Biosimilar Advancements: Understanding the Latest Updates on Humira® with Cyltezo® and Abrilada™

At the time our April 2023 Newsline article Biosimilar Adoption for Humira® in 2023 was published, eight FDA biosimilars for Humira had been approved, and five more were pending approval. As of June, three additional biosimilars are in the market and three are still pending FDA approval. In October, Abrilada™ was granted FDA approval as an interchangeable biosimilar. Now, Abrilada™ along with Cyltezo® are the only two biosimilars that are interchangeable with Humira® without the intervention of the prescribing physician, depending on state pharmacy laws. The chart below

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from Cardinal Health’s biosimilar landscape overview provides a convenient summary.

FDA Approved

Product Company Estimated launch Interchangeability Designation Approved Citrate free Latex free
Abrilada™ Pfizer November 2023 Yes Yes Yes
Amjevita™ Amgen January 31, 2023 No Yes Yes
Cyltezo® Boehringer
Ingelheim		 July 1, 2023 Yes Yes No
Hadlima™ Organon July 1, 2023 No No Yes
Hadlima™ Organon July 31, 2023 No Yes
Hulio® Viatris July 31, 2023 No Yes Yes
Hyrimoz® Sandoz July 1, 2023 No No No
Hyrimoz® Sandoz July 1, 2023 No Yes No
Idacio® Fresenius Kabi July 2023 No Yes Yes
Yuflyma® Celltrion July 1, 2023 No Yes Yes
Yusimry™ Coherus July 1, 2023 No Yes Yes

Pending Approval

Product Company Estimated launch Seeking interchangeability Citrate free Latex free
Amjevita™ Amgen 2024; Phase III trials Yes Yes No
AVT-02 Teva Pending FDA approval Yes Yes Yes
MYL-1401A Mylan Phase III trials

PAAS Tips:

  • Not all biosimilars are interchangeable
  • When the FDA grants an interchangeable biosimilar designation, this means the biosimilar meets additional data requirements proving patients who alternate between the reference product and the biosimilar will have the same clinical result as patients who are being treated with the reference product alone
  • Abrilada™ is expected to be in the market at the end of November 2023
    • PAAS National® will update our Biologic Injectable Medication chart when Abrilada™ available
  • Some large payers are keeping Humira® on formulary for 2023, but others may not
    • Watch for soft rejects alerting pharmacies to preferred biosimilars
    • PBMs may allow Humira® to process, but severely underpay the claim. Try to bill the interchangeable biosimilar first, watching claim adjudication logic, and then consider Humira DAW 9, as appropriate

Audit Target: Linzess® Prescriptions

PAAS National® analysts have noticed an increase in audits targeting Linzess®. Linzess® is a focus of PBM audits not only because of the high cost, but also the manufacturer dispensing requirements. Not following FDA approved guidelines when dispensing this medication will likely result in full recoupment.

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Allergan, the manufacturer of Linzess®, has not provided evidence to the FDA for the safety and efficacy of this medication outside the original container. PAAS has reached out to Allergan looking for additional stability information to appeal audit recoupments; however, they have only confirmed the current requirements. Pharmacies can visit DailyMed for medication information, including How Supplied/Storage and Handling requirements under Section 16 of the drug label information.

While Linzess® is not the only medication required to be dispensed in the original container, it is frequently prescribed for patients in long-term care and for those who have medications in compliance packaging. Unfortunately, there are no exceptions for these situations, and the original container must be given.

Billing Linzess® for quantities other than increments of 30 capsules will make the claim an easy audit target for any PBM to identify the medication was not dispensed in the original container. This is true for many other medications with specific dispensing requirements as well. PAAS has created our Dispense in Original Container Chart, based on the medications we frequently see audited. You can find this and many other Day Supply Charts and Proactive Tips available on the PAAS Member Portal.

PAAS Tips:

  • When receiving a prescription of Linzess® written for a quantity less than 30 capsules, consult with the prescriber to discuss packaging requirements and obtain authorization for an appropriate quantity
  • Check all current prescriptions for Linzess® to ensure they are being dispensed per FDA guidelines
  • Consider adding shelf tags to this medication to flag pharmacy personal of requirement
  • Check if your software vendor can create an alert when NDCs are billed for quantities not valid with package size
  • Remember the Medicare Part D “short cycle dispensing” requirement to dispense no more than a 14-day supply on brand name oral solid medications in LTC settings has an exclusion for products that must be dispensed in their original container
  • Notify and discuss with LTC facilities the packaging requirements of this medication
  • Patients with compliance packaging will need to be educated on the importance of keeping this medication in the original container
  • Self-audit claims on a weekly or monthly basis to ensure appropriate dispensing

NEW PAAS Resource – Printable Signature Logbook

Many pharmacies have made the switch to electronic signature log capture, but paper signature logs have not gone away. Some pharmacies choose to maintain all signature logs through a paper log but those with an electronic signature capture system may still find themselves with the need for a paper signature log. Common reasons for paper logs include:

  • Electronic system outage
  • Curbside pick up
  • Delivery

To aid our member pharmacies in having appropriate documentation on their paper signature logs, PAAS National® is now offering a free printable signature book. To access this new tool, log onto the PAAS Portal, visit the Forms tab then download and the 400+ page Signature Logbook. Send the pdf to your local print shop and have them create a bound book. The form includes a place to document the date filled, acceptance or refusal of a consultation, prescription number, third party program, date picked up, signature, and more!

