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Access and Nondiscrimination in the States Awareness Project 

About the Project

The Access and Nondiscrimination in the States Awareness Project provides public education and awareness of how states are currently valuing health care, the use of value assessments in their health care systems, and potential implications for discrimination and barriers to patient access. As our policymakers at the federal and state level explore avenues to address the cost of prescription drugs, they are frequently turning to solutions that would be detrimental to patient access, like international reference pricing, or reliance on third-party cost-effectiveness analyses to determine the “value” of prescription drugs.  Cost-effectiveness analyses generally rely on the Quality-Adjusted Life Year (QALY). The QALY, along with similar metrics that treat patients as averages, is known to discriminate against people who are chronically ill or disabled.
 
We strongly believe that comparative clinical effectiveness research should work for patients to improve their health decisions, not against them by limiting their access in a one-size-fits-all health system. Therefore, policies to advance value-based health care must mitigate against the misapplication of research in ways that restrict patient access to optimal care, undermine physician/patient shared decision-making, and discourage continued medical progress. This project allows patients and people with disabilities to see where and how states may be using or considering using discriminatory metrics that would limit their access to needed care.

State Awareness Tracker

Alabama
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The law states, “The Medicaid Pharmacy and Therapeutics Committee shall develop its preferred drug list recommendations by considering the clinical efficacy, safety, and cost effectiveness of a product.” 
  • The regulations creating the Drug Utilization Review Board do not reference cost effectiveness and state, “The Medicaid Agency shall provide, by not later than January 1, 1993, for a Drug Utilization Review (DUR) Program for covered outpatient drugs in order to assure that prescriptions are appropriate, medically necessary, and are not likely to result in adverse medical results.”
  • Many of the state’s prescription drug coverage policies demonstrate that treatments that were assessed by ICER and deemed to not be cost effective or for which ICER recommended step therapy tend to be covered with prior authorization requirements or not covered at all.
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Alaska
  • In 2019, Alaska reported to the Kaiser Family Foundation that the state is considering “the use of comparative effectiveness review in drug coverage review," and that the state Medicaid program uses ICER studies.
  • Alaska’s Drug Utilization Review Board considers cost-effectiveness in its analyses. Alaska Medicaid prior authorization clinical criteria for use and standards of care are developed under the authority granted to the Alaska Medicaid Drug Utilization Review Committee in compliance with 7 AAC 120.120, 7 AAC 120.130, 7 AAC 120.140, 42 USC 1396r-8, and 42 CFR 456 Subpart K. 
  • The DUR Board meeting minutes are not specific. 
  • ​There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Arizona
Current Activities: 
  • Introduced February 1, 2022 - SB 1680 would create a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with an “independent third party” that could include ICER.

Landscape for Cost Effectiveness & QALY Considerations: 
  • The state Medicaid program does not openly reference QALYs or ICER studies, though Arizona reported to the Kaiser Family Foundation that the state is considering “the use of comparative effectiveness review in drug coverage review.”
  • The Arizona Health Care Cost Containment System description states, “The AHCCCS Pharmacy & Therapeutics Committee (Committee) is advisory to the AHCCCS Administration and is responsible for evaluating scientific evidence of the relative safety, efficacy, effectiveness and clinical appropriateness of prescription drugs.” Almost all of Arizona’s beneficiaries are enrolled in managed care organizations, therefore there is no state DUR Board.
  • The P&T Committee activities are managed by Provider Synergies.​
  • The state has not proposed to bar the use of QALYs.
Arkansas
Current Activities:
  • Recent litigation in Arkansas held that, “DHS had no legal authority to make a threshold decision that there was a ‘lack of medical necessity’ for a prescription of Exondys, a ‘covered outpatient drug.”

Landscape for Cost Effectiveness & QALY Considerations: 
  • The state Medicaid program reported to Kaiser Family Foundation that the state references published studies from ICER, which rely on QALY and evLYG metrics to determine value and cost effectiveness.
  • The Drug Review Committee does not provide meeting minutes. 
  • A member of ICER’s Midwest CEPAC also serves as:
    • clinical consultant to the Employee Benefits Division for the pharmacy benefit offered to the Arkansas State Employees and Public School Employees;
    • a member of the Arkansas Medicaid Drug Review Committee to develop and maintain the preferred drug list;
    • the University of Arkansas System Pharmacy Advisory Committee, and;
    • a board member for the Arkansas Medicaid Drug Utilization Review Board.
  • Arkansas is reported to rely on reference pricing since 2005 for its state employee program for 12 classes of drugs including antihyperlipidemic-HMG, angiotensin II rec antagonists/direct renin inhibitors, long-acting amphetamines, fibromyalgia-related anticonvulsants, serotonin norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, migraine medications, sedatives, proton pump inhibitors, overactive bladder agents, nasal steroids, and osteoporosis-calcium regulators.
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
California
Current Activities:
  • ​ICER has received a grant from the California Health Care Foundation to develop annual unsupported price increase reports as well as a policymaker guide for using its research to determine “fair” access and pricing to drugs. Advocates are concerned of the implications of this grant given ICER’s reliance on QALYs. Simultaneously, the California legislature is considering AB 1130, which would establish the Office of Health Care Affordability to develop policies for lowering health care costs for consumers, set and enforce cost targets, and create a state strategy for controlling the cost of health care. This bill does not currently contain a ban on the use of the QALY. 

​Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program reported to the Kaiser Family Foundation that the state references published studies from ICER, which rely on QALY and evLYG metrics to determine value and cost effectiveness.
  • The P&T Committee meeting minutes do not describe the evidence base for making decisions. 
  • Proposed QALY Authority: The state has proposed policies that would further codify its ability to reference QALYs:
    • Proposed, 2021: The California Health Care Quality and Affordability Act and a state budget proposal to create an Office of Health Care Affordability empowered to analyze and determine strategies to address costs in a manner that may rely on QALY-based cost effectiveness studies.
    • Proposed, 2020-2021: The California Governor’s proposed budget sought to expand the state's ability to consider the best prices offered by manufacturers internationally, potentially referencing countries that rely on QALYs in considering price, reimbursement and coverage.
    • Proposed, 2019: The California Legislative Analyst’s Office (LAO) proposed the state use formal use of cost- effectiveness analysis for preference of drugs in Medi-Cal and use of a drug spending cap, similar to the State of New York that relies on ICER’s QALY-based cost-effectiveness analyses.
  • The state has not proposed to bar the use of QALYs, though advocates have reached out to policymakers requesting a QALY ban be added to the proposed legislation and budget creating an Office of Health Care Affordability.
Colorado
Current Activities:
  • Policies recently adopted by the newly created Prescription Drug Affordability Board do not mention the provision in the law that precludes the use of quality-adjusted life years (QALYs) in establishing an upper payment limit.

