Analysis, whether current clinical practice consistent with the guidelines in the country.
  • Identification of the existing clinical practice (clinical standards).
Treatment infrastructure study:
  • Identification of the most essential treatment centers, KOLs, national KOLs, experts in the country.
  • Forming a list of potential HCPs and KOLs for the expert interview.
  • A roadmap of 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 study:
  • Identification of parties that can participate on behalf of the Target (company representative / attorney-at-law / other) and timing.
  • Review of the rules for price-setting (for both original and generic drugs) in the country.
Epidemiology study:
  • Assessing the overall country's environment concerning epilepsy, its prevalence, incidence, 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.
Reimbursement study:
  • 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 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.
Key areas covered in the project:
  • Market landscape analysis.
  • Pricing & Reimbursement environment with regards to AEDs.
  • Time and processes to achieve public funding in the country.
  • Anti-epileptics treatment infrastructure overview.
  • Understanding ways of the early market entry.
  • Timelining the P&R pathway process.
  • Analysis of available public funding schemes.
Market landscape analysis:
  • Analysis of Marketing Authorization Holders of the core competitive products in the market.
  • Assessment of the availability of competitive products: drug programs, Early Access Programs, Named Patient Access, targeted import, etc.
  • Research on whether competitive products are being reimbursed in the country.
  • Costing analysis: cost per DDD (WHO), cost per most commonly used/prescribed doses.
  • Pricing analysis: drugs package, a public price per package, EXW price per package, patient discount per package (if applicable), an annual cost per patient, etc.


Anastasiya MAXIMENKO
Partner, Recruitment & Organizational Development
Partner, Pharma & MedTech Market Access
Managing Partner

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