Imagine a situation for your next drug where 98 percent of your patients are rapidly initiated on therapy, where the patient walks out of the office with their initial fill in hand, educated and confident on why they’re on the drug, where they receive caring support to be 95 percent compliant to the regimen, and where data provides deep insights into the patient experience and outcomes.
When Imbruvica® launched in 2013 with a limited network of four independent specialty pharmacies (SP), manufacturers were amazed at the boldness of such a strategy. It caused controversy and anger. We knew the reason for this channel configuration, but many doubted it could be successful. Could such a model work in our industry? The answer has proven to be yes. It worked because it was the right thing to do for the patients, and it has been sustainable because it was aligned with the dynamics at the time within oncology, sites of care and payers.
Now, in 2021, configurations like this for rare disease, self-administered drugs are common, and are highly successful from a patient experience perspective. This trend is clearly apparent when we examine the number of exclusive and limited SP dispensing networks for orphan oral therapies approved in 2019 and 2020 (see below).When we look forward to the 2020s, and think about how we’ll look back from 2030, we see similar momentum building for Health System Specialty Pharmacies (HSSP).
|PRODUCT||GENERIC NAME||COMPANY||INDICATION||APPROVAL DATE||NO. OF SPs||NO. OF SDs|
|Rozlytrek®||entrectinib||Roche||ROS-1 NSCLC, NTRK Fusion||08/2019||12||10|
|Brukinsa®||zanubrutinib||BeiGene||Mantle Cell Lymphoma||11/2019||3||5|
|Tazverik®||tazemetostat||Epizyme||ES and EZH2 FL||01/2020||1||1|
|Ayvakit®||avapritinib||Blueprint||PDGFRA ex18 GIST||01/2020||2||5|
|Retevmo®||selpercatinib||Loxo (Lilly)||RET+ NSCLC and MTC||05/2020||7||6|
The evolution of the US product mix in the 2010s and the science of pharmaceutical manufacturing pipelines will continue to shift our focus to orphan drugs, combination treatments, and cell and gene therapies. At the same time many of the institutions operating HSSPs have spent the past decade building, refining, and optimizing their patient care systems and capabilities, such that today they offer a unique and superior pharmacy experience.Today leading manufacturers are capitalizing on opportunities to engage HSSPs in augmenting established specialty pharmacy networks as a mechanism to further optimize the care of patients on their drugs. The natural next step is a limited SP network made up of only HSSPs. This will be a bold move for the initial manufacturers that take this step, just as the Imbruvica® limited network of independent SPs was a bold move at the time
The HSSP Model Supremacy
Based on their positioning and integration, HSSPs have unique advantages which embody what is possible with pharmacy care. By deploying pharmacy technicians and pharmacists in the specialty clinics in order to support treatment decisions of clinicians and patients, HSSPs can better coordinate the transitions in care and optimize the treatment initiation process in order to drive patient engagement and reduce time to the first fill. While the specific SP model and therapeutic areas of HSSP focus may have differences between organizations, many leverage consistent best practices which support a superior patient experience and optimized clinical outcomes.1 The following HSSP best practices support optimal access, initiation, adherence and outcomes.
- Electronic Health Record (EHR) integration, including full access to patient records and integration of documentation and data reporting tools with the EHR.
- Centralization of the prior authorization and medication pre-certification process for clinic-administered and/or self-administered therapies.
- Dedicated staff to facilitate enrollment in financial support and manufacturer patient assistance programs.
- Decentralized pharmacy personnel integrated with clinical care within the specialty clinics where treatment decisions are made, and patient care is delivered.
- Internal foundation support to assist with medication and care affordability for patients who meet specified financial need and/or access criteria.
Primary Care Golden Age (1980s to 90s)
- Primary care blockbuster era
- Hatch Waxman created waves of lucrative generic launches (1984)
- Massive consolidation in insurers, PBMs, hospital wholesalers and retail pharmacies
First Specialty Models (mid-90s to early-00s)
- First specialty pharmacy (SP), Stadlanders focused on HIV, transplant and MS (1992)
- First manufacturer patient services hubs for MS self-injectables
- Big three wholesalers established their specialty distribution businesses
Manufacturer Channel Influence (mid-00s to early-10s)
- First limited SP networks, Nexavar and Revlimid (2005)
- MMA forced migration to SD and FMV services (2006)
- Early health system (HS) SPs at Fairview, Vanderbilt, Carolinas, Johns Hopkins
Manufacturer Channel Control (mid-10s to early-20s)
- First independent only SP network, Ibruvica (2013)
- White glove SPs take on hub services
- Five launches with exclusive SPs in 2020
- HS SP explosion (79 with dual accreditation and 88 with single accreditation at end of 2020)
- First autologous CGT supply chains, Kymriah and Yescarta (2017)
1 Quittner, A.L., Zhang, J., Marynchenko, M., Chopra, P.A., Signorovitch, J., Yushkina, Y., & Riekert, K. (2014). Pulmonary Medication Adherence and Health-care Use in Cystic
Fibrosis. CHEST, 146(1): 142-151. dio:10.1378/chest.13-1926.
