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NEWS
An Interchangeable Biosimilars vs Authorized Biologics
Battle May Be Looming
Tony Hagen | https://centerforbiosimilars.com
Competitors in the field of adalimumab and insulin products may soon include “authorized biologics” in addition to biosimilars and interchangeable biosimilars, a pharmacy expert explains at the Academy of Managed Care Pharmacy Nexus 2021 meeting.
The FDA has approved 2 interchangeable biosimilars—biosimilars that pharmacists could substitute interchangeably with reference drugs—since July 2021, but manufacturer-developers are seeking interchangeable status for about 7 other biosimilars, according to Jeff Casberg, MS, RPh, vice president of Clinical Development for IPD Analytics.
Casberg participated in a presentation on interchangeable biosimilars at the recent Academy of Managed Care Pharmacy Nexus 2021 meeting in Denver, Colorado.
Interchangeables are potential game changers, but also looming is the possibility of “authorized biologics,” or agents that product manufacturers develop as nonbranded copies of their original drugs, he said.
The theory is that reference product manufacturers will launch authorized biologics to compete against biosimilars and prevent loss of revenues and market share. Presumably, authorized biologics, like biosimilars, would launch at discounts to their reference products. There are no authorized biologics yet, but that seems likely to change soon, Casberg said. The winners in this stuggle may simply be the lowest-cost drugs, he said.
When it comes to pharmacy and therapeutics (P&T) committees and the choice of which drugs are used in health care institutions, the interchangeability designation has some advantage over straightforward biosimilar status, Casberg said. “Realistically, it’s going to come down to cost, but I think interchangeability could be a tiebreaker.”
For some large institutions, it won’t matter whether it’s an interchangeable or not, he said, “if you’re in a hospital or clinic type of facility, you probably don’t need the interchangeability designation. There are policies that guide which products you can interchange as a pharmacist." Then, there are authorized biologics.
“Authorized biologics are interchangeable. They are the same drug, and we don’t call them 'authorized biosimilars.' We call them authorized biologics because calling them authorized biosimilars would suggest biosimilars aren’t quite the same drug, so we call them authorized biologics,” Casberg said.
“Today, we haven’t really seen brand companies have the motivation to bring these authorized products to market, but I think you’ll start to see a few in the future,” he said.
The Interchangeable Pipeline
The drug pipeline is stocked with more potential interchangeables. Semglee, an insulin glargine, that received biosimilar and interchangeable status in July 2021, is a type of a hybrid. It was originally approved in 2020 via a new drug application rather than through the biosimilar regulatory pathway. It references Lantus.
Biocon Biologics and Viatris aim to relaunch Semglee with its interchangeable status and in vial form by the end of the year, at a 5% discount to Lantus and a wholesale acquisition cost (WAC) of $26.94, according to Casberg. However, the goal is also to launch Semglee as an authorized biologic in vial and prefilled syringe versions at a 65% discount to brand, or a WAC of $9.87. That means Biocon Biologics and Viatris are playing the interchangeable and authorized biologic games with the same product, he said.
Several interchangeable biosimilars and authorized biologics could emerge for the reference insulin aspart product Novolog, Casberg said. Those include MYL-1601D, from Viatris, for which biosimilar approval is anticipated in 2021; SAR341402, a Sanofi potential interchangeable, for which no FDA application has yet been filed; and an “interchangeable” authorized biologic candidate, from Novo Nordisk.
Limited exclusivity is awarded to the first interchangeable for a drug type, so if MYL-1601D is approved as an insulin aspart interchangeable, Sanofi’s candidate would not be launchable until 1 year has passed from the first date of marketing of MYL-1601D. The Sanofi product (SAR341402) could be approved in 2022, Casberg estimated.
There is one other authorized biologic pending in the insulin category. Lilly is planning an authorized biologic to follow on its insulin lispro drug Humalog.
Adalimumab Interchangeables
Cyltezo, a biosimilar of adalimumab, referencing Humira, was the second interchangeable approval from the FDA this summer. Soon to follow with an interchangeable approval in the adalimumab biosimilar category could be Abrilada, a Pfizer product, Casberg said.
However, before launching as an interchangeable, Abrilada would have to wait out Cyltezo’s 1-year exclusivity award—which is more complicated than it seems.
Cyltezo’s developer, Boehringer Ingelheim, has a settlement with the maker of Humira, AbbVie, not to bring the product to market until 2023, so that could affect Pfizer’s freedom to make use of the interchangeable designation with Abrilada.
Even before any interchangeable designation, Abrilada has been scheduled for launch as a biosimilar adalimumab in November 2023. It was approved as a biosimilar in 2019.
Another product in the adalimumab biosimilar candidate category is AVT02, from Alvotech. Casberg anticipates this product will launch sometime between 2023 and 2028, given legal hurdles.
AVT02 has the advantage of being a citrate-free, high-concentration formulation version of adalimumab, which would give it footing to compete aggressively against AbbVie’s own citrate-free, high-concentration formulation, which now commands roughly 80% of the market for adalimumab, Casberg said. The other adalimumab biosimilars lined up for US market entry in 2023 are all lower-concentration biosimilars. In addition, Alvotech is seeking interchangeable status for AVT02.
An Authorized Adalimumab?
AbbVie has not announced any intention of launching an authorized biologic of adalimumab to compete with the biosimilar versions, but it has likely been a matter of speculation, Casberg said. “As people who manage formularies and sit on P&T committees and manage budgets, you have to start thinking about how you would manage these authorized biologics if they were introduced to market.
“If we wake up 2 weeks from now and AbbVie says they have launched an authorized Humira at a 20% discount—a year before biosimilars launch—how would you manage that?” he asked. “How would that affect your budget? What would that do to your rebate contracts? Where would you put it on your formularies?”
Other interchangeable biosimilar candidates in the pipeline include NI-071, an infliximab drug from Nichi-Iko, for which interchangeability switching studies have been completed, and ABP 654, an Amgen ustekinumab candidate, which could launch as soon as 2023, Casberg said.
Read the full article here: https://centerforbiosimilars.com
ARTICLE FEATURE
October 27, 2021
AMCP Nexus 2021: A Wrap-Up
Peter Wehrwein | https://managedhealthcareexecutive.com
Disparities, biosimilars and digital therapeutics were among the featured topics at the meeting in Denver that had 1,900 attendees.
Healthcare disparities, biosimilars, and digital therapeutics were among the topics featured at the education sessions of the AMCP Nexus 2021 meeting this week in Denver.
Academy of Managed Care Pharmacy (AMCP) officials said 1,914 people attended the in-person meeting at the Gaylord Rockies Resort and Convention, the first meeting that AMCP has held since AMCP Nexus 2019 meeting in the fall of 2019.
AMCP required attendees to be vaccinated against COVID-19 but also had separate protocol that involved verifying a negative COVID-19 test 72 hours prior the meeting. All attendees were also offered free onsite COVID-19 testing. The meeting had a requirement that people wear masks for indoor activities but from casual observation a large percentage of those in attendance were not wearing masks.
