Fall 2014 - Green Shield Canada

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SEBS 100: AN INTRODUCTION
In the weeks and months…and maybe years to come, you’ll probably be hearing a lot about subsequent entry
biologic drugs (or SEBs for short). Or you might hear about “biosimilars” or “follow-on” biologics.
These terms all refer to the same thing – a type of biologic drug product. But to explain what SEBs are all about,
we first have to go back a step and start with an explanation of biologics.
SO… WHAT’S A BIOLOGIC?
Biologic drugs are currently one of the fastest growing areas in pharmaceutical development. This class of drug
provides treatment options for serious or rare illnesses where no effective treatments were previously available,
such as cancer, rheumatoid arthritis, multiple sclerosis, and diabetes. Familiar drugs like vaccines and insulin are,
in fact, biologics. The chart below shows how biologics differ from traditional drugs.
TRADITIONAL DRUGS
BIOLOGIC DRUGS
Produced through chemical synthesis
Produced using living microorganisms (e.g., bacteria)
Smaller, less complex molecules
Large, complicated molecules
Differences in manufacturing processes
Even small changes in manufacturing process can affect the
unlikely to affect finished product
nature of the finished product and the way it works in the body
While biologics represent a significant development in treating serious illnesses, they can be extremely expensive
compared to traditional drugs. For example, Remicade®, a biologic used to treat several illnesses including Crohn’s
disease, costs approximately $28,000 – $30,000 annually for one plan member. For most plan sponsors, Remicade
will show up as the drug for which the most plan dollars are spent, driven by cost, not volume of claimants.
SO THEN, WHAT’S A SEB?
Subsequent entry biologics is a term used by Health Canada and describes “a biologic product that is similar to
and would enter the market subsequent to an approved innovator biologic product.”1 In Europe these products
are called “biosimilars,” and in the US they’re generally called “follow-on biologics.”
Like regular biologics, SEBs are complicated to develop and manufacture, and even small differences in
production can make a difference in the way they work. Therefore, while they are similar to traditional generic
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drugs in that they are produced after the patent of the original biologic drug (called the “innovator” drug)
expires, they can’t technically be thought of as “generic biologics.” Unlike true generics, which are considered
“bioequivalent” and therefore interchangeable with the brand-name drug, SEBs are only similar to the original
innovator drug. This means that they’re not interchangeable, and any new SEB that comes along is treated like a
new drug. (For more information about generic drugs see our summer 2013 issue of Follow the ScriptTM.)
APPROVING SEBS IN CANADA
Health Canada issued guidelines regarding the approval of SEBs in 2010. Due to the complexity involved in
producing these drugs, manufacturers must follow the same New Drug Submission (NDS) process as other drugs
submitted to Health Canada for review. However, an NDS for a SEB can include a “reduced package” of clinical
and non-clinical data based on the similarity with the designated innovator, or reference, biologic. The reference
biologic must already have adequate safety, efficacy, and effectiveness data available.2
So far Health Canada has approved three SEBs for sale in Canada3:
TRADE NAME
COMMON NAME
MANUFACTURER OF SEB
REFERENCE PRODUCT
DATE APPROVED
Omnitrope®
somatropin
Sandoz
Genotropin®
April 30, 2009
Inflectra®
infliximab
Celltrion
Remicade®
January 15, 2014
Remsima®
infliximab
Celltrion
Remicade®
January 15, 2014
TRADITIONAL DRUGS
ARE SEBs A GOOD THING?
BIOLOGIC DRUGS
Yes!
Biologics tend to be very expensive, and, while SEBs are also pricey when compared to traditional generic
alternatives, they are a less expensive treatment option than the innovator drug. This is good for patients and for
drug plans.
THINGS TO KEEP IN MIND…
A number of biologics will come off patent in the near future, so we expect to see more SEBs become available.
But not all biologics will end up having a corresponding SEB. Since SEBs require the same sort of development
and approval process as biologics, it’s unlikely that a large number of manufacturers will make them, so we won’t
see the expansion of choice to the degree that’s seen with generics. Plus SEBs will likely always remain high-cost
drugs when compared to the cost difference between traditional brands and generics.
Once Health Canada approves a SEB, it’s still up to each province to decide whether to cover it under the
provincial plan. And mandatory generic drug pricing rules won’t apply to SEBs since they’re not considered
generics.
Since these drugs are very costly and SEBs and biologics are not interchangeable, it’s important to ensure that
plan members starting treatment are receiving the most appropriate and cost-effective biologic drug. GSC’s
criteria and approval process for biologics treating conditions such as rheumatoid arthritis, psoriasis, psoriatic
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arthritis, Crohn’s disease, and ulcerative colitis provides a strategy to encourage the use of the most cost-effective
biologics and SEBs first (read more below).
