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Is There a Mathematical Resolution to the Cost-Versus-Value Debate?

Bruce Feinberg, DO; Lincy S. Lal, PharmD, PhD; J. Michael Swint, PhD
Solutions proposed by patient advocates and physicians to control costs provide approaches to valuing new drug/treatments compared with 1 or several prevailing standards of care. Increasingly, however, the debate over cost is transitioning to a debate over value.
Each of the attributes is graded 1 to 5 and presented to the user in a visual 5 x 5 grid of 25 squares, with the X axis having 5 columns, 1 for each attribute, and the Y axis having 5 rows for low to high assessment. The higher the value, the more opaque the grid. The affordability measurement represents an estimate of overall total cost of a therapy, including, but not limited to, acquisition, administration, in-patient versus out-patient care, supportive care, infusions, toxicity monitoring, anti-emetics and growth factors, and hospitalization. Although a detailed methodology that explains the process used to assign grade is not yet available on the NCCN website, a list of the criteria used by the panel members to score the measures is elaborated, suggesting that as per the historical guidelines, the Evidence Block grading system will be by subjective consensus among panel members.

EFFICACY

In regard to efficacy determinations, the tools use significantly different approaches, as evidenced by their use to assess systemic treatment value in stage IV, or metastatic, non-small cell lung cancer. The Value Framework presents 4 different clinical scenarios, 2 comparators at a time, which may include as many as 5 drugs incorporated into treatment cocktails or regimens.

In the DrugAbacus, the comparison is made at the single-drug level even when the drug is only administered as one component of a regimen. Although DrugAbacus currently has information pre-populated for 54 different chemotherapeutic agents, all information is based on the drug’s first approved indication and monotherapy, neither of which may apply to the specific clinical scenario of interest.

NCCN’s approach to MM and CML suggests that an efficacy grade of 1 to 5 will be assigned based on panel consensus for each regimen and comparator. Although all tools limit comparisons to prospective published peer-reviewed study data comparing the new agent or specific regimen of interest with known comparator(s) of interest, NCCN offers some redress by addressing quality, quantity, and consistency of evidence.

TOXICITY

In regard to redress of toxicities, the approaches are again different. ASCO’s Value Framework limits AE inclusion to those grade 3 to 5 only and treats all of them equally. The DrugAbacus also limits to higher grade (3 and 4) AE, then augments that number by determining their influence on value by including toxicities that impact discontinuation rates or impact resource utilization. NCCN takes a more inclusive approach grading toxicity from 1 (not meaningful) to 5 (severe, life threatening). Despite such thoughtful and varied approaches to the impact of safety/toxicity on value, AE burden remains incredibly subjective for most patients. 

Despite such thoughtful and varied approaches to the impact of safety or toxicity on value, AE burden remains incredibly subjective for most patients. Alopecia is unlikely to result in treatment discontinuation or acute care intervention cost, but it is a deciding factor in some patients’ treatment selection. Severe neutropenia has a real mortality risk yet can be effectively prevented, but only at a potentially significant cost. Intermediate grade neuropathy may neither incur acute care intervention cost nor impact treatment intensity, but physicians are all too aware it may become a lifelong disability.

EFFICIENCY

These approaches have their greatest differentiation in the assessment of their cost-effectiveness. The Value Framework separates the clinical assessment from the economic, asking the user to determine value. The DrugAbacus incorporates cost based on Medicare reimbursement, but provides significant latitude for user discretion through the use of price (or value) modifiers. NCCN uses a 1-to-5 grading system incorporated into the visual Evidence Block, but we currently lack insight into their approach to affordability grading (whether it uses absolute dollar thresholds of cost or relative to comparators). Regardless of approach, the inclusion of cost represents a sea change from prior approaches to cancer treatment valuation and selection.

CONCLUSIONS

The ASCO Value Framework, DrugAbacus, and NCCN Evidence Blocks provide opportunities for discussions about the financial costs and associated value gained from the various treatments of oncology patients. By the authors’ own accounts, the ASCO tool is designed as a patient decision-support tool, DrugAbacus is research-focused and informational, and the stated goals of the NCCN are to provide the healthcare provider and patient information to make informed choices.

These tools are not completely intuitive, suggesting providers and patients will need experience or training to optimize them. ASCO clearly states their vision is to preload comparisons into user-friendly software. The DrugAbacus has default values if modifiers are not specified. NCCN’s panel consensus may suffer for subjectivity. Critical evaluations of these approaches to value assessment provide a telescopic view into the existing gaps in evidence and literature, and provide additional opportunities for research.

The complexity of cancer treatment and the related design of clinical trials further complicate tool design. Use of drugs in combination rather than as monotherapy, mandatory or reflexive use of supportive care drugs, crossover trial design, prevailing therapeutic, or best supportive care comparator, are but a sampling of the intricacies of oncologic research that may bedevil any approach to value calculation. Traditional clinical research may itself be problematic in value determination, as declining single-digit participation of adult oncology patients who are often younger and healthier and less diverse than their real-world counterparts may be less than representative of the target population.

Conversations on costs and value at both the patient and population levels may provide insights into areas for improvement in medical education and training. Lastly, it behooves all stakeholders to give consideration whether this is a discussion best conducted at the patient, policy, or payer level as we move toward considering both value and costs in our medical decision processes. EBO

Bruce A. Feinberg, DO, is vice president, Clinical Affairs, and chief medical officer, Cardinal Health Specialty Solutions, Dublin, Ohio.

Lincy S. Lal, PharmD, PhD, is director of HEOR, Clinical Specialty, Specialty Solutions, Cardinal Health, and lecturer, University of Texas School of Public Health in Houston.

J. Michael Swint, PhD, is professor of health economics, Department of Management, Policy and Community Health, University of Texas School of Public Health in Houston, and professor of health economics, Center for Clinical Research and Evidenced-Based Medicine, University of Texas Medical School at Houston.
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8.      Referenced with Permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with NCCN Evidence Blocks™. ©National Comprehensive Cancer Network, Inc 2015.  All rights reserved.  Accessed November 19, 2015. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, NCCN EVIDENCE BLOCKS™, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.
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