{"documentId":"1G6IRAImpactAnalysis2027_stu876VwXyZ123AbCdEfGhI","title":"IRA Negotiation Impact Analysis — Zenvara 2032+ Eligibility","revisionId":"rev-1G6IRAImpact","body":{"content":[{"sectionBreak":{"sectionStyle":{"columnSeparatorStyle":"NONE","contentDirection":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":61,"textRun":{"content":"IRA Negotiation Impact Analysis — Zenvara 2032+ Eligibility\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"TITLE","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":116,"textRun":{"content":"Prepared by Sara Lindqvist, HEOR Director. Distribution: VP Commercial, CCO, CFO, Board package. Quarterly review.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":19,"textRun":{"content":"Executive summary\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":383,"textRun":{"content":"Zenvara (zenvalimab) is a small-molecule biologic eligible for inclusion in the IRA Medicare Drug Price Negotiation Program on the standard 7-year post-approval timeline. FDA approval was March 21, 2025; the selection eligibility window opens January 1, 2032. Under the current statutory timeline, the Maximum Fair Price (MFP) would become effective for Zenvara on January 1, 2034.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":286,"textRun":{"content":"Modeled MFP outcomes range from 38% to 52% off WAC, with a base case at 47% off WAC. Net present value impact across the 5-year period 2032-2036 ranges from -$1.2B (worst case) to -$0.4B (best case) versus a no-IRA counterfactual. Assumes WAC of $14,000 per 480mg vial and Q6W dosing.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":203,"textRun":{"content":"Three scenario branches drive the range: (a) MFP severity, (b) volume erosion in non-Medicare segments through reference pricing, (c) eligibility for the small-molecule extension under HHS rule-making.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":15,"textRun":{"content":"IRA mechanics\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":245,"textRun":{"content":"The IRA Medicare Drug Price Negotiation Program selects up to 15 Part D drugs per year for negotiation. Zenvara is selectable in the year-7-post-approval window (2032) given Part D inclusion at 22 of the top 25 plans by Medicare beneficiaries.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":278,"textRun":{"content":"Selection criteria: total Part D gross spend (last 12-month basis), no biosimilar or generic competition. Zenvara is expected to rank in the top 25 of selectable drugs by 2032 based on current trajectory and indication-expansion modeling. Selection is therefore highly likely.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":214,"textRun":{"content":"Negotiation cycle: 30 days from selection notice for manufacturer to indicate participation. Counteroffer cycle through Spring of selection year. MFP announced August 1 for the next-year January 1 effective date.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":224,"textRun":{"content":"The MFP applies to all Part D dispenses for Medicare beneficiaries. It does not apply to commercial, Medicaid, or 340B; however, the published MFP creates a reference price that downstream payers use in their negotiations.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":35,"textRun":{"content":"Scenario A — Maximum MFP severity\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":277,"textRun":{"content":"Assumption: HHS uses the lower bound of the negotiation framework, MFP set at approximately 52% off WAC ($6,720/vial). Volume erosion in commercial segments: minimal in year 1 of MFP (2034), 8-12% by year 5 (2038) as reference pricing flows through to commercial contracting.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":143,"textRun":{"content":"5-year NPV impact (2032-2036): -$1.2B vs. no-IRA counterfactual. Assumes flat Zenvara WAC, current rebate structure, no indication expansion.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":198,"textRun":{"content":"Mitigations modeled: indication expansion in 2L (IMpact-2 readout 2026), pediatric indication (PIP for AML — speculative), subcutaneous reformulation (Phase 1 PK bridging 2028, market entry 2030).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":24,"textRun":{"content":"Scenario B — Base case\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":97,"textRun":{"content":"Assumption: MFP set at 47% off WAC ($7,420/vial). Volume erosion in commercial: 4-6% by year 5.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":59,"textRun":{"content":"5-year NPV impact (2032-2036): -$780M vs. counterfactual.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":62,"textRun":{"content":"This is the planning case used in 2026 commercial decisions.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":47,"textRun":{"content":"Scenario C — Small-molecule extension granted\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":263,"textRun":{"content":"Assumption: HHS grants the small-molecule MFP extension that the industry is seeking (currently a regulatory proposal, not statutory). Under the proposed extension, small-molecule biologics get an additional 4 years of post-approval protection (11 years vs. 7).