Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658299
Lana Harlan, Katlyn Benskin, C. Gatzke, A. Majors
Abstract Background: Palivizumab is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in high risk pediatric patients. Due to the high cost, handling requirements, administration route, and importance of adherence, palivizumab is best managed by specialty pharmacies able to provide robust clinical services. In collaboration with the health system and surrounding pediatric clinics, a specialty pharmacy management program was established to serve patients receiving palivizumab. Aims: To develop a relationship with local pediatric clinics to provide specialty pharmacy services for patients receiving palivizumab. Methods: The patient medication liaison (PML) completed a query of the internal electronic medical record based on diagnosis code to target high risk infants and newborns meeting approval criteria for palivizumab. Providers were notified and palivizumab was prescribed if warranted. During RSV season, internal referrals were also received from the transition of care team directly from the neonatal intensive care unit. An intake form was created for outside clinic/institutions referring pediatrics meeting criteria. The form included: patient, insurance, prescriber, clinical, and prescription information. The PML initiated contact with the parent/guardian and proceeded with benefits investigation. The PML coordinated refills, clinic visits, and nurse visits. The clinical pharmacist provided education on dosing, administration, side-effects, warnings/precautions, importance of adherence, goals of therapy, and RSV prevention strategies. The outcomes of the project include: number of approved prior authorizations, number of prescription fills for Mizzou Specialty Pharmacy, and the number of patients enrolled in patient assistance. Results: From October 2016 through April 2019, the specialty pharmacy worked with two local pediatric clinics. Two hundred and thirty-nine patients were referred to the pharmacy for benefits investigation; 172 prior authorizations (PAs) were approved: 34 triaged to an outside specialty pharmacy, 129 managed by Mizzou Specialty Pharmacy, 18 chose not to pursue. Finally, 48 PAs were denied and 19 patients were approved for patient assistance. Conclusions: Mizzou Specialty Pharmacy successfully developed relationships with local pediatric clinics to serve their patients receiving palivizumab.
{"title":"Development of a palivizumab specialty pharmacy management program","authors":"Lana Harlan, Katlyn Benskin, C. Gatzke, A. Majors","doi":"10.1080/21556660.2019.1658299","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658299","url":null,"abstract":"Abstract Background: Palivizumab is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in high risk pediatric patients. Due to the high cost, handling requirements, administration route, and importance of adherence, palivizumab is best managed by specialty pharmacies able to provide robust clinical services. In collaboration with the health system and surrounding pediatric clinics, a specialty pharmacy management program was established to serve patients receiving palivizumab. Aims: To develop a relationship with local pediatric clinics to provide specialty pharmacy services for patients receiving palivizumab. Methods: The patient medication liaison (PML) completed a query of the internal electronic medical record based on diagnosis code to target high risk infants and newborns meeting approval criteria for palivizumab. Providers were notified and palivizumab was prescribed if warranted. During RSV season, internal referrals were also received from the transition of care team directly from the neonatal intensive care unit. An intake form was created for outside clinic/institutions referring pediatrics meeting criteria. The form included: patient, insurance, prescriber, clinical, and prescription information. The PML initiated contact with the parent/guardian and proceeded with benefits investigation. The PML coordinated refills, clinic visits, and nurse visits. The clinical pharmacist provided education on dosing, administration, side-effects, warnings/precautions, importance of adherence, goals of therapy, and RSV prevention strategies. The outcomes of the project include: number of approved prior authorizations, number of prescription fills for Mizzou Specialty Pharmacy, and the number of patients enrolled in patient assistance. Results: From October 2016 through April 2019, the specialty pharmacy worked with two local pediatric clinics. Two hundred and thirty-nine patients were referred to the pharmacy for benefits investigation; 172 prior authorizations (PAs) were approved: 34 triaged to an outside specialty pharmacy, 129 managed by Mizzou Specialty Pharmacy, 18 chose not to pursue. Finally, 48 PAs were denied and 19 patients were approved for patient assistance. Conclusions: Mizzou Specialty Pharmacy successfully developed relationships with local pediatric clinics to serve their patients receiving palivizumab.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"21 - 21"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658299","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43840365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658314
T. Platt, Rushabh Shah
Abstract Background: Benchmarking in healthcare is used to evaluate productivity on the basis of workflows, policies and performance in hopes of optimizing current practices and improving patient outcomes. Benchmarking has long been used in pharmacy practice, whether in tracking dispensing activities or optimizing clinical workflows. Internal benchmarking allows organizations to examine internal processes to determine allocation of institutional resources. Currently there is no validated model to evaluate productivity in specialty pharmacy workflows. Aims: To develop and validate a specialty pharmacy productivity benchmarking tool. Methods: A timer tool was developed to allow pharmacists to track the time spent performing activities which we identified as key performance indicators. Key performance indicators were identified as: prior authorizations, appeals of coverage denial, financial assistance activities, clinical onboarding activities, care plan activities and clinical assessments. These times were utilized to establish benchmarks for each key performance indicator. Raw activity number was tracked for each branch utilizing data from specialty management software database, Therigy. From these data, benchmark standards were derived, and all branches were evaluated. Results: Benchmarking standardized to the inflammatory diseases branch showed a near 2.5 fold elevation in workload in the hematology and oncology branch. The pulmonary branch showed a decreased workload compared to inflammatory diseases by approximately 35%. Neurology and infectious diseases within the 20% relative workload range of inflammatory diseases and are considered to have an equal productivity level. Conclusions: Results from this study provide a solid foundation for this benchmarking tool. Moving forward with this model the addition of technician metrics and a broader collection of performance indicators across a larger data collection period will be required to more fully develop the model.
