ASCO Issues Official Position on Cancer Drug Affordability

The American Society of Clinical Oncology (ASCO) has issued an official position statement addressing the affordability of cancer drugs. The position was guided, the organization says, by the principles that value-based solutions should be patient-centered, that oncology professionals should define optimal care using a clinical perspective, that there must be a relationship between the value and cost to the patient, that physicians must be accountable for using drugs appropriately, and that cost-containment strategies should not restrict drug access but should incentivize innovation that leads to clinically meaningful improvements in patient outcomes.

Meaningful Value Frameworks

While the United States tends to make new therapies available to patients with relative speed, ASCO notes, only 19% of recently approved cancer drugs meet the organization’s goals for producing clinically meaningful survival outcomes, and the financial impact of these treatments on patients cannot be ignored. ASCO suggests that establishing a patient-focused value framework will require assessment of a broader range of clinical trial endpoints during research and development as well as the expansion of databases collecting real-world outcomes that allow for the comparison of safety and efficacy.

ASCO points to its article “Raising the Bar for Clinical Trials by Defining Clinically Meaningful Outcomes,” in which it recommends a primary focus on median overall survival and hazard ratios with secondary endpoints of improved 1-year survival and progression-free survival rates, as a useful context for considering a patient-focused framework. The position even suggests that the FDA might limit its approval of new oncology drugs to treatments that meet these suggested endpoints.

ASCO suggests that value-based pathways could be used to align drug pricing and utilization with the value they demonstrate for patients, as well as indication-specific pricing, which would adjust drug prices according to effectiveness in different approved indications. In another approach, outcomes-based pricing would depend upon the treatment outcome of a patient and could be scaled to a population level. With ourcomes-based pricing contracts, if a drug performs poorly in a treatment population, manufacturers would be required to provide discounts and rebates to payers and patients.

Support market competition

Further development and use of generics and biosimilars, ASCO says, also holds the potential to increase value; the organization calls for the government to consider reducing data exclusivity periods for biologics from 12 years to 7 years, and to disallow practices including the following:

• Evergreening: marketing an old drug under a new name
• Product-hopping: making a slight reformulations of a drug in order to maintain market share
• Pay-for-delay: paying generic or biosimilar developers not to introduce competitive products to the marketplace

ASCO further notes that it opposes the use of tiered formularies, which place a higher coinsurance burden on patients for specialty drugs, as well as current prohibitions on the negotiation of volume discounts for the Medicare program. The organization also notes that, though some provider groups have suggested that greater transparency concerning manufacturers’ costs could allow payers and patients greater insight into the relationship between development costs and drug costs, ASCO holds that the establishment of a methodology for value-based pricing would achieve the same goal. Finally, ASCO urges caution concerning re-importation of lower-priced drugs, noting regulatory difficulty and the possible unintended consequence of driving up drug costs in other nations.

Finally, ASCO proposes the following guidelines to help frame policymakers’ thinking as they attempt to address the problem of growing drug costs:

• Efforts to address affordability of cancer drugs must recognize the potential for unintended consequences, and should be tested before a national launch
• Active dialogue among all stakeholders, including patients, must be a feature of the effort to address drug pricing
• The government can play an important role in bringing together experts to test potential solutions, recommend implementation of options, create a transparent and standardized approach to assessing value, and recommend drug pricing and reimbursement based on value
• Solutions to the problem of high drug prices should bear in mind the principles that patients must have access to treatments and should not experience financial harm when receiving care, that providers should have support in delivering appropriate care, and that drug makers should be incented to continue to pursue high-risk drugs

Ultimately, says ASCO, the solution to drug affordability will require redoubled efforts to define value, and to standardize a tested, valid, and reliable framework for assessing value to ensure the patient’s well-being.