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Contract analysis / kickoff-meeting-minutes.docx
kickoff-meeting-minutes.docx
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Medium · 6
Standard · 1
I. Attendees
I. Attendees A. In-Person (San Diego — Genome Dx Therapeutics Inc., 4720 Torrey Pines Road, Suite 300, San Diego, CA 92130) • Theresa Nakamura — General Counsel & Vice President of Regulatory Affairs, Genome Dx Therapeutics Inc. ("GDT") • Kevin Driscoll — Vice President of Market Access & Reimbursement, Genome Dx Therapeutics Inc. • Dr. Priya Sundaram — Vice President of Clinical Development; Principal Investigator,
II. Call to Order and Introductions
Medium
⚑ Assignment / subcontracting
II. Call to Order and Introductions Miriam Calloway called the meeting to order at 10:02 a.m. Pacific Time. Ms. Calloway welcomed all participants, both those present in Conference Room 14A at Genome Dx Therapeutics' San Diego offices and those joining by videoconference, and thanked GDT for hosting the in-person portion of the meeting. Ms. Calloway noted for the record that the engagement letter between Calderwood &
III. Engagement Scope Review
III. Engagement Scope Review Ms. Calloway reviewed the scope of the Calderwood & Harkness engagement as set forth in the February 14, 2024 engagement letter executed by Ms. Nakamura on behalf of GDT. The engagement encompasses the following four principal workstreams:
1. PLA/CPT Coding Strategy. Calderwood & Harkness will conduct a comprehensive analysis an
1. PLA/CPT Coding Strategy. Calderwood & Harkness will conduct a comprehensive analysis and provide a written recommendation on whether GDT should pursue a Proprietary Laboratory Analyses (PLA) code or bill OncoPrecise GXP-47 under an existing CPT code. Based on the outcome of this analysis, Calderwood & Harkness, in coordination with Carraway Regulatory Advisors, will prepare the PLA code application for submission
2. LCD Application and MolDx Technical Assessment. Calderwood & Harkness will prepare and
2. LCD Application and MolDx Technical Assessment. Calderwood & Harkness will prepare and manage the submission of a local coverage determination (LCD) request to Cascade Fiscal Intermediaries, LLC ("CFI"), the Medicare Administrative Contractor responsible for Jurisdiction E (California), where GDT's reference laboratory is located. In connection with the LCD request, Calderwood & Harkness will prepare the MolDx tec
3. Medicare Reimbursement Rate Analysis. Calderwood & Harkness will prepare a formal cross
3. Medicare Reimbursement Rate Analysis. Calderwood & Harkness will prepare a formal crosswalk and gapfill pricing analysis to establish the target Medicare reimbursement rate for OncoPrecise GXP-47, including identification and analysis of comparable tests and their associated Medicare payment rates, and will provide strategic guidance on positioning GDT's target rate within the applicable CMS pricing framework.
4. NCD Pathway Assessment. Calderwood & Harkness will prepare a preliminary feasibility as
Standard
⚑ Commercial term
4. NCD Pathway Assessment. Calderwood & Harkness will prepare a preliminary feasibility assessment evaluating the strategic and practical considerations of pursuing a national coverage determination (NCD) through CMS, including an evaluation of the Coverage with Evidence Development (CED) framework as a potential pathway to conditional national coverage while additional clinical evidence is generated. Ms. Calloway no
IV. Overview of OncoPrecise GXP-47 — Test Characteristics
High
⚑ Non-compete / exclusivity restraint
IV. Overview of OncoPrecise GXP-47 — Test Characteristics A. Presentation by Kevin Driscoll and Dr. Priya Sundaram Mr. Driscoll and Dr. Sundaram delivered a joint presentation providing a comprehensive overview of the OncoPrecise GXP-47 test, its technical characteristics, intended clinical use, and regulatory and intellectual property status. The presentation included slide materials that were displayed on the confe
V. CLARITY-LUNG Clinical Validation Trial — Status Update
V. CLARITY-LUNG Clinical Validation Trial — Status Update A. Presentation by Dr. Priya Sundaram Dr. Sundaram provided a detailed status update on the CLARITY-LUNG clinical validation trial, which is the cornerstone of the clinical evidence base that will support the LCD application and MolDx technical assessment for OncoPrecise GXP-47. Trial Name: CLARITY-LUNG (Clinical Assessment of RNA Immunotherapy Therapy-respons
VI. Coding Strategy Discussion — PLA Code vs. CPT Code
Medium
⚑ Assignment / subcontracting
VI. Coding Strategy Discussion — PLA Code vs. CPT Code A. Presentation by Sean Morrissey and Christopher Aiken Mr. Morrissey and Mr. Aiken presented an overview of the two primary coding pathways available for OncoPrecise GXP-47 under the CMS Clinical Laboratory Fee Schedule, including the advantages and disadvantages of each approach, and provided a preliminary recommendation. Pathway 1 — Existing CPT Code 81455. CP
VII. LCD/MolDx Coverage Strategy Discussion
VII. LCD/MolDx Coverage Strategy Discussion A. Presentation by Miriam Calloway and Sean Morrissey Ms. Calloway and Mr. Morrissey presented the team's proposed strategy for obtaining Medicare coverage for OncoPrecise GXP-47 through the local coverage determination (LCD) process, including the role of the MolDx technical assessment as a prerequisite for LCD issuance. Target Medicare Administrative Contractor. The targe
1. MolDx Technical Assessment Dossier Submission. GDT (through Calderwood & Harkness) sub
1. MolDx Technical Assessment Dossier Submission. GDT (through Calderwood & Harkness) submits a comprehensive technical assessment dossier to Ridgeline Administrative Services. The dossier includes all test technical information, analytical and clinical validation data, clinical utility evidence, health economic analysis, and supporting literature.
