IQVIA Institute. Precision medicine targets specific genes, based on the patient’s condition. Trends in FDA approval of Specialty Drugs 1990 through 2017, RJ Health, 2018. [6] Trends in FDA approval of Specialty Drugs 1990 through 2017 Gene therapy is designed to correct inherited genetic defects therefore it is curative and preventative for future generations.The FDA has approved 4 gene therapies to date, including Zolgensma (Novartis), approved to treat a rare spinal defect. 2019. There are dozens of gene therapy products on the near horizon. When we look back ten years from now, my hope is that we can say “remember when we treated cancer with toxic chemo therapy and genetic disorders went relatively untreated?” That will certainly make the hard work we have to do well worth it. Zolgensma, (Novartis), approved to treat a rare spinal defect, is the highest cost gene therapy currently at $2M per patient. Pharmacy Outlook. Changing DIR fee structure. Collaboration between payers, providers and manufacturers is possible, and most likely the best strategy to ensure cost effective access to quality care. The cost of $850,000 will be partially reimbursed if a patient fails to respond to treatment. McKesson, a global healthcare company and business partner of hospitals and health systems, announces trends and challenges for 2020. It is the highest cost gene therapy, currently at $2M per patient, and total sales of $361M in 2019. FAQs from Genetic and Rare Disease Information Center, U.S. Department of Health and Human Services During the early 1990’s there were fewer than 30 specialty medications approved by the FDA. These therapies bring life changing treatment options and hope to many people who are dealing with rare genetic diseases. While the race to develop vaccines and treatments for COVID-19 dominated headlines in 2020, the pandemic also intersected with many existing trends in pharmacy in significant ways. Pharmacy and healthcare provider markets experienced unprecedented volatility. Significant advancements will bring curative therapies to many individuals suffering from rare hereditary diseases. BioProcess International. This product if approved will be an oral agent and a likely specialty pharmacy play. Specialty drugs are developed mostly for chronic and degenerative diseases like rheumatoid arthritis, cancer and multiple sclerosis. Cancer (oral) and autoimmune treatments were the most influential drug categories in driving higher trend for all lines of business with trends in the double digits. Healthcare will be a … Specialty pharmacy trends: Specialty pharmacy is projected to grow to $500 billion by 2020. [4] The Evolution of Specialty Pharmacy Today, this number has increased to over 400. Peanut allergy is 1 of the most common of the childhood food allergies. Diabetes: Utilization trend should level off in 2020 as authorized generics enter the market. (See Exhibit 51 in our new report.) Puts the onus on the Payer to prove failure of efficacy. As specialty drugs have gained a stronger foothold in the United States, the creation and utilization of specialty pharmacies has also expanded. I review: Volume Based Purchasing – the Netflix Model. 2020 Trends in Pharmacy Care: Technology. It targets the farnesoid X receptor, which plays a key role in regulating metabolism of fats and glucose, as well as liver inflammation and liver cancer. have been made to your 2020 … The first biosimilar was launched in the U.S. in 2015. The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers vi • The federal government and multiple states are pursuing new policies aimed at introducing the commercial importation of drugs intended for foreign markets. The lines between care settings … As we enter a new decade, the healthcare industry will continue to address challenges like reimbursement for high investment therapies and the impact of social determinants of health. There have been 2 chimeric antigen receptor (CAR-T) approvals for certain kinds of non-Hodgkin lymphoma: Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel). They estimate a savings of over $470M over the next five years in addition to a reduction of medical costs to treat progression of the disease. These lifesaving products work by removing T-cells from the patient and genetically re-engineer those cells to target a specific cancer cell as diagnosed by the patient’s health care team. It’s no secret that technology is constantly evolving within the health care landscape, in which harnessing the power of data and automatization can spur significant progress in patient care, reimbursement, and overall efficiency. Expert panelists review the causes, diagnostic work-up, management, and emerging therapies inherent in the evolving paradigm of irritable bowel syndrome. A biosimilar for Tecfidera, used to treat multiple sclerosis, should launch 3Q2020 with the potential to impact annual sales of $3.5M. changes . ... Growth of specialty market (2015-2020) THE SHIFTING LANDSCAPE CERTARA TRENDS BRIEF 5 US specialty drug spending saw a modest annual growth of 3%, from 44.7% in 2018 Chaguturu S. Pipeline Preview 2020. Health plan sponsors are rightly concerned about the possibility that their medical costs could skyrocket if a few of their members started treatment. Nine specialty drugs have lost their patent however only six of them have actually launched a biosimilar due to patent protection, patent litigation and manufacturing challenges. EOC 2020 Update. Genetic information is gathered through genome sequencing where researchers are able to identify specific abnormalities and come up with drugs and therapies targeted towards them. Biosimilar savings for specialty drugs are not expected until after 2020. 