1) A patient with familial hypercholesterolemia (FH) on PCSK9 inhibitors described facing step therapy requirements and high copays to access the drug, with an initial $1000 copay and $400 monthly copay. 2) A study found that only 30.9% of patients prescribed PCSK9 inhibitors ever received the therapy due to prior authorization denials and high copays, with prescription abandonment rates over 75% for copays over $350. 3) Medicare Part D plans have annual out-of-pocket costs for PCSK9 inhibitors and statins of nearly $5000 on average.

1. GLOBAL CARDIOVASCULAR
CLINICALTRIALISTS FORUM
PatientViewpoint on PCSK9 Inhibitors
Marilyn Mann
November 30, 2017

2. Disclosures
• American College of Cardiology: travel expenses
• American Board of Internal Medicine: travel expenses
• Yale Center for Outcomes Research and Evaluation:
consulting fee for serving on a stakeholder advisory
committee for developing a performance measure under a
contract with CMS

3. An FH patient on PCSK9 inhibitors:
We are rejected and/or forced through step therapy in
order to get access.The copay program helps, but my first
copay before it kicks in is $1000. Monthly copay is around
$400 as its now a tier 4 drug on my formulary. … But it
works. It works very well. And if I don’t take it, then I have
no other options, besides apheresis.

4. Prior authorization practices and high copays
are limiting use of PCSK9 inhibitors
• During the first year of availability, 47.2% of patients prescribed a PCSK9
inhibitor received approval.
• Of those approved, 65.3% filled the prescription, resulting in 30.9% of those
prescribed a PCSK9 inhibitor ever receiving therapy.
• Copays varied widely, from $0 for the lowest quartile of patients to more than
$300 per month for the highest quartile.
• Prescription abandonment by patients was most associated with copay costs,
with abandonment rates ranging from 7.5% for those with $0 copay to more
than 75% for copays greater than $350.
Navar AM, Taylor B, Mulder H, et al. Association of Prior Authorization and Out-of-pocket Costs With Patient Access to PCSK9 Inhibitor Therapy. JAMA Cardiol.
2017;2(11):1217-1225.

5. Relationship Between Copay and Prescription Abandonment for
Patients Approved for PCSK9 Inhibitors
NavarAM,Taylor B, Mulder H, et al. Association of PriorAuthorization and Out-of-pocket CostsWith PatientAccess to PCSK9 InhibitorTherapy. JAMA
Cardiol. 2017;2(11):1217-1225.

6. Medicare Part D plans and annual out-of-
pocket costs for PCSK9 inhibitors
• Alirocumab and atorvastatin 80 mg.: $4997
• Evolocumab and atorvastatin 80 mg.: $4968
Kazi DS, Lu CY, Lin GA, et al. Nationwide Coverage and Cost-Sharing for PCSK9 Inhibitors Among Medicare Part D
Plans. JAMA Cardiol. 2017;2(10):1164-1166.

7. Out-of-Pocket Costs for PCSK9 InhibitorTherapy
Under Medicare Part D
Kazi DS, Lu CY, Lin GA, et al. NationwideCoverage and Cost-Sharing for PCSK9 InhibitorsAmong Medicare Part D Plans. JAMA Cardiol.
2017;2(10):1164-1166.