Dan Steiber, RPh, Directions in Specialty Pharmacy® Editor-in-Chief

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Below are specialty pharmacy’s top trends:  

New Specialty Products and Continued Growth

Specialty pharmacy became a reality as the result of the emergence of new drug approvals for disease states that lacked adequate therapy or no therapy at all. These new therapies have resulted in eradicating diseases, or extending the lives or quality of those lives of millions of individuals. Specialty products have given hope  and relief, and our specialty industry continues to expand and evolve as a result new drug approvals. 

Expect that over the course of the next several years products in the categories of oncology, autoimmune disorders, and diabetes will drive therapeutic growth. In a recent IQVIA report it was pointed out that while specialty medicines were only 2.2% of prescription volume it is projected that by the end of 2020 specialty medications will account for nearly 50% of the nation’s drug spending.

The follwing are few examples of specialty products that should be a part of our future if approved:

Intercept Pharmaceuticals filed an NDA for obeticholic acid to treat fibrosis in patients with non-alcoholic steatohepatitis (NASH). This product if approved will be an oral agent and a likely specialty pharmacy play.  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. The FDA has determined that obeticholic acid is a Breakthrough Therapy.  Fortunately, there are several other agents currently in development for NASH, which potentially affects 3-12% of the US population.

There have been 2 chimeric antigen receptor (CAR-T) approvals for certain kinds of non-Hodgkin lymphoma: Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel). Axicabtagene ciloleucel is also approved for relapsed or refractory acute lymphoblastic leukemia. 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. 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.

There are dozens of gene therapy products on the near horizon. These therapies offer immense potential benefits to patients—in some cases offering cures to life-threatening diseases in a single dose. Expect these therapies to be hyper expensive and create a new set of challenges of payers and manufacturers. 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. 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. 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.

Peanut allergy is 1 of the most common of the childhood food allergies. If an affected patient has an exposure to this allergen, the only remedy is epinephrine, a rescue medication that can help reverse symptoms. 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. 

, which was approved by the FDA January 31, 2020, is indicated to reduce the incidence and severity of allergic reactions after accidental exposure to peanut. Viaskin Peanut by DBV Technologies is in development as the second drug that would protect against accidental exposure to peanuts. Like allergy shots, these 2 products build up an immunity to the peanut allergen. Both products will likely end up in the specialty pharmacy space as limited distribution products, primarily due to cost.

The cornerstone of specialty pharmacy accreditation is the establishment of policies and procedures that provide compliance with set standards placing patients first in terms of focusing on optimizing health outcomes, and guides them through complicated therapy management. It has become a standard for both payers and manufacturers that demand evidence of meeting critical standards.

Accreditation has solidly become a must if a specialty pharmacy desires to have access to a limited-distribution product. Payers likewise have set accreditation standards around quality, controlling costs, and documenting positive patient outcomes. As a result, accreditation is necessary to be ‘in-network’ for specialty products. There will be an increasing demand to have obtained accreditation by 2 or more bodies in order to obtain access to both the product and payer space.

As the lines continue to blur between the various flavors of pharmacy, hospitals in particular have experienced tremendous new growth  As a result of the expanding portfolio of specialty products, we are seeing hospitals integrate with medical practices, infusion centers, and home care, and forming new variants of specialty pharmacy to create sophisticated networks delivering comprehensive patient care. For a variety of reasons, including access to limited distribution products, and 340B pricing, hospitals continue to establish their own specialty pharmacies or expand their existing capabilities to include specialty. Nearly all of these hospital-based specialty pharmacies take the step of obtaining accreditation to meet manufacturers’ and payers’ standards of care. 

All 3 of the major Group Purchasing Organizations (GPOs) have developed solutions to assist their members in this space. Much of the shift has been because of the trends around decreasing reimbursement for Part B products in the physician office setting, and 340 B pricing often availed to hospital-based outpatient specialty pharmacies. These pharmacies are in a strong position to provide a continuity of care through integrated systems and data sharing, and coordinating care with Accountable Care Organizations (ACOs) that may participate in risk-based contracting.  Keeping patients in a closed ecosystem provides a greater level of control and accountability. 

In the traditional inpatient hospital model, patients are released from the hospital only to receive their outpatient drug services from traditional entities, such as retail and specialty pharmacy. The shift to hospital specialty facilitates a setting where orders are kept inhouse, resulting in increased revenues and potential profitability. 

New and costlier therapies demand innovation in the way products are paid for by plan sponsors.  In order to assure access to these therapies, the market has turned to value-based reimbursement models. Attend a professional conference and you will see a multitude of presenters speaking on the topic of value-based contracting. A few organizations have taken the plunge. 

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. Likewise, manufacturers are being forced to put ‘skin in the game’ to assure their products create value for patients, providers, and payers.

Artificial Intelligence has changed the manner of how research and development takes place, and how products get approved. What was done purely in the laboratory in the past is now more often done through modeling and algorithms. Computers today can ‘crunch’ the data on countless pages of scientific literature, and that information accelerates the development of new medications. 

Pharmacies are leveraging the power of mobile health apps to reach out to patients, and industry uses these tools to gather accurate information on the status of a patient’s health that drive the development of new drugs. Printable medication also has become a reality, and expect this technology to pave the way for the future of drug development, and to lower the cost for manufacturing drugs.

There are many more trends we could comment on. Please stay tuned to 

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We welcome your feedback on this topic and on any topics, you would like us to cover in future editions of Directions in Specialty Pharmacy. Please reach out to Dan Steiber at 

IQVIA Institute. Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023. IQVIA website. 

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

Chaguturu S. Pipeline Preview 2020. CVS Health website. 

https://payorsolutions.cvshealth.com/insights/pipeline-preview-2020

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Our specialty pharmacy readers are amongst the most informed in health care. 