1,2 Despite accounting for less than 2 percent of all U.S. outpatient prescriptions, it is projected that nine out of ten top-selling drugs will be specialty by 2020 and specialty drugs will account for 47 percent of pharmacy revenue … Spark agreed to the same terms for Luxterna to treat a retinal disease causing blindness. They anticipate approval of 10 – 20 gene therapies annually, driving more than $8.6 Billion in healthcare expenditure by 2025. Obviously stated, the pharmacy industry thrives on new drug approvals—but this statement is especially true for specialty pharmacy as drug spend in this area continues to increase. Unique Reimbursement Models for High Investment Therapy. Significant advancements will bring curative therapies to many individuals suffering from rare hereditary diseases. It has been redesigned to make it easier to find the information you need. And that’s how we’ll change pharmacy benefits for the better. Insight provided by Bryan Klazinga, VP of Pharmacy Benefits. Your 2020 EOC will look different from previous EOCs. Medical Pharmacy Trend Report For 10 years, the Magellan Rx Management Medical Pharmacy Trend Report has unlocked pharmacy trend updates and emerging strategies to manage rising specialty spend on the medical benefit. Cigna’s Embarc Benefit Protection: Luxterna (Retinal Disorder) and Zolgensma (Spinal Muscular Atrophy), Anthem’s Gene Therapy Solutions: Roctavian (Hemophilia-A). • Regulatory efforts to remove the role of rebates in the drug channel system have failed. Denise CabreraLicensed Clinical PharmacistNational Pharmacy Practice Leader   McGriff Employee Benefit Solutions813-682-1515Denise.Cabrera@mcgriffinsurance.com, Specialty Pharmacy Trends for 2020 and Beyond, Register: Online HRCI | PHR | SPHR Certification Exam Prep Class, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet, https://bioprocessintl.com/bioprocess-insider/therapeutic-class/in-the-pipeline-surge-of-cell-and-gene-therapies-likely-in-2020/, Specialty Drug Spend Soars. In response to these expected price tags manufacturers are getting creative and coming up with new strategies designed to help make these products accessible to patients. In 2020, specialty pharmacies must embrace initiatives to quantify improved clinical outcomes, lower costs, and create more value for all stakeholders to obtain maximum compensation for their services. 1 With the rise of personalized medicine and gene editing therapy drug spend is projected to reach $600B in 2020. Increasing complexity and growth in integrated delivery networks. High investment therapies have stretched current reimbursement models beyond their capacity. Sales of Zolgensma totaled $361M in 2019. Specialty and high-cost medications continue to dominate the news. Key Trends in US Specialty Pharmacy Payer Perspectives and Developer Strategies, 2020-23 CERTARA TRENDS BRIEF. Top therapy areas, which contributed to trend, are autoimmune/anti-inflammatory drugs, along with cancer drugs for lung and breast cancer, due to increased costs over older treatments and brand inflation. Stanton D. In the pipeline: Surge of cell and gene therapies likely in 2020. Our specialty pharmacy readers are amongst the most informed in health care. Progress has been exceptional but these high investment therapies have also introduced new challenges for employers and the payer community.4The 1983 Orphan Drug Act was enacted to incentivize research for rare diseases which are estimated to afflict 10% of Americans. See below a snapshot of specialt… Market share shifts and increased requirements also played a part. The FDA has determined that obeticholic acid is a Breakthrough Therapy. Medical pharmacy trends continued to climb with commercial PMPM increasing 10 percent year over year. Specialty drugs currently represent just under 2% of the prescriptions, but nearly 40% of spending in the same channels. IQVIA website. Novartis expects to treat 100 infants each quarter. Specialty products and services were considered the most profitable among all the pharmacy trends for this year, and 2020 will see a bigger market for these medications as they become part of the top pharmacy trends for 2020. We have reorganized or moved some sections, but there are no changes to your plan besides the changes listed below. State of Louisiana’s contract with Asegua/Gilead allows unrestricted access of the drug Epclusa, to treat and cure Hepatitis-C, for their entire Medicaid and prison population. Valued at $144.2 billion in 2018 and predicted to grow to $206 billion by the end of 2020, the global digital health market is growing at a … Intercept