How Korea’s Digital Therapeutics Platforms Are Evaluated by US Health Insurers

How Korea’s Digital Therapeutics Platforms Are Evaluated by US Health Insurers

You’ve built something meaningful, and now the big question is simple and scary at the same time—will US health insurers cover it, yo? If you’re coming from Korea’s fast‑moving digital health scene, the playbook in the US can feel like a maze, but it’s a maze with patterns you can learn and navigate, da. Let’s walk it together in a way that feels practical, friendly, and honest, yo!

Quick Guide

• What US insurers look for first, yo.
• Economic proof that moves committees, da.
• The formulary journey for a Korean DTx, yo.
• Technical due diligence that builds trust, da.
• Evidence portability from Korea to the US, yo.
• Who evaluates and how decisions happen, da.
• Practical checklist and benchmarks for 2025, yo.
• Common pitfalls and how to avoid them, da.
• Case patterns without company names, yo.
• Closing thoughts, da.

What US insurers look for first

Regulatory and labeling signals that reduce friction

• FDA pathway clarity matters more than the specific letter on the clearance, yo. A De Novo or 510(k) with a clearly defined intended use and “Rx only” labeling is a strong opening signal that a P&T committee can act on, yo.
• If you’re MFDS‑authorized as a Class II SaMD, US payers will ask how that maps to FDA expectations and whether your US label mirrors the endpoints you studied, da.
• Breakthrough Device status can help in conversations, but it’s not a golden ticket, yo. Insurers still ask for comparative effectiveness and budget impact before they bless any coverage policy, da.

Clinical evidence hierarchy that feels familiar

• The usual ladder still applies: randomized controlled trials > well‑designed pragmatic trials > large real‑world evidence > observational studies and case series, yo.
• For behavioral health, expect to show a PHQ‑9 or GAD‑7 change of 5–8 points with response and remission rates clearly defined; for insomnia, aim for a 6–8‑point drop on ISI and maintenance at 6–12 months, da.
• Chronic conditions get quantified too: HbA1c reduction of 0.8–1.2 percentage points over 6 months is persuasive; 8–12 mmHg systolic blood pressure reduction with 70% device adherence over 12 weeks is credible, yo.
• Payers love sample sizes that don’t flinch: n≥300 in pivotal RCTs and n≥5,000 in RWE spanning 6–12 months with pre‑specified endpoints, da.

Engagement and adherence as dose of therapy

• “Digital dose” is not fluffy—committees will ask for median weekly active minutes, module completion rates, and 30‑, 90‑, 180‑day retention, yo.
• Benchmarks that open doors: 70% program completion, 50% 90‑day retention, and median 8–12 minutes of weekly therapeutic activity that correlates with outcomes, da.
• Show dose–response curves with adherence quartiles; it’s an easy win when higher engagement equals better clinical delta, yo.

Safety, privacy, and security without drama

• HIPAA compliance is table stakes, but they’ll ask for SOC 2 Type II or HITRUST r2, third‑party pen‑test reports, and signed BAAs with clear incident response SLAs, da.
• AES‑256 at rest, TLS 1.2+ in transit, key rotation, and role‑based access control with SSO/OAuth 2.0 are all expected, yo.
• If you process data outside the US, show exactly how PHI is segregated, anonymized, or localized under a BAA and data processing agreement, da.

Economic proof that moves committees

The PMPM math everyone checks first

• Most payers start with a per‑member‑per‑month lens, yo. If your total cost lands under $1.50–$3.50 PMPM for a targeted cohort with clear eligibility criteria, you’ve got a shot, yo.
• Deliver a transparent budget impact model with claims‑based inputs for ER visits, admissions, specialist encounters, and pharmacy fills; avoid hand‑wavy assumptions, da.

Cost effectiveness and time horizon

• Many committees nod at $50,000–$100,000 per QALY as a comfort zone, but they care more about 12‑ to 18‑month ROI because benefit cycles reset, yo.
• A 1.5–3.0x ROI within 12–18 months with sensitivity analysis for uptake, adherence, and price reductions is the sweet spot, da.

Offsets across benefit silos

• Your solution may lower medical spend but live in pharmacy or digital benefits, yo. Spell out savings in medical claims, behavioral health, and disability/productivity to break the silos, yo.
• Include absenteeism and presenteeism reductions for employer plans—5–8 saved days per engaged member per year can tilt a stop‑loss conversation, da.

Contracting models that de risk adoption

• Payers appreciate outcomes‑based contracts with shared savings or pay‑for‑performance triggers, yo.
• Offer a pilot‑to‑scale staircase: 6 months with strict KPIs, then auto‑expand if thresholds are met, da.
• Tiered pricing by engagement or verified clinical response keeps actuaries comfortable, yo.

