Arthritis Foundation Bringing the Voice of the Patient to Drug Pricing Proposals

Urging consideration learned from patient data for two issues that are most challenging to patients: out-of-pocket costs and inappropriate use of step therapy. 

The Honorable Nancy Pelosi
Speaker, U.S. House of Representatives
1236 Longworth House Office Building
Washington, DC 20515

The Honorable Kevin McCarthy
Minority Leader, U.S. House of Representatives
2468 Rayburn House Office Building
Washington, DC 20515

The Honorable Chuck Schumer
Majority Leader, U.S. Senate
322 Hart Senate Office Building
Washington, DC 20510

The Honorable Mitch McConnell
Minority Leader, U.S. Senate
317 Russell Senate Office Building
Washington, DC 20510

Dear Speaker Pelosi, Minority Leader McCarthy, Majority Leader Schumer, Minority Leader McConnell:

On behalf of the Arthritis Foundation, representing the 54 million Americans with doctor-diagnosed arthritis, we urge you to ensure patient-centeredness is at the core of any drug pricing legislation Congress may consider in the 117th Congress. Any and all efforts to rein in drug prices must prioritize the impact of drug costs to the patient and must be viewed from the lens of the patient. Simply, if patients cannot afford their out-of-pocket costs, they cannot access the treatments and services they need.

Robust data clearly shows the impact of costs on treatment adherence, and for people with chronic disease adherence is essential to maximizing health outcomes while minimizing worsening of their disease. Often, unintended consequences disrupt the patient’s ability to properly manage their health and chronic conditions. Ultimately, barriers to treatment cost the health care system more in the long run as disease progression leads to increased hospitalizations, additional use of other health care services, and higher total associated health care costs. This creates a ripple effect on productivity, employee absenteeism, caregiver costs, and other indirect cost impacts to the patient, health care system, and overall economic costs. Arthritis is a therapeutic area for whom beneficiaries are hit hardest and are most likely to reach the catastrophic coverage phase in Medicare Part D; to reach their maximum out-of-pocket costs in the first quarter of the plan year; and to be negatively impacted by inappropriate use of step therapy protocols.

Arthritis Foundation data strongly supports this assertion -- with financial concerns and step therapy and prior authorization barriers topping the list of arthritis-related challenges every year in our annual priorities survey. As such, reducing out-of-pocket costs and inappropriate use of step therapy are our top priorities this Congress; both issues have strong bipartisan support and the backing of many patient and provider groups.

Guided by this data, we urge consideration of the following priorities for any drug pricing legislation considered this Congress:

Part D Benefit Restructuring
We are pleased that there is bipartisan support for capping out-of-pocket costs in Medicare Part D, and we strongly support passage of a Part D cap at no more than $2,000 a year, including a smoothing mechanism to allow beneficiaries to pay over a plan year.
Currently, many arthritis patients reach the catastrophic phase early in the year, which can cause financial and emotional distress. According to the Kaiser Family Foundation, in 2017 over 1 million beneficiaries enrolled in Medicare Part D had out-of-pocket spending above the catastrophic threshold with average annual out-of-pocket costs exceeding $3,200. Worse, some patients must abandon their Part D drug altogether. In a 2019 Arthritis Foundation survey, 40% of Medicare Part D enrollees reported that they could not access the drugs they need to manage their disease; 19% of Medicare respondents had to switch from Part D to Part B due to out-of-pocket costs. Switching from a drug on which a patient is stable for cost reasons is not clinically appropriate and can lead to significant adverse health outcomes, which ultimately costs more money to the health care system over time.

We urge members of Congress to consider the affordability issues many beneficiaries on fixed incomes have as any negotiations on the upper limit of the cap continue. Even a cap of $2,000 is difficult for many seniors to afford. Smoothing allows patients to have more predictable costs as they pay over time during the plan year.

We urge Congress to incentivize the use of lower-cost biosimilar products. Within the next 3 years, many Part D-covered biosimilars for arthritis will be available for patients. We have long supported the promise of biosimilars to increase competition and drive down prices of both reference and biosimilar products. We encourage Congress to consider the opportunities this expanded market of biosimilars may offer.

