The proliferation of novel cell and gene therapies has many stakeholders within the healthcare system seeking opportunities and strategies to both maximize patient outcomes and minimize cost where possible. With some of these products requiring collection of the patient’s own cells as part of the process or having administration that requires a specific type of care setting, wholesalers were poised to play a significant role within the logistics as many of these products would be adjudicated through the provider buy-and-bill process. While this aligns to the process that providers and health systems are accustomed to for drugs administered by a healthcare provider, the buy-and-bill model presents several challenges specific to curative, high-cost drugs such as cell and gene therapies.
The high cost of gene and cell therapies can create barriers for providers, who may not wish to take on the risk of purchasing, storing, and managing these treatments. Furthermore, as payers look to tightly manage use of these products, reimbursement may also be difficult, particularly as payers explore alternative contracting to minimize their own exposure to the costs of these treatments.
With specialty pharmacy providers being well versed in the dispensing and optimization of drugs for rare and complex specialty conditions, they are poised to evolve their services to support gene and cell therapies. The use of “white bagging” or using a specialty pharmacy to adjudicate and dispense a healthcare provider administered drug has been utilized by both payers and providers to overcome some of the challenges with buy-and-bill. Stakeholders are finding that there may be additional benefits to its use for cell and gene therapies. Both ZOLGENSMA® (onasemnogene abeparvovec-xioi) and LUXTERNA® (voretigene neparvovec-rzyl) have utilized a distribution model that leverages Accredo specialty pharmacy for distribution.
Use of a specialty pharmacy in the distribution process removes the financial burden from the provider, as well as the need for any one-off contracting for the gene or cell therapy. The specialty pharmacy can play a role as an important partner for all stakeholders involved in gene and cell therapies. With alternative and complex contracting emerging for these products, specialty pharmacies can help support coordination between payer and manufacturer. For stakeholders that engage in outcomes-based contracts, specialty pharmacies can even be utilized to collect data, such as patient reported outcomes (PROs), to support those arrangements.
Many patients who are candidates for gene and cell therapies have complex conditions that require significant coordination. Specialty pharmacies have the capabilities and staff to support these patients by supporting their care coordination with the provider(s), which may be viewed as favorable by payers as they seek to optimize the care for these patients. The patients may also benefit from assistance in proactively identifying financial support as well as identifying solutions to potential access barriers.
As patients, providers, and payers attempt to navigate the benefits and challenges that innovations like cell and gene therapies bring to the healthcare system, all of these stakeholders will value where complex and onerous processes can be simplified. Manufacturers of cell and gene therapies should carefully consider how their selected distribution model and adjudication process impacts each stakeholder. By proactively identifying potential pain points, manufacturers can determine how best to support each through the process and minimize any potential threats to patient access. Given their ability to support both patient care and logistics for complex medication, use of a specialty pharmacy partner may be an option to support access to these therapies.
Drug Channels. How Express Scripts plans to disrupt the emerging cell and gene therapy channel. October 10, 2019. Accessed June 15, 2021. https://www.drugchannels.net/2019/10/how-express-scripts-plans-to-disrupt.html
Specialty Pharmacy Continuum. Applying SP expertise to rare and orphan diseases. May 27, 2021. Accessed June 15, 2021. ://www.specialtypharmacycontinuum.com/Clinical/Article/05-16/Applying-SP-Expertise-to-Rare-and-Orphan-Diseases/63531
Cardinal Health. The rise of cell and gene therapies: Three important challenges to overcome for success in the market. July 10, 2019. Accessed June 15, 2021. https://www.cardinalhealth.com/en/essential-insights/the-rise-of-cell-and-gene-therapies.html