2. MolDx Technical Assessment Review. Ridgeline conducts a detailed technical assessment
2. MolDx Technical Assessment Review. Ridgeline conducts a detailed technical assessment of the test, including a review of the submitted dossier, independent literature review, and consultation with subject matter experts as needed. The typical review period is three to six months from the date of dossier submission.
3. LCD Proposal. Following a favorable MolDx technical assessment, CFI issues a proposed
3. LCD Proposal. Following a favorable MolDx technical assessment, CFI issues a proposed LCD. The proposed LCD is published in the Medicare Coverage Database and is subject to a public comment period of a minimum of 45 days, during which stakeholders (including laboratories, physicians, patient advocacy organizations, and the general public) may submit comments on the proposed coverage policy.
4. LCD Finalization. After the public comment period closes and CFI has reviewed and resp
Medium
⚑ Assignment / subcontracting
4. LCD Finalization. After the public comment period closes and CFI has reviewed and responded to public comments, CFI issues a final LCD with an effective date. The final LCD establishes Medicare coverage policy for the test within Jurisdiction E. Target LCD Filing Date. The team's target date for filing the LCD application and MolDx technical assessment dossier is August 2024. Mr. Morrissey explained the rationale
1. Test Description and Intended Use. A comprehensive description of OncoPrecise GXP-47,
1. Test Description and Intended Use. A comprehensive description of OncoPrecise GXP-47, including the 47-gene panel composition, RNA expression analysis methodology, TRI score algorithm, specimen requirements, and intended clinical use in guiding treatment selection for Stage IIIB/IV NSCLC.
2. Analytical Validation Data. A summary of the completed analytical validation study, re
2. Analytical Validation Data. A summary of the completed analytical validation study, referencing the peer-reviewed publication in the Journal of Molecular Oncology Diagnostics (Vol. 18, Issue 4, pp. 412–429, December 2022), including data on precision, accuracy, limit of detection, specimen stability, and interference testing.
3. Clinical Validation Data. A summary of the CLARITY-LUNG interim analysis results (and,
3. Clinical Validation Data. A summary of the CLARITY-LUNG interim analysis results (and, if available by the filing date, any additional clinical validation data from the ongoing trial), as well as data from any prior retrospective studies that support the predictive accuracy of the TRI score.
4. Clinical Utility Evidence. Evidence demonstrating that the TRI score changes treatment
4. Clinical Utility Evidence. Evidence demonstrating that the TRI score changes treatment decisions and improves patient outcomes, including evidence that oncologists modify their treatment recommendations based on TRI score information and that patients who receive TRI-guided treatment have superior clinical outcomes compared to patients who receive standard-of-care treatment selection.
5. Health Economic Analysis. A comprehensive HEOR analysis prepared by Larkfield Health E
5. Health Economic Analysis. A comprehensive HEOR analysis prepared by Larkfield Health Economics, including a clinical utility model and a cost-effectiveness analysis comparing the cost of OncoPrecise GXP-47 testing with the cost savings attributable to avoidance of ineffective ICI therapy in patients predicted to have a low likelihood of response.
