September 2017 Edition Vol.11, Issue 9

Value Discussion in Cancer Care Continues

By Lynne Lederman, PhD

The problem is clear: the cost of new cancer drugs has risen to $100,000 or more per year with no end to cost increases in sight, and patients with cancer are more likely to face bankruptcy than those without. Financial concerns for these patients and their families may result in delayed or missed treatment, and cause distress and hardship.

The American Society of Clinical Oncology (ASCO) recently issued a new position statement addressing affordability of cancer drugs, joining other professional societies that are taking similar positions.1,2

ASCO suggests that potential evidence-based solutions should be developed and tested by all cancer care stakeholders. Among these are having the FDA consider meaningful clinical outcomes rather than small, if statistically significant, benefits to assess drug applications. Another is having Medicare test a value-based pathway to drive provider use and for industry to develop higher-value drugs.

 

Defining the Value of Cancer Therapies

Currently, several tools to define and describe the value of cancer therapies have been developed, including the ASCO Value Framework, the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS), the Memorial Sloan Kettering Drug Abacus, the Institute for Clinical and Economic Review (ICER) collaborative evaluation model, and the National Comprehensive Cancer Network (NCCN) Evidence Blocks, which include an affordability score along with measures of safety, efficacy, quality of evidence, and consistency of evidence.2

Sierra Cheng, BSc, Sunnybrook Odette Cancer Centre, University of Toronto, Ontario, Canada, reported on a study determining whether the ASCO Value Framework and the ESMO-MCBS are measuring the same clinical benefit.3 Her group found that there were only weak-to-moderate correlations between previous and current iterations of the two frameworks. The clinical benefit scores that are derived from them do not correlate with the incremental quality-adjusted life-years (QALYs) used to define clinical benefit, suggesting the frameworks are measuring different constructs of clinical benefit.

Other studies have confirmed the lack of meaningful correlation between the ASCO and ESMO frameworks, and found no correlation between framework outputs (benefits) and drug costs, suggesting a need to reconcile the lack of correlation between drug cost and clinical benefit.4,5 One barrier to using these tools to compare cost and benefit is the variability in and lack of data for toxicities and quality of life (QoL) in reported trials, which limits the utility of benefit frameworks.5

 

Addressing Financial Toxicity

Financial toxicity resulting from cancer care can be considered an adverse event. At ASCO, representatives of payers, patients, providers, and the pharmaceutical industry each offered one possible solution from their perspective.6

Lee N. Newcomer, MD, UnitedHealth Group, said his solution was to remove coverage mandates from state and federal insurance laws, including Medicare and Medicaid, so that high cost, low value treatments would not be covered. He noted that for stage IV non-small cell lung cancer, of the five most popular regimens used in the US, cisplatin plus gemcitabine has an average duration of therapy of 67 days with a cost of treatment of $33,000, whereas the next most popular treatment, cisplatin, bevacizumab, and pemetrexed costs $111,000 for an average duration of 57 days.

Currently, insurance companies must pay for either regimen. He said, “True innovations that have wonderful outcomes will still get a high price, because they won’t have any competitors, and that’s fine with me. But where there is competition, where there are multiple regimens that can obtain the same results we should be allowing competition to get back into the marketplace so that we can provide access to good therapies and keep the money available for those new innovations that are coming down the pipe.”

Dr. Newcomer said that UnitedHealth Care uses the NCCN guidelines for coverage standards so that the payer is not making treatment decisions. The group continues to collect data on the duration of therapy of regimens used in specific patient populations, the associated hospitalization rate, and the total cost of care to help create transparency.

Shelley Fuld Nasso, MPP, Chief Executive Officer of the National Coalition for Cancer Survivorship (NCCS) provided the patient perspective. Her suggestion is to provide better care planning. She said NCCS sees care planning as a way to facilitate the discussion on clinically meaningful treatment options and their benefits and risks. This includes out-of-pocket costs, and indirect costs, e.g., hospital visits and missed work by patient and caregiver, all of which go into a patient’s decision-making.

Ms. Nasso acknowledged that there has been pushback from providers about difficulties caused by including care planning in the Oncology Care Model (OCM). She pointed out that it is harder to have cancer and that the current system requires patients to advocate for themselves to get the treatments they need. She would prefer a system that incorporates care planning for patients.

