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Formulary Evaluations

The Formulary Evaluations section of INNOVATIONS in Pharmacy provides a forum for considering and proposing standards and techniques to inform health decision makers in their assessment of pharmaceutical products and devices for formulary listing. A key issue is the evidence base required to support informed discussion on pricing and access. A theme that runs through many of the commentaries and papers is the importance of recognizing the standards of normal science, in particular the axioms of fundamental measurement. Examples of possible questions to be asked and issues to be addressed are:
  • What are the standards of normal science, including fundamental measurement, that formulary committees should set and manufacturers should address in responding to requests for a formulary submission?
  • To what extent, if any, should formulary committees accept modeled claims for products if the model fails to produce credible, empirically evaluable and replicable claims?
  • What should be the real world evidence standards that formulary committees require to support provisional formulary listing for new products and devices?
  • What evidence standards, including prospective claims assessment and reporting should formulary committees require of a manufacturer to support provisional listing and pricing?
  • Should formulary committees consider the role of prospective disease area and therapeutic class reviews for revisiting product placement, pricing and access in setting formulary submission standards?
  • What should be the minimum evidence standards for monitoring and reporting provisional claims in an observational tracking environment?

View our most recent call for papers: https://pubs.lib.umn.edu/index.php/innovations/article/view/3375

Lecanemab: A Second in Class Therapy for the Management of Early Alzheimer’s Disease

Connie Yoon, Corey Groff, Olivia Criss

2024-03-18

Rejecting False Claims from Markov Simulations in Alzheimer's Disease

Paul Langley

2023-09-25

Cost-Effectiveness of a Hypothetical Gene Therapy for Alzheimer's Disease: A Markov Simulation Analysis

Thuy Chinh Kieu, Kevin Look

2023-09-13

After The QALY: Training for a New Start Paradigm in Health Technology Assessment

Paul C Langley, Elliott M Sogol

2023-03-29

Post-Menopausal Quality of Life Claims: Overlooking the Requirements of Normal Science and Fundamental Measurement in ICER’S Cost-Effectiveness Assessment of Fezolinetant for Moderate to Severe Vasomotor Symptoms

Paul C Langley

2023-03-20

Patient-Centered Core Impacts Sets (PC-CIS): What They Are and What They Are Not

Eleanor M. Perfetto, Suz Schrandt, Omar A. Escontrías, Laurie B. Burke

2023-02-24

Rasch Measurement and Patient Reported Value Claims: A Primer for Hemophilia

Paul C Langley

2022-12-16

Evidentiary Standards for Patient-Centered Core Impact (PC-CIS) Value Claims

Paul C Langley

2022-10-25

Formulary Submissions: Value Claims, Protocols and Outcomes Based Contracting in Rare Disease

Paul Langley

2022-10-03

Concerns with Patient Reported Outcome Measurement and Value Claims for Therapy Response: The Case of Mavacamten and Symptomatic Hypertrophic Cardiomyopathy (SHCM)

Paul C Langley

2022-08-03

Use of an Innovative Pharmaceutical Class Scoring Tool for Prioritized Annual Formulary Review

Holly Sheldon, Audrey Kostrzewa, Shannon Werner, Terry Audley, Adam Biggs, Taylor Mancuso, Mary Frances Picone

2022-06-15

Mapping Impossible Utilities: The ICER Report on Tezepelumab for Severe Asthma

Paul C Langley

2022-05-24

Efficacy and Safety of Innovative Experimental Chimeric Antigen Receptor (CAR) T-cells versus Axicabtagene ciloleucel (Yescarta) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL): Matching Adjusted Indirect Comparisons (MAICs) and Systematic Review

Bayarmagnai Weinstein, Bogdan Muresan, Sara Solano, Antonio Vaz de Macedo, YoonJung Lee, Yu-Chen Su, Yeseul Ahn, Gabriela Henriquez, Christina Carmago, Gwang-Jin Kim, David O. Carpenter

