Efforts to save money on prescription drugs has
Atrial fibrillation (AF) is a major risk factor for stroke, and for decades the anticoagulant warfarin has been the standard treatment to reduce this risk. However, many drug and food interactions make warfarin distressing for patients. A new class of drugs, non-vitamin K antagonist oral anticoagulants (NOACs), has emerged as a more effective and less burdensome alternative. But these drugs also have a higher price than generic warfarin.
New research led by Schaeffer Center Principal Investigator Geoffrey Joyce finds that tools used by insurers and PBMs to contain costs lead to fewer patients using NOACs or warfarin within 30 days of a diagnosis of AF, a discovery that likely leads to adverse health effects for patients.
“Insurers’ efforts to control health spending increasingly rely on restricting access to expensive therapies. In the case of NOACs, these policies can be wise and foolish,” said Joyce, who is also an associate professor at the USC School of Pharmacy.
Step therapy and prior authorization reduce access to high-value care
The study, published in The American Journal of Managed Care, followed a sample of fee-for-service Medicare beneficiaries newly diagnosed with AF. Joyce and her colleagues looked at how patients were affected by two types of policies commonly used to reduce prescription drug costs — step therapy, which forces patients to start with cheaper generic drugs — and prior authorization. , which requires insurer approval before a particular therapy can be used .
Researchers find that these policies work by reducing unnecessary or wasteful use, but in practice create administrative barriers that make it difficult for patients to access medicines, even cheaper generic options.
“We tested the association between coverage restrictions and NOAC use, including initiation and adherence, and whether coverage restrictions were associated with an elevated risk of stroke and bleeding” , says Seth Seabury, principal investigator at the USC Schaeffer Center and associate professor at USC. School of Pharmacy. The team classified Part D plans as unrestricted if at least one NOAC was available without prior authorization or step therapy and restricted if all NOACs were subject to such protocols.
The data revealed that beneficiaries of restricted Medicare Part D plans had a lower likelihood of NOAC use (30.2% versus 32.2% in unrestricted plans) and poorer medication adherence. They also faced longer delays in filling their initial prescription, with only 46% of people in restricted plans getting NOACs within 30 days of AF diagnosis, compared to 55% of those in restricted plans. unrestricted plans.
Reduced access leads to poorer health outcomes
The researchers also examined the association between form restrictions and clinical outcomes. To focus on acute events, they relied solely on medical claims from hospitalized patients or emergency departments.
The results showed that patients on a restricted plan faced a higher overall risk of death, stroke, transient ischemic attack or systemic embolism than those on unlimited coverage.
While the statistical differences uncovered by the study may seem small, they show that more lives can be saved and suffering alleviated by allowing NOAC access to all patients for whom it is appropriate. This is particularly important, according to Joyce, because anticoagulant therapy has long been underused in patients with AF.
“Limiting access to NOACs through stepped therapy or prior authorization may exacerbate the current underuse of anticoagulants and increase the risk of stroke in newly diagnosed AF patients,” states.
Joyce also notes that form restrictions are sometimes appropriate, but should not be used as one-size-fits-all policies.
“Prior authorization and step therapy are most effective when there is clear evidence that services are overused or misused,” he notes. Instead, he suggests identifying and educating the healthcare providers responsible for inappropriate prescribing rather than forcing time-consuming approvals on all doctors and potentially inappropriate therapies on every patient.
“All drug benefit managers and Medicare Part D plans should continually review their formulary policies to ensure patients have timely access to effective medications,” Joyce concludes.
Bo Zhou and Dana Goldman of the USC Schaeffer Center are also co-authors of this study.
The American Journal of Managed Care
The title of the article
Form restrictions and risk of stroke in patients with atrial fibrillation
Publication date of articles
August 4, 2022
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