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P&T Committee Resource Center

General Information/Guidelines

ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System

Guidelines published 2008; reviewed by ASHP 2012 and found to still be appropriate. Details formulary system, role of P&T committees, managing formularies, evaluating drug for inclusion; strategies for managing medication use; incorporating patient safety in decision making

American Journal of Health-System Pharmacists 2008, 2012

ASHP Principles of a Sound Drug Formulary System

Position paper (published 2000 and reviewed 2011) from coalition of organizations to develop guiding principles specifying essential components of a sound drug formulary system

American Journal of Health-System Pharmacists 2000, 2011

Formulary Management

5-page AMCP paper overview of basic info on formulary management including development and role of P&T committee.

Academy of Managed Care Pharmacy 2009

Where We Stand: Formularies

AMCP position paper that supports use of evidence-based formularies to enhance quality of care by encouraging use of medications that are demonstrated to be the safest, mose effective and produce positive patient outcomes.

Academy of Managed Care Pharmacy 2017

ISPOR Global Health Care Systems Road Map: Overview of Health Care in the US

Relatively brief (8 pgs) informative treaty on healthcare financing and roles of various decision makers.  Includes drug pricing and reimbusement process and differences between public and private sectors.  Concise discussion of role of P&T committee and data requirements for submission to formulary.

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2015
 

Other Articles on P&T Committees/Formularies

AMCP Format Dossier Requests: Manufacturer Response and Formulary Inplications for One Large Health Plan

Study evaluated pharmaceutical manufacturers' response to request for a product dossier prepared using AMCP format and to determine if dossier receipt was associated with a favorable fromulary placement.

Journal of Managed Care & Specialty Pharmacy 2013

Pharmacy and Therapeutics Committee: Leadership Opportunities in Medication Safety for Medical Toxicologists

Discusses importance of P&T committees to do assessment of safety of newly approved drug and the committee's role in investigating adverse drug events to improve drug utilization processes.

Journal of Medical Toxicology 2011

The right drug, but from whose perspective? A framework for analysing the structure and activities of drug and therapeutics committees.

Study was based on both US and European drug and therapeutics committees (DTCs - same as P&T).  Informative discussion of goals, organization and decision-making process including importance of promoting evidence-based medicine to change the behavior of physicians.

European Journal of Clinical Pharmacology 2013

Literature review on structure and operation of Pharmacy & Therapeutics Committees

Conclusion was that most influential factors in decision-making process were clinical trial results or drug cost rather than pharmacoeconomic studies.

International Journal of Clinical Pharmacy 2011

How Formularies Make an Impact (Blog)

Discussion of pros and cons of formulary mgmt in general and statewide formularies in particular.

Health Information Designs 2016
 

FDAMA 114

Drug and Device Manufacturer Communications With Payors, Formulary Committees and Similar Entities - Questions and Answers: Guidance for Industry and Review Staff

Solicitation of comments and suggestions for FDAMA 114

FDA Jan. 2017

FDAMA 114: Improving the Exchange of Pharmacoeconimic Data

Proceeding from AMCP Partnership Forum, Mar 2016. Diverse group of stakeholders to provide FDA with considerations for disseminating guidance document on sharing of HCEI to those responsible for formulary decision making

Journal of Managed Care & Specialty Pharmacy 2016

FDA Says Yes to Pre-Approved Communications with Payors but Reaffirms its Approach to Restrictions on Off-Label Communications

Article (written by associate at Becker, Epstein & Green; healthcare law firm) that analyzes FDA Guidance from a legal standpoint

The National Law Review 2017
 

Government Issues/Publications

Medicare Modernization Act: 2007 Final Guidelines - Formularies

CMS Strategy for affordable access to comprehensive drug coverage.  Guidelines for reviewing prescription drug plan formularies and procedures.  Requirements of P&T committees

Centers for Medicare and Medicaid Services (CMS) 2007

Where We Stand: Government-Mandated Pharmacy Benefits

AMCP position statement against mandates imposed by gov't which lead to restrictions on MCO's ability to deliver a quality product and decrease the affordability and financial sustainability of the benefit.  These include mandated formulary content, mandated coverage parity terms and mandated coverage of medications.  Discussion of intended consequences to these mandates.

Academy of Managed Care Pharmacy Revised 2017

Observations on Trends in Prescription Drug Spending

Informative statistical info on drug spending and factors leading to rise in spending 2010-2014

ASPE Issue Brief Mar. 2016
 

Relevant P&T Journal/Managed Care articles

The Changing Roles of P&T Committees: A Look Back at the Last Decade and a Look Forward to 2020

Scope of P&T committees has expanded as larger health systems have emerged servicing both inpatient & outpatient needs in multiple hospitals & ambulatory care centers and as new drugs and biotech therapies enter the market

P&T Journal 2014

Reinventing the Pharmacy and Therapeutics Committee

Current challenges to P&T committees include exploding number of  complex pharmaceuticals with a wider array of indications at unprecedented costs.  At the same time, value-based reimbursement and accountable-care models force focus on cost containment and care mgmt strategies.  Discusses how P&T committees should evolve.

P&T Journal 2012

Tranforming the P&T Committee

Letter to Editor response to above article.  Offers additional thoughts on new, expanding role of P&T Committees

P&T Journal 2013

AMCP Seeks an End to 20 Years of Confusion over FDAMA Section 114

Discussion of regulations needed to clarify boundaries of promotion of pharmacoeconomic data

Managed Care 2016

FDA Revisits Rules on Drug and Device Communication

Discussion of draft guidance on HCEI which clarifites and expands the types of info companies can send P&T and formulary committee under FDAMA 114. Also discussion of Section 204 where drug and device manufacturers want to be able to supply data beyond what is developed through clinical trials.

P&T Journal 2017

More Headlines

Some see the loss of an important, unbiased source of information.
Insurers are proceeding cautiously, but the large insurers are speeding up their approvals.
The move is considered part of the antiterrorism effort.
An impurity has been found to be carcinogenic.
But diabetes group tamp down expectations.
Agency says products for sexual enhancement, weight loss, and bodybuilding have hidden drugs and chemicals.
A meta-analysis that included 18 million participants found no protection from heart disease or stroke.
There is a small difference between them and biosimilars that physicians, patients, and insurers should be aware of.
It will nearly quadruple within the next five years, according to a new report, though concerns about how they’re manufactured remain.