Beware Prescription Drug Affordability Boards

Quick Guide: PDABs at a Glance

Overview: Prescription Drug Affordability Boards, known simply as PDABs, are unelected state panels with the power to limit patient access to life-saving medications and set price controls on treatments..

The Problem: PDABs often do not lower what patients actually pay out-of-pocket for medications. Instead, they create dangerous barriers to care, drug shortages, and limit patients’ treatment options.

Patient Impact: As a result of PDABs, patients are likely to face:

• Reduced Access: PDABs block patient access to the right treatment by removing drugs from formularies, imposing stricter prior authorization rules, or requiring patients to "fail first" on a less expensive medication before they can access the treatment their doctor prescribed. This practice, known as non-medical switching, can cause needless suffering and even be life-threatening.
• Higher Out-of-Pocket Costs: There's no guarantee that any savings from a PDAB's price cap will be passed on to patients. In fact, some studies show that patients may end up paying more for drugs subject to price controls. 
• Drug Shortages: Patient advocates and economists agree that government-imposed price controls, including those set by PDABs, can lead to drug shortages. 
• Discriminatory Practices: PDABs often use discriminatory measures, like the Quality-Adjusted Life Year, to determine a drug’s "value". QALYs are a flawed metric that devalues the lives of people with chronic and life-threatening illnesses.
• Limit Doctor-Patient Relationship: PDABs create policies that override a doctor's prescribing recommendations, shifting the decision-making power from medical experts to government bureaucrats.
• Loss of Vital Programs & Pharmacies: Manufacturers may reconsider or alter the eligibility for their patient assistance programs if a drug is subjected to a UPL, which could leave patients with high out-of-pocket costs.

Our Solution: We advocate for real solutions that address the root causes of high costs, such as increasing transparency for pharmacy benefit managers and expanding patient assistance. We support policies that put patients first and ensure healthcare decisions are made between a patient and their doctor. We categorically reject government price controls and other measures that ration care and limit patient access to the right treatment.

How You Can Help: You can demand change from state lawmakers and insist on policies that protect patient access and affordability. If your state has a PDAB, you can testify at public hearings and advocate for solutions that prioritize the patient experience and lived reality.

PDAB Basics: What Every Patient Should Know

PDABs undermine the doctor-patient relationship by inserting a government board into the decision. Your access to treatment is evaluated based on cost rather than medical need. PDABS promote barriers to access, such as prior authorizations, step therapy, and formulary restrictions. These barriers force patients to switch from effective treatments, delay critical care, or lose access altogether to the specific therapies their doctors prescribe as best for them.

Definition and Core Purpose

Prescription Drug Affordability Boards, commonly known as PDABs, are state-appointed government bodies that have the power to deny patients access to medications based on cost metrics. These unelected and unaccountable boards aim to assess medication affordability and implement Upper Payment Limits (UPLs). These state-level price caps restrict what payers can reimburse for a drug, primarily to reduce costs for state healthcare systems and insurers.

PDABs are an experimental approach that is being tested in approximately a dozen states. Substantial research, patient feedback, and peer-reviewed studies confirm that PDABs introduce new bureaucratic barriers to patient access, ultimately threatening patient access to life-saving and life-sustaining medications. 

There is no guarantee that any savings generated by PDABs will be passed on to patients in the form of lower out-of-pocket costs or drug rebates. Instead, any savings achieved by PDABs are pocketed by payers, such as insurance companies and pharmacy benefit managers. 

PDABs are sold to the public as a method for reducing drug costs. In reality: PDABs threaten the doctor-patient relationship and limit a patient's access to the treatments they need.

Key PDAB Terms

Upper Payment Limit (UPL): A UPL is the highest amount a purchaser (like an insurance company) can pay for a prescription drug. It does not control the price a manufacturer charges or what a patient pays out-of-pocket.

Affordability Review: This is the process a PDAB uses to assess if a drug's cost is too high. Boards look at various factors, but there's no established definition of "affordable" across states or patient communities.

Quality-Adjusted Life Year (QALY): A QALY is a discriminatory health metric that measures the value of a medical treatment by combining the length and quality of a person's life. QALYs devalue human lives, particularly those of patients with chronic illnesses or disabilities, by assuming they have a lesser quality of life than a healthy person. PDABs use QALY metrics to justify price controls that lessen the human value for certain patient communities. Patients Rising categorically rejects QALYs because they are used to ration care and limit a patient's access to the most appropriate treatments. 

How PDABs Work

PDABs follow a multi-step process that can ultimately lead to a drug being designated as "unaffordable" and subject to a price cap.

The Step-by-Step PDAB Process

Here’s the step-by-step process from drug selection to potential price limits: 

1. Drug Selection: PDABs identify drugs for review based on criteria like the Wholesale Acquisition Cost (WAC) or public feedback.
2. Affordability Review: Once a drug is selected, the board conducts a review to determine if it poses an affordability challenge. There is no clear, consistent definition of "affordable," and the criteria used can vary between states and even between different reviews.
3. Price Limit Determination: If a drug is deemed unaffordable, the board may establish a UPL. This UPL sets a cap on what insurers and state programs can reimburse for the drug. The Price Limit has no connection to what patients pay out-of-pocket at the pharmacy counter. 