PAAS Tips:

  • Print at least one copy of the Signature Log Book to be used in the event of a system outage
  • An order form for the PAAS National® bound signature logbook is no longer required; simply log into the PAAS Portal and download the pdf of the Signature Logbook free of charge

OTC COVID-19 Test Prescribing Authority

Some pharmacies are wondering if they are allowed to continue prescribing OTC COVID-19 tests. The eleventh amendment to the Public Readiness and Emergency Preparedness Act (PREP Act) was issued on May 12, 2023 and extends PREP Act coverage through December 31, 2024 to allow licensed pharmacists to order and administer COVID-19 countermeasures including COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests.

Coverage for OTC COVID-19 tests varies by payer. See summary below:

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  • Medicare Part B coverage ceased as of May 12, 2023
  • Medicare Advantage plans may cover and pay for OTC COVID-19 tests as an added benefit
  • Medicaid coverage should continue through September 30, 2024
  • Commercial insurance coverage will vary; however, plans are not required to cover after May 11, 2023

PAAS Tips:

  • The eleventh amendment to PREP Act extends pharmacist prescribing authority through end of 2024
  • Point-of-sale edits should be relied upon to understand if OTC product is covered
  • Only dispense OTC COVID-19 tests upon patient request – do not autofill
  • Ensure you retain documentation of patient request using PAAS’ Attestation form

PAAS Battles MedImpact for DAW 0 Reimbursement on Semglee®

MedImpact sent a memo to network pharmacies dated May 22, 2023, with the subject line Semglee-YFGN (Preferred U-100 Long Acting Insulin). For their participating Medicare Part D plans, MedImpact requested pharmacies to dispense Semglee® (YFGN) at the brand reimbursement. Other insulin glargine products were considered non-formulary with a claim rejection response. The memo goes on to indicate that this ‘brand’ claim must be submitted with a DAW of 9 to get correctly reimbursed, meaning pharmacies that use a default DAW 0 could be incorrectly paid!

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Over the past several months, PAAS National® has been chiding the MedImpact Clinical Services team about this reimbursement decision and the correct biosimilar terminology and DAW utilization.

As pharmacies may be aware, Semglee® (YFGN) is not a brand, but an interchangeable biosimilar. As such, it does not require a DAW code and requiring a DAW 9 for Semglee® (YFGN) would be incorrect according to NCPDP guidance.

NCPDP description of a DAW 0:

This is the field default value that is appropriately used for prescriptions for single source brand, single biologic, cobranded/co-licensed, generic or interchangeable biosimilar products. DAW 0 is not appropriate for a multi-source branded product with available generic(s) or for a reference product with interchangeable biosimilar(s).

NCPDP description of a DAW 9:

This value is used when the prescriber has indicated, in a manner specified by prevailing law, that generic or interchangeable biosimilar substitution is permitted, but the plan’s formulary requests the brand or reference product. This situation can occur when the prescriber writes the prescription using either the brand, reference product, generic or interchangeable biosimilar name and the product is available from multiple sources.

While MedImpact considers Semglee® (YFGN) a brand for reimbursement purposes, it is classified by the FDA as an interchangeable biosimilar. The DAW code definitions (pasted above) from NCPDP state that DAW 0 would be appropriate. Pharmacies should not be negatively impacted financially for failing to use the DAW 9 code. This is not consistent with the industry and is an inappropriate use of DAW 9. DAW 9 states that an interchangeable biosimilar is permitted, but the Plan wants a brand or reference product. Semglee® is not a reference product in this definition (in reference to biologic drugs), Lantus would be.

After months of back and forth, PAAS was just informed by MedImpact that at the end of August, the POS message referencing DAW 9 for Semglee® (YFGN) was removed from all 2023 and 2024 Part D formularies. They are removing all messaging related to DAW 9 for insulin glargine and referencing “Please Dispense Brand for Generic Copay” with no requirement for a DAW 9 reference.

Your membership in PAAS helps us continue to advocate and fight for fair treatment of independent pharmacies.

Use As Directed – What is Your Attack Plan?

