14 minute read
Strategies for boosting biosimilar uptake
Up to 70% adoption rates, millions in savings reported
Strategies for Boosting Biosimilar Uptake
Use of biosimilars could increase if stakeholders, from manufacturers to payors and pharmacists, united to employ all the tools at their disposal, an expert told attendees of the 2021 virtual annual meeting of the Academy of Managed Care Pharmacy (AMCP).
Hospitals and health systems that have taken part in comprehensive approaches to biosimilar utilization report enjoying full adoption of biosimilar use and saving millions of dollars every year, according to Catherine Pham, PharmD, MPH, a postdoctoral fellow in pharmacoeconomics and policy at Kaiser Permanente, in Los Angeles.
“Education, communication and collaboration among stakeholders are key strategies to drive utilization of biosimilars,” Dr. Pham said.
On the regulatory end of the stakeholder spectrum, the FDA and Federal Trade Commission took a step to address biosimilar adoption in early 2020, when they committed to working together to regulate false or misleading promotional statements regarding the drug class (bit. ly/3aOD1mX).
As for the nature of the false or misleading claims, examples can be seen in a Citizen Petition that Pfizer sent to
the FDA in 2018. Pfizer, which manufactures several biosimilar products, including infliximab-dyyb (Inflectra) and filgrastim-aafi (Nivestym), cited statements by several reference biologic manufacturers which suggested that patients often react differently to biosimilars than to their reference products (bit.ly/3nJRIwV). The petition also cited a YouTube video that indicated switching between a biologic and biosimilar “is not a good idea if your medicine is working for you.”
What Providers Can Do
For their part, providers can use formulary policies to encourage use of biosimilars, Dr. Pham noted. “A biosimilar can be officially preferred for use in treatment-naive patients, and policies can also be put in place to switch patients from a reference product to a biosimilar,” she explained.
Dr. Pham said such policies are more likely to succeed if providers have tools built into the electronic health record to guide prescribing and workflow. These tools and others, including therapeutic equivalence protocols, are most effective when developed by pharmacists in collaboration with providers, she noted. At Boston Medical Center, for example, pharmacy leaders established therapeutic equivalence for a switch from reference infliximab (Remicade, Janssen) to infliximab-dyyb (Inflectra, Pfizer) for inflammatory bowel disease (J Manag Care Spec Pharm 2020;26[4]:410-416). This protocol included gathering European and American clinical evidence on the efficacy of infliximab–dyyb, consulting with European providers about their
experiences switching to the biosimilar, and documenting outcomes in their adult IBD patients after switching to the biosimilar and in those remaining on the reference biologic. The strategy resulted in a 97% switch rate to infliximab-dyyb.
What Payors Can Do
Dr. Pham said payors can play their part in increasing uptake by using shared savings programs and other tools to incentivize biosimilars billed through the medical benefit. She anticipates more biosimilars to be processed through the pharmacy benefit in coming years and, for these products, “familiar strategies like formulary tiering, prior authorizations and step therapy requirements can be leveraged to place biosimilars on the same playing field as reference products.”
Data from Magellan Rx Management, in Phoenix, demonstrated that step therapy is indeed one of the most effective strategies that plans can use to encourage biosimilar uptake. “In our analysis, we’ve seen that plans that implement a step therapy policy at the time of biosimilar launch and that have also taken proactive steps like provider outreach, consultation with key opinion leaders, and having P&T committees develop biosimilar-first clinical policies have been able to take the greatest advantage of the savings potential of biosimilars,” Jim Rebello, PharmD, Magellan’s vice president of specialty strategy, told AMCP meeting attendees in a separate presentation.
The analysis found that plans using step therapy achieved 68% and 70% adoption of biosimilar versions of bevacizumab and trastuzumab, respectively, one year after their launch, and 39% uptake of biosimilar versions of rituximab in the nine months after launch. In contrast, plans without a biosimilar step therapy requirement had 13% and 16% uptake of biosimilar versions of bevacizumab and trastuzumab, respectively, and 9% uptake of biosimilar rituximab during the same periods.
Deep Discounts
With the study showing 25% to 40% discounts for biosimilars compared with their reference biologics, plans that don’t use step therapy requirements and maximizing uptake would do well to reconsider their approach, Dr. Rebello suggested. “We’re seeing some natural uptake across all plans, but with a membership size of around 2.3 million lives, the plans with a parity policy are potentially losing out on around $30 million in annual savings.”
—David Wild
The sources reported no relevant fi nancial disclosures.
—Catherine Pham, PharmD, MPH
Boosting Home Pay
continued from page 1
“When clinicians don’t know the basics of how services are reimbursed, it can have a significant impact on both patient care and financial outcomes.”
Dr. Garst urged all clinicians to develop a basic understanding of the payor-source makeup of home infusion pharmacy revenue by organizational structure, which includes four primary pools: commercial payors (47.5% of home infusion revenue, according to NHIA data), Medicare Part D (13.6% of revenue), Medicare Part B (8.9%) and Medicaid (5.33%), with other sources making up the remainder.