2021-11-19

Outcomes of Alvimopan Use in Laparoscopic Intra-abdominal Surgery: A Retrospective Review

Aamir A. Kokan, Sahil Sheth, Katherine Rogers

2021-11-03

A Critical Examination for the Pricing of Eculizumab and Efgartigimod in Myasthenia Gravis

Paul C. Langley

2021-10-25

A Critical Examination of Simulation Pricing and Access Recommendations for Atopic Dermatitis

Paul C. Langley

2021-10-05

Abandoning Eugenics and the QALY

Paul C Langley

2021-07-30

Supping with the Devil: Belief and the Imaginary World of Multiple Myeloma Therapies Invented by the Institute for Clinical and Economic Review

Paul C Langley

2021-07-01

Peter Rabbit is a Badger in Disguise: Deconstructing the Belief System of the Institute for Clinical and Economic Review in Health Technology Assessment

Paul C Langley

2021-05-25

Fundamental Outcome Measurement: Selecting Patient Reported Outcome Instruments and Interpreting the Data they Produce

Stephen P McKenna, Alice Heaney, Paul C Langley

2021-05-11

Fundamental Measurement: The Need Fulfilment Quality of Life (N-QOL) Measure

Paul C. Langley, Stephen P. McKenna

2021-04-09

Medicaid Formulary Decisions and the Institute for Clinical and Economic Review: Abandoning Pseudoscience in Imaginary Pharmaceutical Pricing Claims

Paul Langley

2021-02-16

Let a Thousand Models Bloom: ICER Analytics Opens the Floodgates to Cloud Pseudoscience

Paul Langley

2021-01-20

To Dream the Impossible Dream: The Commitment by the Institute for Clinical and Economic Review to Rewrite the Axioms of Fundamental Measurement for Hemophilia A and Bladder Cancer Value Claims

Paul Langley

2020-12-10

Value Assessment, Real World Evidence and Fundamental Measurement: Version 3.0 of the Minnesota Formulary Submission Guidelines

Paul C. Langley

2020-11-12

The Impossible QALY and the Denial of Fundamental Measurement: Rejecting the University of Washington Value Assessment of Targeted Immune Modulators (TIMS) in Ulcerative Colitis for the Institute for Clinical and Economic Review (ICER)

Paul Langley

2020-09-17

The Great I-QALY Disaster

Paul Langley

2020-08-10

Post QALY: Scientific Approaches to Real World Formulary Decision Making INNOVATIONS in pharmacy 10th Anniversary Celebration Special ‘Call for Papers’ in the Formulary Evaluations Section of the Journal

Paul Langley, Stephen McKenna

2020-07-10

Value Assessment in Cystic Fibrosis: ICER’s Rejection of the Axioms of Fundamental Measurement

Paul Langley

2020-05-14

More Unnecessary Imaginary Worlds – Part 4: The ICER Evidence Report for Crizanlizumab, Voxelotor and L-Glutamine for Sickle Cell Disease

Paul Langley

2020-05-07

More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report

Paul Langley

2020-03-09

Nonsense on Stilts – Part 1: The ICER 2020-2023 Value Assessment Framework for Constructing Imaginary Worlds

Paul Langley

2020-02-14

More Unnecessary Imaginary Worlds – Part 2: The ICER Evidence Report on Modeling Oral Semaglutide for Type 2 Diabetes

Paul Langley

2020-02-07

More Unnecessary Imaginary Worlds - Part 1: The Institute for Clinical and Economic Review’s Evidence Report on Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis

Paul Langley

2020-01-24

Yet another Ersatz World: The ICER Final Evidence Report for Additive Cardiovascular Therapies

Paul Langley

2019-12-30

ICER, ISPOR AND QALYs: A Tale of Imaginary Worlds

Paul Langley

2019-11-18

The Imaginary Worlds of Cure Proportion Modeling: Survivorship and Reference Case Pricing of Transformative Therapies

