Value – National Health Council


The U.S. health care system is undergoing a transformation in how it delivers and pays for care. As traditional fee-for-service gives way to value-based arrangements, understanding the “value” of health care has become a national priority. The National Health Council is focused on ensuring the voice of the patient and patient organizations are an integral part of the value discussion.

Innovation and Value Initiative


The nonprofit Innovation and Value Initiative (IVI) was created to raise the level of discussion regarding value in healthcare and find common ground in the approach to measuring value. The U.S health system is diverse, complex, and ripe for innovation. IVI brings together healthcare leaders from academia, patient advocacy organizations, payers, life sciences companies, providers, delivery systems, and patient communities to advance approaches to value that fit the American context.

Legislative Template for State-Based Legislation: Advancing Health Care Research and Decision-Making Centered on Patients and People with Disabilities


Value Our Health calls on state legislators to protect patients and people with disabilities from policies that would reference discriminatory cost effectiveness analyses based on QALYs and similar metrics, or that would use QALY-based analyses as leverage to reduce government spending by limiting access through the use of step therapy, prior authorization, cost-sharing designs, and tiered formularies. Consideration of research and analysis for Medicaid policies impacting coverage, reimbursement and incentive programs should be transparent to the public and deliberated with input from patients and people with disabilities. Click here to view a template for state legislation protecting patients and people with disabilities from discrimination.

H.R.3 – Elijah E. Cummings Lower Drug Costs Now Act


H.R. 3: House Democrats’ new proposal creates a process that would set prices for up to 250 drugs each year (plus insulins), including those that give patients living with rare diseases or disabilities opportunities to live their optimal quality of life. The plan uses an international reference price backstop — called the average international price (AIM) — to require that HHS-mandated prices for a selected drug do not exceed 120 percent of the drug’s average price across the U.K., Australia, France, Canada, Germany, and Japan. Patients in these countries are routinely denied medicines that they need to survive or to improve their quality of life due to the use of QALYs and average measures of clinical benefit in determining the prices of medicines and who can get them.

Over 60 Leading Patient and Disability Groups Join PIPC in Letter to New ICER VP for Patient Engagement


More than 60 leading patient advocacy and disability groups sent an outreach letter to the Institute for Clinical and Economic Review’s (ICER) new Vice President for Patient Engagement Yvette Venable. The groups applauded the creation of this new position, and look forward to working with Ms. Venable to ensure that ICER develops and implements a robust patient engagement framework. “As organizations that have worked across the spectrum of health care – including life sciences innovation, payer decision-making and value assessment – with missions to improve the quality of life for patients and people with disabilities, we hope that you will engage with us and take advantage of our real-world patient engagement experiences and lessons learned,” the letter states. “Do not hesitate to reach out to us and to the experts in this field described above as you consider patient engagement frameworks that may be fit for use within ICER.”

Center for Disability Rights: State’s Pharmaceutical Proposal Puts Disabled People at Risk


If you have read our response to Governor’s Cuomo’s 2019-2020 Budget you know that we thoroughly comb the budget to analyze every disability related policy we can find. However, occasionally one slips past us. This year we missed one appalling proposal from the Governor in a budget that was admittedly chock full of them. Hidden away in the Health and Mental Hygiene budget was a provision to authorize an independent body to use a method, QALYs (Quality Adjusted Life Years) that is built on disability discrimination to advise the state Drug Utilization Review Board to help determine the price the state is willing to pay for a number of vital medications.

What Else Should I Know About ICER and Its Sickle Cell Disease Value Assessment?


ICER’s assessments are used by private payers, including private Medicare Advantage plans, some Medicaid programs, and the Veterans Administration (VA) to inform formulary development and  utilization management, such as step therapy. ICER’s assessments are precluded by law from being used directly by Medicare. An assessment of low to intermediate value by ICER could lead Medicaid programs, the VA, private insurers, and pharmacy benefit managers to restrict access to the new treatment.

International Reference Pricing…What the Experts are Saying?


Recently, policymakers have proposed International Reference Pricing as a tactic to lower drug prices within the United States. This policy may sound attractive on paper, but there are unintended consequences for patients. Let’s hear what the experts are saying.

Americans Agree: QALYs Have No Place in U.S. Health Care


The Affordable Care Act very clearly states that no one has the authority to deny coverage of items or services ”solely on the basis of comparative effectiveness research“ nor to use such research ”in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.“

Five Ways ICER Fails Patients and People with Disabilities


The Institute for Clinical and Economic Review (ICER) is a private research organization that conducts cost-effectiveness assessments of medicines and health care services. Health insurers and policy-makers use these assessments to guide decisions that impact patient access, which is concerning to the patient and disability community, as their research fails them in multiple ways.