The formulary journey for a Korean DTx

AMCP dossier that lands well

• Submit a polished AMCP Format dossier with clinical, economic, and safety sections plus a transparent economic model and code‑ready billing scenarios, da.
• Include bilingual source data if studies originated in Korea, but lead with US‑population evidence or bridging analyses so reviewers don’t worry about portability, yo.

Cultural and linguistic localization that works

• US payers ask whether content was culturally adapted, not just translated, da.
• Show reading‑level checks (e.g., Flesch‑Kincaid grade 6–8), bilingual modules, and outcomes by language subgroup to close the loop, yo.
• Include human factors testing in diverse US populations and usability scores ≥80 on SUS if you have them, da.

Coding and where it lives on the benefit

• Decide early whether you’ll live under the medical benefit, pharmacy benefit, or digital health carve‑out, yo.
• Map to existing CPT/HCPCS pathways where appropriate and support clinicians with RTM or care management billing when it’s clinically relevant, da.
• If you require a prescription, be explicit about prescriber types, eRx workflow, and how the patient receives activation, yo.

Prior authorization and step therapy

• Expect prior auth with documented diagnosis, prior treatment failure or contraindication, and standardized scales at baseline and follow‑up, da.
• Provide a one‑page PA template, clinical criteria, and evidence‑based step policy suggestions to reduce administrative friction, yo.

Technical due diligence that builds trust

Interoperability that actually integrates

• FHIR R4 endpoints with SMART on FHIR authentication, Epic and Cerner integration guides, and event‑driven webhooks make IT teams breathe easier, da.
• Offer discrete data writes for vitals, questionnaires, and structured outcomes plus CCD or HL7 v2 if legacy systems demand it, yo.

Identity, consent, and governance

• Use verified identity, granular consent, and a clean data minimization policy mapped to HIPAA, da.
• Provide a data dictionary, a lineage map, and a retention schedule; it turns a scary audit into a short meeting, yo.

Cybersecurity and third party attestations

• SOC 2 Type II, ISO 27001, and if possible, 27701 for privacy are strong credibility markers, yo.
• Red team annually, patch in defined windows, and publish a security whitepaper with SBOMs for your mobile and web apps, da.

Algorithmic transparency and fairness

• If you use ML, report AUC, sensitivity/specificity, calibration slope 0.9–1.1, and performance parity across age, sex, and race/ethnicity with gaps <5%, yo.
• Offer a model card and allow payer audit of drift monitoring over 12 months, da.

Evidence portability from Korea to the US

Bridging trials and external controls

• Use Korean RCTs for signal, then run US bridging studies that replicate endpoints and collect US claims where possible, yo.
• External control arms from US registries can shorten timelines if your matching strategy is pre‑specified and peer reviewed, da.

Health equity and SDOH adjustments

• Insurers need to see performance across Medicaid‑eligible proxies, rural ZIPs, and lower‑income cohorts, yo.
• Show differential engagement strategies—SMS nudges, low‑data modes, and clinician augmentation for patients with high SDOH risk, da.

Engagement design that lasts

• Prove that therapeutic content remains effective past week eight, yo.
• Show stickiness with variable reinforcement schedules, personalized pathways, and human coaching escalation rules that keep completion ≥70%, da.

BYOD performance and accessibility

• Document consistent performance across iOS and Android versions and devices, including low‑end hardware, yo.
• Accessibility compliance with WCAG 2.1 AA and screen‑reader support is increasingly checked, da.

Who evaluates and how decisions happen

PBM and payer committees

• Pharmacy and Therapeutics committees now often include a digital health subcommittee, yo.
• Expect 2–3 cycles of review, clinical first, then economic, then contracting, with security review running in parallel, da.

Employers and stop loss

• Self‑insured employers lean on PBM digital formularies and internal benefits leaders, yo.
• Stop‑loss carriers want hard savings within 12 months and clear exclusion criteria to avoid adverse selection, da.

Integrated delivery networks and value based care

• Health systems care deeply about workflow, credentialing, and clinical time impact, da.
• If your DTx reduces nurse minutes per patient by 15–25% while improving outcomes, you’ve got friends in care management, yo.

Medicaid and Medicare considerations

• Medicaid plans prioritize equity, language support, and device access paths, da.
• Medicare pathways for digital therapeutics remain in motion, so many payers rely on internal coverage policies and pilots before scaling, yo.