The meeting’s app listed 52 exhibitor and the exhibition hall was teeming with people during the meeting, which started on Monday and ended Thursday. The featured keynote speaker on Tuesday as Sekou Andrews, an inspirational speaker and spoken word artist.
“I had envisioned this meeting as a ‘managed care pharmacy reunion,’ but I didn’t anticipate the electricity that permeated every session and networking experience,” said Susan Cantrell, RPh, CAE, the CEO of AMCP. “It’s a catalyst for the work AMCP is undertaking through our new strategic priorities — optimize value and access, address health disparities, and smart membership growth — to get patients the medications they need at a cost they can afford.”
In addition to the broad themes of the education session, the meeting included poster presentations on research into nuts-and-bolts issues in managed care and manage care pharmacy, such as the economic burden of migraine, the demographics of people who take antiobesity medications and screening for hepatitis C at federally qualified health centers after the start of a pharmacist-led management program of the direct acting antivirals.
The meeting started on Monday with a panel discussion on best practices in addressing healthcare disparities and three other education sessions focused on disparities. Three of the education sessions focused on biosimilars and three others, on digital therapeutics.
In the Monday panel discussion, Aimee Loucks, Pharm.D., BCPS, manager, specialty pharmacy programs and formulary, Kaiser Permanente Washington, described a program to identify whether health plan practices, such as prior authorization and utilization management edits, might inadvertently contribute to healthcare disparities.
In a session on Tuesday, Sharon K. Jhawar, Pharm.D., MBA, BCGP, chief pharmacy officer of the SCAN Health Plan, a Medicare Advantage in Southern California, and Timshel Tarbet, MBA, BSP, CCP, vice president of excellence and diversity, described the health plan’s effort to reduce racial disparities in medication adherence. They both emphasized that dealing with disparities is a process that is not accomplished quickly or perfectly in the first attempts.
“It is a journey — we are learning so much through this process” said Jhawar.
Jeffrey Casberg, vice president, clinical pharmacy, for IPD Analytics, a drug management and market access company, was one of the speakers on biosimilars. “I think the theme is that it seems like the tide is turning, market share is picking up, adoption is picking up,” he said in an interview with Managed Healthcare Executive®.
In the Tuesday afternoon session on prescription digital therapeutics, the panelists were enthusiastic about the data collection inherent to digital therapies. Patrick Gleason, Pharm.D., BCPS, FCCP, FAMCP, assistant vice president, health outcomes, at Prime Therapeutics, said data from digital therapies will make it easier for payers to administer value-based contracts for those therapies.
“The payer can audit if they are concerned about that the information that is being provided back and fulfillment of the terms of the contract,” Gleason said. “But it is a lot less of burden on the payer in value-based contract as result of the way the data is being collected.”
Read the full article here: https://managedhealthcareexecutive.com
ARTICLE FEATURE
October 22, 2021
ARTICLE FEATURE
October 21, 2021
AMCP Nexus 2021: Biosimilars Are Gathering Momentum — and
Interchangeability May Not Matter for Many of Them
Peter Wehrwein | https://managedhealthcareexecutive.com
Consultant Jeffrey Casberg says biosimilars are coming on strong and that interchangeability may not be much for the products dispensed through specialty pharmacies because specialty pharmacies are often in frequent touch with physicians.
Jeffrey Casberg, M.S., RPh, was a speaker at one of the three sessions devoted to biosimilars at the AMCP Nexus 2021 meeting in Denver, and he is not alone in believing that biosimilars are gathering momentum.
“I think the theme is that it seems like the tide is turning, market share is picking up, adoption is picking up,” said Casberg, who is vice president, clinical pharmacy, for IPD Analytics, a drug management and market access company, in an interview with Managed Healthcare Executive®.
Casberg said he expects less push back from physicians as they prescribe biosimilars and their patients don’t report adverse reactions. And like many in the pharma industry he has an eye on 2023 when biosimilars to Humira (adalimumab) are expected to come on the market.
“I think over next 24 months, including the launch of the Humira biosimilars, will be the turning point,” he said.
Much has been made of interchangeability of biosimilars — whether the biosimilar can be substituted for the brand-name reference product at the pharmacy without the prescriber getting involved. Casberg said interchangeability will be a major factor in the insulin market because insulin tends to be dispensed at regular pharmacies. The FDA approved the first interchangeable insulin product, Semglee (insulin glargine-yfgn) in July. The reference brand-name product is Lantus (insulin glargine). But Casberg said interchangeability may not matter as much for the biosimilars dispensed through specialty pharmacies.
“Specialty pharmacies tend to have a lot of patient-provider contact anyways so they are going to be calling the physician for approvals whereas at the pharmacy things are done more rapidly and the pharmacist can take advantage of that interchangeability designation.
State-level pharmacy laws may affect interchangeability. The distribution of Semglee started this week, Casberg said, so the legal status of interchangeability will start to get tested.
Physicians are more likely to be comfortable with starting a patient on a biosimilar rather than switching them from a reference brand-name drug to a biosimilar. But Casberg said he expects some payers to start requiring “conversion” to a biosimilar. “Once they do, that is going to be a turning point,” he said.
In his presentation on Wednesday, Casberg shared data that showed the drop in the average sales price of the reference brand-name since the first biosimilar was approved, the number of biosimilars, and the market share of the biosimilars and the reference product. In some cases — notably, Remicade (infliximab) — the biosimilars haven’t cut into the reference product’s market share. Even so, the biosimilars seem to have had exerted some downward pressure on the price of Remicade. Casberg says price pressure without significant market share isn’t tenable over the long term.
“If biosimilars don’t end up being adopted eventually, manufacturers won’t make the products and we won’t see ASP (average sales price) decreases. We need biosimilars adoption to make this work.”
Read the full article here: https://managedhealthcareexecutive.com
REPORT FEATURE
April 21, 2020
National trends in prescription drug expenditures and projections for 2021
Various | https://academic.oup.com
Abstract
Purpose
To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2021 in the United States, with a focus on the nonfederal hospital and clinic sectors.
Methods
Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2021 were reviewed—including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, coronavirus disease 2019 (COVID-19) pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2021 were based on a combination of quantitative analyses and expert opinion.
Results
In 2020, overall pharmaceutical expenditures in the United States grew 4.9% compared to 2019, for a total of $535.3 billion. Utilization (a 2.9% increase) and new drugs (a 1.8% increase) drove this increase, with price changes having minimal influence (a 0.3% increase). Adalimumab was the top drug in 2020, followed by apixaban and insulin glargine. Drug expenditures were $35.3 billion (a 4.6% decrease) and $98.4 billion (an 8.1% increase) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals the decrease in expenditures was driven by reduced utilization. Several new drugs that will influence spending are expected to be approved in 2021. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic.
Conclusion
For 2021, we expect overall prescription drug spending to rise by 4% to 6%, whereas in clinics and hospitals we anticipate increases of 7% to 9% and 3% to 5%, respectively, compared to 2020. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.