Pharmaceuticals filed an NDA for obeticholic acid to treat fibrosis in patients with non-alcoholic steatohepatitis (NASH). Although our name is new, our history isn’t. Can Formulary Management Bring It Down to Earth?, Managed Care, 2019, FAQs About Rare Diseases, Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services, 2017, https://www.cigna.com/newsroom/news-releases/2019/pdf/cigna-health-services-business-pioneers-an-innovative-solution-to-affordably-bring-life-changing-therapies-to-patients.pdf, http://image.messageinsite.com/lib/fe5615707d600c747210/m/2/757027d4-dff0-4c1b-a50a-ce78326b9917.pdf, 5 Ways Talking to Strangers May Boost Your Emotional Intelligence, Driving Optimal Results Through Individual/Team Performance-Based Incentive Compensation Plans, The Future of Benefits Administration Technology for HR Professionals, Most Brokers Say They Have All the Answers, Is Western Governors University Accredited | Read the Latest World News - News World, The Three Top Challenges to Earning a Degree, Factors in Assessing Your Hiring Strategy - HRProfessionalsMagazine, Recruiting Tips During Times of Uncertainty, Profile: Emily M. Dickens, SHRM Corporate Secretary and Chief of Staff, Preview of SHRM-Atlanta SOAHR Conference March 25-27. Specialty medication is expected to increase to 50% of drug costs by 2020. 2 Emerging Trends in the Specialty Drug Industry Brought to you By: S ... $400 billion by 2020.3 Clearly, the use of and spend on specialty drugs in ... snapshot of specialty pharmacy mergers and acquisitions in 2016.4 To properly serve their patients, pharmacists working in the outpatient setting—whether or not During 2020, the COVID-19 pandemic disrupted every aspect of the pharmaceutical channel—and our lives. Direct and indirect remuneration (DIR) fees are not going away in 2020 … Specialty drugs are expected to represent almost 50 percent of total prescription drug spending in 2020. There is a $62B market for biosimilars over the next four years as competition in the specialty drug market increases. Drug Channels Institute estimates that in 2019, the 10 largest specialty pharmacies owned by health systems had specialty pharmacy revenues of $190 million to $470 million. Accredited residency programs meet specific standards and guidelines. Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023. These high investment therapies have stretched current reimbursement models beyond their capacity. Those 2 products are likely to be joined by a third CAR T-cell therapy for lymphoma: Celgene’s lisocabtagene maraleucel (liso-cel) for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma. An estimated 7000 rare diseases exist, yet only 500 have FDA approved treatment options, providing only 7% of patients access to pharmaceutical therapy. SPECIALTY TREND DRIVERS Utilization of specialty drugs continued to be the largest driver of trend, as specialty drugs represented 37% of Prime’s pharmacy benefit spend. Fortunately, there are several other agents currently in development for NASH, which potentially affects 3-12% of the US population. The biosimilar for Truvada is expected to launch in 2021. You can watch the full video below. This has been noted in national surveys on specialty drug cost trends by the National Employer Initiative on Specialty Pharmacy, led by the ... Planning a Specialty Drug Strategy Through 2020 . Novartis has agreed to annuity payments for Zolgensma over five years. Expect these therapies to be hyper expensive and create a new set of challenges of payers and manufacturers. Accreditation is granted by ASHP in partnership with AMCP under the Required Competency Areas, Goals, and Objectives for PGY1 Managed Care Pharmacy Residencies.. Find an Accredited Residency The American Journal of Pharmacy Benefits. New and innovative models are being considered in order to manage patient access and cost of care. Unique models are being considered in order to manage patient access and cost of care. Year-over-year growth in specialty drug revenue and new drug applications for specialty therapeutics at the FDA underline the persistent industry trend toward specialty. More than 900 investigational new drug applications have been submitted to the FDA in 2020. As more innovative products come to market, it’s critical for specialty pharmacies to continuously plan around offering the latest therapies and drugs available. Because of the drop in employer healthcare spending in the first half of 2020 and the uncertainty around spending in the second half of the year, HRI is projecting 2021 medical cost trend relative to 2020 estimated healthcare costs, normalizing for COVID-19, rather than actual 2020 costs. It is a pre-exposure prophylaxis for HIV and will have the potential to impact nearly $3B in annual sales. It would not address short term budget issues but would prevent hospitals from marking drug costs up significantly and avoid issues with DRG payments. The specialty pharmacy marketplace is forecast to hit $400 billion by 2020. THE SHIFTING LANDSCAPE ACCESS TRENDS IN SPECIALTY PHARMACY 2020-23 7 US specialty drug spending saw a modest annual growth of 3%, from 44.7% in 2018 to 47.7% in 2019 per ESI.10 On