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Humira Budget Impact Analysis & Biosimilar Management Report
Published 2022
The 2023 launch of biosimilar versions of AbbVie’s Humira (adalimumab) will represent the largest loss-of-exclusivity event in the history of pharmaceuticals (based on Humira’s annual sales of over $20B) and one of the most important formulary management and financial decisions for payers, pharmacy benefit managers (PBMs), and hospitals in recent memory.
Starting in late January 2023 and continuing through 2024, 14 or more biosimilar Humira products may launch, including both original-formulation (50 mg/mL) and new, high-concentration (HC) formulation (100 mg/mL) products. At this time, approximately 85% of the sales volume is in the new (HC) formulation. Several products are likely to launch with an interchangeability designation, although the significance of this designation for the product’s clinical or financial success with payers, pharmacies, hospitals, and manufacturers is unclear. It is likely there will be a wide range of pricing formats offered by AbbVie and biosimilar manufacturers for their products. Formulary decisions by payers and PBMs could significantly impact the financial performance of their pharmacy benefits over the next few years.
For hospitals that dispense Humira through 340B pricing, this conversion to biosimilar Humira may also impact financial performance. As additional intelligence is available, IPD Analytics will continue to update subscribers with information that may impact management decisions.
This report will help stakeholders in the industry understand the major topics surrounding this market shift, including biosimilar launch, pricing, and budget outlook, management opportunities, hospital reimbursement strategies, and more.
360° Insights: Amylyx's Relyvrio
December 2022
Amylyx’s Relyvrio (sodium phenylbutyrate and taurursodiol; formerly AMX0035) is an oral, fixed-dose combination therapy approved by the FDA on September 29, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). Relyvrio is designed to target the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways. Amylyx is also investigating AMX0035 for the potential treatment of Alzheimer's disease and Wolfram syndrome.
ALS is a rare, fatal, progressive neurodegenerative disorder that affects upper and lower motor neurons. A loss of motor neurons in the brain and spinal cord initially leads to focal weakness, with muscle weakness spreading over time. Most patients die of respiratory failure within 2 to 5 years of symptom onset.
Currently, there are no treatments that stop or significantly slow the progression of ALS. Prior to the approval of Relyvrio, riluzole and Mitsubishi Tanabe’s Radicava/Radicava ORS (edaravone) were the only two drugs approved by the FDA to treat the disease; however, each of these three treatments has only been shown to provide a modest benefit.
Amylyx has initiated the Phase 3, placebo-controlled PHOENIX trial to evaluate the efficacy and safety of Relyvrio. Given that Relyvrio received a traditional approval from the FDA, confirmatory results from this trial are not required for ongoing approval. The results, however, will be of interest, as questions have been raised regarding Relyvrio’s efficacy. Herein, we provide a selection of key points included in our full reports.
Biosimilar Pipeline Report
Winter 2022/2023
In this report, IPD Analytics provides an outlook for potential approvals and launches across the biosimilar landscape over the 2023–2026 horizon.
Our team of pharmacists, PhD scientists, and intellectual property attorneys continuously monitor and update our comprehensive pipeline intelligence database.
Subscribers use this report as a companion to our online Clinical Development Tracker within our Payer & Provider Insights platform, which provides up-to-date clinical pipeline information on thousands of products across various disease classes and therapeutic areas. In tandem, these reports deliver insight into trending classes that will affect the competitive landscape and your drug spend.
Digital Therapeutics Using Cognitive Behavioral Therapy
January 2023
Cognitive behavioral therapy (CBT) is a type of psychotherapy that focuses on changing current behavior without attempting to determine or evaluate why the behavior exists. CBT is effective in treating depression, anxiety disorders, addiction, eating disorders, and even digestive conditions such as irritable bowel syndrome (IBS). CBT can be provided via several modes of delivery, including face-to-face, telehealth, internet-based delivery, and now, DTx.
In this report, our Executive Clinical Pharmacists explore current DTx products that deliver CBT, payer coverage for various modes of CBT, and why payers should consider evaluating the cost-effectiveness and availability of CBT delivery modalities to determine the appropriateness of DTx coverage in light of other modes of CBT delivery that are already routinely covered.