Read the full report here: https://academic.oup.com
ARTICLE FEATURE
April 21, 2020
ARTICLE FEATURE
October 8, 2020
EY Announces Winners for the Entrepreneur Of The Year® 2020
Florida Award
EY | www.ey.com
EY builds on three decades of honoring unstoppable entrepreneurs in Florida
Ernst & Young LLP (EY US) is pleased to announce the winners of the Entrepreneur Of The Year® Florida Award. Entrepreneur Of The Year® is one of the preeminent competitive business awards for entrepreneurs and leaders of high-growth companies. This group of unstoppable entrepreneurial leaders transforming our world was selected by an independent judging panel made up of previous award winners. Florida award winners were unveiled during the program’s first-ever virtual awards gala, hosted by Deborah Norville, anchor of Inside Edition, on October 8, 2020. To watch the replay, visit the Florida program website.
"We've seen some truly inspiring and innovative entrepreneurs come through our program over the years. There are many successful entrepreneurs in this world, but building something of long-term value takes incredible grit, persistence and ambition," said Mike Pattillo, Entrepreneur Of The Year Florida Program Director. "We are proud to announce the 2020 Florida winners, unstoppable leaders who have thrived in adversity and continue to fuel growth around the globe. They are a wonderful addition to our global alumni community of past winners, and we look forward to supporting them as they continue to make an impact.”
The winners for the Entrepreneur Of The Year 2020 Florida Award are:
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Nancy Smith | Analytic Partners, Miami, FL
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Chris Gannon | Bolay Restaurant Partners, Palm Beach Gardens, FL
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Joey D. Batchelor | Guardian Fueling Technologies, LLC, Jacksonville, FL
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Maurice R. Ferré, MD | Insightec, Inc., Miami, FL
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Howard B. Krass | IPD Analytics, LLC, Aventura, FL
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Dagan T. Kasavana | Phoenix Tower International, Boca Raton, FL
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Taylor Hamilton and Jesse Tomalty | reCommerce, Deerfield Beach, FL
Nominees were evaluated based on six criteria, including overcoming adversity; financial performance; societal impact and commitment to building a values-based company; innovation; and talent management.
Read the full article here: ey.com
Related articles: 5 Things to Know in #MiamiTech
Further Dissecting the Launch of Adalimumab Biosimilars in the US
Stanton Mehr | https://biosimilarsrr.com
As we inch closer to the January 2023 date for the launch of the first US adalimumab biosimilar, industry watchers are more closely scrutinizing which company, if any, will have a competitive advantage in this lucrative marketplace.
Just to reset, the series of settlements signed by AbbVie currently puts Amgen’s Amjevita® first to be released, followed by several others according to the schedule we first published in May 2019.
A few developments have occurred since then, primarily the subsequent FDA approval of Hulio®, Hadlima®, and Abrilada®. Momenta was acquired by Johnson & Johnson in October 2020 and is no longer a separate entity or operating in the biosimilar business. But Coherus filed for approval in December 2020, and Alvotech and its partner Teva filed in November 2020. Celltrion, which completed its phase 3 trial, is on the verge of filing for approval, and Fresenius Kabi may join the crowd in filing this year as well.
The more interesting question is how these products might be differentiated. First, there are two concentrations: Two agents (Celltrion’s CT-P17 and Alvotech’s) will be available at the 100-mg/mL dose (which is a dosage offered by AbbVie’s Humira®), while the others will be dispensed at the 50-mg/mL dose.
Second is the availability or importance of a citrate-free formulation. The citrate-free formulation of Humira® is supposed to be associated with less injection-site pain, at least according to anecdotal evidence, but the value of this formulation has not been proven in clinical trials. Some of the planned biosimilars, such as Amjevita and Hulio, are citrate free. Other biosimilar manufacturers may roll out citrate-free adalimumabs, but this may not have a strong effect on payer coverage decision-making. Jeffrey Casberg, MS, RPh, Vice President, Pharmacy, IPD Analytics, believes that payers could ask patients to make a trade-off based on cost sharing: Would they pay more for a citrate-free version, if the preferred product is at a lower copay?
Third is the issue that has been looming for a couple of years now—the potential for Boehringer Ingelheim to score interchangeability status for Cyltezo®, which would be unique among adalimumab biosimilars. Boehringer Ingelheim cannot launch until July 2023, making it the third scheduled biosimilar to market. This will hurt whatever leverage Boehringer may have as the sole adalimumab interchangeable biosimilar. For example, should Amgen seal its payer contracts prior to January 2023, Boehringer will have to offer serious discounts just to get its foot in the door for the 2024 contract year. Mr. Casberg suspects that, in the end, Cytelzo won’t be the first biosimilar to be dubbed interchangeable; he thinks one of the insulins may be more likely to earn that distinction.
At this point, neither Celltrion nor Alvotech/Teva has signed licensing agreements with AbbVie. This raises an intriguing scenario. According to Mr. Casberg and the IPD Analytics team, “There is a possibility that these two agents could launch as early as late summer or fall of 2022.” Mr. Casberg told BR&R, “This is based on an assessment of publicly available information by IPD’s intellectual property group.”
Mr. Casberg emphasized, “I’m not saying that a 2022 launch is likely to occur, but that it could occur.” If this should occur, it could seriously upset the adalimumab settlement apple cart. If Celltrion or Alvotech decided to start marketing early, it may be launching at risk—but that’s a risk that might yield riches for a biosimilar maker emboldened by the prospect of a major cut of $16 billion in sales. If we have learned anything about the biosimilar market, it is that the first to launch has a big advantage over the others.
Read the full article here: https://biosimilarsrr.com
ARTICLE FEATURE
October 8, 2020
EY Announces Howard Krass of IPD Analytics, LLC as Entrepreneur Of The Year® 2020 Florida Award Winner
Ernst & Young LLP (EY US) today announced that Howard Krass of IPD Analytics, LLC was named an Entrepreneur Of The Year® 2020 Florida Award winner. The Entrepreneur Of The Year Awards program is one of the preeminent competitive awards for entrepreneurs and leaders of high-growth companies. The award recognizes those entrepreneurial leaders who are excelling in overcoming adversity; financial performance; societal impact and commitment to building a values-based company; innovation; and talent management. Howard Krass was selected by an independent judging panel. The award was announced through the program’s first-ever virtual awards gala, hosted by Deborah Norville, anchor of Inside Edition, on October 8, 2020.
Since 1986, EY US has honored entrepreneurs whose ingenuity, spirit of innovation and tenacity have driven their companies’ success, transformed their industries and made a positive impact on their communities. Howard Krass will go on to become a lifetime member of the esteemed multi-industry community of award winners, with exclusive, ongoing access to the experience, insight and wisdom of fellow alumni and other ecosystem members in over 60 countries — all supported by vast EY resources.
As a Florida award winner, Howard Krass is now eligible for consideration for the Entrepreneur Of The Year 2020 National Awards. Award winners, as well as the Entrepreneur Of The Year National Overall Award winner, will be announced Thursday, November 19, during a virtual awards gala. The awards are the culminating event of this year’s virtual Strategic Growth Forum®, the nation’s most prestigious gathering of high-growth, market-leading companies. The Entrepreneur Of The Year National Overall Award winner will then move on to compete for the EY World Entrepreneur Of The Year™ Award in June 2021.