Establishment and Composition

PDABs are composed of unelected and unaccountable political appointees. Many boards do not include patient, provider, or caregiver representatives. This underrepresentation can lead to discussions and decisions that are missing an essential patient perspective.

Scope of Authority

A PDAB's authority and who it affects can vary by state. Most PDABs can only set UPLs for state-regulated plans, not for federally regulated plans or self-funded plans under ERISA, unless those plans choose to opt in. This can create a disjointed system where some patients are affected by price controls while others are not.

The "Unaffordable" Determination

The process for determining "unaffordable" is often inconsistent and lacks transparency. According to Health Affairs, PDAB consideration of affordable “rarely include aspects of drug value.” Boards may change their evaluation criteria from one review to the next. PDAB's methodology has been criticized for being subjective and not based on a consistent, defined set of rules for every drug.

Timeline and Lack of Patient Input

PDAB reviews can take months, which can delay the implementation of new treatments. While PDABs often provide opportunities for public comment, these are sometimes announced with little notice, are held during business hours, and may not lead to meaningful changes in the board's decisions. 

According to the Tigerlily Foundation, a national women's health and oncology organization dedicated to education, advocacy, and hands-on support for young women before, during, and after cancer focusing on eradicating the disparities of age, stage and color, “Even when there are opportunities for patients to come to meetings to give their perspective and comments, these meetings are long and challenging to attend, sometimes announced with only 24 hours’ notice and are usually held during normal business hours when most are working.”

Recent patient surveys have shown that PDABs often ask oversimplified questions that fail to capture the real-world reasons why patients struggle with affordability, such as insurance barriers or a fear of losing assistance programs.

As one example, in March 2025, Maryland’s Prescription Drug Affordability Board asked for patient input, and then patient perspectives were ignored. 

• When asked that savings go directly to patients - the board recommended no action.
• When asked if the board would ensure confidentiality protections - the board recommended no action.
• When asked if the board would provide meaningful opportunity for public comment - the board recommended no action.

VIDEO: PDABs Board Members Aren't Listening to Patients

 

Current PDA Landscape (Updated 2025) 

The PDAB landscape is constantly evolving, with some states strengthening their boards while others reject or dissolve them.

States with Active PDABs: As of July 2025, nine states have an active PDAB or a similar drug cost entity: Colorado, Maine, Maryland, Minnesota, New Jersey, New York, Ohio, Oregon, and Washington.  Ohio's PDAB has been inactive since 2021.

UPL Authority: Four states currently have the authority to set Upper Payment Limits (UPLs): Colorado, Maryland, Minnesota, and Washington. While no state has officially implemented a UPL yet, Colorado is currently in the rulemaking process for its first one on the drug Enbrel.

Recent Developments: New Hampshire officially dissolved its PDAB on July 1, 2025, as part of its state budget legislation. In Virginia, Governor Glenn Youngkin vetoed PDAB legislation for the second consecutive year in 2025. 

Proposed PDABs: In 2024, states that have considered PDAB legislation include Connecticut, Illinois, Iowa, Kentucky, Michigan, Nebraska, Rhode Island, South Carolina, Vermont, Wisconsin, and West Virginia.

The Critical Issue: Upper Payment Limits (UPLs) and What They Really Mean

At Patients Rising, we stand firm in our commitment to empowering patients and ensuring uninterrupted access to the life-saving and life-changing treatments they need. We unequivocally reject policies that devalue human lives, ration care, or introduce unnecessary barriers between patients and their healthcare providers.

Understanding UPLs from a Patient Perspective

Upper Payment Limits (UPLs) act as a price cap set by a PDAB on what payers, such as insurance companies, can reimburse for a drug. It's crucial to understand that UPLs are payer reimbursement caps, not patient cost caps. In other words, it doesn’t require lower costs that patients pay at the pharmacy counter. 

What UPLs Actually Are: Payer Reimbursement Caps, NOT Patient Cost Caps

UPLs represent the highest allowable reimbursement rate that purchasers within a state can provide for a prescription drug product. They act as a price cap on the amount that a payer, such as a private or public health plan, can reimburse for a drug. UPLs do not dictate the manufacturer's pricing, nor do they directly impact what a consumer pays out of pocket. The supposed "savings" generated by UPLs go to the state, insurance companies, and Pharmacy Benefit Managers (PBMs), not necessarily to the patients who rely on these medications.

The Fundamental Disconnect: No Guarantee Savings Reach Patients

There is a fundamental disconnect between UPLs and actual patient savings. Without specific legislative language mandating that these cost savings be passed directly to patients through reduced drug costs, lower cost-sharing, or decreased premiums, payers are highly likely to retain these benefits themselves. The boards implementing UPLs lack the authority to set limits on patient out-of-pocket costs. Evidence suggests that UPLs are unlikely to generate significant savings at the pharmacy counter for patients. In essence, a UPL fails to address the real problems patients identify as drivers of unaffordability.

Manufacturer Assistance Programs: How Existing Programs Help Patients

Many patients already find their medications affordable thanks to existing manufacturer assistance programs. For instance, manufacturer copay assistance programs enable the vast majority of commercially insured patients using drugs such as Enbrel to pay $0-$25 out-of-pocket per month. Additionally, Patient Assistance Programs (PAPs) are available for uninsured and underinsured individuals. 

