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DMARDs

Diseases and Conditions Journal Club

Take the Guess Work Out of Biologic Rheumatoid Arthritis Choice

April 9, 2024

Rheumatoid arthritis (RA) is a chronic inflammatory disorder that not only affects the joints but can exert systemic influence, potentially impacting various body systems. The journey through RA treatment is unique for each individual, necessitating a personalized approach. Enter precision medicine for rheumatoid arthritis—the practice of tailoring treatment to the individual characteristics of each patient.

Today we delve deep into how molecular signature testing is revolutionizing treatment decision-making in RA.

Understanding Molecular Signature Testing

Within precision medicine for rheumatoid arthritis, molecular signature testing is emerging as a novel way we can identify whether individuals might benefit from certain biologic medications. The molecular signature is essentially a unique ‘barcode’ of gene expression within an individual’s immune cells. This can predict the body’s response to different treatments.

The Study At Hand: A Pivotal Discovery

Recently, a critical study titled “Patient outcomes improve when a molecular signature test guides treatment decision-making in rheumatoid arthritis,” published in the Expert Review of Molecular Diagnostics, has provided substantial evidence supporting the integration of molecular signature testing in managing RA.

In the study, researchers elucidated the role of a specific test—the Molecular Signature Response Classifier (MSRC). The MSRC is designed to predict whether patients with RA will respond to tumor necrosis factor inhibitor (TNFi) therapies, a common class of biologic drugs used in treatment. These medications include Enbrel, Humira, Cimzia, Simponi, and Remicade as well as their biosimilar equivalents.

Unlocking Personalized Treatment Strategies

Biologic medications, which target specific components of the immune system, have transformed the landscape of RA treatment. However, the response to these drugs can vary significantly among patients—a challenge that precision medicine for rheumatoid arthritis seeks to address.

The Molecular Signature Response Classifier (MSRC) test functions as a sophisticated investigative tool employed to decipher the intricate workings of your immune system, particularly in relation to rheumatoid arthritis (RA). At its core, the MSRC examines the patterns of gene expression, which can be envisioned as the “on” or “off” switches of genes within your immune cells. These patterns can provide crucial insights into your body’s unique response to specific medications, specifically tumor necrosis factor inhibitors (TNFis)—a class of biologic drugs frequently utilized in RA treatment.

By measuring these gene expressions, the MSRC can predict with a remarkable degree of accuracy whether your body is likely to respond favorably to TNFis, thus avoiding the potential trial and error associated with medication effectiveness. This personalized approach not only guides your healthcare provider in selecting the most appropriate treatment for your condition but also reflects a conscientious and empathetic stride towards optimizing your healthcare experience, minimizing unnecessary interventions and focusing on treatments that align with your body’s individual genetic makeup.

The study showcases how MSRC testing can predict the efficacy of TNFi medications for individuals with RA. This innovative approach posits that using a patient’s molecular signature could improve rates of remission and help in selecting the most fitting biologic therapy.

Simply put, it seeks to take the guess work out of biologic therapy choice.

The Research Outcomes: A Patient-Centric View

Improving Patient Journeys

By analyzing a pooled cohort of patients who were subjected to MSRC testing to guide biologic therapy selections, the study demonstrated a significant improvement in patient outcomes, notably in remission rates and achieving low disease activity. Specifically, patients in the MSRC-tested arm achieved higher proportions of clinical disease activity index (CDAI) low disease activity or remission (CDAI-LDA/REM) and remission alone (CDAI-REM), compared to those in the external control group, over a six-month period. Furthermore, a notable improvement was observed in minimally important differences (MID) in CDAI scores, indicating a meaningful reduction in disease activity from baseline.

The Promise of Precision Medicine in Action

Each RA patient’s battle is distinct, often filled with trials and adjustments in treatment regimens. The clear message from this research is that precision medicine for rheumatoid arthritis, epitomized by molecular signature testing, can facilitate a more targeted treatment approach—a leap forward from the one-size-fits-all strategy.

What This Means for You: Precision Medicine’s Role

Contemplating Biologic Treatment Options

If you are considering initiating biologic therapy or are reevaluating your current regimen, precision medicine for rheumatoid arthritis offers a scientific beacon. By assessing your unique molecular signature, clinicians can better forecast which therapy aligns with your body’s intrinsic biology.

Precision Medicine for Rheumatoid in Clinical Practice

The clinical implications are considerable. The integration of molecular testing in treatment planning could not only enhance patient outcomes but potentially streamline the therapeutic trajectory, reducing the trial-and-error approach that many patients and their doctors face.

Collecting the Pieces: The Broader Implications

Beyond Individual Outcomes

Precision medicine’s implications extend beyond individual patient care not only for rheumatoid arthritis but also other autoimmune conditions such as multiple sclerosis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, etc. This paradigm has the potential to enhance healthcare resource utilization by optimizing medication selection and reducing the economic burden of ineffective treatments.

Concluding Thoughts: The Precision Medicine Landscape

As we navigate the intricate landscape of RA, molecular signature testing stands as a promising lighthouse, guiding us towards safe harbors of effective treatment options. By embracing the tailored approach that precision medicine for rheumatoid arthritis offers, we can look forward to a future where patients are not only treated but understood on a molecular level.

Call to Action: Partner with Precision

If you are at a crossroads in your RA treatment journey, consider discussing molecular signature testing with your healthcare provider. It is a step towards a personalized treatment plan crafted with your unique genetic makeup in mind, offering the potential for improved outcomes and quality of life.

References

Molecular Signature Testing: PrismRA

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 advise you to speak with your medical professional if you have questions concerning your symptoms, diagnosis, and treatment.

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.