Is Real-World Evidence Used in P&T Monographs and Therapeutic Class Reviews?

Journal of Managed Care & Specialty Pharmacy
Jason T HurwitzDaniel C Malone

Abstract

Payers are faced with making coverage and reimbursement decisions based on the best available evidence. Often these decisions apply to patient populations, provider networks, and care settings not typically studied in clinical trials. Treatment effectiveness evidence is increasingly available from electronic health records, registries, and administrative claims. However, little is known about when and what types of real-world evidence (RWE) studies inform pharmacy and therapeutic (P&T) committee decisions. To evaluate evidence sources cited in P&T committee monographs and therapeutic class reviews and assess the design features and quality of cited RWE studies. A convenience sample of representatives from pharmacy benefit management, health system, and health plan organizations provided recent P&T monographs and therapeutic class reviews (or references from such documents). Two investigators examined and grouped references into major categories (published studies, unpublished studies, and other/unknown) and multiple subcategories (e.g., product label, clinical trials, RWE, systematic reviews). Cited comparative RWE was reviewed to assess design features (e.g., population, data source, comparators) and quality using the Good Res...Continue Reading

References

Feb 5, 2000·The New England Journal of Medicine·P Kwan, M J Brodie
Dec 12, 2001·Epilepsia·P Kwan, M J Brodie
Mar 19, 2003·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Brenda MotheralPaul Stang
May 21, 2003·Annals of Internal Medicine·Hyon J KwonM Miles Braun
Nov 3, 2005·The European Respiratory Journal·M M HoeperJ Niedermeyer
Jan 27, 2007·Annals of Neurology·Anna L Luciano, Simon D Shorvon
Sep 25, 2007·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Louis P GarrisonC Daniel Mullins
Feb 21, 2008·The Annals of Pharmacotherapy·James M BackesPatrick M Moriarty
Jan 22, 2011·Pharmacoepidemiology and Drug Safety·G C AlexanderR S Stafford
Apr 9, 2011·Journal of Correctional Health Care : the Official Journal of the National Commission on Correctional Health Care·Kenneth L Appelbaum
Apr 4, 2012·Journal of Managed Care Pharmacy : JMCP·Musetta Y LeungNathan D West
Aug 15, 2012·The American Journal of Gastroenterology·Gary R LichtensteinWilliam J Sandborn
May 2, 2014·The Cochrane Database of Systematic Reviews·Andrew AnglemyerLisa Bero
Apr 1, 2015·Journal of Comparative Effectiveness Research·Joel S WeissmanOlubode A Olufajo
Nov 10, 2015·Journal of Clinical Epidemiology·Sally C MortonRobert W Dubois
May 28, 2016·Journal of Managed Care & Specialty Pharmacy·Eleanor M PerfettoBernadette Eichelberger
Sep 27, 2016·Journal of Managed Care & Specialty Pharmacy·James D ChambersMatthew D Chenoweth
Dec 14, 2016·The New England Journal of Medicine·Rachel E ShermanRobert M Califf

❮ Previous
Next ❯

Citations

Feb 9, 2018·International Journal of Technology Assessment in Health Care·Elisabeth M OehrleinEberechukwu Onukwugha
Dec 1, 2020·Journal of Managed Care & Specialty Pharmacy·Daniel C Malone
Dec 1, 2020·Journal of Managed Care & Specialty Pharmacy·Boshen JiaoBeth Devine
Dec 31, 2020·Journal of Managed Care & Specialty Pharmacy·Shuxian ChenBeth Devine
Sep 1, 2021·Journal of Managed Care & Specialty Pharmacy·NikoLetta M MargaretosJames D Chambers

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.