A crucial oversight in many UPL reviews is the failure to consider these existing assistance programs, leading to an incomplete picture of true patient affordability. Unfortunately, copay accumulator programs undermine these efforts by preventing manufacturer assistance from counting toward a patient's deductible or out-of-pocket maximum, often forcing patients to abandon treatment.

Who's Really Affected: State vs. Federal Coverage Gaps

The reach of UPLs is often limited, creating significant coverage gaps. Medicare and Medicaid programs are federally regulated and not subject to state PDABs or UPLs. This means that older adults, who largely rely on Medicare, are explicitly excluded from any potential (though unproven) benefits of UPLs. Similarly, self-insured plans under ERISA are generally outside state UPL authority. This fragmented application means that UPLs address only a portion of the healthcare market, leading to skewed data analyses that include ineligible populations and failing to provide universal solutions for all patients.

Patient Access Concerns and Real-World Impact

Increased Utilization Management: Prior authorization, step therapy, non-medical switching 

UPLs fundamentally threaten patient access, according to the Alliance for Aging Research. Insurers and PBMs are likely to respond to UPLs by increasing utilization management tactics such as prior authorization requirements and step therapy protocols. Even more alarming is the increased likelihood of non-medical switching, where patients are forced off effective treatments to cheaper, non-equivalent alternatives solely due to cost considerations. Such practices disrupt continuity of care and can lead to serious health complications for stable patients.

According to a 2025 survey of regional and national health plan payers with PDAB-related experience and covering hundreds of millions of lives revealed significant concerns regarding the implementation of UPLs, “77% of health plan payers believe UPLs would disrupt patient access to prescription drugs due to coverage changes, tiering adjustments, increased cost-sharing, or supply chain complications, including pharmacies potentially refusing to stock medicines with UPLs.” 

Formulary Manipulation

PDABs often trigger formulary manipulation, where insurers reshuffle drug lists, place UPL-affected drugs on higher, less favorable tiers, or outright exclude them from coverage, according to research by the Partnership to Fight Chronic Disease. This results in higher out-of-pocket costs for patients through increased copays or coinsurance. Patients may be forced to switch to a more expensive drug that generates higher profits for PBMs, or to less effective options due to formulary constraints.

Therapeutic Non-Equivalence: “Similar” Drugs Aren't Interchangeable 

The assumption that drugs with the same "mechanism of action" (MoA) are interchangeable is clinically unsound and dangerous for patients. For many patients, "therapeutic alternatives" are not true alternatives at all. Even within the same class have unique pharmacological effects that make them non-equivalent for specific patients. Forcing a switch can compromise disease control and may even render the original effective drug useless upon restarting. That’s why PDABs should not make blanket policies overriding doctors’ prescribing recommendations.

Provider and Supply Chain Impact

UPLs create significant financial risks for healthcare providers and the entire supply chain. Reduced reimbursement rates can threaten the financial viability of physician practices, clinics, and pharmacies, especially independent and rural facilities. The Community Oncology Alliance warns that “if payments are not set appropriately, and the UPL is below the acquisition price, the ability for independent practices to keep their doors open becomes untenable. If practice economics are inadvertently upended by UPLs, practices will be forced to cut staff, decrease the number of patients they see, ration their drug supply, and/or close their doors.” 

Providers may become unwilling or unable to stock and administer critical medications if reimbursement falls below acquisition costs. This could lead to treatment delays, increased administrative burdens, and a shift towards choosing specific low-cost drugs over those truly best for the patient.

Manufacturer Withdrawal Risks

What happens when companies pull products? Manufacturers are not obligated to accept a UPL and may choose to withdraw their products from state markets. This is a grave concern that could lead to reduced availability of essential medicines in states implementing UPLs. Such withdrawals would leave patients without access to their critical medications, potentially forcing them to seek care across state lines. This creates a dangerous precedent where patients are held hostage by price controls, risking their health and well-being.

Limited Medication Options 

By narrowing the range of available and accessible treatments, UPLs limit patient choice. Patients with chronic conditions often require access to a broad spectrum of treatments within a drug class due to varying responses and potential tolerance build-up. When UPLs force formulary restrictions or exclusions, patients may be left with fewer or no suitable options, undermining the doctor-patient relationship and their ability to receive personalized care.

Delayed Access to New Treatments

UPLs pose a direct threat to medical innovation. Manufacturers may become disincentivized from investing in research and development for new therapies or additional indications, particularly for high-cost or rare conditions, if they cannot recoup their substantial R&D costs. This could delay or halt the development of future life-saving and life-improving treatments, impacting patients who currently have limited or no options. The most unaffordable thing in the world is a treatment that never gets developed.

Risk of shortages and cross-state care seeking 

A significant risk associated with UPLs is the potential for drug shortages. If manufacturers limit supply or withdraw products, or if pharmacies cannot stock them profitably, patients could face a scarcity of critical medicines. This could force patients to travel long distances or across state lines to access their prescriptions, placing an enormous burden on already vulnerable individuals, particularly those who rely on out-of-state centers of excellence for rare disease care. 

Specific Vulnerable Patient Populations

Pediatric patients: Limited FDA-approved options 

Pediatric patients are particularly vulnerable. Therapeutic alternatives for many conditions are based on adult populations, leaving children with significantly fewer FDA-approved treatment options. For example, Children’s Hospital Colorado raised concerns with Colorado’s PDAB review of Enbrel, the preferred drug for treating children with juvenile idiopathic arthritis (JIA).  There are far fewer FDA-approved options for juvenile inflammatory arthritis than for adult rheumatoid arthritis. UPLs impacting these limited options could force children into less suitable or more invasive treatments, such as intravenous infusions, which increase costs and burden families. Experimenting with children's lives without their consent is unethical.