Sources:
Health Canada, Fact Sheet: Subsequent Entry Biologics in Canada, September 2009,
1
www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/fs-fi/fs-fi_seb-pbu_07-2006-eng.php
Health Canada, Information and Submission Requirements for Subsequent Entry Biologics (SEBs), March 2010,
2
www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php
John Norman and Livia Aumand, Subsequent Entry Biologics in Canada, Gowlings, May 2014,
3
www.fdli.org/docs/canadian/john-norman-subsequent-entry-biologics-in-canada.pdf?sfvrsn=0
GSC’s Biologic Management Policy
Our Biologic Management Policy, which would also apply to SEBs, effectively manages biologic costs while
promoting your plan members’ health. And it’s an innovation unique to GSC: a two-tiered formulary. All GSC
plans default to covering only certain biologics within a class first, allowing plan members to move on to other
biologics in the class only when they experience an undesired response to the first drug. The formulary is
regularly updated based on each biologic’s effectiveness, safety, cost, and provincial drug formulary status.
This is how it works...
g
For each medical condition that a biologic is indicated for, our Pharmacy Services Team analyzes the drug,
taking a few factors into consideration:
g
g
g
g
effectiveness and safety based on the current scientific literature
per treatment costs based on historic claims data
provincial drug formulary listing status
Based on the analysis, each biologic is categorized as either:
g
Tier 1: PREFERRED LISTING
or
OR
g
g
g
Tier 2: NON-PREFERRED LISTING
The approach is “first try this, then try that.” Plan members are advised to try the Tier 1 option, and then, if
it’s ineffective or the plan member is intolerant, they try the Tier 2 option.
The prescribing physician must complete a Special Drug Authorization Form which is evaluated by our Special
Drug Authorization Department to make sure the plan member is receiving the most cost-effective drug for
the condition.
Given that the biologic options have equivalent effectiveness and safety, this two-tier approach makes sure that
the most cost-effective biologic is eligible first, before moving to the Tier 2 option.
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THE
BEHIND COUNTER
WHAT’S THE BUZZ ON BIOLOGICS?
In each issue of Follow the Script™, we interview a member of our pharmacy team
about a current topic. In this issue, we ask GSC pharmacist Sal Cimino about
dispensing biologic drugs.
FtS: We’ve been hearing a lot about biologics recently, but does the average pharmacist who dispenses in a community
pharmacy actually see prescriptions for them often?
Sal: Well, first, you have to remember that things like insulin and human growth hormone are biologics, so
yes, most community pharmacists are going to see those prescriptions regularly. However, when you’re talking
about the more expensive biologics that treat rarer conditions, you probably won’t see prescriptions for those
every day in your neighbourhood pharmacy. These aren’t everyday drugs. Remember, biologics represent only
0.3% of GSC’s drug claims – that’s not very many people accessing these types of drugs. It’s their cost, not
their volume that causes all the attention.
FtS: So, would those expensive biologics even be available at my neighbourhood pharmacy?
Sal: You could probably arrange to get drugs like Humira® or Enbrel® at your pharmacy – they could order
them in if they don’t have them in stock. But biologics are often available through specialty pharmacies that
are designated by the drug manufacturers to distribute their products.
FtS: That’s another phrase we’re hearing more about – “specialty pharmacies.” So, you have to take your biologic
prescription to a special store someplace to get it filled? Isn’t that inconvenient?
Sal: Not necessarily. Often the specialty pharmacies are community pharmacies; they just have an
arrangement with the biologic manufacturer to handle specific products. For example, Humira and Enbrel are
self-injected drugs that don’t have any special storage requirements, so they can be placed and dispensed in
community pharmacies. A lot of these biologics require special storage – like the drug has to be kept
refrigerated at all times – that many community pharmacies can’t provide. And drugs like Remicade have to
be mixed and infused, so your neighbourhood pharmacy is unlikely to be part of that kind of network. There
are some specialty pharmacies where dispensing biologics is all they do. These would typically be part of, or
close to, drug infusion clinics.
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FtS: Are there other things that set the specialty pharmacies apart? Are there any special processes or training
requirements when biologics are involved?
Sal: Some pharmacists take additional courses to enhance their knowledge of the diseases that are treated
by these drugs. And some pharmacists may need training for mixing the infusion drugs but other than that,
no other training would be needed. There are some different administration processes required when handling
the really expensive biologics. For example, in addition to any benefits coverage plan members have, they are
usually part of a patient assistance program with the manufacturer. And the manufacturer requires reporting so
they can follow up with the patients and track outcomes. All this results in some extra paperwork for specialty
pharmacies. Sometimes patients need some training too. If they’re prescribed a self-injected drug like Humira
or Enbrel, they’ll need to learn how to do the injections before they can pick up the drug at their
neighbourhood pharmacy.
FtS: This edition of Follow the Script™ also talks about SEBs. Are there any differences between dispensing biologics
and SEBs?
Sal: SEBs are just another biologic from a pharmacist’s point of view. There are no practical differences at the
pharmacy.
FtS: Sal, thank you for opening our eyes to this particular topic.
Sal: My pleasure…may you and the readers never require a biologic or SEB! But if you do, they represent
amazing medical advancements.
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