Pub Date : 2019-09-03DOI: 10.1080/21556660.2019.1658291
Rachel Chelewski, K. Johnson, A. Zuckerman, Joshua DeClercq, Leena Choi, Megan E. Peter, A. Langone
Abstract Background: Post-transplant patients require complex medication regimens to ensure the survival of the transplanted organ and patient overall well-being. These regimens are frequently adjusted, initiated, or discontinued after transplantation. Pharmacist (PharmD) expertise can be utilized to optimize post-transplant medication use. Aims: This study describes the creation and corresponding outcomes of a Collaborative Pharmacy Practice Agreements (CPPA) between PharmDs and physicians within a renal transplant clinic. Methods: After the Tennessee (TN) Pharmacist Association and TN Medical Association finalized legislation approving CPPAs for licensed PharmDs in TN (effective July 1, 2014), the Vanderbilt Renal Transplant Clinic and integrated health system pharmacy (IHSP) developed a CPPA, which was approved by the Vanderbilt University Medical Center (VUMC) Pharmaceutical, Diagnostics, and Therapeutics Committee and VUMC Medical Board. To evaluate the outcomes of the CPPA, we assessed the type of authorizer for immunosuppressant (IS) prescriptions (nurse, physician, or PharmD; measured as % of IS prescriptions) and the volume of IS prescriptions across three 7-month intervals: 1) before PharmD clinic integration (11/1/14–5/31/15), 2) with PharmD integration without a CPPA (12/1/15–6/30/16), and 3) with PharmD integration and a CPPA (4/1/17–10/31/17). Adult patients with at least one IS prescription generated in each time interval were included. Frequency of safety concerns and staffing requirements resulting from the CPPA were collected. Finally, we assessed the total volume of prescriptions filled by the IHSP. Results: Following PharmD prescription management under a CPPA, physician and nurse refill workload for IS prescriptions reduced from 42.7% and 57.3% to 8.7% and 5.9%, respectively. Overall prescription generation to the IHSP increased from 13,523 prior to PharmD integration to 45,320 after integration with a CPPA. No safety concerns were reported in any of seven quarterly reviews, and the IHSP has grown from a team of eight in 2015 to 23 team members in 2018. Conclusions: After implementing a CPPA, more IS and non-IS prescriptions were generated by pharmacists, which reduced physician and nurse burden and allowed pharmacy staff growth. Pharmacists in collaborative practice agreements are uniquely suited to closely monitor patients’ post-transplant medication regimens, ensuring safety and effectiveness of therapy.
{"title":"Development of a collaborative pharmacy practice agreement to improve efficiency and management of prescribing in a renal transplant clinic","authors":"Rachel Chelewski, K. Johnson, A. Zuckerman, Joshua DeClercq, Leena Choi, Megan E. Peter, A. Langone","doi":"10.1080/21556660.2019.1658291","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658291","url":null,"abstract":"Abstract Background: Post-transplant patients require complex medication regimens to ensure the survival of the transplanted organ and patient overall well-being. These regimens are frequently adjusted, initiated, or discontinued after transplantation. Pharmacist (PharmD) expertise can be utilized to optimize post-transplant medication use. Aims: This study describes the creation and corresponding outcomes of a Collaborative Pharmacy Practice Agreements (CPPA) between PharmDs and physicians within a renal transplant clinic. Methods: After the Tennessee (TN) Pharmacist Association and TN Medical Association finalized legislation approving CPPAs for licensed PharmDs in TN (effective July 1, 2014), the Vanderbilt Renal Transplant Clinic and integrated health system pharmacy (IHSP) developed a CPPA, which was approved by the Vanderbilt University Medical Center (VUMC) Pharmaceutical, Diagnostics, and Therapeutics Committee and VUMC Medical Board. To evaluate the outcomes of the CPPA, we assessed the type of authorizer for immunosuppressant (IS) prescriptions (nurse, physician, or PharmD; measured as % of IS prescriptions) and the volume of IS