S-2. Criteria Review

A drug qualifies for inclusion on the SDL if it meets all the rule criteria. Refer to TAC Section 354.1853 (Subchapter F: Specialty Drugs).

Medical Condition

A drug will meet these rule criteria if the drug is to treat and is prescribed for a person with a complex, chronic, or rare medical condition that is:

  • Progressive
  • Debilitating or fatal if left untreated or undertreated
  • Has no known cure


HHSC evaluates a drug for inclusion on the SDL after the drug has been on the Medicaid formulary for at least six months. A claim utilization report will identify all pharmacy types dispensing each drug in Medicaid (traditional and managed care). A drug will meet this rule criteria if the utilization report identifies specialty pharmacies are the type of pharmacy dispensing the drug at least 70% of the time. HHSC will consider all drug strengths, specific to the formulation, fulfilling all four specialty drug criteria for inclusion on the SDL.

Special Handling or Storage

HHSC reviews the information submitted by the drug manufacturers on the Electronic Certification of Information. The manufacturer identifies if the drug meets any of the following specifications:

  1. The manufacturer allows only specific pharmacies or pharmacy chains to dispense the drug
  2. The drug needs to be administered within less than 48 hours after dispensing
  3. Requires protective handling (e.g., hazardous drugs with mutagenic, carcinogenic, teratogenic, or adverse reproductive effects, or requires laminar flow hoods for preparation or mixing)
  4. Requires aseptic techniques for compounding per federal and state standards
  5. Requires the patient to receive specific labs for therapeutic efficacy, toxicity, or physiological testing (e.g., renal function, liver enzyme tests, complete or partial blood counts) at baseline and during or post-drug treatment
  6. Requires highly-specialized storage equipment or facilities that are not commonly available in retail pharmacies (e.g., more than just refrigeration)

Special Education and Treatment Maintenance

HHSC will identify if the drug meets both of the following specifications:

  1. Do patients using the drug require complex education to promote appropriate utilization of the drug, or is there a need to educate on proper storage, preparation, and administration?
  2. Do patients using the drug require treatment maintenance, such as complex dosing, intensive monitoring, or clinical oversight?