“If clinicians can master this information, they will better understand what questions to ask of their patients,” he said. “For example, Medicaid plans vary from state to state and are typically adequate for drugs and services, but they are dependent on a drug’s NDC [National Drug Code] and vial sizes. So, changing vial sizes at will can create negative downstream consequences for the revenue cycle.”
The home infusion pharmacy clinical team also should be aware of the life cycle of a medication’s PA, Dr. Garst noted. “Just because you had a PA previously does not mean it is still good. If your clinicians don’t have access to the authorization or payor fields in the electronic record, then there needs to be another way that they are kept informed as to when a PA expires, such as an alert or user-defined notation that is easily visible during the ongoing management and dispensing process.”
PAs are an area in which it’s particularly important for the revenue cycle team and clinical team to work together, Dr. Garst said. If, for example, there is a delay in obtaining a home infusion PA for a high-cost drug, what are the options for the patient? Is it acceptable to skip or delay a dose while waiting for the PA, or should an alternative site of care be used, such as the hospital outpatient department, until the PA is in place?
Billing for drug waste—defined as the amount of drug discarded and not administered—also requires education for pharmacists and technicians. “You need a training process for your staff to ensure that the compounding record accounts for any waste,” Dr. Garst said. “The clinical team should know that there are times when vial size is very important.”
As an example, a patient is prescribed drug A at a dose of 860 mg every two weeks. Drug A is available in two vial sizes, 100 and 400 mg. Prescribing three 400-mg vials yields a total dose of 1,200 mg, resulting in waste of 340 mg. Alternatively, prescribing two 400-mg vials plus a single 100-mg vial yields a total dose of 900 mg and waste of only 40 mg. “Vial selection as illustrated in the first option could trigger a payor audit as to why so much drug is being wasted,” Dr. Garst said. “Randomly interchanging vial sizes can be a nightmare for the revenue cycle team. I saw this happen sometimes even after training my team. It seems elementary but can easily get lost in the shuffle of other items clinicians are working on.”
Many payors now require the use of “level of effort” (LOE) codes for compounded medications. These complexity codes, defined by the Agency for Healthcare Research and Quality, range from 1 to 5, with 1 representing minimal complexity and/or requiring only one to four minutes of a pharmacist’s time. An LOE designation of 5 is reserved for very highrisk services that involve extensive diagnosis or treatment options, an exceptional amount or complexity of data, and/or requiring 60 minutes or more of the pharmacist’s time. “It’s important to ensure that both the intake team and the clinical team understand [these LOE] designations,” Dr. Garst said. “Not all payors require it, so the best practice is to use it. If the claim is rejected, it should say why, and then you can adjust accordingly.”
These processes can be improved with templates to facilitate consistent capture of data regarding therapy or drug class, method of administration, physician orders and refills, Dr. Garst said. “Most electronic records have the capability for dropdowns, checkboxes and limited free text, but some providers don’t use these functions. They provide consistent documentation for all parties involved and help you better meet payor requirements.”
Watch Your Data
Claims rejections are not something that happens at the whim of CMS; the culprit usually is faulty documentation, noted Greg Miller, RPh, a senior consultant with BluePeak Advisors, a division of Gallagher Benefit Services and a Medicare compliance consulting firm. That’s why it is crucial for providers to critically review their data before submission. This is particularly important with formulary administration (FA) and coverage determinations, appeals and grievances (CDAG), Mr. Miller said. Ensure that universes are within the time frame that CMS plans to study. Be certain that coding is correct and that PA effectuations have not been entered into the claims adjudication system incorrectly—a top finding in FA audits. Also review calls to make sure any CDAG cases are handled and classified correctly, and that member letters are easy to understand and include elements such as the language preferred by the member and appeal rights information.
Bonnie Kirschenbaum, BSc, MS, a pharmacy consultant specializing in reimbursement and a member of the Specialty Pharmacy Continuum advisory board, agreed that data integrity is key to maximizing reimbursement. She expects the growth of home care to continue.
“As the move away from inpatient services to alternate sites of care continues, a variety of home infusion services become attractive offerings both to patients and providers,” Ms. Kirschenbaum said. “However, success depends on knowing the intricacies and requirements of each payor and building these into both your clinical and revenue systems to provide appropriate, safe clinical care and be paid. There are no shortcuts here, just lots of methodical step-by-step development to get to this point.”
For a primer on key aspects of payment, Ms. Kirschenbaum suggested accessing her “Fundamentals of Drug Reimbursement: An Online Tool Kit to Build Your Expertise!” at www.pharmacypracticenews.com/ToolKit.
—Gina Shaw and Karen Blum
The sources reported no relevant fi nancial relationships other than stated employment.
