Formulary Management Research Articles

A Pilot Study on the Drug Price Revision Strategy in Japan: A Comparison Among Fiscal Years 2018, 2020, and 2022

Objective: Japan has resumed its health technology assessment to decide how to reduce high-cost drug prices. While drug price rules in Japan are comprehensive, they do not necessarily capture differences in product characteristics. This study examined the drug price revision strategy in Japan using migraine treatment with triptans as an example. Cost data from fiscal years (FY) 2018, 2020, and 2022 were utilized. Methods: A cost-utility analysis was conducted from the perspective of healthcare payers, focusing on Japanese patients aged over 18 years experiencing migraines. The study employed a base-case model with probabilities derived from a network meta-analysis. Direct costs included medical and drug costs. Effectiveness was assessed using the European Quality of Life 5-dimensions—3-level questionnaire. Deterministic and probabilistic sensitivity analyses were conducted to examine the level of uncertainty. Results: In FY2018, sumatriptan and eletriptan were cost-effective; however, the other triptans were dominated by sumatriptan. In FY2020, sumatriptan and eletriptan were cost-effective, and rizatriptan was extended-dominated; nevertheless, the other triptans were dominated by sumatriptan. In FY2022, naratriptan and eletriptan were cost-effective; however, the other triptans were dominated by naratriptan. The hierarchy of triptan strategies varied in each fiscal year. Conclusions: This study provides valuable insights into the drug price revision strategy in Japan. The variations could be problematic because in Japan, formulary management of triptans, for example, those for migraine, may face revaluation every other year. Discussions regarding this issue will be further explored in the future.

Oncology stewardship practice in the United States: A Hematology/Oncology Pharmacy Association national survey.

The treatment of cancer is associated with high risk for toxicity and high cost. Strategies to enhance the value, quality, and safety of cancer care are often managed independently of one another. Oncology stewardship is a potential framework to unify these efforts and enhance outcomes. This landscape survey establishes baseline information on oncology stewardship in the United States. The Hematology/Oncology Pharmacy Association (HOPA) distributed a 38-item survey composed of demographic, institutional, clinical decision-making, support staff, metrics, and technology sections to 675 HOPA members between 9 September 2022 and 9 October 2022. Most organizations (78%) have adopted general pharmacy stewardship practices; however, only 31% reported having established a formalized oncology stewardship team. More than 70% of respondents reported implementation of biosimilars, formulary management, and dose rounding as oncology stewardship initiatives in both inpatient and outpatient settings. Frequently cited barriers to oncology stewardship included lack of clinical pharmacist availability (74%), lack of oncology stewardship training (62%), lack of physician/provider buy-in (32%), and lack of cost-saving metrics (33%). Only 6.6% of survey respondents reported their organization had defined "value in oncology." Lack of a formalized stewardship program was most often cited (77%) as the rationale for not defining value. Less than one-third of respondents have established oncology stewardship programs; however, most are providing oncology stewardship practices. This manuscript serves as a call to action for stakeholders to work together to formalize oncology stewardship programs that optimize value, quality, and safety for patients with cancer.

Medication use evaluation of tocilizumab implementation in COVID-19 treatment guidelines: A causal inference approach.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Introduction of new medications to health-system formularies is often not accompanied by assessments of their clinical impact on the local patient population. The growing availability of electronic health record (EHR) data and advancements in pharmacoepidemiology methods offer institutions the opportunity to monitor the medication implementation process and assess clinical effectiveness in the local clinical context. In this study, we applied novel causal inference methods to evaluate the effects of a formulary policy introducing tocilizumab therapy for critically ill patients with coronavirus disease 2019 (COVID-19). We conducted a medication use evaluation utilizing EHR data from patients admitted to a large medical center during the 6 months before and after implementation of a formulary policy endorsing the use of tocilizumab for treatment of COVID-19. The impact of tocilizumab on 28-day all-cause mortality was assessed using a difference-in-differences analysis, with ineligible patients serving as a nonequivalent control group, and a matched analysis guided by a target trial emulation framework. Safety endpoints assessed included the incidence of secondary infections and liver enzyme elevations. Our findings were benchmarked against clinical trials, an observational study, and a meta-analysis. Following guideline modification, tocilizumab was administered to 69% of eligible patients. This implementation was associated with a 3.1% absolute risk reduction in 28-day mortality (odds ratio, 0.86; number needed to treat to prevent one death, 32) attributable to the inclusion of tocilizumab in the guidelines and an additional 8.6% absolute risk reduction (odds ratio, 0.65; number needed to treat to prevent one death, 12) linked to its administration. These findings were consistent with estimates from published literature, although the effect estimates from the difference-in-differences analysis exhibited imprecision. Evaluating formulary management decisions through novel causal inference approaches offers valuable estimates of clinical effectiveness and the potential to optimize the impact of new medications on population outcomes.