Prescription Digital Therapeutics: Guide for Manufacturers
September 2022
The utilization of digital therapeutics (DTx) has increased in recent years, especially since the start of the COVID-19 pandemic. With the growing interest in DTx, manufacturers have increased their investments in this space, and there is a robust pipeline of DTx products.
In this paper, we will focus on a subset of DTx products known as prescription digital therapeutics (PDTs), which are only available as a prescription through consultation with a healthcare professional. Currently, there are over 10 PDTs on the market, with more expected to enter the market within the next few years.
Although it is often difficult to ascertain the sales and utilization information for PDTs, we have drawn on our deep experience to outline the primary factors that we believe will determine the success of future PDT products. In addition to identifying these factors, we also provide specific guidance for manufacturers to consider in designing and marketing their PDT products.
360° Insights: Karuna Therapeutics' KarXT
October 2022
IPD Analytics’ 360° Insights provide a comprehensive analysis to help you examine products and companies from every angle. These synchronous reports across IPD’s multiple platforms aggregate our analyses of intellectual-property protection, clinical data, payer reimbursement, and financial outlook, providing a 360° view of the market landscape.
Karuna Therapeutics is developing KarXT (xanomeline and trospium) for the treatment of schizophrenia and Alzheimer's disease psychosis. Xanomeline is a new molecular entity that has demonstrated antipsychotic and pro-cognitive properties; trospium is a muscarinic antagonist that offsets the peripheral cholinergic effects of xanomeline. Trospium was first approved as Allergan's Sanctura in 2004 for the treatment of overactive bladder.
Karuna has indicated that it plans to submit a New Drug Application (NDA) to the FDA for schizophrenia in mid-2023, which would allow for approval of KarXT sometime in 2024. The company has also indicated it will submit a supplemental NDA (sNDA) for use of KarXT as an adjunctive treatment for schizophrenia soon after filing for the monotherapy indication.
If approved, KarXT would be the first muscarinic agonist for the treatment of schizophrenia to enter the market. Herein, we provide a selection of key points included in our full reports.
U.S. Prescription Drug Importation
September 2022
As the affordability of prescription drugs continues to be a top concern for consumers in the United States, drug importation, the practice of importing prescription drugs from another country, has been proposed as an approach to reducing drug costs. Although several states have passed bills that establish drug importation programs, these cannot be implemented without first being authorized by the FDA. Since the FDA created the Final Rule, “Importation of Prescription Drugs” (effective as of November 30, 2020), there has been strong opposition from the pharmaceutical industry and reservations from stakeholders, based on safety concerns and lack of certainty around cost savings. Minimally, drug importation has the potential to lower prices for cash-paying patients. If implemented widely and if it is successful in exerting competitive pricing pressure into the market, drug importation could have a far-reaching impact on patients.
In this report, IPD’s executive clinical pharmacists discuss how drug importation would work under the Final Rule, current and proposed legislation, individual importation, drug importation programs by state, the potential impact of drug importation on the pharmaceutical market, and barriers to drug importation.
Drug Price Reform Measures in the 2022 Inflation Reduction Act
August 2022
The Inflation Reduction Act of 2022 is a budget reconciliation bill that addresses drug prices, corporate taxes, climate change, and energy security. It was passed by the U.S. Senate on August 7, 2022, passed by the U.S. House of Representatives on August 12, 2022, and signed into law on August 16, 2022, by President Biden.
Although the full impact of the bill is not yet understood, there are several provisions that would potentially impact drug prices. In this report, our team of clinical pharmacists deliver insight into the drug price reform measures in the 2022 Inflation Reduction Act and potential impacts to stakeholders in the market.
Brand Drugs with Expected Generic Competition in Canada in
2H 2022-2024
August 2022
In IPD’s latest report, Brand Drugs with Expected Generic Competition in Canada in 2H 2022–2024, our Canadian legal and regulatory analysts identify 36 brand-name small-molecule drugs covered by data protection or patent portfolios for which the generic competition likely would begin during 2H 2022–2024. For each of these brand-name drugs, (1) data protection appears to have expired (or is close to expiring), and (2) the relevant patent(s) already have expired, are close to expiring, or may be subject to being revoked in court proceedings, or brand companies appear to have reached settlement agreements.
