April 04, 2017
4 min read

Insurance appeals, denials delay patient access to PCSK9 inhibitors

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High denial rates and long processes from insurance providers prohibit high-risk patients with familial hypercholesterolemia and clinical atherosclerotic CVD from accessing PCSK9 inhibitors, according to a paper in Clinical Cardiology.

“In addition to the patients not being treated with an appropriate medication, one of the most egregious things that’s occurring right now is that the payers, by denying these prescriptions, are undermining the patient–doctor relationship, and there used to be sanctity in that relationship. There no longer is,” Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, chief medical officer at Excel Medical Clinical Trials, clinical affiliate professor of biomedical science at Florida Atlantic University, Boca Raton and president of the American Society for Preventive Cardiology, and colleagues wrote in the paper.

Since the FDA approval of two PCSK9 inhibitors, alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen), denials have been on the rise, although many clinicians prescribed these treatments to lower LDL in patients.

Baum referred to a Symphony study in 2016 demonstrating an 80% initial denial rate, and a final approval rate among commercial and Medicare patients, respectively, of only 25% to 50%. Another study from the FH Foundation noted that 79% of prescription medication denials for patients with familial hypercholesterolemia (FH) were for PCSK9 prescriptions.

“There are other times where [the insurance company will] say, ‘We won’t approve that PCSK9 inhibitor, but we’ll approve the other one,’ and believe it or not, we have had numerous situations where we will then prescribe the other one, and then get denied,” Baum told Cardiology Today.

Researchers wrote that the list price for both PCSK9 inhibitors is $14,000 a year. The Institute for Clinical and Economic Review predicted that the medication would cost the United States $1.2 billion the first year after FDA approval, although the actual cost was $83 million. “Such prognostications likely precipitated a high level of caution among payers, causing frequent denials and a challenging appeal process,” Baum and colleagues wrote.

Insurance company processes

The ability of PCSK9 inhibitors to lower LDL has been established, but the language within FDA-approved prescribing information has led to payer approval and reimbursement inconsistencies. Some of the definitions that have contributed to this include maximally tolerated statin therapy, heterozygous FH, homozygous FH, clinical atherosclerotic CVD and additional lowering of LDL.

“Formulary restrictions have been employed by insurance providers as a strategy to limit use of more costly medications,” Baum and colleagues wrote.


Prior authorizations and appeals require a substantial amount of paperwork with data that allow the payer to see that the medication is necessary for the patient, which often takes a lot of time to complete. Insurance companies use this paperwork to justify that the patient will not overuse the prescribed medication, according to the researchers.

“Far fewer clinicians actually prescribe the drug, and that’s largely because doctors became frustrated with the whole process,” Baum told Cardiology Today. “It takes many hours for each of these prescriptions, so you have to have an office that’s willing to devote time, energy and resources to fight the denials and to try to gain access for our patients. Most offices just don’t have the bandwidth to be able to do that.”

Baum and colleagues suggested methods and technologies that could accelerate the process, including payer websites, case managers and online functionality. “Keeping in mind that PCSK9 [inhibitors] are intended for the highest-risk patient population in whom time is most definitely plaque, shortening the time from prescription to acquisitions of medications will likely be clinically meaningful,” they wrote.

Step therapy is commonly seen in clinical practice as a cost-effective measure on behalf of the insurance companies. “Though this custom can reduce short-term prescription costs, it may have a negative impact on long-term patient outcomes,” Baum and colleagues wrote. “In fact, savings attributed to lower formulary costs may actually be due to health-adverse effects such as nonadherence and diminished access to medicines.”

Prolonged time to treatment

Patients with atherosclerotic CVD and familial hypercholesterolemia are at high risk for future CV events, and Baum and colleagues wrote that they should be treated quickly without utilizing step therapy first.


“I have one patient with severe familial hypercholesterolemia,” Baum told Cardiology Today. “He had [an MI] at age 17. His LDL is over 400 [mg/dL] on no therapy. On therapy, it’s in the 200s. He clearly qualifies, and it took over a year to get him approved. When I say it’s capricious, there genuinely seems to be no rhyme or reason for this.”

In instances of repeated denials from an insurance company, Baum recommended that physicians tell their patients to be proactive and be engaged. “When a doctor writes a prescription and sends in a prior authorization to an insurance company, they don’t have to keep track of it,” Baum told Cardiology Today. “They don’t have to file it and put it in their records. However, when a patient contacts the insurance company and says, ‘I’ve been denied such and such a drug,’ they then have to start a clock, and they have to keep record of it. They have a different responsibility to the patient.” – by Darlene Dobkowski

For more information:

Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, can be reached at sjbaum@fpim.org.

Disclosure : Baum reports serving on scientific advisory boards for Akcea, Amgen, Ionis, Regeneron and Sanofi; speaking for Amgen, Boehringer Ingelheim, Lilly and Merck; and receiving research grants from Amgen, Boehringer Ingelheim, Esperion, Gemphire, Madrigal, Regeneron, Regenex and Sanofi. Please see the full study for the other researchers’ relevant financial disclosures.