It probably varies by insurance company… but here are some guidelines from a medical education provider: PCSK9 Inhibitors - StatPearls - NCBI Bookshelf
The American College of Cardiology, American Heart Association, and the National Lipid Association 2018 published guidelines on the use of PCSK9 inhibitors in adults
PCSK9 inhibitors are recommended for the following groups:[15]
-
In patients with cardiovascular disease at very high risk whose LDL-C level remains ≥70 mg/dL (≥1.8 mmol/L) on a maximally tolerated statin and ezetimibe therapy, adding a PCSK9 inhibitor is reasonable.
-
In patients with severe primary hypercholesterolemia (LDL-C level ≥190 mg/dL [≥4.9 mmol/L]), without calculating 10-year ASCVD risk, if the LDL-C level on statin plus ezetimibe remains ≥100 mg/dL (≥2.6 mmol/L) and the patient has multiple factors that increase subsequent risk of ASCVD events, a PCSK9 inhibitor may be considered.
-
In patients 30 to 75 years of age with heterozygous FH and an LDL-C level of 100 mg/dL or higher (≥2.6 mmol/L) while taking maximally tolerated statin and ezetimibe therapy, the addition of a PCSK9 inhibitor may be a considered.
-
In patients 40 to 75 years of age with a baseline LDL-C level of 220 mg/dL or higher (≥5.7 mmol/L) who achieve an on-treatment LDL-C level of 130 mg/dL or higher (≥3.4 mmol/L) while receiving maximally tolerated statin and ezetimibe therapy, the addition of a PCSK9 inhibitor may be considered.
Also - this was interesting:
Despite approved labeling and support by consensus statements, nearly all public and private insurers placed requirements of PA for PCSK9i in response to the initial price tag of $14 000 per year. Subsequent lukewarm support from cost-effectiveness analyses further consolidated payers’ position.
https://www.ahajournals.org/doi/10.1161/CIRCOUTCOMES.119.005910
PCSK9 inhibitors are specifically approved for patients with familial hypercholesterolemia, or those with atherosclerotic cardiovascular disease who are unable to achieve satisfactory lipid levels through dietary measures and statin use.
Yet insurance coverage rates were low, even when patients met labeled indications. When the researchers examined the factors associated with insurance coverage, the most important factor was the type of insurance: Commercial third-party insurers approved the drugs about 24% of the time, while Medicare approved them nearly 61% of the time (P less than .01).
Older age, prescriptions by a cardiologist or other specialist, and a diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) were also associated with higher rates of coverage by insurers (Circulation. 2017 Oct 30. doi: 10.1161/CIRCULATIONAHA.117.028430).
The researchers analyzed data from 9,357 patients with a prescription for a PCSK9 inhibitor. About 60% of the patients had a diagnosis of clinical ASCVD. In all, 4,397 patients (47%) had their prescriptions for PCSK9 inhibitor therapy covered, and 53% of coverage requests were rejected. Nearly 65% of patients who received approval went on to fill their prescription.
There was no association between LDL-C level and the likelihood of approval. In the 32 cases in which the LDL-C levels were 330 mg/dL or greater, 59% of patients were not approved for coverage.
Noncommercial payers were more likely to approve the medication (odds ratio, 12.32; 95% confidence interval, 7.09-21.39), as was Medicare (OR, 5.37; 95% CI, 4.23-6.80).
A recent cost-effectiveness analysis of evolocumab added to standard therapy showed that an annual cost of $9,669 would achieve an incremental cost-effectiveness ratio of $150,000 per quality-adjusted life year gained among patients with LDL levels 70 mg/dL or greater. (JAMA Cardiol. 2017;2[10]:1069-78). Evolocumab is currently listed at $14,523, putting it above that value.
“Now that clinical trial outcome data demonstrating reductions in major cardiovascular events and formal cost-effectiveness studies have identified value-based prices for these medications, it would be hoped that progress can be made such that a greater proportion of eligible patients can be treated,” Gregg C. Fonarow, MD, professor of cardiovascular medicine and science director at the Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, and the lead author of the cost-effectiveness study, said in an interview.
Both sets of findings cut to the heart of the debate over pricing of new medications. PCSK9 inhibitors have a clear benefit in lowering LDL and reducing risk of heart attack, but the drugs’ price tags may limit their availability.
First, the indiscriminate high rejection rates irrespective of baseline risk are disappointing. For example, it is hard to justify denying PCSK9i in every 2 out of 3 familial hypercholesterolemic patients with established ASCVD given their extremely high risk of subsequent cardiovascular events.
https://www.mdedge.com/cardiology/article/150500/cad-atherosclerosis/insurance-approvals-are-hard-get-new-pcsk9-inhibitors
related:
