Non Medical Switching: A Proven Danger Among DOACs

Just before Thanksgiving in 2021, CVS Caremark, the largest pharmacy benefit manager (PBM) in the country, sent a letter to Beth Waldron, a North Carolinian patient suffering from acute venous thromboembolism (VTE), a serious blood clotting condition including deep-vein thrombosis (DVT) and pulmonary embolism (PE). VTE is commonly treated with direct oral anticoagulants (DOACs), a widely available treatment which lessens the formation of blood clots by inhibiting the enzyme factor Xa. CVS Caremark’s letter detailed their decision to remove all DOACs from its 2022 formulary list except for rivaroxaban, a drug which contains DOAC rivaroxaban. Over 3 million Americans afflicted with VTE who were taking apixaban received the same letter from CVS Caremark.

Beth, along with 150,000 other patients, were most stable on apixaban as it best fit their unique clotting and bleeding profiles, yet despite the wishes of clinicians who had written patients’ prescriptions, these patients were forced to either transition to rivaroxaban or pay 100 percent of the cost of apixaban. While CVS Caremark also offers warfarin, a traditional non-DOAC anticoagulant, warfarin is less safe and more demanding with many dietary and drug interactions and frequent dosage changes.

PBMs such as CVS Caremark serve as the middlemen in the pharmaceutical marketplace. They buy medicines from drug companies at a discounted price and sell them to individual pharmacies at a profit. Due to vertical integration, PBMs negotiate with pharmaceutical manufacturers and wholesalers to decide which medications are covered. PBMs’ sudden decision to change the formulary and force stable patients off their current medication to another based on arbitrary profit intentions is called non-medical switching, and it poses a serious risk to those on anticoagulants as these medications are not interchangeable.  

The American Society of Preventive Cardiology and Partnership to Advance Cardiovascular Health conducted a national survey on 254 victims of non-medical anticoagulant medication to comprehend its adverse effects. Each anticoagulant is uniquely tailored to patients based on their diverse medical background, so switching a medication that is already working will often harm the patient: 28 percent of patients after the switch reported side effects, and 22 percent reported resurfacing symptoms. However, the switch poses a more serious risk, with 7 percent of patients having a heart attack and 4 patients having a stroke. Patients’ lives should not be traded for a profit by unnecessary, manipulative health plans. These medical tolls, coupled with 43 percent of switched patients making repeated doctor visits, 40 percent reporting additional lab tests, 17 percent having to visit the pharmacy again, and 5 percent being hospitalized, all lead to frustration and non-adherence from the patient. This exasperation causes one out of five patients to stop taking their anticoagulant medication altogether, putting them at even higher risk of clotting. Even more concerning is how insurers force the switch: 94% of patients’ insurers suddenly discontinue the medication, and 83% increase the patients’ out-of-pocket expenses. This is particularly calamitous because 94% of patients depend on their anticoagulant to go about their daily lives. They are forced to cope with the switch and pay the price. Still, after switching, patients struggled to enjoy themselves with 36% unable to continue hobbies, 31% unable to fully participate in life events, and 23% unable to fulfill caregiving responsibilities. Through this pernicious system, the patient is cast aside in abject mental health, with 52% feeling helpless, 65% frustrated, and 59% confused. Despite this harsh reality, 83% of patients understand that keeping their blood thinner is important, and 96% place high value on having the right one. Patients both want and need their treatment decisions to stay between them and their doctors, and it is up to physicians to ensure the correct dynamic.4 

For example, this anticoagulant switch was reversed after a physician-led campaign which was generally espoused by Beth Waldren’s social media outcry. The ASPC, the Partnership to Advance Cardiovascular Health (PACH) and the ACC all mobilized their medical experts to head an advocacy movement resisting CVS’s decision. After numerous letters written to CVS Caremark and the worsening of problems after the switch, including two observed instances of acutely adverse thrombotic events in North Carolina, CVS reversed their decision six months after implementing it.

This incident should serve as both a model for how physicians can protect themselves and their patients from non-medical switching and as a call for future protection against the threat of large-scale switching. Non-medical switching blights countless medications: in a 2019 study of over 800 patients who experienced non-medical switching, the Alliance for Patient Access found that almost 60 percent of patients experienced a complication from the new medication, causing almost 40 percent to stop taking their medicine altogether.

Physician advocacy is the bedrock for preventing non-medical switching; the personal stories and unmediated experiences of doctors encourage more accurate and compelling advocacy efforts. Like in the rebuttal to CVS’s rivaroxaban switch, physician advocacy roles are amplified in larger institutions such as the ASCP and the ACC. Within an organization of similarly oriented physicians and educators, physicians can write letters and emails letter to PBMs and policymakers to steer them away from non-medical switching. They should advocate for policies that ensure patients already on stable treatment cannot deviate to an alternative medication without the approval of the physician, effectively protecting the patient from non-medical switching.  

Additionally, digital advocacy is a promising route for increasing public knowledge of non-medical switching, a presence which will put pressure on PBMs to avoid it. Social media has proven to be an effective route, as in the case of Beth Waldron, to quickly raise awareness to a specific non-medical switch reactively, but these outlets can instead be used proactively to prevent switching before they happen. Educating the public and policymakers about the effects of non-medical switching is paramount to put protections in place and to ensure that patients know about the risks that their PBMs are taking as they are the ones who suffer. 

References 

1. Waldron B. Nonmedical switching of anticoagulants: The patient impact when formulary exclusions limit drug choice. Research and Practice in Thrombosis and Haemostasis. 2022;6(2):e12675. doi:10.1002/rth2.12675 

2. Baum DrSJ. Non-medical switching an unmitigated threat to patient care. Am J Prev Cardiol. 2023;13:100470. doi:10.1016/j.ajpc.2023.100470 

3. Julia S, James U. Direct Oral Anticoagulants: A Quick Guide. Eur Cardiol. 2017;12(1):40-45. doi:10.15420/ecr.2017:11:2 

4. Advocacy Statements - American Society for Preventive Cardiology. Accessed June 11, 2024. https://www.aspconline.org/advocacy-statements 

5. Craycroft-Andrews S, Smart C, Jones D, Dunn S, Jarnigan R, Morrison SR. PHARMACY AND THERAPEUTICS (P&T) COMMITTEE. Published online 2022. 

6. A Study of the Qualitative Impact of Non-Medical Switching. Alliance for Patient Access; 2019. Accessed June 17, 2024. https://allianceforpatientaccess.org/a-study-of-the-qualitative-impact-of-non-medical-switching/