Principles in Practice
Generic Substitution
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
Slide 1
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Formulary
Management
• An integrated patient care process that
enables physicians, pharmacists and other
healthcare professionals to work together to
promote clinically sound, cost-effective
pharmaceutical care.
Academy of Managed Care Pharmacy. Concepts in Managed Care Pharmacy Series
Pharmaceutical Care. 1997.
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
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• The substitution of drug products that
contain the same active ingredient(s) and
are chemically identical in strength,
concentration, dosage form and route of
administration to the product described.
Academy of Managed Care Pharmacy. Principles of a Sound Drug Formulary System. 2000.
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
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Generic
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hereSubstitution
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• Brand name Zovirax® for Acyclovir
• However, therapeutic classes such as
hormones and drugs with narrow
therapeutic index (anticonvulsants,
anticoagulants, etc.) may not be appropriate
for generic substitution
Academy of Managed Care Pharmacy. Principles of a Sound Drug Formulary System. 2000.
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
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Therapeutic
Substitution
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• The substitution of drug products that
contain different chemical entities, but
which should produce similar treatment
effects, the same pharmacological action, or
chemical effect when administered to
patients in therapeutically equivalent doses.
Academy of Managed Care Pharmacy. Principles of a Sound Drug Formulary System. 2000.
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
Slide 5
Therapeutic
Substitution
Example
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title
• A common example is switching COX-2
Inhibitors such as Celebrex® to ibuprofen.
Academy of Managed Care Pharmacy. Principles of a Sound Drug Formulary System. 2000.
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
Slide 6
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andFormulary
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Drug
• A continually updated list of medications
and related information, representing
the clinical judgment of physicians,
pharmacists and other experts in the
diagnosis and/or treatment of disease
and promotion of health.
Academy of Managed Care Pharmacy. Principles of a Sound Drug Formulary System. 2000.
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
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Pharmacy
Benefit
Management
• An organization that manages pharmaceutical benefits for a
managed care organization, other medical providers or an
employer. PBMs contract with clients interested in optimizing the
clinical and economic performance of their pharmacy benefit.
PBM activities may include some or all of the following: benefit
plan design, creation/administration of retail and mail service
networks, claims processing and managed prescription drug
care services such as drug utilization review, formulary
management, generic dispensing, prior authorization and
disease and health management.
AMCP: Guiding Principles for Effective Electronic Messaging
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
Slide 8
ClickMulti-Source
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Products
• Drug products for which the original
branded patent has expired and the product
is available from several sources (the
branded product as well as generic versions
are available).
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
Slide 9
Maximum Allowable Cost
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(MAC)
• A contractual policy that dictates upper limits that
a plan will pay for generic and multi-source brand
drugs.
• Generally, the MAC price is established by taking
the prices of widely available generic distributors
and using the average of these, or alternatively, the
lowest of these to set the MAC reimbursement
rate.
Thomas N, Larson LN, Bell NN. Pharmacy Benefits Management. Brookfield, WI: International Foundation of
Employee Benefit Plans;1996.
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
Slide 10
Hatch-Waxman
Reform
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• Brand manufacturers will be granted only one 30
month stay on the approval of a generic
competitor.
– Certain requirements to secure, shorten or terminate 30month stay
• 180 Day Exclusivity Provision
– This was amended to establish circumstances when a
generic manufacturer would lose its 180 day
exclusivity, including failure to bring product to the
market in specified time period.
Copyright © 2002 - 2005 – Academy of Managed Care Pharmacy (AMCP)
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