Ms. Nasso said that although some patients might be interested in the cost of therapy, some will not understand what the total cost of care represents, or may only be interested in what they have to pay. “A lot of patients don’t want to talk about it because they don’t want to feel judged. Some people believe you get what you pay for. Some may not want to spare any expense to save their life.”

“At the NCCS, we have focused our efforts this year on protecting cancer patients and survivors as Congress has considered legislation to repeal and replace the Affordable Care Act (ACA). Financial toxicity is a huge challenge for patients and families, even with health insurance. Each of the various proposals to replace the ACA would have been devastating for people with cancer and cancer survivors. The plans would result in millions more people uninsured, but importantly, they would also result in skinnier health insurance plans—plans that do not adequately cover the significant medical needs of cancer patients and survivors. While efforts to repeal and replace the ACA have failed for now, we are still very concerned and will remain vigilant to ensure cancer survivors’ needs are represented. The insurance marketplace and the expansion of Medicaid have been key avenues for cancer survivors to gain coverage for their treatment and ongoing surveillance and medical needs after cancer treatment,” she said.

Leonard Saltz, MD, Memorial Sloan Kettering Cancer Center, said that the one thing he wants is to make the cost of medications available, so that providers and patients can have an informed discussion. He observed that providers are good at explaining side effects of drugs, including discussions of “bowel function and sexual function, like we are talking about the weather,” yet find financial discussions uncomfortable, the way doctors once found it difficult just to tell patients they had cancer. The direct discussion of financial consequences with patients now “is a primary clinical responsibility. I would argue as a profession, as academicians, these are issues we should be putting in our publications, in our ASCO presentations, in our journal articles,” in much the same way that serious side effects of cancer drugs are now discussed.

Matthew Shaulis, President, North America, Oncology, Pfizer, Inc., New York, New York, focused on market-based solutions. He thinks that in time there may be changes in cost as more drugs with similar mechanisms of action reach the market and stimulate competition. However, Dr. Saltz pointed out that as more PD-1 and PD-L1 targeting drugs have reached the market their prices have increased.

There was also disagreement on the effects of copay assistance and patient access programs. Dr. Newcomer thinks companies have used these programs to provide expensive, therapies that have been excluded from formularies free to patients for the first 90 days, at which point they become “established” patients for whom it would be too disturbing to change to a less expensive equivalent treatment.

 

 

Looking Ahead

Value discussions in cancer care are only beginning. The use of real-world data and patient reported outcomes has been suggested as a way to address some deficiencies of the current value calculators, which are currently based on randomized clinical trial data.7

As Ms. Nasso points out, the interests of payers and industry are often at odds, and patients are stuck in the middle. “Our payment systems reward volume of care, even with the experimentation of payment models that reward value over volume. Cancer care providers advocate on behalf of their patients, but we cannot deny that incentives in the system are not always in the best interests of patients. We need to find some common ground to ensure that patients get the right medicines at the right times. The financial toxicity patients and families face is staggering. We have to be able to reward and encourage innovation without bankrupting the system.”

 

References

  1. ASCO Offers Path to Addressing Affordability of Cancer Drugs in New Position Statement. July 19, 2017. https://www.asco.org/advocacy-policy/asco-in-action/asco-offers-path-addressing-affordability-cancer-drugs-new-position
  2. ASCO Position statement on addressing the affordability of cancer drugs. http://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
  3. Cheng S, McDonald E, Cheung MC, et al. Do the American Society of Clinical Oncology (ASCO) Value Framework and the European Society of Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale measure the same construct of clinical benefit? J Clin Oncol. 2017 35(suppl;abstr 6509).
  4. Del Paggio JC, Sullivan R, Schrag D, et al. Delivery of meaningful cancer care: a retrospective cohort study assessing cost and benefit with the ASCO and ESMO frameworks. Lancet Oncol. 2017;18:887-894.
  5. Becker DJ, Lin D, Lee S, et al. Exploration of the ASCO and ESMO Value Frameworks for antineoplastic drugs. J Oncol Pract. 2017;13:447,e653-e665.
  6. Zafar SY, Newcomer LN, McCarthy J, et al. How should we intervene on the financial toxicity of cancer care? One shot, four perspectives. 2017 ASCO Educational Book. DOI: 10.14694/EDBK_174893.
  7. Nabhan C, Feinberg BA. Value-based calculators in cancer: current state and challenges. J Oncol Pract. 2017;13:499-506.

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