Paul Langley

2019-10-03

Another Rush to Judgement: The Imaginary Worlds of ICER and Recommendations in Duchenne Muscular Dystrophy

Paul Langley

2019-09-04

Sugammadex compared with Neostigmine/Glycopyrrolate: An Analysis of Total PACU Time, Responsiveness, and Potential for Economic Impact

Yoon Jung Lee, Kayla Leigh Money, Amber Elliott

2019-07-05

Tracking and Reporting Outcomes in Medical Marijuana: Establishing Condition Specific State Level Registries

Paul C Langley

2019-04-22

A Practice Based Behavioral Health Management Registry (BHMR): Implementation, Structure and Content

Paul C Langley

2019-04-22

Meeting Physician Compliance Recommendations in the Management of Opioids in Chronic Pain: The Chronic Pain Management Registry (CPMR)

Paul Langley

2019-02-25

A Practice Based Chronic Pain Management Registry (CPMR): Structure and Content of Proposed Patient and Patient/Provider Platforms

Paul Langley

2019-02-21

Establishing Credibility for Medical Marijuana: The Proposed Prometheus Dispensary Registry for Botanical Cannabis

Paul Langley

2019-01-09

Establishing Practice Risk Management and Outcomes Claims for Medical Marijuana Dispensaries: Questions Legislators Should Ask

Paul Langley

2019-01-09

Outcomes, Registries and Medical Marijuana: Towards Establishing Dispensary Monitoring and Reporting Standards

Paul Langley

2018-11-30

CVS Health and the Imaginary Worlds of the Institute for Clinical and Economic Review (ICER)

Paul Langley

2018-11-20

Blockchains, Formulary Evaluations and Health Technology Assessment

Paul Langley, Robert E Martin

2018-11-20

If You Build it Will They Come? Patients, Providers and Blockchains in Health Technology Assessment

Paul Langley, Robert E Martin

2018-11-20

Blockchains, Property Rights and Health Technology Assessment in the Pharmaceutical and Device(s) Industries

Paul Langley, Robert E Martin

2018-11-20

Information or Evidence? Abandoning Imaginary Worlds for Blockchains in Health Technology Assessment

Paul Langley

2018-10-29

Alternative Facts and the ICER Proposed Policy on Access to Imaginary Pharmacoeconomic Worlds

Paul Langley

2018-04-17

Another Imaginary World: The ICER Claims for the Long-Term Cost-Effectiveness and Pricing of Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors in Tardive Dyskinesia

Paul C. Langley

2017-10-12

Resolving Lingering Problems or Continued Support for Pseudoscience? The ICER Value Assessment Update

Paul C. Langley

2017-10-12

Transparency, Imaginary Worlds and ICER Value Assessments

Paul C. Langley

2017-10-12

More Imaginary Worlds: A Systematic Review of the Status of Modeled Cost-Effectiveness Claims Published in the Journal of Medical Economics from January 2016 to December 2016

Paul C Langley, Taeho Greg Rhee

2017-09-26

Potentially Actionable Targets: Evidence Standards for Credible Next Generation Sequencing Technology Assessment Claims

Paul C Langley

2017-09-11

The Imaginary Worlds of ISPOR: Modeled Cost-Effectiveness Claims Published in Value in Health from January 2016 to December 2016

Paul C Langley, Taeho Greg Rhee

2017-05-19

Rush to Judgement: Imaginary Worlds and Cost-Outcomes Claims for PCSK9 Inhibitors

Paul C Langley, Dr

2017-05-16

True North: Building Imaginary Worlds with the Revised Canadian (CADTH) Guidelines for Health Technology Assessment

Paul C Langley

2017-05-04

Imaginary Worlds and the Institute for Clinical and Economic Review (ICER) Evidence Report: Targeted Immune Modulators for Rheumatoid Arthritis

Paul C Langley

2017-05-04

Intelligent Design and Imaginary Worlds in Cost-Effectiveness Claims: An Overview of Commentaries in INNOVATIONS in Pharmacy from July 2016 to February 2017

Paul C Langley

2017-03-09

Imaginary Worlds and Efficiency Frontiers: Should We Abandon the IQWiG Health Technology Assessment Model?

