Brent Moody, MD; Madelaine A. Feldman, MD; and Steven Newmark, JD, MPA, with Lisette Hilton
The Dermatology Digest interviewed 3 experts on the topics of nonmedical switching and formulary exclusions, asking them to put these issues into perspective for dermatologists. These experts offered answers to the question of what dermatologists can do to help patients in their practices and to advocate for changes at state and federal levels.
REMARKS BY BRENT MOODY, MD, Chair of the American Academy of Dermatology (AAD) Patient Access and Payer Relations Committee and a dermatologist in Nashville, Tennessee.
THE DERMATOLOGY DIGEST: As someone involved in dermatology advocacy, politics, and practice, do you feel nonmedical switching and formulary exclusions are problems in dermatology today?
DR. MOODY: Yes. When we are talking about nonmedical switching, it is the process of changing a stable patient’s medication for nonmedical reasons, such as a change in insurance coverage or formulary. The chief concern is if a patient is stable from a medical standpoint, there is no reason to change their medicine.
If we look at what are the consequences of changing the medicine, in the best-case scenario the patient is going to have to learn about a new medicine, which may have a different dosing regimen or schedule and different side effect profile. Other things could happen include the new medication possibly being not as effective for their condition as their current medicine, particularly if they are stable.
From the practice standpoint, it is not simply a matter of sending another prescription. These are complicated patients with complicated problems, so generally to switch you are going to need to have an office visit that might not otherwise need to occur. If the medicine the patient is on gets dropped and you have to look at what is currently on formulary for that carrier, then a decision needs to be made. And that is a decision that cannot be made lightly. So, there is some practice disruption as well.
THE DERMATOLOGY DIGEST: What can dermatologists do?
DR. MOODY: The individual dermatologist for an individual patient in some instances can go through an exception process. This is an additional time burden on the dermatologist, and those appeals or prior authorizations may not be successful. From the perspective of the bigger “house of dermatology,” we do not like that the patient through no fault of their own is going to either have to change the medicine or potentially change their insurance company. And they might not have the ability to change their insurance company if they get their insurance from their employer.
Our position in dermatology is we want to advocate for these patients. We recently have put out a call to our members who primarily treat these complicated patients to share their stories with us, so we can gather more data to learn exactly what are the real-world consequences of nonmedical switching. We are in the data-gathering mode and have set up a portal on AAD.org where members can go and tell their story about how this is disruptive to their practice or their patients.
REMARKS BY MADELAINE (MATTIE) A. FELDMAN, MD, President of the Coalition of State Rheumatology Organizations, Chair of the Alliance for Safe Biologic Medicines, and a practicing rheumatologist in New Orleans, Louisiana.
THE DERMATOLOGY DIGEST: Dermatologists and rheumatologists share concerns regarding non-medical switching and formulary exclusions. Where does the Coalition of State Rheumatology Organizations stand on these issues and why?
DR. FELDMAN: The Coalition of State Rheumatology Organizations is an organization of over 40 state rheumatology organizations around the country. We stand united against nonmedical switching and the great number of formulary exclusions we have been seeing over the last 5 years.
As rheumatologists and dermatologists, alike, we treat chronic autoimmune conditions. Whether it is psoriasis or psoriatic arthritis, it can take us 18 months to get a patient stable. Then, out of the blue and sometimes without even notification, that drug is no longer covered.
It is very frustrating and is occurring more and more frequently. Over the last few years, the formulary exclusion lists for CVS Caremark and Express Scripts have grown from 80% to 200%. With Express Scripts far and away the king of exclusions, one of the most recent exclusions affects dermatologists. They recently bumped secukinumab, which treats psoriasis and psoriatic arthritis, off the formulary in favor of ixekizumab. Although it has a similar mechanism of action, patients may not respond to the new drug.
THE DERMATOLOGY DIGEST: How does the issue affect providers and patients?
DR. FELDMAN: It hampers and curtails our ability to take care of patients. Maine in 2018 passed a state law that required insurers to report the changes to formulary. In the first quarter of recording this there were 300 formulary changes. It was found that out-of-pocket costs for patients that were affected went up 80%. Whether it was for step therapy or dropping from the formulary, it is tantamount to the same effect on patients. Patients could file an appeal, but certain medicines were routinely denied and over half of the appeal requests were denied.