 

Communities of Color

Increasing access barriers without addressing financial ones, disproportionately harms communities of color and low-income individuals. Drugs selected for affordability review often target chronic conditions like HIV and arthritis, which have a higher prevalence in Black and Hispanic communities. If PDABs continue this trend, existing health disparities will undoubtedly widen. Moreover, copay accumulator programs, which strip away patient assistance, have been shown to disproportionately affect non-White patients, exacerbating racial and ethnic inequities in drug access.

 

Rare Disease Patients

Rare disease patients are frequently targeted by PDABs, as their high-cost orphan drugs are often deemed "unaffordable". The use of Quality-Adjusted Life Years (QALYs), even when indirectly referenced, is particularly discriminatory against rare disease patients, as it undervalues treatments that improve quality of life but don't offer a "cure" or return to "perfect health". With only 5% of rare diseases having FDA-approved treatments and many patients seeking specialized, often out-of-state, care at Centers of Excellence, UPLs threaten to sever access to the few available therapies and disincentivize future research.

 

Patients Living with Chronic Conditions 

Patients living with complex chronic conditions, such as autoimmune diseases and various cancers, rely on continuous, individualized care. Forcing non-medical switches or limiting access to effective biologics carries the risk of irreversible disease progression, increased pain, disability, and a diminished quality of life. QALYs, which PDABs have considered, devalue the lives of people with chronic illnesses by implying a lesser quality of life than a healthy person, forever.

 

Rural & Underserved Patients

The negative impacts of UPLs, such as drug shortages or reduced provider willingness to stock certain medications, will disproportionately affect rural clinics and facilities in underserved communities. Patients in these areas already face challenges with fewer local providers, longer travel distances for care, and limited access to specialists. UPLs would only exacerbate existing access challenges and widen health equity gaps. As one patient testified to the Colorado PDAB:

 

“The Colorado Prescription Drug Affordability Board is currently considering capping prices on certain medications. While the idea may sound like it would help patients, the reality could be very different. These price controls may not actually lower what patients pay, but they could create serious barriers—like drug shortages or reduced access in smaller communities like ours.” 

 

“I think about how this could affect my own grandmother, and so many others across the West Slope. People here can’t afford to lose options when it comes to their health. We already deal with fewer providers and longer travel for care. If certain medications are pulled from the market or no longer supplied to our area, it could have real consequences.”

 

Low-Income & Dual-Eligible Patients

Low-income patients, including those who are uninsured or on Medicaid, are disproportionately harmed by policies that fail to deliver true affordability. While UPLs aim to lower costs for the state, they do not directly reduce out-of-pocket costs for patients. Many low-income patients, even those with minimal copays, struggle with affordability due to cumulative healthcare costs. UPLs also risk disrupting vital safety-net programs like Medicaid and 340B, which are critical for ensuring access to therapies for vulnerable populations.

 

Data Problems and Process Flaws

Flawed Data and Lack of Transparency

The Colorado Prescription Drug Affordability Board, which is often heralded as a leader in PDABs, demonstrates the flawed process, significant data issues and lack of transparency involving PDABs. Patients have raised concerns regarding process integrity, including skewed statistics, discriminatory data sets, and inconsistent interpretation.

 

Inconsistent methodologies and changing evaluation criteria

There is a dire need for procedural safeguards and thorough, objective analyses of the likely impacts of Upper Payment Limits (UPLs). PDABs propose rules that are largely undefined, lacking specificity on the UPL level, range, process, method, or criteria for its determination. PDAB rules and guidance merely restate statutory factors and list various "price and cost metrics" they "may consider" without detailing how this information will be used to establish a UPL. This "make it up as you go" approach means the process is subjective, with evaluation criteria potentially changing between drug reviews. This lack of transparency undermines confidence in the decisions and overall process.

 

APCD data errors and miscategorizations

Some state PDABs have acknowledged errors in the system they use to establish costs.

For example, the All-Payer Claims Database (APCD) has contained known errors dating back to 2022, affecting approximately 7% of claims and skewing metrics such as patient counts, Average Wholesale Acquisition Cost (WAC), Average Paid Per Person Per Year (APPY), and total payer and patient costs. Without accurate underlying data, detailed methodologies, and data dictionaries, how can PDABs appropriately evaluate costs.

 

Problematic patient surveys including wrong populations

PDABs often conduct flawed and, in some cases, illegal patient surveys. For example in Colorado, responses included non-Colorado residents, violating statutory requirements, and Medicare beneficiaries were included despite UPLs not applying to Medicare-covered drugs, which are federally regulated, according to A pilot study by the Patient Inclusion Council (PIC) confirmed that Medicare patients experienced the most prescription drug affordability challenges, and their inclusion in overall analyses skewed results.

 

Lack of baseline monitoring for post-implementation tracking

Despite requests, there has been no discussion on the methodology for establishing monitoring activities or baseline metrics to assess the consequences of a UPL. The cost-benefit analysis report provided no substantive data establishing a baseline for the healthcare system, fiscal impact on patients, or a definition of "affordability". Without a reference point for comparison, it is impossible to systematically measure or interpret the outcomes of a UPL or define what constitutes a successful outcome. Promises of monitoring and safeguards after implementation are seen as "flying the plane while building it" and are not a substitute for proactive protections.

