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Biosimilar Papers by Stanton R Mehr
Journal of Medical Economics, 2017
This is a commentary on biosimilars. It defines biosimilars, discusses some of the obstacles to b... more This is a commentary on biosimilars. It defines biosimilars, discusses some of the obstacles to biosimilar adoption, and financing (including rebates)
Papers by Stanton R Mehr
American health & drug benefits, 2015
Significant innovations in the treatment of patients with multiple sclerosis (MS) have primarily ... more Significant innovations in the treatment of patients with multiple sclerosis (MS) have primarily addressed the frequency of flare-ups in relapsing-remitting MS (RRMS). Many advances have been made in this area, and the medical community may be on the verge of a serious discussion of what constitutes a truly effective MS treatment. Certainly, it is important to further delay MS flare-ups and more effectively treat RRMS symptoms. However, great strides in reducing or preventing MS-related disability and providing neuroprotection have been elusive. Many unmet needs are still voiced by patients with MS, clinicians, and caregivers. Current information on the need for progress in various areas is reviewed in this article, including psychosocial care, treatments for progressive MS, biomarker identification, functional outcome measures, individualization of treatment, reducing side effects of medications, and improving medication adherence.
Journal of Medical Economics, 2017
Journal of Pharmacy and Pharmacology
The paper is to determine the types of approaches preferred by medical and pharmacy directors of ... more The paper is to determine the types of approaches preferred by medical and pharmacy directors of US payer organizations to enhance the Pharmacy & Therapeutic decision-making process and how medications accepted onto the formulary should be covered. An online interactive survey of US medical and pharmacy directors was conducted in 2012. In addition to a 10-point Likert scale (10 = agree completely, 1 = disagree completely), qualitative responses and interpretive analysis were used to explore beliefs about certain statements. The results showed that the 30 respondents (20 medical directors and 10 pharmacy directors) rated current progress in obtaining usable CER (comparative-effectiveness research) at only an average of 4.17 on the 10-point scale. They hoped to regularly utilize CER information in formulary decision making by 2015 (average rating, 6.03). The rating of evidence-based medicine use in coverage decision making today was somewhat higher, at an average of 7.08 (medical dire...
The American journal of managed care, 2014
The American journal of managed care, 2014
The American journal of managed care, 2014
The American journal of managed care
Much of the testing required for the regulatory approval of a biosimilar is focused on proving th... more Much of the testing required for the regulatory approval of a biosimilar is focused on proving that the new drug is sufficiently similar to the reference biologic in structure, pharmacokinetics or pharmacodynamics, clinical efficacy, and safety. However, the reference drug may itself have gone through some changes in the years since its approval, including those caused by alterations in the manufacturing process. Do these changes increase the risk that the reference drug may cause unexpected outcomes? It is up to the US Food and Drug Administration to decide whether the changes merit the need for additional studies to confirm that the drug meets the structural or clinical outcomes standard for the reference agent. Although it is extremely rare, a change in the production of one biologic drug (ie, epoetin alfa) did result in unanticipated serious immunologic side effects.
The American journal of managed care, 2012
The American journal of managed care, 2012
The American journal of managed care, 2012
The American journal of managed care, 2012
The American journal of managed care
Pharmaceutical Medicine
Unlike in Europe, US healthcare systems and payers are still awaiting significant savings related... more Unlike in Europe, US healthcare systems and payers are still awaiting significant savings related to biosimilar utilization. Costs related to biologic use continue to rise at double-digit rates, and biosimilars are seen as a major tool to control costs and increase access to biologic drugs. However, one 2018 report indicated that US$3.2 billion (only 3%) of biologic spending is subject to competition from biosimilar products. Although the European Medicines Agency did a great deal of pioneering work in biosimilar regulation, the US Food and Drug Administration is moving at approximately the same pace as the European Medicines Agency, based on the number of approvals at the same time after implementation of its regulatory pathway. Several unique factors in the USA have conspired to limit biosimilar access (e.g. delayed regulatory policies, extended patent litigation activities, federal reimbursement policies, the widespread use of rebate contracting, and limited competition). The US Federal Government is taking the initiative in an attempt to address these factors, and speed both biosimilar development and patient access. To date, the most significant cost savings in the US system associated with the introduction of biosimilars may be their ability to halt price increases of the reference product. The complexity of the healthcare delivery system, and how it is financed, will remain challenging to payers, manufacturers, health providers and patients as they seek ways to manage health expenditure growth.
Managed care interface, 2006
The origins of the Pharmacy and Therapeutics (P&T) Committee is intertwined with the evolution of... more The origins of the Pharmacy and Therapeutics (P&T) Committee is intertwined with the evolution of the modern practice of pharmacy. Although the P&T Committee has been uniquely developed to help make coverage decisions, this implies that its technology assessment function, particularly with regard to medicines, has paved the way to more cost-effective and evidence-based practice. This article, which briefly traces the lineage of the first known "formulary" employed during the Revolutionary War to today's P&T Committee, argues that its true function--technology assessment--serves as the basis for coverage decisions throughout health systems.
