ASCO Tackles the Issue of the High Cost of Cancer Drugs

In July, ASCO issued a comprehensive set of recommendations to remedy the problem of escalating drug pricing on cancer therapies.¹ ASCO’s position statement comes at a time when new cancer drugs are routinely priced at $100,000 a year or more—imatinib (Gleevec) costs up to $146,000 a year²—causing many patients—24%—to choose not to fill their prescription or take less—20% of patients—than the prescribed amount.³ With more than 1.6 million Americans estimated to get a cancer diagnosis in 2017,⁴ it could mean that upward of between 320,000 and 384,000 patients this year will limit their prescription use or forgo it altogether. In addition, patients with cancer are 2.5 times more likely to file for bankruptcy after a cancer diagnosis compared to the general population and are at greater risk for death from any cause.⁵

Developed by ASCO volunteer leaders and adopted by the Society’s Board of Directors, the ASCO Position Statement on Addressing the Affordability of Cancer Drugs presents a review of several cost-cutting solutions proposed by policymakers to address the high cost of cancer drugs, including allowing Medicare to negotiate drugs prices and legalizing the importation of drugs, and offers ASCO’s perspective on which ones should be tested, primarily from the standpoint of how they would impact patient care. 

Defining Value in Cancer Care

However, before the national debate on how to control the rising cost of drugs can move forward, there has to be a consensus on how to define value in cancer therapeutics, according to Blase N. Polite, MD, Associate Professor of Medicine and Executive Medical Director for Accountable Care at the University of Chicago Medicine and Immediate-Past Chair of ASCO’s Government Relations Committee and a co-signer of ASCO’s drug affordability position statement.

“ASCO has been involved in seeking solutions to address the rising cost of cancer care, including the drug approval process and defining drug value, for a long time,” said Dr. Polite. “We had raised the issue of how to design clinical trials that would produce clinically meaningful results several years ago,⁶ and we developed the concept for the ASCO Value Framework.⁷ But we did not have, from a policy standpoint, an answer to the question we are often asked when visiting members of Congress, ‘What is ASCO’s position on the price of drugs?’ This position statement provides that answer.”

In addition to ASCO, the European Society for Medical Oncology has released a value framework, which is compatible with ASCO’s Value Framework. Other efforts to determine drug value include Memorial Sloan Kettering’s Drug Abacus, the Institute for Clinical and Economic Review’s Value Assessment Framework, and the National Comprehensive Cancer Network’s® Evidence Blocks™ value initiative.

Assessing the Value of Cancer Drugs

ASCO’s six guiding principles in its recommendations to reduce cancer drug costs, including the establishment of a panel of stakeholders to determine which proposals will be effective and the development of a uniform approach to assessing the value of drugs, are as follows: 

• Value-based solutions that are patient-centered and evidence-driven should inform drug prices in the United States.
• Oncology professionals should define optimal care and provide a framework to assess the comparative value of cancer treatment options from a clinical perspective.
• There should be a real and consistent relationship between the value of a specific drug and its cost to patients.
• Physicians do not control the launch price of drugs. However, they do determine how drugs are used and are accountable for appropriate utilization.
• Cost-containment strategies should not limit the ability of patients to receive access to appropriate care or for providers to prescribe such care.
• Cost-containment strategies should incentivize—not hamper—innovation that results in clinically meaningful improvements in patient outcomes.

Determining Potential Solutions

The potential solutions outlined in ASCO’s statement include the following possible measures:

• Limit U.S. Food and Drug Administration (FDA) assessments for approval of new drug indications and therapies to those that meet or exceed incremental benefits in overall survival and progression-free survival, rather than focusing on small benefits that achieve statistical significance in large clinical trials.
• Test different value-based pricing strategies, such as value-based pathways to better align the pricing and utilization of drugs with the value they have for patients; indication-specific pricing, which is based on a drug’s effectiveness in different approved indications; and outcomes-based pricing, with which reimbursement would depend on how effective the drug is in a specific patient.

“If pharmaceutical companies produce incredible products, such as immunotherapies that are actually curing people of metastatic disease, they will not have a problem making a profit on their investment. If they are producing products that extend life by 2 to 3 weeks those drugs should not be priced at $10,000 a month,” said Dr. Polite.

One approach to controlling drug costs ASCO is not recommending is the use of payment bundles, whereby all costs for treating a patient, including drugs, are bundled into a single episode-based payment.