the basis of non-discounted spending, specialty growth has been outpacing traditional product growth, with a 10% to 0.3% dollar volume increase, per IQVIA. Specialty Biosimilar Pipeline $62 Billion Biosimilar Market 2020 – 2024. In 2020, spend will nearly double and specialty will represent half of all drug spend. Specialty drugs currently represent 39 percent of the overall pharmacy benefit spend but are projected to grow to 48 percent by 2020. Several trends will further address the need to change the way we deliver and pay for healthcare in the U.S. Value based arrangements and risk sharing across plan sponsors, PBMs, Payers and manufacturers is being considered in order to sustain affordability, ensure access to care and continue to incentivize manufacturer research and development efforts. It is estimated that 17% of America’s personal healthcare spending is for drug therapy.1 With the rise of personalized medicine and gene editing therapy drug spend is projected to reach $600B in 2020. The State of Specialty Pharmacy 2020: Market Data and Trends (video) In May, I recorded a brief video webinar for an on-demand business education session at Asembia's 2020 Specialty Pharmacy Summit Virtual Experience. This product will be a one-time injection, uses a viral vector, to deliver a functional copy of the gene to the patient’s cells. Total trend could rise slightly, reflecting higher drug prices, as insulins are considered biologics from March 2020. There are a couple of products aimed at building up a level of tolerance, which can help prevent a fatal allergic reaction due to accidental exposure. Spark Therapeutics has agreed to VBR for its gene therapy, Luxturna, which cures a retinal disease causing blindness. Specialty Pharmacy Trends for 2020 and Beyond. Oncology: Trend could be up slightly in 2020 due to increased utilization and pricing of oral drugs, such as Ibrance ® (palbociclib). Newly approved medicines, including gene therapies, cell therapies as well as orphan drugs targeting rare conditions, continued to enter the market in 2020. The following . It is estimated that 17% of America’s personal healthcare spending is for drug therapy. By focusing on total health, not just prescriptions, we’re thinking bigger. 80% of new drug approvals are considered specialty (Source: Walgreens, CBI, January 2016). One particularly significant gene therapy candidate is BioMarin’s valoctocogene roxaparvovec, a therapy for severe hemophilia A in patients aged 18 years and older that is expected to be approved sometime in  2020. Marc Stranz, PharmD, and Justin Linhorst, MBA. DIGITAL TRANSFORMATION is advancing industries, altering consumer behavior, and reinventing society at every level. Increasingly blurred lines between care settings. We’re the pharmacy benefits manager behind Anthem, Inc., so finding new ways to help customers and their members is second nature. These therapies offer immense potential benefits to patients—in some cases offering cures to life-threatening diseases in a single dose. 2020-06-18 19:11:00. While initially often opened independently, many specialty pharmacies have been acquired by traditional chain pharmacies and investment firms in recent years. If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. Specialty drugs are chemically more complex and are referred to as biologics because they are derived from living organisms or their products, such as a human or animal protein, hormone or antitoxin. /publications/specialty-pharmacy-times/2020/February2020/editors-note-top-trends-for-2020-in-specialty-pharmacy, Copyright Specialty Pharmacy Times 2006-2019, 2 Clarke Drive Suite 100 Cranbury, NJ 08512 P:609-716-7777 F:609-716-9038, https://www.iqvia.com/en/insights/the-iqvia-institute/reports/medicine-use-and-spending-in-the-us-a-review-of-2018-and-outlook-to-2023, https://payorsolutions.cvshealth.com/insights/pipeline-preview-2020. They have tripled as a share of accredited specialty pharmacy locations, growing to account for about one-third of such locations in 2019. Specialty pharmacies are designed specifically to manage the necessary handling, storage, and distribution of complex therapy drugs that require high-touch patient management. Digital disruption and big data are shifting the way businesses interact with consumers and accelerating change at a … Hospitals are integrating with medical practices, … by Denise Cabrera. Supplemental indications on existing specialty therapies has led to an increase in use, as well as an aging population of baby boomers contributing to the increased use or volume of specialty drugs being prescribed. Editor's Note: Top Trends for 2020 In Specialty Pharmacy, Dan Steiber, RPh, Directions in Specialty Pharmacy® Editor-in-Chief. Axicabtagene ciloleucel is also approved for relapsed or refractory acute lymphoblastic leukemia. Paying a fixed fee for use of the drug, over the next five years, will allow them to treat over 30,000 individuals by 2024. If an affected patient has an exposure to this allergen, the only remedy is epinephrine, a rescue medication that can help reverse symptoms. CVS Health website. 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