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biologics

Self-Injection Videos

How to inject Cosentyx

December 5, 2017
How to inject Consentyx

Continuing with our self-injection series, Dr. Farrell teaches us how to inject Cosentyx. Cosentyx, also known as secukinumab, is a monoclonal antibody that blocks interleukin-17. This is a cytokine that is overactive in diseases such as psoriasis, psoriatic arthritis, and ankylosing spondylitis.  That being said, Cosentyx is FDA approved for ankylosing spondylitis, moderate to severe plaque psoriasis, and psoriatic arthritis.  Cosentyx comes as a pen or autoinjector as well as the prefilled syringe.  It also comes in two different doses: 150 mg and 300 mg.

Preparing for your injection

  • Keep your medication stored in the refrigerator until use
    • Before injecting medication, take the autoinjector or prefilled syringe out of the refrigerator.
    • Allow it to warm up to room temperature.
  • Pick a place in your house that is clean and has room for your materials (such as the kitchen table).
  • Wash your hands thoroughly with either:
    • Soap & water
    • Hand sanitizer
  • Choose an area to inject – Thigh or Stomach.
    • Choose an area that is intact and clear.
    • It should not have any of the following:
      • Cuts
      • Scrapes
      • Bruises
      • Psoriasis patches
      • If you have extensive psoriasis, inject between patches
      • Moles
      • Scars
    • Please rotate area each time you inject (shown in picture below).

Areas to inject subcutaneous medication

  • Cleanse chosen area
    • Cleanse chosen area with either of the following:
      • Alcohol swab
      • Alcohol and a cotton ball
    • Use the chosen alcohol material to “swipe” area
      • Can either use a circular motion or wipe in “strips”
      • Allow the area to dry

Injecting Consentyx with an autoinjector/pen

  • Observe the medication in the window to be sure that it is clear (no cloudiness or crystals)
    • You will see a small air bubble within the window, this is normal and will not cause harm when injecting
  • Remove the cap
  • Press the tip of the auto-injector down in the skin at a 90 degree angle until it is flush with the skin
  • Press button and hold for 15 seconds
  • Viewing window will turn yellow or blue, but continue to hold the button for the full 15 seconds
  • Lift the auto-injector straight up

Injecting Consentyx with a prefilled syringe

  • Pull off the cap and observe the syringe to be sure that it is clear (no cloudiness or crystals)
  • Pinch the skin around the injection site and enter at a 45-degree angle
  • Press the plunger (slowly) to administer the medication
  • Once the medication is fully administered, the plunger will reach the bottom and a spring will place a cover over the needle

After the injection

  • Properly dispose of the entire autoinjector/pen or prefilled syringe
    • Sharps Container
      • Can be purchased at your local pharmacy
      • Disposal
      • Hospitals may take full sharps containers, ask first.
      • Pharmacies and Doctors’ offices are not allowed to take used syringes or needle
  • Discard remaining materials in the trash (cap, alcohol swabs, etc.)

For more information regarding Cosentyx, please follow this link.

Credits

Jessica Farrell, PharmD.  Clinical Pharmacist, The Center for Rheumatology/Associate Professor, Albany College of Pharmacy and Health Sciences

With the help of Autumn Koniowka. Doctor of Pharmacy Candidate Class of 2018, Albany College of Pharmacy and Health Sciences, and Megan Phillips. Doctor of Pharmacy Candidate Class of 2018, Albany College of Pharmacy and Health Sciences.

A special thanks to Tammy Garren, PhD. Instructional Designer, Center for Innovative Learning, Albany College of Pharmacy and Health Sciences.

Injection site image: By British Columbia Institute of Technology (BCIT). Download this book for free at http://open.bccampus.ca [CC BY 4.0 (http://creativecommons.org/licenses/by/4.0)], via Wikimedia Commons

Medical Disclaimer

This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advised you to speak with your medical professional if you have questions concerning your symptoms, diagnosis and treatment.

Diseases and Conditions Patient Advocacy

Guide to living with rheumatoid arthritis: part 3

August 30, 2017
the prior authorization process: how medication get covered by your insurance company

If you’re reading this post, there’s a good chance you’ve just been diagnosed with rheumatoid arthritis (RA).  In Part 1 of the Guide to Living with Rheumatoid Arthritis, we went over the symptoms, diagnosis, and treatment of rheumatoid arthritis.  In Part 2 of the Guide to Living with Rheumatoid Arthritis, we went over expectations, how to break the news to your loved ones and your boss, as well as important topics like food, exercise, and lifestyle.

