John Santilli, AMI

The biopharmaceutical drug pipeline focuses on specialty drugs and rare diseases. Today, specialty pharmacy drugs are more often available in a dosage form that patients can administer themselves, such as a tablet, capsule, pill, patch or subcutaneous injection. As specialty pharmacy continues to grow rapidly, it has become an essential assessment for industry stakeholders. Driving this growth are manufacturers that create specialty medications for chronic and complex disease states and the healthcare stakeholders working to manage the expense of these medications.

However, like the Pfizer vaccine for Covid-19 and some others in development, which requires ultra-low temperatures and cold chain storage, many specialty drugs may have special requirements for handling procedures and administration, including the necessity of having rigidly controlled environments (e.g., highly specific temperature controls) to ensure product integrity.

What’s more, they are often only available through a limited distribution network, such as a network of specialty pharmacies, which has proven to be a key consideration for manufacturers of specialty drugs that need to gain access to patients and payer networks. This is why most manufacturers want to utilize specialty pharmacies that have the capability to effectively and efficiently serve patients, providers and payers.

Specialty hub services providers have paralleled the growth of specialty pharmaceuticals and have played a major role in managing the increasing complexity of their use. About 15 years ago, specialty hub programs emerged to help industry stakeholders manage the use of specialty drugs. Over this period, the market for specialty hub services has grown in complexity as industry stakeholders work to develop successful strategies. As the specialty hub services marketplace evolves:

The number of companies entering the market to offer services continues to increase as they observe a growing opportunity.

The pace of mergers and acquisitions in the market is rising as companies seek to broaden their products and services and expand geographically.

Digitalization of specialty hub services continues to grow in importance.

Specialty hub services providers are expanding facilities and staff as products and services they offer are becoming increasingly specialized.

Connecting value-based payment methods to the specialty hub is beginning to grow.

When bringing a specialty drug to market, pharma manufacturers need to determine whether to offer a specialty hub service program in-house or through external vendors, often on a product-by-product basis. The advantage of working with a specialty hub is that the manufacturer will have a single point of contact for their therapies along the patient journey.

A lot is at stake. For example, a challenge one leading specialty hub service company* faced while working with one of its pharmaceutical clients to launch a new oncology drug was to gain market access and develop stronger relationships with patients and payer networks.

The pharma manufacturer selected the specialty hub as a result of its success establishing preferred networks for similar drugs. The specialty hub determined that a specialty pharmacy network that possessed highly specific expertise in supporting patients with cancer and their complex treatment regimens would be needed. While evaluating the client’s request, the specialty hub realized that it needed to identify a source of business intelligence that would be able to identify specialty pharmacies that offered both the pre- and post-dispense services needed for oncology drugs.

Specialty pharmacy services such as risk evaluation and mitigation strategy (REMS) programs, reimbursement experience and data reporting capabilities were highly desirable.

Other services needed were patient education, adherence monitoring, copay assistance, benefits investigations, prior authorization support and clinical and call center support.

Also important were specialty pharmacies with the resources to arrange for a nurse or a home health aide to administer the first dose of an injectable drug and provide training to the patient.

The specialty hub helped its client develop a drug distribution strategy that required a network of limited distribution pharmacies to serve a small patient population. The objective was to identify a small number of specialty pharmacies that had experience with dispensing oncology drugs to include in its limited distribution network.

As specialty pharmacies increasingly dispense infused oncology drugs, health plans and pharmacy benefit manager (PBMs) that provide insurance or sponsor coverage have increased leverage with patients that often require patients to use company-owned specialty pharmacies. As a result, the pharma company and the specialty hub established additional necessary criteria that included specialty pharmacy ownership.

Criteria included geographic coverage, accreditation status and range of patient, payer and pharma services offered. The hub also needed to identify an executive contact and email address and phone number for the specialty pharmacies meeting its criteria.

After assessing internal and external options to meet the client’s requirements, the specialty hub searched for a company that could provide the required business intelligence.

The company would need to have a deep understanding of the needs of the market and the ability to meet the demand for more comprehensive intelligence on specialty pharmacies, including ownership, executive contacts and emails limited distribution drugs dispensed, chronic conditions and more. To keep up with updates, new data items and new source entities, the company would need to have the capacity to provide healthcare stakeholders with the timely, accurate information they need on specialty pharmacies electronically as well.

An integral key to the successful treatment of a cancer patient is the ability of a specialty pharmacy to have the proper oncology drug conveniently available where and when it is needed, and with the administrative and clinical support required.

The specialty hub selected a vendor to help define the information needed and, importantly, that offered the resources and capabilities to identify specialty pharmacies that would be able to dispense oncology drugs as part of a limited network. In addition to oncology, the vendor’s database monitors about 30 or more chronic conditions.

The vendor’s resources include a database that tracks about 1,100 specialty pharmacy primary dispensing facilities that are operated by independents, health systems, insurers, PBMs, wholesalers, specialty hubs, retailers and food and drug chains.

After the first screening eliminated about 85% of the pharmacies in the database, the specialty hub and vendor further limited this group of specialty pharmacies by identifying the ownership. This was an important screening because ownership may impact the makeup of the network if owned by an insurer or PBM.

The specialty hub’s client required that the specialty pharmacies have dispensing locations with national geographic coverage. Additional screening followed that included those specialty pharmacies that had achieved both Utilization Review Accreditation Commission (URAC) and Accreditation Commission for Health Care (ACHC) accreditation status. The specialty hub perceived accreditation as providing exceptional service to patients and would be a critical component when considering pharmacy contracts. This screening reduced the list to about 25 specialty pharmacy companies.

The final screen was to identify the range of patient, payer and pharmaceutical services offered by each of the specialty pharmacies and determine that they met both the pre- and post-dispense services identified by the pharma client.

With this final curated list of specialty pharmacies, the vendor identified the pharmacy executive in charge, as well as their phone number and email address. The business intelligence enabled the specialty hub to successfully meet its pharma client’s needs and begin to discuss establishing contracts with these specialty pharmacies.

John Santilli is Co-Founder and President of Access Market Intelligence (AMI).

Articles

Case study on closing the gap between new specialty drugs and specialty pharmacies