Today, clinicians are able to treat an expanding list of debilitating, chronic and life-threatening disorders thanks to the healing properties of immunoglobulin (Ig) and other plasma-derived therapies. In the U.S., intravenous immune globulin (IVIG) has several on-label indications. In clinical practice, however, IVIG is frequently used for off-label purposes when clinicians perceive a clinical benefit for its use.
In recent years, because of increased utilization and the lengthy production cycle for bringing plasma-derived therapies to market, manufacturers have been challenged to produce enough supply to meet demand. Plus, with just three manufacturers producing 85 percent of all North American sales, when one company experiences a supply disruption, it can cause a sudden and serious shortage felt across the industry.
“The challenge of supplying the U.S. market means every gram of plasma a supplier can produce is needed and every change in the industry has market-wide repercussions,” says April Yoo, PharmD, MPH, BCPS, senior portfolio executive, pharmacy at Vizient.
The challenges of the plasma market
Manufacturing plasma-derived products is not as simple as churning out new pills.
The production cycle for plasma products can take as long as 12 months, from the time plasma is donated to the time the product is released to the market. Understandably, the testing and handling of blood products is highly regulated at every step to safeguard the purity of these products against transfusion-transmittable pathogens.
The lengthy production cycle makes forecasting a challenge, especially if there are changes in the market causing shifts in demand, such as when a manufacturer must remove a product from the market due to FDA regulations or manufacturing concerns.
“Manufacturers typically forecast one to three years out,” says Yoo. “Every gram is accounted for well ahead of time with very little room for flexibility.”
Increasing clinical utilization of Ig products is also placing pressure on manufacturers to ensure minimal waste and produce as many end products from plasma as possible. More and more primary immunodeficiency disease patients are benefiting from IVIG, thanks to better detection and diagnosis and improved access to Ig products.
In addition, utilization of IVIG for off-label indications has climbed over the past two decades, placing additional demands on the market for Ig products. "Off-label utilization can be 50% of the use of Ig products. That is an extremely high rate for any pharmaceutical product to be used off label," adds Yoo. "For Ig in particular, manufacturing just cannot keep pace with the demand for use."
Because of the limited donor pool, complex production and distribution process, and increasing number of clinical conditions supported by IVIG, the tight supply of Ig is not expected to end anytime soon. With all of these forces at play, hospitals must carefully evaluate their utilization of this limited and valuable resource.
Best practices for responsible Ig stewardship
The appropriate use of Ig products requires active management among many stakeholders across a hospital or health system. “The institution really needs to set guardrails and guidelines on the therapeutic indications for utilization of IVIG because it can be used for such a wide range of indications,” says Yoo. “There needs to be an expectation that these products are being used judiciously.”
Follow these suggestions to improve stewardship of Ig products at your organization:
1. Anticipate utilization - Review your utilization of Ig regularly and communicate with your Ig suppliers, specialty distributor and Vizient about potential changes in utilization, especially if an increase in demand is anticipated. As necessary, consider alternative Ig brands to obtain the total grams your organization needs.
2. Align stakeholders - Engage everyone on the team, including buyers, formulary managers, physicians, pharmacists and nurses. All stakeholders should be aligned on the diagnosis, treatment dosing and indications for use.
3. Prioritize clinical indications - The increased utilization of IVIG places significant additional demands on the market from clinicians on behalf of their patients. Clinical considerations a provider may review for the effective use of Ig products include indication for use such as chronic vs. acute, and if Ig is considered first-line therapy in such indications or if it is used as an adjunctive therapy.
4. Commit to a supplier - In a tight market, Vizient, suppliers and distributors rely heavily on members’ historical usage and future projections. While hospitals may be tempted to jump from distributor to distributor or supplier to supplier to obtain all the grams they need, this can decrease visibility to historical run rates, hampering their ability to get the supply they need.
5. Place small, frequent orders - With Ig in short supply, it is important to order on a frequent basis and anticipate your future need as well. “It comes back to judicious use. Order what you need frequently, but don’t stockpile or overinflate your ordering practices,” she says. “While it may be tempting to stockpile during a tight market, a hospital may end up taking away from another member that may not have any Ig in stock.”
Conserving a vital therapeutic resource
Long-term solutions to address the tight supply of Ig products are underway by suppliers, including increasing yields of Ig from plasma, introducing new fractionation technologies, and growing plasma donations at collection centers. Distributors are also looking for advancements in ordering practices to make the process more transparent.
In the short term, however, clinicians, pharmacists and management teams need to work together to create sound strategies around Ig product management.
Every September, Vizient conducts a plasma annual needs assessment (ANA), where members complete a self-assessment based on their historical utilization and estimated use of Ig and albumin for the following calendar year. The survey is conducted via the Plasma E-Manager platform, a secure online site that connects Vizient, supplier, distributor and member. It is important for members to complete the plasma ANA to assist Vizient in the accurate forecasting of member product needs.
What can members do to gear up for the Plasma ANA?
- Make sure you have an active user name and password
- Login to the Plasma Program E-Manager
- Verify that the account you are seeing matches your location
Vizient will present a Web-based tutorial and demonstration of the application to help members complete their assessment successfully. Please join us on one of the dates below.
Also, Vizient released its July 2019 Drug Price Forecast, a detailed analysis and projection of anticipated trends in pharmaceutical pricing based upon the purchasing patterns of its member organizations. Included in the forecast is additional information about supply challenges in the IVIG market. Access the forecast here.
For more information about the management of Ig and other plasma-derived products, contact our team today.