Now that you’re acquainted with RA, you may have realized that some of these medications are very expensive.  In Part 3 of Guide to Living with Rheumatoid Arthritis I’ll be covering the way doctors prescribe medications, how health insurance pays for the cost of medications, and finally how they end up in your possession.

The Process

As we’ve discussed previously, to treat rheumatoid arthritis you need to fight fire with fire.  In the case of RA, fire = a disease modifying anti-rheumatic drug or DMARD.  This is a medication that puts the immune system back in-check and calms it down.

They’re are two kinds of DMARDs: conventional DMARDs and biologics.  Conventional DMARDs like methotrexate are less complex and do not target a particular cytokine (type of inflammation).  They tend to cost less and typically don’t need pre-approval from your insurance company. Fortunately, methotrexate is the gold standard for the treatment of rheumatoid arthritis.

Biologics are the second type of DMARDs. These medications are a lot more complex and they do target a specific cytokine.  Biologics are typically used if there’s a good reason you can’t take a conventional DMARD or if they haven’t worked in the past.  Sometimes a rheumatologist may use a biologic and a conventional DMARD at the same time because they work better together.  Biologics come as self-injectable pens, prefilled syringes, and infusions (i.e., via an IV going into your veins).

Unlike conventional DMARDs, biologics are VERY expensive and do need pre-approval or prior authorization from your insurance company before starting the medication.  This means your doctor needs to justify this medication to the insurance company.

Prior Authorization

You may have heard your doctor say, “I’m going to need to get a prior authorization”.  A prior authorization is the process by which your doctor and his or her team will justify the use of the medication to your insurance company.  It typically involves A LOT of paperwork and phone calls.  Sometimes the process takes weeks to days, but sometimes it can take months.  If this is your first biologic, it typically takes 2 – 3 weeks from the moment your doctor prescribes the medication to the moment you receive it.  But again, every situation is different.  This is just an average.

First, every single medical office does prior authorizations slightly differently.  Let’s go through an example.

Getting started

  • Your doctor talks to you about the risks and benefits of a certain medication. If you consent to treatment, he or she will ask his assistant to start a prior authorization.
  • The assistant then gathers all your medical insurance information and starts filling out forms. There’s a different form for every medication and for every different insurance company.  The assistant then sends your doctor’s last progress note stating why you should receive this medication.  The package is then sent to your health insurance plan.
  • At this point, your health insurance plan will go over your case and decide whether they will approve the medication. The medical reviewers follow a strict set of guidelines set forth by the insurance plan.
  • Let’s say they don’t approve the medication. In some cases, your doctor could appeal their decision by speaking to a medical director at the insurance company.  At times, they want more information or a written letter with supporting scientific papers.  Sometimes this works and sometimes it doesn’t.  If it does great!  If it doesn’t your doctor may try to look into patient assistance programs if one is available or they may alter your treatment plan.

You’re approved!

Now let’s say the medication gets approved! The insurance company will contact your doctor’s office and let them know.  Because these medications are so expensive, your local pharmacy will not carry them.  They may need to go to a specialty pharmacy who will mail them to your house.

  • The assistant will alert your doctor and he/she will send the prescription to your pharmacy.
  • The specialty pharmacy then prepares the script and sets a delivery date with you.
  • The medication is then mailed to your house.
  • The process is a little different when it comes to infusible biologics. In this case, the medication will NOT be mailed to your house.  Instead, once your doctor’s office obtains the prior authorization, the infusion team at your doctor’s office will call to set up an appointment.  Sometimes, you may need to go to an infusion clinic or a hospital for treatment.

Now you see why prior authorizations take a long time!

Biologic medications

There are many types of biologic medications that work in all sorts of different ways, however, they are given in either of these forms:

  1. Infusions
  2. Self-injectables
  3. Pills

If prescribed an infusion you will get the medicine at your doctor’s office, an infusion center, or a hospital.  Treatment can range between 1-5 hours.  The doctor’s office will give you the medication and bill your insurance.