prescriptions across three 7-month intervals: 1) before PharmD clinic integration (11/1/14–5/31/15), 2) with PharmD integration without a CPPA (12/1/15–6/30/16), and 3) with PharmD integration and a CPPA (4/1/17–10/31/17). Adult patients with at least one IS prescription generated in each time interval were included. Frequency of safety concerns and staffing requirements resulting from the CPPA were collected. Finally, we assessed the total volume of prescriptions filled by the IHSP. Results: Following PharmD prescription management under a CPPA, physician and nurse refill workload for IS prescriptions reduced from 42.7% and 57.3% to 8.7% and 5.9%, respectively. Overall prescription generation to the IHSP increased from 13,523 prior to PharmD integration to 45,320 after integration with a CPPA. No safety concerns were reported in any of seven quarterly reviews, and the IHSP has grown from a team of eight in 2015 to 23 team members in 2018. Conclusions: After implementing a CPPA, more IS and non-IS prescriptions were generated by pharmacists, which reduced physician and nurse burden and allowed pharmacy staff growth. Pharmacists in collaborative practice agreements are uniquely suited to closely monitor patients’ post-transplant medication regimens, ensuring safety and effectiveness of therapy.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"14 - 14"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658291","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43945049","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: 10.1080/21556660.2019.1658313
S. Ness, Ron Lucas
Abstract Background: Many specialty drugs have lost patent exclusivity and more specialty generics (SGs) are expected in the future. Payers continue to look for ways to manage health care costs in the specialty pharmacy space and SG products offer the opportunity for savings. Given increasing interest in SGs, manufacturers are expected to invest more than $100 billion in the development of SGs over the next five years. To remain competitive, pharmacies must have access to SG products and access to competitive pricing for SGs, which can be obtained by accessing pharmaceutical manufacturer agreements through MHA Specialty Pharmacy Solutions. Aims: Understand purchase patterns of newly launched SGs and see if increased access to product was facilitated by the entrance of a SG. Methods: To determine purchase patterns of newly launched SGs, the rate of change of both the brand and generic products were measured for five specialty drugs across MHA pharmacy members. When possible, the brand rate was measured by the units of brand product purchased the quarter prior to the generic launch compared to the number of units in first quarter 2019 (1Q19). The generic product rate was measured by the units of generic product in the quarter it launched compared to units in 1Q19. To detect changes in product access to SGs, the number of corporations dispensing the brand was measured in the quarter prior to the generic launch compared with the number of corporations dispensing the generic in 1Q19. Results: Brand imatinib (Gleevec1) number of units decreased 80% while generic imatinib units grew by 134%. The number of corporations dispensing generic imatinib increased 34%. Brand hydroxyprogesterone caproate (OHPC) (Makena2) number of units decreased 67% while generic OHPC units grew by 641%. The number of corporations dispensing generic OHPC increased 38%. Brand abiraterone acetate (Zytiga3) number of units decreased 63% while generic abiraterone units grew by 289%. The number of corporations dispensing generic abiraterone increased 60%. Brand tetrabenazine (Xenazine4) and brand dalfampridine ER (Ampyra5) could not be measured due to limited distribution. Generic tetrabenazine units increased 2967% and the number of corporations dispensing increased 2114%. Generic dalfampridine ER units increased 1451% and the number of corporations dispensing increased 463%. Conclusions: Pharmacies purchasing through MHA Specialty Pharmacy Solutions are able to expand their access to products and quickly adopt SGs in order to grow their businesses and serve patients.
