Table 2. . Key input parameters.
| 24-month TLR rates | Value | Source (year) | Ref. |
|---|---|---|---|
| PTA – grade A/B dissections | 27.4% | Fujihara et al. (2017) PTA sub cohort <120 mm lesion length, no Rutherford 5 or 6. See supplementary materials. | [6] |
| PTA – grade C/D/E/F dissections | 82.6% | Fujihara et al. (2017) PTA sub cohort <120 mm lesion length, no Rutherford 5 or 6 (shown for reference only, not used in model calculation, as stent treatment was assumed for all severe dissections) | [6] |
| PTA + Tack – grade A/B dissections | 7.7% | Brodmann et al. (2023) TOBA II PTA sub cohort. See supplementary materials. | [16] |
| PTA + Tack – grade C/D/E/F dissections | 13.9% | Brodmann et al. (2023) TOBA II PTA sub cohort. See supplementary materials. | [16] |
| BMS | 26.9% | Katsanos et al. (2016), Table 2 | [12] |
| DES | 19.4% | ZILVER-PTX and ZILVER-PTX SAS (12-month data) | [13,14] |
| Strategy and reintervention probabilities | |||
| Non-severe dissections – status quo | 100% left untreated | Assumption for analysis | |
| Severe dissections – status quo | 100% stent-treated (85% BMS, 15% DES) | Assumption for analysis | |
| Non-severe dissections – Tack-supported | 100% Tack treatment | Assumption for analysis | |
| Severe dissections – Tack-supported | 100% Tack treatment | Assumption for analysis | |
| Reimbursement | |||
| Inpatient DRG 252 | $22,933 | IPPS FY (2023) | |
| Percent | 48.4% | Based on latest CMS data (2021) MEDPAR | |
| Inpatient DRG 253 | $18,342 | IPPS FY (2023) | |
| Percent | 37.0% | Based on latest CMS data (2021) MEDPAR | |
| Inpatient DRG 254 | $12,543 | IPPS FY (2023) | |
| Percent | 14.6% | Based on latest CMS data (2021) MEDPAR | |
| Resulting weighted DRG inpatient | $19,720 | Computed from inputs above | |
| Outpatient APC 5192 (PTA) | $5215 | HOPPS CY (2023) | |
| Outpatient APC 5193 (stent, or isolated atherectomy) (applies to stent[s] and to Tack) | $10,615 | HOPPS CY (2023) | |
| Outpatient APC 5194 (atherectomy + stent) (applies to stent[s] and to Tack) | $17,178 | HOPPS CY (2023) | |
| OBL (PTA) | $2987 | CY (2023) payment rate | |
| OBL (Stent(s), or isolated atherectomy) (applies to stent[s] and to Tack) | $8337 | CY (2023) payment rate | |
| OBL (atherectomy + stent[s]) (applies to stent[s] and to Tack) | $11,473 | Final CY (2023) OPPS payment rate | |
| Percent of procedures outpatient (vs inpatient) | 53.8% | Medicare Phys. Supplier Proc. Summary (CPT) (2020) | |
| Percent of outpatient procedures performed in OBL | 34.6% | Medicare Phys. Supplier Proc. Summary (CPT) (2019) | |
| Device prices | |||
| PTA | $516 | Estimate based on 2022 market research data – POBA catheter, fempop indication | |
| DCB | $1590 | Estimate based on 2022 market research data | |
| BMS | $840 | Estimate based on 2022 market research data – BMS, fempop indication | |
| DES | $2085 | Estimate based on 2022 market research data – DES, fempop indication | |
| Tack | $1945 | Current list price, as communicated by the manufacturer | |
| Scoring balloon | $1352 | Estimate based on 2022 market research data – specialty balloon | |
| Atherectomy | $2210 | Estimate based on 2022 market research data – atherectomy device, total (rotational/directional/laser) | |
| Device utilization – see appendix | |||
| Distribution of dissections | |||
| Type A | 11.2% | TOBA II PTA cohort, core lab-reported | |
| Type B | 19.1% | TOBA II PTA cohort, core lab-reported | |
| Type C | 46.1% | TOBA II PTA cohort, core lab-reported | |
| Type D | 23.6% | TOBA II PTA cohort, core lab-reported | |
| Type E | 0.0% | TOBA II PTA cohort, core lab-reported | |
| Type F | 0.3% | TOBA II PTA cohort, core lab-reported | |
| QALY decrement | |||
| QALY decrement per TLR | -0.059 | Salisbury et al. (2016) | [18] |
BMS: Bare metal stent; CMS: Centers for Medicare and Medicaid Services; CPT: Current procedural terminology; CY: Calendar year; DCB: Drug-coated balloon; DES: Drug-eluting stent; DRG: Diagnosis-related group; HOPPS: Hospital Outpatient Prospective Payment System; OBL: Office-based lab; OPPS: Outpatient Prospective Payment System; PTA: Percutaneous transluminal angioplasty; QALY: Quality-adjusted life year; SAS: Single arm study; TLR: Target lesion revascularization.