If you’re prescribed a medication that is self-injected, the medication will be mailed directly to you.  This may seem very daunting, however, many clinics have a team in place to help you through this process.  In my clinic, we have a dedicated team that will help you inject the medication for the first time in a supervised setting.  During that visit you can ask questions that you may have about the medication: how to store it, how to dispose of the syringes and/or pens, what to do when traveling with biologics, side effect, etc.

If you’re prescribed an oral biologic medication, then the medication will be mailed directly to your house and you would take it just like you would take any other pill, i.e., follow your doctor’s written instructions.

What if your insurance company does not want to cover the full cost of your medication or if you have a high deductible plan?

You should rest assured that there are several financial assistance options available if your insurance will not cover the full cost of the medication or if you have a high deductible plan.  Mind you, this does not guarantee that you will qualify but you won’t know unless you try.

For Commercial Insurance Plans (Group, Individual, Exchange) not Medicare

Some commercial insurance companies let their customers use a copay assistance card issued by the pharmaceutical company to help with the cost of the drug.  Call me old-fashioned, but in my experience, talking to an actual human being is much faster and effective than email or using a contact form.  For more information call the appropriate phone number listed below. If your plan allows the use of a copay card, the drug can often be obtained at a much smaller charge.

For Medicare Plans

The same medication options and medication administration options are available if you have Medicare or a Medicare Supplemental Plan, except you CANNOT use a copay assistance card.

Depending on the type of Medicare/supplemental plan that you have, the coverage of in-office infusions or self-administered shots widely vary.  They may cover the entire cost or only a portion of the medication.  For example, if your doctor prescribed you rituximab, your insurance company may cover 80% of the cost of the medication, leaving you with 20% of the total bill.  When a medication costs about $22,000, 20% is a lot!

It’s always advisable to contact the doctor’s office or Medicare to find the out-of-pocket costs before receiving any treatment to fully understand the potential costs.

Regardless if you have a Medicare, commercial health insurance plan or if you do not have any health insurance at all, you may still qualify for financial assistance if you cannot afford treatment.  Pharmaceutical companies and other non-profit organizations have many options that can even cover the full cost of treatment.

If you have concerns or questions about the costs of your treatment, please speak to your doctor or the patient advocate in your doctor’s office.

Conclusion

I hope this guide to living with rheumatoid arthritis has been informative and that you learned some valuable information about your diagnosis.  Here are a few final thoughts:

  • Please follow your rheumatologist’s management plan. If you have any concerns, about your symptoms or your medications, it’s always important to keep an open line of communication.
  • It’s important to tell all your different doctors about your new diagnosis and any new medications that you are taking.
  • Always carry an updated list of you medications in your wallet. You never know when someone may ask for it.  The doctor in the emergency room may not have access to your doctor’s records at 2 AM.
  • Make sure that you regularly follow-up with your rheumatologist in clinic. Your doctor may need to adjust your medications and watch for any side effects or complications.
  • If you cannot make a follow-up appointment, please contact your doctor’s office at least 48 hours in advance and re-schedule.
  • Learn as much as you can about your condition.
  • Talk to your friends and your family about your condition. You’re not alone.
  • Stay positive, keep active, and keep smiling!

Please leave your comments or questions below.

 

Co-written by Jessica Chapman, MD and Ilene Leveston, Patient advocate

Edited by Jessica Farrell, PharmD

Patient assistance programs for non-Medicare patients

Cimzia

1 (866) 952 – 7968

https://cimplicityonline.com/

Enbrel

1 (888) 4ENBREL or 1 (888) 436 – 2735

https://www.enbrel.com/support/financial-assistance/

Humira

1 (800) 4HUMIRA or 1 (800) 448 – 6472

http://www.abbviepaf.org/

https://www.humira.com/humira-complete/cost-and-copay

Simponi

1 (877) MYSIMPONI or 1 (877) 697 – 4676

http://www.janssenprescriptionassistance.com/simponi-cost-assistance

Remicade

http://www.janssenprescriptionassistance.com/remicade-cost-assistance

Xeljanz

1 (855) 493 – 5526

http://ra.xeljanz.com/rheumatoid-arthritis-support-resources/financial-help

Orencia

1 (800) ORENCIA or 1 (800) 673 – 6242

https://www.orencia.bmscustomerconnect.com/orencia-patient-assistance

Actemra

1 (800)-ACTEMRA or 1 (800) 228-3672

https://www.genentech-access.com/hcp/brands/actemra/find-patient-assistance.html

Kevzara

1 (844) 538 – 9272

https://www.kevzarahcp.com/kevzara-connect

https://www.kevzara.com/kevzara-copay-card

Rituxan

https://www.genentech-access.com/hcp/brands/rituxan/rituxan-ra/find-patient-assistance.html

Note: Rules, regulations, and contact information are subject to change.