{"title":"Development of a specialty pharmacy productivity benchmarking model","authors":"T. Platt, Rushabh Shah","doi":"10.1080/21556660.2019.1658314","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658314","url":null,"abstract":"Abstract Background: Benchmarking in healthcare is used to evaluate productivity on the basis of workflows, policies and performance in hopes of optimizing current practices and improving patient outcomes. Benchmarking has long been used in pharmacy practice, whether in tracking dispensing activities or optimizing clinical workflows. Internal benchmarking allows organizations to examine internal processes to determine allocation of institutional resources. Currently there is no validated model to evaluate productivity in specialty pharmacy workflows. Aims: To develop and validate a specialty pharmacy productivity benchmarking tool. Methods: A timer tool was developed to allow pharmacists to track the time spent performing activities which we identified as key performance indicators. Key performance indicators were identified as: prior authorizations, appeals of coverage denial, financial assistance activities, clinical onboarding activities, care plan activities and clinical assessments. These times were utilized to establish benchmarks for each key performance indicator. Raw activity number was tracked for each branch utilizing data from specialty management software database, Therigy. From these data, benchmark standards were derived, and all branches were evaluated. Results: Benchmarking standardized to the inflammatory diseases branch showed a near 2.5 fold elevation in workload in the hematology and oncology branch. The pulmonary branch showed a decreased workload compared to inflammatory diseases by approximately 35%. Neurology and infectious diseases within the 20% relative workload range of inflammatory diseases and are considered to have an equal productivity level. Conclusions: Results from this study provide a solid foundation for this benchmarking tool. Moving forward with this model the addition of technician metrics and a broader collection of performance indicators across a larger data collection period will be required to more fully develop the model.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"34 - 34"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658314","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48151039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658324
A. Parenté, Bryce Sutton, A. Petrilla, C. Teigland
Abstract Background: Emerging disease-modifying therapies (DMTs) have evolved as an alternative treatment for patients with multiple sclerosis (MS). The efficacy and safety of established DMTs (interferons, glatiramer acetate, natalizumab, fingolimod and mitoxantrone) have been well studied and clinical trials with small sample sizes have suggested that emerging DMTs (iteriflunomide, dimethyl fumarate/BG-12, alemtuzumab and pegylated IFN) may have distinct advantages relative to established DMTs including better outcomes and reduced healthcare resource utilization. However, there is limited real-world information regarding which DMTs (established vs. emerging) provide the best clinical response and outcomes in managed care populations of patients with MS. Aims: To compare MS related healthcare use within one year of initiating emergent and established DMTs among Managed Medicaid individuals diagnosed with MS in the US. Methods: A large national sample of patient-level administrative healthcare claims data was used for this analysis. MS patients aged 18 years and over with a new prescription fill for an established or emergent DMT between 2013 and 2016 were evaluated. Patients were eligible if they were continuously enrolled in a health plan with pharmacy and medical coverage for at least 6 months before and 1 year after initiation of therapy. Four types of healthcare use were examined: MS-related hospitalizations, emergency room (ER) visits and relapse events (inpatient and outpatient). Multivariate negative binomial models with robust standard errors were used to estimate the association between MS related healthcare use and type of DMT. All models adjusted for age, gender, Charlson index and geographic region. Results: During the study period, 6981 Managed Medicaid individuals with a MS diagnosis initiated a DMT. Of those, 79.8% were female, 50.4% were aged 40–64 years and 21.5% were on emergent DMTs. Emergent DMT users had fewer hospitalizations compared to first generation DMT users within one year of initiating therapy (adjusted risk ratio [ARR] = 0.64, 95% confidence interval [CI]: 0.46–0.88) and fewer outpatient relapses (ARR = 0.86%, CI: 0.79–0.95). Differences in inpatient relapses and ER visits were not observed by DMT type. Conclusions: This study suggests emergent DMTs are associated with reduced MS-related hospitalizations and outpatient relapses within one year of initiating therapy. Studies examining a longer treatment time frame and additional outcomes are warranted to confirm these findings.
