1
Marketing authorizationMFDS
Output: Marketing authorization and label
Scope: Korean regulatory supply
Compare market pathways
Align systems by decision stage without forcing them into one universal route.
South Korea
Japan
Germany
United States
🇰🇷 South Korea：MFDS authorization, HIRA reimbursement assessment, NHIS price/contract negotiation and MOHW listing are separate; RSA, use-volume and flexible pricing solve different problems.; 🇯🇵 Japan：Japan uses rules-based NHI price listing after approval; selective cost-effectiveness assessment adjusts price after listing rather than acting as a universal coverage gate.; 🇩🇪 Germany：GKV access begins at launch, while AMNOG benefit assessment and reimbursement negotiation determine the later price; the 2026 reform adds mandatory price-volume terms and fund-specific patent-group contracting.; 🇺🇸 United States：Choose benefit, payer and site of care before drawing the pathway; the United States has no single national reimbursement decision.
RegulatoryHTA / assessmentPrice / negotiationCoveragePost-listing
South Korea
MFDS authorization, HIRA reimbursement assessment, NHIS price/contract negotiation and MOHW listing are separate; RSA, use-volume and flexible pricing solve different problems.
2
Reimbursement suitability assessmentHIRA
Output: Reimbursement suitability and evidence conclusion
Scope: National Health Insurance benefit proposal
3
RSA / CEA exemption eligibilityHIRA / MOHW rules
Output: Eligibility for a defined exceptional assessment or agreement route
Scope: Eligible disease, product and evidence conditions only
4
Price negotiation and contractingNHIS
Output: Reimbursement price and applicable contract
Scope: NHI listing and contracted conditions
5
NHI listing noticeMOHW
Output: Final NHI listing, price and conditions
Scope: National benefit under notice terms
6
Post-listing managementNHIS / HIRA / MOHW
Output: Use-volume, expenditure, evidence or contract adjustment
Scope: Mechanism-specific product and period
Japan
Japan uses rules-based NHI price listing after approval; selective cost-effectiveness assessment adjusts price after listing rather than acting as a universal coverage gate.
1
New drug approvalPMDA / MHLW
Output: Marketing approval and label
Scope: Approved Japanese indication
2
NHI listing and pricing reviewMHLW / Chuikyo
Output: Eligibility and applicable pricing method
Scope: National health insurance listing
3
Initial NHI drug priceMHLW
Output: One official reimbursement price under the pricing rules
Scope: NHI claims for the listed product
4
Cost-effectiveness evaluationCEA expert groups / Chuikyo
Output: ICER appraisal and post-listing price adjustment
Scope: Only designated products/indications and price-adjustment scope
5
Biennial / special price revisionMHLW / Chuikyo
Output: Revised NHI price
Scope: Products meeting survey/rule conditions
Germany
GKV access begins at launch, while AMNOG benefit assessment and reimbursement negotiation determine the later price; the 2026 reform adds mandatory price-volume terms and fund-specific patent-group contracting.
1
EU marketing authorizationEMA / European Commission
Output: Union marketing authorization
Scope: Approved indication across EU/EEA as applicable
2
AMNOG dossier at first placing on marketManufacturer / G-BA
Output: Evidence package for added-benefit assessment
Scope: GKV target population and comparator subgroups
3
Zusatznutzen resolutionG-BA
Output: Binding added-benefit resolution by subgroup
Scope: GKV price negotiation and prescribing information
4
Erstattungsbetrag and price-volume termsGKV-Spitzenverband / manufacturer
Output: National reimbursement amount plus negotiated or statutory price-volume rule
Scope: GKV supply; negotiated scope and statutory rules
5
Patent-group rebate contract branchSickness fund / association / prescriber
Output: Tendered contract and preferred medicine within an eligible therapeutic group
Scope: Fund/group/product-specific; medical exception remains
6
NUB / ZE hospital fundingInEK / hospitals / sickness funds
Output: Temporary innovation status or additional payment route
Scope: Named hospital, case and DRG context
United States
Choose benefit, payer and site of care before drawing the pathway; the United States has no single national reimbursement decision.
1
NDA / BLA approvalFDA
Output: Marketing authorization and approved label
Scope: Federal legal supply boundary
2
Coverage policy / formulary decisionCMS, MAC, state Medicaid or health plan
Output: National/local coverage rule or plan formulary status
Scope: Named payer, benefit, indication and population
3
HCPCS / NDC operational codingCMS or plan / pharmacy network
Output: Billable product/service identity
Scope: Claim route and setting; not coverage itself
4
ASP / WAC / AMP / URA / MFP / 340B layerCMS, manufacturer, Medicaid and federal programmes
Output: Distinct statutory or commercial price metric
Scope: Metric-specific products, payers and transactions
5
Contracting and utilization managementManufacturer, PBM, plan and provider
Output: Rebate/contract plus PA, step edit or site-of-care rule
Scope: Named plan, channel, provider and member
6
First funded patientPlan, provider and dispensing/acquisition channel
Output: Authorized treatment, paid claim and available product
Scope: Individual patient at a capable site