US Commercial Plans Increase Choice Of Biosimilar And Originator Products; Market Net Prices Decrease.

Biosimilars drugs are almost identical copies of original biologic products. Early biosimilars had slower adoption and savings than expected; however, biosimilars launched in recent years have had more success. With several biosimilar launches planned in the next few years, it is important to understand how the state of the market might foretell significant market savings in the future.

Biosimilar underutilization alone does not foretell a broken biologics market.

Biosimilars offer the potential for cost savings and expanded access to biologic products; however, there are concerns regarding the rate of biosimilar uptake. We assessed the relationship between biosimilar and originator pricing, coverage, and market share by describing four case studies that fall into two categories: (1) sole preferred coverage strategy (ie, aim is to have originator product preferred; biosimilar(s) non-preferred), defined as steep average sales price (ASP) reductions for originator products (decline in net prices by at least 50% following the introduction of biosimilar competition by 2022) and (2) non-sole preferred coverage strategy (ie, aim is to have originator product preferred alongside biosimilar products), defined as moderate ASP reductions for originator products with (net prices did not decline by at least 50% of its pre-biosimilar competition value). We found that originators with sole preferred coverage strategies maintained formulary preference and market share relative to originators with non-sole preferred coverage strategies.

Balancing Evidence and Need: Variation in US Commercial Payer Coverage of Esketamine.

Purpose: Variations in US commercial health plan coverage policies affect how patients access medications. Plans may vary in treatment access criteria, line of therapy, and prescriber requirements. In this study, we examined coverage of esketamine hydrochloride (Spravato) for major depressive disorder (MDD) and treatment-resistant depression (TRD) to answer the following question: how do US commercial health plans cover esketamine, and how do they guide prompt patient access to the drug?

Methods: We used information from the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes coverage policies issued by 18 large commercial health plans in the United States.

US commercial health plan coverage dynamics in pulmonary arterial hypertension therapies.

Background: Health plan coverage is central to patient access to care, especially for rare, chronic diseases. For specialty drugs, coverage varies, resulting in barriers to access. Pulmonary arterial hypertension (PAH) is a rare, progressive, and fatal disease.

Commercial coverage of specialty drugs, 2017-2021.

Health plans guide their enrollees' access to specialty drugs through coverage policies. We examined a set of health plan policies to determine if they have become more or less stringent over time. We did so by comparing the consistency of policies with Food and Drug Administration (FDA) label indications.

Variation in Medicaid and commercial coverage of cell and gene therapies.

Growth in the availability of cell and gene therapies (CGTs) promises significant innovation in the treatment of serious diseases, but the high cost and one-time administration of CGTs has also raised concern about strain on health plan budgets and inequity in access. We used coverage information from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database for 18 large commercial health plans in the US and information from state Medicaid websites to examine variation in coverage of 11 CGTs in August 2021. We found that US commercial and Medicaid health plans imposed restrictions in 53.

Cost-Effectiveness of Nadofaragene Firadenovec and Pembrolizumab in Bacillus Calmette-Guérin Immunotherapy Unresponsive Non-Muscle Invasive Bladder Cancer.

Objectives: Nadofaragene firadenovec is a gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) undergoing Food and Drug Administration review. Pembrolizumab is approved for treating patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS). We evaluated the cost-effectiveness of these treatments compared with a hypothetical therapeutic alternative, at a willingness-to-pay threshold of $150 000 per quality-adjusted life-year (QALY) gained, in CIS and non-CIS BCG-unresponsive NMIBC populations.

Oral treatments for outpatient COVID-19: Effectiveness and value.

Ms Beinfeld and Nahn and Drs Whittington, Mohammed, and Pearson report grants from Arnold Ventures, Kaiser Foundation Health Plan Inc., The Patrick and Catherine Weldon Donaghue Medical Research Foundation, Blue Cross Blue Shield of Massachusetts, and The Commonwealth Foundation, during the conduct of the study; and other from America's Health Insurance Plans, Anthem, AbbVie, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Cambia Health Services, CVS, Editas, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, Health Partners, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Premera, Prime Therapeutics, Regeneron, Sanofi, United Healthcare, HealthFirst, Pfizer, Boehringer-Ingelheim, uniQure, Humana, Sun Life, and Envolve Pharmacy Solutions, outside the submitted work. Dr Yeung received a contract from ICER to be an evidence author for COVID-19 outpatient treatments.

Mavacamten for hypertrophic cardiomyopathy: effectiveness and value.

Funding for this summary was contributed by Arnold Ventures, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Sun Life Financial, uniQure, and United Healthcare. Beinfeld, Nhan, Rind, and Pearson are employed by ICER.

Anti B-cell maturation antigen CAR T-cell and antibody drug conjugate therapy for heavily pretreated relapsed and refractory multiple myeloma.

Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Beinfeld, Fluetsch, and Pearson are employed by ICER.

The effectiveness and value of nadofaragene firadenovec, oportuzumab monatox, and pembrolizumab for BCG-unresponsive non-muscle-invasive bladder cancer.

: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Beinfeld, McKenna, Rind, and Pearson are employed by ICER.

Cost-effectiveness of using N-terminal pro-brain natriuretic peptide to guide the diagnostic assessment and management of dyspneic patients in the emergency department.

The cost-effectiveness of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) in dyspneic patients in emergency departments (EDs) is unknown. The objective of this study was to assess the cost-effectiveness of NT-pro-BNP testing for the evaluation and initial management of patients with dyspnea in the ED setting. A decision model was developed to evaluate the cost-effectiveness of diagnostic assessment and patient management guided by NT-pro-BNP, compared with standard clinical assessment.

