This article is sponsored by Option Care Health.

Perceived as the new “wonder drug,” immunoglobulin (IG) is a go-to therapy for healthcare providers seeking to bolster their patients’ immune systems; however, as demand grows, particularly for oncology and off-label indications, the supply can’t keep pace. Between 2012 and 2018, distribution of IG grew 66% in North America and Europe,1,2 leading to shortages and leaving providers scrambling for solutions. Those shortages have increased in 2019. 

Derived from donated human plasma, IG is a costly but crucial—even lifesaving—therapy that boosts the immune systems of patients who are missing antibodies due to a condition or as a result of medical treatment. The FDA-approved indications are numerous—including chronic lymphocytic leukemia, primary immune disorders (PID) and chronic inflammatory demyelinating polyneuropathy (CIDP).3,4 Off-label uses are even more varied. 

The shortage of intravenous (IVIG) and subcutaneous (SCIG) forms of therapy is being addressed through various less-than-ideal measures in an effort to stretch the limited supply, including by ordering dose alterations, or delaying or canceling treatment. But there are alternatives that ensure patients can get the therapy they need, such as switching to a different brand of IG when appropriate. Option Care Health’s industry-leading expertise, drug access and support in IG therapy provides a unique perspective on opportunities to manage the current IG shortage. 

In light of the complexity and cost, infusion pharmacists have long played a vital role in guiding clinicians who prescribe IG to their patients. That expertise is even more essential now that IG is in short supply and healthcare providers increasingly rely on the pharmacist to recommend the most appropriate formulation. Working as part of a collaborative multidisciplinary team, Option Care Health infusion pharmacists have the training and expertise to engage with physicians and clinical care teams to formulate the best possible solution for each patient, helping ensure the right drug gets to the right patient at the right dose at the right time. 

Patient-Centric Care 
It begins with care focused on the patient to ensure therapy success, even in the face of shortages. Anchored by a dedicated IG infusion pharmacist and IG nurse, the Option Care Health team develops a disease-specific customized care plan. Option Care Health’s patient navigators play a crucial role in ensuring patients have access to their vital care by connecting them with manufacturer-sponsored financial assistance programs when needed. 

Each IVIG patient is monitored during the entire infusion by a highly trained nurse who watches for adverse drug reactions and monitors vital signs and rate changes. 

Therapy is started only after an Option Care Health infusion pharmacist interviews the patient, takes a complete history and communicates recommendations to the prescribing physician. 

Information that is particularly important to assess in the face of shortages includes: 
  • Diagnosis: Based on the patient’s diagnosis, is IG the most appropriate therapy? If so, what brand of IG is the most suitable? 
  • Past experience: Has the patient had a reaction to a specific IG drug in the past? If so, which one and what was the reaction? 
  • Need for financial assistance: Does the patient require help to pay for the medication? The pharmacist can identify alternative IG medications that will be effective for the patient that also offer manufacturer-sponsored copay assistance plans. 

When an IG drug is in short supply and unavailable, the pharmacist works directly with the patient to discuss their medication options and, if they are switched to another therapy, provides education regarding the new drug, advises them on proper usage and helps them learn how to monitor for drug side effects. The high-level, on-site monitoring provided by the nurse is particularly key when a patient is switched to an alternative therapy. 

IG therapy access and management 
In light of shortages, IG drugs are prioritized to those who are most acutely in need of IG therapy, such as youth and patients with PID. After those priority needs are met, IG drugs typically are allocated to larger companies that have the broadest patient reach as the most extensive providers of the therapy. Option Care Health’s nationwide reach and relationships with a large number of manufacturers of IG mean the company has the broadest possible access to the products, which provides much-needed flexibility during a shortage. Option Care Health provides more than 80,000 IG infusions nationwide, contracts with more than 800 health plans, and has a >96% success rate in overturning benefit denials.

In the rare cases where there are no available IG therapy options, such as in the case of disease refractory to IG therapy or severe reactions, the pharmacist can identify and recommend non-IG alternatives, such as other limited distribution drugs. 

IG drug shortages create significant stress for patients in desperate need of therapy and their physicians who prescribe their treatment. Option Care Health’s comprehensive and collaborative clinical care, led by a highly skilled infusion pharmacist, with broad access to IG therapies and the ability to address and resolve financial challenges ensures patients can continue to get the IG care they need to stay as healthy as possible .


REFERENCES
  1. Appleby J. As off-label use spreads, supplies of niche drugs and patients’ patience grow short. Kaiser Health News. https://khn.org/news/ivig-intravenous-immune-globulin-off-label-use-niche-drugs-short-supply/. Sept. 24, 2019. Accessed Dec. 2, 2019. 
  2. Immunoglobulin Access. Plasma Protein Therapeutics Association. https://www. pptaglobal.org/images/Data/Ig_Access.pdf. July 16, 2019. Accessed Dec. 2, 2019. 
  3. Immune globulin intravenous indications. Food and Drug Administration. Updated March 5, 2018. Accessed Dec. 1, 2019. https://www.fda.gov/vaccines-blood-biologics/ approved-blood-products/immune-globulin-intravenous-igiv-indications. Accessed Dec. 2, 2019. 
  4. Quinti I, Pesca A, Bonnani L, et al. Clinical use of polyvalent immunoglobulins. Blood Transfus 2013 Sep 11 (Suppl 4) S 33-39. 
  5. Data on file, Option Care.