Generic Substitution Principles in Practice Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 1

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 Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 2 Formulary Management

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 Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 3 Generic Substitution

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 Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 4 Generic Substitution Example

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 Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 5 Therapeutic Substitution

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 Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 6 Therapeutic Substitution Example

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 Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 7 Drug Formulary

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 Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 8 Pharmacy Benefit Management

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). Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 9 Multi-Source Products

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. Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 10 Maximum Allowable Cost (MAC)

Brand manufacturers will be granted only one 30 month stay on the approval of a generic competitor. –Certain requirements to secure, shorten or terminate 30- month 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. Click here and overtype for title Copyright © – Academy of Managed Care Pharmacy (AMCP)Slide 11 Hatch-Waxman Reform