A Formulary Management Group Consensus.

A Formulary Management Group Consensus.

Formulary Management of Sodium-Glucose Cotransporter-2 Inhibitors and Glucagon-Like Peptide-1 Receptor Agonists


 Health Canada has approved 4 sodium-glucose cotransporter-2 (SGLT2) inhibitors (ertugliflozin, dapagliflozin, canagliflozin, and empagliflozin) and 5 glucagon-like peptide-1 (GLP-1) receptor agonists (semaglutide, liraglutide, dulaglutide, lixisenatide, and exenatide), with 5 fixed-dose combination products (SGLT2 inhibitors: dapagliflozin-metformin, canagliflozin-metformin, and empagliflozin-metformin; GLP-1 receptor agonists: liraglutide–insulin degludec and lixisenatide–insulin glargine).
 Data protection has ended for all SGLT2 inhibitors in Canada as well as their fixed-dose combinations. Eleven dapagliflozin generics are currently available, and there are several canagliflozin and empagliflozin generics under review at Health Canada. Patent protection has not expired for GLP-1 receptor agonists.
 There is heterogeneity in public drug program reimbursement criteria for each SGLT2 inhibitor and GLP-1 receptor agonist ranging from restricted to unrestricted benefit.
 This Environmental Scan highlights that as SGLT2 inhibitors and GLP-1 receptor agonists have matured, additional indications (heart failure, chronic kidney disease, weight management) have been added to their initial Health Canada–approved indication (type 2 diabetes mellitus). SGLT2 inhibitors are beginning to lose their exclusivity status and are experiencing generic competition.

Medicine formulary writing for hospitals: A systematic review on development, approval, dissemination, and review

Background: A hospital formulary is a guiding manual developed to enhance the rational prescribing of medicines based on the local prevalence of diseases and hospital settings. This systematic review aimed to identify and evaluate the existing literature on hospital formulary development and management to ensure the availability of safe, cost-effective, quality, and efficacious medicines that all practitioners must use. Methods: A qualitative evidence and experience synthesis approach was chosen to create evidence on the development and use of hospital formulary. PubMed was the database used to search for similar reviews using Boolean operators. Results: Out of 1,347 potentially relevant literature and abstracts identified and screened, 25 publications were used in developing the hospital formulary. The hospital formulary should be developed and reviewed after using the current STG/NEMLIT to use updated medicine lists and indications. Medicines selected for the model are “medicines of choice.” The development of hospital formularies should be based on a comprehensive and transparent process that involves a multidisciplinary team of experts, a clear selection criterion, a reliable and updated source of information, and a regular evaluation of the clinical and economic outcomes. Conclusion: Hospital formularies promote the rational, safe use of medicines to improve the quality and efficiency of healthcare.

Revitalizing oncology medications access in Saudi Arabia: Current challenges and recommendations by the Saudi Oncology Pharmacy Assembly.

