Stacey Ness, PharmD, AAHIVP, CSP, MSCS

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 Study

 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&mdash;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:

		2% decrease in overall specialty utilization, which is the first time in the 7-year history of inclusion of specialty in this study that use of specialty products fell.

		38% increase in medications used to treat inflammatory conditions (including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, and psoriatic arthritis).

		1% increase in the use of medications to treat HIV.

		14% decrease in the use of medications that treat hepatitis C virus (HCV); markedly decreased from the 289% growth seen in this category in the 2015 study period, and a further 25% increase in this category in the 2016 study period.

		29% decrease in the use of medications that treat multiple sclerosis (MS).

		2% decrease in the use of injectable osteoporosis medications.

		Relatively stable use among all oncology products, with a 1% decrease in oral oncology products. 

Given that the same methodology was used for the 2015 study

 (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 study

 (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:

		Orencia and Orencia Clickject (abatacept)

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.

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.

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.

Articles

The shifting landscape in specialty dispensing among pharmacies that service patients in senior care settings and long-term care facilities.