 

Discriminatory Practices

The PDAB process has also been heavily criticized for discriminatory practices, particularly concerning the use of Quality-Adjusted Life Years (QALYs).

 

QALY usage: How quality-adjusted life years discriminate

QALYs quantify the quality and quantity of life a medical intervention provides, aiming to assess its value relative to its cost. However, this method is widely seen as discriminatory, as it often undervalues the potential benefits for patients with rare diseases and disabilities. QALYs combine length of life with quality of life, where one QALY equals one year in perfect health, which oversimplifies and overlooks important aspects of personal health and well-being. This approach inherently devalues the lives of people with disabilities or chronic illnesses. For example, a rare disease patient may find that their life is "fractionalized" or deemed less valuable, which is characterized as "naked ugly discrimination".

 

Prohibited yet present: Hidden use in third-party assessments

Despite clear statutory and federal prohibitions, PDABs continue to reference QALYs in their evaluations. The use of QALYs has been banned in Medicaid affordability decisions and is prohibited by the ACA for comparative effectiveness in setting Maximum Fair Prices (MFPs) under the Inflation Reduction Act (IRA). Colorado's PDAB statute specifically bans the use of QALY measures. However, even when explicitly banned, there are concerns that the Board cannot "unsee" data using QALYs, which contaminates the entire process. Additionally, some PDABs rely on third-party entities like PORTAL and ICER, which utilize traditional cost-effectiveness assessments based on QALYs. These third-party assessments are built on underlying discriminatory data from public opinion surveys that appeal to "ableist bigotry" by asking healthy, non-disabled people questions like "would you rather be dead or blind" to determine disability weights.

 

Devaluing certain lives: Impact on disabled, elderly, rare disease patients

QALY data has no place in affordability and pricing decisions since it favors cures and perfect health, and does not include actual quality of life information determined by patients themselves. The use of QALYs discriminates against the elderly, disabled, and chronically ill. Treatments for rare disease patients are often not favored by QALY assessments because they rarely provide a "cure" or return to "perfect health," but rather aim to stop progression or improve quality of life, which is undervalued by QALYs.

 

Process Criticisms

The overall PDAB process has drawn widespread criticism for its operational approach, its disregard for market complexities, and its significant financial outlay without proven patient benefits.

 

"Make it up as you go" approach: Lack of predictable frameworks

PDABs rush through the rulemaking process without disclosing crucial information. The absence of a predictable framework deprives stakeholders of a meaningful opportunity to comment. 

 

Ignoring market realities: PBM, wholesaler, provider roles

The PDAB's approach overlooks the complex roles of pharmacy benefit managers (PBMs), wholesalers, and providers in the drug supply chain. Setting a UPL is not a direct cost saving for patients; the drug still goes through insurance companies and PBMs, who then decide formulary placement and patient out-of-pocket costs. There is no guarantee that savings generated by a UPL will be passed on to patients, as payers often retain these savings. Instead, UPLs could lead to negative consequences like increased utilization management, formulary reshuffling, higher out-of-pocket costs for patients, and reduced reimbursement for providers and pharmacies. If reimbursement rates cause a financial loss, providers may be unable or unwilling to stock or administer essential medications.

 

High state costs: Millions spent without demonstrated patient savings

PDABs are costly to implement and operate, with states spending millions without demonstrably lowering patient costs. For example, Colorado has spent over $2 million and Maryland has spent $3 million, yet neither has completed value assessments for their full list of drugs or implemented UPLs. Despite these expenditures, the Board has not saved patients a single dollar at the pharmacy counter. The lack of quantifiable data and the admission that benefits are "difficult to quantify" in cost-benefit analyses further underscore the inefficiency.

 

Why PDABS Waste Time And Money

 

Impact on Medical Innovation

Prescription Drug Affordability Boards (PDABs) and their Upper Payment Limits (UPLs), while intended to address affordability, raise significant concerns about their potential to hinder medical innovation and patients' access to breakthrough therapies.

 

Research and development concerns

The implementation of UPLs and other price controls can discourage investments in research and development (R&D) for new therapies, especially for rare diseases and complex conditions. Manufacturers may be unable to recoup their R&D costs if the prices of their products are capped in certain states. The Inflation Reduction Act (IRA) has already led some companies to suspend development for rare diseases, a trend that state-level UPLs could exacerbate. Furthermore, setting price negotiations before biosimilars enter the market can deter biosimilar competition, which in turn reduces investment in R&D. Unlike federal programs that often target late-stage lifecycle products, state UPLs could target earlier-lifecycle products, creating unpredictability and a broader scope for price setting that could affect a wider range of therapeutic areas. The most unaffordable treatment, as noted by advocates, is one that is never developed.

 

Patient access to breakthrough therapies

UPLs risk limiting patient access to new or novel treatments. For patients living with chronic diseases, medical innovation is crucial, offering hope and the promise of improved quality of life. For instance, patients with advanced cancers, such as stage four breast cancer, depend on new immunotherapy medications to maintain a better quality of life and avoid the severe side effects of traditional harsh chemotherapies. The lack of reinvestment resulting from price controls could also reduce R&D for new drugs and new indications, which is particularly critical in oncology, where over 60% of drugs have multiple indications that expand their utility across different cancer types. Developing new therapies is an extremely lengthy and expensive process, often taking over 12 years and billions of dollars to bring to market.