A cost-effectiveness analysis of a hypothetical catheter-based strategy for the detection and treatment of vulnerable coronary plaques with drug-eluting stents.

Aim: Extensive efforts are underway to develop methods for the detection and treatment of vulnerable/high-risk coronary artery plaques. We utilized decision analysis to evaluate the hypothetical clinical benefits and cost-effectiveness of a catheter-based strategy.

Methods And Results: Currently, stenotic coronary plaques are treated without regard to vulnerability.

Cost-effectiveness analysis in the assessment of diagnostic imaging technologies.

In many ways, diagnostic technologies differ from therapeutic medical technologies. Perhaps most important, diagnostic technologies do not generally directly affect long-term patient outcomes. Instead, the results of diagnostic tests can influence the care of patients; in that way, diagnostic tests may affect long-term outcomes.

Diagnostic imaging costs: are they driving up the costs of hospital care?

Purpose: To retrospectively determine how changes in utilization of computed tomography (CT), magnetic resonance (MR) imaging, and other imaging technologies between 1996 and 2002 influenced costs of inpatient hospital care at one large academic medical center.

Materials And Methods: Institutional review board did not require its approval or patient informed consent for studies with use of billing data. Patient anonymity was protected by removal of potentially identifying information.

Cost-effectiveness of whole-body CT screening.

Purpose: To make preliminary estimates of the effectiveness (in life-years) and cost-effectiveness (in costs per life-year) of whole-body computed tomographic (CT) screening.

Materials And Methods: Costs and effectiveness (in life-years) of onetime whole-body CT screening relative to those of no screening were calculated by using a decision-analytic model. It was assumed that any benefits from screening were due to earlier detection of disease and improvement in survival relative to survival with routine care.

Medicare's national coverage decisions, 1999-2003: quality of evidence and review times.

In 1998 Medicare amended its procedures for making national coverage decisions for new technologies in an attempt to make the process more transparent and evidence based. We examined the quality of evidence for sixty-nine technologies reviewed by Medicare since then. Determinations by the Centers for Medicare and Medicaid Services (CMS) have generally been consistent with the strength of evidence.

Metastatic colorectal carcinoma: cost-effectiveness of percutaneous radiofrequency ablation versus that of hepatic resection.

Purpose: To evaluate the relative cost-effectiveness of radiofrequency (RF) ablation and hepatic resection in patients with metachronous liver metastases from colorectal carcinoma (CRC) and compare the outcomes, cost, and cost-effectiveness of a variety of treatment and follow-up strategies.

Materials And Methods: A state-transition decision model for evaluating the (societal) cost-effectiveness of RF ablation and hepatic resection in patients with CRC liver metastases was developed. The model tracks the presence, number, size, location, growth, detection, and removal of up to 15 individual metastases in each patient.

Reorganizing the system of care surrounding laparoscopic surgery: a cost-effectiveness analysis using discrete-event simulation.

Purpose: To determine the cost-effectiveness of a proposed reorganization of surgical and anesthesia care to balance patient volume and safety.

Methods: Discrete-event simulation methods were used to compare current surgical practice with a new modular system in which patient care is handed off between 2 anesthesiologists. A health care system's perspective, using hospital and professional costs, was chosen for the cost-effectiveness analysis.

Cost-effectiveness of uterine artery embolization and hysterectomy for uterine fibroids.

Purpose: To compare the cost-effectiveness of uterine artery embolization (UAE) with that of hysterectomy for women with symptomatic uterine fibroids.

Materials And Methods: The authors developed a decision model to compare the costs and effectiveness of UAE and hysterectomy. In the model, a cohort of women aged 40 years with a diagnosis of uterine fibroids and no desire for future pregnancy was followed up until menopause.

Cost-effectiveness of hepatic metastasectomy in patients with metastatic colorectal carcinoma: a state-transition Monte Carlo decision analysis.

Objective: To evaluate the cost-effectiveness of hepatic resection ("metastasectomy") in patients with metachronous liver metastases from colorectal carcinoma (CRC), and to investigate the impact of operative and follow-up strategies on outcomes, cost, and cost-effectiveness.

Summary Background Data: There is substantial evidence that resection of CRC liver metastases can result in long-term survival in some patients. However, several unresolved issues are difficult to address using currently available clinical data.

Hospital costs of uterine artery embolization and hysterectomy for uterine fibroid tumors.

Rationale And Objectives: The purpose of this study was to compare the total actual hospital costs of uterine artery embolization (UAE) and hysterectomy for treatment of uterine fibroid tumors and to evaluate factors that might influence cost.

Materials And Methods: Total actual hospital costs were collected from the institution's cost accounting system on patients who underwent UAE (n = 57) or hysterectomy (n = 300) for uterine fibroids between 1998 and 2001. Electronic medical records were reviewed to collect clinical information.

Abdominal aortic aneurysms: cost-effectiveness of elective endovascular and open surgical repair.

Purpose: To evaluate the cost-effectiveness of elective endovascular and open surgical repair of infrarenal abdominal aortic aneurysms (AAAs) by taking into account short- and long-term outcomes.

Materials And Methods: A Markov decision model was developed to evaluate quality-adjusted life-years (QALYs) and lifetime costs of endovascular and open surgical repair. The incremental cost-effectiveness ratio (CER) was calculated for endovascular repair relative to open surgery in a cohort of 70-year-old men with an AAA between 5 and 6 cm in diameter.