{"title":"Understanding purchasing patterns and product access of newly launched specialty generics","authors":"S. Ness, Ron Lucas","doi":"10.1080/21556660.2019.1658313","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658313","url":null,"abstract":"Abstract Background: Many specialty drugs have lost patent exclusivity and more specialty generics (SGs) are expected in the future. Payers continue to look for ways to manage health care costs in the specialty pharmacy space and SG products offer the opportunity for savings. Given increasing interest in SGs, manufacturers are expected to invest more than $100 billion in the development of SGs over the next five years. To remain competitive, pharmacies must have access to SG products and access to competitive pricing for SGs, which can be obtained by accessing pharmaceutical manufacturer agreements through MHA Specialty Pharmacy Solutions. Aims: Understand purchase patterns of newly launched SGs and see if increased access to product was facilitated by the entrance of a SG. Methods: To determine purchase patterns of newly launched SGs, the rate of change of both the brand and generic products were measured for five specialty drugs across MHA pharmacy members. When possible, the brand rate was measured by the units of brand product purchased the quarter prior to the generic launch compared to the number of units in first quarter 2019 (1Q19). The generic product rate was measured by the units of generic product in the quarter it launched compared to units in 1Q19. To detect changes in product access to SGs, the number of corporations dispensing the brand was measured in the quarter prior to the generic launch compared with the number of corporations dispensing the generic in 1Q19. Results: Brand imatinib (Gleevec1) number of units decreased 80% while generic imatinib units grew by 134%. The number of corporations dispensing generic imatinib increased 34%. Brand hydroxyprogesterone caproate (OHPC) (Makena2) number of units decreased 67% while generic OHPC units grew by 641%. The number of corporations dispensing generic OHPC increased 38%. Brand abiraterone acetate (Zytiga3) number of units decreased 63% while generic abiraterone units grew by 289%. The number of corporations dispensing generic abiraterone increased 60%. Brand tetrabenazine (Xenazine4) and brand dalfampridine ER (Ampyra5) could not be measured due to limited distribution. Generic tetrabenazine units increased 2967% and the number of corporations dispensing increased 2114%. Generic dalfampridine ER units increased 1451% and the number of corporations dispensing increased 463%. Conclusions: Pharmacies purchasing through MHA Specialty Pharmacy Solutions are able to expand their access to products and quickly adopt SGs in order to grow their businesses and serve patients.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"33 - 33"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658313","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47335217","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: 10.1080/21556660.2019.1658323
D. Levy, J. Chiao, J. Dang, C. Hood, D. Supina, H. Feuersenger
Abstract Background: Hereditary angioedema (HAE) is characterized by recurrent, debilitating attacks of angioedema that may require immediate (on-demand) treatment. HAE prophylactic therapy may reduce the need for on-demand treatment by decreasing the frequency and severity of attacks, which may in turn impact treatment costs. Subcutaneous C1-inhibitor (C1-INH [SC], HAEGARDA®, CSL Behring) at the FDA-approved dose of 60 IU/kg is indicated as routine prophylaxis to prevent attacks in patients with HAE. In the pivotal phase III COMPACT trial, the median reduction in attack rate relative to placebo was 95% with twice-weekly C1-INH (SC) 60 IU/kg, and the median reduction in on-demand medication use was >99%. Aims: We examined patterns of on-demand medication use in patients treated with C1-INH (SC) 60 IU/kg in a long-term, open-label extension (OLE) of the COMPACT trial. Methods: The OLE of the COMPACT trial was a multicenter, international, randomized, parallel-arm study that evaluated patients aged ≥6 years with ≥4 attacks over 2 consecutive months before enrollment. The trial included patients from the COMPACT trial and C1-INH (SC)-naïve patients. Patients were randomized to receive C1-INH (SC) 40 IU/kg or 60 IU/kg twice weekly for 52 weeks or up to 140 weeks (US patients only). The time-normalized number of uses of medication for treatment of HAE attacks was an exploratory endpoint. Results: Of the 63 patients in the 60 IU/kg group, 35 had a total of 371 attacks, of which 229 (61.7%) were treated with on-demand medication: 84% (192/229) were treated with 1 medication, 62% with C1-INH (IV), and 38% with icatibant. The majority of treated attacks (113/229) were severe. A total of 28 patients (44.4%) had no attacks, 11 (17.5%) had no treated attacks, and 24 (38.1%) had ≥1 treated attack. Post-hoc analysis of annualized on-demand medication use showed that 39 patients (61.9%) treated with C1-INH (SC) 60 IU/kg did not use any on-demand medication; 66.7% used it less than once per year (mean (SD): 3.8 (9.6) uses/year; median: 0.0 uses/year). Between months 25 and 30, 87% of patients (20/23) did not use any on-demand medication (mean: 0.08/month, or ∼1 use/year). Conclusions: On-demand medication use remained consistently low during prophylactic therapy with C1-INH (SC) in the OLE study, with two-thirds of patients using medication less than once per year. Reduction in on-demand medication use over time should be considered in cost-effectiveness analyses of HAE prophylactic therapies.
