Definition of self-injectable

[participant5]

How do plans define "self-injectables"? Would drugs like Somatuline Depot be considered non-self injectable because it is given as a deep subcutaneous injection?

[deb01720]

It would still be considered a self-injectable drug. However, there may be certain circumstances in which a patient is unable to self-administer it and therefore, some plans may require prior authorization.

[david.calabrese]

We define 'self-injectables' as those products whose administration is more often than not going to be conducted by the individual patient or caregiver within the home, versus within a clinic-based setting. While most deep intramuscular injections are administered by healthcare professionals within the clinic setting, Somatuline Depot is an exception to this rule. It is a depot product that can be safely self-administered on a monthly basis, and the assumption is that the majority of users are doing so. Thus, we would consider it to be a 'self-administered' product.

[chantell.reagan]

Although there is no formal definition of “self-injectable”, a variety of standards could be used to make an individual determination. Routes of administration including intravenous, intra-arterial, intrathecal, intravitreal, intra-articular, etc. require special training and monitoring and would not be considered to be “self-injectable.” However, certain products intented for subcutaneous (SC) use many not necessarily be considered “self-injectable” either. Some products clearly state in their prescribing information that the product should not be self-administered (i.e. Nplate, Cimzia). Other products depend on how and where the products are administered (by the patient or incident to a physician’s service - i.e. Procrit or Aranesp). Additionally, Medicare considers drugs to be “self-injectable” when administered that way >50% of the time.

Even though Somatuline Depot is administered through a deep SC injection, it is marketed for use by healthcare professionals OR patients. Because it doesn’t require daily administration, there could be some cases where administration in the office could be preferred. From a benefit coverage perspective, nothing prevents this product from being covered through the pharmacy benefit. For patients in whom self-administration is not preferred, exceptions could be made on a case-by-case basis (the patient can always purchase the drug in retail and then bring it to the office).

Based on some comments we received from our members, strictly from a pharmacy perspective, this drug would be considered “self-injectable”. However from a provider/specialty pharmacy perspective, some may feel that this technique might be better suited for administration by a healthcare professional.

Sources:

Somatuline Depot prescribing information

Medicare Part B versus Part D coverage issues

[mark.rubino]

Aetna generally considers IM injections, particularly in the buttocks, as physician-administered. A patient who has a care-giver at home who can perform the injection would be reimbursed.