Paul C Langley

2017-02-13

Multiple Sclerosis and the Comparative Value Disease Modifying Therapy Report of the Institute for Clinical and Economic Review (ICER)

Paul C Langley

2017-02-01

HAS Should Not Be NICE: Rejecting Imaginary Worlds in the French Technology Assessment Guidelines

Paul C Langley

2017-01-30

Denkbeeldige Wereld: The New Dutch Guidelines for Economic Evaluations in Healthcare

Paul C Langley

2017-01-10

Dreamtime: Version 5.0 of the Australian Guidelines for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC)

Paul C Langley

2017-01-10

Validating Imaginary Worlds? The AdViSHE Assessment Tool

Paul C Langley

2017-01-10

Nullius in verba: Version 2.0 of the University of Minnesota, School of Social and Administrative Pharmacy Program, Proposed Guidelines for Formulary Evaluation

Paul C Langley

2016-12-08

Creative Destruction: Next Generation Sequencing in Drug Development, Formulary Evaluations and Pricing

Paul C Langley

2016-11-23

Next Generation Sequencing Claims in Precision Medicine: Questions a Formulary Committee Should Ask

Paul C Langley

2016-11-11

Imaginary Worlds: The Status of Modeled Quality Adjusted Life Year Claims for New Oral Anticoagulants in Atrial Fibrillation Published Between January 2012 and February 2016

Paul C Langley, Taeho Greg Rhee

2016-09-09

Cost-Effectiveness and Formulary Evaluation: Imaginary Worlds and Entresto Claims in Heart Failure

Paul C Langley

2016-09-09

Imaginary Worlds: The European Network for Health Technology Assessment (EUnetHTA) Recommendations for Health Economic Evaluations

Paul C Langley

2016-08-24

Imaginary Worlds: The Status of Modeled Economic Evaluation Claims Published in Value in Health January 2015 to December 2015

Paul C Langley, Taeho Greg Rhee

2016-07-12

Imaginary Worlds: A Systematic Review of the Status of Modeled Cost-Effectiveness Claims Published in the Journal of Medical Economics from January 2015 to December 2015

Paul C Langley, Taeho Greg Rhee

2016-07-08

Great Expectations: Cost-Utility Models as Decision Criteria

Paul C Langley

2016-07-08

Imaginary Worlds: The Status of Simulation Modeling in Claims for Cost-Effectiveness In Diabetes Mellitus

Paul C Langley, Taeho Greg Rhee

2016-07-08

Supporting Formulary Decisions: The Discovery of New Facts or Constructed Evidence?

Paul C Langley

2016-07-08

He Ao Pohewa: The PHARMAC Prescription for Pharmacoeconomic Analysis in New Zealand and the Standards of Normal Science

Paul C Langley

2016-07-08

Sunlit Uplands: The Genius of the NICE Reference Case

Paul C Langley

2016-07-05

Nullius in verba: The University of Minnesota Social and Administrative Pharmacy Program proposed Guidelines for Formulary Evaluations

Paul C Langley

2016-07-05

Modeling Imaginary Worlds: Version 4 of the AMCP Format for Formulary Submissions

Paul C Langley

2016-07-05

Imaginary Worlds: Modeled claims for cost-effectiveness published in PharmacoEconomics January 2015 to December 2015

Paul C Langley

2016-07-01

Greater Expectations for Pharmaceutical Value: Better Care, Healthier People, Smarter Spending

Jon C. Schommer, Brian Isetts

2016-07-01

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