Diane Wolfe, RPh

A convergence of factors in specialty patient care have spurred innovation and creativity from providers, payers, and pharmaceutical companies to adapt to an evolving landscape. The growing demand for specialty care, shifting prescriber habits, and new reimbursement models have all forced stakeholders to reevaluate their specialty care and adjust their practices to optimize patient outcomes.

M Health Fairview, Sentara Healthcare, Novant Health and MedStar Health have each employed a coordinated strategy to meet the increasingly complex demands of specialty patient care. Those health systems recently participated in a webinar on that subject hosted by Shields Health Solutions that I moderated. Below, I share some of their key insights from our discussion:

First and foremost, among changes to the landscape, the market for specialty drugs 

 from $162 billion in 2015 to $248 billion in 2020. That growth curve will continue on an upward trend, as 

 of new molecular entities awaiting FDA approval through 2021 are classified as specialty pharmaceuticals.

There has also been a shift in prescriber behavior, as more than half of all physicians are employed by medical groups or health systems and integrated delivery networks (IDNs) account for a higher percentage of scripts written. As value-based reimbursement models become more widely adopted and health systems assume more risk for patient outcomes, prescribers have more incentive than ever to encourage adherence and monitor their patients more closely.

Health-system specialty pharmacies have several inherent advantages in meeting the ongoing challenges in specialty patient care and are well-equipped to adapt to new demands that may arise.

Integrated health systems have more data at their disposal today than ever before, which have aided in developing much more sophisticated measuring tools. Paper-based patient surveys on a clipboard with a set of generic questions have been replaced by software that generates detailed service and experience metrics. It can show patient satisfaction measurements and benchmark those data against similar pharmacies, providing a crucial litmus test that helps the health-system pharmacies stay competitive in the market and provide the best possible patient experience.

Today’s technology capabilities have also been instrumental in improving outcomes and ultimately controlling the cost of care. Therapy management systems have come a long way in their development over the past decade, helping to improve data analytic capabilities, measure adherence, and measure understanding of quality-of-life metrics and lab values.

Even with the tremendous advances in data and reporting, there remains room for growth in benchmarking and defining what constitutes success—especially related to controlling costs for the patient. Lessons learned from the data can help mitigate unnecessary spending on trips to the emergency department or a clinic visit, but there’s still much to learn on individual patient spending and strategies for controlling it.

Many of the roadblocks that arise in treating complex patients stem from access issues—access to the right payer network or to the right limited distribution drug to prescribe the patient. But health-system specialty pharmacies in a network with the size, scope, and scale of the Shields network have developed extensive connections with those payers and drug manufacturers that separate them from other types of pharmacies.

When a health system-based specialty pharmacy has the advantage of continuity of care, the burden of responsibility that comes with value-based reimbursement is much more manageable. Keeping a patient within the health system means the care team can oversee every aspect of the patient’s care. Those critical relationships with payers and manufacturers are an important way to establish continuity and ensure the patient is getting the appropriate treatment.

The future of specialty care will rely even more heavily on digital tools that enhance the patient experience. The pandemic forced a shift to a more digital-centric model of care with the adoption of telehealth and providers have found instances in which telehealth may even be preferable to in-person care.

Pharmacies that can leverage digital technologies such as telehealth for patient management, monitoring, and drug adherence will stand to make tremendous strides in their outcomes. Enhanced digital tools will also bring the ability to share clinical data insights across health systems more freely. The value of sharing insights across providers cannot be overstated when discussing the rare and orphan diseases that have limited clinical data for reference.

For health system-based specialty pharmacy in particular, challenges are coming in the form of payer-pharmacy benefit manager-specialty pharmacy conglomerates that could threaten the relationships health systems have with payer networks. Payer relationships outside of the health system have led to some troubling trends, such as the practice of payer-mandated white bagging, in which prescriptions for physician-administered drugs are filled at a third-party pharmacy.

This practice is jeopardizing patient safety and can potentially compromise the quality of patient care. ASHP issued an 

By continuing to demonstrate value through exceptional, high-touch patient care and leveraging its vast array of resources, the health system-based specialty pharmacy is well positioned to answer the challenges of today while continuing to evolve with the inevitable changes of complex patient care.

Diane Wolfe, RPh, is the Vice President of Network Strategy at Shields Health Solutions.

 is the premier specialty pharmacy accelerator health system leaders trust to elevate clinical, operational and financial performance.

Articles

Growing demand for specialty care, shifting prescriber habits, and new reimbursement models have forced stakeholders to adjust practices to optimize patient outcomes.

Health-System Specialty Pharmacy Built to Evolve

Late in May, I was offered the opportunity to attend the virtual annual meeting of the American Society of Clinical Oncology (ASCO). Originally slated to take place in Chicago, ASCO20, like so many other conferences and events, transitioned to an online format because of the coronavirus disease 2019 (COVID-19) outbreak.