{"title":"Patterns of on-demand medication use in patients with hereditary angioedema treated long-term with prophylactic subcutaneous C1-inhibitor","authors":"D. Levy, J. Chiao, J. Dang, C. Hood, D. Supina, H. Feuersenger","doi":"10.1080/21556660.2019.1658323","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658323","url":null,"abstract":"Abstract Background: Hereditary angioedema (HAE) is characterized by recurrent, debilitating attacks of angioedema that may require immediate (on-demand) treatment. HAE prophylactic therapy may reduce the need for on-demand treatment by decreasing the frequency and severity of attacks, which may in turn impact treatment costs. Subcutaneous C1-inhibitor (C1-INH [SC], HAEGARDA®, CSL Behring) at the FDA-approved dose of 60 IU/kg is indicated as routine prophylaxis to prevent attacks in patients with HAE. In the pivotal phase III COMPACT trial, the median reduction in attack rate relative to placebo was 95% with twice-weekly C1-INH (SC) 60 IU/kg, and the median reduction in on-demand medication use was >99%. Aims: We examined patterns of on-demand medication use in patients treated with C1-INH (SC) 60 IU/kg in a long-term, open-label extension (OLE) of the COMPACT trial. Methods: The OLE of the COMPACT trial was a multicenter, international, randomized, parallel-arm study that evaluated patients aged ≥6 years with ≥4 attacks over 2 consecutive months before enrollment. The trial included patients from the COMPACT trial and C1-INH (SC)-naïve patients. Patients were randomized to receive C1-INH (SC) 40 IU/kg or 60 IU/kg twice weekly for 52 weeks or up to 140 weeks (US patients only). The time-normalized number of uses of medication for treatment of HAE attacks was an exploratory endpoint. Results: Of the 63 patients in the 60 IU/kg group, 35 had a total of 371 attacks, of which 229 (61.7%) were treated with on-demand medication: 84% (192/229) were treated with 1 medication, 62% with C1-INH (IV), and 38% with icatibant. The majority of treated attacks (113/229) were severe. A total of 28 patients (44.4%) had no attacks, 11 (17.5%) had no treated attacks, and 24 (38.1%) had ≥1 treated attack. Post-hoc analysis of annualized on-demand medication use showed that 39 patients (61.9%) treated with C1-INH (SC) 60 IU/kg did not use any on-demand medication; 66.7% used it less than once per year (mean (SD): 3.8 (9.6) uses/year; median: 0.0 uses/year). Between months 25 and 30, 87% of patients (20/23) did not use any on-demand medication (mean: 0.08/month, or ∼1 use/year). Conclusions: On-demand medication use remained consistently low during prophylactic therapy with C1-INH (SC) in the OLE study, with two-thirds of patients using medication less than once per year. Reduction in on-demand medication use over time should be considered in cost-effectiveness analyses of HAE prophylactic therapies.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"42 - 42"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658323","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41689989","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: 10.1080/21556660.2019.1658310
Ryan Nix, Brooke Looney, Carson Lamb, Megan E. Peter, A. Zuckerman
Abstract Background: Sorafenib and regorafenib are oral multikinase inhibitors used to treat some cancers, but adverse events for both drugs are common and often cause patients to discontinue therapy or reduce their dose within several months of initiating therapy. Pharmacists have the potential to prevent discontinuation by closely monitoring and addressing patients’ adverse reactions. Aims: To assess whether a pharmacist-initiated tailored intervention reduced patient discontinuations and dose reductions due to adverse reactions from sorafenib and regorafenib. Methods: We conducted a historically controlled intervention (initiated Aug 2017) to detect and address adverse events in patients prescribed sorafenib and regorafenib. All patients who initiated therapy after August 2017 were in the intervention group (IG); at treatment initiation, IG patients received initial pharmacist counseling and a welcome kit containing educational materials, urea based creams, therapeutic socks and pill container (sorafenib only). During the 90 days after initiating treatment, pharmacists called IG patients six times to conduct assessment questionnaires, designed to detect common adverse reactions at each interval. Pharmacists addressed adverse events by providing additional counseling, referring patients for clinic appointment or requesting ancillary medications. The comparison group (CG) patients initiated therapy between September 2016 and August 2017. CG patients only received pharmacist counseling at treatment initiation. We collected patient demographics and treatment indication, and compared how many patients discontinued or reduced dose in the IG vs the CG. Results: We assessed 33 patients (16 IG vs 17 CG). Most were female (61%) and White (88%); median age 53 years. Common indications were hepatocellular carcinoma (36%), acute myeloid leukemia (30%) and desmoid tumor (21%). In the 90 day follow-up, IG had lower rates of treatment discontinuation (13% vs 29%) and dose reduction due to side effects (13% vs 18%) than CG. Combined events of either discontinuation or dose reduction due to side effects were less frequent in the patients in the IG than the CG (25% vs 65%). Conclusions: Patients treated with sorafenib or regorafenib were less likely to discontinue therapy or reduce doses due to adverse reactions after receiving a pharmacist-led phone intervention. Findings suggest tailored phone assessments are effective in detecting and treating adverse reactions, thus enabling patients to remain on therapy longer and without dose modification.
