New Delaware Bulletin Reinforces Patient?Centered Step Therapy Exceptions, Limits Carrier Use of Biosimilars

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DE| Delaware Department of Insurance Bulletin No. 165 reiterates that insurers, health service corporations, and managed care organizations writing individual and group coverage subject to Title 18 must maintain clear, accessible step therapy exception processes as required under 18 Del. C. §§ 3381 and 3591, preserving the central role of a provider’s clinical judgment in determining when step therapy is not medically appropriate for a patient. The Bulletin clarifies that the narrow exclusion in subsections (e) of those statutes only permits carriers to require a patient to try an AB?rated generic equivalent before covering the equivalent branded prescription drug and does not extend to biologics or their biosimilars, which are not “branded prescription drugs” and do not have AB?rated generic equivalents. The Department states it is therefore inappropriate for carriers to interpret or implement Sections 3381 and 3591 in a way that applies the subsection (e)(1) exception to biologics/biosimilars, and advises that questions be directed to the Department’s compliance email; the Bulletin is effective immediately.

Click here to see DE Domestic & Foreign Insurers Bulletin No. 165

  • Bulletin
  • Delaware
  • Department of Insurance

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