 

Balancing affordability with innovation

The core challenge lies in balancing the goal of making medications affordable with the need to sustain medical innovation. Policies must be meticulously designed to preserve patient access and prevent unintended consequences that could undermine patient care and disincentivize R&D. Ultimately, policymakers should prioritize affordable solutions that actively support, rather than hinder, medical innovation.

 

Real-World PDAB Implementation: Case Studies

Colorado's Experience

Colorado is notably the only state that has identified a drug, Enbrel, to which an Upper Payment Limit (UPL) will be applied. This precedent-setting process has drawn significant scrutiny regarding its methodologies, data integrity, and patient impact.

 

Enbrel case study and outcomes

The Colorado Prescription Drug Affordability Board voted for Enbrel to be subject to a UPL, kicking off a months-long process to determine the specific amount. However, the proposed rule for Enbrel's UPL has been criticized for being "little more than a blank template," lacking specificity on the proposed UPL level, range, process, method, or criteria for its determination. This has been described as a "make it up as you go" approach, undermining confidence in the Board's decisions. The Board's own cost-benefit analysis for Enbrel's UPL was criticized for containing no quantifiable data and admitting that benefits were "difficult to quantify" due to the complex pharmaceutical supply chain and the absence of a set UPL.

Significant data integrity issues have emerged, including acknowledged errors in the All-Payer Claims Database (APCD) dating back to 2022, affecting approximately 7% of claims and skewing metrics for Enbrel such as patient counts, Wholesale Acquisition Cost (WAC), and total payer and patient costs. For example, the number of Enbrel utilizers cited by the Board changed from 2,279 to 3,692 and then to 2,744 across different review phases for the 2021 data year, without transparent, evidence-based methodologies for correction. Furthermore, the patient survey used in affordability reviews was deemed "deeply flawed," including non-Colorado residents and Medicare beneficiaries, despite UPLs not applying to Medicare-covered drugs which are federally regulated. This meant the data did not accurately reflect the affordability landscape for the population the PDAB intends to impact.

The International Foundation for AutoImmune & Autoinflammatory Arthritis notes that patients using Enbrel, particularly those with commercial insurance, often pay between $0-$50 out-of-pocket per month due to manufacturer copay assistance programs, which the Board has largely dismissed in its analyses. This raises concerns that UPLs could lead to negative consequences such as increased utilization management (e.g., prior authorizations, step therapy), formulary reshuffling, higher out-of-pocket costs, and reduced access, especially since therapeutic alternatives are not always interchangeable.

 

Patient advocacy responses

A major concern is the lack of patient representation on the Board itself, with no state PDAB currently requiring a patient or consumer representative as a voting member. This has led to criticisms that patient voices and lived experiences are overlooked. Patient engagement has been "chronically low" and inadequate due to limited community awareness campaigns, short feedback periods, and a perceived dismissal or even hostility towards patient input from some Board members.

Advocates have vehemently opposed the continued use of Quality-Adjusted Life Years (QALYs) in PDAB evaluations, even indirectly, citing their discriminatory nature against people with disabilities, chronic illnesses, and older adults. Although Colorado's statute specifically bans QALYs, concerns remain that the Board cannot "unsee" such data once presented, thereby contaminating the process. Advocates argue that QALYs undervalue treatments for rare diseases, which rarely provide a "cure" but significantly improve quality of life.

Repeated calls have been made for a transparent and consistent methodology for setting UPLs, for establishing baseline monitoring activities, and for concrete assurances from supply chain stakeholders that patient access will not be disrupted.

 

Lessons learned

Colorado's experience highlights several critical lessons. First, UPLs, as currently designed, do not necessarily translate to direct patient savings at the pharmacy counter. Secondly, the process has been costly for the state (over $2 million by last fall) with only a few drugs deemed unaffordable and minimal direct impact on patient affordability demonstrated. Thirdly, there's a clear need for early, continuous, and meaningful patient engagement, ensuring their perspectives are central to decision-making, rather than an afterthought. The importance of clear data stratification, such as excluding Medicare beneficiaries from analyses targeting state-regulated plans, has also become evident for accurate assessments. Lastly, there is significant concern that UPLs risk undermining existing patient assistance programs and disincentivizing research and development (R&D) for new therapies, particularly for rare diseases and complex conditions.

 

Maryland's Supply Chain Focus

Maryland enacted legislation creating the first PDAB in 2019 and is one of the states with the authority to establish UPLs. In 2025, the Maryland Board began affordability reviews for six drugs, including Farxiga, Jardiance, Ozempic, Trulicity, Dupixent, and Skyrizi. The state's legislation, however, notably does not define "therapeutic alternative.” 

Despite its stated intentions, Maryland’s PDAB has dismissed patient concerns and lacked meaningful public input. The underlying model legislation for PDABs, developed by NASHP (funded by Arnold Ventures, also a main funder of ICER), was designed for states to use cost-effectiveness analyses generally based on QALYs, which are known to discriminate against individuals with disabilities and chronic illnesses. Maryland’s PDAB statute allows for QALYs to be assessed, a patently discriminatory measure. 

