Patient and patient advocate Beth Waldron used her social media platform to criticize CVS Caremark’s removal of Eliquis (apixaban) from its national formulary. CVS took notice.
Managed Healthcare Executive
It all started in November 2021 when Beth Waldron, a patient advocate in Chapel Hill, North Carolina, received a letter from CVS Caremark, the pharmacy benefit manager (PBM) of CVS Health. Eliquis (apixaban), the blood thinning medication she had been taking for eight years, would no longer be on the PBM’s national formulary beginning in January 2022, the letter said.
Waldron, like many other people whose pharmacy benefits are managed by CVS Caremark, was facing the prospect of being forced to switch from Eliquis, an anticoagulant that was working for her, to another one with uncertain safety and efficacy consequences.
“It has been great,” Waldron says about Eliquis. “Everything has been nice and boring and stable. What you want as a patient is to be nice and boring and off your doctor’s radar.” Waldron was eventually granted an exemption from CVS Caremark’s formulary decision and has stayed on the Eliquis, and her insurance plan, the North Carolina State Health Plan (a plan for state employees, teachers and dependents), added Eliquis back to it's formulary, effective Feb. 9, 2022.
But her disagreement with CVS Caremark about the formulary change and her social media posts escalated into a situation that resulted in two phone calls earlier this month from someone at CVS Health, who Waldron said told her that his department was working on behalf of the office of the company’s president and CEO, Karen Lynch. Waldron said the caller wanted to know why she was upset and posting on Twitter if she had gotten the prior authorization to continue on Eliquis. It was then that Waldron came to believe that he had accessed her medical records.
“I think this call was about me as an advocate, but they reached an advocate by accessing my medical information. And that is not cool. That just feels wrong,” Waldron says. “There needs to be some protection in place for that.”
Waldron tweeted on Monday that she had filed a formal complaint that the two phone calls from CVS Health were a Health Insurance Portability and Accountability Act (HIPAA) violation. She said the first one occurred on April 7 when she was at her mother’s house as a caregiver, and she had a longer follow-up call the next day.
“If they wanted to talk to me about my tweets, if they wanted to talk to me about the Eliquis formulary issue, or even if they wanted to inquire about the adverse events, they could have direct messaged me. They could have emailed me. There are multiple pathways they could have reached out to me and set up formal meeting or phone call about that.”
In a prepared statement, CVS Health said it regretted “any misunderstanding resulting from our outreach to Ms. Waldron. Because she is a PBM member, our member services team contacted her after she tagged us in her social media posts. Our intent was to listen to and address her concerns, as we do for any complaint, we receive from a PBM member.” A company spokesman said company officials would not comment beyond the prepared statement.
Waldron is one of a number of patient advocates who have been fighting CVS Caremark’s decision to drop Eliquis from its national formulary. The PBM’s health plan clients can elect to deviate from the national formulary, but it has considerable sway over which drugs get covered by the health plans that contract with PBM.
The decision is another chapter in an ongoing controversy about “nonmedical switching” and PBM formulary decisions that critics say interfere with medication decisions made by physicians and patients. The PBMs say their formulary decisions are an important way to rein in pharmaceutical costs and that there are avenues for exemptions, such as the one that Waldron received, to protect patients.
CVS Caremark has defended the decision to drop Eliquis. In a prepared statement, the company said that while American Heart Association/American College of Cardiology/Heart Rhythm Society and 2021 CHEST guidelines recommend direct oral anticoagulants, such as Eliquis, over the traditional anticoagulant, warfarin, neither guideline lists a specific agent as preferred. The statement also mentions the formulary exemptions processes.
Waldron, who was working for a group called the National Blood Clot Alliance, said patient advocacy groups started to hear about CVS Caremark dropping Eliquis in October 2021. Still, it was a shock when she got the letter from CVS Caremark around Thanksgiving: “I didn’t think it was coming for me,” she says. She put in a request for exemption to the formulary change but was also preparing to switch to another drug.
Waldron, 53, whose first jobs were as a policy analyst for North Carolina’s Medicaid program and Blue Cross Blue Shield, was 34 years old when she had a clotting episode that led to a diagnosis of venous thromboembolism (VTE) and a lifelong treatment with medication to keep her blood from clotting. At that time, the only anticoagulation medication available was warfarin, which is a challenge to dose correctly and requires frequent trips to a clinic. Waldron brought her young son along.
“A lot of older people take these medications, so it was always kind of a novel thing to have a 3-year-old at the clinic” she says. Her VTE diagnosis also put her on a different career path, one as a thrombosis patient advocacy and educator career that included five years as an educator at the University of North Carolina School of Medicine.