Landscape for Cost Effectiveness & QALY Considerations: 
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The DUR Board does not provide details about the evidence base in its meeting minutes.
  • The meeting minutes of the P&T Committee do not describe in details the evidence base for making decisions. 
  • Proposed QALY Authority, 2020: The Colorado Department of Health Care Policy and Financing released a report entitled “Reducing Prescription Drug Costs in Colorado,” which proposed “monitoring new ways to price prescription drugs, including QALY pricing methodologies” from ICER.
  • Passed QALY Authority, 2021: The state created (SB 21-175) a Prescription Drug Affordability Board that did not explicitly bar reference to QALYs within the commission’s authority to assess the value of treatments that would be considered for an upper payment limit and would explicitly authorize the Board to contract with an “independent third party” to assess treatment value, that could include ICER.
  • Passed QALY Restriction, 2021: The state created (SB 21-175) a Prescription Drug Affordability Board that barred the use of QALYs as part of the methodology for establishing an upper payment limit for a prescription drug. The Board and its advisory council will not be operational until January 1, 2022.
Connecticut
  • The state Medicaid program has not openly referenced QALYs or ICER studies in recent years.
  • ICER recommendations helped shape the state’s Medicaid coverage on topics such as sleep apnea treatment, breast cancer imaging, and Proprotein Convertase Subtilisin/Kexin Type 9 inhibitors according to an agency presentation to the Connecticut Healthcare Cabinet in 2017. Such detailed information was not found in public records over the 2019-2021 period identifying the evidence used for Medicaid decision-making on drug coverage.
  • In its mission statement, the Connecticut Medical Assistance Pharmacy DUR program states that its goal is to facilitate the “appropriate and cost effective delivery of pharmaceutical care with non-biased, independent professional reviews of published literature for advisement on educational programs” and does not make any statement restricting use of QALY-based cost effectiveness analyses.
  • The state does not publish DUR Board meeting minutes or make public the evidence used to support decisions related to its coverage and reimbursement of prescription drugs.
  • Proposed QALY Authority, 2019: H.B. 7174 would have called for maintaining a list of “cost effective” drugs as determined by the State Comptroller, with no bar on use of metrics such as QALYs.
  • Proposed QALY Ban, 2021: H.B. 6242 would prohibit any “insurer, health care center, fraternal benefit society, hospital service corporation, medical service corporation or other entity that delivers, issues for delivery, renews, amends or continues a health insurance policy” from using a dollars-per-quality adjusted life year or any similar measure as a threshold for coverage, reimbursement or incentives. The bill is not limited to prescription drugs, but applies broadly to health care services.
Delaware
  • The state Medicaid program reported that the state references published studies from ICER, which rely on QALY and evLYG metrics to determine value and cost effectiveness.
  • The P&T Committee is described as, “The committee’s objective is to achieve quality pharmaceutical care for recipients enrolled in Delaware’s Medical Assistance programs while providing significant taxpayer savings.” 
  • The state’s DUR Board description does not include reference to cost effectiveness, stating, “The Board makes recommendations for which combination of interventions would most effectively lead to improvement in the quality of drug therapy, and periodically re-evaluates and, if necessary, modifies the recommended interventions.”
  • Meetings website and schedule not operational. 
District of Columbia
  • The district’s Medicaid program reported that the state references published studies from ICER, which rely on QALY and evLYG metrics to determine value and cost effectiveness.
  • The district’s DUR Board “shall ensure that prescribed drugs are clinically appropriate, medically necessary, cost effective, and not fraudulently obtained or prescribed.” 
  • The district does not publish DUR Board or P&T committee meeting minutes or make public the evidence on cost effectiveness used to support decisions related to its coverage and reimbursement of prescription drugs.
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Florida
  • Vida Health and Florida Alliance for Healthcare Value recommended employer use of QALYs at the Florida Alliance’s 26th Annual “Best of the Best” Showcased Innovation in Achieving Value in Employer-Sponsored Healthcare, stating that employers should, "Consult reports from the Institute for Clinical and Economic Review (ICER) when making decisions within the drug space as they provide valued intellectual perspectives and analysis, especially with regard to exceedingly high drug pricing."
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • Past state DUR Board and P&T Committee meetings are not publicly available, nor are meeting minutes made public.
  • State statute says, “The agency shall purchase goods and services for Medicaid recipients in the most cost-effective manner consistent with the delivery of quality medical care” and “The agency shall implement a Medicaid prescribed-drug spending-control program that includes…A Medicaid preferred drug list, which shall be a listing of cost-effective therapeutic options recommended by the Medicaid Pharmacy and Therapeutics Committee established pursuant to s. 409.91195 and adopted by the agency for each therapeutic class on the preferred drug list” and “The agency may specify the preferred daily dosing form or strength for the purpose of promoting best practices with regard to the prescribing of certain drugs as specified in the General Appropriations Act and ensuring cost-effective prescribing practices.”
  • The state PDL is described as “a listing of cost-effective, safe and clinically efficient medications for each of the therapeutic classes on the list.”
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Georgia
  • The state Medicaid program reported that the state references published studies from ICER, which rely on QALY and evLYG metrics to determine value and cost effectiveness.
  • The DUR Board and P&T Committee meeting minutes are not published nor is the evidence base for decisions publicly available.
  • The DUR Board is described as, “The Board reviews drug therapy, drug studies and utilization information, thus enabling the Department to identify the most cost-effective policies for its members.”
  • The P&T Committee charter states, “The decisions from P&T will proceed to the Strategy Development committee (SDC) who will make PDL decisions through financial analyses that are consistent with P&T decisions. The SDC will manage drug cost using a multi-disciplinary standardized approach to identify, develop, and implement long and short-term strategies in support of health plan financial and other business objectives. Data and analytics will optimize decision-making.”
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Hawaii
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The DUR Board and P&T Committee meeting minutes are not published nor is the evidence base for decisions publicly available.
  • The DUR Board is described on the state website as, “The Prospective Drug Utilization Review (ProDUR) process promotes optimal and cost-effective use of pharmaceuticals, lessens the chance of unnecessary or inappropriate use of medications, helps identify possible drug-related problems, and promotes optimal clinical outcomes.”
  • A duty of the DUR Board is described in state regulations as, “Determine the content and mix of educational programs and interventions for practitioners, designed to enhance the clinical appropriateness and cost effective use of prescription drugs with primary emphasis on therapeutic outcomes and quality of care.”
  • Introduced, HB 18, 2021: Hawaii introduced legislation modeled on a NASHP template bill to reduce prescription drug costs for residents by establishing maximum wholesale drug prices that are the same as the prices in Canada, which relies on QALYs in pricing and coverage decision-making.
Idaho
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The state relies on third parties in establishing its formulary, including Provider Synergies, which describes itself as developing preferred drug list recommendations using a process that “combines clinical and financial information in a competitive contracting process.” They also state, “These recommendations also consider an analysis of disruption and savings models based on the expected impact of alternative PDL recommendations.” Their model emphasizes cost savings stating, “Provider Synergies uncovers cost saving opportunities for our clients through our financial modeling process. We provide quarterly reports detailing preferred drug list recommendations to optimize the net cost of drugs for our clients.”
  • In meeting minutes, the Idaho P&T Committee referenced cost effectiveness in its decision-making but did not discuss specific studies referenced.
  • The DUR Board website states, “The goals of the program are to reduce potentially inappropriate prescribing and dispensing of medications, enhance the counseling of patients, and reduce growth in expenditures for drugs.
  • The P&T Committee website states, “The Idaho Medicaid Pharmacy and Therapeutics Committee (P&T Committee) is comprised of Idaho health practitioners – physicians, physician assistants, and pharmacists – who are committed to providing the right care at the right price.”
  • The law states, “The Director of the Department of Health and Welfare, acting upon the recommendation of the Pharmacy and Therapeutics Committee, may determine that a non-prescription drug product is covered when the non-prescription product is found to be therapeutically interchangeable with prescription drugs in the same pharmacological class following evidence-based comparisons of efficacy, effectiveness, clinical outcomes, and safety, and the product is deemed by the Department to be a cost-effective alternative.”
  • The law states, “The purpose of supplemental rebates is to enable the Department to purchase prescription drugs provided to Medicaid participants in a cost-effective manner.
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Illinois
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The state uses “drug monographs and clinical reviews provided by the University of Illinois Chicago.” The University has contracted in the past with ICER to conduct cost effectiveness analyses but does not have public information available on the methods used in its work for the state.
  • The Drugs and Therapeutics Advisory Board “makes recommendations based upon evidence-based clinical factors including safety, effectiveness, and outcomes.”
  • The Board’s meeting minutes do not specifically reference the evidence being relied on to make recommendations.
  • According to the state’s description, “The Illinois Drugs and Therapeutics Advisory Board (D&T Board) provides the Department with recommendations on the prior approval status of new drugs and Preferred Drug List (PDL) policies that promote the clinically appropriate and evidence-based use of cost-effective drugs for Medicaid customers.”
  • The Preferred Drug List is “based upon clinical efficacy, safety, and cost effectiveness…The Department develops recommendations based on efficacy and safety data contained in the clinical monographs along with the net cost data. The Drugs and Therapeutics Advisory Board reviews the Department’s PDL proposals in each therapeutic class for clinical soundness.”
  • Additionally, “The Department has implemented utilization controls, including prior approval requirements, on several specialty drugs in the following classes: immunosuppressive agents, erythropoietin stimulating agents, HIV medications, hepatitis C agents, cystic fibrosis medications, oncology agents, and medications for orphan diseases. The goals of the specialty drug utilization controls are to encourage the use of the most cost- effective medications where clinically appropriate and to ensure utilization is consistent with treatment guidelines.
  • Proposed QALY Authority, 2020: Legislation HB3493 would create a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with a “third party contractor” that could include ICER.
  • The state has not proposed to bar the use of QALYs.
Indiana
  • The state uses “primary literature” in drug coverage decisions.
  • The state does not publish meeting minutes from the Drug Utilization Review Board.
  • The DURB is authorized to consider health economic data and cost data (see IC 12-15-35-19 and IC 12-15-35-35).
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Iowa
  • The state Medicaid program reported that the state references published studies from ICER, which rely on QALY and evLYG metrics to determine value and cost effectiveness.
  • The DUR Commission meeting minutes do not explicitly refer to the evidence relied on for its recommendations.
  • The DUR website states, “Established in 1984, the DUR Commission is charged with promoting the appropriate and cost-effective use of medications within the Iowa Medicaid member population.”
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Kansas
  • The state refers to “analyses published in the literature” in drug coverage decisions.
  • The DUR Board meeting minutes do not explicitly refer to the evidence relied on for its recommendations.
  • The website states, “The Kansas Medical Assistance Program (KMAP) has created a preferred drug list (PDL) to promote clinically appropriate utilization of pharmaceuticals in a cost-effective manner without compromising the quality of care.” 
  • The website also states, “A Preferred Drug List Advisory Committee, composed of practicing physicians and pharmacists, ensures that extensive clinical review of drug products takes place. The Advisory Committee's review and recommendations are based on evidence-based clinical information, not cost. Evidence-based medicine means providing treatments that have been shown to be effective, beneficial and have high value and not providing treatments that have been shown to be ineffective, harmful or have poor value.”
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Kentucky
​
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The Kentucky Preferred Drug Listing (PDL) is defined by Kentucky law as “a listing of selected drugs available to fee-for-service recipients that have been included based on proven clinical and cost effectiveness and that prescribers are encouraged to prescribe if medically appropriate.”
  • The state law calls for drug review considerations to include an “assessment of the cost of the drug compared to other drugs used for the same therapeutic indication and if the drug offers a substantial clinically-meaningful advantage in terms of safety, effectiveness, or clinical outcome over other available drugs used for the same therapeutic indication. Cost shall be based on the net cost of the drug after federal rebate and supplemental rebates have been subtracted.”
  • The Pharmacy and Therapeutics Advisory Committee (P&T) does not publish meeting minutes, only an agenda, options, recommendations and decisions.
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Louisiana
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The Medicaid Pharmaceutical and Therapeutics (P&T) Committee does not publish meeting minutes.
  • Among its duties, the Outcomes Research Section of the Office of Outcomes Research and Evaluation at the University of Louisiana supports Louisiana Medicaid by serving as a consultant to the Louisiana Medicaid Drug Utilization Review Board.
  • Louisiana’s managed care organizations (MCO) maintain a DUR program.
  • As an example, Louisiana Healthcare Connections publicly emphasizes that its “members receive drug therapy that is appropriate, high quality and cost effective.”
  • There are no legislative proposals to reference QALYs, whether by referencing ICER or foreign prices or policies.
  • The state has not proposed to bar the use of QALYs.
Maine
Current Activities:
  • Maine has signed into law LD 1636 which was initially designed to import QALYs from Canada by directly referencing the QALY-based prices paid for drugs in four Canadian provinces. The bill has been amended to now require reporting on potential savings should Maine reference Canadian pricing, but it does not directly activate reference pricing. 
​
Landscape for Cost Effectiveness & QALY Considerations: 
  • ​The state Medicaid program has publicly referenced the QALY through use of ICER studies.
  • The Maine DUR Board meeting minutes do not consistently provide detail on the evidence being used to make recommendations.
  • A treatment for hereditary amyloidosis, Onpattro, was deemed “not preferred” because it did not meet ICER’s cost effectiveness threshold, despite also being deemed as providing benefit to some patients.
  • Passed, 2019: The state enacted legislation to create a Prescription Drug Affordability Board that would not bar reference to QALYs.
  • The Affordability Board was presented with information from ICER about its QALY-based reports and how they are used by State Medicaid programs and the Department of Veterans Affairs.
  • The Affordability Board was presented with information from NASHP about its model legislation to use a “Canadian Reference Rate” without raising Canada’s reliance on QALYs.
  • Introduced, QALY Authority, LD1636, 2021: Maine introduced legislation to reduce prescription drug costs for residents by referencing prescription drug costs in Canada, which relies on QALYs in pricing and coverage decision-making.
  • The state has not proposed to bar the use of QALYs.
Maryland
Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The DUR Board does not publish meeting minutes. 
  • The P&T Committee meeting minutes do not provide details on the evidence base for decisions. 
  • Passed, MD HB768, 2019: The state enacted legislation to create a Prescription Drug Affordability Board that would not bar reference to QALYs and would allow the Board to enter into a contract with a qualified, independent third party for any service necessary to carry out the powers and duties of the board.
  • The Affordability Board received a presentation from ICER on how to leverage its reports in the Board’s work.
  • Introduced, MD 1167, 2021: Proposed QALY Ban, 2021: The bill would prohibit state use of the QALY to establish what type of health care is cost–effective or recommended or as a threshold to make coverage, reimbursement, incentive program, or utilization management decisions, whether the decisions are by the agency or from a third party.
Massachusetts
Current Activities:
  • Governor Charlie Baker filed his health care bill, SB 2774, An Act Investing in the Future of our Health, on March 17, 2022. The bill expands the Health Policy Commission’s authority to determine the value of a drug beyond Medicaid to private payers. As written, the bill allows for use of cost-effectiveness assessments and analysis by a third-party, and it does not include a QALY ban. The bill requires disclosure of methods used by third parties and disclosures of potential limitations of that research. 
  • Introduced, H. 201 and S 753, 2021: The legislature introduced bills explicitly barring QALYs, stating "The Health Policy Commission shall not develop or utilize, directly or indirectly through a contracted entity or other third-party, a dollars-per-quality adjusted life year or any similar measures or research in determining whether a particular health care treatment is cost effective, recommended, the value of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost-sharing, or incentive policies or programs." 
  • Introduced, H. 1256 and S. 745, 2021: The legislature introduced a bill barring the devaluation of life lived with disability in healthcare decisions, including specifically barring assumptions of reduced quality of life due to disability or chronic condition or that their lives are less worth saving in considerations related to formularies and determinations of the value of treatment.
  • Both bills were heard before the Joint Committee on Health Care Financing on November 9, 2021. Written testimony is not available online. Future hearing dates have not been posted.
  • On February 3, 2022, S.2651 "An Act relative to pharmaceutical access, costs and transparency” was reported our of the Senate Ways and Means Committee. As currently drafted, the legislation includes language stating the commission "shall not employ a measure or metric that assigns a reduced value to the life extension provided by a treatment based on a pre-existing disability or chronic health condition of the individuals whom the treatment would benefit.” 

Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program has openly referenced QALYs or ICER studies.
  • There are accounts of verbal confirmation that they are used to make coverage decisions. 
  • The DUR Board does not provide meeting minutes. 
  • In 2017, the state sent a letter to CMS requesting authority to adopt a closed formulary and allow MassHealth to select drugs that “meet the clinical needs of the vast majority of members and that they are cost effective...” CMS denied the application but responded to MassHealth in June 2018 that it would consider a demonstration allowing certain drugs to be excluded based on cost-effectiveness or other approved criteria."
  • In 2019, the state legislature authorized the Health Policy Commission to identify a proposed value for prescription drugs as part of determining supplemental rebates.
  • The Massachusetts Health Policy Commission has indicated directly to patient and disability representatives that ICER has a contract to help the commission develop its value framework.
  • The DUR Board publicly relied on ICER studies in evaluating a mental health treatment in 2019.
Michigan
Current activities: 
  • The Michigan legislature introduced HB 5842 creating a Prescription Drug Affordability Board. While the legislative language does not explicitly bar the use of QALYs in assessing the value of treatments, it includes language barring its use “to identify a subpopulation for which a prescription drug product would be less cost effective due to severity of illness, age, or preexisting disability.” It also calls for the use of a cost effectiveness analysis for drugs extending life that “weighs the value of all additional lifetime gained equally for any individual, no matter the severity of illness, age, or preexisting disability.” The legislative intent is not clear related to the Board’s authority to use QALY-based value assessments to value drugs and identify those that will be subject to an upper payment limit.
​
​Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • The preamble of the statute creating the P&T Committee says, “the state of Michigan desires to provide the greatest possible access to cost effective prescription drug coverage for all of its citizens, including, but not limited to, those receiving services through its Medicaid Program” and the law allows the committee to consult “with outside experts in order to perform its duties.”
  • The P&T Committee meeting minutes did not specifically reference ICER studies or use of cost effectiveness or QALYs, though the meeting materials were not available for review before September 8, 2020.
  • The DUR Board meeting minutes did not specifically reference ICER studies or use of cost effectiveness or QALYs, though the meeting materials were not available for review before December 10, 2019.
  • In 2020, the Governor’s Prescription Drug Task Force indicated support for referencing other countries that use QALYs by recommending, “As an alternative, legislative action could be taken to establish a process for setting an upper payment limit for certain prescription drugs based on rates set by other countries, such as Canada, as a reference.”
  • The same report supported creation of a drug affordability review board that was touted in the news by state legislators as supporting the creation of a Prescription Drug Affordability Board similar to the one created in Maryland.
  • The state has not proposed to bar the use of QALYs.​