According to Mark Fendrick, M.D., the director of the Center for Value-Based Insurance Design at the University of Michigan, “Maryland has appropriated $1 million annually for the operation of its PDAB. The focus on controlling top-line costs without a direct mechanism to ensure patient savings, coupled with the potential for increased administrative barriers (like prior authorizations or step therapy) and shifts in formulary design by Pharmacy Benefit Managers (PBMs) and insurers, raises concerns about the actual benefit to patients.” 

Maryland’s Prescription Drug Affordability Board, which has the authority to negotiate prescription drug prices, was created five years ago and has to date spent more than $3 million in taxpayer funds. Yet patients have yet to save a cent.

 

Watch the Maryland PDAB Silence Patients

 

 

Patient-Centered Alternatives

PDABs contradict and undermine patient needs. We need healthcare reforms that expand access and reduce patients’ real out-of-pocket costs. Prescription Drug Affordability Boards are ineffective, unproven, and pose significant risks to patient access and medical innovation, leading to calls for their indefinite postponement, ban, or outright repeal.

 

Ban or Repeal PDABs

Patients Rising is fighting to protect patient access and restore the doctor-patient relationship. We believe that PDABs are not the solution to America’s healthcare challenges. They are unelected bodies that impose price controls, threaten access to life-saving medications, and fail to put patients first. Instead of solving the problem of affordability, PDABs create new layers of bureaucracy that disproportionately harm the most vulnerable patients.

We must move past the idea that "cost containment" should come at the expense of patient health and dignity. We urge policymakers to repeal PDABs and instead focus on real, patient-centered solutions. This includes promoting transparency, holding pharmacy benefit managers accountable, and empowering patients with tools to manage their care.

Every patient should have access to the right treatment at the right time. Patients and their doctors are the best judges of what constitutes value in healthcare. By working together, we can dismantle these bureaucratic barriers and build a system that truly puts patients first.

 

Pause UPL Implementation

States should immediately pause all UPL implementation until fundamental issues regarding patient savings, access, data accuracy, and transparent methodologies are comprehensively addressed and legislative safeguards are in place. Oregon, for example, paused its assessments to better understand affordability.

 

Repeal or Ban PDABs

States should repeal PDAB legislation altogether, as New Hampshire did, or for states to exercise their option not to adopt UPLs. Virginia's governor vetoed PDAB legislation due to patient outcry, demonstrating that such efforts can be successful.

 

PDAB Reform Requirements

Mandatory Patient Representation

No state PDAB currently requires a patient representative as a voting member. This absence often leads to patient voices and lived experiences being overlooked in decision-making processes. Advocates have repeatedly called for patient inclusion as a serious and unresolved issue. Reforms should mandate the inclusion of patient representatives with lived experience in chronic, complex, or rare disorders, as well as professional or lived experience in health equity, disability rights, and racial justice. This aligns with the federal government's recognition of patient value by requiring patient representatives on Pharmacy & Therapeutics (P&T) committees.

 

Meaningful engagement processes

Patient engagement in PDABs has been "chronically low" and inadequate. This is often due to limited community awareness campaigns, short feedback periods, and a perceived dismissal or even hostility towards patient input from some Board members. PDABs should be continuously obliged to seek community input and feedback, with specific requirements for engaging advisory councils regularly. The responsibility to engage patients, caregivers, and providers must rest with the PDAB, not be solely borne by patient organizations, and should involve proactive outreach to trusted stakeholders in relevant disease communities. Clear, transparent, and consistent methodologies for UPL setting are also crucial to build confidence in the Board's decisions.

 

Require Savings Goes to Patients

States with PDABs need to pass explicit legislative language requiring that all cost savings be passed directly to patients. Insurance companies and PBMs should not keep savings that are meant for patients. Other reforms should include capping copayments, banning copay accumulator and maximizer policies, and requiring rebates to be passed through to patients at the pharmacy counter.

 

Robust Monitoring and Safeguards

PDABs and UPLs are considered "untested and unproven," with no state yet demonstrating that they can lower patient costs without creating harmful downstream effects. There is a significant lack of a defined methodology for establishing monitoring activities or baseline metrics to evaluate the impact of UPLs. Advocates urge the board to obtain concrete assurances from all supply chain stakeholders (manufacturers, insurers, PBMs, and providers) regarding how they will respond to UPL implementation. 

A transparent monitoring framework must be designed and published for public comment in advance of any UPL finalization. Additionally, legislative safeguards are needed to proactively protect patients from adverse consequences, such as prohibiting alterations to formulary placement, the imposition of new prior authorization or step therapy requirements, or non-medical switching of patients stable on treatment across the full therapeutic class. Concerns about the potential for UPLs to cause drug shortages or reduce availability have also been voiced by health plans themselves.

 

Protecting Vulnerable Populations

The pursuit of drug affordability through PDABs carries specific risks for vulnerable patient populations, necessitating targeted protections and careful consideration of health equity.

 

Orphan drug exemptions: Removing rare disease treatments from reviews

Orphan drugs, developed to treat rare medical conditions (affecting fewer than 200,000 individuals), are often high-cost and thus highly susceptible to being targeted by PDABs for review. The Orphan Drug Act of 1983 provides vital incentives for their development, including market exclusivity and R&D tax credits. UPLs risk undermining these incentives, potentially hindering or halting the development of treatments for rare disorders. Advocates propose exempting orphan drugs from affordability reviews and UPLs to ensure continued patient access and research. For many rare diseases, few or no FDA-approved treatments currently exist, making ongoing innovation critical.

