NCODA Urges CMS to Reconsider Proposed QSSD Policy for Fixed-Combination New Formulations
Published Date:
Re: CMS-4215-P (RIN 0938-AV90) – Proposed § 429.125(b)(4)(i), QSSD Treatment of Certain Fixed-Combination New Formulations
The Network for Collaborative Oncology Development & Advancement (NCODA) and NCODA Executive Council members, a group of nationally recognized senior oncology leaders, appreciate the opportunity to provide comments regarding the proposed modification to the fixed-combination drug policy at § 429.125(b)(4)(i) under the Medicare Drug Price Negotiation Program.
NCODA is a national nonprofit organization that represents more than 17,000 multidisciplinary oncology professionals across 6,000+ sites of care. We are dedicated to advancing patient-centered, evidence-based cancer care.
While we appreciate CMS’s efforts to provide greater clarity regarding Qualifying Single Source Drug (QSSD) eligibility, we respectfully encourage the Agency to carefully consider the policy implications of aggregating certain fixed-combination products with another product held by the same NDA or BLA holder when an added component creates a new formulation and enables an alternative route of administration. Our concern is that the proposed test could treat the products as a single QSSD without a sufficiently transparent, product-specific assessment of clinically meaningful value to patients and the care system.
NCODA recognizes CMS’s legitimate interest in preventing circumvention of drug selection or application of an agreed maximum fair price (MFP), and we recognize Congress’s direction to aggregate across dosage forms and strengths, including new formulations. Those provisions do not, however, specify when a fixed combination containing an added active component should be treated as a new formulation of the same drug rather than as a clinically distinct fixed combination. CMS should resolve that boundary through narrow, reproducible, product-specific criteria.
The therapies affected by this proposal can be more than alternative presentations of an existing product. They may be supported by product-specific evidence regarding pharmacokinetics, immunogenicity, safety, administration, and patient experience, as applicable, and reviewed by FDA under the relevant statutory pathway. Although FDA approval and QSSD classification serve different statutory purposes, the evidence supporting a separate approval may demonstrate clinically meaningful distinctions that CMS should evaluate rather than presume away.
NCODA is concerned that the proposed framework may unintentionally blur these important distinctions. Ingredient identity, common ownership, and route enablement are relevant, administrable factors, but they should not be conclusive without considering product-specific clinical, patient, and care-delivery evidence.
From the medically integrated oncology perspective, route-of-administration innovation may provide value beyond convenience. Depending on the therapy and individual patient, it may shorten administration time, reduce intravenous-access burden, improve the patient and caregiver experience, and preserve limited infusion capacity – factors that can support timely access to care close to home. CMS should evaluate these outcomes using product-specific clinical evidence, patient-reported outcomes, administration and resource-use data, and real-world evidence.
Recent real-world evidence illustrates why product-specific review matters. In an early descriptive analysis of 98 patients, subcutaneous nivolumab plus hyaluronidase-nvhy was administered in 3 to 5 minutes; patient characteristics, treatment patterns, and safety were comparable to intravenous nivolumab, and travel-distance variability was greater among subcutaneous recipients. The authors concluded that subcutaneous administration may support care for patients with higher geographic burden.1
We are also concerned about the broader precedent this proposal may establish. Advances in oncology increasingly occur through improvements to existing therapies, including new formulations, novel delivery mechanisms, fixed-dose combinations, and other innovations designed to improve safety, effectiveness, and/or the patient experience. Without an explicit clinical-meaningfulness standard and a transparent, product-specific evidentiary process, the proposed test could create uncertainty for future route-of-administration innovation.
Innovation in oncology should be recognized not only through the discovery of entirely new molecular entities, but also through meaningful advances that improve the way patients receive care. Many of these improvements require substantial scientific investment, rigorous clinical evaluation, and independent regulatory review before becoming available to patients.
CMS’s statement that formulation- and route-specific clinical benefit can be considered during negotiation under proposed § 429.510(e) is important. But valuation within a combined QSSD does not substitute for a sound, transparent classification standard.