About Entrepreneur Of The Year®
Entrepreneur Of The Year® is the world’s most prestigious business awards program for unstoppable entrepreneurs. These visionary leaders deliver innovation, growth and prosperity that transform our world. The program engages entrepreneurs with insights and experiences that foster growth. It connects them with their peers to strengthen entrepreneurship around the world. Entrepreneur Of The Year is the first and only truly global awards program of its kind. It celebrates entrepreneurs through regional and national awards programs in more than 145 cities in over 60 countries. Winners go on to compete for the EY World Entrepreneur Of The Year™ title. ey.com/us/eoy
About EY Private
As Advisors to the ambitious™, EY Private professionals possess the experience and passion to support private businesses and their owners in unlocking the full potential of their ambitions. EY Private teams offer distinct insights born from the long EY history of working with business owners and entrepreneurs. These teams support the full spectrum of private enterprises including private capital managers and investors and the portfolio businesses they fund, business owners, family businesses, family offices and entrepreneurs. Visit ey.com/private
About EY
EY is a global leader in assurance, tax, strategy, transaction and consulting services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities.
EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. Information about how EY collects and uses personal data and a description of the rights individuals have under data protection legislation are available via ey.com/privacy. For more information about our organization, please visit ey.com.
ARTICLE FEATURE
May 15, 2020
VIDEO INTERVIEW
April 29, 2020
IPD Analytics Experts Discuss Humira's Influence on Biosimilars
Center for Biosimilars | www.centerforbiosimilars.com
Video Transcript:
CfB: Hello, I'm Matthew Gavidia. Today on MJH Life Sciences News Network, The Center for Biosimilars is pleased to welcome Dr Leslie fish, vice president of Clinical Pharmacy for IPD analytics and Jeffrey Casper, vice president of Clinical Pharmacy for IPD analytics.
So, important litigation is now completed, and we now know the path to competitor biosimilars to adalimumab. Can you discuss the significance of this progress and what it means for the adalimumab market in 2023?
Casberg: Sure. Here at IPD, we have been watching for potential biosimilar Humira [adalimumab, AbbVie] for quite a few years now. We thought there could have been a biosimilar launch as early as 2019, or even 2020 [or] 2021. But as we watched the trials proceed between AbbVie and these competitors, AbbVie was winning these trial cases. The result of AbbVie winning is biosimilar manufacturers of Humira have signed what's called settlement agreements. So, they've sat down with AbbVie and signed a document stating that they won't launch their biosimilar product until x date. Currently, there's about 9 settlement agreements signed. Within those 9 settlement agreements with 9 manufacturers, 5 of them have approved products already. One of the reasons why we speculate that the biosimilar manufacturers sign these so-called settlement agreements is that if they had pushed and won in court early, they could have launched, but they probably would not have been able to launch with the full label. In other words, all the indications wouldn't have been there. So, we speculate at IPD that 1 of the motivations to sign the settlement agreement is AbbVie then gave them the full label to come out in 2023. So again, there are 9 manufacturers that have signed. 5 [have been] approved currently and there could be a number more on the way. see more
Will COVID-19 Clog Generics, Biologics Pipeline?
Specialty Pharmacy Continuum | by Karen Blum | www.specialtypharmacycontinuum.com
The drug pipeline for 2020 is heavy on generics, biosimilars and 505(b)(2) drugs that are slight variations of existing products. But whether those launches will be affected by the ongoing COVID-19 pandemic is a bit more difficult to predict, industry experts noted during an AMCP webinar.
A number of notable generic launches are expected in 2020, said Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, who are both vice presidents of pharmacy for the research organization IPD Analytics.
Generics for emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead); dimethyl fumarate (Tecfidera, Biogen); dexlansoprazole (Dexilant, Takeda); and fingolimod (Gilenya, Novartis) could drive drug prices down significantly, Dr. Casberg said.
Six potential generic entrants are in the works for the smoking cessation medicine varenicline (Chantix, Pfizer), which is expected to lose patent exclusivity this year, Dr. Fish said. Payors are looking forward to lower-cost options for the widely used drug, with sales of $702 million, she noted.
Nine potential generics could hit the market for fesoterodine (Toviaz, Pfizer), an antispasmodic for the treatment of overactive bladder symptoms, which also is expected to lose patent exclusivity this year. A number of other generics and branded drugs are available to treat the condition, Dr. Fish noted, making this an area ripe for drug utilization management.
In the Pipeline
About a dozen notable 505(b)(2) drugs have been approved or have approvals pending, the speakers said. These include ethinyl estradiol-levonorgestrel (Twirla, Agile), a transdermal birth control system approved in February, and apomorphine (APL-130277, Sunovion), a sublingual dopamine receptor agonist for the acute, intermittent treatment of “off” episodes in patients with Parkinson’s disease, approved in May.
This year also should see a number of launches of biosimilars, the speakers predicted. This includes HSP-130 (Hospira/Pfizer) and Rolontis (Hanmi Pharma/Spectrum) for pegfilgrastim, expected between June and October; SB8 (Samsung Bioepis/Merck) for bevacizumab, expected in September; and ABP 798 (Amgen/Allergan) for rituximab, expected in the fourth quarter, Dr. Fish said. They’ll join six approved biosimilars for pegfilgrastim, three for bevacizumab and three for rituximab.
“We believe with this many biosimilars in the market, we will see decreased cost, but the decrease will be seen through increasing rebates and better contracting in both the brand and biosimilar space,” Dr. Fish said.
The presenters also referenced a number of new branded products that have been approved or are expected to be approved this year. These include bempedoic acid (Nexletol, Esperion) and bempedoic acid-ezetimibe (Nexletol, Esperion), approved as a first-in-class adjunctive therapy for patients requiring additional cholesterol lowering beyond that seen with standard treatments, and inclisiran (Novartis), an experimental subcutaneous PCSK9 inhibitor expected to be approved in the fourth quarter.
Pandemic Pressures
The COVID-19 pandemic could affect new drug approvals, Dr. Fish said during a question-and-answer period. The FDA has been back and forth, saying there would or would not be delays, she noted. As of April 17, the agency announced that everything coming to near term, especially oncology and orphan medications, and those for serious diseases, will not be delayed, she said. However, several manufacturers have reported they were going to slow down or delay clinical studies because they are shifting gears to work on potential COVID-19 therapies. It’s also difficult now for study participants to get to their physicians for checkups or lab tests, Dr. Fish said. Combined, she said, these factors could result in a larger number of medications being approved in 2021.
VIDEO INTERVIEW
April 27, 2020
ARTICLE FEATURE
April 22, 2020
Drug Pipeline for 2020 Strong in Generics, Biosimilars
Specialty Pharmacy Continuum | by Karen Blum | www.specialtypharmacycontinuum.com
The drug pipeline for 2020 appears heavy on generics, biosimilars and 505(b)(2) drugs that are slight variations of existing products, said industry experts during a webinar sponsored by the Academy of Managed Care Pharmacy (AMCP).
