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.
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
Latest Updates:
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Colorado
Maryland
Oregon
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- Many states have or are considering adoption of a prescription drug affordability board (PDAB). Their goal is to allow the state to review and evaluate the reimbursement rate and/or coverage for pharmaceuticals. Most have fairly broad parameters of how they can assess a drug’s value, and specifically permit the state to rely on third-party research or contract directly with a third-party for the purpose of fulfilling its duties. The PDAB landscape has changed and evolved rapidly. This landscape analysis gives updates on PDABs and their potential to rely on discriminatory value assessments as of May 22, 2024.
- The updated final rule governing Section 504 of the Rehabilitation Act, which protects the rights of people with disabilities in programs and activities receiving federal financial assistance, bars health care decisions made using measures that discount gains in life expectancy — which would likely include the quality-adjusted life year (QALY), and the combined use of QALYs, and equal value of life years gained (evLYG). As state Medicaid programs work to become compliant with the rule, it will make the implementation of many of the National Association of State Health Policy (NASHP)’s legislative templates for state legislatures challenging, as they intentionally allow for reference to QALYs and similar measures.
Colorado
- The PDACC meets this Friday, December 12, 2024. Click here to register. Comments may be sent to [email protected].
- Stelara, Cosentyx and Enbrel were deemed unaffordable and the Board is considering UPLs. At the advisory council meeting, there was a robust discussion of developing a tool to understand the impact of UPLs, a process welcomed by the patient community although with many unanswered questions about what entity will conduct such a tool and its impact on the timeline for regulatory meetings and consideration of UPLs. The full PDAB also met on October 18 to hold the first rulemaking hearing. The slides from the meeting may be viewed here.
Maryland
- The next meeting of the Prescription Drug Affordability Board Stakeholder Council (PDASC) will take place on December 16, 2024. More information can be found here. At the most recent November 25, 2024 PDAB meeting, cost effectiveness analysis and international reference pricing continued to be listed among the methodologies that could be used by the Board to establish a UPL, despite concerns raised by patients and people with disabilities. Comments to the PDAB may be sent to [email protected].
- The Maryland Legislative Policy Committee approved the PDAB’s UPL Plan, despite comments from groups opposing its approval. As background, the PDAB reviewed a revised UPL Plan that did not respond to the comments from 38 organizations. The comment letter was not listed as a comment received for the meeting on their website, although receipt was confirmed by email. The revised UPL Plan continues to reference international prices from countries that use QALYs and similar measures and cost effectiveness analyses, with no safeguards against use of discriminatory value assessments, potentially violating federal law under Section 504 of the Rehabilitation Act.
- The PDAB has asked for “emergency action” for updates to regulations covering the cost review process. The proposed changes, among other things, would allow for the PDAB to make a preliminary determination of affordability ahead of their final determination. Notably, the concept of the preliminary determination was already outlined and approved in the UPL Action Plan and cost reviews are currently underway.
Oregon
- The next meeting of the Oregon PDAB is December 18, 2024. Register here or comment by December 14 here.
- The Oregon PDAB met on November 20, during which the Board approved a UPL Plan despite concerns about the influence of QALYs and similar measures, as well as the impact on formulary placement and patient access and affordability. On October 16, the Oregon Prescription Drug Affordability Board met to discuss an Upper Payment Limit report for the legislature. Members of the Board stated that the Oregon PDAB is permitted to reference ICER studies and measures similar to QALYs such as evLYGs, contrary to federal law and regulations and Oregon state law barring use of “quality of life in general” measures, a bill strongly advocated by Disability Rights Oregon. Their use is implicated in referencing entities that rely on QALYs and similar measures, including foreign countries and the Veterans Health System.
Alabama
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
Alaska
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
Arizona
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.
- In 2022, the legislature introduced SB 1680, creating a Prescription Drug Affordability Board with authority to consider value and cost effectiveness of drugs. The legislation did not ban use of QALYs and similar measures, raising concerns that the state could partner with entities such as PORTAL and ICER that historically support the use of QALYs and evLYGs to value health care.
