Updated January 14, 2022 // Editor's note: This story has been updated with comments from the American College of Cardiology addressing CVS Caremark's formulary change.
Patients looking to refill a prescription for apixaban (Eliquis) through CVS Caremark may be in for a surprise following its decision to exclude the direct oral anticoagulant (DOAC) from its formulary starting January 1.
The move leaves just one DOAC, rivaroxaban (Xarelto), on CVS' commercial formulary and is being assailed as the latest example of "non-medical switching" used by health insurers to control costs.
In a letter to CVS Caremark backed by 14 provider and patient organizations, the nonprofit Partnership to Advance Cardiovascular Health (PACH) calls on the pharmacy chain to reverse its "dangerously disruptive" decision to force stable patients at high risk of cardiovascular events to switch anticoagulation, without an apparent option to be grandfathered into the new plan.
PACH president Dharmesh Patel, MD, Stern Cardiovascular Center, Memphis, Tennessee, called the formulary change "reckless and irresponsible, especially because the decision is not based in science and evidence, but on budgets. Patients and their health care providers, not insurance companies, need to be trusted to determine what medication is best," he said in a statement.
Craig Beavers, PharmD, vice president of Baptist Health Paducah in Paducah, Kentucky, said that, as chair of the American College of Cardiology's Cardiovascular Team Section, he and other organizations have met with CVS Caremark medical leadership to advocate for patients and to understand the company's perspective.
"The underlying driver is cost," he told theheart.org | Medscape Cardiology.
Current guidelines recommend DOACs in general for a variety of indications, including to reduce the risk of stroke and embolism in nonvalvular atrial fibrillation and to prevent deep vein thrombosis, but there are select instances where a particular DOAC might be more appropriate, he observed.
"Apixaban may be better for a patient with a history of GI bleeding because there's less GI bleeding, but the guidelines don't necessarily spell those things out," Beavers said. "That's where the clinician should advocate for their patient and, unfortunately, they are making their decision strictly based off the guidelines."
Requests to speak with medical officers at CVS Caremark went unanswered, but its executive director of communications Christina Peaslee told theheart.org | Medscape Cardiology that the formulary decision "maintains clinically appropriate, cost-effective prescription coverage" for its clients and members.
"Both the American Heart Association/American College of Cardiology/Heart Rhythm Society and 2021 CHEST guidelines recommend DOACs over warfarin for treatment of various cardiology conditions such as atrial fibrillation, but neither list a specific agent as preferred — showing that consensus clinical guidelines do not favor one over the other," she said in an email. "Further, Xarelto has more FDA-approved indications than Eliquis (e.g., Xarelto is approved for a reduction in risk of major CV events in patients with CAD or PAD) in addition to all the same FDA indications as Eliquis."
Peaslee pointed out that all formulary changes are evaluated by an external medical expert specializing in the disease state, followed by review and approval by an independent national Pharmacy & Therapeutics Committee.
The decision to exclude apixaban is also limited to a "subset of commercial drug lists," she said, although specifics on which plans and the number of affected patients were not forthcoming.
The choice of DOAC is a timely question in cardiology, with recent studies suggesting an advantage for apixaban over rivaroxaban in reducing the risk of recurrent venous thromboembolism as well as reducing the risk of major ischemic or hemorrhagic events in atrial fibrillation.
Peaslee said CVS Caremark closely monitors medical literature for relevant clinical trial data and that most clients allow reasonable formulary exceptions when justified. "This formulary exceptions process has been successfully used for changes of this type and allows patients to get a medication that is safe and effective, as determined by their prescriber."
The company will also continue to provide "robust, personalized outreach to the small number of members who will need to switch to an alternative medication," she added.
Beavers said negotiations with CVS are still in the early stages but, in the meantime, the ACC is providing healthcare providers with tools, such as drug co-pay cards and electronic prior authorizations, to help ensure patients don't have gaps in coverage.
In a January 14 news release addressing the formulary change, ACC notes that a patient's pharmacy can also request a one-time override when trying to fill a nonpreferred DOAC in January to buy time if switching medications with their clinician or requesting a formulary exception.
During discussions with CVS Caremark, it says the ACC and the American Society of Hematology "underscored the negative impacts of this decision on patients currently taking one of the nonpreferred DOACs and on those who have previously tried rivaroxaban and changed medications."
The groups also highlighted difficulties with other prior authorization programs in terms of the need for dedicated staff and time away from direct patient care.
"The ACC and ASH will continue discussions with CVS Caremark regarding the burden on clinicians and the effect of the formulary decision on patient access," the release says.
In its letter to CVS, PACH argues that the apixaban exclusion will disproportionately affect historically disadvantaged patients, leaving those who can least afford the change with limited options. Notably, no generic is available for either apixaban or rivaroxaban.
The group also highlights a 2019 national poll, in which nearly 40% of patients who had their medication switched were so frustrated that they stopped their medication altogether.
PACH has an online petition against non-medical switching, which at press time had garnered 2126 signatures.
One signee, Jan Griffin, who survived bilateral pulmonary embolisms, writes that she has been on Eliquis [apixaban] successfully since her hospital discharge. "Now, as of midnight, Caremark apparently knows better than my hematologist as to what blood thinner is better for me and will no longer cover my Eliquis prescription. This is criminal, immoral, and unethical. #StopTheSwitch."
Follow Patrice Wendling on Twitter: @pwendl . For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook .
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Cite this: CVS Caremark Formulary Change Freezes Out Apixaban - Medscape - Jan 13, 2022.