Good LDL Control When PCSK9 Inhibitors Given In-Hospital After Interventions

Adding a PCSK9 inhibitor to maximally tolerated statins after a coronary or peripheral artery revascularization can help patients achieve LDL cholesterol goals better than standard care, data from the ELL-ASCVD study shows.

By enabling patients to have access to the PCSK9 inhibitors before discharge through a Meds-to-Beds (M2B) program, the researchers found that by 6 months 92% got to goal (LDL < 70 mg/dL) compared with just 40% of those in a retrospective standard-care cohort. Nearly 80% of the M2B patients achieved an LDL of < 55 mg/dL at the same time point, versus only 25% of the historical controls (P < 0.001 for both comparisons).

Senior study author Leandro Slipczuk, MD, PhD (Montefiore Medical Center, Bronx, NY), said an aggressive and proactive approach to cholesterol lowering is indicated, but underused, for these high-risk patients.

“The [PCSK9] medications are there to lower cholesterol, they’re approved, the insurance companies cover it, and they’ve decreased their [costs], but people are still not using it,” Slipczuk told TCTMD. “There’s physician inertia [and] multiple other barriers, but making sure that patients get the medications that are indicated by the guidelines is essential.”

Slipczuk said a M2B program may be the way to bridge the gap for many patients not at LDL goals because it removes multiple barriers, helps streamline the prior authorization process, and allows medications to be delivered right to the patient’s bedside or home. The essential elements of the program are scalable for other hospitals and worth the effort to get fairly quick LDL-lowering results, he believes.

PCSK9 inhibitors are part of the cholesterol guidelines for ASCVD patients, but the manufacturers of alirocumab (Praluent; Sanofi/Regeneron) and evolocumab (Repatha; Amgen) had been previously forced to cut their prices by about 60% after they were initially listed at nearly $15,000 annually. Despite price cuts, recent analyses suggest that the rejection rate by insurers is still around 31%.

While different insurers have preferences over the PCSK9 that they will cover, the majority of patients enrolled in the M2B program were able to get the medication through their insurers and in some cases qualify for programs that deferred costs further, said Slipczuk. Still, eight patients who were initially enrolled could not get the medication approved and four others had high out-of-pocket costs that prevented them from initiating therapy. Those patients were not part of the final analysis.

ELL-ASCVD Results and Implications

For the study, published recently in JACC: Advances, Slipczuk and colleagues led by Daniel Lorenzatti, MD (Montefiore Medical Center), enrolled 72 patients (median age 66 years; 38% women; 57% Hispanic). Most (69%) had undergone PCI, 18% had CABG, and 13% had a peripheral vascular procedure for PAD. More than 90% had hypertension and 71% had diabetes. At baseline, 90% were on a statin, 89% were on a high-intensity statin, and 28% were on ezetimibe.

The median LDL level at baseline was 96 mg/dL. Approximately one-third of patients had Medicare as their primary insurance, 36% had Medicaid, 21% had private insurance, and 11% had unknown insurance status. The historical control group consisted of 136 matched patients, with no major differences in race/ethnicity or insurance type compared with the PCSK9 inhibitor cohort and few differences in ASCVD risk factors and comorbidities.

At 6 months, the median reduction in LDL levels from baseline was 66% in the PCSK9 inhibitor group and 25% in the historical controls (P < 0.001). This corresponded with median LDL levels of 33 mg/dL and 77 mg/dL, respectively.

In addition to patients denied medication by insurance and those prevented from taking the drugs due to costs, 12 patients who were part of the initial enrollment group did not start the medication because their general practitioner or cardiologist withdrew the prescription, which Slipczuk and colleagues say likely reflects “either disagreement with the guideline-recommended therapy or a preference to pursue alternative approaches.” It also illustrates real-world challenges eligible patients have with getting these medications and is in line with other research showing access issues.

Over long-term follow-up, an additional concern is maintaining uninterrupted access to the medications.

“Sometimes the patients get readmitted to the hospital or even to another hospital and maybe someone doesn’t realize they should maintain the drug and so they cancel the medication on discharge,” Slipczuk said.

To counter this, the ELL-ASCVD investigators are using an integrated pharmacy care model that tracks medications and notifies prescribers if the PCSK9 inhibitor has been interrupted or discontinued. They say future research should focus on long-term efficacy of this type of initiative on both outcomes and healthcare resources in broader patient populations.