{"title":"Comparison of healthcare utilization among managed Medicaid individuals diagnosed with multiple sclerosis treated with emergent versus established disease modifying therapy","authors":"A. Parenté, Bryce Sutton, A. Petrilla, C. Teigland","doi":"10.1080/21556660.2019.1658324","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658324","url":null,"abstract":"Abstract Background: Emerging disease-modifying therapies (DMTs) have evolved as an alternative treatment for patients with multiple sclerosis (MS). The efficacy and safety of established DMTs (interferons, glatiramer acetate, natalizumab, fingolimod and mitoxantrone) have been well studied and clinical trials with small sample sizes have suggested that emerging DMTs (iteriflunomide, dimethyl fumarate/BG-12, alemtuzumab and pegylated IFN) may have distinct advantages relative to established DMTs including better outcomes and reduced healthcare resource utilization. However, there is limited real-world information regarding which DMTs (established vs. emerging) provide the best clinical response and outcomes in managed care populations of patients with MS. Aims: To compare MS related healthcare use within one year of initiating emergent and established DMTs among Managed Medicaid individuals diagnosed with MS in the US. Methods: A large national sample of patient-level administrative healthcare claims data was used for this analysis. MS patients aged 18 years and over with a new prescription fill for an established or emergent DMT between 2013 and 2016 were evaluated. Patients were eligible if they were continuously enrolled in a health plan with pharmacy and medical coverage for at least 6 months before and 1 year after initiation of therapy. Four types of healthcare use were examined: MS-related hospitalizations, emergency room (ER) visits and relapse events (inpatient and outpatient). Multivariate negative binomial models with robust standard errors were used to estimate the association between MS related healthcare use and type of DMT. All models adjusted for age, gender, Charlson index and geographic region. Results: During the study period, 6981 Managed Medicaid individuals with a MS diagnosis initiated a DMT. Of those, 79.8% were female, 50.4% were aged 40–64 years and 21.5% were on emergent DMTs. Emergent DMT users had fewer hospitalizations compared to first generation DMT users within one year of initiating therapy (adjusted risk ratio [ARR] = 0.64, 95% confidence interval [CI]: 0.46–0.88) and fewer outpatient relapses (ARR = 0.86%, CI: 0.79–0.95). Differences in inpatient relapses and ER visits were not observed by DMT type. Conclusions: This study suggests emergent DMTs are associated with reduced MS-related hospitalizations and outpatient relapses within one year of initiating therapy. Studies examining a longer treatment time frame and additional outcomes are warranted to confirm these findings.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"43 - 43"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658324","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48059334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658327
M. McCall, P. Koerner, Richard T. Miller, Melanie Radi
Abstract Background: Hemophilia A is a genetic bleeding disorder caused by a deficiency in factor VIII (FVIII). FVIII maintains bleeding homeostasis within the body through its downstream effects on the intrinsic clotting cascade. The extent of the disease – mild, moderate or severe – depends on the amount of available FVIII in the blood. Patients with severe disease (FVIII levels <1%) experience spontaneous bleeds into the joints or muscles causing pain, inflammation and discomfort. Left untreated, this may lead to long-term complications such as joint damage, chronic pain or joint replacements. Treatment of hemophilia A involves replacing FVIII through either on-demand or prophylactic infusion of antihemophilic FVIII products. On-demand treatment involves infusing the FVIII product at the time of a bleed to stop the event. Prophylactic therapy is the routine replacement of FVIII to prevent bleeds from occurring. The Medical and Scientific Advisory Council recommends the use of a prophylactic regimen, particularly in patients with severe disease, to maintain FVIII levels above 1%. This has been shown to reduce bleeds and joint damage over on-demand treatment, and may have the potential to improve health outcomes. Prophylactic treatment with standard half-life (SHL) rFVIII products are typically infused three to four times a week due to an approximate half-life of 8-12 hours. This can have a great impact on patient quality of life, adherence to therapy and treatment outcomes. Improved technology such as PEGylation and fragment-crystallization (Fc) immunoglobulin protein fusion introduced rFVIII products with a half-life of 1.5 to 1.8 times that of standard therapies. These extended half-life (EHL) rFVIII products maintain FVIII levels similar to SHL rFVIII products with an infusion frequency of once to twice weekly. This may present an opportunity for patients to achieve the clinical benefit of prophylactic treatment without the potential limitations and burden of treatment with SHL rFVIII products. EHL rFVIII products have demonstrated efficacy for prophylactic therapy by reducing bleed rates in patients with hemophilia A, particularly in many clinical trials. However, the benefit of using EHL over SHL rFVIII products for prophylactic therapy has not been universally established, and there is no recommendation for one product over the other. A few studies have indirectly compared EHL and SHL rFVIII products or have looked at patient outcomes and bleed rates after switching from SHL to EHL rFVIII products. Limited studies currently exist that directly compare treatment outcomes between EHL and SHL rFVIII products in a real-world patient population. Aims: The primary objective of this study was to compare annualized bleed rates (ABRs) of hemophilia A patients on prophylactic therapy prescribed either EHL or SHL antihemophilic rFVIII products. Secondary objectives were to compare quality of life outcomes (pain, missed school or work, use of mobilit