An HSSP Network Test Case
Now let’s make this concept concrete. Consider muscular dystrophy (MD), which is a group of various inherited diseases which damage and weaken muscles over time. The Muscular Dystrophy Association (MDA) maintains a roster of 222 US-based care locations at top health care institutions which are part of its MDA Care Center Network. 135 of these MDA Care Center locations are associated with HSSPs, with 64 locations having at least one SP accreditation (URAC, ACHC or CPPA) and 53 locations operating an HSSP with dual SP accreditations. Using the panel of 64 MDA Care Centers with an accredited HSSP and presumed ability to provide daily Rx status and dispense data as the basis for a limited HSSP network, how durable would this limited pharmacy network be in the complicated US healthcare system? Let’s break it down and consider key payers, programs and inflection points in the context of an orphan, self-administered, pharmacy benefit product:
- Medicare — Similar to commercial payers, Medicare Part D follows a regional contracting approach but with fewer contractual lockouts of HSSPs due to any willing provider requirements. While HSSP participation in Medicare plans is nearly universal, plan administration via Pharmacy Benefit Manager (PBM) administrators could raise risks related to financial impacts of DIR fees and HSSP willingness to participate with aggressively constructed Medicare Part D contracts.
- Commercial payers — Due to the regionalized footprints of commercial payers, aligning the dispensing network to the identified 64 HSSPs raises the likelihood that network dispensing sites regionally align to the service area of commercial payers allowing patient referrals to those organizations. However, care must be taken to ensure that the network of 64 HSSPs includes open-door HSSP dispensing locations with sufficient commercial contract and national coverage to support areas with commercial payer and network HSSP misalignment. While not all HSSP locations are open door dispensing locations, those who have invested in the open-door model have the infrastructure and operations to accept and support open-door volume from the non-network locations.
- Patient transition from MDA Care Center to community for care — Individual HSSPs will maintain internal definitions of a “patient” which aligns to their for-profit/ non-profit status and organizational mission. Patients who transition care from the MDA Care Center to community provider locations can be serviced by the open door HSSP network location(s).
- Open market scripts — Similar to what we noted under patient transitions, prescriptions originating from nonHSSP clinical locations could be supported by open door HSSP network location(s).
- Veterans Affairs (VA)/Department of Defense (DOD) — VA and DOD access can introduce challenges to limited dispensing networks if not properly planned, due to the need to provide Federal Supply Schedule (FSS) pricing for eligible dispenses. There are multiple options for this customer segment. It could be serviced via a network of specialty distributors, it could acquire product via a direct purchasing relationship with the manufacturer, or it could be serviced via an open door HSSP location with experience or contractual relationships to serve VA and DOD service members domestically and abroad.
- 340B — The HSSP-only network should not lead to a proportionally greater 340B volume. Within our network of 64 locations, we can presume a high percentage of organizations will have 340B eligibility for internal patients and eligible dispenses. However, HSSPs typically operate as a closed-door/own-use dispensing model which prevents the establishment of elaborate HSSP contract pharmacy networks or dispensing for patients from external, non-affiliated clinics. Additional consideration must be made to the role of 340B covered entities which are non-MDA care centers in order to ensure that network design meets the intent of the 340B program.
340B-Medicaid Duplicate Discounts — This HSSPonly network should significantly decrease the risk of duplicate discounts because 340B contract pharmacy fills would be minimized or eliminated. By establishing an SP network which reduces the ability of PBMs to force dispenses to their restricted pharmacy networks, we eliminate the primary driver for 340B contract pharmacy volume under a traditional open or limited dispensing network scenario.
The Most Common Manufacturer Point Of Resistance
Manufacturer channel management teams remain hesitant to embrace HSSP networks because of perceived operational burden due to contracting, data requirements and account management for the requisite number of HSSP network members to provide national coverage. Intermediaries like Acentrus, Asembia, Trellis, Shields and Excelera have emerged as solutions which can mitigate the operational and implementation impacts for a manufacturer, including network requirements assessment, contract execution and data sharing. While these intermediaries won’t provide a perfect solution to the implementation requirements of our network of 64 HSSPs, concerns about unrealistic operational workload can be mitigated by properly vetting their coverage, capabilities and alignment to proposed network participants.
The maturation of the HSSP marketplace has reached a point where an HSSP-only dispensing model is viable. We’re very much at an “Imbruvica-moment” and thoughtful design is critical to the success of this type of pharmacy network. In the same way that the Imbruvica model was successful because it was aligned with holistic market dynamics at the time within oncology, sites of care and payers, a similar holistic context should be considered for an HSSP-only network. Consider the risks from potential regulatory or statutory changes. What are the impacts of restriction or limitation of the 340B program and resulting financial viability of the HSSP network? The 340B program is an economic driver of HSSP investiture, and fundamental changes to program administration or patient definition would have a significant impact on the ongoing investment in and viability of HSSP programs. What are the impacts of changes to state-level regulations on payer policies, dispensing networks, medication access and pricing policies? These have created a patchwork national regulatory landscape which continues to evolve rapidly. HSSPs are not insulated from these changes, and key impacts like changes to any willing provider statutes, Medicaid program structure (e.g. block grants), or ability to define dispensing networks should be considered for an HSSP-only network.
The HSSP-only network will not be appropriate for every product; but for smaller patient population products covered under pharmacy benefit and with patient care heavily concentrated at institutional centers of excellence, a limited SP network of HSSPs represents a feasible configuration to deliver an optimal patient experience and drive patient outcomes.
What products in your pipeline could be candidates for this innovative dispensing channel model? Do you have the courage and knowledge to champion this model within your organization.