 

Anti-discrimination enforcement: Ban QALYs

QALYs are discriminatory and cannot be used in federal programs, including Medicaid. PDABs should not be allowed to use or reference QALY-based assessments. Any PDAB that references a QALY should be disqualified. Board members cannot "unsee" such data once presented, thereby contaminating the process.

 

Health equity considerations: Addressing disparate impacts

The lack of patient representation from communities of color on PDABs means board members may lack specific knowledge about the impact of these conditions and affordability challenges on these communities. Additionally, practices like copay accumulator and maximizer programs have been shown to disproportionately affect non-White patients, exacerbating racial and ethnic disparities in prescription drug access. UPL implementation can exacerbate existing access challenges, particularly in underserved and rural areas where healthcare access is already limited. Advocates stress the need for policies that actively remove barriers to treatment, especially for vulnerable groups like Black women diagnosed with breast cancer and those living with metastatic disease.

 

Patient Rights and Advocacy

As Prescription Drug Affordability Boards (PDABs) gain traction across states, many patient advocates, organizations, and businesses are raising significant concerns about their effectiveness and potential risks to patient access and medical innovation. Understanding your rights and how to engage with these boards is crucial to ensuring that efforts to improve drug affordability truly benefit patients.

 

How Patients Can Engage with PDABs

Patient engagement is a vital, yet often challenging, aspect of the PDAB process. Patient voices are frequently overlooked by PDABs, and that’s exactly why Patients Rising is working so hard to help patients change that.

 

Public Comment Opportunities

PDABs generally offer opportunities for public comment and input at various stages of their review process. However, these opportunities can be limited, with short feedback periods and insufficient public awareness campaigns. Meetings can be lengthy and challenging to attend, often scheduled during normal business hours. No state PDAB currently mandates a patient or consumer representative as a voting member on the board itself. This absence of direct patient representation often means that boards may overlook patient needs and experiences.

 

Testimony and storytelling guidelines

Sharing personal stories and experiences is a powerful tool in advocating for patient-centered policies. Patients are the ultimate recipients of medications and offer crucial insights into disease management, access barriers, and treatment preferences that cannot be captured by financial models alone. Our voice is the most powerful weapon in advocating for change. When providing testimony, it is important to:

 

• Be direct in explaining how PDAB policies negatively impact your out-of-pocket costs or access.
• Clearly articulate that "affordability" must incorporate value from your personal perspective, as the term is often undefined by PDABs.
• Highlight real-world consequences, such as being forced to switch medications due to insurance, experiencing disease progression after losing access, or facing significant travel burdens for care.
• Emphasize that you support affordability but not at the expense of patient access or medical innovation.

While PDABs are intended to lower prescription drug costs, their mechanisms often create complex challenges for patients regarding access and out-of-pocket expenses.

 

Is Your Medication at Risk?

Patients Rising is dedicated to breaking down barriers to care, advocating for real solutions for rising costs, demanding transparency and accountability, and restoring the doctor-patient relationship. Your unique experiences are invaluable in this fight, as patients are the ultimate decision-makers regarding their health and tratment value.

We believe that decisions about your care should be made between you and your doctor, free from interference by bureaucratic mandates or cost-cutting measures that compromise access. 

Unfortunately, PDABs often operate without direct patient representation on their boards, leading to patient concerns being overlooked and their voices dismissed as "speculative".

Your voice is your most powerful weapon in advocating for change. Here's how you can join Patients Rising and make a tangible difference:

 

Share Your Story

Personal narratives are critical in illustrating the real-world impact of healthcare policies. Your experiences with disease management, access barriers, and treatment preferences offer crucial insights that cannot be captured by financial models alone. Patients Rising provides tools and platforms to help amplify your story, whether through social media campaigns, letter-writing assistance, or direct testimony.

 

Engage in Advocacy:

Join our patient advocacy team to advocate for policies that.

• Expand patient representation: We strongly recommend that PDAB legislation mandate the inclusion of consumer/patient representatives with lived experience, and clear requirements for regular engagement with advisory councils.
• Educate lawmakers: Help policymakers understand that PDABs often focus on insurer and government savings, not direct patient cost reduction, and can create new barriers to access.
• Support Patient-Centered Solutions: Instead of price controls, we advocate for proven solutions that directly benefit patients, such as:
  • Capping out-of-pocket costs and banning copay accumulator and maximizer policies to ensure financial assistance counts towards deductibles and out-of-pocket limits.
  • Reforming Pharmacy Benefit Managers (PBMs) to enhance transparency and ensure cost savings and rebates are passed directly to consumers.
  • Implementing prior authorization and step therapy reform to reduce burdens and prevent delays or denials of medically necessary treatments.

 

Stay Informed

Keep track of PDAB activities in your state and be aware of warning signs like lack of transparency, inconsistent methodology, and the use of discriminatory metrics like Quality-Adjusted Life Years (QALYs). These metrics often undervalue treatments for rare disease patients, people with disabilities, and those with chronic illnesses.

Patients Rising is committed to working with you to ensure that policies promote affordability without compromising access or health outcomes. Your participation is vital.