Prescriptions rejected and not filled with newer, more expensive drugs against cholesterol, linked to increased risk of stroke

Patients appear to be at higher risk for heart problems or stroke when prescriptions of newer cholesterol-lowering drugs are denied by insurance companies or not met by patients, according to a new study conducted in the United Kingdom. Circulation: quality and cardiovascular outcomes, a journal of the American Heart Association.

The drugs, PCSK9 inhibitors (PCSK9i), can dramatically reduce low-density lipoprotein (LDL) levels, the "bad" cholesterol, in the blood. But they are also more expensive than other prescription treatments – they cost about $ 14,000 a year when this study was conducted in 2015-17. Last fall, the American Heart Association encouraged pharmaceutical companies to lower their prices to improve patient access.

The study examined medical records and pharmacy claims for about 139,000 high-risk adults over a period of 29 months after the first release of drugs in 2015. On average Patient results were followed for 11½ months from the date of the prescription.

The researchers found:

Insurers have rejected about two-thirds of prescriptions for those most at risk.

Patients were 16% more likely to have a cardiovascular event (heart attack, unstable angina, angioplasty, coronary artery bypbad, cardiac arrest, heart disease or stroke attributed to obstruction of the arteries) if their prescription was refused if it was filled for almost a year of treatment.

Patients were 21% more likely to have a cardiovascular event if they had an approved prescription but did not complete it.

"Our study shows that when high-risk groups of individuals with familial hypercholesterolemia or already established atherosclerosis are rejected for prescribed PCSK9i treatments, this can have consequences," said lead author Kelly D Myers, BS, Chief Technology Officer at the FH Foundation, a leading nonprofit research and advocacy organization focused on reducing heart disease by promoting scientific understanding and factual care for familial hypercholesterolemia. .

"We have both treatment guidelines and medications available to help lower cholesterol and badociated cardiovascular events in the most vulnerable high-risk patients, while maintaining barriers in the health care system – such as higher treatment costs, strict restrictions on approvals, Medicare rules, payment badistance and lack of coverage delay treatment. "

PCSK9i drugs are usually injected once or twice a month, often with other cholesterol-lowering drugs, including statins. The new drug is approved to treat two groups of high-risk patients: those with a hereditary disease defined by a defect in the way the body treats LDL called familial hypercholesterolemia (FH) and those with plaque buildup that have LDL high despite other treatments.

Donald Lloyd-Jones, MD, a member of the editorial board of the American Heart Association's 2018 Cholesterol Guidelines, noted that this study had reviewed data from 2015-17, before several positive steps were taken to improve the relevance, availability and availability of this drug. affordable for the people who can best enjoy it.

"After a thorough review of the science, the American Heart Association guidelines now support the use of PCSK9 inhibitors for certain populations – after the use of statins and ezetimibe – and we encourage clinicians and payers to consider it when determining prescription approvals, "said Lloyd-Jones, director of the Department of Preventive Medicine at Northwestern University. "In addition, the Association has taken bold steps by working directly with pharmaceutical companies to address the significant costs that can hinder access to lifesaving drugs, so we hope to see this trend change and that data will show that people have access to medicines, the drugs they need and use them to their advantage. "

Among the other conclusions of the study:

Orders written for women were more likely to be rejected than those of men.

Discharges were more common among blacks and Hispanics than among whites.

15% of prescriptions were dropped by patients, a rate that researchers say was due to high financial participation. The average proportion of discontinued prescriptions was $ 233.30, more than $ 100 more than for covered prescriptions.

About two-thirds of the discontinued prescriptions involved Medicare patients.

The authors noted that the use of a large set of data and the duration of the study were the strengths of the research. But the data fail to understand why claims were rejected, LDL levels of individuals, drug samples provided to patients, deaths and missed diagnoses of cardiovascular disease. They also noted potential biases from the study team – FH Foundation staff and advisors – adding that their research questions were rooted in patients' health concerns and their experiences. Refusal of claims.