Tag Archives: oncology value frameworks

Next Steps for Value Frameworks?

by Amanda Patton, ACCC Communications

ACCC17-Value Framework Panel (2)The mantra of “moving from volume to value” is ubiquitous in healthcare today.  So what do cancer programs need to know about evolving value frameworks in oncology? Attendees at the ACCC 43rd Annual Meeting, CANCERSCAPE, in Washington, D.C., heard real-time updates on two of the leading frameworks—ASCO’s work-in-progress Value Framework  and NCCN’s Evidence Blocks™.

Both value frameworks aim to be tools used in support of patient―physician shared decision-making according to panelists Stephen Grubbs, MD, FASCO, Vice President of Clinical Affairs, American Society of Clinical Oncology, and Robert Carlson, MD, CEO, National Comprehensive Cancer Network.

ASCO’s Value Framework was not built on drug pricing, but to have a discussion with a patient on potential financial toxicity and the benefit of the treatment in the context of how much the treatment will cost the patient, explained Dr. Grubbs. ASCO’s framework uses three primary parameters to calculate value: clinical benefit, toxicities of treatment, and cost. “Our goal at ASCO is to develop a tool that could be customized with information for each individual patient,” said Dr. Grubbs.

After receiving more than 400 comments on its original Value Framework draft, ASCO published a revised version in May 2016.  Grubbs made clear, however, that ASCO’s framework is still a work in progress. “It’s not yet ready for use,” he stressed.

In 2017 ASCO is working on improving the framework methodology, Dr. Grubbs explained, noting that a current weakness is that the framework is set up to compare a randomized clinical trial between two different treatments.  “If I have a treatment where I use drug A versus drug B, and than I have a trial that compares drug B to drug C—how do I compare drug A to drug C?” Work is underway at ASCO to address cross-trial comparisons and also to “anchor the net health benefit score in some meaningful way,” Grubbs shared. Finally, ASCO will continue work with patient advocates and patients to identify endpoints that are meaningful for patients.

On the other hand, NCCN’s Evidence Blocks are operationalized. NCCN’s goal was to create a “flexible value system that could be used to develop each patient’s equation for what is valuable,” said Robert Carlson, MD, CEO, National Comprehensive Cancer Network. NCCN Evidence Blocks are built on five metrics:

  • Effectiveness (efficacy)
  • Safety (adverse events, toxicities)
  • Data quality
  • Data consistency
  • Affordability

The Evidence Blocks are presented in a graphic format so that a user can look for “30 different options in about 4 or 5 seconds and come up with regimens that would be optimal for a specific circumstance,” Dr. Carlson said.

Like ASCO, NCCN intends the Evidence Blocks to support a patient-centered approach to integrating a value discussion into everyday practice. “We look at Evidence Blocks as a conversation starter, not an answer,” Carlson said.  “We don’t tell the patient, because the Evidence Block looks like this, this is what you should do. It’s a question of what’s most important to them.”

Currently, 33 of the NCCN guidelines have Evidence Blocks associated with them. By the end of 2018 all of the NCCN guidelines that have systemic therapies should have Evidence Blocks, according to Carlson. NCCN also intends to expand the Evidence Blocks into other treatment modalities. “We are now starting to look at other modalities, radiation oncology, surgical oncology, and diagnostics . . . in terms of the same sort of scales,” he said.

Rounding out the discussion, panelist Ali McBride, PharmD, MS, BCPS, The University of Arizona Cancer Center added perspective on the cost/value discussion as it may unfold on the frontlines of care. “Many patients may not be able to afford the 20% copay cost for IV therapy, let alone the out of pocket cost for many oral therapies,” he said. “We have to spend a lot of time detailing out those costs for patients, and if they can’t afford it, we have to say, then what’s our next step in that guideline pathway?”

All three panelists noted the need for financial transparency for patients and providers as one component of the value discussion.

In closing, panel moderator Christian Downs, JD, MHA, Executive Director, ACCC, asked panelists to consider what the value framework discussion might look like 10 years down the road.

Acknowledging the difficulty of making any predictions about the future shape of the oncology value discussion, Dr. Carlson envisions technology playing a pivotal role. “My own expectation and hope is that within a decade we will have computer-based systems that patients are able to interact with directly and help define and discover their own value system,” he said. Such a system would enable patients to indicate if they were more concerned with neurotoxicity or cardiotoxicity, for example. Plus the system would also have the capacity to query payers so that patients could know the financial impact of their therapy.

