The National Psoriasis Foundation's 7 Guidelines for Biosimilar Substitution

The National Psoriasis Foundation Medical Board released a statement supporting the prohibition of biosimilar substitution pending the fulfillment of 7 key measures.

Just as National Psoriasis Month draws to a close, the National Psoriasis Foundation (NPF) released a position statement on the use of biosimilars for the treatment of psoriasis and psoriatic arthritis, an inflammatory joint disease affecting up to 30% of psoriasis patients.

Although the group says it welcomes the use of biosimilars, it also says it “supports a prohibition on biosimilar substitution” unless “certain minimal thresholds are met.” These criteria were created to protect patients, pharmacists, insurers, and patients from potential adverse events, a company press release stated.

The 7 conditions governing biosimilar substitution, according to NPF, are as follows:

• The biosimilar has been designated by the FDA as interchangeable with the prescribed biologic for the specified indicated use;
• The biosimilar has a unique nonproprietary name to eliminate confusion, to allow providers to accurately track the therapeutic agent in a patient's permanent record, and to allow for the collection of adverse event information;
• The biosimilar product follows the same route of administration and dosage form as the reference product;
• The pharmacist notifies the prescriber in writing or electronic communication of the intention to substitute at least 24 hours prior to the substitution;
• If explicit permission from prescribing physician and patient is not obtained within 24 hours, then the original prescription must be filled;
• The patient (or patient's authorized representative) must be informed and educated about a biosimilar substitution at the point of sale; and
• Upon notification of a substitution, the pharmacy and the prescribing physician are to retain a permanent record in the patient's medical record of the biosimilar substitution.

Items on NPF’s list that may prove to be the most challenging to fulfill include the naming requirement and the issue of interchangeability, both of which were outlined in detail on the Specialty Pharmacy Times website earlier this year. In addition, some pharmacists are concerned about the administrative burdens associated with the implementation of many of these standards.

“While the chronic disease community welcomes new and affordable treatments — including biosimilars – patients with psoriasis and psoriatic arthritis are keenly aware of the risks associated with biologics, including suppression of the immune system and a lack of long-term safety data for new treatments,” noted Leah McCormick Howard, JD, director of government relations and advocacy at the National Psoriasis Foundation. “For that reason, the National Psoriasis Foundation Medical Board felt it was critical that we develop a position statement which recommends that the patient-provider relationship remain at the center of all treatment planning.”

When asked if these guidelines will help shape those of other patient advocacy organizations, Howard added, “The National Psoriasis Foundation works closely with many other patient organizations and provider groups on this and other access and research issues and is in the process of sharing our statement with these partners as many of them develop their own statements.”