Value Our Health Principles


Policymakers and industry stakeholders are discussing policies that will have a significant impact on what treatments patients and persons with disabilities can access. Many of these involve the use of discriminatory standards that undervalue the lives of older adults, patients, and persons with disabilities. Value Our Health supports assessing the value of any treatment using tools that are consistent with the goals of personalized, patient-centered medicine and do not discriminate against people based on age and/or with disabilities, chronic conditions, and diseases. Adopting the following principles can help ensure that value-driven health care works for all Americans.

QALY Executive Summary


Value assessment in general, and the use of cost-effectiveness in particular, is receiving renewed interest as a tool for controlling health care spending. Currently, the most common method for determining incremental cost-effectiveness of healthcare interventions is based on a calculation of quality-adjusted-life-years (QALY). While the model has a basic appeal for making population-level decisions (by reducing patient populations to single, aggregate numeric values), it also poses several significant concerns from the vantage point of patient-centeredness and efforts to preserve access to needed care for individual patients and people with disabilities.

Australia Case Study


Australia utilizes multiple methods to limit spending on medicines, including international reference pricing, therapeutic reference pricing, and health technology assessments with lowest cost comparators. The health technology assessments, which help to determine reimbursement for medicines covered through Australia’s public health insurance, utilizes quality-adjusted life year (QALY)-based cost-effectiveness assessments.4 Application of these stringent assessments have resulted in challenging barriers for patients in Australia where innovative new medicines are often placed out of reach for those who need them.

Canada Case Study


Canada’s current pharmaceutical pricing policies have led to significant delays and access restrictions for patients who require new and innovative medicines. In addition to regulatory approval, the current coverage and reimbursement process for new drugs includes numerous steps that can impede access: a review of all patented medicines by the Patented Medicine Prices Review Board (PMPRB), assessments that utilize the quality-adjusted-life-year (QALY) conducted by the Canadian Agency for Drugs and Technologies in Health (CADTH), and additional negotiations and product listing agreements with Provincial public drug plans. This complex and many-layered process acts as a barrier to innovate drugs and creates delays in access for patients.

Ireland Case Study


To make decisions about coverage and reimbursement, Ireland uses quality-adjusted life year (QALY)-based assessments conducted by the National Centre for Pharmacoenomics (NCPE). NCPE generally recommends that Medicines which fall below €45,000 ($50,987) cost per QALY be reimbursed by the Health Service Executive (HSE), the Irish Department of Health, while medicines that fall above this threshold are usually not covered. This arbitrary cost-effectiveness threshold is applied only to medicines. Additionally, due to budgetary constraints within HSE, even when drugs are approved by NCPE, patients do not automatically receive access to the treatment. These dynamics result in significant access barriers for Irish patients who are suffering from serious and complex conditions.

United Kingdom Case Study


Rigid assessments of treatment value, government-driven decisions on formularies and coverage, and insufficient health care budgets have long stood in the way of U.K. patients who need access to the latest innovative medicines. The high rate of rejections by the National Institute for Health and Care Excellence (NICE), the group that advises the National Health Service (NHS) on coverage decisions and makes decisions based on a cost-effectiveness threshold of between £20,000 and £30,000 ($25,700 – $38,560) per quality-adjusted life year (QALY), is one major reason why U.K. patients are often denied access to new medicines.

Sickle cell disease advocates shared their concerns with ICER


The American Society for Hematology stated, “ASH, however, has tried to stress why the SCD community is unique and outline our concerns about the potential adverse impact ICER’s assessment could have on recent and future progress of new therapies” – the SCD community is on the cusp of benefiting from new, potentially life-changing, treatments and cannot afford a setback. Sick Cells stated, “We urge ICER to suspend the review at this time, as this review is premature and inappropriate. The lack of published quality of life and real-world data for these new treatments severely limits ICER’s ability to measure the benefit of them.” Several advocates commented as individuals with their personal stories living with sickle cell disease that ICER’s assessment was unable to capture.

Establishing a Prescription Drug Affordability Board


On February 18, 2020, the Washington State Senate passed SBB 6088, a bill establishing the prescription drug affordability board (board). The legislation did not bar the Board from utilizing discriminatory quality-adjusted life years (QALYs) as the metric for determining whether treatments exceed certain thresholds. The Board also would not have included representation from patients or people with disabilities, only “five members who have expertise in health care economics or clinical medicine appointed by the governor.” The bill was vetoed by the Governor and may be reconsidered in the next legislative session.