Big data (if the promise is realized) may change the face of value frameworks, noted Dr. Grubbs.  The potential of extensive real-world databases will bring “much more information on what happens to patients outside the narrow clinical trial that has the best, the most robust patients. . . [and extend to] what happens in the real-world. . . . if we had a big data system that had all this information about what happened to everybody and you could really home in on what happens to a 75-year-old person who was not in the clinical trial and have the cost data, you might come up with a very different looking value [framework] from what we’re showing you here today.”

Finally, as value frameworks continue to evolve, community cancer programs and practices have an important role to play, panelists agreed.  “There’s a huge reservoir of expertise and experience in community oncology, and we’d love to tap that, to learn from that. [One of the] ways you can help us, is to continually give us feedback in terms of whether we have it right or wrong. . . . talk to us,” Dr. Carlson said.

Dr. Grubbs concurred, adding that community oncologists are key to making value frameworks functional. “When you see this come out, please make comments back to ASCO on how to make this better, because nobody is going to get this right…right from the beginning.”

Cooling Down ICER? Five Questions to Consider

By ACCC Communications

Three jigsaw puzzles pieces (sm)Although the value-based reimbursement train has definitely left the station and is picking up speed, those in the oncology community continue to grapple with the thorny issues around understanding and defining value in cancer care. Treatment innovations and costs are driving the value discussion in oncology. New and emerging immuno-oncology therapies, while bringing unprecedented clinical value to many patients, often carry price tags of $100,000 a year or more, and are front and center in these discussions. Patient access in an era of high-priced pharmaceuticals continues to be a major challenge, particularly as many of these innovative therapeutics entail high co-pays and/or co-insurance payments. The result is that some patients face major hurdles to accessing these innovative options.

For those in the oncology community, staying up-to-date on current and proposed value frameworks is essential—not only to advance innovation in cancer care and to ensure patient access to new therapeutic options, but also to protect cancer program economic viability in an era where payment and reimbursement may become increasingly tied to value.

In a recent Institute for Clinical Immuno-Oncology (ICLIO) webinar, a panel of leading experts provided real-world perspectives on value framework development in oncology in the U.S., with a particular focus on the Institute for Clinical and Economic Review (ICER), which has gained prominence in the past 18 months.  For those in the oncology community who may not be familiar with ICER, panelist Jennifer Hinckel, MSc, McGivney Global Advisors, provided background and offered the following five questions to consider in assessing the organization’s recent report related to non-small cell lung cancer (NSCLC):

  • Does ICER have the appropriate expertise to interpret complex clinical data given that there are not disease-specific clinical experts on staff or advisory panels?
  • Does ICER have processes in place to adequately prevent or limit bias or policy/political aims from slipping into its reports?
  • Is ICER’s approach of evaluating products close to the time of approval (or pre-approval) appropriate, given its methodology of including only randomized controlled trial (RCT) data?
  • Does ICER have sufficient staffing to review and update reports in disparate disease areas and to ensure accuracy?
  • Would ICER’s various approaches meet the standards of peer view in a widely published journal?

In a recent op-ed published in the Oncology Business Review, leading lung cancer experts (including ICLIO Advisory Committee Chair, Lee Schwartzberg, MD, FACP) suggest some level-setting principles for value frameworks including the following:

  • Have disease experts as evaluators and authors
  • Have patient-centered endpoints, conclusions, and definitions of value
  • Use rigorous methodologies reflecting evidence-based medicine
  • Apply continuous review and revision
  • Hold peer review and authorship to scientific standards.

Listen to the full ICLIO webinar discussion here.

As noted in a newly-released white paper from the Institute for Clinical Immuno-Oncology, all of the existing first-generation value frameworks have strengths and weaknesses. Each wrestles with defining value, and each exposes inherent tensions between payer concepts of value and the perspectives of patients and providers. As the field of immuno-oncology continues to expand, all stakeholders will need to stay informed and be prepared contribute to ongoing development of value frameworks that consider not only cost and clinical benefit, but patients’ perspectives on value in cancer care.  In the months ahead as the oncology community contributes to the discussion on value determination methodologies in the context of payer negotiations and political pressure to lower costs and enact drug pricing reform, as well as working to ensure access to new and emerging immunotherapy and combination therapies, ICLIO will continue to offer support and resources for the multidisciplinary team serving patients in communities close to home.


ICLIO is an Institute of the Association of Community Cancer Centers (ACCC). In September 2016,  ACCC submitted comments in response to ICER’s national call for proposed improvements to its Value Assessment Frameworks.