Source/Disclosures
Disclosures: Feldman reports having had advisory board roles with Bristol-Myers Squibb, Eli Lilly & Co. and Merck. Newmark reports no relevant financial disclosures.
December 14, 2020
7 min read
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Formulary exclusions, non-medical switching jeopardize disease control, patient trust

Source/Disclosures
Disclosures: Feldman reports having had advisory board roles with Bristol-Myers Squibb, Eli Lilly & Co. and Merck. Newmark reports no relevant financial disclosures.
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Starting Jan. 1, 2021, patients with inflammatory conditions who are part of the Express Scripts formulary will be forced to switch from the IL-17 inhibitor secukinumab to ixekizumab — whether they or their doctor condone this change or not.

The exclusion of secukinumab (Cosentyx, Novartis) in favor of ixekizumab (Taltz, Eli Lilly & Co.) is just one of more than 300 excluded drugs on the Express Script formulary. The 2021 formulary change also excludes an additional 14 specialty drugs for the treatment cardiovascular conditions, type 2 diabetes and pulmonary conditions, and moves 11 drugs from preferred to non-preferred status.

The recent exclusion of secukinumab in favor of ixekizumab on the Express Scripts 2021 formulary has cast new light on the controversy of non-medical switching, which could adversely impact patients with autoimmune and rheumatic diseases. Source: Adobe Stock

Non-medical switching of therapies based on what appears on a pharmacy benefit manager’s formulary that year is all too common. Although the impact of these switches can be fairly benign for the majority of patients, for those with complex and clinically challenging autoimmune and rheumatic diseases, the consequences can be disastrous.

“It can take 1 to 2 years to get many of our patients stabilized on a medication,” Madelaine A. Feldman, MD, president of the Coalition of State Rheumatology Organizations and clinical assistant professor of medicine at Tulane University School of Medicine, told Healio Rheumatology in an interview. “To just arbitrarily stop that medication and switch to another, and then expect the patient to do as well is just wishful thinking.”

Madelaine A. Feldman

Steven Newmark, JD, MPA, director of policy and general counsel at the Global Healthy Living Foundation, has spent considerable time investigating the issue. “What concerns us most about non-medical switching is when it occurs without the consent or knowledge of the treating physician,” he said. “When insurers start to disrupt the doctor-patient relationship by switching patient treatments for non-medical reasons, without the chance of an appeal, it can lead to greater distrust in the health system and various treatment options.”

Despite the potential drawbacks, PBMs have made decisions for their 2021 formularies that are likely to have drastic impacts on rheumatology patient care across the country.

Decisions in the Rheumatology Space

As the two largest PBMs, Express Scripts and CVS Caremark have borne the brunt of criticism on the contributing role of PBMs in rising prescription drug costs and dwindling patient access — a critique not entirely without merit.

In the last 3 years, CVS Caremark extended their list of excluded formulary drugs by 88% while Express Scripts’ own exclusion list grew by 208%. In January 2020, both PBMs expanded their drug exclusion lists, with CVS Caremark adding 109 drugs to its list while Express Scripts added 54 drugs.

While Express Scripts, across the board, has the highest number of new drug exclusions at 70, CVS Caremark has listed a number of high-profile exclusions for autoimmune conditions, including tocilizumab (Actemra, Genentech), vedolizumab (Entyvio, Takeda), certolizumab pegol (Cimzia, UCB), anakinra (Kineret, Sobi) abatacept (Orencia, Bristol Myers Squibb), golimumab (Simponi, Janssen) and ixekizumab.

Healio Rheumatology reached out to Express Scripts and CVS Caremark for comments on this topic.

“Medication to treat inflammatory conditions was the highest driver of spending for commercial plans in 2019,” an Express Scripts spokesperson responded in an email. “In order to help manage rising costs for payers and patients, we are preferring Taltz on Express Scripts 2021 National Preferred Formulary as an effective, lower net-cost alternative than the previously preferred Cosentyx.”

While cost savings is certainly an important issue for many patients, whether switching dictated by a PBM truly translates to cost savings for the patient is up for debate. Also up for debate is whether any cost savings is worth the potential adverse patient outcomes that may occur.

Physical Consequences

“Of all the possible consequences of switching a patient who is on successful treatment with one medication to another medication, loss of disease control is number one,” Feldman said.

This is just the beginning, according to Feldman. She described a cascade of physical damage that may occur when a stable patient is taken off of a drug that is working. She suggested that loss of disease control may lead patients to neglect another health condition, thereby necessitating more medical attention and cost.

Relapse and disease progression may also occur, which can lead to symptoms requiring intervention with steroids. This, in turn, can result in any number of infections.

“All of this can lead to hospitalization, which can lead to a lost job or reduced work productivity and the ability of the patient to help provide for their family,” Feldman said. “The ramifications go on and on.”

