Biosimilar Adoption for Humira in 2023

NCPA Multiple Locations Conference Panel Discussion Part 2 of 2

On February 25, 2023, President of PAAS National®, Trent Thiede, had the privilege of participating in a Panel Discussion entitled Marketplace Prescription Dynamics Sure to Shape Your Business Strategies. While traversing several different topic areas, there are two core issues that are important for PAAS members: discount/cash cards and biosimilar adoption in 2023. PAAS Audit Assistance members can see Discount/Cash Cards Are Disruptors in the Industry from our March Newsline.

While Semglee® was the first interchangeable biosimilar to market back in 2021, Humira has been grabbing attention because of its status as the pharma-GOAT: Greatest Of All Time (in terms of sales) as coined by Doug Hoey from NCPA. If you’re not familiar with the onslaught of biosimilars, reference this chart below from Cardinal Health’s biosimilar landscape overview. To summarize, there are 8 FDA approved biosimilars, and 5 more pending FDA approval. Cyltezo, which should be coming to market this summer, has been approved as an interchangeable biosimilar. Four additional products referenced are seeking interchangeability status.

FDA Approved

Product Company Estimated launch Concentration Seeking interchangeability Citrate free Latex free Needle size
Amjevita™ Amgen January 31, 2023 Low (50MG) No Yes Yes 29G Syr. / 27G Pen
Hadlima™ Organon July 1, 2023 Low (50MG) No No Yes 29G Syr. / 29G Pen
Cyltezo™ Boehringer
Ingelheim		 July 1, 2023 Low (50MG) Yes, Approved
October 18, 2021		 Yes No 27G Syr. / 27G Pen
Yusimry™ Coherus July 1, 2023 Low (50MG) No Yes Yes Unknown
Hulio™ Viatris July 31, 2023 Low (50MG) No Yes Yes 29G Syr. / 29G Pen
Hyrimoz™ Sandoz July 1, 2023 Low (50MG) No No No 27G Syr. / 27G Pen
Abrilada™ Pfizer November 20, 2023 Low (50MG) Yes Yes Yes 29G Syr. / 29G Pen
Idacio™ Fresenius Kabi September 30, 2023 Low (50MG) No Yes Yes 29G Syr. / 29G Pen

Pending Approval

Product Company Estimated launch Concentration Seeking interchangeability Citrate free Latex free Needle size
SB5-HC Organon July 1, 2023 High (100MG) Yes Yes Yes 29G Syr. / 29G Pen
AVT-02 Teva July 1, 2023 High (100MG) Yes Yes Yes Unknown
Yuflyma Celltrion July 1, 2023 High (100MG) No Yes Yes 29G Syr. / 29G Pen
ABP – 501 HC Amgen TBD High (100MG) Yes Yes No 29G Syr. / 27G Pen
Hyrimoz HCF Sandoz July 1, 2023 High (100MG) No Yes No 27G Syr. / 27G Pen

While Amjevita™ came to market in January, pharmacies need to be cognizant that it is a biosimilar but does not have interchangeability status. PAAS Audit Assistance members can see Biologic Drug Substitution in this month’s Newsline for additional information on biologic substitutions.

Biosimilar adoption relies, at least in part, on pharmacists. There was a report issued by Cardinal Health that identified > 60% of dermatologists, rheumatologists, and gastroenterologists would NOT feel comfortable prescribing a biosimilar if it did not have the interchangeability designation. Pharmacists can think of these biosimilars as alternative brands. There’s not likely to be great uptake in market share unless providers are aware and more willing to prescribe.

Additionally, OptumRx, Express Scripts and Prime Therapeutics are keeping Humira on formulary at parity with biosimilars, meaning patients won’t have a financial reason to switch. Why change to a biosimilar if you can continue to take Humira for no additional cost? Perhaps patients new to therapy could try a biosimilar first, but it seems to reason that adoption will be slow in 2023.

PAAS Tips:

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Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.

  • Access Services
    • Audit Documentation Submission Guidance
    • An online form to submit safe filling and billing questions
    • Your PAAS Membership Manual
  • Newsline
    • Monthly newsletter articles, written by our expert PAAS analyst team, provide safe filling and billing tips and relays relevant/current PBM trends to be help prevent audits
    • Search the Newsline Archive to get PAAS tips at the click of a button
    • Special Edition Newslines including: Top 10 articles of the prior year, DMEPOS Article Series and a Self-Audit Article Series
    • Ability to print monthly issues or individual articles
  • Proactive Tips
    • Audit flags – list of various claim attributes the PBMs use to select claims for audit
    • Billing insulin vials – flowchart to assist whether you should bill Medicare Part B vs Part D
    • DAW Codes Explained – use to understand when to effectively use DAW codes, their definitions and why claims may be flagged for audit if a DAW code is used incorrectly
    • Basic DMEPOS documentation guidance
    • Onsite Credentialing Checklist and expanded definitions of policies and procedures
    • Proof of refill request and affirmative response form for DMEPOS items
    • Steps on how to prepare for an onsite audit
    • And more!
  • Days’ Supply Charts
    • Utilize the days’ supply charts for inhalers, insulins, nasal sprays, eye drops and topicals to aid you in calculating the correct days’ supply
    • Guidance on overbilled quantities and incorrect days’ supply account for a sizable portion of audit chargebacks
    • Additional miscellaneous charts, which include: Dispense in Original Container and Return to Stock
  • Forms
    • Signature Logbook for print
    • Signature Trifold Mailer
    • Fax and Email Coversheet
    • Patient Attestation for over-the-counter COVID-19 test kits
  • On-Demand Webinars
    • Short webinars on hot topics in the PBM industry. Here are a few examples:
      • USP 800 Compliance
      • Cultural Competency Training
      • Dispensing Prescriptions Off-Label
      • Biologic Medications and Interchangeability
      • Continuous Glucose Monitor Requirements for Medicare Part B

PAAS Tips:

  • MORE AUDITS, MORE INSIGHT – PAAS National® is the industry-leading defender of community pharmacy dealings with Prescription Benefit Programs, including Caremark, Express Scripts, Humana, Medicaid, OptumRx, Prime Therapeutics., and more. PAAS assists on all third-party audits, including: desktop audits, onsite audits, invoice audits, OIG/Medicaid audits, Medicare B audits. The PAAS team is dedicated to helping you! We have five pharmacists and a complement of technician analysts with over 50 years of dedicated audit assistance experience. PAAS continuously updates their database with every audit received — in fact, we even keep a scorecard on individual auditors.
  • Get answers to your questions on days’ supply calculations, drug substitutions, billing practices, required documentation, prior authorization requirements, record retention, and internal audit procedures – just to name a few. As a trusted partner, we will provide tailored guidance to help you proactively prevent audits. Remember, the prescription claims you submit today are the audits of the future.
  • Keep your employees engaged and help lower audit risk by adding all employees to the portal and giving them permission to access these tools, resources and eNewsline. For more information review September 2019 Newsline article, What Are You Waiting For? Make Sure ALL of Your Employees are Added to the PAAS Portal!
  • Contact PAAS at (608) 873-1342, if you would like a tour of your PAAS Member Portal, so you can reap all the benefits of your PAAS Audit Assistance. We appreciate you being a member.

Trent Thiede, PharmD, MBA
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