Medical Disclaimer

This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advised you to speak with your medical professional if you have questions concerning your symptoms, diagnosis and treatment.

RheumDoctor Learning Center

RheumDoctor Learning Center: What is a cytokine?

May 31, 2017
A picture of interleukin 6 a cytokine thought to be involved in giant cell arteritis

A cytokine is a type of protein in the body that helps cells communicate.  Here are some types of cytokines:

  • Lymphokines: Cytokines produced by lymphocytes
  • Monokines: Cytokines produced by monocytes
  • Chemokines: Cytokines that attract other cells
  • Interleukin (IL-): Cytokines produced by leukocytes that help regulate the immune system.

Sometimes cells make cytokines and those cytokines directly affect them.  This is autocrine action.  If the cell makes a cytokine and it affects a nearby cell, this is paracrine action.  Finally, if a cell makes a cytokine and it affects distant cells, this is endocrine action.

How are cytokines and autoimmune diseases related?

Researchers have identified many cytokines such as IL-1β, IL-6, IL-17, and TNF-α that play an important role in autoimmune diseases.  This information is then used to make biologic medications that specifically block problematic cytokines.


References

MedicineNet.com

Image of interleukin 6 molecule by Ramin Herati [Public domain], via Wikimedia Commons

Diseases and Conditions Featured

Biosimilars: How they may affect your autoimmune disease?

May 10, 2017
Biosimilars: How they may affect your autoimmune disease?

You may have recently heard about biosimilars for many autoimmune diseases like rheumatoid arthritis, psoriatic arthritis, and Crohn disease or maybe you haven’t even hear about biosimilars at all! A biosimilar is a medication that is a “copycat” version of a biologic but may have some small differences. The patent, which prevents other companies from making a product, on many biologics will expire soon opening a new opportunity for the development of biosimilars. While these medications are just beginning to come into the US market you can already find them in Europe.

What are biosimilars and what can I expect when I use them? Are they better than the real medication, what is the cost? Read on to get the answer to all these questions and more!

What is a Biosimilar?

First of all, to understand biosimilars you must first understand what biologics are. Biologics are a class of medication used to treat many different autoimmune diseases.  Scientist make biologics with living cells or tissues inside a yeast or bacteria.  They are very complex molecules. Conventional medications, like methotrexate and hydroxychloroquine, are produced through specific reactions which produces a very precise molecule with a distinct structure. These medications are the same every time, the same materials, used in the same way produce the same drug.  These molecules are NOT complex. Biologics don’t always make an exact replica as living cells make them.  These are sensitive to the environment including light, temperature and nutrients.

Now add in the addition of a biosimilar. A biosimilar is a biologic that if it can show that it is “highly similar” to another, already approved biologic.  The original biologic is the “reference product”. The FDA requires these products to meet strict safety and efficacy standards just like biologics. The company then needs to prove that their biosimilar is a match for the already approved product for a particular disease.  After this happens, the biosimilar automatically gets approval to treat other diseases the reference product already has approval for.  For example, a biosimilar that has approval for rheumatoid arthritis would then automatically get approval for psoriatic arthritis if the reference product has approval for both.

Isn’t this the same as a generic?

The reality is that it’s a little bit more complicated than that. Think of a brand and generic medication as the recipe for a hamburger at a fast food chain. If you follow the same recipe you get the same hamburger every time, a hamburger in China tastes the same as one made in Albany, NY. Biologics and biosimilars are more like the recipe for sourdough bread. You can follow the same recipe every time but if the weather is different the bread may turn out different. The bread may have a slightly different texture but it will still fulfill its purpose. So biosimilars are not generics because they are NOT exactly the same as their reference medication.  It’s just that the difference is so small that it really should work about the same.

Cost savings?

Treatment with biologics is expensive. But the benefits, like an increase in quality of life, far outweighs the cost. What if you could get similar effects at a decreased cost? That is where biosimilars come into the picture. After the patent on a biologic has expired other companies are able to create drugs using the same process to get a biosimilar medication. Multiple companies producing the same product forces competition and a decrease in price.  This is what theoretically should happen.  In reality, we actually don’t anticipate a significant decrease in cost partly due to the complex process to produce the product.

