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Subsequent entry biologics (SEBs) are a current controversial topic in health care in Canada. Skin patients whose treatment plan may include a biologic (especially those with psoriasis, psoriatic arthritis, metastatic melanoma and hidradenitis supperativa) should be aware of this new category of drugs and the impact it might have on their treatment plan.
 

• SEBs are not “generics” and cannot be interchanged or substituted without the advice of a physician. This means the pharmacy should not change a prescription to a SEB without written direction to do so from the prescribing physician.

• Patients should know the trade name of the biologic therapy that has been prescribed for them and be sure that is the one they receive.

• While SEBs are designed to be very similar to the reference originator drugs with essentially the same clinical response in terms of efficacy and  safety,  it should be understood that SEB’s are different drugs from their reference or originator drugs and could have different side effects, different efficacy and different long term safety issues that have not been subjected to the same clinical trial research requirements as the reference drugs 

• SEB’s  have a short cut* to approval which means

– SEBs will likely be less expensive than their reference  drug 

– Safety and efficacy on the SEBs  haven’t been subjected to the same testing requirements in Canada prior to approval

– More Canadians should have access to this class of treatment  given that costs are lower




*Because the current approval process in Canada ( and in many other countries) allows manufacturers of SEBs to present clinical safety and efficacy data from the reference drug rather than having to conduct the same rigorous clinical trials themselves, the rationale is that these new ‘similar’ medications can be offered  more quickly and at a lower price. 

 More information available at http://www.biotech.ca/en/policy-matters/health-bio/seb.aspx



Fill out the form below which will send the letter directly to your HR Manager. Double check that you’ve got your Manager’s correct email address. If you don’t know who your HR Manager is, contact your organization’s HR department and ask for the name and email of the person who liaises with the insurance company.


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Because no two patients are the same, we strongly encourage you to add your own personal story to the letter before sharing it. It helps to explain the impact that your condition has had on your life and work; how it affects you emotionally and physically; tell them about how much medication and treatment have helped – or not. Help your HR Manager understand why managing the condition is so important to you, their employee, and the work you do every day.



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The Canadian Skin Patient Alliance (CSPA) is dedicated to providing education and information to Canadian skin patients and their families along with health-care providers and decision-makers.

It’s important for skin patients and their families to have access to the most up-to-date information on their condition or disease. As a crucial member of your care team, you’ll want to be on the cutting edge so you can have informed discussions with your health-care professionals and get the best possible outcomes.

 

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