Prevent Legal Risk by Avoiding These 5 Home Infusion Documentation Pitfalls
Home infusion providers can protect themselves from legal exposure by heeding several common errors in documenting therapeutic encounters, said Elizabeth Rudolph, JD, MSN, RN, the founder and CEO of Jurex Center for Legal Nurse Consultants, during the 2021 virtual annual meeting of the National Home Infusion Association. Among the common mistakes she described are the following: 1. Not documenting contemporaneously. “Whenever possible, you should document the encounter contemporaneously rather than summary charting at a later point in time,” Ms. Rudolph said. “Contemporaneous is more credible in court. However, sometimes it happens that you will have to make a late entry, which is superior to no entry at all. If you have to make a late entry in the record, follow your organization’s policies and procedures about such entries. Be sure to indicate that it is a late entry so that it does not appear that you have something to hide.” 2. Using unfamiliar terminology. Ms. Rudolph described the case of a home infusion nurse who had checked a box in the medical record, indicating that a patient was “diaphoretic” (excessive sweating/clammy skin). During examination in court, she was asked what “diaphoresis” means, and was unable to answer. “Only use a term if you are very familiar with it and all of its variations,” Ms. Rudolph said.
3. Using vague language. “When you use vague terms such as ‘appears to’ or ‘seems to,’ it calls your credibility into question,” Ms. Rudolph said. “How you put words together tells a lot about you. Be factual and objective.” 4. Using colloquial abbreviations. “Documentation should contain commonly understood medical abbreviations only,” Ms. Rudolph said. “Don’t use terms like ‘FF’ for ‘frequent flyer.’ That kind of thing does not fly with a jury.”
5. Keeping a separate personal diary about clinical
encounters. “Such a diary is discoverable in court and is usually not privileged, and it shows that you’re concerned about being sued,” Ms. Rudolph said. “Be very careful about keeping your own notes. The question will arise: Why didn’t you include this in your charting? It’s not a good look to have separate notes.
“The health care environment today is much more litigious than it once was. Any patient, at any time, could sue you,” Ms. Rudolph said. “It’s important to know the landscape and the land mines along the way. The medical record is the first piece of evidence anyone suing you will get. You will need solid documentation to rebut any allegations against you and reduce your liability.”
Slow Rebound for Drug Sales in 2021
The first few months of 2021 have been marked by a slow rebound in prescribing and drug sales, with effects varying by specialty area, according to new IQVIA data presented at the 2021 virtual annual meeting of the Academy of Managed Care Pharmacy.
Doug Long, the vice president of industry relations at IQVIA, said significant drops in provider visits and ongoing use of telehealth are two of the main reasons why he projected a net loss of
111 million prescriptions through June 2021, or a 3.8% reduction compared with the expected number of prescriptions during a normal year.
“During the lockdowns, it was almost impossible to see a doctor,” Mr. Long said. Indeed, in 2020, there were 1 billion fewer provider visits that would normally lead to a diagnosis, representing roughly a 21% reduction in the expected number of “diagnosis visits,” he noted.
“The biggest gaps in diagnosis visits were for people who didn’t go see their oncologist, didn’t go see their gastroenterologist, their dermatologist or their ophthalmologist, which means they didn’t get their PSA [prostate-specific antigen], their mammograms and those sorts of diagnostic procedures,” Mr. Long said.
“The good news is that, in 2021, we expect diagnosis visits to be down 12% more than what one would expect during a typical year, which is certainly better than last year, but that’s still a gap of 288 million diagnosis visits,” he told attendees. “So we’re not out of the woods yet.”
The greatest projected decreases in prescriptions through June 2021 will be in oncology (30% lower than expected) and pediatrics (45% lower than expected), with a nearly absent cough, cold and flu season, accounting for much of the drop in prescriptions in the latter group.
Growing specialty drug sales have been a bright spot in medication spending during the pandemic, Mr. Long said, with spending in this area increasing by a moving annual total (MAT) of 7% by February 2021, compared with a 2% MAT growth in sales of traditional medications during the same period.
Sales of cancer drugs, immunologic agents and diabetes medications saw the greatest increases in 2020, collectively accounting for 63% of absolute global growth in drug sales, he said.
Telehealth
One trend affecting prescribing patterns is the increased use of telehealth, an approach that “is here to stay, but is yet to be seen how much of a role it will play,” Mr. Long said. “The challenge with telehealth is that it does not generate nearly as many new prescriptions as a regular doctor visit or a regular institutional visit would, and that’s probably because people spend less time on a telehealth call and doctors are less willing to initiate new therapy. But probably the primary reason for that is the lack of taking vitals and diagnostic tests and things of that sort.”
—David Wild
The sources reported no relevant fi nancial disclosures.
A net loss of 111 million
prescriptions is projected through June 2021, 3.8% down
from a non-pandemic year
Free CME now available! Free CME
0.25 AMA PRA Category 1 Credit™ per module
Emerging Strategies in Relapsed/Refractory Multiple Myeloma
A three-part CME activity
RELEASE DATE: NOVEMBER 20, 2020 EXPIRATION DATE: DECEMBER 31, 2021
This activity is jointly provided by Global Education Group and Applied Clinical Education.
This activity is supported by an educational grant from Sanofi and Karyopharma.
Distributed via CMEZone.com and Audioeducate.com
Want to take this activity on your Amazon Alexa device? Try the CMEZone skill. Just say “Alexa, enable CMEZone” on your voice activated device. Instructions to claim CME credit will be given during the survey at the end of each module.
Faculty Shaji Kumar, MD
Professor of Medicine Consultant, Division of Hematology,
Department of Internal Medicine Mayo Clinic Cancer Center Rochester, MN