Cancer care is posing immense challenges to healthcare systems globally. Advances in screening, monitoring, and treating cancer improved patient outcomes and survival rates yet amplified the disease burden. Multiple barriers might impede early access to innovative therapies. We thoroughly examined the current challenges in oncology medication access in Saudi Arabia and provided consensus recommendations to revitalize the process. A focus group discussion was conducted. Expert healthcare providers (pharmacists and physicians) were invited to participate based on prespecified criteria. The research team conducted a qualitative analysis of the discussion to identify themes and formulate recommendations. Fourteen experts were equally distributed into two groups, limiting the number in each group to 7. Pharmacists were 12 (∼86%), and physicians were 2 (∼14%). Ten were practicing in governmental hospitals, four representing different sectors; regulatory bodies, including Ministry of Health, National Unified Procurement Company, and Saudi Food and Drug Authority. Five themes were identified: national cancer burden, local data availability, pharmacoeconomic evaluation, patients reported outcomes, administration, and procurement. Consensus recommendations were formulated to optimize the formulary management process, enabling informed decision-making and facilitating early medication access for cancer patients. The formulary management process can be enhanced by addressing the national cancer burden, promoting local data availability, conducting pharmacoeconomic evaluations, focusing on patient outcomes, and improving administration and procurement procedures. Implementing these recommendations can improve access to oncology medications and improve patient care outcomes in Saudi Arabia.

The Role of Clinical Pharmacists in Antimicrobial Stewardship Programs (ASPs): A Systematic Review.

Antimicrobial resistance (AMR) is a major global health threat, increasing deaths and healthcare costs. Antimicrobial stewardship programs (ASPs) have been implemented to optimize antibiotic use and curb resistance. This systematic review aimed to summarize evidence on the role and impact of pharmacists in hospital ASPs. A comprehensive literature search was conducted across databases to identify relevant studies published from 2016 to 2023. Twenty-four studies met the inclusion criteria, comprising global observational and randomized clinical trials. Pharmacists performed various stewardship activities, including prospective audits, formulary management, de-escalation, guideline development, and education. Pharmacist-led interventions significantly improved antibiotic prescribing, reduced unnecessary antibiotic use, optimized therapy, and enhanced outcomes. Multiple studies found that pharmacist reviews decreased the time to optimal antibiotics and improved guideline compliance without affecting readmissions or revisits. De-escalation programs safely reduced antibiotic duration and length of stay. Acceptance rates for recommendations were high. Pharmacist stewardship curbed overall antibiotic use, costs, and duration across hospital departments, leading to savings. While most studies showed positive impacts, fewer detected significant changes in resistance or mortality over short periods. More research is needed, but current evidence demonstrates that pharmacists play critical roles in ASPs, leading to improved antibiotic use and patient outcomes. These findings support integrating pharmacists into stewardship activities, significantly extending programs to ambulatory settings.

A primer on managed care pharmacy.

This primer defines the practice of managed care pharmacy and introduces key competencies of managed care pharmacy organizations, including pharmacy benefit design and implementation, formulary and medication utilization management, clinical program development and implementation, quality and safety program management, and promotion of affordability.

Dapagliflozin


 The CADTH Formulary Management Expert Committee (FMEC) concluded there was an unmet need to reduce the progression of chronic kidney disease (CKD), especially for those patients without diabetes, given the lack of reimbursed options.
 Evidence from the DAPA-CKD trial, the largest trial with the longest follow-up identified by a systematic review, demonstrated that patients with CKD treated with dapagliflozin had a slower decline of estimated glomerular filtration rate, a reduction in the urinary albumin to creatinine ratio, and increased time to cardiovascular and renal events compared with placebo.
 FMEC concluded that reimbursement should be restricted to patients eligible for the DAPA-CKD trial, which included meeting diagnostic criteria for CKD and treatment with an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker at the maximum-tolerated dose.

Changes In Net Prices And Spending For Pharmaceuticals After The Introduction Of New Therapeutic Competition, 2011-19.

Previous research has demonstrated that the introduction of a new brand-name pharmaceutical competitor does not lower list prices for existing competitive therapies. However, no study has systematically evaluated the impact of new therapeutic competition on net prices of pharmaceutical products. We identified new therapies approved during the period 2013-17 that were competitors for existing treatments. We used a novel peer-reviewed algorithm to estimate the net prices of existing therapies. We implemented regression models to estimate changes in these net prices after the approval of the new therapeutic competition during the period 2011-19. Across twelve therapeutic classes with new drug entrants in 2013-17, the introduction of new therapeutic competition was associated with a 4.2percent decrease in annual net price growth. The introduction of new brand-name therapies in twelve therapeutic classes reduced net commercial spending on existing therapies by $10.4 billion-an 18.5percent reduction in projected spending absent therapeutic competition. Our findings demonstrate that new therapeutic competition allows pharmacy benefit managers to use formulary management to decrease net prices and reduce drug spending, contrary to observed trends in list price increases.