Statement on Health Policy Commission Regulation to Value Prescription Drugs


On February 5, 2020, the Massachusetts Health Policy Commission (HPC) finalized regulations outlining their approach to assessing the value of prescription drugs. As groups representing patients and people with disabilities, the affordability of health care is a significant priority. That being said, HPC’s regulations put patient access at risk, and may ultimately do more harm than good for patients. They set the stage for third-party analyses by groups like the Institute for Clinical and Economic Review (ICER) and rely on international reference pricing, which relies on QALY-based assessments in determining the “value” of treatments.

NCD letter to CMS on QALYs and Organ Transplants


February 3, 2020, NCD letter to Centers for Medicare and Medicaid on QALYs, organ transplants: NCD advised CMS of its bioethics report on QALYs and made several recommendations. NCD advised CMS to refrain from pursuing means of reducing Medicare and Medicaid prescription drug costs that attempt to model US pricing after the pricing in other countries, which may heavily rely on QALYs and often deny people with disabilities access to needed care. NCD also recommended CMS rescind its Advanced Notice of Proposed Rulemaking, which proposed an international price index for Medicare Part B.

ICER’s Revised Framework for 2020 Fails to Incorporate Input from Patients and People with Disabilities


February 2, 2020, ICER’s Revised Framework for 2020 Fails to Incorporate Input from Patients and People with Disabilities: On Jan. 31, the Institute for Clinical and Economic Review (ICER) released its final revisions to its value assessment framework. While the revised framework seeks to formalize a patient engagement program, the program falls short in committing to meaningful incorporation of patient perspectives and preferences into ICER’s reviews. ICER commits to work with patient groups throughout the process, but it does little to ensure that the patient voice is heard. The framework also makes it clear that economic analysis still maintains primacy at ICER and would be counted as more valuable than patient input.

Webinar – ICER Draft Evidence Report on Sickle Cell Disease: An Overview, Next Steps and Expectations


We welcomed interested stakeholders, patients, advocates, caregivers and families to join a webinar about the progress of the ICER assessment to-date. ​ICER’s draft evidence report on sickle cell disease was released on January 23, and the webinar will review the contents of the report and provide guidance and information for advocates who may want to provide comments on the report.

Prescription Drug Cost Transparency Report for Measurement Year 2018


January 10, 2020, Prescription Drug Cost Transparency Report for Measurement Year 2018: California’s Administration announced an intent to propose establishing a single market for drug pricing within the state for all purchasers—Medi-Cal, California Public Employees’ Retirement System, Covered California, private insurers, self-insured employers, and others— in which California would invoke a most-favored-nation clause requiring manufacturers to offer prices at or below the price offered to “any other state, nation, or global purchaser.” In doing so, California would be referencing prices in other countries that use quality-adjusted life years (QALYs) and similar metrics to determine the cost effectiveness and coverage of drugs.  Click here to view the California plan.

PIPC Submits Letter to CMS on Proposed International Pricing Index


December 31, 2019, International Pricing Index Letter: Organizations representing patients, people with disabilities, family members, caregivers, veterans, seniors, providers, and others in response to the Advance Notice of Proposed Rulemaking released by the Center for Medicare & Medicaid Services (CMS) to utilize an “International Pricing Index” (IPI) to set reimbursement for medicines in Medicare Part B. The letter highlights concerns that this new policy would import QALY-based standards to key U.S. health programs. “Addressing health care costs, including drug prices, is an important and meaningful effort that should center on achieving outcomes that matter to those being served by health systems (patients, people with disabilities, veterans, seniors and other marginalized communities) such as improved quality of care and lower out-of-pocket costs,” the letter states. “We are hopeful the Administration will reconsider their plan to import international cost-effectiveness standards into the U.S. and instead advance patient-centered, non-discriminatory approaches and establish meaningful protections for our communities in future demonstrations.”

Disability Groups Letter on the “Value” of Medications


We are writing in response to proposals from both the Commonwealth of Massachusetts Executive Office and the Massachusetts Health Policy Commission related to their consideration of the “value” of medications as a part of the oversight and administration of prescription drug pricing. The affordability of health care is a significant priority for patients and people with disabilities, and we applaud efforts to reduce the cost of care.

NCD Quality Adjusted Life Report


November 6, 2020, Quality-Adjusted Life Years and the Devaluation of Life with Disability: The National Council on Disability (NCD)—an independent federal agency– released a study examining “Quality-Adjusted Life Years” (QALYs) as a health care cost-effectiveness measure that guides coverage decisions regarding drugs and treatments by private and public health insurers. In its study, NCD found sufficient evidence of discriminatory effects of the measure to warrant concern, including: concerns raised by bioethicists, patient rights groups, and disability rights advocates; and the inability of patients to obtain coverage of needed healthcare in countries where QALYs are used frequently. NCD also found that when the state of Oregon attempted to apply QALYs to its Medicaid state plan in the 1990s, it was found to violate the Americans with Disabilities Act as inherently discriminatory.