Practical checklist and benchmarks for 2025

Clinical minimums before first meeting

• One pivotal RCT with n≥300 or two strong RCTs with pooled analysis, plus 6–12‑month RWE with n≥5,000, yo.
• Pre‑specified primary endpoint met with p<0.05 and effect size clinically meaningful by guideline standards, da.

Economic thresholds that persuade

• PMPM under $3 for the target cohort, ROI ≥1.5x within 12–18 months, and a scenario analysis that still beats 1.2x at conservative uptake, yo.
• Include a downloadable actuarial appendix with ICD‑10, CPT/HCPCS, and unit cost assumptions, da.

Technical table stakes that pass review

• SOC 2 Type II, HITRUST or equivalent, BAAs ready, FHIR R4 integration guides, SSO with SAML/OIDC, yo.
• Clear uptime SLOs ≥99.9% and incident response within 72 hours with root‑cause analysis, da.

Go to market sequence that shortens cycles

• Start with an outcomes‑based pilot at one national payer’s regional plan, then expand to employer coalitions and IDNs with case studies, yo.
• Equip clinical champions with order sets, PA templates, and training modules under 30 minutes, da.

Common pitfalls and how to avoid them

Overreliance on small single site trials

• Multisite heterogeneity matters; replicate results across geographies and care settings, yo.
• Use independent statisticians and publish your SAP, da.

ROI that’s vague or too optimistic

• Tie savings to paid claims categories and validate unit costs with the payer’s own data during diligence, yo.
• Show what happens if adherence drops 20% and price stays flat—credibility beats bravado, da.

Ignoring frontline workflow

• If it adds clicks or minutes for clinicians, adoption dies quietly, yo.
• Offer turnkey onboarding, EHR buttons, and patient education that reduces inbound calls, da.

Underestimating contracting lift

• Align on benefit placement, coding, PA, step therapy, and data feeds before pricing, yo.
• Pre‑fill all legal exhibits—security, privacy, data sharing, and service levels—to shave weeks off redlines, da.

Case patterns without company names

Insomnia CBTi pathway

• Evidence: ISI −7.2 at 8 weeks, maintained at 6 months; 72% module completion, 55% 90‑day retention, yo.
• Economics: ER visit reductions for sleep‑related complaints and fewer hypnotic prescriptions, PMPM ~$1.40, ROI ~1.8x in 12 months, da.
• Operational: Rx workflow with PA baseline ISI and follow‑up at week 8, da.

Hypertension self management pathway

• Evidence: −10.5 mmHg SBP at 12 weeks with connected BP cuff and coaching escalation, 68% device adherence, yo.
• Economics: Fewer hypertensive crises and cardiology visits, medical offset visible in 9–12 months, PMPM ~$2.30, da.
• Technical: FHIR vitals write‑back and alerts into care team inbox, yo.

Depression and anxiety PDTx pathway

• Evidence: PHQ‑9 −6.1 and GAD‑7 −5.4 at 12 weeks, remission 28% vs 14% control, yo.
• Safety: Suicidality screening with same‑day escalation, 24×7 coverage protocol documented, da.
• Economics: Reduced behavioral health visits per member but improved quality scores; PMPM ~$2.80, outcomes‑based price floors, yo.

Musculoskeletal digital therapy pathway

• Evidence: Oswestry Disability Index −12 points at 12 weeks, opioid Rx reduction 18%, yo.
• Economics: Avoided PT sessions and imaging, medical offset within 9 months, da.
• Workflow: Employer TPA integration and PT referral loops in EHR, yo.

Closing thoughts

Building trust step by step

• US payers don’t say yes because something is cool—they say yes because the math, the medicine, and the mechanics line up, yo.
• From Korea to the US, the bar is high, but it’s a bar you can clear with disciplined evidence, da.

Partnering with payers and providers

• Bring humility, publish your negative findings, and let clinical partners co‑design pathways that fit their day, yo.
• Offer contracts that share risk and celebrate outcomes together, da.

What success looks like in year one

• A clean pilot with clear KPIs, a peer‑reviewed paper in progress, two strong case studies, and a scalable contracting template, yo.
• Then it’s rinse, refine, and expand without losing the soul of the product that helps patients feel better, da.

Why Korea to US can be a winning bridge

• Korea’s speed, product craft, and behavioral design are real advantages, yo.
• When paired with US‑grade evidence, security, and economic storytelling, you’re not just crossing a bridge—you’re building one others will want to walk too, da.

If you’re mapping your own route and want a sanity check on endpoints, PMPM math, or an AMCP dossier outline, I’m cheering for you and happy to trade notes, yo!