The shifting landscape in specialty dispensing among pharmacies that service patients in senior care settings and long-term care facilities.
Last year represented a marked change in specialty dispensing among pharmacies that service patients (ie, residents) who live in senior care settings, such as long-term care (LTC) facilities.
The 2017 Managed Health Care Associates (MHA) Independent Long Term Care Member Study1 includes a section on specialty medications, consisting of an analysis of LTC pharmacy dispensing data and the trends noted versus previous years. Although this is MHA’s seventh year looking at specialty within LTC, due to methodology changes—including short-cycle dispensing requirements—results cannot be compared among years prior to study period 2015.
This year’s study periods include an analysis of data from January 1, 2015, to September 30, 2015 (study period 2016), versus January 1, 2016, to September 30, 2016 (study period 2017). The analysis included claims data from 1389 pharmacies encompassing more than 199 million claims. More than 3.6 million patients were represented in the study. This article will examine some overall trends, as well as take a deeper dive into specific therapeutic categories.
The results from this study illustrate that LTC pharmacies included in the analysis have seen the following:
Given that the same methodology was used for the 2015 study2 (data from January 1, 2013, to September 30, 2013 [study period 2014], versus January 1, 2014, to September 30, 2014 [study period 2015]), as was used in the 2016 study3 (study period 2015 versus study period 2016) and the 2017 study (study period 2016 vs study period 2017), we were able to note the comparisons seen in Figure 1.
Biologics for inflammatory conditions was the only specialty therapeutic category to grow significantly, by 38%, in 2017. This growth comes on the heels of similar growth posted in this therapeutic category in the 2016 study (37%). These products are used to treat diseases such as rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis.
Year-over-year growth in prescription count was noted for each of the following:
Humira continues to be the most widely used biologic for inflammatory conditions in the LTC patient population. Taltz (ixekizumab) was approved in March 2016 and will be included in the 2018 study. Three biosimilars in this therapeutic category were also approved in 2016, which are anticipated to impact the inflammatory conditions landscape moving forward: Inflectra (infliximab-dyyb), a biosimilar to Remicade; Erelzi (etanercept-szzs), a biosimlar to Enbrel; and Amjevita (adalimumab-atto), a biosimilar to Humira.
Use of medications that treat HCV fell 14% in the 2017 study; a significant drop-off from the 289% growth seen in this category in the 2015 study period, and a 25% increase in the 2016 study period. This may be a signal that the initial wave of patients who were most in need of therapy have now been treated with the newer direct-acting antivirals.
There are signals that further treatment may continue at a more moderate pace. Because increasing HCV drug therapy use was a significant factor in overall specialty growth over the past several years, we can now see that the slowing utilization in this therapeutic category has also significantly contributed to a decrease in overall specialty utilization this year.
We continue to see evolution in this marketplace, as the approval of new agents Zepatier (elbasvir and grazoprevir), Epclusa (sofosbuvir and velpatasvir), and Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) added to the treatment arsenal in 2016. Harvoni (ledipasvir and sofosbuvir), whose use in this population decreased 30% from study period 2016 to study period 2017, continues to be the market leader by a significant margin (see Figure 2).
The trend in oncology marked the third consecutive year with a slight decrease (—2% in study years 2015 and 2016 and –1% in 2017) in oral oncology products in the LTC space. Although overall growth dipped slightly in the oral oncology space, there was significant growth in many branded oral oncology agents from study period 2016 to 2017.
Among the branded agents experiencing growth in the LTC space are the following:
The continued flat-to-decreased prescribing in the oral oncology therapeutic category within LTC may be due to many of the newer oral oncology agents’ being launched as limited distribution products through preferred specialty pharmacies, which continues to serve as a barrier to access to these agents for residents in an LTC facility setting.
Prescriptions for HIV therapies in the LTC setting grew by 1% from the 2016 to 2017 study period. This may continue to reflect the fact that a growing number of individuals aged 55 and older are living with HIV. The CDC estimates that this age bracket accounted for more than one-quarter (26%) of the 1.2 million people living with HIV infection in the United States in 2013.4
This represents an increase from 19% in 2010 and 24% in 2012 and is expected to continue rising. Furthermore, older Americans are more likely than younger ones to be diagnosed with HIV infection later in the course of their disease, which means a later start to treatment and potentially more damage to their immune system. This represents a potential opportunity for LTC facilities specializing in HIV/AIDS treatment.
Multiple Sclerosis (MS)
MS therapies within LTC demonstrated a 29% decrease in the use of medications to treat MS in study period 2017. Avonex (interferon beta-1a), Extavia (interferon beta-1b), and Gilenya (fingolimod) all posted sustained or increased growth in the 2017 study.
Glatopa (glatiramer acetate subcutaneous injection), the first generic disease-modifying agent in the MS space, also posted significant growth. Copaxone (glatiramer acetate subcutaneous injection) once again pulled ahead of Rebif (interferon beta-1a) in use to regain its spot as the most used MS drug in the LTC setting by prescription count.
Rebif was the most used drug in the 2015 and 2016 studies. The newer oral disease modifying agents for the treatment of multiple sclerosis, Aubagio (teriflunomide) and Tecfidera (dimethyl fumarate), continue to have minimal use in the LTC setting. This may largely be due to these agents’ having limited distribution through preferred specialty pharmacies, which, as noted in other therapeutic areas, continues to serve as a significant barrier to access for residents in an LTC facility setting.
Other recently approved agents, Plegridy (peginterferon beta-1a) and Lemtrada (alemtuzumab), which both received FDA-approval in 2014, had minimal use in the LTC patient population. Zinbryta (daclizumab) was approved in May 2016, and it will be included in the 2018 study.
