August 05, 2019
By A. Mark Fendrick, MD, University of Michigan, School of Public Health
A. Mark Fendrick, MD, director at the University of Michigan Center for Value-Based Insurance Design, weighs the pros and cons of patient support programs, focusing on value-based insurance models and out of pocket costs.
Hi, my name is Mark Fendrick. I am a practicing general internist, and I've devoted 20 years of my career to advocating for the concept of value‑based insurance design, which is a health insurance model that does not set consumer out‑of‑pocket cost based on the cost of the service, but instead, on the clinical value of the service.
This concept should hopefully align a little bit more our spending to where the health that we get from individuals and populations.
For over two decades, I have studied the impact of consumer cost sharing on access to affordability of and adherence to high‑value, evidence‑based clinical services. Unfortunately, as we have been asking Americans to pay more for both high and low‑value care, they have been using less of both high and low‑value care.
One of the ways to reduce cost‑related nonadherence—and hopefully increase access to high‑value service—is patient support programs. We strongly support the use of patient support programs when a service is clinically indicated.
We frown on those patient support programs where people are given certain types of incentives or subsidies to do services that may not be the most efficient or of the highest benefit for them. We have advocated for what we call precision patient assistance programs only in the circumstance where a service would be clinically indicated.
I support patient support programs when my patient's only other alternative is a bake sale, a Kickstarter program, or he or she would have to forego on rent or limit food intake. I don't think any American should have to do those things to be able to get the care that is clinically indicated to improve his or her individual or a population's health.
What is exciting to me as a clinician is the recent innovation and my ability to improve individual and population health. I call that "Star Wars" science.
The problem is, our ability to deliver these amazing innovations to patients who need them are stuck in the Stone Age, and I call that "Flintstones" delivery. One way to bring the Stone Age to the space age is patient support programs.
It may not be well known that the typical American has to have $1,000 or more deductible in their health plan, and they pay that amount out‑of‑pocket before their insurance kicks in. Unfortunately, the Federal Reserve showed last year that 40% of Americans don't have $400 in the bank.
These out‑of‑pocket expenditures as you might expect are particularly problematic for people with socioeconomic insecurity or those with very expensive chronic diseases such as rheumatoid arthritis, Crohn's disease, psoriasis, etc. There is a problem presented there when a patient has to pay $1,000 out‑of‑pocket and barely has $400 in their bank account.
We've been very pleased that in circumstances where patients are indicated to have high‑cost drugs and are unable to afford the out‑of‑pocket cost, that patient support programs come through allowing patients to get the care they need. Most patient support programs step up and pay a patient's out‑of‑pocket cost to get a particular service. In most situations, and the research would show, patient support programs do decrease the ever‑increasing out‑of‑pocket expenditure.
It would be my hope that these patient support programs would be more precise in the fact that they would only be used in situations when the service that is provided under the program is the best clinical alternative for that patient, and not used in a way to get around a formulary or something similar.
As you might expect, if the patient's costs go down, someone has to pick up that payment, and usually it's the payer.
There are some rare situations that the utilization of a service may actually lower the total cost of care so much so that the use and increased adherence that may come with a patient support program will make the patient healthier or perhaps decrease the need for preventable hospitalizations, ER visits, or other expensive interventions. That would be the ultimate win‑win.
I don't believe that's particularly common across the board in patient support programs, but we have seen some evidence that some of these very finely‑tuned programs for high‑need patients can not only help the patient in terms of patient‑centered outcomes, lowered out‑of‑pocket costs, but also for the payer, decreasing total cost of care. That is really dependent on the clinical scenario.
In the field of medication adherence, something I've been involved in for over two decades, we often try hard to draw a straight line between reducing patients' out‑of‑pocket costs either through value‑based insurance design programs or patient support programs that lead to increased adherence of what we think are evidence‑based services.
Ultimately, down the road, why we prescribe evidence‑based services is to improve individual and population health.
Because of our lack of data, our lack of patients, and our need for answers, we often don’t die studies that are long enough to look at. Programs to reduce adherence show that adherence actually improves, and that improved adherence leads to the patient‑centered outcomes.
Patient support programs can be a controversial issue in that some stakeholders believe that many of the programs are just an end around to get patients not to follow what would be considered a recommended formulary decision, a step therapy program, or other interventions that are put in place to allow efficient spending of our health care dollars.
That's why those of us at the V‑BID Center have called for this precision patient assistance program to actually make sure only those dollars go to services that are clinically indicated and not for a branded drug for where there is a truly chemically equivalent generic available.
This truce that we're calling for between manufacturers and payers would ask the manufacturers to provide more information on medication appropriateness, have much stricter guidelines to who might receive these patient assistance programs.
For example, one guideline would not allow these assistance programs to exist when a generic drug is truly available, but also ask the payers to exclude cost sharing assistance when it's not clinically appropriate. At the same time, when it is clinically appropriate, create guidelines to make it easy, not more difficult, for the patients to get the services they need.
Another goal of the guidelines is to also back away from patient assistance accumulative programs that take the monies that used to come from these assistance programs and have them applied to the patients' deductible. In some situations, they are no longer applied to the deductible, and these patients end up in a situation that we call the copay surprise. They are halfway through their treatment, realize their patient assistance program is fully expended, but the haven't met their deductible with money they don't have.
The more precise we are with these patient assistance programs will allow the dollars to only go for those situations when the patient really needs them when they're clinically indicated, as opposed to more of a one‑size‑fits‑all approach where the patient assistance programs could go to clinically indicated services and not clinically indicated services.
I hope the latter would fall by the wayside to allow more headroom for more money to go to high‑value services.
Brixner D, Rubin DT, Mease P, et al. Patient Support Program Increased Medication Adherence with Lower Total Health Care Costs Despite Increased Drug Spending [published online July 2019]. J Manag Care Spec Pharm. 2019 Jul;25(7):770-779. doi: https://doi.org/10.18553/jmcp.2019.18443