摘要背景：索拉非尼和瑞戈非尼是用于治疗某些癌症的口服多激酶抑制剂，但这两种药物的不良事件很常见，通常会导致患者在开始治疗后的几个月内停止治疗或减少剂量。药剂师有可能通过密切监测和处理患者的不良反应来防止停药。目的：评估药剂师启动的量身定制的干预措施是否减少了索拉非尼和瑞戈非尼不良反应导致的患者停药和剂量减少。方法：我们进行了一项历史对照干预（始于2017年8月），以检测和解决索拉非尼和瑞戈非尼处方患者的不良事件。2017年8月后开始治疗的所有患者均属于干预组（IG）；在治疗开始时，IG患者接受了最初的药剂师咨询和欢迎试剂盒，其中包含教育材料、尿素乳膏、治疗袜和药丸容器（仅索拉非尼）。90年代 在开始治疗几天后，药剂师给IG患者打了六次电话，进行评估问卷，旨在检测每个间隔的常见不良反应。药剂师通过提供额外的咨询、转诊患者预约诊所或要求辅助药物来解决不良事件。对照组（CG）患者于2016年9月至2017年8月开始接受治疗。CG患者仅在治疗开始时接受药剂师咨询。我们收集了患者的人口统计数据和治疗指征，并比较了有多少患者停用或减少了IG和CG的剂量。结果：我们评估了33例患者（16例IG vs 17例CG）。大多数是女性（61%）和白人（88%）；中位年龄53 年。常见的适应症为肝细胞癌（36%）、急性髓系白血病（30%）和硬纤维瘤（21%）。在90年代 在第二天的随访中，IG的停药率（13%对29%）和因副作用而减少的剂量（13%对18%）低于CG。IG组患者因副作用而停药或减少剂量的联合事件发生率低于CG组（25%对65%）。结论：接受索拉非尼或瑞戈非尼治疗的患者在接受药剂师主导的电话干预后，不太可能因不良反应而停止治疗或减少剂量。研究结果表明，量身定制的电话评估在检测和治疗不良反应方面是有效的，从而使患者能够在不改变剂量的情况下更长时间地接受治疗。
{"title":"A targeted approach to reducing rates of discontinuation and dose reduction in patients receiving sorafenib or regorafenib","authors":"Ryan Nix, Brooke Looney, Carson Lamb, Megan E. Peter, A. Zuckerman","doi":"10.1080/21556660.2019.1658310","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658310","url":null,"abstract":"Abstract Background: Sorafenib and regorafenib are oral multikinase inhibitors used to treat some cancers, but adverse events for both drugs are common and often cause patients to discontinue therapy or reduce their dose within several months of initiating therapy. Pharmacists have the potential to prevent discontinuation by closely monitoring and addressing patients’ adverse reactions. Aims: To assess whether a pharmacist-initiated tailored intervention reduced patient discontinuations and dose reductions due to adverse reactions from sorafenib and regorafenib. Methods: We conducted a historically controlled intervention (initiated Aug 2017) to detect and address adverse events in patients prescribed sorafenib and regorafenib. All patients who initiated therapy after August 2017 were in the intervention group (IG); at treatment initiation, IG patients received initial pharmacist counseling and a welcome kit containing educational materials, urea based creams, therapeutic socks and pill container (sorafenib only). During the 90 days after initiating treatment, pharmacists called IG patients six times to conduct assessment questionnaires, designed to detect common adverse reactions at each interval. Pharmacists addressed adverse events by providing additional counseling, referring patients for clinic appointment or requesting ancillary medications. The comparison group (CG) patients initiated therapy between September 2016 and August 2017. CG patients only received pharmacist counseling at treatment initiation. We collected patient demographics and treatment indication, and compared how many patients discontinued or reduced dose in the IG vs the CG. Results: We assessed 33 patients (16 IG vs 17 CG). Most were female (61%) and White (88%); median age 53 years. Common indications were hepatocellular carcinoma (36%), acute myeloid leukemia (30%) and desmoid tumor (21%). In the 90 day follow-up, IG had lower rates of treatment discontinuation (13% vs 29%) and dose reduction due to side effects (13% vs 18%) than CG. Combined events of either discontinuation or dose reduction due to side effects were less frequent in the patients in the IG than the CG (25% vs 65%). Conclusions: Patients treated with sorafenib or regorafenib were less likely to discontinue therapy or reduce doses due to adverse reactions after receiving a pharmacist-led phone intervention. Findings suggest tailored phone assessments are effective in detecting and treating adverse reactions, thus enabling patients to remain on therapy longer and without dose modification.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"30 - 30"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658310","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49098517","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: 10.1080/21556660.2019.1658325
