Reimbursement FAQs: IVIG vs SCIG, Medicare Benefits and More

I have read that primary immune deficient patients should start with a loading dose of intravenous immune globulin (IVIG) before switching to subcutaneous immune globulin (SCIG). But, I fear that asking the insurance company for a change in therapy before the date of reauthorization will trigger a review, causing more paperwork for my staff and unnecessary stress for my patient. Is there evidence that shows patients can safely and successfully start out on SCIG rather than IVIG?

Yes, there is research showing a patient can be treated with SCIG without using a loading dose of IVIG. One such article, titled Improvement in Quality of Life Measurements in Newly Diagnosed Patients with Primary Immunodeficiency Receiving Directly Initiated Subcutaneous Replacement Therapy with Vivaglobin, was printed in the February 2010 edition of The Journal of Allergy and Clinical Immunology. According to the article’s authors, “Therapy can be successfully initiated with a SCIG loading phase in newly diagnosed PID[D] patients, challenging the widespread recommendation for an initial intravenous IgG phase, and resulting in substantial improvement in HRQL [health related quality of life] indicators.”¹

I have a patient who has maxed out COBRA options and is considering conversion options. One plan being considered places this patient’s Vivaglobin under the pharmacy benefit for self-injectables. But, all medications in this particular category have a 30 percent copayment with none of the patient’s responsibility going toward the yearly out-of-pocket maximum. There is no way a patient of normal means can afford that. What other options does this patient have?

It’s possible that the insurance representative in this case is a salesperson who has no knowledge of particular medications. This patient should first ask for a written copy of the drug formulary to confirm the placement of Vivaglobin under the pharmacy benefit. If Vivaglobin does fall under the pharmacy benefit and none of the costs go toward the yearly out-of-pocket maximum, then it is unlikely a patient of normal means will be able to afford the medication. In this case, the patient has two options. Option one would be to choose a different plan. Option two would involve exploring with the prescribing physician whether changing from subcutaneous infusions to intravenous infusions is an option. If so, the benefit would most likely then fall under the medical portion of the plan. Once under the medical portion, the patient would qualify to meet the out-of-pocket maximum and eventually have infusions covered at 100 percent.

What classifies a Medicare patient as homebound? And, who can certify a patient as homebound?

For a patient to receive services in the home, a physician must certify that patient as homebound. It is not necessary for the patient to be confined to bed or even completely to the home to obtain homebound status. For instance, if leaving the home requires a great deal of effort, he or she may qualify for homebound status. And, once certified homebound, a patient may still leave the home for purposes such as infrequent family outings, medical appointments and church services. Specifically, the Medicare benefit policy states:

“It is expected that in most instances, absences from the home that occur will be for the purpose of receiving health care treatment. However, occasional absences from the home for nonmedical purposes, e.g., an occasional trip to the barber, a walk around the block or a drive, attendance at a family reunion, funeral, graduation, or other infrequent or unique event would not necessitate a finding that the patient is not homebound if the absences are undertaken on an infrequent basis or are of relatively short duration and do not indicate that the patient has the capacity to obtain the health care provided outside rather than in the home.”²

I would like to prescribe Hizentra, but because the package insert recommends prescribing at 153 percent of the intravenous dose, it seems unreasonably expensive. Is that prescribing dose necessary?

The U.S. Food and Drug Administration (FDA)-approved labeling for Hizentra does state that the recommended dose of Hizentra is 153 percent of the intravenous dose. However, several wellrespected immunologists prescribe one-to-one dosing for their primary immune deficient patients. According to data released from a Phase III study at a meeting of the European Society for Immunodeficiencies, “Hizentra (IgPro20) provides primary immunodeficiency (PI) patients with a safe and effective alternative to other immunoglobulin therapies when given in equivalent doses.”³

I have a patient who insists her insurance company will approve only one brand of IVIG, but she does not respond well to that particular brand. Are insurance companies now dictating which brands of IVIG can be used?

Because there is no generic IVIG, insurers generally do not specify a particular brand. I checked several major insurer IVIG policies and formularies, and none of them specified a preference for a particular brand of IVIG. However, infusion providers do enter into exclusive contracts for certain brands as a cost-saving measure. So, your patient is most likely being informed by her provider that she can be treated with only one particular brand of IVIG. If this is the case, she is either misunderstanding or is being misled by her provider. I suggest your patient call her insurer directly and ask whether her preferred IVIG is covered. It may be necessary for her to change providers.

Editor’s Note: The content of this article isintended to provide a general guide to the subject matter. Specialist advice should be sought about yourspecific circumstances.