Expected Generic Launches
A number of notable generic launches are expected in 2020, said Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, who are both vice presidents of pharmacy for the research organization IPD Analytics.
Generics for emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead); dimethyl fumarate (Tecfidera, Biogen); dexlansoprazole (Dexilant, Takeda); and fingolimod (Gilenya, Novartis) could drive drug prices down significantly, Dr. Casberg said.
Six potential generic entrants are in the works for the smoking cessation medicine varenicline (Chantix, Pfizer), which is expected to lose patent exclusivity this year, Dr. Fish said. Payors are looking forward to lower-cost options for the widely used drug, with sales of $702 million, she noted.
Nine potential generics could hit the market for fesoterodine (Toviaz, Pfizer), an antispasmodic for the treatment of overactive bladder symptoms, which also is expected to lose patent exclusivity this year. A number of other generics and branded drugs are available to treat the condition, Dr. Fish noted, making this an area ripe for drug utilization management.
505(b)(2)s and Biosimilars in the Pipeline
About a dozen notable 505(b)(2) drugs have been approved or have approvals pending, the speakers said. These include ethinyl estradiol-levonorgestrel (Twirla, Agile), a transdermal birth control system approved in February, and apomorphine (APL-130277, Sunovion), an oral dopamine receptor agonist for the off-periods experienced by patients with Parkinson’s disease, pending approval in May. Given that 40% to 60% of these patients develop off-periods that can worsen and a transdermal product is seen as more convenient than apomorphine injection (Apokyn, U.S. WorldMeds), this product could be used extensively, Dr. Fish said.
This year also should see a number of launches of biosimilars, the speakers predicted. This includes HSP-130 (Hospira/Pfizer) and Rolontis (Hanmi Pharma/Spectrum) for pegfilgrastim, expected between June and October; SB8 (Samsung Bioepis/Merck) for bevacizumab, expected in September; and ABP 798 (Amgen/Allergan) for rituximab, expected in the fourth quarter, Dr. Fish said. They’ll join six approved biosimilars for pegfilgrastim, three for bevacizumab and three for rituximab.
“We believe with this many biosimilars in the market, we will see decreased cost, but the decrease will be seen through increasing rebates and better contracting in both the brand and biosimilar space,” Dr. Fish said.
New Branded Products
The presenters also referenced a number of new branded products that have been approved or are expected to be approved this year. These include bempedoic acid (Nexletol, Esperion) and bempedoic acid-ezetimibe (Nexletol, Esperion), approved as a first-in-class adjunctive therapy for patients requiring addition cholesterol lowering beyond that seen with standard treatments, and inclisiran (Novartis), an experimental subcutaneous PCSK9 inhibitor expected to be approved in the fourth quarter.
The COVID-19 pandemic could have an impact on new drug approvals, Dr. Fish said during a question and answer period. The FDA has been back and forth, saying there would or would not be delays, she noted.
As of April 17, the agency announced that everything coming to near term, especially oncology and orphan medications, and those for serious diseases, will not be delayed, she said. However, several manufacturers have reported they were going to slow down or delay clinical studies because they are shifting gears to work on potential COVID-19 therapies. It’s also difficult now for study participants to get to their physicians for checkups or lab tests, Dr. Fish said. Combined, she said, these factors could result in a larger number of medications being approved in 2021.
IPD Analytics Experts Discuss the Insulin Pipeline
Center for Biosimilars | www.centerforbiosimilars.com
Video Transcript:
CfB: Hello, I'm Matthew Gavidia. Today on MJH Life Sciences News Network, The Center for Biosimilars® is pleased to welcome Dr Leslie Fish, vice president of Clinical Pharmacy for IPD Analytics, and Jeffrey Casberg, vice president of Clinical Pharmacy for IPD Analytics. Can you both introduce yourselves and tell us a little bit about your work?
Casberg: Sure, Jeff Casberg, again, one of the vice presidents of clinical pharmacy at IPD. We service many different constituents in the pharmaceutical landscape: payers, pharma manufacturers, specialty pharmacies, retail pharmacies, etc. I work with these manufacturers and payers to help them interpret formulary management and other aspects of the pharmaceutical landscape such as [what] we're speaking to today on biosimilars.
Fish: Hi, I'm Leslie Fish and I do the same thing that Jeff does. We each take different areas and one of the areas that I actually work with is oncology.
CfB: So, going to the first question, Leslie, can you please tell us about the biosimilars that have been launched already in 2020 and the launches you anticipate for the remainder of the year?
Fish: Sure. I'm going to divide these into 2 questions. And I'm first going to talk about what we're seeing right now currently with biosimilars and then I can actually take question 2, which is, what are we going to be seeing for the rest of the year and what should it look like? So, first of all, on the market, as far as biosimilars for oncology, we have Herceptin [trastuzumab], Avastin [bevacizumab], Rituxan [rituximab], Neulasta [pegfilgrastim], and Neupogen [filgrastim]. Historically, we've seen very slow trends and utilization with the current biosimilar medications we have. see more
Pharmacy Policy Experts Describe Changes in Biosimilar Adoption Curve
Tony Hagen | https://ajmc.com
Pharmacy experts from IPD Analytics explained the potential for authorized biologics, which would compete, potentially on the same price footing, with biosimilars.
“Authorized biologics” have been conceptualized as products that might one day compete with biosimilars, but although this hasn’t happened so far, the first authorized biologics are on the horizon, according to pharmacy analysts who spoke at the recent Academy of Managed Care Pharmacy (AMCP) Nexus 2021 meeting.
A biosimilar is a highly similar copy of a brand biologic, and an authorized biologic is the brand manufacturer’s attempt to compete on the same price level with the biosimilar without having to lower the price of the originator biologic.
One advantage of this strategy is that the manufacturer could maintain a high price of the reference product and promote it as a trusted brand that patients are already familiar with. At the same time, the authorized biologic, which would be the same drug as the original brand, could compete against biosimilars for a lower price.
“Today, we haven’t really seen brand companies have the motivation to bring these authorized products to market, but I think you’ll start to see a few in the future,” said Jeff Casberg, MS, RPh, a vice president of pharmacy for IPD Analytics.
Casberg and Leslie Fish, RPh, PharmD, also a vice president of pharmacy at IPD Analytics, discussed trends in biosimilar marketing and payer policies toward these agents in a joint presentation at the AMCP meeting.
First Authorized Biologics
One of the first authorized biologics to emerge would likely be a version of the insuline glargine product Semglee, which has been marketed as a new drug in the United States for several years but recently won FDA approval as a biosimilar and interchangeable form of Lantus, a blockbuster insulin drug from Sanofi.
The makers of Semglee, Biocon Biologics and Viatris, aim to market the drug as an interchangeable at a 5% discount to Lantus and as an authorized biologic at a 65% discount to Lantus. In addition, Novo Nordisk, maker of the reference insulin aspart product Novolog, is expected to try to bring an authorized biologic for that drug to market, Casberg said.
