PBIRx®
Intelligent Solutions in Pharmacy Benefits
612 Wheelers Farms Road, Milford, CT 06461
(888) 797-2479
What are PCSK9
Inhibitors?
PCSK9 inhibitors are a new class of drugs that can greatly
reduce LDL (Low Density Lipoprotein) cholesterol levels. LDL is the “Bad Cholesterol” associated with
increased risk of heart disease, including heart attack and stroke.
What does PCSK9 stand
for?
PCSK9 stands for Proprotein Convertase Subtilisin Kexsin 9.
How much do they
cost?
We do not yet know the specific cost but do know they will
initially range about $6-12K per year.
Are these drugs currently
available?
Two different brands of this drug Praluent™ (alirocumab) and
Repatha™ (evolocumab) will be approved third quarter 2015.
What does the FDA
say?
The FDA has not formally approved these drugs for market. It
is highly expected they will formally approve this drug in the coming months.
An FDA medical advisory committee has recommended approval of these drugs for
certain conditions.
Are the PCSK9’s for
everyone with “high cholesterol”?
No. As of today, the
FDA medical advisory committee has unanimously recommended use of these drugs
in people with HoFH (Homozygous Familial Hypercholesterolemia). This is a rare
genetically induced high cholesterol disorder that affects 1 in 2000 people.
Additionally the committee was split for recommendation for
use for people with any other indication for these agents.
Other indications
include:
All patients
with high LDL cholesterol
Patients
that are “statin resistant”
Patients
that are “statin intolerant”
Why is the FDA advisory committee not
unanimous for these other indications?
All the data
is not yet available. Studies to date have proven that these drugs will reduce
LDL by up to 60%. While in theory this is a good sign, it has yet to be shown
that this will result in lower heart disease rates. Two studies involving 20,000 patients are
currently under way but the results will not be avialable until at least 2017.
Why the caution?
Historically other cholesterol reducing agents have been
approved based upon their cholesterol improving abilities, but later studies
showed limited outcomes benefits. These agents include niacin, fibrates and
Zetia™ (ezetimibe). While they have all found a place in the cholesterol
lowering arsenal their actual results are much less then the initial studies
had shown.
Are there other
concerns?
Yes. As
with any other newly approved drug there is an unknown side effect adverse
event profile. New drugs are studied in controlled populations. After
drugs come to market they are exposed to a much greater cross section of the
general population. Invariably unknown issues come to light. What is known to
date is that the PCSK9 inhibitors have shown a greater degree of “cognitive
dysfunction” vs. placebo. While not
statistically significant in the limited studies to date, it is an issue of
concern for the FDA advisory committee.
Additionally theses drugs will initially be available only
in a subcutaneous injectable form. Similar to Insulin in administration, they
will be administered either once or twice monthly depending on the PCSK9 dispensed.
Historically there is some resistance to
injections from a portion of the population. An oral version of this drug is
currently under study.
Are PCSK9 drugs a
“cure”?
No. These agents will lower LDL cholesterol levels but will
not treat the underlying causes. This means that these drugs, and any other
cholesterol lowering drugs, must be given for the lifetime of the
patient.
What is the current
treatment for lowering cholesterol?
The drug class of choice is the “Statins”, for which there
are many low cost generics available. This is a class of drugs with proven
effectiveness in lowering LDL. While highly effective there is a subset of
patients that are resistant to the positive effects of statins and others who
suffer from its side effects, primarily muscle pain.
How much do statins
cost?
Generic statins cost around $100 per year.
Crestor™(rosuvastatin), a brand statin, can cost around $450 per year.
How many Americans
have “high cholesterol”?
70 million Americans have high LDL.
Are there other means
of lowering cholesterol?
Yes. Diet, exercise
and stress control are all contributing factors and can be controlled, or
mitigated, by lifestyle changes.
What does PBIRx recommend?
At this point in time we recommend restricted use of these
medications only for those with HoFH, or patients at high CV risk that are
statin intolerant or statin resistant. We work within the guidelines of the
American College of Cardiology and American Heart Association as to the
definition of these conditions.
Our recommendation is to only allow use of these agents with
a Prior Authorization from your PBM, after consultation with the patient’s
doctor.
Because of the potential costs involved we believe you, the
payer, have a right to know that this drug is being prescribed under the most
optimum conditions and being used correctly and appropriately.
As these are a new class of drugs, with multiple
competitors, incoming information is evolving rapidly, and criteria and
situations may change. As your pharmacy consultants we strive to be aware of
this evolving landscape and will keep our clients informed.
