Drug Price Negotiation & Health Equity
Since its founding, the Partnership to Improve Patient Care (PIPC) has been at the forefront of applying principles centered on patients and people with disabilities to the nation’s health care system – from the generation of comparative clinical effectiveness research at the Patient-Centered Outcomes Research Institute (PCORI), to the translation of evidence into care in a manner that achieves value to the affected patients and people with disabilities. Evidence should work to improve individual health decisions, not limit access to a one-size-fits-all health system.
Therefore, policies to determine the treatments worth providing - and the people worth treating - must protect against reliance on value assessments based on discriminatory metrics and evidence of effectiveness whose conclusions are based averages. Too often, policies fail people with disabilities and chronic conditions, older adults and communities of color who may be devalued by an algorithm or whose outcomes are not reflected in the data, exacerbating health inequity.
Therefore, policies to determine the treatments worth providing - and the people worth treating - must protect against reliance on value assessments based on discriminatory metrics and evidence of effectiveness whose conclusions are based averages. Too often, policies fail people with disabilities and chronic conditions, older adults and communities of color who may be devalued by an algorithm or whose outcomes are not reflected in the data, exacerbating health inequity.
IRA Implementation
The Inflation Reduction Act became law in August, 2022, and included provisions authorizing the Medicare to establish a “fair price” for certain drugs. We urge all stakeholders to take advantage of opportunities to use their voice to protect against disability bias and ensure consideration of outcomes that matter to patients.
Every life is valuable.
The statute calls for consideration of several factors that will require robust input from affected patients and people with disabilities to ensure that treatments for people with disabilities and chronic conditions are not devalued due to the inherent bias of historic research and value assessment methods. Factors include 1) judgements of a therapeutic advance, 2) comparative clinical effectiveness research that account for subpopulations including people with disabilities that protects against discrimination, and 3) the extent to which an unmet need may be met by the treatment.
We hope you will join PIPC in urging CMS to provide an iterative process of implementation with multiple points of input from patients and people with disabilities, as well as notice and comment as part of formal efforts to gather information as the agency establishes a formal and predictable engagement process for each selected drug. For example, it would be useful for CMS to have an ombudsman as a central point of contact for patients and people with disabilities to ensure early and routine engagement with affected patients and people with disabilities on negotiated drugs.
Help us call on CMS to sets standards protecting against the use of biased or discriminatory assessments of therapeutic value and to ensure systematic, robust, guaranteed, transparent engagement with affected patients and people with disabilities.
Every life is valuable.
The statute calls for consideration of several factors that will require robust input from affected patients and people with disabilities to ensure that treatments for people with disabilities and chronic conditions are not devalued due to the inherent bias of historic research and value assessment methods. Factors include 1) judgements of a therapeutic advance, 2) comparative clinical effectiveness research that account for subpopulations including people with disabilities that protects against discrimination, and 3) the extent to which an unmet need may be met by the treatment.
We hope you will join PIPC in urging CMS to provide an iterative process of implementation with multiple points of input from patients and people with disabilities, as well as notice and comment as part of formal efforts to gather information as the agency establishes a formal and predictable engagement process for each selected drug. For example, it would be useful for CMS to have an ombudsman as a central point of contact for patients and people with disabilities to ensure early and routine engagement with affected patients and people with disabilities on negotiated drugs.
Help us call on CMS to sets standards protecting against the use of biased or discriminatory assessments of therapeutic value and to ensure systematic, robust, guaranteed, transparent engagement with affected patients and people with disabilities.
Key Dates to Watch
Spring 2023
CMS has committed that it will issue guidance on the negotiation process for 2026 and invite public comment on key elements.
- It will be important for CMS to hear input from patients and people with disabilities regarding:
- The methodology and data used to determine the maximum fair price, including reinforcement that the langue of the IRA clearly intends to bar the use of QALYs or similar discriminatory metrics.
- The role that patients and people with disabilities should play throughout the negotiation process, including clear comment opportunities and robust engagement of communities impacted by the selected drugs.
Summer 2023
CMS has committed that it will update its guidance for the negotiation process for 2026 and data collection requests and seek additional comment.
- It will be important for CMS to hear input from patients and people with disabilities regarding:
- What constitutes high-quality, patient-centered data
SEPTEMBER 1, 2023
The initial list of drugs subject to negotiation will be published. This date marks the start of the negotiation process.
Prior to this date, PIPC would like to see:
- Notice and comment as part of an RFI to establish engagement practices with the patient and disabilities community
- Notice and comment on the potential list of selected drugs
- The appointment of an ombudsman for patients and people with disabilities
OCTOBER 1, 2023
The Secretary shall enter into agreements with the manufacturers of selected drugs.
Prior to this date, PIPC would like to see:
- Opportunities for notice and comment on the factors that will come into play in negotiation including judgements of a therapeutic advance, standards for CER that account for subpopulations and disability, defining unmet need based on the patient perspective
- Clear guidance that the QALY and similar metrics, along with organizations and reports that rely on them, will not be used in this process
- Development of patient-centeredness criteria for the process
SEPTEMBER 1, 2024
The Secretary must publish the maximum fair prices for such a negotiated drug.
Prior to this date, PIPC would like to see:
Prior to this date, PIPC would like to see:
- An established process for patients to voice concern should access to a needed treatment be restricted due to this process.
2026-2028
The Secretary is then required to implement the Drug Pricing and Negotiation Program and the Special Rule to Delay Selection and Negotiation of Biologics for Biosimilar Market Entry for 2026, 2027, and 2028 by program instruction or other forms of guidance. While not explicitly prescribed in the IRA’s text, certain provisions within the drug price negotiation program will require additional instruction prior to implementation, including:
- What type of information will be weighted in the negotiation and renegotiation process? Are there clear opportunities for affected stakeholders, including patients and people with disabilities to provide input? What are they?
- Will the Secretary select the highest spending drugs on the top 50 list each year?
- Will potential access challenges within a therapeutic class be considered?
- How will the Secretary determine when an amount is “fair” to act as the negotiated price of a drug?
- What type of research can the Secretary rely on to determine a “fair” price for a drug? Will there be standards for patient-centeredness on this research?
- What metrics and methodology will the Secretary accept when determining a “fair” price for a drug? Can we confirm that QALYs and other discriminatory metrics will not be used?
- How will the Secretary determine when a drug eligible for renegotiation is to be renegotiated?
Tell Congress: Pass The Protecting Health Care for All Patients Act
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The Protecting Health Care for All Patients Act would advance the recommendation of the National Council on Disability calling for the bar on use of the quality-adjusted life year (QALY) and similar metrics that discriminate to be extended to all federal programs, including Medicaid.
We urge all Members of Congress to support this legislation as an important step forward to unambiguously bar QALYs and protect all people from health care discrimination. |
“As with the Americans with Disabilities Act, legislation barring QALYs in all federal programs can pass if Members of Congress on both sides of the aisle are determined to work together to get it done. Even in a divided Congress, there are issues such as ending disability discrimination in health care that everyone can agree on. I am grateful that Chair McMorris-Rodgers introduced the bill and is prioritizing its passage. Reach out to your Members of Congress to support the Protecting Health Care for All Patients Act as an important step forward to unambiguously bar QALYs and protect all people from health care discrimination."
- PIPC Chair Tony Coelho
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We will update this section routinely as open comment opportunities arise to protect patients and people from use of discriminatory metrics in health care decisions and to advance use of an evidence base that values health equity. Sign up using the form below to stay informed about the latest developments.
