Current through all regulations passed and filed through September 16, 2024
(A) For a drug to be considered for
coverage without prior authorization in accordance
with rule 5160-9-03 of the Administrative Code, the following
information may be requested from the manufacturer or labeler:
(1) Trade name of the drug.
(2) Generic name of the drug.
(3) National drug code number
(NDC).
(4) Package sizes
available.
(5) Strengths.
(6) Therapeutic use(s).
(7) List of therapeutic
ingredients.
(8) Direct, average
wholesale price, wholesale acquisition cost and average manufacturer
price.
(9) Bioavailability and
bioequivalency data.
(10) Letter(s)
of approval of new drug application (NDA), or abbreviated new drug application
(ANDA).
(11) Product labeling as
approved by the food and drug administration.
(12) A statement of justification for
coverage without prior
authorization including cost effectiveness and relative merits.
(B) Final determination by the
Ohio department of medicaid (ODM) of a drug's inclusion on or removal from the
list
described in paragraph (C) of rule 5160-9-03 of
the Administrative Code will be based on a review and analysis of the
information required in paragraph (A) of this rule in addition to an analysis
of such factors as:
(1) Specific attributes
and/or benefits of the drug.
(2)
Availability and cost effectiveness of the drug in relation to alternative
products.
(3) Availability of
bioequivalent generic products.
(4)
Provision of a supplemental rebate payment for a drug that reduces the
acquisition cost.
(C)
Newly-marketed drugs
(1)
New products with
the same active ingredient, dosage form, and brand or generic designation as a
product that is already covered by ODM will be added to coverage under the same
conditions as the existing covered product.
(2)
New products
within a therapeutic category listed on the ODM "Preferred Drug List" (PDL)
will be added to coverage with prior authorization using the same criteria
outlined in the PDL document until the new product is reviewed by the ODM
pharmacy and therapeutics committee.
(3)
New products not
within a therapeutic category listed on the ODM PDL will be added to coverage
with prior authorization criteria consistent with the product labeling approved
by the federal food and drug administration.
Effective: 4/1/2017
Five Year Review
(FYR) Dates: 01/13/2017 and
04/01/2022
Promulgated
Under: 119.03
Statutory Authority: 5160.34, 5164.02
Rule
Amplifies: 5160.34, 5162.03, 5164.754, 5164.755, 5164.7510
Prior
Effective Dates: 4/7/77, 9/19/77, 12/21/77, 12/30/77, 7/8/78, 10/1/78, 5/9/86,
11/1/86, 10/1/87, 2/1/88, 1/13/89 (Emerg), 4/13/89, 6/1/89, 7/1/94, 10/1/97,
2/3/00 (Emer), 5/1/00, 8/30/01, 3/31/03 (Emer), 6/12/03, 7/24/08,
5/16/14