Arkansas
Landscape for Cost Effectiveness & QALY Considerations:
- 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.”
- 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.
California
Landscape for Cost Effectiveness & QALY Considerations:
- 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 have expressed concern about this partnership.
- In 2022, California formally established 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. There is currently no safeguard in place against the Office using QALYs and similar metrics.
- 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:
Landscape for Cost Effectiveness & QALY Considerations:
- The PDACC meets this Friday, December 12, 2024. Click here to register. Comments may be sent to [email protected].
- Stelara, Cosentyx and Enbrel were deemed unaffordable and the Board is considering UPLs. At the advisory council meeting, there was a robust discussion of developing a tool to understand the impact of UPLs, a process welcomed by the patient community although with many unanswered questions about what entity will conduct such a tool and its impact on the timeline for regulatory meetings and consideration of UPLs. The full PDAB also met on October 18 to hold the first rulemaking hearing. The slides from the meeting may be viewed here.
Landscape for Cost Effectiveness & QALY Considerations:
- Policies 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.
- 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
Landscape for Cost Effectiveness & QALY Considerations:
- 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
Landscape for Cost Effectiveness & QALY Considerations:
- 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
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- The District of Columbia noticed its next P&T Committee meeting for December 5, 2024.
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
Florida
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- Florida has noticed its next DUR Board meeting for December 12, 2024.
Landscape for Cost Effectiveness & QALY Considerations:
- 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.”
Georgia
Landscape for Cost Effectiveness & QALY Considerations:
- 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.”
Hawaii
Landscape for Cost Effectiveness & QALY Considerations:
- 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
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
Illinois
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- Legislation was introduced in the Illinois House (HB 4472) on January 17, 2024 creating a Health Care Availability and Access Board, using a model aligned with the NASHP template legislation for creation of Prescription Drug Affordability Boards. The bill missed the deadline to move forward, but the issue is still of interest in Illinois.
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
Indiana
Landscape for Cost Effectiveness & QALY Considerations:
- 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).
Iowa
Landscape for Cost Effectiveness & QALY Considerations:
- 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.”
- In 2024, the legislature introduced HF 2408 / SF 2238, creating a PDAB authorized to engage third parties and create criteria for assessing affordability and recommending UPL. QALYs and similar measures are not banned from use, opening the door to third-party contracts with entities supporting their use, including ICER and PORTAL.
Kansas
Landscape for Cost Effectiveness & QALY Considerations:
- 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.”
Kentucky
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
- In 2024, the legislature introduced HB 823 to create a Prescription Drug Affordability Board. The bill bars use of QALYs or similar measures “to identify subpopulations for which a treatment would be less cost-effective due to severity of illness, age, or preexisting disability” and limits use of cost effectiveness to studies “that weigh the value of all additional lifetime gained equally for all patients.
Louisiana
Landscape for Cost Effectiveness & QALY Considerations:
- 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.”
Maine
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- A bill introduced in the Maine legislature, LD 1829, would amend the existing Prescription Drug Affordability Board to add a 6th Board member and would be authorized to reference Medicare negotiated prices in setting upper payment limits on selected drugs. It is not known whether the methodology for Medicare negotiated prices will implicate use of alternative measures of cost effectiveness. The bill has passed the Senate and will be transmitted to the Governor.
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.
Maryland
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- The next meeting of the Prescription Drug Affordability Board Stakeholder Council (PDASC) will take place on December 16, 2024. More information can be found here. At the most recent November 25, 2024 PDAB meeting, cost effectiveness analysis and international reference pricing continued to be listed among the methodologies that could be used by the Board to establish a UPL, despite concerns raised by patients and people with disabilities. Comments to the PDAB may be sent to [email protected].
- The Maryland Legislative Policy Committee approved the PDAB’s UPL Plan, despite comments from groups opposing its approval. As background, the PDAB reviewed a revised UPL Plan that did not respond to the comments from 38 organizations. The comment letter was not listed as a comment received for the meeting on their website, although receipt was confirmed by email. The revised UPL Plan continues to reference international prices from countries that use QALYs and similar measures and cost effectiveness analyses, with no safeguards against use of discriminatory value assessments, potentially violating federal law under Section 504 of the Rehabilitation Act.