Investigating physicians' views on non-formulary prescribing: a qualitative study using the theoretical domains framework.

Well-designed and well-maintained drug formularies serve as a reliable resource to guide prescribing decisions; they are associated with improved medicine safety and increased efficiency, while also serving as a cost-effective tool to help manage and predict medicine expenditure. Multiple studies have investigated the inappropriate prescribing of non-formulary drugs (NFDs) with statistics indicating that up to 70% of NFD usage being inappropriate or not following the ascribed NFD policies. To explore physicians' views and influences on their prescribing of non-formulary drugs. Data collection and analysis were underpinned using the Theoretical Domains Framework (TDF). Thirteen semi-structured interviews were conducted within Hamad Medical Corporation, the main provider of secondary and tertiary healthcare in Qatar, with physicians who had submitted a NFD request in thepreceding 12months. Three overarching themes were identified: providing evidence-based care for individual patients; influences of others; and formulary management issues. Subthemes were mapped to specific TDF domains: environmental context and resources; social influences; professional role and identity; beliefs about consequences; goals; intentions. The behavioral influences identified in this study can be mapped to behavior change strategies facilitating the development of an intervention to promote appropriate prescribing of NFDs with implications for medicine safety and healthcare efficiency.

Prescription digital therapeutics: Applying Medicaid experience to value assessment and formulary management.

Digital therapeutics (DTx) are a rapidly growing therapeutic category with more than 150 clinical trials evaluating US Food and Drug Administration-regulated DTx to develop additional evidence by the end of 2022. Investments in DTx development have doubled since 2019, reaching $14.7 billion in 2021. Prescription DTx are regulated by the US Food and Drug Administration and require demonstration of efficacy and safety prior to commercialization and reimbursement by payers. Drawing insights from the Massachusetts Medicaid program's early experience with prescription DTx, we provide an overview of this new category of therapeutics and suggest a roadmap for payers and policymakers to evaluate the value of prescription DTx for their member population. Finally, we propose solutions to potential challenges that may be encountered in the DTx coverage and reimbursement management.

HPR33 Impact of Inflation Reduction Act (IRA) on Commercial Plans’ Approach to Managing Drugs

The Inflation Reduction Act (IRA) of 2022 allows the government to negotiate prices of selected drugs covered under Medicare Parts B and D. Such drugs will be subjected to a maximum fair price (MFP), where the manufactures will be levied to discount their drug. As a result, commercial plans are also likely to revisit their formulary management strategy to adapt to the change in Medicare-levied prices. This research aims to describe the potential impact of IRA on pricing and management of drugs under commercial plans in response to IRA.

HPR114 Formulary Management of Biologics in Plaque Psoriasis in Canada

Plaque psoriasis (PsO) biologics can be categorized as old-generation (anti-tumour necrosis factor and anti-interleukin (IL) 12/23 biologics) or new-generation (IL-17 and -23 inhibitors), the latter demonstrating improved efficacy in head-to-head trials. There is also an opportunity cost paid for originator biologics after loss of exclusivity (LoE) given the delayed launches and limited uptake of biosimilars in Canada. The aims of this study were to review the current funding and exclusivity status, comparative evidence, and utilization of PsO biologics, and estimate expenditures on these drugs since LoE in Canada.

Clinical pharmacy services in acute care setting during mass gatherings (Hajj): Insights from a task force