To better understand these potential realities, CreakyJoints, an advocacy group for arthritis patients, recently surveyed 85 Tennessee residents who were diagnosed with a chronic or rare disease on topics surrounding non-medical switching. Findings showed that 95% of respondents reported a worsening of symptoms when their formulary delayed access to the medication that had initially been prescribed. As a result, 39% reported having to miss work and 22% reported hospitalization. While 68% of respondents said that their medications were less effective after switching, just 9% said that the new option was better.

The Express Scripts spokesperson wrote that “a careful approach based on objective evaluations from independent physicians” is followed before formulary changes are made. “Clinical appropriateness of the drug — not cost — is the foremost consideration,” they wrote. “The prescribing physician always makes the final decision regarding an individual patient’s drug therapy. In rare occasions when a patient is not able to use the preferred option, we recommend that our clients offer an efficient review process to assist those patients in obtaining a non-formulary medication in these instances of medical necessity.”

Steven Newmark

Newmark said that greater communication and transparency from PBMs like Express Scripts on these issues would be welcome. “It is difficult to put an exact number on how common non-medical switching is because we are not privy to the actual costs that PBMs pay for drugs, which makes it challenging to know when a decision is made for purely cost reasons,” he said.

Feldman was more direct. “They talk about the greater good and how saving money saves the system money, but the reality is that it does not save anyone money but them,” she said.

Psychological Consequences

To really understand the impact of non-medical switching in the rheumatology space, it is important to understand “the entire patient journey,” Feldman said. “Many patients have fear at diagnosis that they are never going to get better. They are always waiting for the next shoe to drop, and this creates a huge psychological burden.”

After decades of trial and error, rheumatology has finally arrived at a place where there are drugs that can put patients into stable remission. “The idea that a third party can make a decision that that patient can no longer receive that medication creates immense psychological ramifications that are often far greater than the initial psychological impact at diagnosis,” Feldman said.

Clinical experience has led Feldman to arrive at a stark conclusion about non-medical switching. “It is not a choice a patient would make, nor do they want to hear about making it,” she said.

Perhaps more problematic is that, often, they don’t hear about it. The choice is simply made for them.

Further results from CreakyJoints showed that 44% of patients reported never receiving any notification that their medication had been switched. While 48% said they were notified by their insurance company, 32% said that they were informed secondhand by their pharmacist and 21% said their physician informed them. Moreover, just 28% said that the reason why the change was made was transparent.

“One of the major problems communicated to us by patients is that they did not know they were switched until they tried to pick up their medications at the pharmacy and realized that what they have been taking, possibly for years, is no longer covered by their insurer,” Newmark said. “The surprise stems from the insurer usually only sending a single piece of mail that details the switch in medical jargon that the average patient does not understand.”

This puts patients in a difficult predicament, according to Newmark. One option is to pay what may end up being an exorbitant copay for the medication that they have been taking successfully for years or start on a new medication after years of stability. Thus, they are left standing in their kitchen or at the pharmacy counter with the prospect of making a decision that could have life or death consequences, without their physician present.

Offering Solutions

While rheumatologists and their patients often feel helpless at the mercy of the bureaucracy, they have started to fight back, and see results. In 2018, Illinois Gov. Bruce Rauner signed bill HB4146 into law, which protects patients in that state from mid-year formulary or utilization management restrictions. Feldman was instrumental in the passing of this legislation, having testified before the Senate Special Committee on Medicaid Managed Care.

Other findings from the CreakyJoints data set would suggest that this is a welcome turn of events. In that study, 98% of respondents support legislation preventing or limiting non-medical switching of medications.

Feldman said that “strongly worded” bills on non-medical switching have been passed in Texas and Maryland, while California, Colorado and Louisiana also have comparable legislation. An active bill is also moving through the state legislature in Ohio.

While not everyone has the time or efficacy to testify before a legislature, Newmark suggested that a good first step is for rheumatologists and patients to take an active role into understanding what is and what is not included in their insurance coverage. “From a patient perspective, each person needs to make sure that their medications are covered on their formulary when they sign up for their health plan every year,” he said. “If they get their plan through their employer, they need to let their employer know what medications they take so that they do not choose health plans that exclude these medications.”

While Feldman is encouraged by the increasing number of legislative efforts taking place around the country, she understands that non-medical switching is not likely to go away any time soon. “We would like to think that making the case to the insurance company that this is bad for the patient would work,” she said. “But it does not. So, we just have to keep explaining that this leads to fear, stress and reduced quality of life. The impact runs deep.”

For more information:

Steven Newmark, JD, MPA, can be reached at 515 Midland Avenue, Upper Nyack, NY 10960; email: snewmark@ghlf.org; JessicaDaitch@hotmail.com.

Madelaine A. Feldman, MD, can be reached at 2633 Napoleon Ave. #530, New Orleans, LA 70115; email: madelainefeldman@gmail.com.