Minnesota
Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The Drug Formulary Committee meeting minutes do not describe the evidence being reviewed to inform their recommendations.
  • Introduced, HF 1668, 2019-2020 and HF 801, 2021: The state legislature introduced a bill to create a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with “professional and technical assistance” that could include entities that rely on QALYs.
  • The Health Services Advisory Council provides advice on health care benefit and coverage policies and “shall consider available evidence regarding quality, safety, and cost-effectiveness when advising the commissioner.” This is not limited to prescription drugs. 
  • The state has not proposed to bar the use of QALYs.
Mississippi
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • The P&T Committee states that “Drugs and drug classes are evaluated for their safety, efficacy, and overall cost value and the committee will make subsequent recommendations to the Executive Director regarding prior authorization criteria for these drugs and classes.”
  • The P&T Committee meeting minutes do not describe the evidence used to support its decisions.
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • The state has not proposed to bar the use of QALYs.
Missouri
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • Introduced, SB 310, 2019: The legislature introduced a bill to create the Drug Cost Review Commission which was unclear on how third party information may be used in its considerations.
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • The state has not proposed to bar the use of QALYs.
Montana
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The DUR Board “helps the department to ensure that medications prescribed for Medicaid clients are appropriate, medically necessary, cost effective, and unlikely to result in adverse side effects.”
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • The Montana Department of Public Health and Human Services highlights ICER as one of their “Practitioners Educational Resources.”
  • The state has not proposed to bar the use of QALYs.
Nebraska
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • The P&T Committee by-laws state, “The purpose of the PDL is to provide appropriate pharmaceutical care to Medicaid recipients in a cost-effective manner.”
  • The P&T Committee meeting minutes do not detail the evidence used to make decisions.
  • “The goals of the DUR Board are to improve the quality of pharmacy services and to ensure rational, cost-effective medication therapy for Nebraska Medicaid recipients.” 
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • The state has not proposed to bar the use of QALYs.
Nevada
  • ​While the state did not report reliance on QALYs or ICER in drug coverage reviews in 2019, the state DUR Board meeting notes indicate that ICER studies were relied on to make decisions.
  • The DUR Board meeting minutes do not consistently provide details about the evidence base. 
  • In January, 2020, the DUR Board referenced ICER’s study of MS drugs according to its meeting minutes.
  • Introduced, SB 378, 2019: The legislature introduced a bill establishing the Prescription Drug Affordability Board and the Prescription Drug Affordability Stakeholder Council authorizing the Board to prescribe an upper payment limit for a prescription drug that meets certain requirements after an affordability review.
  • Passed, SB378, 2019: The legislature passed a law enacting changes to its P&T Committee from prior existing law that required the Committee to make its decisions based on evidence of clinical efficacy  and  safety  without  consideration  of  cost.  The new law changed the P&T Committee to the Silver State Scripts Board and authorized the  Board  to  consider  cost  if  there  is  no  significant difference  in  the  clinical  efficacy,  safety  and  patient  outcomes  of  two  or  more drugs.
  • The Silver State Scripts Board only has meeting minutes for 2020-2021 and they do not provide detail on the evidence used to make decisions.
  • The state has not proposed to bar the use of QALYs.
New Hampshire
Current Activities:
  • The New Hampshire Prescription Drug Affordability Board meets regularly. A remote link to join the meetings is available within its agenda document.
 
Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The New Hampshire DUR Board does not post meeting minutes.
  • The state established a Prescription Drug Affordability Board that may consider “Data compiled by the department of health and human services” which is not precluded from including QALY-based cost effectiveness analyses.
  • The state has not proposed to bar the use of QALYs.
New Jersey
Current activities:
  • On January 11, 2022, the state legislature reintroduced a bill creating a Prescription Drug Affordability Board. Bill, SB 329. The bill does not include provisions barring the use of quality-adjusted life years in determining the value of treatments that may be subject to payment limits. The bill passed the Committee on Health, Human Services and Senior Citizens and has been referred to Budget and Appropriations.
Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • Introduced, A583, 2018-2019 and A2418, 2020-2021: The legislature introduced a bill that would create a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with an “independent third party” that could include ICER.
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • The state has not proposed to bar the use of QALYs.
New Mexico
Current Activities:
  • Endorsed Legislation, 2022: The Legislative Health and Human Services Committee endorsed legislation creating a Prescription Drug Affordability Board that would review the affordability of prescriptions drugs based on a variety of factors including the “the relative financial impacts to health, medical or social services costs as can be quantified and compared to baseline effects of existing therapeutic alternatives” which may pose a risk of consideration of QALYs. The bill also more explicitly bars consideration of QALYs in the methodology used by the board to establish the upper payment limit.

Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The DUR Board does not publish meeting notes or minutes.
  • Introduced, HB154, 2021: The legislature introduced a bill that would create a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with an “independent third party” that could include ICER.
  • The state has not proposed to bar the use of QALYs.
New York
Current activities:
  • New York has introduced SB 8901, which would import QALYs from Canada by directly referencing the QALY-based prices paid for prescription drugs in four Canadian provinces. The bill has passed out of the Finance Committee and been referred to Rules. 
  • The DUR Board continuously recruits for its Board membership, including 3 seats for consumers, one of which is currently an open seat.
​
Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • The DUR Board meeting minutes do not consistently provide details on the evidence base for making decisions.
  • The DUR Board activities related to New York’s Preferred Drug Program include “then review of drug cost information."
  • ICER has published information touting New York’s use of ICER as “as an independent arbiter of cost-effectiveness.”
  • The state has referenced ICER in DUB Board decisions related to cystic fibrosis treatments in creating a supplemental rebate target, interpreted by the media as the state saying the drug was “not worth its price.”
  • The state referenced ICER’s assessment of migraine treatments on September 20, 2018.
  • The state heard a presentation from ICER in making a DUR Board decision related to spinal muscular atrophy, resulting in a recommended supplemental rebate target amount.
  • The FY2020 Budget codified authority for the state to reference a third party such as ICER in its decisions stating, “Such rebate may be based on evidence-based research, including, but not limited to, such research operated or conducted by or for other state governments, the federal government, the governments of  other  nations, and third party payers or multi-state coalitions.”
  • The state has not proposed to bar the use of QALYs.
North Carolina
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • The Medicaid and Health Choice Preferred Drug List Review Panel does not detail the evidence used to make decisions.
  • The state has not proposed to bar the use of QALYs.
North Dakota
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The Drug Use Review Board did not include reference to evidence from ICER to make recommendations, though the handouts did include footnotes to supportive evidence.
  • DUR Board meeting minutes do not provide references. 
  • Enacted, SB 2212, 2021: The bill provides for a legislative management study of prescription drug pricing, importation, and reference pricing, and the role pharmacy benefit managers play in drug pricing.
  • Introduced, SB 2170, 2021: The legislature introduced a bill directly referencing the prices paid for drugs in five Canadian provinces. In Canada, before applying for coverage by the provinces, all drugs must complete a Common Drug Review by CADTH, which uses QALYs. 
  • The state has not proposed to bar the use of QALYs.
Ohio
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • Ohio has instituted a “Prescription drug transparency and affordability advisory council” to provide recommendations to the state related to the purchasing of prescription drugs.
  • Among the council’s recommendations was an emphasis on “health equity when developing prescription drug policies.”
  • The P&T Committee meeting minutes do not detail the evidence used to make decisions.
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • The state has not proposed to bar the use of QALYs.
Oklahoma
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • DUR Board meeting minutes indicate that the Oklahoma Drug Utilization Review Board used ICER’s QALY-based studies to invoke prior authorization in March, 2019 for treatments for long-term prophylaxis for hereditary angioedema and again in July, 2019 for treatment of spinal muscular atrophy.
  • Enacted, HB2587, 2020: The state legislature responded to the DUR Board’s consideration of QALYs when it passed and the state enacted the Nondiscrimination in Health Care Coverage Act barring the use of QALYs as a threshold to establish what type of health care is cost effective or recommended, or as a threshold to determine coverage, reimbursement, incentive programs or utilization management decisions, whether it comes from within the agency or from any third party.
  • Introduced, SB734, 2021: The state legislature introduced a bill allowing reference to the ceiling price for drugs, as reported by the Government of Canada Patented Medicine Prices Review Board, for the purpose of determining the referenced rate to pay for prescription drugs. The Patented Medicine Prices Review Board explicitly establishes prices based on a cost-utility analysis model in which health outcomes are expressed as QALYs.
  • Oklahoma’s DUR Board packet provides detailed information and references to the evidence base to be considered and is publicly available.
Oregon
Current Activities:
  • The state’s waiver is currently under consideration for renewal. The federal comment period is currently open through April 13, 2022. The waiver renewal application does not bar the state’s current use of QALYs to establish its prioritized list of services. Oregon’s proposed waiver renewal requests authority to allow the state to use its own drug reviews instead of relying on FDA approval, particularly for drugs approved under the FDA’s accelerated pathway. Oregon did not state whether QALYs would be a consideration in decisions to restrict access to certain prescription drugs, but did acknowledge the state’s use of QALYs to determine its prioritized list of services and to require use of a lower cost treatment before accessing a more costly service:
    • Page 257: "OHA understands that advocates have concerns that some uses of Quality-adjusted life years (QALY’s) may create or exacerbate disparities in coverage for people with disabilities. OHA and the Health Evidence Review Commission (HERC) take these concerns very seriously and work to ensure equitable treatment and services for OHP members. QALYs currently play only a minor role in decisions by the Health Evidence Review Commission, usually in comparing two treatments for the same condition. OHA does not believe they are used to discriminate against people with disabilities. Most often, a more cost-effective treatment may be preferred over a less cost-effective one. At other times, a trial of a lower-cost treatment must be tried before a more costly service can be used. Regardless, any estimate of QALY’s would only be one consideration among many in terms of evaluating cost-effectiveness.”
    • Page 574: "Quality-adjusted life years (QALY’s) currently play only in a minor role in any decisions by the Health Evidence Review Commission, usually in comparing two treatments for the same condition. They are not used to discriminate against people with disabilities. Most often, a more cost-effective treatment may be preferred over a less cost-effective one. At other times, a trial of a lower-cost treatment must be tried before a more costly service can be used." 

Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • The P&T Committee does not provide details on the evidence being used to make decisions in its meeting notes.
  • The state references QALYs in determining its prioritized list of services under a Medicaid waiver.
  • The Health Evidence Review Commission describes sources that rely on QALYs as “sources generally produce high quality evidence and are preferred by HERC” including the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) and the National Institute for Clinical Excellence (NICE) - United Kingdom.
  • QALYs were referenced in determinations of coverage for Community Health Workers, in an evidence review on colorectal cancer screening, in an evidence review related to heart failure monitoring, and in determining coverage criteria for GERD treatment.​
  • Enacted, SB844, 2021: The state legislature introduced a bill creating a Prescription Drug Affordability Board, which had been amended to include a bar on the use of QALYs in the Board’s considerations.
Pennsylvania
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • The bylaws state, “The P&T Committee will ensure that PDL management is based on sound clinical evidence and is both safe and cost-effective.”
  • According to a letter from the Office of Medical Assistance Programs, “When drugs within a class are clinically equivalent, the P&T Committee considers the comparative cost-effectiveness of all drugs in the class.”
  • The P&T Committee meeting minutes do not detail the evidence used to make decisions.
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • Introduced, HB 2212, 2020: The legislature introduced a bill creating a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with a third party that could include ICER.
  • Introduced, HB 1722, 2021: The legislature introduced a bill creating a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with a third party that could include ICER.
  • The state has not proposed to bar the use of QALYs.
Rhode Island
Current activities:
  • Introduced January 25, 2022 – SB 2076, which would import QALYs from Canada by directly referencing the QALY-based prices paid for drugs in four Canadian provinces. The bill was referred to Senate Health and Human Services. The bill received a hearing on March 22, 2022.
 
Landscape for Cost Effectiveness & QALY Considerations:
  • ​The state Medicaid program does not openly reference QALYs or ICER studies.
  • The P&T Committee bylaws state, “The Committee will ensure that the PDL is based on sound clinical evidence that is both safe and cost-effective.”
  • The P&T Committee does make references to cost effectiveness but not the evidence being referenced. (influenza, diabetes, antipsychotics, and CNS agents) 
  • Introduced, S 0498, 2021: The legislature introduced a bill creating a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with an “third party” that could include ICER.
  • The state has not proposed to bar the use of QALYs.
South Carolina
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • There is no public record of their use.
  • The law establishing the P&T Committee states, “In determining safety and efficacy, the committee may consider all submitted public comment or clinical information including, but not limited to, scientific evidence, standards of practice, peer-reviewed medical literature, randomized clinical trials, pharmacoeconomic studies, and outcomes research data.”
  • The P&T Committee meeting minutes do not detail the evidence used to make decisions.
  • The state has not proposed to bar the use of QALYs.
South Dakota
  • The state reported use of information from OptumRx in drug reviews.
  • The Optum website touts being a “trusted partner in nearly every state.”
  • The P&T Committee provides details on the evidence being used to make decisions. 
  • The P&T Committee meeting minutes specifically reference ICER studies.
  • The Preferred Drug List (PDL) is a list developed by North Dakota Medicaid in conjunction with the North Dakota Drug Use Review Board (DUR Board) and adopted by the Department.. 
  • The state has not proposed to bar the use of QALYs.
Tennessee
Current activities:
  • The Tennessee, TennCare, waiver application was reopened for public comments in August, 2021. Its status is pending. As part of the TennCare III waiver application, the state sought authority to advance a closed formulary based on cost effectiveness.
 
Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program does not openly reference QALYs or ICER studies. Tennessee reported the Kaiser Family Foundation that the state is considering “the use of comparative effectiveness review in drug coverage review.”
  • The state requested that CMS allow TennCare to adopt a commercial-style closed formulary, which may cover only one drug in each therapeutic area, potentially allowing for reference to QALY-based cost-effectiveness analyses. With regard to drugs approved through the accelerated pathway at the FDA, “The state proposes that it have flexibility to exclude these new drugs from its formulary until market prices are consistent with prudent fiscal administration or the state determines that sufficient data exist regarding the cost effectiveness of the drug.” The waiver was approved on January 8, 2021 and but reopened for federal public comments in August, 2021.
  • TennCare also relies on OptumRx to manage its Drug Utilization Review Board activities.
  • The Pharmacy Advisory Committee, making PDL recommendations, lists ICER as a preferred source of high quality evidence.
  • The law creating the TennCare Pharmacy Advisory Committee states, “The committee may receive written studies, data and information relative to the cost-effectiveness of drugs being considered for placement on the preferred drug list.”
  • The pharmacy advisory committee did not have publicly available meeting minutes.
  • The state has not proposed to bar the use of QALYs.
Texas
Current Activities:
  • Texas is seeking applications for its Drug Utilization Review Board. It has openings for a pharmacist and a child and adult psychologist. Applications are due by July 1, 2022. You may find more information here. 
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • According to Provider Synergies, “The Texas Health and Human Services Commission (HHSC) has retained Magellan Medicaid Administration to provide Preferred Drug List (PDL) development and management and Supplemental Rebate contracting services. Provider Synergies, LLC is an affiliate of Magellan Medicaid Administration, and became a wholly-owned subsidiary of Magellan Health Services in 2009.”
  • The DUR Board does not specifically identify the evidence supporting its recommendations.
  • The state has not proposed to bar the use of QALYs.
Utah
  • According to the P&T Committee bylaws, “If clinical and therapeutic considerations are substantially equal, then the P&T Committee shall recommend to DMHF that it consider only cost.”
  • The P&T Committee meeting minutes do not detail the evidence used to make decisions.
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • The state has not proposed to bar the use of QALYs.
Vermont
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • The Vermont Legislature enacted the Pharmacy Best Practices and Cost Control Program from the Fiscal Year 2002 Appropriations Act, H 485, which mandated that: "The commissioner of prevention, assistance, transition, and health access shall establish a pharmacy best practices and cost control program designed to reduce the cost of providing prescription drugs, while maintaining high quality in prescription drug therapies. The program shall include a preferred list of covered prescription drugs that identifies preferred choices within therapeutic classes for particular diseases and conditions, including generic alternatives, utilization review procedures, including a prior authorization review process, and any other cost containment activity adopted by rule by the commissioner, designed to reduce the cost of providing prescription drugs while maintaining high quality in prescription drug therapies."
  • The DUR Board cited high net cost to Medicaid and lack of cost-effectiveness to justify its recommendation of continuing prior authorization for MAT medication (Meeting notes on April 6, 2021).
  • The DUR Board deferred coverage of a treatment for polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults despite showing “some benefit to patients with this disease” citing that it is “more than ten times the cost required to meet the ICER cost-effectiveness threshold.”
  • The Green Mountain Care Board is appointed by the Governor for six-year terms and is tasked to oversee the development and implementation, and evaluate the effectiveness, of health care payment and delivery system reforms designed to control the rate of growth in health care costs; promote seamless care, administration, and service delivery; and maintain health care quality in Vermont.
  • Introduced, S. 246, 2020: This bill proposes to authorize and direct the Green Mountain Care Board to evaluate the costs of certain high-cost prescription drugs and recommend methods for addressing those costs. The information the Board uses to conduct an affordability review may include “the estimated value or cost- effectiveness of the prescription drug product.”
  • The Green Mountain Care Board Prescription Drug Technical Advisory Group was presented with information about the model legislation being proposed by NASHP, including the New York drug cap model and international reference pricing.
  • The state has not proposed to bar the use of QALYs. 
Virginia
Landscape for Cost Effectiveness & QALY Considerations:
  • Virginia has introduced SB 376, legislation that would create a Prescription Drug Affordability Board in the State of Virginia. The legislation does not bar the use of QALYs in the Board’s considerations of affordability or treatment value. The bill will not move forward in 2022.
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • The DUI Board meeting minutes do not consistently provide details on the evidence base for making decisions. 
  • The P&T Committee meeting materials referenced ICER’s study related to rheumatoid arthritis treatments in its decisions related to coverage.
  • The P&T Committee materials are not made available in the archives, and the meeting minutes do not detail the evidence used to make decisions.
  • The DUR Board referenced hepatitis C treatments being cost effective in support of coverage of treatments.
  • Introduced, HB 691, 2020: The legislature introduced a bill creating a Prescription Drug Affordability Board that would not bar reference to QALYs to “to study, review, and regulate the cost of prescription drugs.”
  • The state has not proposed to bar the use of QALYs.