IPD’s Canadian Life-Cycle Insights coverage includes loss-of-exclusivity reports to help our subscribers forecast generic entry and prepare for shifts in the market landscape.
Drug Pipeline Report &
Podcast 2H 2022
August 2022
This is the second issue of a bi-annual pipeline report IPD will release in 2022.
In this report, IPD Analytics provides detailed summaries of key drugs nearing potential FDA approval in the coming months.
Our team of pharmacists, PhD scientists, and intellectual property attorneys continuously monitor and update our comprehensive pipeline intelligence database.
This report is used as a companion to our online Clinical Development Tracker, which provides up-to-date clinical pipeline information on thousands of products across various disease classes and therapeutic areas. In tandem, these reports deliver insight into trending classes that will affect the competitive landscape and your drug spend.
360° Insights: Axsome's AXS-05
July 2022
IPD Analytics’ 360° Insights help you analyze products and companies from every angle with aggregated, synchronous updates across our multiple platforms. Together, the full reports from each platform provide a comprehensive, 360° view of the market landscape.
Axsome’s AXS-05 is a fixed-dose combination of dextromethorphan and bupropion that is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). Although bupropion is an antidepressant, Axsome has stated that the primary reason for including it in the combination product is to increase the bioavailability of dextromethorphan.
If approved, AXS-05 will be the second FDA-approved NMDA receptor antagonist for the treatment of MDD, after Janssen’s Spravato (esketamine).
In this report, our legal and regulatory analysts provide a background on patenting antibodies at the European Patent Office (EPO) and its member states. We then synthesize and analyze multiple case studies involving the validity and potential infringement of broad, functionally defined antibody patents.
IPD’s European Life-Cycle Insights coverage includes periodic macro reports to help our subscribers identify read-through from one case to another and to understand larger issues at play.
Patenting of Antibodies in Europe
July 2022
The FDA’s Priority Review Voucher (PRV) program was designed to incentivize the creation of medications for unmet needs and underserved disease areas.
With PRVs averaging a sales price of over $100 million and a record high sales price of $350 million, this program offers a substantial incentive for the development of medications for three underserved categories: tropical diseases, rare pediatric diseases, and medical countermeasures. The redemption of a PRV may result in benefits to drug manufacturers that include generating revenue 4 months sooner on a drug and/or earning 4 months of additional revenue prior to generic entry, potentially beating a competitor to the market, and getting a drug approved and on payer formularies by the beginning of the year.
In this paper, we evaluate the benefits of using a PRV through three case studies, assess potential return-on-investment (ROI) calculations, provide a summary of PRVs sold to date, and assess how PRVs may be utilized in the future.
The FDA's Priority Review Voucher Program: Potential Benefits and Risks for Manufacturers and Outlook for Future Use
February 2022
Biosimilar Pipeline Report: Mid 2022
May 2022
In this report, IPD Analytics provides an outlook for potential approvals and launches across the biosimilar landscape over the 2022–2025 horizon.
Our team of pharmacists, PhD scientists, and intellectual property attorneys continuously monitor and update our comprehensive pipeline intelligence database.
Use this report as a companion to our online Clinical Development Tracker, which provides up-to-date clinical pipeline information on thousands of products across various disease classes and therapeutic areas. In tandem, these reports deliver insight into trending classes that will affect the competitive landscape and your drug spend.
Market Performance Outlook
Recent and Near-Term Drug Approvals to Watch
November 2021
This is the second issue of a recurring series to track the market potential of select products that are likely to impact the market in the coming years.
The report includes both recent and near-term approvals, combining insight from IPD’s expert forecasters with manufacturer earnings reports, presentations, statements, and press releases as well as clinical and regulatory developments.
Drug Pipeline Report: 1H 2023
January 2023
In this report, IPD Analytics provides detailed summaries of key drugs nearing potential FDA approval in the coming months. Our team of pharmacists, PhD scientists,
and intellectual property attorneys continuously monitor and update our comprehensive pipeline intelligence database.
Use this report as a companion to our online Payer & Provider Insights and Clinical Development Tracker areas, which provide up-to-date clinical pipeline information on thousands of products across various disease classes and therapeutic areas. In tandem, these reports deliver insight into trending classes that will affect the competitive landscape and your drug spend.