6. Bibliography of Peer-Reviewed Publications. A comprehensive bibliography of supporting
6. Bibliography of Peer-Reviewed Publications. A comprehensive bibliography of supporting peer-reviewed publications, estimated at 40 or more publications, including studies on the biological basis of the 47-gene panel, prior gene expression profiling studies in NSCLC, ICI response prediction literature, and health economic analyses of precision oncology diagnostics. B. Discussion Points Ms. Calloway emphasized that
VIII. Medicare Reimbursement Rate — Preliminary Discussion
VIII. Medicare Reimbursement Rate — Preliminary Discussion A. Presentation by Kevin Driscoll and Sean Morrissey Mr. Driscoll presented GDT's target Medicare reimbursement rate for OncoPrecise GXP-47 and provided context regarding the importance of the reimbursement rate to GDT's financial projections and capital planning. Mr. Morrissey provided an overview of the pricing methodology and preliminary crosswalk analysis
IX. NCD Pathway — Preliminary Discussion
IX. NCD Pathway — Preliminary Discussion Ms. Calloway briefly introduced the national coverage determination (NCD) pathway as a longer-term strategic objective for OncoPrecise GXP-47. While the immediate priority is to obtain Medicare coverage through a local coverage determination, an NCD would provide uniform Medicare coverage nationwide, eliminating the need to obtain separate LCDs from each MAC jurisdiction. Two
1. Traditional NCD Pathway. Under this approach, GDT (or another interested party) would
1. Traditional NCD Pathway. Under this approach, GDT (or another interested party) would submit a formal NCD request to CMS. CMS would open a national coverage analysis (NCA), conduct an independent review of the clinical evidence, and issue a proposed NCD followed by a public comment period and a final NCD decision. The traditional NCD pathway typically requires a robust and mature evidence base, including completed
2. Coverage with Evidence Development (CED). Under the CED framework, CMS may grant condi
2. Coverage with Evidence Development (CED). Under the CED framework, CMS may grant conditional national coverage for a test or treatment while additional clinical evidence is generated under a CMS-approved clinical study protocol. CED may be appropriate when CMS determines that the existing evidence base is promising but insufficient to support a full NCD. CED would allow Medicare beneficiaries to access OncoPrecise
X. Financial and Covenant Considerations
X. Financial and Covenant Considerations A. Presentation by Raymond Ota Mr. Ota provided important financial context for the engagement and flagged a specific covenant issue that requires attention. GDT Financial Overview. Mr. Ota reported that GDT's current annual cash burn rate is approximately $34 million, reflecting ongoing expenditures for the CLARITY-LUNG trial, laboratory operations, GXP-12 commercial activiti
XI. Roles, Responsibilities, and Workstream Assignments
Medium
⚑ Assignment / subcontracting
XI. Roles, Responsibilities, and Workstream Assignments The team reviewed and confirmed the allocation of roles, responsibilities, and workstream assignments across all parties to the engagement. The following tables summarize the agreed-upon assignments. A. Calderwood & Harkness LLP B. Carraway Regulatory Advisors, Inc. C. Larkfield Health Economics, LLC D. Genome Dx Therapeutics Inc. Ms. Calloway noted that all wor
XII. Action Items
XII. Action Items The following action items were identified and assigned during the meeting:
XIII. Key Deadlines and Milestones Summary
Medium
⚑ Assignment / subcontracting
XIII. Key Deadlines and Milestones Summary The following table summarizes the key deadlines and milestones identified during the meeting: Ms. Calloway noted that the team should treat the June 28, 2024, AMA submission deadline and the December 31, 2024, PCNB covenant testing date as the two most critical near-term deadlines on the project timeline. Missing the AMA submission deadline would delay the PLA code assignme
XIV. Next Meeting
XIV. Next Meeting The team agreed to the following meeting cadence going forward: • Bi-weekly project status calls will commence the week of March 4, 2024. These calls will include representatives from Calderwood & Harkness, GDT, Carraway Regulatory Advisors, and Larkfield Health Economics. Mr. Driscoll will coordinate scheduling and circulate calendar invitations to all participants by March 4, 2024. • Next in-depth
XV. Adjournment
XV. Adjournment The meeting was adjourned at 12:42 p.m. Pacific Time / 3:42 p.m. Eastern Time. Ms. Calloway thanked all participants for their time and contributions. She confirmed that Calderwood & Harkness would prepare and circulate these meeting minutes for review by all attendees within two business days of the meeting.
XVI. Distribution
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⚑ Confidentiality undertaking
XVI. Distribution These minutes have been distributed to the following individuals: • Theresa Nakamura, General Counsel & VP of Regulatory Affairs, Genome Dx Therapeutics Inc. • Kevin Driscoll, VP of Market Access & Reimbursement, Genome Dx Therapeutics Inc. • Dr. Priya Sundaram, VP of Clinical Development, Genome Dx Therapeutics Inc. • Raymond Ota, Chief Financial Officer, Genome Dx Therapeutics Inc. • Miriam Callow