Washington
Current activities:
  • The Washington State legislature has passed SB 5532, a bill establishing a prescription drug affordability board. It does not prohibit the use of metrics such as quality-adjusted life years (QALYs) by the Board as part of its process for conducting an affordability review or in the process for determining which drugs will be made subject to an affordability review, with potential implications for a discriminatory impact in the treatments chosen for payment limits. The legislation does bar QALYs as part of the methodology for calculating the “upper payment limit” for drugs selected based on the affordability review. The governor has signed the bill into law. 

Landscape for Cost Effectiveness & QALY Considerations:
  • The state Medicaid program reported that they reference the QALY through use of ICER studies in drug coverage reviews.
  • The P&T Committee also serves as the Medicaid Drug Utilization Review (DUR) Board as required by federal law.
  • Recommendations by the P&T Committee “will be solely based on available evidence, not on cost considerations. The cost analysis will be performed after the meeting and does not include the P&T Committee.”
  • The Emerging Therapies Workgroup is charged with providing input to HCA on funding related to emerging therapies, and relies on information from ICER in its deliberations. An Emerging Therapies Workgroup member stated, “I think those of us who are methodologists really respect NICE’s process and think of it as being fairly state of the art. They’ve really kept up.”
  • The state referenced QALYs in its assessment of hip surgery procedures for treatment of femoroacetabular impingement syndrome in 2019.
  • The state referenced QALYs to determine that Cardiac Artery Calcium Scoring is a non-covered benefit.
  • The state referenced QALYs in evaluating treatments for epilepsy and depression in 2019. In 2020, the Heath Technology Clinical Committee recommended that vagal nerve stimulation for epilepsy be covered with conditions, but that vagal nerve stimulation for depression and transcutaneous vagal nerve stimulation not be covered.
  • The state references ICER and QALYs in evaluating non-pharmacologic pain treatments, recommending the addition of adding acupuncture and chiropractic benefits.
  • QALYs were used to help the state make a coverage decision related to whole exome sequencing.
  • The Heath Technology Clinical Committee commissioned a report related to Sacroiliac joint fusion that highlighted its QALYs.
  • QALYs were considered in a recommendation from the Heath Technology Clinical Committee that Vertebroplasty, Kyphoplasty and Sacroplasty are not covered benefits.
  • The state considered an evidence report considering QALYs in reviewing Cell-free DNA Prenatal Screening for Chromosomal Aneuploidies.
  • HTCC considered evidence on the QALY-based cost effectiveness of tinnitus. The final report stated, “Evidence is lacking with respect to cost outcomes.
  • The state referenced QALYs in its assessment of proton beam therapy in 2019.
  • Passed and Vetoed, SB 6088, 2019: The legislature passed SB 6088 establishing a prescription drug affordability board, which is tasked with considering whether the price of a treatment “exceeds the proposed value” by considering factors such as “the price of therapeutic alternatives.” The legislation did not bar reference to discriminatory QALY-based value assessments.
  • Introduced, SB 5020, 2021: The legislation was amended to state, “Unsupported price increase report" does not include reports that use analyses that use the cost-per-quality adjusted life year or similar measure to identify subpopulations for which a treatment would be less cost-effective due to severity of illness, age, or preexisting disability.” The referenced report is authored by ICER.
West Virginia
  • The state Medicaid program does not openly reference QALYs or ICER studies.
  • The P&T Committee meeting minutes do not detail the evidence used to make decisions.
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • The state has not proposed to bar the use of QALYs.
Wisconsin
  • The state Medicaid program references ICER studies as part of its drug reviews.
  • The Wisconsin Department of Health Services - Division of Medicaid Services (DMS) is implementing a preferred drug list and supplemental rebate program for Wisconsin Medicaid, BadgerCare, and SeniorCare. DMS has retained Provider Synergies and the Medicaid fiscal agent, DXC Technology, to provide PDL management and supplemental rebate contracting services.
  • The DUR Board meeting minutes do not detail the evidence used to make recommendations.
  • Introduced, AB 544, 2021: The legislature introduced a bill creating a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with an “independent third party” that could include ICER. The Governor’s Task Force on Reducing Prescription Drug Prices also proposed a prescription drug affordability board.
  • The state has not proposed to bar the use of QALYs.
Wyoming
  • The state Medicaid program references ICER studies as part of its drug reviews.
  • It is a goal of the P&T Committee that, “The costs of drug therapy shall be considered after clinical and patient considerations are addressed.”
  • The P&T Committee and DUR Board merged in 2010, and the meeting minutes are not detailed.
  • The state has not proposed to bar the use of QALYs.
Funding for this project provided by Biogen, Gilead, Genentech, and Pfizer.
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