{"title":"Comparison of extended to standard half-life recombinant factor VIII therapy in patients with hemophilia A on prophylactic therapy","authors":"M. McCall, P. Koerner, Richard T. Miller, Melanie Radi","doi":"10.1080/21556660.2019.1658327","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658327","url":null,"abstract":"Abstract Background: Hemophilia A is a genetic bleeding disorder caused by a deficiency in factor VIII (FVIII). FVIII maintains bleeding homeostasis within the body through its downstream effects on the intrinsic clotting cascade. The extent of the disease – mild, moderate or severe – depends on the amount of available FVIII in the blood. Patients with severe disease (FVIII levels <1%) experience spontaneous bleeds into the joints or muscles causing pain, inflammation and discomfort. Left untreated, this may lead to long-term complications such as joint damage, chronic pain or joint replacements. Treatment of hemophilia A involves replacing FVIII through either on-demand or prophylactic infusion of antihemophilic FVIII products. On-demand treatment involves infusing the FVIII product at the time of a bleed to stop the event. Prophylactic therapy is the routine replacement of FVIII to prevent bleeds from occurring. The Medical and Scientific Advisory Council recommends the use of a prophylactic regimen, particularly in patients with severe disease, to maintain FVIII levels above 1%. This has been shown to reduce bleeds and joint damage over on-demand treatment, and may have the potential to improve health outcomes. Prophylactic treatment with standard half-life (SHL) rFVIII products are typically infused three to four times a week due to an approximate half-life of 8-12 hours. This can have a great impact on patient quality of life, adherence to therapy and treatment outcomes. Improved technology such as PEGylation and fragment-crystallization (Fc) immunoglobulin protein fusion introduced rFVIII products with a half-life of 1.5 to 1.8 times that of standard therapies. These extended half-life (EHL) rFVIII products maintain FVIII levels similar to SHL rFVIII products with an infusion frequency of once to twice weekly. This may present an opportunity for patients to achieve the clinical benefit of prophylactic treatment without the potential limitations and burden of treatment with SHL rFVIII products. EHL rFVIII products have demonstrated efficacy for prophylactic therapy by reducing bleed rates in patients with hemophilia A, particularly in many clinical trials. However, the benefit of using EHL over SHL rFVIII products for prophylactic therapy has not been universally established, and there is no recommendation for one product over the other. A few studies have indirectly compared EHL and SHL rFVIII products or have looked at patient outcomes and bleed rates after switching from SHL to EHL rFVIII products. Limited studies currently exist that directly compare treatment outcomes between EHL and SHL rFVIII products in a real-world patient population. Aims: The primary objective of this study was to compare annualized bleed rates (ABRs) of hemophilia A patients on prophylactic therapy prescribed either EHL or SHL antihemophilic rFVIII products. Secondary objectives were to compare quality of life outcomes (pain, missed school or work, use of mobilit","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"46 - 47"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658327","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42226554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658301
S. Alford, M. Ng, D. Meade
Abstract Background: Evaluating changes to historical treatment costs is critical for healthcare professionals to make informed business decisions. However, real-world clinical and cost outcome data is challenging to use regularly without significant data science knowledge or resources. Aims: This study sought to demonstrate the potential value in user-friendly analytics tools to identify drivers of costs and outcomes. Methods: The IBM Access and Value Connect solution was used to analyze a patient cohort of metastatic breast cancer (mBC) patients treated in the most recent 12, 36, and 60 months in the IBM MarketScan; Commercial and Medicare Supplement Database. We used the interactive visual explorer tool to quickly (<15 min) determine the mean total per-patient-per-month (PPPM) cost associated with mBC overall and for select side-effects by age group (45–54, 55–64, 65–74, and 75+), and generated histograms for mean total PPPM overall and for leukopenia and neutropenia by age group for each study period. Results: The mean total PPPM across all mBC patients ranged from $6,562 for the 75+ age group at 60 months to $14,201 for the 45–54 age group at 12 months. For those who experienced leukopenia, the mean total PPPM ranged from $10,319 for the 75+ age group at 60 months to $19,598 for the 45–55 age group at 60 months. Similarly, for those who experienced neutropenia, the mean total PPPM ranged from $10,593 for the 65–74 age group at 60 months to $21,784 for the 45–54 age group at 12 months. Conclusions: These methods show that it is possible to make PPPM costs easily available without data science, clinical, or programming knowledge with interactive, visual analytics. The results showed that in general PPPM costs are higher for younger patients overall and among those who experience leukopenia or neutropenia. This is likely due to the practice to aggressively treat younger patients.