Additional Specialty Therapeutic Categories
In addition to the therapeutic categories highlighted previously, several other categories posted growth within the LTC space. Hemophilia agents grew 60% in the 2017 study, and there was significant growth from agents that fall into bleeding disorders support (such as aminocaproic acid and tranexamic acid), which more than tripled.
Cystic fibrosis treatments posted a 13% increase in the 2017 study, led primarily inhaled tobramycin. Treatments for the symptoms of Huntington’s disease showed 351% growth, led by tetrabenazine, the generic form of Xenazine. ITP agents Nplate and Promacta grew 42%, and agents for iron overload grew by 114%.
Agents for oncology support (driven primarily by Xgeva) increased 26%, and treatments for pulmonary fibrosis grew 25%. Prescriptions for antirejection medications for organ transplants grew 1% during the 2017 study (see Figure 3).
One of the newer therapeutic categories to watch is the proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. PCSK9s were approved by the FDA in the United States almost 2 years ago, offering a new and different treatment option for patients with certain types of high cholesterol.
Praluent (alirocumab) was approved on July 24, 2015, and Repatha (evolocumab) received approval on August 27, 2015. These drugs represent some of the most significant additions to the therapeutic arsenal for treating high cholesterol since the first statins were approved in 1987.5
Utilization in the 2017 study was significant, and product uptake was swift during that time period. The 2018 study will be the first time that data are available to determine year-over-year growth.
Overall Specialty Trends
Although the average number of specialty prescriptions dispensed per LTC pharmacy per month has remained relatively constant throughout the study periods from 2015 to 2017, the total specialty pharmaceutical spending increased significantly until 2016, before decreasing in the 2017 study period for the first time since tracking spending in this study (see Figure 4).
It is anticipated that the large overall total annual specialty pharmaceutical spending increase previously seen was driven in large part by the significant increase in hepatitis C utilization and spend during that time period, and the drop off in utilization in that therapeutic category in 2017 is largely the reason that overall spending in specialty decreased this year.
Furthermore, it was found that the percentage of prescriptions dispensed with a co-payment for specialty pharmaceutical products steadily increased from 33% in study period 2014 to 38% in study period 2017, which may reflect an increased utilization in senior care settings other than skilled nursing facilities, such as assisted living and continuum of care retirement communities (CCRCs; see Figure 5).
When the patient did experience a co-payment, the average per specialty prescription was found to be $148 in study period 2017, a decrease from a high of $169 in study period 2015 (see Figure 6). A significant and seemingly increasing challenge faced by LTC pharmacies in providing specialty drugs to residents of senior care facilities is navigating access issues caused by limited distribution. It is common business practice in the LTC industry that 1 pharmacy services the entire LTC facility.
LTC pharmacies have the expertise and understanding of the regulations and nuances that accompany servicing facility residents. If the LTC dispensing pharmacy cannot access the specialty drug needed to fulfill an order, significant barriers are created, most notably getting the facility resident the specialty medication in a timely manner as per federal regulations.
Additionally, this also creates fragmented care that is difficult to manage for the dispensing pharmacy, attending physician, consultant pharmacist, and nurses who are responsible for storage and administration of the medication.6
Based on the data for disease states such as oral oncology and multiple sclerosis, it is hypothesized that patients in LTC settings may be disproportionately affected by access issues due to limited distribution of the drug through preferred specialty pharmacies.
Despite challenges such as specialty limited distribution, preferred or narrow specialty pharmacy payer networks, and compliance with the Risk Evaluation and Mitigation Strategies program requirements, these data confirm that LTC pharmacies continue to provide specialty pharmaceuticals to patients across all LTC settings; however, the pace at which specialty has been growing for the past 7 years seems to have abated. Providing quality, accessible specialty pharmacy services to facilities that care for these patients remains of utmost importance as the population in the United States ages.
About the Authors
Kimberly Binaso, PharmD, RPh, BS, BCGP, FASCP, FASHP, is currently the vice president of Clinical Services for Managed Healthcare Associates, a health care services organization located in Florham Park, New Jersey. Dr. Binaso is a certified consultant pharmacist in the state of New Jersey (CCP), fellow of both the American Society of Consultant Pharmacists (FASCP) and the American Society of Health Systems Pharmacists (FASHP), and a board certified geriatric pharmacist (CGP). For the past 15 years, she has held several clinical management and leadership positions, working extensively with both consultant and clinical pharmacist teams in senior care. She is an active member of the American Society of Consultant Pharmacists, the American Society of Health Systems Pharmacists, and the American Medical Directors Association. Dr. Binaso serves as a national visiting professor and senior care expert presenter contributing posters and articles on a variety of geriatric clinical issues.
Stacey Ness, PharmD, RPh, CSP, MSCS, AAHIVP, has worked in both national specialty pharmacy and payer organizations and has experience in clinical management, adherence and persistency programs, as well as chronic disease cost optimization strategies. Dr. Ness is active in the Consortium of Multiple Sclerosis Centers, Academy of Managed Care Pharmacy, National Home Infusion Association, National Association of Specialty Pharmacy, Specialty Pharmacy Certification Board, and Hematology and Oncology Pharmacy Association, and she has served on the Minnesota Medicaid Drug Formulary Committee since 2008. She is a multiple sclerosis certified specialist, a credentialed HIV pharmacist, and a certified specialty pharmacist. She also currently serves as the senior director of Specialty Clinical Services at Managed Health Care Associates, Inc., a health care services organization based in Florham Park, New Jersey.