New-To-Market Drugs — Point32Health

Initial criteria

• Request is for an FDA-approved indication or recognized off-label use as specified
• Coverage is determined based on New-To-Market drug classification as follows:
• Step 1: If existing Clinical Coverage Criteria for previously reviewed medications with the same indication exist, coverage for the New-To-Market drug is determined using those criteria AND documentation from the requesting physician showing that the Member has had a treatment failure of, or is unable to tolerate, two or more formulary alternative medications within the same therapeutic class (or, if none are listed, two or more formulary alternatives with the same FDA-approved indication)
• Step 2: If no existing Clinical Coverage Criteria exist, and formulary alternative medications are available to treat the same condition, coverage for the New-To-Market drug is determined by documentation from the requesting physician showing that the Member has had a treatment failure of, or is unable to tolerate, two or more formulary alternative medications within the same therapeutic class (or, if none are listed, two or more formulary alternatives with the same FDA-approved indication)
• Step 3: If no formulary alternatives exist and the New-To-Market drug is a novel agent (first of its kind in a new class), coverage is determined using documentation from the requesting physician showing that all other available lines of treatment consistent with generally accepted principles of professional medical practice and/or guidelines from nationally recognized entities have been exhausted

Approval duration

12 months or up to a complete course of therapy if less than 1 year