{"title":"Cost of leukopenia and neutropenia in metastatic breast cancer within last 12, 36, and 60 months using a curated disease model","authors":"S. Alford, M. Ng, D. Meade","doi":"10.1080/21556660.2019.1658301","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658301","url":null,"abstract":"Abstract Background: Evaluating changes to historical treatment costs is critical for healthcare professionals to make informed business decisions. However, real-world clinical and cost outcome data is challenging to use regularly without significant data science knowledge or resources. Aims: This study sought to demonstrate the potential value in user-friendly analytics tools to identify drivers of costs and outcomes. Methods: The IBM Access and Value Connect solution was used to analyze a patient cohort of metastatic breast cancer (mBC) patients treated in the most recent 12, 36, and 60 months in the IBM MarketScan; Commercial and Medicare Supplement Database. We used the interactive visual explorer tool to quickly (<15 min) determine the mean total per-patient-per-month (PPPM) cost associated with mBC overall and for select side-effects by age group (45–54, 55–64, 65–74, and 75+), and generated histograms for mean total PPPM overall and for leukopenia and neutropenia by age group for each study period. Results: The mean total PPPM across all mBC patients ranged from $6,562 for the 75+ age group at 60 months to $14,201 for the 45–54 age group at 12 months. For those who experienced leukopenia, the mean total PPPM ranged from $10,319 for the 75+ age group at 60 months to $19,598 for the 45–55 age group at 60 months. Similarly, for those who experienced neutropenia, the mean total PPPM ranged from $10,593 for the 65–74 age group at 60 months to $21,784 for the 45–54 age group at 12 months. Conclusions: These methods show that it is possible to make PPPM costs easily available without data science, clinical, or programming knowledge with interactive, visual analytics. The results showed that in general PPPM costs are higher for younger patients overall and among those who experience leukopenia or neutropenia. This is likely due to the practice to aggressively treat younger patients.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"23 - 23"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658301","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41559308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658330
R. Brook, M. Sax, J. A. Carlisle, J. Smeeding
Abstract Background: Cancer care is shifting from chemotherapy to more effective targeted immunotherapies. New therapies, some existing therapies with expanded indications (including maintenance) and many therapies with price increases require re-evaluation. Many agents are handled through specialty pharmacies (SPs). Aims: The onslaught of newer oncology therapies have increased economic concerns. Coinsurance and benefit limitations can leave patients “financially toxic” but produce outcomes that justify coverage. Efforts utilizing immuno-oncology (chimeric antigen receptor [CAR]-T therapy and tumor-agnostic treatments) directed at molecular signatures are revolutionizing chemotherapy. There are ≥165 CAR-T therapies in trials, three marketed tumor-agnostic drugs used in combination with other oncology agents. The objective was to determine oncology areas of most concern to managed care plans. Methods: An online survey invitation was sent to officers of US healthplans and PBMs covering: officer and plan information, cancer ranking (lowest = 1 to 13 = highest), copays, benefit design, cancer management, and concerns today and in 5 years from budgetary and medical points of view (POVs). The results were compared with prior surveys. Results: Eighty-five respondents completed the survey. Respondents served on a variety of committees from plans covering multiple member types including Commercial FFS = 41%, Medicaid = 70%, IDN = 57%, HMO/PPO = 22% and Employer self-funded = 22%. Oncology was the third highest ranked SP – condition covered 85.3%↑3.5% and 51.2% of respondents reported they participated in oncology accountable care/disease management organizations; 88.5% covered oncology genomic tests; 13.8% used value-based contracting for oncology. The cancers most concerning were: lung = 11.1, breast = 10.8, colon and rectal = 9.7, prostate = 8, melanoma = 7.6, leukemia = 7.4, myeloma = 7.4, non-Hodgkin’s lymphoma (NHL) = 7.3, pancreatic = 5.7, kidney = 5.1, endometrial = 4.9, bladder = 4.7 and thyroid = 2.9. Cancer management is: 61.2%↓7.7% sometimes leave specialists alone, always follow NCCN guidelines 67.4%↑ 6%, sometimes follow other guidelines or pathways 81.3% and 53.1% sometimes follow internal protocols. Oncology outranked other newer expensive therapies as a financial concern – combination oncology therapy was ranked first = 68%, CAR-T second 35.3%. Cancer was consistently a top concern from medical care (47.2% today, 50% in 5 years) and budgetary (50% today, 60.9% in 5 years) POVs. Conclusions: Improvements in oncology agents and the growth of immuno-oncology have implications that require plans to focus on benefit design, adopt newer agents and utilize pathways.