The arrival of authorized biologics will roughly coincide with the appearance of interchangeable biosimilars. These agents are like biosimilars in that they are highly similar to the reference, or brand, product, but they have undergone additional switching studies to ensure that clinical outcomes are the same for patients regardless of whether they switch several times between the reference and biosimilar products.
The chief difference between an interchangeable and a biosimilar is that a pharmacist cannot automatically dispense a biosimilar at the pharmacy counter without first notifying the prescribing physician.
In theory, pharmacists could also dispense authorized biologics at will because they would come from the same factory as the reference product.
“Authorized biologics are interchangeable. They are the same drug, and we don’t call them 'authorized biosimilars.' We call them authorized biologics because calling them authorized biosimilars would suggest biosimilars aren’t quite the same drug, so we call them authorized biologics,” Casberg said. So far, 2 biosimilars have been approved as interchangeables in the United States, Semglee and Cyltezo, which is a biosimilar of Adalimumab. Both approvals were granted in 2021.
Biosimilar Acceptance
Biosimilars have been available in the United States for 6 years, but their acceptance has been battered by reference drug manufacturer competition, payer policies that have been slow to promote the use of biosimilars, and insufficient education about biosimilars, which has contributed to physician and patient resistance toward using these agents, according to Fish.
Then there’s the COVID-19 pandemic, which has put some slack into the FDA’s biosimilar review and approval process. “When the pandemic arrived, the first thing that happened was that the clinical trials for biosimilars were delayed or postponed, or actually some even stopped totally. You could not get patients in to see their doctors,” she said.
“The FDA had to take all the people who looked at all the biosimilar data and put them into COVID-19 medication review; but the next thing, which was important for all medications that are in the pipeline, is that the FDA could not get into plants to do manufacturing inspections. In fact, that’s still delayed,” Fish said.
That said, there are many success stories of biosimilars that have captured significant market share from reference products, she said. From mid-2019 to mid-2021, biosimilar forms of rituximab took a 53% share of the market away from the originator brand, Rituxan.
During that same period, bevacizumab biosimilars gained a market share of 68% vs 4% in mid-2019. This trajectory was also seen for trastuzumab biosimilars, which achieved a market share of 68% by mid-2021, up from 4% in mid-2019.
Cumulative savings in the trastuzumab market, as a result of these lower-cost entrants, amounts to $2.5 billion, Fish said.
Read the full article here: https://ajmc.com
ARTICLE FEATURE
November 1, 2021
IPD Analytics Executive Offers Perspective on Biosimilar Uptake and Policy
Tony Hagen | https://centerforbiosimilars.com
Payers have moved from toe-in-the-water biosimilar policies to aggressive management, contributing to much more robust savings in recent years, according to Leslie Fish, RPh, PharmD, vice president of pharmacy at IPD Analytics.
The arrival of biosimilars in the United States has followed a winding path, which is the result of initial poor acceptance and, lately, the COVID-19 pandemic, which has gummed up the approval and factory inspections process at the FDA.
But 6 years into biosimilar marketing, it’s possible to see progress and resistance on a more granular level, according to Leslie Fish, RPh, PharmD, vice president of pharmacy at IPD Analytics, who spoke about biosimilars at the Academy of Managed Care Pharmacy (AMCP) Nexus 2021 meeting.
Patent barriers are to blame for some of the wet powder in biosimilar launches, limited physician and payer acceptance are other causes, and the intrusion of COVID-19 priorities at the FDA is another. But aggressive marketing by reference product manufacturers to ward off biosimilar success also can claim a role in slowness of biosimilar acceptance in the United States, Fish said.
“When the pandemic arrived, the first thing that happened was that the clinical trials for biosimilars were delayed or postponed, or actually some even stopped totally. You could not get patients in to see their doctors,” she said.
“The FDA had to take all the people who looked at all the biosimilar data and put them into COVID-19 medication review; but the next thing, which was important for all medications that are in the pipeline, is that the FDA could not get into plants to do manufacturing inspections. In fact, that’s still delayed,” she said.
Not a lot was known about biosimilars 6 years ago when they debuted, Fish said. Biosimilars entered the market at prices much higher than some may have expected. This may have been because people were primed to expect the same thing to happen for biosimilars as happened for generics, which arrived in some cases at discounts of 60% to 70% off the originator brand prices. “It wasn’t near there at all,” she said.
Partly, this was because there was less competition and biologics are costly to develop and manufacture—as much as $200 million for an individual biosimilar, according to an Amgen estimate.
“But back in 2015, 2016, there was not a lot of education,” Fish said. The FDA and CMS eventually began educating the public more broadly about biosimilars.
Oncologists Were Early Adopters
One thing that happened was that oncologists were among the first adopters, and to this day they are the most enthusiastic, as a group, about biosimilars, judging by their embrace of these agents. Fish said oncologists are well educated about biosimilars, have a favorable view of them, and have adopted them at a rapid pace.
“I’ve been going to the American Society of Clinical Oncology meetings for years. Five years ago, there must have been at least 3 or 4 different biosimilar lectures. And every year since then there have been lots of biosimilar lectures during those meetings,” she said.
By comparison, rheumatologists also are well educated about these agents, but are moderately favorable in their view of them, and uptake has been slow, Fish said. Gastroenterologists are at the tail end of the adoption curve, being moderately educated on biosimilars, possessing unfavorable views of them, and being slow about adopting them.
Another brake on the progress of biosimilars has been the web of contracts, rebates, and revenue streams between manufacturers and payers and clinical institutions, which in combination with a lack of payer management of prescription practices has stunted the development of this market, Fish said.
“So, you see a biosimilar on the market, but not a lot of utilization. You also could see it being put on formulary, but there are no step therapies,” she said.
Payers may be slow to adopt biosimilars, may cling to manufacturer rebates for originator products, or may jump into biosimilars and suffer the uncertainty of unclear financial benefits of doing so, she said. “That sort of middle, in-between area is that the payer will put a biosimilar on formulary but won’t take the reference product off.”
Payers may only dip a toe into the biosimilar pond by tweaking their policies just a little, such as by requiring a smaller co-pay for the biosimilar, which Fish described as “semimanagement.” More recently, the payer stance toward biosimilars has been characterized by aggressive management. “You see formularies that are going to get whittled down if there is more than 1 biosimilar product.”
But this form of management may assume an odd shape, she said, because payers may put a few biosimilars and their reference product on formulary, or just a brand and a biosimilar, or 2 biosimilars, she said.
A Look at Individual Trends
Fish reviewed some of the trends in individual biosimilar adoption. Infliximab biosimilars accounted for just 11% of market share in mid to late 2019, and even by the end of the second quarter of 2021, the originator product, Remicade, held a 75% share, she noted.
The story is better for short-acting filgrastim (Neupogen), she said. The biosimilar Zarxio had a 57% share of the market in the third quarter of 2019, vs 40% for Neupogen, and by the second quarter of this year, the originator held just a 26% share of the market.
