Time to Ease Up on Prior Authorization for PCSK9 Inhibitors?

Making the pathway to prescription less burdensome for the highest-risk patients could maximize benefit, experts argue.

Time to Ease Up on Prior Authorization for PCSK9 Inhibitors?

BALTIMORE, MD—Now that manufacturers have slashed prices on PCSK9 inhibitors, experts gathered here at a special prevention symposium ahead of the annual Society of Cardiovascular Computed Tomography (SCCT) meeting last week think it’s time for payers to loosen the prior authorization protocols for the highest-risk patients, so long as physicians remain accountable for their prescribing behavior.

Alirocumab (Praluent; Regeneron/Sanofi) and evolocumab (Repatha; Amgen) were launched in 2015, but enthusiasm for their use only blossomed following results from the blockbuster FOURIER trial in 2017 showing a decrease in hard CVD events with evolocumab versus placebo. Cost still limited use, however, with several cost-effectiveness analyses blaming the drugs’ estimated $14,000 price tag for the fact that about one-third of patients with approved prescriptions never received them. But another likely reason for the limited uptake is the laborious paperwork, mandatory specialist visits, and nonstandardized insurance requirements that physicians must navigate before they can prescribe these drugs to their patients.

The manufacturers of first alirocumab and then evolocumab announced in 2018 that they would cut their prices substantially. In November, the joint American College of Cardiology/American Heart Association cholesterol guidelines were updated to say that adding a PCSK9 inhibitor is “reasonable” for patients who do not respond to maximally tolerated statins and ezetimibe, although the guideline committee notes the uncertainty of the cost-effectiveness of these drugs.

Ease Up on Prior Authorization?

Khurram Nasir, MD, MPH (Yale University School of Medicine, New Haven, CT), who addressed the topic of pricing and access to PCSK9 inhibitors in a presentation during the symposium, told TCTMD that before this drug class hit the market, cardiologists had embraced a “dogmatic approach of not talking about cost.” However, “if we talk to the patient, that's a central piece of how they think about [their care],” he said.

In addition to market forces, he credits the eventual price drops largely to physician and societal advocacy. “Now that's done, we have to go back to the payers and say the status quo cannot remain,” Nasir said. “There is this huge distrust between the physicians and the payers. Nine out of 10 physicians hate prior authorization, and I can understand that, but there was a reason for that. So now the reason's gone, we need to ease up.

We cannot anticipate a therapy of this cost without any prior authorization, but I think we can improve the process so the right people can get it at the right time. Khurram Nasir

“We cannot anticipate a therapy of this cost without any prior authorization, but I think we can improve the process so the right people can get it at the right time,” he continued, noting that it currently takes an average of 4 to 6 hours to complete the “hugely bureaucratic” prior authorization paperwork.

Specifically, Nasir first argued for the elimination of prior authorization for patients with familial hypercholesterolemia (FH) and established atherosclerotic cardiovascular disease. “And then, rather than have a random prior authorization process, [let’s] standardize it,” he said, adding that the requirements should reflect the guideline recommendations. “As long as we keep on doing these things, we'll need these checks and balances.” Nasir also advocated for the digitization of prior authorization.

The case of PCSK9 inhibitors is a “great case study for us within the cardiology community so we’re not repeating the same mistakes as newer novel therapies come along,” he said. “I think this is a great learning opportunity because never in the past have we had the option of such a costly medication that was beneficial, that would be applied a lot.”

Narrowing Down the Risk

Session chair Ron Blankstein, MD (Brigham and Women’s Hospital, Boston, MA), told TCTMD that Nasir gave a “very provocative talk,” and that “I think he's right. Now that the price of PCSK9 inhibitors has come down, there is a burden on payers to minimize some of the barriers such as prior authorization to make it more available to our patients. These are medications that we know work, particularly for high-risk patients.”

Although he works for the Department of Defense and admittedly isn’t affected by prior authorization requests in general, Emilio Fentanes, MD (Tripler Army Medical Center, Honolulu, HI), who attended the session, told TCTMD that it’s “a big deal that a lot of civilians do deal with and I think the administrative aspect of that can be limiting.”

The most important aspect from Nasir’s recommendations is the built-in accountability facet, he said. If prior authorization “becomes more simple but it also adds accountability to physicians to really prove that they have taken the necessary steps, . . . [it can act] kind of like a treaty—that the insurance company or the payer should do their part but the doctors should [also] do their part. That accountability is key in this proposal.”

In discussion following Nasir’s presentation, Michael J. Blaha, MD, MPH (Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, MD), said he “loves the idea” that the guidelines can outline a very-high-risk patient group who might benefit the most from PCSK9 inhibitor treatment, but “what we’ll see when we see analyses come out from the existing clinical trials of who fits into the very-high-risk group, it’s going to be the majority of all ASCVD patients.”

This is namely because patients can be labeled as such just by being older than 65 years or having conditions like hypertension and diabetes. “Maybe up to 70% of patients with ASCVD will be ‘very-high-risk,’ which maybe might not discriminate as well, but it's a step in the right direction,” Blaha said, asking Nasir what he things is the right percent of patients with ASCVD who should truly be considered very-high-risk.

This aspect of the guidelines was “two steps forward, one step back, where they wanted to emphasize high risk but then they wanted to have as many people within the high-risk group,” Nasir responded. The evidence right now supports that patients with multiple events, recent ACS, and FH with cardiovascular disease are “no-brainers” to be included in the very-high-risk cohort, he said, adding that there are also indications that maybe those with high-risk diabetes and peripheral arterial disease could be labeled as such.

“Age is going to be an arbitrary cutoff and we’ll need to refine that,” Nasir continued. “At some point, . . . as the cost continues to come down, we can be more flexible in how many patients we can treat.”

The ongoing VESALIUS-CV study, which is looking at the effect of evolocumab in 13,000 patients without a prior MI or stroke, will “hopefully further establish the role of PCSK9 inhibitors in patients who have not yet had an ASCVD event, further expanding the role of prevention,” Blankstein said.

Ultimately, Nasir said, “the future is bright for PCSK9s in 2020 and beyond.” While there were initial obstacles, he added, “we are all getting together and having more consensus than disagreements. More importantly, we have more options.”

  • Nasir K. PCSK9 inhibitors: cost, access, (present) & future. Presented at: SCCT 2019. Baltimore, MD. July 11, 2019.

  • Nasir and Fentanes report no relevant conflicts of interest.
  • Blankstein reports serving as a consultant to Amgen and receiving grant/research support from Amgen and Astellas.
  • Blaha reports receiving grants/research support from the Amgen Foundation and the Aetna Foundation and serving as a consultant to the Amgen Foundation, Novo Nordisk, Novartis, and Medicure.