{"title":"United States health plan cancer concerns in 2019","authors":"R. Brook, M. Sax, J. A. Carlisle, J. Smeeding","doi":"10.1080/21556660.2019.1658330","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658330","url":null,"abstract":"Abstract Background: Cancer care is shifting from chemotherapy to more effective targeted immunotherapies. New therapies, some existing therapies with expanded indications (including maintenance) and many therapies with price increases require re-evaluation. Many agents are handled through specialty pharmacies (SPs). Aims: The onslaught of newer oncology therapies have increased economic concerns. Coinsurance and benefit limitations can leave patients “financially toxic” but produce outcomes that justify coverage. Efforts utilizing immuno-oncology (chimeric antigen receptor [CAR]-T therapy and tumor-agnostic treatments) directed at molecular signatures are revolutionizing chemotherapy. There are ≥165 CAR-T therapies in trials, three marketed tumor-agnostic drugs used in combination with other oncology agents. The objective was to determine oncology areas of most concern to managed care plans. Methods: An online survey invitation was sent to officers of US healthplans and PBMs covering: officer and plan information, cancer ranking (lowest = 1 to 13 = highest), copays, benefit design, cancer management, and concerns today and in 5 years from budgetary and medical points of view (POVs). The results were compared with prior surveys. Results: Eighty-five respondents completed the survey. Respondents served on a variety of committees from plans covering multiple member types including Commercial FFS = 41%, Medicaid = 70%, IDN = 57%, HMO/PPO = 22% and Employer self-funded = 22%. Oncology was the third highest ranked SP – condition covered 85.3%↑3.5% and 51.2% of respondents reported they participated in oncology accountable care/disease management organizations; 88.5% covered oncology genomic tests; 13.8% used value-based contracting for oncology. The cancers most concerning were: lung = 11.1, breast = 10.8, colon and rectal = 9.7, prostate = 8, melanoma = 7.6, leukemia = 7.4, myeloma = 7.4, non-Hodgkin’s lymphoma (NHL) = 7.3, pancreatic = 5.7, kidney = 5.1, endometrial = 4.9, bladder = 4.7 and thyroid = 2.9. Cancer management is: 61.2%↓7.7% sometimes leave specialists alone, always follow NCCN guidelines 67.4%↑ 6%, sometimes follow other guidelines or pathways 81.3% and 53.1% sometimes follow internal protocols. Oncology outranked other newer expensive therapies as a financial concern – combination oncology therapy was ranked first = 68%, CAR-T second 35.3%. Cancer was consistently a top concern from medical care (47.2% today, 50% in 5 years) and budgetary (50% today, 60.9% in 5 years) POVs. Conclusions: Improvements in oncology agents and the growth of immuno-oncology have implications that require plans to focus on benefit design, adopt newer agents and utilize pathways.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"8 - 8"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658330","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48281888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658306
Nanxin Li, E. Sawyer, K. Maruszczyk, M. Slomka, T. Burke, A. Martin, J. O’Hara
Abstract Background: Hemophilia B (HB) is a rare disease caused by congenital Factor IX (FIX) deficiency. HB requires life-long management to prevent or manage bleeding and associated morbidity. Although HB affects only a small portion of the population, it is associated with high overall cost and imposes a significant financial burden on individuals, payers, and society in general. Due to variation in patient clinical characteristics and treatment choice, cost and healthcare resource utilization associated with disease management can vary significantly from patient to patient. Aims: To review published direct costs and healthcare resource utilization associated with the management of HB in the US. Methods: A systematic literature review was conducted by searching electronic databases (e.g. MEDLINE, Tufts CEA registry) to identify full-text studies (March 2009–March 2019). Additionally, a manual search for abstracts from relevant conferences was performed (from 2016). Studies were included in the review using pre-defined inclusion/exclusion criteria for population, study type, language (English), and location (US). Publications consisting of budget impact analysis, cost, burden of disease, healthcare resource utilization, and economics evaluations were included. Results: Of 693 titles and abstracts screened, a total of 17 studies evaluating cost and resource utilization in patients with HB in the US were included. Data sources for these studies included: medical records (n = 5), insurance claims databases (n = 10), and surveys (n = 2). Reported cost and resource use varied across studies depending on severity of the disease, treatment regimen, and product type: extended (EHL) or standard half-life (SHL). The cost of FIX replacement therapy constitutes the majority of costs in HB management. Among patients with severe or moderate HB, reported mean annual cost of FIX ranged from $187,070 to $925,864 with an average of $560,801. Annual cost of EHLs could exceed more than twice the cost of SHLs. For example, mean annual cost of EHL FIX was $921,291 vs $478,096 for SHL FIX. Rates of healthcare resource utilization were also substantial for patients with HB and include hospitalizations, emergency room visits, and physician visits. Conclusions: This systematic literature review found significant economic burden associated with HB in the US. The substantial costs and health resources utilized by patients highlight unmet needs remaining in HB.
{"title":"Economic burden of hemophilia B in the US: a systematic literature review","authors":"Nanxin Li, E. Sawyer, K. Maruszczyk, M. Slomka, T. Burke, A. Martin, J. O’Hara","doi":"10.1080/21556660.2019.1658306","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658306","url":null,"abstract":"Abstract Background: Hemophilia B (HB) is a rare disease caused by congenital Factor IX (FIX) deficiency. HB requires life-long management to prevent or manage bleeding and associated morbidity. Although HB affects only a small portion of the population, it is associated with high overall cost and imposes a significant financial burden on individuals, payers, and society in general. Due to variation in patient clinical characteristics and treatment choice, cost and healthcare resource utilization associated with disease management can vary significantly from patient to patient. Aims: To review published direct costs and healthcare resource utilization associated with the management of HB in the US. Methods: A systematic literature review was conducted by searching electronic databases (e.g. MEDLINE, Tufts CEA registry) to identify full-text studies (March 2009–March 2019). Additionally, a manual search for abstracts from relevant conferences was