- The PDAB has asked for “emergency action” for updates to regulations covering the cost review process. The proposed changes, among other things, would allow for the PDAB to make a preliminary determination of affordability ahead of their final determination. Notably, the concept of the preliminary determination was already outlined and approved in the UPL Action Plan and cost reviews are currently underway.
-
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
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:
Landscape for Cost Effectiveness & QALY Considerations:
- Michigan introduced S. 483, which would create a Prescription Drug Affordability Board (PDAB). The bill was passed out of the Committee on Finance and Insurance and Consumer Protection on September 27, 2023 after a hearing where advocates submitted testimony against the bill. On October 4, 2023, S. 483 passed the state Senate largely along party lines. Several amendments to the bill were offered by Members, including that at least one member of the Board be a member of a patient advocacy organization, but these were ultimately not adopted. Consideration of the bill will now move to the House.
- The bill would establish a PDAB to institute upper payment limits for the most expensive prescription drugs. The Board, which is appointed and does not maintain spots specifically for patient representatives, would have the authority to review and comment on all prescription drug costs impacting residents of Michigan. The bill includes some language related to the QALY and cost-effectiveness metrics, but it is not a broad QALY ban. The language does not address how the QALY may be used to discriminate by setting QALY-based cost thresholds. Any finalized upper payment limits established by the PDAB would apply to all purchases of the drug intended for sale in Michigan. If enacted, Michigan would become the seventh state to establish a PDAB.
- In a column for the Oakland Press, Laura Bonnell, a mother of two daughters with cystic fibrosis and the president of the Bonnell Foundation: Living with Cystic Fibrosis, voices her concerns about Michigan’s proposed Prescription Drug Affordability Board (PDAB).
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.
Minnesota
Landscape for Cost Effectiveness & QALY Considerations:
- The Minnesota state legislature passed legislation (S.F. No. 2744) establishing a process for setting upper payment limits for prescription drugs that included a provision barring the use of a cost effectiveness analysis using the quality-adjusted life year or similar measure in determinations related to affordability or upper payment limits. It also sets the upper payment limit for some drugs at the Medicare maximum fair price. The bill was signed into law by the governor on May 24, 2023. Patient and disability groups will be monitoring implementation closely.
- 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.
Mississippi
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 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.
Missouri
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 detail the evidence used to make recommendations.
Montana
Nebraska
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 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.
Nevada
Landscape for Cost Effectiveness & QALY Considerations:
- In January, 2020, the DUR Board referenced ICER’s study of MS drugs according to its meeting minutes.
- 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.
New Hampshire
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.
New Jersey
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- New Jersey has noticed several upcoming meetings of its Drug Utilization Review Board (DURB) to take place on the following dates:
- July 17, 2024
- October 16, 2024
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.
- 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.
New Mexico
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.
New York
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.”
North Carolina
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
North Dakota
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
Ohio
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.
- 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.
Oklahoma
Landscape for Cost Effectiveness & QALY Considerations:
- 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 next meeting of the Oregon PDAB is December 18, 2024. Register here or comment by December 14 here.
- The Oregon PDAB met on November 20, during which the Board approved a UPL Plan despite concerns about the influence of QALYs and similar measures, as well as the impact on formulary placement and patient access and affordability. On October 16, the Oregon Prescription Drug Affordability Board met to discuss an Upper Payment Limit report for the legislature. Members of the Board stated that the Oregon PDAB is permitted to reference ICER studies and measures similar to QALYs such as evLYGs, contrary to federal law and regulations and Oregon state law barring use of “quality of life in general” measures, a bill strongly advocated by Disability Rights Oregon. Their use is implicated in referencing entities that rely on QALYs and similar measures, including foreign countries and the Veterans Health System.
- 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
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 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.
- In 2021, the legislature introduced HB 1722 creating a Prescription Drug Affordability Board authorized to perform cost reviews relying on cost-effectiveness analyses. The bill does not bar reference to QALYs or similar measures.
