An in-house specialty pharmacy program can be critical for operating in today’s healthcare environment. Many hospitals and health systems that have never owned their own specialty pharmacy, but are considering building one, contemplate working with a partner or going it alone. Some may have an established program and are looking for help to improve or expand their services through unlocking previously untapped revenue, improving medication cost savings and developing new clinical programs. Others may have an existing discharge or outpatient pharmacy and aim to turn it into a specialty pharmacy, and many are starting out from scratch. While some hospitals can manage independently, those lacking specific expertise should strongly consider working with a specialty pharmacy partner to navigate the complex process.
The Role of a Specialty Pharmacy Partner
A specialty pharmacy partner will begin the collaboration with a strategy that examines data, evaluates needs and assesses the opportunity that exists for the health system based on actual prescriptions. Together, the organizations find new opportunities that will benefit the health systems’ patients and financial stability.
There are many steps to buildinga specialty pharmacy, from the construction build process to opening and contracting with payors and wholesalers to earning and maintaining accreditation. Having the needed pharmacy and clinical staff on board to help with patient medication access, patient assistance and ensuring adherence is part of building an integrated specialty pharmacy program.
It can be challenging for a health system to adequately source dedicated experts across so many areas in a short amount of time. An experienced partner fills these gaps and gets a specialty pharmacy program up and running quickly. This ability directly impacts how soon the patient journey can be eased through simplifying complex processes to make medications more accessible, reduces provider burden by taking over administrative tasks and creates financial stability through leveraging specialty pharmacy as a revenue generator.
Five Essential Areas of Expertise Needed to Open a Specialty Pharmacy
When opening a specialty pharmacy for the first time, the ability to service the greatest number of patients possible is a key to success. A strategic partner helps sequence the following steps, accelerates progress and minimizes delays to scale quickly when opening a specialty pharmacy.
- Specialty Pharmacy Team Members: Pharmacists, technicians and pharmacy liaisons will be needed to lead the integrated specialty pharmacy program. This integrated model reduces care fragmentation, allows the clinical team to manage the care of their patients across the continuum, and simplifies the journey for patients. These team members educate patients on their specialty medications, perform benefits investigation, seek prior authorization approvals, provide patient assistance and financial guidance, guide on clinical appropriateness criteria and implement medication adherence strategies.
These services unburden providers and clinical staff and improve medication management so they can spend more time providing care to patients. A study demonstrated that when pharmacists were integrated into care teams, at least one drug-related problem was identified and prevented in 93% of patients. While a specialty pharmacy partner does not have to provide outsourcing services for pharmacy operations, many hospitals and health systems choose to have their partner oversee hiring and training and manage the operation of the specialty pharmacy to ensure a connected strategy.
- URAC and ACHC Accreditation: The Utilization Review Accreditation Commission (URAC) and the Accreditation Commission for Health Care (ACHC) are the two most sought-after accreditations demonstrating a seal of quality for pharmacy operations and patient management services. Once accredited, pharmacies can grow their services more quickly because they are better equipped to handle complex specialty medications. The accreditation process is complex and can take a year or more to achieve without expertise of the changing accreditation standards, measures and data reporting. Fall 2025, URAC is expected to change their focus areas and expand requirements around medication distribution. A partner helps to navigate these types of evolving changes.
A partner with a seasoned team of accreditation experts works alongside the health system pharmacy team to prepare their program for initial accreditation, ongoing compliance, and provides an audit roadmap including mock audit preparations. The team also ensures required documentation are accessed and prepared and maintains ongoing policies and procedures for reaccreditation readiness.
- Manufacturer and Payor Access: Navigating manufacturer and complex payor networks presents significant challenges. A specialty pharmacy partner accelerates access by helping a hospitalgain entry to limited distribution medications and restrictive payor networks. Achieving meaningful access often requires a strategic approach carried out over a span of several years, involving alignment with clinical performance standards, operational excellence, comprehensive data reporting, specialty pharmacy accreditation access, strategic contract negotiation and strong wholesaler coordination. Effective wholesaler coordination and supply chain alignment are critical components that complement specialty pharmacy efforts to streamline distribution. Leveraging the expertise of a specialized partner is essential to overcoming long-term access barriers and ensuring efficient delivery of complex therapies within restrictive network environments.
- 340B Drug Pricing Program: With the rising prevalence of disease and increasing costs of specialty medications, the financial impact for a healthcare organization that owns its own pharmacy can be significant. This is especially the case for hospitals and health systems that participate in the 340B Program. Contract pharmacy restrictions that manufacturers place on 340B hospitals make it more challenging to navigate access and provide a direct service to patients. Increasing manufacturer restrictions make owning a specialty pharmacy a critical step toward maximizing savings. Pharmaceutical 340B savings provide a great deal of financial relief for covered entities caring for the most vulnerable patients. A partner with 340B expertise will optimize the 340B Program and save dispensing fees paid to contracted pharmacies, all while navigating the complexities of the regulatory and compliance landscape.
- Patient Management Software: Specialty pharmacy is unique and complex and requires specific specialty pharmacy dispensing and patient managementsoftware to help manage patients and program development. Patient management software is critical to ensure the patient/prescription journey is as simple and patient centered as possible. There are several steps in the prescription journey from the time a prescription is written until a patient successfully starts therapy that can cause disruptions, frustration and potential abandonment by the patient. These steps involve providers, patients, pharmacies and payors. Connecting these steps in the most efficient way is complex. The right patient management software goes beyond prescription fulfillment by offering a real-time view that navigates these workflow complexities. Patient enrollment, medication access tracking and usage, task sequencing and prioritization along with role-based workflows and actionable data are important functions to evaluate. Hospitals and health systems should look for a specialty pharmacy partner with innovative technology that supports financial, operational and clinical performance, while prioritizing patient care.
With the rise in specialty pharmacy demand, it’s essential to have life-saving therapies broadly available – as quickly as possible. A partner provides a core team with knowledge and experience across multiple facets of the specialty pharmacy proactively identifying patients, overcoming barriers that prevent care, improving access to medications and streamlining medication delivery. If a hospital or health system wants their specialty pharmacy program up and running as quickly and efficiently as possible, a knowledgeable partner provides the best path forward.

Derek Dennis
Derek Dennis, PharmD, is vice president of client services for Clearway Health.