performed (from 2016). Studies were included in the review using pre-defined inclusion/exclusion criteria for population, study type, language (English), and location (US). Publications consisting of budget impact analysis, cost, burden of disease, healthcare resource utilization, and economics evaluations were included. Results: Of 693 titles and abstracts screened, a total of 17 studies evaluating cost and resource utilization in patients with HB in the US were included. Data sources for these studies included: medical records (n = 5), insurance claims databases (n = 10), and surveys (n = 2). Reported cost and resource use varied across studies depending on severity of the disease, treatment regimen, and product type: extended (EHL) or standard half-life (SHL). The cost of FIX replacement therapy constitutes the majority of costs in HB management. Among patients with severe or moderate HB, reported mean annual cost of FIX ranged from $187,070 to $925,864 with an average of $560,801. Annual cost of EHLs could exceed more than twice the cost of SHLs. For example, mean annual cost of EHL FIX was $921,291 vs $478,096 for SHL FIX. Rates of healthcare resource utilization were also substantial for patients with HB and include hospitalizations, emergency room visits, and physician visits. Conclusions: This systematic literature review found significant economic burden associated with HB in the US. The substantial costs and health resources utilized by patients highlight unmet needs remaining in HB.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"28 - 28"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658306","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48480993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658318
Wendy Sun, R. Reeve, Timothy Ouellette, Martha Stutsky, Rachel De Jesus, Michael J Huffer, S. Mougalian
Abstract Background: Non-adherence is an important issue in cancer care as more oral cytotoxic and targeted agents become available. Although oral therapies may be more convenient for patients, measuring and optimizing adherence is challenging. The Nomi system records real-time medication taking behavior from a “smart” prescription bottle and displays the data on a web-based interface. Nomi can also communicate with patients via text message to intervene in cases of non-adherence. Aims: The objective is to report the results of a 28-patient pilot study aiming to assess Nomi’s ability to assist patients taking capecitabine, an oral chemotherapy agent with a complex, cyclical regimen. Methods: Eligible patients were prescribed capecitabine for breast, colorectal, pancreatic, or biliary cancer. The study had a pre-intervention stage, during which patients were monitored, and an intervention stage, in which the text messaging feature was enabled. Adherence was defined as the number of correct doses (both timing and quantity) over the total number of prescribed doses. Conversions were events in which patients took a dose after receiving a text intervention (from Nomi). Adherence throughout the study was calculated from the data that the bottles collected – we calculated adherence scores for each patient, during each cycle and study period (pre vs. post-intervention), defined as the number of correct doses (both timing and quantity) over the total number of prescribed doses. We defined three categories of patients by percent change in adherence: category 1 (>8%), category 2 (−8% to 8%), and category 3 (< −8%). Results: We collected data from 28 patients (24 pre/post and 4 pre-only). On average, patients were 84% adherent (N = 28; SD = 11%). During pre-intervention, patients had a self-adherence of 89% (SD = 12%), and afterwards, they had an average adherence of 90% (SD = 6%). Most of the patients in category 1 demonstrated a substantial conversion rate (> 35%). Patients in category 1 tended to live in regions with lower average household income (Mean = $58,937) than those in category 2 (Mean = $77,482) and category 3 (Mean = $90,972). Of survey respondents, 56% indicated that they would want to continue using Nomi, while 67% indicated that they would recommend it to others Conclusions: This innovative technology is able to monitor, measure and intervene for patients taking capecitabine in real-time. Adherence overall was high, and some patients appeared to benefit more from text message interventions. Future work should focus on patients deemed high risk for non-adherence.
{"title":"A novel tool to monitor adherence to oral oncolytics: a pilot study","authors":"Wendy Sun, R. Reeve, Timothy Ouellette, Martha Stutsky, Rachel De Jesus, Michael J Huffer, S. Mougalian","doi":"10.1080/21556660.2019.1658318","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658318","url":null,"abstract":"Abstract Background: Non-adherence is an important issue in cancer care as more oral cytotoxic and targeted agents become available. Although oral therapies may be more convenient for patients, measuring and optimizing adherence is challenging. The Nomi system records real-time medication taking behavior from a “smart” prescription bottle and displays the data on a web-based interface. Nomi can also communicate with patients via text message to intervene in cases of non-adherence. Aims: The objective is to report the results of a 28-patient pilot study aiming to assess Nomi’s ability to assist patients taking capecitabine, an oral chemotherapy agent with a complex, cyclical regimen. Methods: Eligible patients were prescribed capecitabine for breast, colorectal, pancreatic, or biliary cancer. The study had a pre-intervention stage, during which patients were monitored, and an intervention stage, in which the text messaging feature was enabled. Adherence was defined as the number of correct doses (both timing and quantity) over the total number of prescribed doses. Conversions were events in which patients took a dose after receiving a text intervention (from Nomi). Adherence throughout the study was calculated from the data that the bottles collected – we calculated adherence scores for each patient, during each cycle and study period (pre vs. post-intervention), defined as the number of correct doses (both timing and quantity) over the total number of prescribed doses. We defined three categories of patients by percent change in adherence: category 1 (>8%), category 2 (−8% to 8%), and category 3 (< −8%). Results: We collected data from 28 patients (24 pre/post and 4 pre-only). On average, patients were 84% adherent (N = 28; SD = 11%). During pre-intervention, patients had a self-adherence of 89% (SD = 12%), and afterwards, they had an average adherence of 90% (SD = 6%). Most of the patients in category 1 demonstrated a substantial conversion rate (> 35%). Patients in category 1 tended to live in regions with lower average household income (Mean = $58,937) than those in category 2 (Mean = $77,482) and category 3 (Mean = $90,972). Of survey respondents, 56% indicated that they would want to continue using Nomi, while 67% indicated that they would recommend it to others Conclusions: This innovative technology is able to monitor, measure and intervene for patients taking capecitabine in real-time. Adherence overall was high, and some patients appeared to benefit more from text message interventions. Future work should focus on patients deemed high risk for non-adherence.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"38 - 38"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658318","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46835028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658286
