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The pathway to value: A complicated journey begins with one step
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“Why do you have to go and make things so complicated?”
– Avril Lavigne
The intensity of coverage of drug costs and value in oncology care in peer-reviewed journals, the popular oncology press, the media in general and social media in particular seems to have increased.
After several years of volume-to-value transition, outcry — and sometimes outrage — over escalating drug costs, and development of models and metrics for evaluating value, it would be nice to think that the increased coverage reflected real progress. It is not easy to tell whether that is true.
‘Shaky’ evidence
With a few notable exceptions, efforts toward improving value in oncology care are clouded by inconsistency and uncertainty.
Take, for example, ASCO’s position statement on the affordability of cancer drugs (see related article).
This is a thoughtful statement on the value proposition in oncology and defines important principles such as evidence-based, value-driven solutions to drive drug pricing by developing useful value frameworks, defining a consistent relationship between drug costs and value, prescribing responsibly and containing cost without sacrificing meaningful outcomes.
This document also includes recommendations related to the use of generics and biosimilars, and recommendations to disallow practices such as “evergreening,” “product hopping” and “pay-for-delay.” The statement concludes with wide-ranging recommendations for health care professionals, insurers, economists and politicians.
All of this sounds appropriate, but the data and evidence behind some of these recommendations are — to say the least — shaky.
Value frameworks are a good example. Many organizations have developed methodologies for evaluating the value of various interventions for cancer. These include the NCCN Evidence Blocks, the ASCO Value Framework (ASCO-VF) and the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS).
These models base value on estimates of toxicity, cost and benefit.
Two of them — ASCO-VF and ESMO-MCBS — determine outcomes based on results from randomized controlled trials. The NCCN process is more qualitative, and the outcomes component is slightly less well defined.
Most practicing oncologists would probably acknowledge that neither ASCO-VF nor ESMO-MCBS is particularly intuitive or user-friendly, but they represent important initial efforts to place metrics around the value proposition. Both frameworks required very substantial effort during development and revision and, although the aims of both are broadly similar, it is important to point out they were specifically designed to address their respective U.S. and European systems.
That said, the primary clinical benefit measure for both scales is based on the outcomes reported in randomized clinical trials.
Two studies have explored correlations between the ASCO-VF and the ESMO-MCBS (see related article). Although the study methodologies were different, both investigated randomized clinical trials of oncology drugs and compared the two frameworks for correlations in the benefit thresholds.
The results were not encouraging. Both studies demonstrated only fair correlations between the value frameworks. Perhaps even more disappointing — although maybe not surprising — was the negative correlation between the calculated value and drug costs observed in one of the studies.
Acknowledging that this is a complicated subject, reading these studies in detail left me bewildered.
The descriptions of analytic techniques, HRs, survival benefits, CIs, curative-intent grading and toxicity adjustments led me to conclude that, for now, these models have limited clinical utility.
Maybe we need something simpler to help us make value-based decisions.
Overthinking value
Recognizing the complexity of the subject and the iterative nature of developing such frameworks, I cannot help but wonder whether we are in danger of overthinking this subject.
Biosimilars are another example.
The recommendations concerning biosimilars seem to make sense but, again, the situation is not so clear.
Despite the claims that these agents would help to bend the cost curve in the United States, many experts doubt whether the cost reductions seen in Europe with biosimilars will be reproduced on this side of the ocean.
As an example, cost reductions for biosimilars to filgrastim (Neupogen, Amgen) have been estimated in the 45% to 60% range in Europe. In the United States, the estimated savings so far has been only about 10%.
Several other examples exist, and the explanations for this apparently disappointing effect on costs include production costs; the regulatory gamesmanship mentioned above, which includes pay-for-delay; a complicated and slow process for FDA approval; and pending litigation regarding pricing. Despite the hope that biosimilars will affect the costs of cancer care in the United States as they have in Europe, it does not appear to be that simple.
Whether we can achieve universally accepted frameworks for measuring value in oncology is an open question. Although this is a reasonable goal, it is important not to let the perfect become the enemy of the good. There are many interventions we can make to incrementally improve value and reduce costs without involving complex methodology.
One nice example is reported in a study by Ellis and colleagues from UPMC Hillman Cancer Center. This group uses clinical care pathways systemwide to provide guidance on appropriate therapy based on efficacy, toxicity and, when these are equivalent, cost.
Based on results of a randomized trial that demonstrated equivalent efficacy in chemotherapy-resistant disease, clinicians modified their care pathway in 2014 to replace cetuximab (Erbitux, Eli Lilly) with panitumumab (Vectibix, Amgen).
With this intervention, researchers observed a rapid change in prescribing — driven by the care pathway — with estimated annualized cost savings to the system of more than $700,000. Of course, this is one of many examples of care pathway-driven changes in medical or surgical cancer care that demonstrate a simple intervention to improve value.
The pathway to consistent assessment of value in cancer care is tortuous, long and complicated, but of enormous importance to ensuring the greatest benefit for our patients.
However, in the spirit of the quote from Lao Tzu — “The journey of 1,000 miles begins with one step” — let’s not forget that solutions do not have to be complicated. Just follow the pathway.
References:
ASCO position statement on addressing the affordability of cancer drugs. Available at: www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/documents/2017-ASCO-position-statement-affordability-cancer-drugs.pdf?et_cid=39454952&et_rid=1760459169&linkid=position+statement. Accessed Aug. 8, 2017.
Bennett CL, et al. Lancet Oncol. 2017;doi:10.1016/S1470-2045(16)30653-2.
Cheng S, et al. J Clin Oncol. 2017;doi:10.1200/JCO.2016.71.6894.
Del Paggio JC, et al. Lancet Oncol. 2017;doi:10.1016/S1470-2045(17)30415-1.
Ellis PG, et al. J Oncol Pract. 2017;doi:10.1200/JOP.2016.019232.
For more information:
John Sweetenham, MD, FRCP, FACP, is HemOnc Today’s Chief Medical Editor for Hematology. He also is senior director of clinical affairs and executive medical director of Huntsman Cancer Institute at University of Utah. He can be reached at john.sweetenham@hci.utah.edu.
Disclosure: Sweetenham reports he has no relevant financial disclosures.