Medical Necessity Criteria for Targeted Immunomodulatory Biologics
Drug Class – Targeted Immunomodulatory Biologics (TIBs). This drug class includes Humira
(adalimumab), Amevive (alefacept), Raptiva (efalizumab), Enbrel (etanercept), Kineret (anakinra), Cimzia
(certolizumab), Simponi (golimumab), Orencia SQ (abatacept). All of these medications are given by
subcutaneous injection (under the skin) with the exception of Amevive, which is given intramuscularly.
NOTE: Remicade (infliximab), Orencia (abatacept), and Rituxan (rituximab), which are intravenously-
administered medications used to treat many of the same conditions, are covered by TRICARE under the
medical rather than the pharmacy benefit.
Background – After evaluating the relative clinical and cost effectiveness of these agents, the DoD P&T
Committee recommended that the following medications be designated as non-formulary under the
Uniform Formulary. This recommendation has been approved by the Director, TMA.
Enbrel (etanercept)
Kineret (anakinra)
Cimzia (certolizumab)
Simponi (golimumab)
Orencia SQ (abatacept)
Patients currently using a nonformulary agent may wish to ask their doctor to consider a formulary
alternative.
Special Notes:
1. Active duty cost share always $0 in all points of service for all three tiers; Active duty cost share always
$0 in all points of service for all three tiers; TRICARE does not cover non-formulary medications for active
duty service members unless they are determined to be medically necessary.
2. MTFs will be able to fill non-formulary requests for non-formulary medications only if both of the
following conditions are met: 1) a MTF provider writes the prescription, and 2) medical necessity is
established for the non-formulary medication. MTFs may (but are not required to) fill a prescription for a
non-formulary medication written by a non-MTF provider to whom the patient was referred, as long as
medical necessity has been established.
3. Quantity and/or days supply limits apply to Enbrel, Humira, Kineret, Cimzia, Simponi, and Orencia SQ.
No more than a 4-week supply will be dispensed at any one time at retail network pharmacies (no
multiple fills for multiple cost shares); no more than a 6- to 8-week supply will be dispensed at any one
time at the TMOP. Usual program limits apply to Raptiva and Amevive. Please see the
Formulary Search
Tool
for specific limits.
4. Amevive, which is given via intramuscular injection, is not available at the TMOP.
5. Medications in this class are given for a number of different rheumatological, dermatological, and
gastrointestinal conditions. Not all drugs are FDA-approved (or effective) for all conditions. Three of the
1
2
3