Journal of Medical Economics, 2017
This is a commentary on biosimilars. It defines biosimilars, discusses some of the obstacles to b... more This is a commentary on biosimilars. It defines biosimilars, discusses some of the obstacles to biosimilar adoption, and financing (including rebates)
American health & drug benefits, 2015
Significant innovations in the treatment of patients with multiple sclerosis (MS) have primarily ... more Significant innovations in the treatment of patients with multiple sclerosis (MS) have primarily addressed the frequency of flare-ups in relapsing-remitting MS (RRMS). Many advances have been made in this area, and the medical community may be on the verge of a serious discussion of what constitutes a truly effective MS treatment. Certainly, it is important to further delay MS flare-ups and more effectively treat RRMS symptoms. However, great strides in reducing or preventing MS-related disability and providing neuroprotection have been elusive. Many unmet needs are still voiced by patients with MS, clinicians, and caregivers. Current information on the need for progress in various areas is reviewed in this article, including psychosocial care, treatments for progressive MS, biomarker identification, functional outcome measures, individualization of treatment, reducing side effects of medications, and improving medication adherence.
Journal of Medical Economics, 2017
Journal of Pharmacy and Pharmacology
The paper is to determine the types of approaches preferred by medical and pharmacy directors of ... more The paper is to determine the types of approaches preferred by medical and pharmacy directors of US payer organizations to enhance the Pharmacy & Therapeutic decision-making process and how medications accepted onto the formulary should be covered. An online interactive survey of US medical and pharmacy directors was conducted in 2012. In addition to a 10-point Likert scale (10 = agree completely, 1 = disagree completely), qualitative responses and interpretive analysis were used to explore beliefs about certain statements. The results showed that the 30 respondents (20 medical directors and 10 pharmacy directors) rated current progress in obtaining usable CER (comparative-effectiveness research) at only an average of 4.17 on the 10-point scale. They hoped to regularly utilize CER information in formulary decision making by 2015 (average rating, 6.03). The rating of evidence-based medicine use in coverage decision making today was somewhat higher, at an average of 7.08 (medical dire...
The American journal of managed care, 2014
The American journal of managed care, 2014
The American journal of managed care, 2014
The American journal of managed care
Much of the testing required for the regulatory approval of a biosimilar is focused on proving th... more Much of the testing required for the regulatory approval of a biosimilar is focused on proving that the new drug is sufficiently similar to the reference biologic in structure, pharmacokinetics or pharmacodynamics, clinical efficacy, and safety. However, the reference drug may itself have gone through some changes in the years since its approval, including those caused by alterations in the manufacturing process. Do these changes increase the risk that the reference drug may cause unexpected outcomes? It is up to the US Food and Drug Administration to decide whether the changes merit the need for additional studies to confirm that the drug meets the structural or clinical outcomes standard for the reference agent. Although it is extremely rare, a change in the production of one biologic drug (ie, epoetin alfa) did result in unanticipated serious immunologic side effects.
The American journal of managed care, 2012
The American journal of managed care, 2012
The American journal of managed care, 2012
The American journal of managed care, 2012
The American journal of managed care
Pharmaceutical Medicine
Unlike in Europe, US healthcare systems and payers are still awaiting significant savings related... more Unlike in Europe, US healthcare systems and payers are still awaiting significant savings related to biosimilar utilization. Costs related to biologic use continue to rise at double-digit rates, and biosimilars are seen as a major tool to control costs and increase access to biologic drugs. However, one 2018 report indicated that US$3.2 billion (only 3%) of biologic spending is subject to competition from biosimilar products. Although the European Medicines Agency did a great deal of pioneering work in biosimilar regulation, the US Food and Drug Administration is moving at approximately the same pace as the European Medicines Agency, based on the number of approvals at the same time after implementation of its regulatory pathway. Several unique factors in the USA have conspired to limit biosimilar access (e.g. delayed regulatory policies, extended patent litigation activities, federal reimbursement policies, the widespread use of rebate contracting, and limited competition). The US Federal Government is taking the initiative in an attempt to address these factors, and speed both biosimilar development and patient access. To date, the most significant cost savings in the US system associated with the introduction of biosimilars may be their ability to halt price increases of the reference product. The complexity of the healthcare delivery system, and how it is financed, will remain challenging to payers, manufacturers, health providers and patients as they seek ways to manage health expenditure growth.
Managed care interface, 2006
The origins of the Pharmacy and Therapeutics (P&T) Committee is intertwined with the evolution of... more The origins of the Pharmacy and Therapeutics (P&T) Committee is intertwined with the evolution of the modern practice of pharmacy. Although the P&T Committee has been uniquely developed to help make coverage decisions, this implies that its technology assessment function, particularly with regard to medicines, has paved the way to more cost-effective and evidence-based practice. This article, which briefly traces the lineage of the first known "formulary" employed during the Revolutionary War to today's P&T Committee, argues that its true function--technology assessment--serves as the basis for coverage decisions throughout health systems.