The direct oral anticoagulants (DOACs) starting coming on the market in 2010. Although many times more expensive than warfarin, DOACs freed patients from warfarin’s web of testing, dietary restrictions and clinic visits. “When these medications came along it was, for patients, so fantastic,” says Waldron. She conferred with her long-time hematologist and got a second opinion before making the decision to switch to Eliquis eight years ago.
A group called the Partnership to Advance Cardiovascular Health served as an umbrella organization for the advocacy groups who became concerned last fall about CVS Caremark dropping coverage of Eliquis. In December 2021, the partnership sent a letter urging CVS Caremark to reverse its decision. Removing Eliquis from the formulary, they said, would result in nonmedical switching and could increase patients’ risk of stroke and death.
“It’s very important that patients and their healthcare providers make decisions about the patient’s healthcare together,” said Leslie Lake, president of the National Blood Clot Alliance, one of the organizations that signed the letter to CVS and the group that Waldron worked for. “It should not be done by a third party who knows nothing about the patient’s health situation. This is a PBM that makes decisions typically based on financial needs and not on the healthcare needs of a patient.” Lake is also a pulmonary embolism survivor who had her blood clotting event in June 2018.
Lake said she has not heard about any adverse events that have resulted from switching from Eliquis to Xarelto (rivaroxaban), but there is confusion among patients about why they have to switch and how to administer the drugs, she said.
“Eliquis is typically taken twice a day. Xarelto is taken once a day,” Lake said. “We are getting inquiries from patients who are confused about how to take their medication. We’ve had some patients asking if they should cut the Xarelto pill in half and take it twice a day because they took Eliquis twice a day. That means that patients’ dosing could be incorrect, and that puts them at a higher risk of getting a blood clot.”
Waldron says she is personally aware of eight serious adverse events — either thromboembolic stroke or clinically significant bleeding — in patients affected by the formulary change. One of these events was in a young person in their 20s, she says. There is some evidence that Eliquis may cause less bleeding and recurrent VTE than Xarelto (rivaroxaban). A recently published study analyzed claims data for patents with VTE who started taking either of the medications. The study, however, doesn't address those who have switched medications. (See below for more information on this study.)
“For me, personally, for my type of blood clots, the clinical studies show that patients have lower risk of recurrent clot and lower risk of major bleeding — including intracranial and serious internal bleeding abdomen — while taking Eliquis,” she says. But Waldron says she is working on behalf of others. She says her husband has told her that she should have just hung up when CVS called.
“And I thought, 'No, I am not going to do that,' because I want try to get to someone in the company who can fix this.
“I am not disgruntled, I am not a crazy person, I am not any of those things,” Waldron continued. “I just want to reach someone in the company with the power to — if not fix this — at least make it make better because genuine adverse events are happening.” Study Finds Eliquis Resulted in Less Bleeding than Xarelto
In a comparative effectiveness and safety study using real-world data, patients with VTE who had started taking Eliquis had a lower rate of recurrent VTE and intracranial and gastrointestinal bleeding compared with those who had started taking Xarelto, according to a study published online in December 2021 in the Annals of Internal Medicine.
Investigators, led by Ghadeer K. Dawwas, Ph.D., in the Department of Biostatistics, Epidemiology, and Informatics at Perelman School of Medicine, University of Pennsylvania, used Optum’s deidentified Clinformatics Data Mart Database to compare claims data of Eliquis and Xarelto for safety and effectiveness.
They conducted a retrospective study of new users of these medications with VTE who had at least one prescription for Eliquis or Xarelto from Jan. 1, 2015, to June 30, 2020. The effectiveness outcome was recurrent VTE, a composite of deep venous thrombosis and pulmonary embolism. The primary safety outcome was a composite of gastrointestinal and intracranial bleeding.
Investigators analyzed claims of 18,618 patients treated with Eliquis and 18,618 treated with Xarelto.
Investigators found that of those taking Eliquis, 475 patients had recurrent VTE (8.9 events per 100 person-years) compared with 595 Xarelto users (11.4 events per 100 person-years). Of those taking Eliquis, 386 patients had gastrointestinal and intracranial bleeding events (7.2 events per 100 person-years) compared with 577 among Xarelto users (11.0 events per 100 person-years).
“These findings suggest that apixaban has superior effectiveness and safety compared with rivaroxaban and may provide guidance to clinicians and patients regarding selection of an anticoagulant for treatment of VTE,” investigators wrote.
They suggested that pharmacokinetics may explain the difference in the therapies. One randomized, crossover study found less fluctuation in plasma concentrations.
The study had several limitations, including the lack of information on patient body-mass index, lifestyle variables, and over-the-counter medications; laboratory values were available for a small subset of patients; there was a reliance on diagnostic codes; and only severe outcomes that resulted in hospitalization were included.