Within the next three to five years, the drug pipeline is expected to continue to boom with specialty medications dominating the list. Specialty medications are high-cost prescription medications used to treat complex medical conditions such as multiple sclerosis, cystic fibrosis, oncology and inflammatory diseases. The pipeline includes new therapies for cancer such as HER2-positive breast cancer, non-small lung cancer, Alzheimer’s, multiple sclerosis (MS), human immunodeficiency virus (HIV) and inflammatory diseases, and many of these new treatments offer convenient oral or self-administered options for treatments versus standard infusion products.
As new cell and gene therapies, targeted biologics and precision medicines advance across oncology, rare disease, neurology and autoimmune conditions quickly; hospitals and health systems can no longer react to these therapies once they become available. These groundbreaking therapies have exciting potential to treat and cure diseases while minimizing burden on patients; however, they create major clinical, operational and financial implications that must be planned for years in advance.
Helping hospitals plan and adopt new therapies for patients
Specialty pharmacy plays a unique role in helping hospitals prepare for these new therapies while also connecting patients to breakthrough therapies. Pharmacists, as medication experts, are well versed in the research behind new therapies coming to market. They continuously monitor the drug development pipeline including therapies in clinical trials, under review by the U.S. Food and Drug Administration (FDA) and how they can be introduced safely and effectively into a health system.
Staying current with this information allows hospitals to quickly plan and adopt new medications as they reach the market. Ensuring timely access to innovative medications can have a profound impact on patient outcomes. Below are four ways hospitals and health systems should anticipate, prepare for and operationalize breakthrough therapies to help their patients.
- Engage early with manufacturers – Leveraging established relationships with drug manufacturers can help health systems research new products, clinical information and education before medications hit the market. Manufacturers typically provide clinically backed research and assets for education, which can help physicians and clinics become equipped for unique monitoring programs or administration requirements. Once a medication has been approved by the FDA and is on the market, manufacturers also work with health systems to provide clinical data. This data typically includes how often the medication is dispensed, how often patients experience adverse effects that may lead to discontinuing therapy, adherence and favorable clinical outcomes.
- Operational readiness – Assessing the operational infrastructure and readiness required to launch a new therapy is a critical step. This process can involve gathering key stakeholders from medical, pharmacy, legal, procurement, finance, business development and strategy to participate in a collaborative process to determine the steps needed to improve the operational infrastructure. Implementing new therapies and ensuring they meet clinical and financial expectations tests a health system’s integration and cross-departmental collaboration. Since many of these new therapies will require unique monitoring and program coordination, staff needs to be trained and prepared for the new workflow requirements in advance. This will ensure the hospital is prepared to administer the new medication when it becomes available – not many months later. This includes meeting new requirements, developing standard operating procedures for in-clinic injections, educating providers, updating technology systems and shipping and storing the medications.
- Data-driven patient identification – Hospitals and health systems should prepare for new specialty medications by reviewing their technical infrastructure and procedures. Electronic health records (EHRs) can identify patients for clinical inclusion criterion for a specific breakthrough therapy through evaluating diagnosis codes, lab values and biomarkers, disease severity or progression indicators and history of prior therapies. Partnering with the health system’s technology team to set up a weekly screening monitoring dashboard and implementing EHR best practice alerts to proactively identify eligible patients help to identify patients in need of treatment.
- Mitigate financial impact – Hospitals and health systems must have a clear understanding of payor dynamics and the ability to negotiate directly with payors. These therapies often involve significant financial risk, which should be carefully considered during coverage negotiations. Elements such as prior authorization requirements, geographic access challenges, patient financial support, appropriate staff training, legal and risk management oversight, coordination among key stakeholders and the development of a reliable procurement pathway all need to be considered before a new therapy comes to market.
Establishing the optimal billing structure for new therapies is another critical step. Evaluating factors such as treatment costs, reimbursement rates, payor mix, projected revenue and funds flow provides essential insights for strategic decision-making, risk mitigation and long-term financial sustainability.
A dramatic shift towards more research and development in specialty pharmacy medications is providing better treatment options for patients with unique and chronic illnesses. Health systems and hospitals are adapting to this change by working closely with their specialty pharmacy experts and partners to prepare for the next wave of drug pipeline therapies in the next three to five years.
Photo: nevarpp, Getty Images
Brandon Newman has more than 20 years of healthcare experience leading and operating specialty pharmacies across independent, PBM-owned and health system settings. He is passionate about transforming the way patients experience pharmacy and believes that care is best delivered locally.
Brandon believes that patients facing complex or life-altering diagnoses shouldn’t have to navigate barriers within a fragmented system to access the medications they need. At Clearway Health, he champions innovative solutions that combine technology, expertise and dedicated support to simplify the process for hospitals and providers – improving affordability, efficiency and outcomes for patients nationwide. A proven culture builder, Brandon understands that people are the cornerstone of organizational success and creates an environment where great people can do their best work in service of healthcare organizations, providers and patients.
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