Long-acting filgrastim (pegfilgrastim) biosimilars have taken an incrementally larger share of the market from Neulasta and its wearable injector version (Neulasta Onpro). Starting in the third quarter of 2019, the reference drug held just a 55% share of the market, and that declined to 52% by the second quarter of 2021, Fish said. Those are still large shares of the market for biosimilars.
“What really makes it interesting is that pegfilgrastim biosimilars are not just against Neulasta, but against Neulasta Onpro,” Fish said. “So, this is different than we were anticipating what the utilization of pegfilgrastim was going to be. We began looking at the utilization, and we saw a very big uptake against both the on-body applicator and the regular version of Neulasta.”
“Besides that, the manufacturer had tried to convert everybody to the on-body applicator and they were doing an amazing job of that,” she said.
A more traditional—or predictable—uptake curve has been seen in use of rituximab biosimilars. Fish noted that from 100% use of the originator brand, Rituxan, in the third quarter of 2019, biosimilars had assumed a 53% share of the market by the second half of 2021.
Rituximab is used in oncology and rheumatology, but it has been better received among oncologists, Fish said. However, the more recent market share numbers indicate that rheumatologists are picking up the biosimilar versions of rituximab.
The same pattern is seen for the bevacizumab market, which was dominated by the originator brand in the third quarter of 2019 (96%). By the second half of 2021, the reference brand share was 32%. Fish estimated cumulative bevacizumab biosimilar savings of $1.4 billion in the United States.
An almost identical biosimilar trajectory is notable in trastuzumab, where the reference brand went from a 96% share in the second half of 2019 to a 32% share by the middle of 2021, with cumulative savings of $2.5 billion, Fish said.
Epoetin alfa biosimilars have followed a relatively flat trajectory since mid-2019, according to Fish. Starting from a 41% market share, they now represent 44% of the market.
It’s important to note that the average sales prices (ASPs) for biosimilars and reference products have been decreasing over time, so the competition has stopped the upward march of reference product prices and resulted in savings for both reference products and biosimilars, Fish said.
The trastuzumab reference product (Herceptin) had seen a 15% ASP drop by mid-2021; Avastin (bevacizumab), 13%; Rituxan, 8%; Neulasta, 47%; Neupogen, 3%; Epogen/Procrit (epoetin alfa), 37%; and Remicade, 50%, according to Fish’s figures.
Read the full article here: https://centerforbiosimilars.com
ARTICLE FEATURE
November 1, 2021
ARTICLE FEATURE
April 21, 2020
AMCP Presenters Predict 4 More Biosimilar Launches in 2020
Center for Biosimilars | by Tony Hagen | www.centerforbiosimilars.com
The year 2020 has already seen 4 biosimilar launches in the United States, and those could be augmented by several more, although the coronavirus disease 2019 (COVID-19) pandemic has introduced a wild card to the mix, said presenters at the American Academy of Managed Care Pharmacy eLearning Days virtual meeting.
But the pipeline from 2021 to 2025 is stocked with at least 5 approved biosimilars to adalimumab, and potentially 4 others, all of which could conceivably launch in 2023, and 14 other potential biosmilar products, which could make the next several years a very active growth time for the US biosimilar space, the presenters said.
The pace of clinical trials has also been affected, and with regard to approvals, the FDA’s most recent notice has been that there will be no “near-term” affect on these, said Leslie Fish, RPh, PharmD, who co-presented with Jeffrey Casberg, MS, RPh, in the session, "Drug Pipeline: Traditional Pharmaceuticals and Bisoimilars." Both are experts on the pharmaceutical pipeline with IPD Analytics.
One thing that could happen is that any delays caused by COVID-19 in 2020 could lead to a slew of backlogged approvals or launches in 2021, Fish said.
A lot of companies have stated that they are going to slow their existing studies or hold up new studies of various agents, because they’re now working on COVID-19 therapies or vaccines, she added. see more
ARTICLE FEATURE
April 21, 2020
A Look at the Generic and Biosimilar Drug Pipeline
AMCP | by Kerri Fitzgerald | www.amcp.org
During a presentation at AMCP eLearning Days, Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, both vice president of pharmacy at IPD Analytics, LLC, discussed potential generic and biosimilar drugs coming to market, including projected timelines and implications for managed care pharmacy.
To reduce drug approval time, the U.S. Food and Drug Administration (FDA) has changed policies that speed up medication approvals, including accelerated and expedited reviewers, shorter studies, and use of surrogate markers. However, this often means less data are available about clinical efficacy and side effects at launch and more post-marketing studies are required.
The speakers detailed notable brands losing exclusivity in the near future and what that means for the treatment landscape. In the HIV treatment landscape, Atripla® (efavirenz/emtricitabine/tenofovir disproxil fumarate) will lose exclusivity in September. There are four new potential entrants to the space in 2021 and two in 2029. Truvada® (emtricitabine, tenofovir disoproxil fumarate) will also lose exclusivity in September. A new potential entrant could come this year, with nine potential options in 2021.
In the oncology space, Afinitor® (everolimus) 2.5, 5, and 7.5 mg already have a generic on the market, with four potential other generics in the pipeline. Afinitor® (everolimus) 10 mg has an additional four potential generic options. Zortress® (everolimus) 0.25, 0.5, 0.75, and 1.0 mg have three potential generic options.
Byetta™ (exanitide), a glucagon-like peptide-1 treatment for type 2 diabetes, will lose exclusivity this year, with two potential generic entrants. Dalirsp® (roflumilast) is a phosphodiesterase-4 inhibitor for the treatment of chronic obstructive pulmonary disease that will lose exclusivity this year or in 2021. There are 12 potential new generic entrants. Chantix® (varenicline) for smoking cessation has a loss of exclusivity this year or in 2021, with six potential generic entrants available between this year and 2022.
In March, the approved marketing applications for the small subset of “biologic products” such as insulin and human growth hormone, which for complex historical reasons were previously approved by the FDA as drugs under the new drug application (NDA) process, were deemed to be biologics. A 505(b)(2) is an NDA that has some efficacy and safety information from the applicant but also relies on information that comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.
The speakers then discussed some notable 505(b)(2)s that are pending approval:
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Rizaport® (rizatriptan benzoate) for migraine headache
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Naloxone nasal spray 8 mg for opioid overdose
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Trevyent® (treprostinil) for pulmonary arterial hypertension
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Apomorphine, a dopamine receptor agonist for Parkinson’s disease
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Celecoxib 56 mg/tramadol 44 mg tablet for severe pain
In addition, several biosimilars are expected to launch this year, including:
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HSP-130 (pegfilgrastim) in June
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SB8 (bevacizumab) in September
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Rolontis (pegfilgrastim) in October
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ABP 798 (rituximab) during the fourth quarter
There also appear to be 14 potential biosimilar agents that will launch in the next five years for ranibizumab (Lucentis®), eculizumab (Soliris®), ustekinumab (Stelara®), abatacept (Orencia®), golimumab (Simponi®), and more.