Value Assessment in Drug Pricing
We recognize the need to lower drugs prices, and to the extent that Congress may consider value assessment as a lever to lower drug prices, we urge consideration of patient-centered principles that would consider value to the patient in any cost-effectiveness methodology. These principles include:

  • Prohibiting use of methodologies that rely on Quality Adjusted Life Years (QALYs). QALYs are inappropriate for determining long-term value of treatments and if universally applied by payers could easily disqualify many, if not all, biologic medications for rheumatoid arthritis (RA) from being covered, per the 2017 ICER review of RA drugs. We have major concerns about the use of QALYs in connection with the proposed International Pricing Index measures in current proposed legislation. QALYs are discriminatory measures for people with chronic diseases, as some QALY-based reviews have determined RA to be a condition worse than death. This conclusion is unacceptable, and we urge Congress to work with the patient community and other stakeholders to develop a more appropriate, patient-centered approach to setting value benchmarks.
  • Requiring the use of Real-World Evidence (RWE) in any cost effectiveness reviews. Robust collection of RWE is essential to truly measure the efficacy and value of treatments. Clinical trial data is limited and insufficient to capture the full scope of how treatments will work in patients. They do not capture the heterogeneity of disease, represent diversity of the patient population, or adequately represent patients with co-morbidities. Congress should work with PCORI, the FDA, and other stakeholders to develop requirements for the use of RWE in value assessment.
  • Appropriate consideration of contextual considerations and impacts important to patients. Individual patient experiences do not often align with economic models, and there are many factors that influence patient treatment regimens and adherence, from overly burdensome utilization management requirements to prohibitive out-of-pocket costs, caregiver burden, and inability to physically administer certain treatments, among others. The Arthritis Foundation has collected a significant amount of data to support the importance of contextual considerations among people with arthritis. For example, data collected on patients with RA supports the notion that many or most RA patients: o Cycle over several medications over the lifetime course of their disease
    • Change medications early in their disease treatment
    • Must overcome significant systemic barriers to receive doctor-prescribed medications or treatments options
    • Often receive more medications for pain and depression and therefore accrue additional costs to the health care system when their RA is not well controlled
  • Meaningful patient engagement. Patients should be included as a key voice during discussions of value assessments for drug pricing at every step of the process.

We also urge consideration of the patient impact and recommend robust testing of any policy proposals to ensure their feasibility and appropriateness for the U.S. health care system.

Other Out-of-Pocket Protections
We urge inclusion of critical out-of-pocket protections in any drug pricing legislation, including:

  • Ensuring out-of-pocket costs are based on the net price, not the list price, of prescription drugs. This is especially important for patients who pay co-insurance, a percentage of the drug cost that can be as high as 40% in commercial and Exchange plans.
  • Allowing more flexibility within HDHP-HSAs to provide coverage for treatments to manage chronic disease without meeting the deductible. In 2019, the IRS expanded the list of eligible treatments that could be covered pre-deductible to include some additional chronic disease and preventive care treatments, but unfortunately did not include arthritis. Forms of arthritis like rheumatoid arthritis are chronic diseases that require consistent treatment to prevent worsening of disease, which is precisely what the expansion of treatments was intended for. As the use of HDHPs and the number of employers offering HDHP-only plans increases, the ability of people with high out-of-pocket costs like those with RA to receive their standard treatments pre-deductible would go a long way towards protecting their ability to remain adherent to their treatment.
  • Encouraging payers and PBMs to pass on rebates to patients at the point-of-sale, as some have already pledged to do. In 2021, several states, including IN, NM, OR, and CA introduced legislation to ensure that payers and PBMs reduce the amount paid by the patient by a percentage of the rebate received by the manufacturer, and we would support this approach at the federal level as well.
  •  Ensuring patients have access to health plans without co-insurance for specialty tier drugs. In a 2017 Arthritis Foundation survey 27% of respondents cited co-insurance as their top access challenge. The Arthritis Foundation supports policies that would cap specialty tier out-of-pocket costs or ensure there is at least one health plan available to patients that includes an out-of-pocket cap.

For any drug pricing proposals that may be considered, we urge any savings from those proposals to be used to directly improve patient access and care, such as improving and accelerating real-time benefit tools; promoting value-based insurance design programs; and expanding coverage for needed health benefits.

Above all, we strongly urge you to ensure patients are included in the process and encourage you to work with the patient advocacy community early and often to avoid unintended consequences from any given proposal. We offer the Arthritis Foundation as a resource to collect patient data and feedback on policy proposals you may consider. If we can be of assistance in any way, please contact Anna Hyde, Vice President of Advocacy and Access, at [email protected].


Steven Taylor
Executive Vice President
Mission & Strategic Initiatives
Arthritis Foundation

cc: Chair Frank Pallone, Jr., U.S. House Committee on Energy & Commerce
Ranking Member Cathy McMorris, U.S. House Committee on Energy & Commerce
Chair Robert Scott, U.S. House Committee on Education and Labor
Ranking Member Virginia Foxx, U.S. House Committee on Education and Labor
Chair Richard Neal, U.S. House Committee on Ways & Means
Ranking Member Kevin Brady, U.S. House Committee on Ways & Means
Chair Ron Wyden, U.S. Senate Committee on Finance
Ranking Member Mike Crapo, U.S. Senate Committee on Finance
Chair Patty Murray, U.S. Senate Committee on Health, Education, Labor & Pensions
Ranking Member Richard Burr, U.S. Senate Committee on Health, Education, Labor & Pensions