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":128,"textRun":{"content":"Effect: MFP effective date moves from 2034 to 2038. NPV impact for the 2032-2036 window: -$420M (versus the base case -$780M).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":79,"textRun":{"content":"Probability of extension being granted: 25-35% per current industry guidance.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":13,"textRun":{"content":"Sensitivity\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":188,"textRun":{"content":"The dominant sensitivity is volume erosion in non-Medicare segments. A 200 bps difference in commercial volume erosion at year 5 (8% vs 6%) changes the 5-year NPV by approximately $180M.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":275,"textRun":{"content":"The second-largest sensitivity is the WAC trajectory. The model assumes flat WAC through 2034; a 4% annual WAC increase (consistent with current oncology trend) would increase the gross-revenue base by $580M over the period, offsetting roughly two-thirds of the MFP impact.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":259,"textRun":{"content":"Third sensitivity: indication expansion. Each net-new approved indication adds approximately $90M in annual Part D net revenue at maturity. Adjuvant breast cancer (currently in Phase 3 design) would, if successful, materially shift the post-2034 trajectory.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":24,"textRun":{"content":"Strategic implications\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":197,"textRun":{"content":"Pre-MFP (2026-2031): aggressive indication expansion, geographic expansion, and patient access program scale. Goal is to maximize the addressable lifetime patient population before MFP effective.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":171,"textRun":{"content":"MFP year (2034): coordinated public-affairs response, P&T-level repositioning, defensive net-price management with commercial payers to slow reference-pricing diffusion.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":235,"textRun":{"content":"Post-MFP (2034-2040): lifecycle management dominant. Subcutaneous reformulation (if PK-bridging succeeds) creates a parallel product not subject to the existing MFP. Combination products with adjacent assets may extend the franchise.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":18,"textRun":{"content":"Comparable cases\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":251,"textRun":{"content":"The first 10 IRA-negotiated drugs (selected 2023, effective 2026) had MFP set at 38-79% off WAC across the cohort. Oncology drugs in the cohort (Imbruvica) faced approximately 38% off WAC. Cardiovascular and metabolic agents faced higher reductions.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":298,"textRun":{"content":"Zenvara's position is similar to the oncology comparators in the first cohort: clinically essential, no biosimilar competition expected, established premium pricing. The 47% base-case is at the higher end of the comparable cohort because Zenvara is single-agent (no companion-product complexity).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":38,"textRun":{"content":"Decision points for executive review\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":96,"textRun":{"content":"Q3 2026: confirm 2027 commercial plan assumptions on volume and net price under each scenario.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":77,"textRun":{"content":"Q1 2027: indication-expansion go/no-go on adjuvant breast (Phase 3 design).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":55,"textRun":{"content":"Q1 2028: subcutaneous reformulation phase-2 go/no-go.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":72,"textRun":{"content":"Q3 2029: pre-MFP scenario-planning workshop with executive leadership.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":71,"textRun":{"content":"Q1 2031: pre-selection messaging and stakeholder engagement strategy.\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":18,"textRun":{"content":"Cross-references\n","textStyle":{"bold":true}}}],"paragraphStyle":{"namedStyleType":"HEADING_2","direction":"LEFT_TO_RIGHT"}}},{"paragraph":{"elements":[{"startIndex":1,"endIndex":98,"textRun":{"content":"2026 Commercial Plan (1P1…), Lifecycle Management Roadmap (1Q4…), Evidence Dossier Index (1I8…).\n","textStyle":{}}}],"paragraphStyle":{"namedStyleType":"NORMAL_TEXT","direction":"LEFT_TO_RIGHT"}}}]},"documentStyle":{"pageNumberStart":1,"marginTop":{"magnitude":72,"unit":"PT"},"marginBottom":{"magnitude":72,"unit":"PT"},"marginLeft":{"magnitude":72,"unit":"PT"},"marginRight":{"magnitude":72,"unit":"PT"},"pageSize":{"height":{"magnitude":792,"unit":"PT"},"width":{"magnitude":612,"unit":"PT"}}},"namedStyles":{"styles":[{"namedStyleType":"NORMAL_TEXT","textStyle":{"fontSize":{"magnitude":11,"unit":"PT"}}},{"namedStyleType":"TITLE","textStyle":{"fontSize":{"magnitude":26,"unit":"PT"},"bold":true}},{"namedStyleType":"HEADING_1","textStyle":{"fontSize":{"magnitude":20,"unit":"PT"},"bold":true}},{"namedStyleType":"HEADING_2","textStyle":{"fontSize":{"magnitude":16,"unit":"PT"},"bold":true}}]},"lists":{},"inlineObjects":{},"headers":{},"footers":{},"footnotes":{},"suggestionsViewMode":"DEFAULT_FOR_CURRENT_ACCESS"}