ARTICLE FEATURE
January 23, 2020
Express Scripts Coverage, FDA Label Update Boost Rybelsus
RADAR on Drug Benefits | by Sharon Bender | www.aishealth.com
Access to Novo Nordisk’s Rybelsus (semaglutide)—the first oral glucagon-like peptide-1 receptor agonist (GLP-1) to treat adults with type 2 diabetes—got a major boost January 17th, 2020 when Novo said Express Scripts, part of Cigna Corp., will cover the agent. Rybelsus was approved in September 2019 and is available as a once-daily tablet version of the drugmaker’s Ozempic (semaglutide), a weekly injection launched in 2018.
“We’ve been keeping a keen eye on the new 2020 formulary postings, watching weekly, and monitoring all the big payers’ formularies, and it’s been interesting to note that it looks as though Novo is still in negotiations” for Rybelsus, Jeffrey Casberg, M.S., R.Ph., Director of Clinical Pharmacy at IPD Analytics, told AIS Health. “You would think by now, more often than not you’d see more formularies updated, and we haven’t seen that yet.” IPD provides drug intelligence and consulting to stakeholders across the pharmaceutical landscape.
Casberg represented the payer community on the Institute for Clinical and Economic Review’s (ICER) November policy roundtable panel in which clinical, manufacturer, payer, and patient advocate participants discussed key questions identified by ICER researchers related to oral semaglutide’s cost-effectiveness. A report of the panel’s recommendations, “Oral Semaglutide for Type 2 Diabetes: Final Policy Recommendations,” was published December 9, 2019 along with ICER’s “Oral Semaglutide for Type 2 Diabetes: Effectiveness and Value, Final Evidence Report.” ICER is an independent non-profit research organization. see more
ARTICLE FEATURE
January 10, 2020
Jeff Casberg, RPh, MS Weighs in on Rybelsus
A recent article in the Pink Sheets quoted Jeff on the comments he provided as a panelist at the ICER meeting on Rybelsus.
PRESENTATION
December 19, 2020
Leslie Fish, RPh, PharmD Speaks to Students at UMass
Even with her busy year-end work schedule, our VP of Clinical Pharmacy, Leslie Fish, PharmD, found time to speak on drug pricing to students in the "Health Policy and the Practice of Medicine" interstitial curriculum at University of Massachusetts Medical School.
PRESENTATION
September 30, 2019
Leslie Fish, RPh, PharmD Participates in the Advisory Board Company's Value Summit
Happy to have one of IPD’s Executive Clinical Pharmacists, Leslie Fish, R.Ph, Pharm.D., participate in The Advisory Board Company's Value Summit to share perspectives on how different parts of the industry define, measure, and drive medical value.
BLOG FEATURE
August 12, 2019
Q&A, Part II: How Payers and Providers are Responding to the
Biosimilar Market
The conversation continues around biosimilar management and strategy in Part II of The Advisory Board Company's blog post. In this feature, IPD’s Executive Clinical Pharmacists, Leslie Fish, Pharm D. and Jeffrey Casberg, RPh discuss how payers are responding to the evolving biosimilar market and what providers need to know to make the most of this evolving space.
Read it now: Q&A, Part II: How payers and providers are responding to the biosimilar market
BLOG FEATURE
August 5, 2019
Q&A: What Providers Need to Know About a Changing Biosimilar Market
Two senior members of our Clinical Pharmacy team, Leslie Fish, Pharm D. and Jeffrey Casberg, RPh, recently sat down with the research team at The Advisory Board Company to talk about how the biosimilar market is evolving and why it is critical that health systems develop a cohesive and comprehensive biosimilar strategy.
ARTICLE FEATURE
August 2, 2019
National Trends in Prescription Drug Expenditures and Projections
for 2019
The cost of prescription drugs continues to be a center of focus for the news media, regulators, payers, providers, manufacturers, and many others across the health care landscape. This important article from AJHP, which leverages IPD’s proprietary data and expert insights on forthcoming approvals from the FDA, addresses some of the critical factors driving these costs.
Read it here: National trends in prescription drug expenditures and projections for 2019
ARTICLE FEATURE
May 10, 2019
ICER, IPD Announce New Analytics Partnership
Health Economics | www.heatlheconomics.com
The Institute for Clinical and Economic Review (ICER) will leverage IPD Analytics’ (IPD) data and insights to bolster its reviews of “high-impact, high-cost therapies” as part of a new collaborative effort, the organizations announced last week.
The initiative was announced Thursday, May 9.
IPD brings to the table a “deep, informed and fully independent analysis” of the biopharmaceutical industry.
“IPD analytics is an unbiased, independent organization that works to drive efficiency and transparency in the prescription drug market,” ICER President Steven Pearson said in a statement. “We value their rigorous and thoughtful analysis of the drug pipeline and we look forward to using this information as a key resource to support our internal horizon scanning efforts and to inform our process for selecting assessment topics."
PRESS RELEASE
May 9, 2019
The Institute for Clinical and Economic Review (ICER) Will Now Leverage Data and Insights from IPD Analytics
Bay Harbor Islands, FL – May 9, 2019
The Institute for Clinical and Economic Review (ICER) has reached an agreement with IPD Analytics, LLC (IPD) whereby ICER will leverage IPD’s data, expertise, and assessments to advance their horizon scanning efforts across the pharmaceutical and biologic markets.
ICER is an independent and non-partisan research organization that objectively evaluates the clinical and economic value of prescription drugs, medical tests, and other health care innovations. IPD combines purpose-built data curation mechanisms with an experienced team of uniquely qualified experts to provide deep, informed, and fully independent analysis on the biopharmaceutical industry’s current state and trajectory.
The collaboration involves ICER incorporating IPD’s proprietary data assets and analyses as a tool to ensure comprehensive and accurate reviews of high-impact, high-cost therapies. By leveraging these capabilities, ICER will benefit from this increased capacity to scan, interpret, and anticipate key shifts in the landscape.
“IPD Analytics is an unbiased, independent organization that works to drive efficiency and transparency in the prescription drug market,” said Steven D. Pearson, MD, MSc, President of ICER. “We value their rigorous and thoughtful analysis of the drug pipeline, and we look forward to using this information as a key resource to support our internal horizon scanning efforts and to inform our process for selecting assessment topics.”
Howard Krass, CEO of IPD Analytics, also shared excitement for the collaboration. “We believe in ICER’s mission, and are pleased to work with them in furthering our shared goal of enhancing transparency regarding drug availability and pricing.”
About ICER
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.
About IPD Analytics
IPD Analytics is a provider of insight, transparency, and efficiency for stakeholders across the pharmaceutical landscape. The company identifies, projects, and quantifies the impact of competitive landscape shifts in the biopharmaceutical market. By combining proprietary data with uncommon expertise, IPD syndicates meaningful insights and curated information across four key capabilities: Life Cycle Insights, Payer and Provider Insights, Market and Financial Insights, and Coding and Reimbursement.
Follow IPD Analytics on LinkedIn to learn more.
Media Contact:
Veronica Fowler
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