There have been surveys looking at patients who have chronic diseases that were affected by nonmedical switching. CreakyJoints.org surveyed 85 chronic or rare disease patients and found 58% had their insurance company make changes to their health plan’s formulary that reduced coverage of their prescribed medication. Ninety-five percent of those who underwent nonmedical switching had worsening of their symptoms; 40% had to miss work; 22 had to be hospitalized; and less than 10% said that the new option worked as well or better.1
What makes it even worse is that it is not based on efficacy and safety data. No. It all has to do with profits.
THE DERMATOLOGY DIGEST: What can dermatologists do?
DR. FELDMAN: One thing when doing the peer-to-peer is to ask the other person on the phone (hopefully, another physician) what their specialty is, when they graduated from medical school, where they practiced, and how long they have been out of practice. Say you want to take in this information because if anything goes wrong with the patient because of this forced switch, you want to have the name of the person who denied them staying on their drug. Believe it or not, that does work. It does not always work, but it is worthwhile documenting all that information in the patient’s chart.
Get involved in your state advocacy to pass legislation that bans nonmedical switching or passes legislation with step therapy that allows for grandfathering. The Coalition of State Rheumatology Organizations has partnered with other professional and patient organizations to get some strong step therapy bills passed in the last year. The Coalition of State Rheumatology Organizations has a map tool on our website at CSRO.info. You can just click on your state and see if there is any legislation that bans nonmedical switching or allows for grandfathering.2
Then send in letters in support. If you have patient stories, bring them in to testify before the legislature. Patient stories make a huge difference.
If anyone wants more information, they can email info@CSRO.info. We help lots of professional organizations form coalitions and help us with this much-needed legislation. The Safe Step ACT legislation of 2021 has been introduced in Congress and puts forth criteria to override step therapy protocols, such as allowing grandfathering of patients who are stable on their medications. Please contact your representative to support this piece of legislation.3
REMARKS BY STEVEN NEWMARK, JD, MPA, Director of Policy and General Counsel of the Global Healthy Living Foundation (GHLF) at GHLF.org, which helps to improve the lives of people with chronic disease through better access to care, education, support, advocacy, and patient-centered research.
THE DERMATOLOGY DIGEST: Where does the Global Healthy Living Foundation stand on these issues and why?
MR. NEWMARK: When it comes to these issues, particularly medical switching, we believe that the continuity of care, especially when a patient is stable on a medication, is paramount to maintaining as healthy a lifestyle as possible. We understand that certain things may cause an insurer to change their formulary—a drug approval, a drug recall, change in pricing, etc. However, we believe that any change should be made before a plan year starts so that patients can make decisions about which plan they want based on the coverage they need. We also believe that doctors should have the ability to override these changes if they believe they are not in the best interest of the patient’s long-term health.
THE DERMATOLOGY DIGEST: Does the doctor have a voice when insurance companies switch or entirely change a medication?
MR. NEWMARK: It depends on the laws in the state in which the change is made. Some states require insurers to have an appeal process, where they must follow certain regulatory protocols. Others allow insurers to create a process entirely of their own. In the end, there are only so many appeals that a physician can file before the final decision is ultimately made by the insurer.
THE DERMATOLOGY DIGEST: What might dermatologists not know about these issues and what can they do?
MR. NEWMARK: What they can do is have patients work with groups like GHLF, so that we can amplify their stories to state legislators who may consider legislation that provides better regulations around these changes.
Right now, only 6 states in the country provide some protection against nonmedical switching practices, and we are hoping in the coming years to expand that. The best way to do that is to amplify the voices of patients who are dealing with these issues. We need to be able to show legislators how widespread this issue is so that we can combat insurers when they argue these instances are quite rare.
REFERENCES
- CreakyJoints.org. Tennessee patient sentiment toward non-medical drug switching.
Accessed March 22, 2021. https://creakyjoints.org/advocacy/tennessee-patientsentiment-toward-non-medical-drug-switching/ - Coalition of State Rheumatology Organizations. Legislative map tool. Accessed March 22, 2021. https://csro.info/legislation-in-your-state.html
- Coalition of State Rheumatology Organizations. Action Center. Accessed March 22, 2021.
https://csro.info/advocacy-campaigns.html.
