Steven M. Schwartz, PhD

Specialty drug utilization is increasing, as are the associated challenges around adherence, cost, and delivery of optimal value. Specialty drugs are reported to represent 39% of the overall pharmacy benefit spend, with projections to increase to 48% by 2020.

 The prices for specialty drugs had a reported average increase of 9.6% from 2014 to 2015, and are expected to continuously rise, with the largest growth expected within oncology.

 The specialty medication pipeline is also expanding, comprising 60% of all new drug approvals in 2017,

This growing landscape offers patients with complex and chronic conditions more treatment options; however, increased utilization is often associated with certain challenges. Health care stakeholders face increasing pressure to address the rising costs of these specialty medications while continuing to provide affordable and accessible care.

A 2017 Express Scripts report documented that 118 specialty drugs entered the market over the preceding 5 years, with predictions outlining another 25 expected annually until 2022.

 This indicates that health care stakeholders—payers in particular&mdash;must prepare strategies to address the expanding number and costs of specialty medications that this large influx of new drug developments might preface.

Payers are joining forces with pharmacy benefit managers (PBMs) to enhance their ability to combat the increase in drug prices.

 As more specialty medications enter the market, payers and PBMs are being more selective in their formulary management, and negotiating better pricing structures. Manufacturers want to be included on the larger plans’ formularies; therefore, price negotiations often lead to offering payers and PBMs a larger discount or rebate.

 Within formulary management, dose optimization and utilization management are 2 proactive strategies that payers and PBMs might use to address the increasing costs.

For the purposes of one program—implemented at Diplomat Specialty Pharmacy in Flint, Michigan&mdash;dose optimization is defined as consolidating a patient's regimen into fewer units without a change in their dosing frequency. Dose optimization strategies offer a potentially valid, clinically based intervention in which payers can realize a direct drug cost savings, and indirect medical cost avoidance. Dose optimization programs have been evaluated with once-daily, oral maintenance medications using various methods that produced varied results.

 These studies were conducted in medication classes such as gastroesophageal reflux disease (GERD), anxiety and depression, and hypercholesterolemia.

While the current literature describes dose optimization in the nonspecialty space, there is limited literature on dose optimization strategies used for specialty products.

A specialty pharmacy developing a dose optimization program could evaluate the implications and viability for specialty products, since they work closely with payers and providers. A successful dose optimization program within a specialty pharmacy could contribute a significant cost savings for payers, further mitigating the rising costs of specialty medications. Therefore, the goal of this pilot program was to evaluate the scenarios and opportunities for dose optimization within a selected group of oncolytics.

This Diplomat program was designed as a proof of concept to illustrate the implications and barriers associated with dose optimization in a specialty pharmacy setting. This setting offers access to many specialty medications, and uses a high-touch model of therapy management for patients with complex conditions, such as cancer, multiple sclerosis, psoriasis, human immunodeficiency virus (HIV), and others. With more than 1100 products currently in development, oncology is one of the fastest-growing specialty segment on the market.

 This growth is what led the specialty pharmacy to focus on dose optimization opportunities within this population.

Diplomat’s oncology program delivers comprehensive care management to help patients address complex aspects of their treatment and condition. The crossfunctional oncology team is composed of specialized clinicians, and nonclinicians leveraging evidence-based care for treatment optimization, improved care coordination, and therapeutic cost management. The steps the team followed are displayed in the Figure below.

The retrospective prescription evaluation of oral oncology medications identified 58 initial opportunities for dose optimization. Financial contingencies varied for each stakeholder, and did not always align among the patient, the payer or PBM, and the pharmacy, which hindered dose optimization recommendations. During the evaluation phase, it was imperative to assess the impact on these stakeholders, including patient, payer, and pharmacy, to ensure a win for all. As shown in Table below, several circumstances would have resulted in a therapy delay that could potentially have adversely affected patient outcomes and adherence.

Table — Scenarios Impeding Dose Optimization

Additional Prior Authorization Requirement

Specialty pharmacy is uniquely positioned to ensure proper patient care while optimizing medication adherence and outcomes. If we anticipated that the dose optimization program would negatively impact patients, as shown in Table 1, we excluded those patients from the dose optimization program. Specifically, we excluded:

Patients who had a change in therapy to a different medication during the evaluation time period

Patients whose providers initiated a dose-optimized prescription without any intervention from the pharmacy

Patients who would face increased financial responsibility, such as a copay, or a change in financial assistance	

One patient would have been required to resubmit a grant application for financial assistance if a dose-optimized prescription were pursued. The outcome of the application would be unknown until the prescription was processed and could potentially compromise the patient’s current financial assistance.

Overall, we successfully optimized dosing for 9 of 58 patients.

For payers and PBMs, this optimization produced a cost savings of approximately $135,000 that was not payer- or medication-specific.

of qualifying prescriptions via phone, and received responses within 5 days of initial contact. Of the 9 potential prescriptions, we received 6 and successfully filled 5. The sixth prescription received a payer mandate rejection that necessitated it be transferred to a different pharmacy.	

For the 3 patients for whom we did not receive a dose-optimized prescription, the provider indicated either that the patient was not interested in dose optimization at this time or that the patient had swallowing issues and preferred the smaller formulation.

This proof-of-concept study of dose optimization in a specialty pharmacy setting evaluated various scenarios and identified significant barriers. Importantly, this program illustrated how stakeholders might influence one another, creating competing financial and service contingencies.

Articles

Dose optimization strategies offer a potentially valid, clinically based intervention in which payers can realize a direct drug cost savings, and indirect medical cost avoidance.