How will I know what the medication is?

Biosimilars will have the same base name as the biologic they replicate. They will have an extra suffix after the name to differentiate them from the replicated drug. Naming the products in this way ensures you know what drug it replicated (through the base name) and that it is not the “real thing”, but in fact a biosimilar (through the suffix). For example, infliximab is the generic name for Remicade- the branded version. The biosimilar produced by Janssen Biotech is infliximab-dyyb. The addition of the “dyyb” shows that it is a biosimilar to infliximab.

If I have an allergy to the reference medication, am I allergic the biosimilar medication?

Just because you are allergic to the reference medication does not mean you will be allergic to the biosimilar, but it also does not mean you won’t be. True antibody derived allergic reactions are uncommon. Injection site reactions are much more common. There are many factors that can affect if you will have a reaction and what type of reaction it will be.

Some of these factors include:

  • Source of the protein used to make the biosimilar
  • What type of cell the protein was made in
  • Alteration in the protein structure. This can occur from something as simple as a change in storage temperate to changes in the manufacturing process.

As always, if you experience any type of reaction, call your doctor or get to an emergency center right away.

What biosimilars are approved in the U.S.?

At the time of this post there 4 products which have FDA approved biosimilars. This includes

  • adalimumab-atto, biosimilar to Humira (adalimumab)
  • etanercept-szzs, biosimilar to Enbrel (etanercept)
  • infliximab-abda and infliximab-dyyb, biosimilar to Remicade (infliximab)
  • filgrastim-sndz, biosimilar to Neupogen (filgrastim)

There are many other products currently being studied and this list will soon grow larger.

Is it as good as the real thing? What should I expect?

This is probably your biggest concern with using a biosimilar. When you find a treatment that works, you don’t want to jeopardize your health by changing your medications. Believe me, neither does your doctor. Maybe you are wondering if a biosimilar will do the same and possibly save you money? The FDA approval process ensures that biosimilars are just as effective (AND SAFE) as the biologic being replicated. Researchers need to prove that their product has the same clinical effect as the reference product. In the U.S., the FDA require strict safety and efficacy studies prior to approval and post-marketing studies.  These efforts help clinicians keep track of real-world experience with newly approved medications. Over the next few years it will be important for both patients and providers to stay up-to-date with post-marketing information related to the use and experience with biosimilars.

Do you have any experiences using biosimilars? Share them below!

 

Author: Alexis Bruno, Doctor of Pharmacy Candidate graduating May 2017 from Albany College of Pharmacy and Health Sciences.

Reviewed and approved by:  Jessica Farrell, PharmD.  Clinical Pharmacist, The Center for Rheumatology/Associate Professor, Albany College of Pharmacy and Health Sciences

 

References

  1. Center for Biologics Evaluation and Research. What Are “Biologics” Questions and Answers [Internet]. U S Food and Drug Administration. Center for Drug Evaluation and Research; 2015 [cited 2017Mar26]. Available from: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm133077.htm
  2. Center for Drug Evaluation and Research. Information on Biosimilars [Internet]. U S Food and Drug Administration. Center for Drug Evaluation and Research; 2016 [cited 2017Mar26]. Available from: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/
  3. Biosimilars: More Treatment Options Are on the Way [Internet]. U S Food and Drug Administration. Office of the Commissioner; 2016 [cited 2017Mar27]. Available from: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm436399.htm
  4. What is a biosimilar medicine? Supplemental Guide. NHS England. 2015 September 24.
  5. How biosimilars are approved [Internet]. 2017 [cited 2017 May 1]. Available from: http://www.amgenbiosimilars.com/the-basics/how-biosimilars-are-approved/
  6. Christl L. Biosimilar product labeling [Internet]. U S Food and Drug Administration. Center for Drug Evaluation and Research; 2016 [cited 2017Mar27]. Available from: https://www.fda.gov/Drugs/NewsEvents/ucm493240.htm
  7. Center for Drug Evaluation and Research. List Of Licensed Biological Products With (1) Reference Product Exclusivity And (2) Biosimilarity Or Interchangeability Evaluations To Date. US Food and Drug Administration, 2017. [cited 2017 May 1] Available from : https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM549201.pdf

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