BackgroundHajj is the largest mass gathering worldwide that takes place every year in Makkah, Saudi Arabia. This paper aims to provide a comprehensive guide and expectations for delivering and optimizing clinical pharmacy services during one of the largest mass gatherings in the world, Hajj pilgrimage MethodsA task force initiated and included members of clinical pharmacists who previously participated in delivering clinical pharmacy services during the Hajj pilgrimage, members of the Saudi Society of Clinical Pharmacy (SSCP), and policymakers from different sectors and representatives from pharmaceutical care of the Ministry of Health (MOH). The members established an expert task force to conceptualize and draft the proposed suggestions highlighting the roles and responsibilities of clinical pharmacists during the annual Hajj season. ResultsThe task force determined the following key domains 1) pharmaceutical care (administration and strategic plan, resources, formulary management); 2) pharmacists' activities (clinical pharmacy services and documentation, professional training and development, and staff credentials, and qualifications); 3) challenges and proposed solutions. The task force was divided into groups to draft each domain and provide suggested statements and insights for each section. Finally, the group members of the task force issued 15 opinion statements. ConclusionMass gatherings such as Hajj pilgrimage, represent a unique opportunity to demonstrate the value of pharmacists in advancing health care delivery within a multidisciplinary team. These suggestions and insights could guide the implementation of clinical pharmacy services in acute settings during mass gatherings (Hajj). Future studies should focus on assessing the applicability and the impact of the provided suggestions.

Formulary Management of Biologics in Plaque Psoriasis


 Unlike the new-generation biologics (interleukin [IL]-17 and IL-23 inhibitors), all old-generation biologics (anti–tumour necrosis factor [TNF] and anti–IL-12/23 biologics) for plaque psoriasis (PsO) have now lost their exclusivity status and most were launched prior to the pan-Canadian Pharmaceutical Alliance. In addition, biosimilar versions of the old-generation biologics have had limited uptake and delayed launches in Canada spanning multiple years, suggesting a significant opportunity cost paid for these drugs after loss of exclusivity.
 Modern clinical evidence, which is more rigorous than the evidence supporting the old-generation drugs and includes head-to-head trials comparing IL-17 and IL-23 inhibitors with anti-TNF and anti–IL-12/23 biologics, have demonstrated greater efficacy with the new-generation biologics.
 In Canada, despite access to newer and more efficacious treatments, physicians continue to prescribe old-generation drugs to patients newly initiating a biologic for PsO (25% of patients in 2020), and the new-generation biologics are also less costly on an average per patient basis at list price compared with the most utilized old-generation biologic (ustekinumab).
 Public payers have spent $28 million (at list price) on biologics initiated for PsO beyond their loss of exclusivity from 2016 to 2020 ($600 million for biologics initiated for any indication), and that figure is likely much higher today. Notably, some IL-17 biologics will lose data protection within the next 2 years, which will further increase this opportunity cost.
 It is prudent that decision-makers review the place in therapy of biologics for PsO. Based on the findings of this report, the policy recommendation is to assess the clinical and economic value of old-generation biologics in the context of current evidence standards in PsO. The promotion of the use of new-generation biologics should be considered by payers to support the appropriate use of biologics in PsO, which would improve patient outcomes with budget savings or neutrality (assuming no confidential pricing agreements with the old-generation biologics) versus the status quo.

Formulary Management of Targeted Immune Modulators in Ulcerative Colitis


 Health Canada has approved 7 targeted immune modulators for the treatment of adults with moderate to severe ulcerative colitis, which include 5 biologics (adalimumab, infliximab, golimumab, ustekinumab, and vedolizumab) and 2 small molecules (tofacitinib and ozanimod). Biosimilars for adalimumab and infliximab and generics for tofacitinib are currently available in the Canadian market; however, although their patent protection has expired, there are no biosimilars for golimumab and ustekinumab.
 All targeted immune modulators have undergone pan-Canadian Pharmaceutical Alliance negotiations and concluded with a Letter of Intent except for ustekinumab, which is the only targeted immune modulator not included on any public formularies for ulcerative colitis. Coverage is consistent across all drug plans except for golimumab and tofacitinib, which is not covered by all jurisdictions for ulcerative colitis.
 Most public drug plans have implemented or have announced a biosimilar policy to promote the use of biosimilars over originator biologics. The listing status for targeted immune modulators in ulcerative colitis is similar across public drug plans; however, there is heterogeneity in criteria requirements for prior treatments and diagnosis definitions.
 Considering these factors and the emergence of new data, it would be important to reassess these drugs and evaluate their place in therapy. Further research, such as horizon scanning, utilization analyses, and long-term effectiveness and safety studies, is warranted for targeted immune modulators to ensure the appropriate use of these drugs in the treatment of moderate to severe ulcerative colitis.

