Prescription Drug Advisory Boards: What They Are and Why They Matter to Patients

It’s no secret that the high cost of healthcare is a significant concern for most Americans. The total national health expenditure in 2021 increased by 2.7% from the previous year to 4.3 trillion dollars which was 18.3% of the gross domestic product. The federal government held the majority of the spending burden at 34%, with individual households a close second at 27%. A cornerstone component of medical treatment is the access to prescription drugs. In 2019 in the U.S., the government and private insurers spent twice as much on prescription drugs as in other comparatively wealthy countries. Despite catchy phrases that poll well, and “simple” solutions by politicians that promise to fix the problem—such as Prescription Drug Advisory Boards (also known as Drug Pricing Advisory Boards)—it is mindful to remember one thing: if it sounds good to be true, then it probably isn’t true.

CANN PDAB infographic: What are they and why do they matter? (https://tiicann.org/dpab-project.html)

While list prices of prescription drugs continue to increase, medication costs do not represent the largest share of healthcare costs or the largest growth in healthcare costs in the United States. The cost burden on patients is so untenable for many that some have to decide between paying for medications, food, or mortgages. However, due to a number of incentives and the role of loosely regulated pharmacy benefit managers (PBMs), there is little direct relationship between drug list prices and patient cost burdens. This fact is only just now being appreciated by lawmakers but is not currently reflected in our healthcare funding schemes. As such, the discourse surrounding lowering cost is a consistently turbulent sea navigated by diverse public and private parties, with the language around drug pricing assuming efforts to curb costs relate to patient costs and access – but not explicitly saying so (and for good reason). Some proposals are government related, such as federal drug pricing proposals. Recent developments are state-level focused closer to home. One such development is the Prescription Drug Advisory Boards, or PDABs.  

PDABs are part of state divisions of insurance. Drug pricing efforts, in the general sense, could be a good thing. PDABs are being marketed to the public as a better means to make drugs more affordable for patients. However, the details of the implementation of developing PDABs are wherein lies significant challenges. Overall, the boards focus specifically on the prices of the drugs. However, the focus on pricing is mainly related to what governments, insurance companies, hospitals, and pharmacies are paying for the medications. This purview and the monitored metrics associated with PDABs do not necessarily translate into the actual costs patients pay at the pharmacy counter.

Because these designs are singularly focused on the “cost” to payors, current proposals and initiatives benefit both public and private payors at the expense of the patient access and the provider-patient relationship. It is unacceptable for any planned PDAB activity to disrupt the patient-provider relationship. Community Access National Network (CANN) has consistently opposed any policy initiative that might increase administrative barriers and patient burdens. Two examples are step-therapy and prior authorization. Activities such as these are considered what is known as utilization management. Utilization management helps lower prescription drug spending for public and private payors but creates additional costs for patients financially and logistically, affecting their continuity of care, amounting to a cost burden shift, not a meaningful increase of access to affordable, high-quality care and treatment for patients.

Additionally, the narrow specific focus on the list prices of drugs overlooks essential issues. Lowering the list price for medications can, for example, harm organizations that depend on revenues from the 340B Drug Pricing Program. The 340B program allows safety net clinics and organizations to purchase prescription drugs from manufacturers at a discounted price while being reimbursed by insurance carriers at a non-discounted cost. The surplus enables these entities to provide many services that the low-income populations they serve depend on. This is especially vital to low-income people living with HIV that do not have the means to afford all of their healthcare needs.

It is imperative that PDABs receive input directly from patients and caregivers as well. PDABs are aggregating a large amount of data. However, more of that data needs to include considerations of the patient experience. For example, drug rebate reductions can impact care and support services, such as transportation assistance or mental health services at federally qualified health centers (FQHCs). Moreover, there needs to be an examination of the actual pass-through savings to patients. Most importantly, PDABs need to explore how pricing decisions affect patient access. A lower drug list price is not beneficial to patients if it creates or increases administrative burdens or increases costs for patients in other ways outside of paying for the cost of medication.

Most policymakers do not always have robust experience in understanding the nuances of dealing with public health programs, clinics, and populations. This is especially true regarding the marginalized community of people living with or at risk for acquiring HIV, those affected by Hepatitis C, or people who use drugs. PDABS must be held accountable for acquiring anecdotal qualitative and quantitative data regarding patient experience, accessibility, and affordability while developing recommendations related to drug pricing. As it stands, of the states that have implemented a PDAB, none have statutorily mandated metrics monitoring patient experience and access.

Patients, caregivers, and advocates with direct experience and greater understanding of the policy landscape around healthcare access play a vital role in helping to shape legislation and informing proper implementation of programs to meet the goals those programs were “sold” on. If monitored metrics do not consider or reflect patient experiences, then the program is simply not about increasing access for patients.

PDABs, fortunately, do have numerous opportunities for patients, caregivers, advocates, and providers to become involved and to elevate patient priorities over that of other stakeholders. Getting involved and staying involved with a state’s PDAB work is critically necessary to ensure any final work or regulation is patient-focused.

CANN will be present and offering feedback at various PDAB meetings in affected states. The next meeting CANN will be attending is virtual for the state of Colorado, on July 13th at 10am Mountain time. You can register here and participate in ensuring any action taken reflects patient needs.