Market Access
Coverage intelligence, reimbursement analysis, market forces, and competitive positioning across the Mays Cancer Center oncology portfolio.
$1631.2B
Combined TAM
6
Active Molecules
10
Market Forces Tracked
9
Competitor Trials
Market Access Modules
Coverage and coding intelligence for the oncology portfolio
- National Coverage Determinations
- Local Coverage Determinations
- MAC Contractor Analysis
- HCPCS / J-Code Directory
- ASP + 6% Reimbursement
- Buy-and-Bill Economics
Market Forces Analysis
Key regulatory, payer, competitive, scientific, and economic forces shaping the portfolio
regulatory · 2025–2029
Regenerative Medicine Advanced Therapy (RMAT) designation enables rolling review, priority review, and potential accelerated approval for 186RNL in recurrent GBM.
regulatory · 2025–2028
FDA has granted multiple designations to targeted protein degraders, signaling willingness to evaluate PROTACs. Arvinas' ARV-471 (Phase 3) will set precedent for DT2216.
payer · 2024–2030
CMS has established clear J-code and reimbursement pathways for Pluvicto. Growing acceptance of radiopharmaceuticals improves future coverage for 186RNL.
competitive · 2025–2026
AbbVie's navitoclax Phase 3 in myelofibrosis (TRANSFORM-1) could establish a BCL-XL inhibitor standard, potentially reducing DT2216's differentiation narrative.
competitive · 2025–2030
Multiple GBM therapies advancing (oncolytic viruses, CAR-T, IDH inhibitors). While none target the same mechanism as 186RNL, they compete for patients and investigator attention.
scientific · 2024–2035
The rapid adoption of PSMA-directed theranostics validates the radiopharmaceutical modality, benefiting both Pluvicto commercially and 186RNL's development pathway.
economic · 2025–2028
Texas CPRIT funding continues to support Mays Cancer Center programs. Multiple active grants ($3.2M for Avasopasem, $900K for MBD6) with renewal opportunities.
payer · 2025–2030
Payers increasingly requiring prior authorization for high-cost oncology therapies. Pluvicto already requires PA from most commercial plans; trend may extend to novel therapies.
regulatory · 2024–2028
Gilead's discontinuation of magrolimab (anti-CD47) in AML due to safety concerns validates BSI-082's SIRPα-targeting approach that avoids RBC toxicity.
economic · 2025–2027
Novartis investment in Lu-177 production capacity ($300M+ in new facilities) expected to ease supply constraints that have limited Pluvicto patient throughput.
Trial-to-Approval Pathway Intelligence
Estimated timelines and probability assessments for portfolio molecules
DT2216
CTCL / PTCL · Phase 1/2
Next Milestone
Phase 2 expansion cohort readout
12–18 months
Top Accelerator
FDA Fast Track + Orphan Drug designations
Top Risk
Novel PROTAC modality — no oncology regulatory precedent
186RNL
Recurrent GBM · Phase 2
Next Milestone
Phase 2 primary endpoint readout (OS)
6–12 months
Top Accelerator
FDA Fast Track + Orphan Drug + RMAT designations
Top Risk
Single-arm trial — may face regulatory scrutiny
Sacituzumab Govitecan
Recurrent GBM · Phase 2
Next Milestone
Phase 2 interim analysis
18–24 months
Top Accelerator
Proven ADC platform (FDA-approved in TNBC and UC)
Top Risk
BBB penetration uncertainty for ADC
BSI-082
Advanced solid tumors · Phase 1a/1b
Next Milestone
First patient dosed (Feb 2026) → dose escalation
24 months
Top Accelerator
SIRPα/CD47 axis validated by magrolimab data
Top Risk
First-in-class anti-SIRPα — no clinical precedent
Pluvicto
mCRPC (pre-chemo) · Approved (label expansion)
Next Milestone
PSMAddition readout (mHSPC expansion)
Active
Top Accelerator
Only civilian center in South Texas
Top Risk
177Lu supply constraints
Portfolio Market Opportunity
Total addressable market across all therapeutic areas
Cutaneous T-Cell Lymphoma (CTCL)
$1.2BPeripheral T-Cell Lymphoma (PTCL)
$800MAcute Myeloid Leukemia (AML)
$5BSmall Cell Lung Cancer (SCLC)
$2BGBM Therapeutics
$3.2BBrain Tumor Radiotherapy
$1.8BPediatric Brain Tumors
$800MRadioligand Therapy (global)
$4BmCRPC (post-ARPI, post-taxane — VISION)
$2.5BmCRPC (post-ARPI, pre-chemo — PSMAfore)
$3.5BmHSPC (potential — PSMAddition)
$8BPluvicto Reimbursement Intelligence
The only commercially approved molecule — comprehensive payer and reimbursement analysis
J9055
J9055 (lutetium Lu 177 vipivotide tetraxetan)
Per Dose
$42,500
Full Course (6 cycles)
$255,000
- Pluvicto REMS certification
- Nuclear medicine suite with appropriate shielding
- Authorized user (AU) with NRC radioactive materials license
- Radiation safety officer on staff
- Radioactive waste disposal capability
Most commercial payers require PA. Key requirements: PSMA PET/CT confirming PSMA positivity, documentation of prior ARPI failure, pathology confirming prostate adenocarcinoma, ECOG PS 0-2.
Coverage Policies
Medicare coverage determinations for portfolio therapies
J-Code: J9399 (unclassified antineoplastic) transitioning to J9055
Medicare covers Pluvicto for FDA-approved indications under Part B as a physician-administered drug. Reimbursement via hospital outpatient or freestanding nuclear medicine facility. ASP-based reimbursement with buy-and-bill model.
J-Code: J9055
MAC: Palmetto GBA (MAC JM)
Covers Pluvicto for PSMA-positive mCRPC per FDA labeling. Requires prior PSMA PET/CT demonstrating PSMA-positive disease. Documentation of prior ARPI therapy (and prior taxane for VISION indication) required.
J-Code: J9055
MAC: Novitas Solutions (MAC JL/JH)
Covers Pluvicto for FDA-approved indications. Requires PSMA PET/CT within 90 days of treatment initiation. Site must be Pluvicto REMS-certified. Up to 6 cycles covered.