Pharmacist biosimilar survey reveals knowledge gaps.

Biosimilars are of increasing significance to pharmacy practice, with the potential to improve patient access to biologic therapies and help reduce overall health care costs. This web-based survey assessed pharmacists' understanding of biosimilars, including interchangeability. WebMD LLC fielded a survey including true or false and Likert-type questions to the Medscape pharmacist and certified pharmacy technician (CPT) panel in March 2021. Those practicing in community, home care or infusion, hospital or health system, managed care, outpatient, or specialty pharmacy settings and currently providing prescription services, or formulary or benefit management related to biologic products were included, to a quota of 500 responses. Results were analyzed descriptively. Data are reported for 507 of 992 respondents (265 did not meet eligibility criteria, 220 responded after the survey closed), including 498 pharmacists and 9 CPTs. These respondents worked in a community setting (66%), outpatient or ambulatory or other setting (16%), hospital or health system setting (14%), or managed care (5%). Overall, 87% and 91% of respondents knew that the biosimilar had equivalent efficacy and safety, respectively, to its reference product. Only 20% understood that a pharmacist can substitute a Food and Drug Administration-approved interchangeable without approval of the prescriber. However, 53% responded that they felt it was appropriate for a pharmacist to dispense an interchangeable in place of its reference product without authorization from the prescriber if consistent with state law; a numerically smaller proportion of community pharmacists understood this concept than the other groups (50% vs. 54%-61%). Only 11% of respondents knew that no biosimilars were designated as interchangeable at the time of the survey, with a numerically greater proportion of managed care pharmacists showing awareness than other groups. Slightly more than 50% of respondents felt that they were moderately or very comfortable in responding to patients' biosimilar questions. Gaps remain in pharmacists' understanding and comfort with key concepts about biosimilar products, including interchangeability, suggesting the need for further education.

Specialty pharmacy turnaround time impediments, facilitators, and good practices.

BACKGROUND: Patients receiving specialty medications have conditions that are often complex, high cost, and high need. Prompt treatment initiation is essential for the appropriate management of many conditions treated by specialty products. Improving the turnaround time (TAT) of specialty pharmacy prescriptions helps ensure patients receive the medication they need in the necessary time frame to optimize health outcomes. Despite a clinical justification for improved TAT, there is a gap in the literature describing what factors impact these times. OBJECTIVE: To determine factors that may influence specialty pharmacy TATs and to identify good practices that specialty pharmacies use to improve TAT. METHODS: This qualitative study used 4 focus groups with specialty pharmacy subject matter experts. Each focus group represented different specialty pharmacy types, including health system, payer-associated, retail chain, and independent specialty pharmacies. Attitudes, beliefs, and experiences regarding specialty pharmacy TAT were captured. Open-ended questions and prompts eliciting impediments, facilitators, and good practices associated with specialty pharmacy TAT were asked of participants. Data were analyzed thematically. RESULTS: Fifteen individuals participated across 4 focus groups: payer-associated (n = 4), independent (n = 3), health system (n = 5), and retail chain (n = 3) specialty pharmacies. Average TATs varied across specialty pharmacy type and by prescription type (clean vs intervention). Several interconnected themes were identified, including barriers with health benefits formulary management, prior authorization delays, differences in requirements between managed care organizations, and miscommunication with physicians, among others. Five subthemes were identified during the discussion of factors influencing TAT, including patient characteristics, pharmacy characteristics, provider characteristics, clinical situations, and health benefit design and formulary considerations. Pharmacy workflow improvements through technology integration are thought to improve TAT. In addition, participants noted facilitators including specialization among pharmacists and technicians in certain diseases, particularly hepatitis C and cancer. Some good practices included using patient financial advocates, technology integration, and a structured patient onboarding process, which were found to minimize delays caused by prior authorization, communication, and formularies. CONCLUSIONS: A multitude of factors impacting specialty pharmacy prescription TAT were identified. Multidisciplinary coordination between pharmacies, physicians, and managed care organizations is essential to ensure patients receive medications in the necessary time frame to optimize health outcomes. DISCLOSURES: This study was conducted with support from Pfizer.