Being curious, as I had never attended and was eager to hear about the most promising oncology treatments in development, I quickly registered and selected the sessions I was most interested in from the agenda. What I wasn’t prepared for was the overwhelming amount of content: 5290 abstracts, to be exact.

How would I ever choose? I decided the most efficient plan of attack would be to start by attending the Opening and Highlights Sessions and then seek out other content that would meet my goal of ensuring I covered the most important topics of the conference.

The first morning of the conference, agenda and a huge mug of coffee in hand, I settled in front of my computer for the Opening Session. ASCO President Skip Burris kicked the meeting off with a heartwarming recorded message and then welcomed David Fajgenbaum, MD, who shared his courageous journey as a patient with Castleman’s disease and his quest to find a cure. To say he was inspiring doesn’t begin to do justice to this man’s incredible fortitude.

Following the keynote, I listened to several Highlights Sessions on both Saturday and Sunday, delivered by clinicians around the world. In addition to hearing from the subject matter experts presenting, there was a constant exchange of messaging via the chat.

Questions were posed, opinions were stated, and attendees even commented on their locations and time of day. One woman shared that she was participating from her garden in Germany. Although there was apparently some difficulty with online meeting access, for me the virtual engagement was remarkable and the technology superb.

In addition to the virtual sessions, many large manufacturers presented multiple abstracts, highlighting the strength of the oncology pipeline. The trend continues toward those drugs that become more targeted to both tumor mutations and those that treat orphan diseases. Below are a few of the products I heard and/or read about.

 is the first fully human monoclonal antibody targeting the RANK Ligand, a mediator of osteoclast activity. It is being studied in several phase 2 trials for the treatment of giant cell tumor of the bone as well as its effects on markers of bone destruction in prostate and breast cancers.

is being evaluated in multiple phase 3 studies for metastatic colorectal cancer with both FOLFIRI and FOLFOX.

are both fully human monoclonal antibodies being evaluated for advanced solid tumors.

is currently in pre-clinical models of breast cancer.

is a candidate in phase 2 trial for patients with pulmonary sarcomatoid carcinoma and other types of non-small cell lung cancer that have the MET exon 14 skipping mutation.

is being evaluated in phase 3 trial for first-line treatment of metastatic triple negative breast cancer.

), when given in combination with androgen deprivation therapy for non-metastatic castration resistant prostate cancer, significantly improves overall survival versus androgen deprivation therapy alone.

 for FDA approval for RET fusion-positive NSCLC in 1Q 2020 and hopes to have approval in 6 months. It will compete with Lilly’s selpercatinib (see below); however, based on pralsetinib’s complete response rate, experts expect to see significant uptake of pralsetinib.

BMS presented data from 2 clinical trials of 

 combinations for non-small cell lung cancer. With 

, BMS presented updated study results from the phase 2 KarMMA trial of 

 is a novel immunotherapy that binds to TGIT, whereas 

Is a PD-L1 checkpoint inhibitor. Together, the 2 compounds have the potential to improve anti-tumor activity and have yielded positive results in the phase 2 CITYSCAPE trial for PD-L1 positive metastatic non-small cell lung cancer.

 is an investigational bispecific antibody targeting both B-cell maturation antigen and CD3 receptors on T-cells. It is being studied for multiple myeloma in several trials. The patients had been previously treated with a proteasome inhibitor and an immunomodulatory drug and had relapsed or were refractory. Treatment resulted in significant responses from 67% of patients and complete responses in 3 patients.

was shown to selectively reduce tumor size in metastatic urothelial carcinoma in patients with metastatic castration-resistant prostate cancer.

, is being studied in locally advanced mUC with genetic mutations.

 studies in non-small cell lung cancer, as well as medullary thyroid cancer. They also presented additional data for ongoing evaluation of 

 is being studied in combination with chemotherapy as a first-line treatment for metastatic triple-negative breast cancer in the phase 3 KEYNOTE-355, showing a statistically significant improvement in progression-free survival in patients whose tumors expressed PD-L1 with an increase to a median of 9.7 months.

I was personally drawn to learning more about the gene therapy but will have to review the abstracts later. One of the most exciting is VB-111 (ofranergene obadenovec), which is a first-in-class targeted anti-cancer gene therapy from 

 for platinum-resistant ovarian cancer. Early results provided a response rate of more than 58%.

In addition to the highlights above, there was significant attention on CAR-T therapies. Both 

 reported impressive results. I’ve marked those abstracts to review later.

All in all, the first virtual ASCO conference was a huge hit for me. Not only were there more than 42,750 attendees (a new record) from 138 different countries, but also those 5290 abstracts and more than 2300 oral and poster presentations. Yes, it was overwhelming, but in an intriguing way. ASCO also presented its 2020 Education Program virtually, August 8—10, and I’m already making plans to attend the Annual Meeting again in 2021, whether it is held in person or online.

Diane Wolfe, RPh, is National Director of Manufacturer Relations, ExceleraRx Corp.

Like so many other conferences and events, ASCO transitioned to an online format because of the coronavirus disease 2019 (COVID-19) outbreak.
 