Rhode Island
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- The Rhode Island Senate passed S2719 on May 21st and the text was referred to House Committee on Health and Human Services. The bill creates a Drug Cost Review Commission. The bill’s definition of “excess costs” outlines a methodology for cost effectiveness analysis that could rely on QALYs and similar measures. The bill specifically mentions referencing the cost effectiveness or value of a drug as part of its analysis, yet does not bar the use of discriminatory measures such as QALYs. The Rhode Island session adjourned, and the PDAB bill did not move forward.
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)
South Carolina
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.
- 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.
South Dakota
Landscape for Cost Effectiveness & QALY Considerations:
- 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..
Tennessee
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.
Texas
Landscape for Cost Effectiveness and QALY Considerations:
- 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.
Utah
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
Vermont
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- On May 31, Vermont Governor Phil Scott signed S. 98 into law. The initial bill directed the Green Mountain Care Board to conduct an affordability review using cost-effectiveness studies, which included language limiting the use of quality-adjusted life years (QALYs) that was modeled on language used in other states to allow for use of cost effectiveness measures, such as the equal value of life year gained (evLYG). However, the final version passed into law directs the Board to instead create a framework for a program that regulates the cost of prescription drugs in Vermont. The final bill details considerations for the Board in developing this cost-regulating framework, but these considerations do not include limiting the use of QALYs or other cost-effectiveness measures. As required by the bill, the Board must provide its preliminary framework by January 15, 2025.
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 Vermont Legislature enacted the Pharmacy Best Practices and Cost Control Program from the Fiscal Year 2002 Appropriations Act, H 485, which mandated the establishment of a pharmacy best practices and cost control program designed to reduce the cost of providing prescription drugs.
- 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 health care payment and delivery system reforms designed to control the rate of growth in health care costs in Vermont.
- 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.
Virginia
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- Virginia held its most recent P&T meeting on October 8, 2024.
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 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.
- Legislation creating a Prescription Drug Affordability Board was passed in the Virginia legislature (HB 570 and SB 274), and subsequently vetoed by the Governor on April 8, 2024. The language limiting the use of quality-adjusted life years (QALYs) was modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limited the use of QALYs only to identifying subpopulations and only focused on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
Washington
Current Activities:
Landscape for Cost Effectiveness & QALY Considerations:
- At the most recent November 18, 2024 meeting, the PDAB staff discussed its use of ICER Analytics and cost effectiveness as part of its deliberations, indicating an intent to reference QALYs and similar measures in its assessments. Click here to view more information about the meeting, its agenda and transcripts.
- At the May 22, 2024 meeting, the Program on Regulation, Therapeutics, and Law (PORTAL) provided information to the Prescription Drug Affordability Board on “Considerations for Conducting Affordability Reviews,” including cost effectiveness. PORTAL is known to be aligned with ICER, which considers QALY-based cost effectiveness to be the gold standard. PORTAL has also in the past referenced the evLYG as a measure to consider in affordability reviews. On September 18, the Board met and discussed its affordability review process, including the potential reference to premiums as a component of affordability reviews. Click here to view the schedule and review prior meetings.
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 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.
- In 2022, Washington State passed SB 5532 creating a Prescription Drug Affordability Board. The language limiting the use of quality-adjusted life years (QALYs) has been the model for other states, where it has been found to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). The language limits the use of QALYs only to identifying subpopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
West Virginia
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
- In 2024, the legislature introduced H.B. 5682, creating a Prescription Drug Affordability Board authorized to do cost reviews relying on cost effectiveness. The bill does not bar the use of QALYs and similar measures.
Wisconsin
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
- In 2023, the legislature introduced AB 747 to create a Prescription Drug Affordability Board with authority to set an UPL. The criteria for the Board’s consideration did not exclude QALYs and similar measures.
Wyoming
Landscape for Cost Effectiveness & QALY Considerations:
- 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.
Funding for this project provided by Biogen, Gilead, Genentech, Merck, and Pfizer.
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