Comment Letter with Over 50 Organizations on ICER’s 2020 Framework


October 18, 2019, Over 50 Organizations Comment on ICER’s 2020 Framework: The letter stated, “Above all, we urge ICER to put patients and people with disabilities at the center of all of your assessments. While we share your interest in lowering healthcare spending and addressing affordability, ICER’s use of discriminatory methods in its value assessments gives insurers tools to restrict patient access, an unethical tactic that puts the most vulnerable at an increased risk of worse health outcomes, increased out-of-pocket costs associated with their care, and potential adverse events. ICER’s value assessments do not promote affordability for patients, but instead give payers justification to create barriers to treatment coverage that benefit their own bottom line. Yet, when patients are treated first with the right treatment for their individual condition, they are more likely to adhere to treatment, become healthier, and holistically save the healthcare system money.”

ICER’s Concern for Patients: Where’s the Beef?


The Institute for Clinical and Economic Review, commonly known as ICER, wants everyone to believe that it cares about patients and that its value assessments of new drugs and treatments are intended to help them. How do we know that? It’s become the organization’s central talking point as it makes the rounds in advance of finalizing its revised Value Assessment Framework for 2020, which describes the methodology the organization will use in its assessments beginning next year.

ICER’s List of Key Sickle Cell Disease Stakeholder Organizations


ICER receives input on its reviews from patients and their families, patient advocacy organizations, clinicians, clinical societies, insurers, and drugmakers. We invite the public to submit recommendations for key stakeholders in any of these categories. The following is a list of organizations from which ICER has requested input as well as those that have provided public comments during the review. None of these individuals or organizations is responsible for the final content of ICER’s report, and it should not be assumed that they support any part of the report, which is solely the work of the ICER team and its affiliated researchers.

Sick Cells Comment on ICER’s Insufficient Stakeholder List


Sick Cells is pleased to submit comments about the Institute for Clinical and Economic Review (ICER) Sickle Cell Disease: Stakeholder List. The sickle cell disease (SCD) community has a vast reach of community-based organizations. Each region of the United States faces its own, unique challenges. With this in mind, each CBO works within its local governments and healthcare systems to increase access to and quality of care for SCD patients and families. Partner organizations of the SCDAA should be evaluated as stand-alone CBOs.

Sick Cells Letter to ICER on Draft Scoping Document


Sick Cells is pleased to have the opportunity to submit comments in response to the Institute for Clinical and Economic Review’s (ICER’s) Draft Scoping Document on treatments for sickle cell disease (SCD). Sick Cells is a patient advocacy organization that aims to elevate the voices of the SCD community. We would like to offer the following suggestions to ICER for consideration.

Sickle Cell Stakeholder Letter


As key stakeholders in the sickle cell disease (SCD) community, we recommend you postpose the SCD review and reschedule the review for a later date. We agree with and understand the Institute for Clinical and Economic Review’s (ICER) overarching mission to ensure SCD patients have access to effective and affordable treatments. After review of the Draft Scoping Document, we have concerns about ICER’s ability to accurately evaluate Crizanlizumab and Voxelotor at this time.

Value Assessments – the Impact on People with Rare Diseases


The Partnership to Improve Patient Care (PIPC) and Everylife Foundation for Rare Diseases held a webinar about value assessments, their potential to limit access and innovation for rare disease treatments. The webinar featured Sara van Geertruyden, Executive Director, Partnership to Improve Patient Care; Ari Ne’eman, Disability Advocate, Partnership to Improve Patient Care; Siri Vaeth, Executive Director, Cystic Fibrosis Research, Inc.; and Christina Hartman, Senior Director of Policy and Advocacy, Everylife Foundation for Rare Diseases.

Value Our Health Capitol Hill Briefings – Event Recap


The panelists shared their concern about current value assessments, like those conducted by the Institute for Clinical and Economic Review (ICER), because the metrics they use, like the quality-adjusted life year (QALY) and equal value life-year gained (evLYG), treat patients as averages.  Mr. Ne’eman explained that the QALY is a tool used in therapeutic value assessment. “It is designed to reduce the many different people and things that people seek from health care — improvement in quality of life, life extension — to a single number.” Insurers, researchers, and governments around the globe use the QALY to assess the benefit of different health interventions, often leading to people with disabilities being left out in the cold. For example, said Mr. Ne’eman, under one QALY measure, one “year in a life with moderate multiple sclerosis is worth 54 percent of the year in the life of a hypothetical non-disabled person.”