R. Brook, Sheila Arquette
{"title":"The National Association of Specialty Pharmacy Abstract Program","authors":"R. Brook, Sheila Arquette","doi":"10.1080/21556660.2019.1658286","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658286","url":null,"abstract":"","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"1 - 1"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658286","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47257167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658317
A. Stewart, R. Wells, Jennifer Young, L. Strauss, Starla M. Wise, Laura Granetzke, Sandhya Kumar, J. Speiser, A. Guzik, N. O’Connell
Abstract Background: The new calcitonin gene-related peptide (CGRP) medications offer an exciting alternative to daily preventative migraine treatments. Finding effective and efficient ways to educate patients can be challenging for providers and pharmacists alike given the treatments are subcutaneous injections with extended half-lives and data is limited on long-term efficacy and adverse effects. Aims: We aimed to develop and evaluate a patient-oriented, multidisciplinary presentation to inform patients about the new CGRP drug class to decrease provider and pharmacist education burden while increasing patient understanding. Methods: Three live, one-hour CGRP informational sessions were conducted jointly by a headache medicine neurologist and clinical pharmacist from the institution’s specialty pharmacy. Prior to medication initiation, patients were educated about CGRP pathophysiology, benefits, risks, injection technique, and logistics of cost and medication access. The third presentation was video recorded and transitioned to an online platform. Participants completed surveys before and after watching the in-person or online session. Patients had the ability to fill these self-injectable therapies at the institution’s specialty pharmacy, who assisted with benefits investigation and prior authorization. If within payor network, the patient was offered specialty pharmacy services. Results: A total of 84 patients participated in the session (41 in-person; 43 online). Patients had frequent headaches (mean = 18/month; SD = 9.2) with severe (MIDAS >21) headache-related disability (mean MIDAS score = 63.1). Participants reporting confidence in understanding CGRP significantly increased from 68% to 97% following the informational session (p < .001) for those completing both the pre- and post-survey question (n = 69). There was also a significant increase from 84% to 97% in participants reporting comfort with injection technique (p = .008, n = 70). For both measures, there was no statistically significant difference between the in-person and online sessions. Nearly all participants (97%) would recommend the session to family or friends with migraine. Conclusions: The multidisciplinary informational session was an effective and efficient method of educating patients about these new treatments while concurrently decreasing provider and pharmacist education burden. The online video was as effective as the in-person session in educating patients, but improved access and availability.
{"title":"Impact of multidisciplinary patient education sessions on expectations and understanding of new calcitonin gene-related peptide treatments","authors":"A. Stewart, R. Wells, Jennifer Young, L. Strauss, Starla M. Wise, Laura Granetzke, Sandhya Kumar, J. Speiser, A. Guzik, N. O’Connell","doi":"10.1080/21556660.2019.1658317","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658317","url":null,"abstract":"Abstract Background: The new calcitonin gene-related peptide (CGRP) medications offer an exciting alternative to daily preventative migraine treatments. Finding effective and efficient ways to educate patients can be challenging for providers and pharmacists alike given the treatments are subcutaneous injections with extended half-lives and data is limited on long-term efficacy and adverse effects. Aims: We aimed to develop and evaluate a patient-oriented, multidisciplinary presentation to inform patients about the new CGRP drug class to decrease provider and pharmacist education burden while increasing patient understanding. Methods: Three live, one-hour CGRP informational sessions were conducted jointly by a headache medicine neurologist and clinical pharmacist from the institution’s specialty pharmacy. Prior to medication initiation, patients were educated about CGRP pathophysiology, benefits, risks, injection technique, and logistics of cost and medication access. The third presentation was video recorded and transitioned to an online platform. Participants completed surveys before and after watching the in-person or online session. Patients had the ability to fill these self-injectable therapies at the institution’s specialty pharmacy, who assisted with benefits investigation and prior authorization. If within payor network, the patient was offered specialty pharmacy services. Results: A total of 84 patients participated in the session (41 in-person; 43 online). Patients had frequent headaches (mean = 18/month; SD = 9.2) with severe (MIDAS >21) headache-related disability (mean MIDAS score = 63.1). Participants reporting confidence in understanding CGRP significantly increased from 68% to 97% following the informational session (p < .001) for those completing both the pre- and post-survey question (n = 69). There was also a significant increase from 84% to 97% in participants reporting comfort with injection technique (p = .008, n = 70). For both measures, there was no statistically significant difference between the in-person and online sessions. Nearly all participants (97%) would recommend the session to family or friends with migraine. Conclusions: The multidisciplinary informational session was an effective and efficient method of educating patients about these new treatments while concurrently decreasing provider and pharmacist education burden. The online video was as effective as the in-person session in educating patients, but improved access and availability.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"37 - 37"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658317","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41475553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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