NCODA respectfully recommends that CMS not finalize proposed § 429.125(b)(4)(i) as drafted. If CMS proceeds, the final rule should require: (1) affirmative evidence from FDA-approved labeling or review materials of a direct causal nexus between the added component and the alternative route; (2) a product-specific evaluation of indications, intended populations, component activity, treatment regimen, and clinically meaningful differences in efficacy, safety, tolerability, administration burden, patient preference, access, and resource use; and (3) a published rationale and a timely opportunity to correct factual errors and submit relevant evidence. Ingredient lists and route fields alone should not be determinative. Products in which the added component has independent disease-directed activity or creates a materially different therapeutic regimen should remain outside the proposed aggregation pathway. When evidence is ambiguous, CMS should consult FDA and practicing oncology clinicians.
Even when products are aggregated for QSSD purposes, CMS should expressly evaluate formulation-specific evidence under proposed § 429.510(e) and explain how material evidence affected the initial offer. For each aggregation determination, CMS should publish the relevant NDA or BLA, NDC and HCPCS mapping, shared and added components, routes of administration, and FDA sources supporting its conclusion.
NCODA supports CMS’s commitment to improving affordability and ensuring Medicare beneficiaries have access to high-quality cancer care. Affordability, timely access, and therapeutic innovation are interdependent. Because CMS states that it cannot credibly quantify the proposal’s longer-term effects, NCODA also recommends monitoring patient access, utilization, site-of-care shifts, administration burden, and formulation-development activity, with public reporting and reconsideration if material unintended consequences emerge. We offer these comments in the spirit of supporting a policy framework that continues to encourage meaningful therapeutic innovation while preserving patient access to evidence-based treatment advances. We welcome continued dialogue with CMS and other stakeholders as these policies evolve.
Respectfully,
Michael Reff, RPh, MBA
Founder & Executive Director
NCODA
Jonas Congelli, RPh
Associate Executive Director
NCODA
NCODA Executive Council
Sam Abdelghany, PharmD, MHA, BCOP
Executive Director, Pharmacy Services
Chair, Yale University Oncology Institutional Review Board
Smilow Cancer Hospital at Yale New Haven Health
Paul Chadwick
Chief Value and Procurement Officer
Florida Cancer Specialists & Research Institute
Austin Cox, PharmD
Vice President, Pharmacy Services
Florida Cancer Specialists & Research Institute
Natalie Dickson, MD, MMHC, FASCO, FACP
President and Chief Executive Officer
Tennessee Oncology
Nancy J. Egerton, PharmD, BCOP
Clinical Pharmacist
Willamette Valley Cancer Institute and Research Center
Scott Freeswick, PharmD, MS
Vice President and Chief Pharmacy Officer
Memorial Sloan Kettering Cancer Center
Dallas Gallagher, DNP, FNP-C, AOCNP
Pancreatic Cancer APP Navigator
UC San Diego Health
James Gilmore, PharmD
Chief Pharmacy and Procurement Officer
American Oncology Network, LLC
Lucio Gordan, MD
President and Managing Physician
Florida Cancer Specialists & Research Institute
Xylina Gregg, MD
Physician Partner
Utah Cancer Specialists
Kirollos Hanna, PharmD, BCPS, BCO, FACCC, FAPO, FHOPA
Director of Pharmacy and Assistant Professor of Pharmacy
Minnesota Oncology and Mayo Clinic College of Medicine
Kenneth Komorny, PharmD, BCPS
Vice President and Chief Pharmacy Officer
Moffitt Cancer Center
Corinne Shamehdi, PA-C
Associate Director of Membership and Professional Development
NCODA
Nathan Shumway, DO, FACP
Medical Oncologist
Texas Oncology
Michelle Taymuree, PharmD, MBA
Senior Director of Clinical Excellence
NCODA
Stephen Ziter, MBA
Chief Operating Officer
NCODA
Reference:
- Gordan LN, et al. J Clin Oncol. 2026;44(suppl 16):1530. doi:10.1200/JCO.2026.44.16_suppl.1530.