PIPC Strongly Opposed to Reliance on Foreign QALY Standards in CMS’ Final Rule Imposing “Most Favored Nation” Drug Pricing in Medicare Part B
Today, the Centers for Medicare and Medicaid Innovation (CMMI) finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) model that would impose so-called “Most Favored Nation” drug pricing in Medicare Part B. PIPC is deeply concerned about embedding in U.S. policy the use of cost-effectiveness standards like the quality-adjusted life year (QALY), which devalues the lives of people with disabilities and older patients. Whether it’s adopted into a payment price, benchmark, coverage policy, or reimbursement incentive, reliance on QALY-based policy is the wrong approach for patients and people with disabilities. Adopting the values of other countries that routinely deny patients access to breakthrough treatments for serious and disabling conditions puts American patients at risk of the same outcome. We support the agency’s goal of lowering drug prices for all Americans, but it is critical that it is done in ways that respect existing statutory safeguards against QALYs and work for all Americans.
We look forward to working with Congress and the administration on steps to ensure Medicare protects people with disabilities and complies with the current laws that bar the use of QALYs and similar measures in Medicare decisions.
Today, the Centers for Medicare and Medicaid Innovation (CMMI) finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) model that would impose so-called “Most Favored Nation” drug pricing in Medicare Part B. PIPC is deeply concerned about embedding in U.S. policy the use of cost-effectiveness standards like the quality-adjusted life year (QALY), which devalues the lives of people with disabilities and older patients. Whether it’s adopted into a payment price, benchmark, coverage policy, or reimbursement incentive, reliance on QALY-based policy is the wrong approach for patients and people with disabilities. Adopting the values of other countries that routinely deny patients access to breakthrough treatments for serious and disabling conditions puts American patients at risk of the same outcome. We support the agency’s goal of lowering drug prices for all Americans, but it is critical that it is done in ways that respect existing statutory safeguards against QALYs and work for all Americans.
We look forward to working with Congress and the administration on steps to ensure Medicare protects people with disabilities and complies with the current laws that bar the use of QALYs and similar measures in Medicare decisions.
Background
Last February, the Partnership to Improve Patient Care (PIPC) joined more than 100 organizations representing patients, people with disabilities, and older adults in sending a letter to CMMI opposing the use of the GLOBE and GUARD models. We shared research demonstrating how the GLOBE and GUARD models would import standards for policymaking used in Organisation for Economic Co-operation and Development (OECD) countries that devalue many patients people with disabilities, ignore differences in the needs of individual patients and their families, and lead Americans to experience similar delays in access to innovation.
Low QALY values for disabling conditions and inaccurate measures of quality of life and health improvement can lead policymakers to determine that care is not cost effective or worth covering. These calculations may fail to reflect how people adapt to disability, the value of greater independence, or the benefits of accommodations and supportive services.
We have also examined how HTA processes in the UK diverge from the U.S.’ patient-centered principles, including key shortcomings such as failure to meaningfully capture the full range of outcomes (health and quality of life) that matter to patients and caregivers; imposition of evidence standards that disadvantage patients with serious diseases and conditions; lack of transparency and flexibility in HTA processes; and failure of patient input to meaningfully shape decision outcomes. Patients in the UK encounter long delays in access to new tests and treatments and reduced flexibility for physicians to tailor care to the needs of different patients, an outcome that the National Council on Disability has recognized as a risk of importing QALY-based values to the United States.
| pipc_statement_globe_final.pdf |