The top audit discrepancy year after year is invalid days’ supply or refill too soon – which are essentially the same issue. Submitting prescription claims with an accurate days’ supply is often the responsibility of a pharmacy technician doing data entry, while pharmacists are focused on clinical accuracy and may not be paying attention to this “clerical” issue. It is important that all pharmacy staff members (technicians and pharmacists) understand the audit implications of submitting an incorrect days’ supply and how each staff member can contribute to success. With that in mind, the pharmacy team can develop an attack plan to be both accurate and consistent.

First, understand …

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that the submission of an accurate days’ supply is important for appropriate claims adjudication and impacts patient copay, pharmacy reimbursement, and PBM refill edits. While PBMs require pharmacies to submit an accurate days’ supply, it may be helpful to think of these implications – knowing why helps pharmacy staff understand the importance and may help justify spending the extra time (where appropriate).

Second, staff must be trained how to perform the mathematical calculations. How would your staff estimate the days’ supply for an insulin or topical cream prescription with a sig of “use as directed”? If each staff member gives you a different answer, then you have an audit problem waiting to happen. In general, days’ supply is simply the total quantity dispensed divided by the daily (or weekly, monthly) dose. Data entry staff should perform the calculations and document, while dispensing technicians and/or verifying pharmacists can double check those calculations for accuracy.

Third, you must have a plan for how to address certain dosage forms where the basic calculation does not come so easily. Common examples include topical creams, vaginal creams, insulin, diabetic test strips, bowel prep kits, migraine meds, starter kits and pancreatic enzymes.

  • If a prescription sig reads “use as directed”, then you don’t have enough information and must contact the prescriber’s office for more information and make a clinical note
  • If a days’ supply is not calculable, consider a maximum daily dose for insulin, test strips and pancreatic enzymes
  • Migraine meds may require an estimated number of headaches per month
  • Starter kits should be confirmed “as directed on package”
  • Confirm dosing for bowel prep kits – remember products generally have a beyond use date of 48 hours upon reconstitution
  • Use the manufacturer dosing calculator for Santyl
  • Leverage PAAS’ days’ supply charts available on the PAAS Portal for insulin, topicals, eye drops, nasal inhalers and oral inhalers

PBM auditors will expect that any clarifications regarding instructions for use end up on the dispensing label to communicate instructions to patients – see this month’s article Auditor’s Latest Trick for Flagging “Misfilled” Prescriptions.

PAAS Tips:

  • Do not rely on the days’ supply field on e-prescriptions alone as it is often incorrect and would not satisfy an auditor (you might even consider the pros versus cons of having e-prescription days’ supply field auto-populate)
  • Make sure that dispensing technicians and verifying pharmacists can “see” the days’ supply during verification, whether performing on screen or reviewing printed “back tags”
  • Consider performing small “self-audits” to spot check your team for accuracy and consistency
  • If you cannot mathematically estimate the days’ supply (with an equation), then an auditor will consider the prescription to be essentially “use as directed” and require more information

$32 Million Kickback Scheme Involving Medicare and TRICARE

According to an August 18, 2023 press release from the U.S. Attorney’s Office, District of New Jersey, a former president of a pharmacy business pleaded guilty to a scheme that violated the Federal Anti-Kickback statute. For a little over 3 years, this individual engaged in fraudulent activity by paying marketing companies to direct prescriptions for expensive medications with high reimbursement to his pharmacies. The marketing companies would identify Medicare and TRICARE beneficiaries and convince them over a recorded phone call to try expensive creams and migraine medications. Then they forwarded these recorded phone calls with a pre-printed prescription pad for the medications with high margins to telemedicine companies. For every beneficiary referred for a prescription, the marketing company would provide a kickback and the telemedicine company would pay the doctors to approve the prescriptions. These prescriptions were then filled at the pharmacies in which they had a kickback agreement. The pharmacies received payment and sent part of each reimbursement to the marketing companies as a kickback. This scheme caused a loss of over $32 million dollars billed to Medicare, TRICARE, and other federal health benefit programs. This violation of the Anti-Kickback Statute has a potential penalty of five years in prison and a maximum fine of $250,000, or twice the gross gain or loss that occurred, whichever is greatest.

Ensure your pharmacy has a robust Fraud, Waste, and Abuse Compliance Program in place for employees to understand the repercussions of violating laws and regulations such as the False Claims Act and the Anti-Kickback laws. Contact PAAS National® for more information on our comprehensive program that is easy to set-up, web based and customized for your pharmacy.

PAAS National® Announces USP 800 Compliance Program

PAAS National® is excited to announce the USP 800 Compliance Program for community pharmacies. Developed by community pharmacists, PAAS brings you a community pharmacy tailored approach to USP 800 operational needs.

“Empowering community pharmacies with best-in-class, web-based programs to ensure employee safety and maintain pharmaceutical standards are at the forefront of our priorities. Compliance with USP 800 reinforces our commitment to community pharmacies in reducing their liability while improving patient safety and upholding the highest industry standards in handling hazardous drugs,” stated Carmen Fusselman, Vice President at PAAS National®. “PAAS will provide you with the information necessary to implement a fully functional USP 800 Compliance Program with the least necessary interruption to your day-to-day business.”