• Develop and use generic and biosimilar drugs.
• Limit the financial burden that payer policies place on patients, including the trend toward tiered formularies.
• Allow Medicare to test negotiation of drug payments on a -value-based pathway approach.
• Encourage greater transparency on drug pricing, especially on drugs that received federal funding or philanthropic research support, to allow patients and payers to make an informed comparison of the relationship between drug development costs and the price of the drug;
• Enable reimportation of drugs. Although this strategy assumes that all other developed countries have some regulatory framework in place to control the quality and price of drugs, ASCO cautions that drug reimportation would have to be tested to resolve safety concerns and warns that widespread use of this practice would cause the price of drugs to rise in other countries.

ASCO’s Recommendations

ASCO is proposing the following recommendations to guide the above efforts to address the affordability of oncology drugs by the Trump Administration, Congress, or other entities:

• Solutions to address the affordability of cancer drugs should be identified, evaluated, prioritized, and tested.
• The community at large, including health-care providers, patient advocates, payers, hospitals, experts in health economics and health outcomes, representatives from the pharmaceutical and biotechnology industries, Congress and Administration policymakers, must actively participate in any effort to develop policy solutions to address the affordability of cancer drugs.
• Congress and/or the Administration can play an important role in bringing together a diverse group of experts to identify, evaluate, and prioritize a series of demonstrations designed to test some of the solutions presented in ASCO’s statement, and once tested, to recommend implementation for those that are successful. A high-priority effort of this group should be to propose a strategy for blending various value frameworks into a transparent and standardized approach to assessing value, and recommending drug pricing and reimbursement based on the value delivered. 

The Next Steps

“ASCO’s hope is that our position statement will help elevate the dialogue on the issue of drug pricing,” said Dr. Polite. “The root of the problem is that there is no correlation between the value that a drug provides and the price that is charged. You want people to be rewarded for developing blockbusters that will really impact survival outcomes in patients, but you do not want that same reward to go to drugs with an incremental benefit. Until we have a health-care system that understands there needs to be some correlation between the price and the value of a drug and that does not penalize the provider for giving the right patient the right drug at the right time, we will never solve this problem.”

This statement is a conversation starter. As much as people think we are in a political morass in terms of drug pricing that we can never get out of, we at ASCO do not believe that to be true.

— Blaise N. Polite, MD

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Now that ASCO has published its position statement confronting the affordability of cancer drugs, it will take its findings and recommendations to members of the Trump Administration, the Office of Management and Budget, the Centers for Medicare & Medicaid Services, and Congress to continue the dialogue to find solutions to reduce the burden of cancer costs on patients, physicians, and the health-care system.

“This statement is a conversation starter. As much as people think we are in a political morass in terms of drug pricing that we can never get out of, we at ASCO do not believe that to be true,” said Dr. Polite. “Everyone gets paralyzed by discussions of drug value. And although value is hard to define and there is not one definition out there that is perfect, we are much further down the road than we were even 1 or 2 years ago. Once we can come to a consensus on the definition of drug value, we can test a number of strategies to reduce cancer costs, including new clinical efficacy endpoints, provisions for Medicare drug payment negotiation, and value-based payment pathways. It’s not easy, but it can be done.” ■

DISCLOSURE: Dr. Polite reported no conflicts of interest.

REFERENCES

1. ASCO Position Statement on Addressing the Affordability of Cancer Drugs. Released on July19, 2017. Available from 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.

2. Gorkin L, Kantarjian H: Targeted Therapy: Generic imatinib—impact on frontline and salvage therapy for CML. Nat Rev Clin Oncol 13:270-272, 2016.

3. Zafar SY, Peppercorn JM, Schrag D, et al: The financial toxicity of cancer treatment: A pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience. Oncologist 18:381-390, 2013.

4. American Cancer Society: Cancer Facts & Figures 2017. Available from https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2017.html.

5. Ramsey SC, Bansal A, Fedorenko CR, et al: Financial insolvency as a risk factor for early mortality among patients with cancer. J Clin Oncol 980-986, 2016.

6. Ellis LM, Bernstein DS, Voest EE, et al: American Society of Clinical Oncology Perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol 32:1277-1280, 2014.

7. Schnipper LE, Davidson NE, Wollins DS, et al: Updating the American Society of Clinical Oncology Value Framework: Revisions and reflections in response to comments received. J Clin Oncol 34:2925-2934, 2016.