The PAAS USP 800 Compliance Program will reduce a pharmacy’s exposure to hazardous drugs through physical processes, written policies and training to ensure compliance with USP 800.

If you would like more information about PAAS USP 800 Compliance Program, please visit paasnational.com/usp800 or contact PAAS National® at (608) 873-1342 or info@paasnational.com.

Breyna™ – The First FDA Approved Symbicort® Generic With a 0.1 Gram Problem

Breyna™, like Symbicort® is approved as a maintenance therapy for people with COPD and for asthma patients ages 6 and older. For Breyna™ to become a regular generic, the manufacturer (Viatris) had to submit an Abbreviated New Drug Application (ANDA) to the FDA. Viatris had to prove that Breyna™ is comparable to Symbicort® in dosage form, strength, route, quality, performance characteristics, and intended use. Below is a chart comparing Symbicort®, its authorized generic and the new “regular” generic Breyna™ (also known as an ANDA generic).

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Product NDC Labeler FDA Application Number Package

Size (gm)

 Source
Symbicort® 80-4.5 MCG 00186-0372-20 AstraZeneca 021929 10.2 Brand
Budesonide-Formoterol Fumarate 80-4.5 MCG 00310-7372-20 Prasco 021929 10.2 Authorized Generic
Breyna™ 80-4.5 MCG 00378-7502-32 Mylan 211699 10.3 ANDA Generic
Symbicort® 160-4.5 MCG 00186-0370-20 AstraZeneca 021929 10.2 Brand
Budesonide-Formoterol Fumarate 160-4.5 MCG 00310-7370-20 Prasco 021929 10.2 Authorized Generic
Breyna™ 160-4.5 MCG 00378-7503-32 Mylan 211699 10.3 ANDA Generic

PAAS Tips:

  • The Breyna™ inhaler comes in a package size of 10.3 gm, which is different than Symbicort® and its authorized generic that come in a package size of 10.2 gm
    • PAAS would recommend the pharmacy obtain a new prescription for Breyna™ due to the different package sizing. If a prescriber writes for Symbicort® 10.2 gm, one inhaler with 5 refills, a total of 61.2 gm was authorized. If a pharmacy bills and dispenses all 6 fills using the Breyna™ NDC, this would be 61.8 gm total. If audited, a PBM could recoup the last claim due to dispensing an overbilled quantity that was not authorized.
  • See our updated Inhaler Chart on the PAAS Portal
  • What is an Authorized Generic?
    • An authorized generic is the exact same drug product as the brand, including both active and inactive ingredients
    • It is often made in the same facility and on the same equipment as the brand with the generic name on the label instead of the brand name, and sold at a lower price
    • Note that the FDA approval numbers are the same for the brand and the authorized generic
    • Considered to be therapeutically equivalent to its brand-name drug because it is the same drug
  • What is a Regular Generic (ANDA)?
    • An ANDA generic is the same brand-name drug in active ingredients, conditions of use, dosage form, strength, route and for the most part labeling, but may have certain minor differences such as inactive ingredients
    • Typically developed and made by a company other than the company that makes the brand-name drug.
    • Has a different FDA application number than the brand name and authorized generic
    • Must confirm bioequivalence to the brand name
  • See the FDA website for additional discussion on Authorized Generics

Signature Required – Proving Patient Receipt

The Public Health Emergency for COVID-19 ended on May 11, 2023, and PBMs notified pharmacies that they would once again be requiring signatures for proof of patient receipt of medications. Since then, PAAS National® analysts have taken questions about what format signatures logs should take. The following tips should help your pharmacy stay compliant.

PAAS Tips:

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  • Point of sale electronic signature logs should contain:
    • Prescription number
    • Date filled or fill number
    • Date of pick-up
    • Signature of the patient or the representative who picked-up the medication for the patient
  • Delivery logs should contain:
    • Patient name
    • Prescription number
    • Date filled or fill number
    • Date delivered – cannot be pre-printed
    • Delivery address – pharmacy, patient, or facility
    • Signature of the patient or the representative who accepted the delivery
  • Check your delivery logs for a blank date field (i.e., not pre-populated) and consult with your software vendor to add a signature date field (or electronic date stamp), if needed
  • Consider using the PAAS National® Trifold Mailer if unable to get a patient signature upon delivery
  • Pharmacies using manual signature logs should consider downloading and printing the PAAS National® Signature Log Book from the “Forms” tab on the PAAS Member Portal
  • Pharmacies mailing prescriptions have additional requirements to prove receipt
  • Be aware of PBM return to stock policies by using the PAAS National® Return to Stock chart