Melissa Swoope, C. Bertram, Randi Krouskos, G. Peeler, C. Wood
Abstract Background: Hepatitis C (Hep C) is a liver infection caused by the Hep C virus. It is the most common, chronic, blood-borne infection in the US. It is estimated to affect as many as 3 million Americans and is the leading cause of liver transplants in the US. Hep C is often curable with newer antiviral therapy that is short in duration of treatment and more tolerable than traditional therapies. Aims: To measure the impact of a high-touch, specialty clinical program on driving therapy completion of glecaprevir/pibrentasvir in Hep C patients. Methods: This study was performed from a single center specialty pharmacy (SP). We evaluated patients initiating glecaprevir/pibrentasvir from February to March 2019. The outreach strategy included onboarding new-to-therapy patients by pharmacy technician specialists through the completion of a “Welcome Call”. The technician specialists determined the best time with every patient’s input for the pharmacist to follow up with a “New Start Pharmacist Initial Counseling Call”. A clinical pharmacist completed the Hep C counseling call. Afterward, a nursing refill reminder call was completed. Also, a “Patient Care Coordinator Refill Reminder Call” was coordinated to set up the shipment of the medication. After the patient completed their final refill, a nurse generated an “End of Therapy Call” to determine whether completion of therapy occurred. Results: Of the 46 patients managed by the SP, 44 patients received the cumulative days’ supply required to complete therapy. The SP had a 100% completion rate of therapy for the patients that were eligible to continue therapy. Two patients, due to allergic reactions, were not eligible to complete therapy. As such, this resulted in an overall completion rate of 96%. All patients received an initial counseling call. Thirty of the 46 patients received refill reminder calls from a nurse; 16 patients were not eligible for this call due to the patient reaching out to the pharmacy prior to the refill reminder call for their shipment, refill not applicable or allergies to the medication. Forty-four patients had end-of-therapy calls completed. Conclusions: A collaborative, high-touch SP, managing Hep C patients, drove a high rate of completion of glecaprevir/pibrentasvir Hep C therapy (100% of patients eligible). Specialty pharmacies that demonstrate improved Hep C completion rate outcomes with robust, coordinated care processes can be more confident in building future value-based reimbursement models with payers and pharmaceutical manufacturers.
{"title":"Impact of a high-touch, collaborative, patient-centric, hepatitis C specialty clinical program on completion of glecaprevir/pibrentasvir therapy","authors":"Melissa Swoope, C. Bertram, Randi Krouskos, G. Peeler, C. Wood","doi":"10.1080/21556660.2019.1658325","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658325","url":null,"abstract":"Abstract Background: Hepatitis C (Hep C) is a liver infection caused by the Hep C virus. It is the most common, chronic, blood-borne infection in the US. It is estimated to affect as many as 3 million Americans and is the leading cause of liver transplants in the US. Hep C is often curable with newer antiviral therapy that is short in duration of treatment and more tolerable than traditional therapies. Aims: To measure the impact of a high-touch, specialty clinical program on driving therapy completion of glecaprevir/pibrentasvir in Hep C patients. Methods: This study was performed from a single center specialty pharmacy (SP). We evaluated patients initiating glecaprevir/pibrentasvir from February to March 2019. The outreach strategy included onboarding new-to-therapy patients by pharmacy technician specialists through the completion of a “Welcome Call”. The technician specialists determined the best time with every patient’s input for the pharmacist to follow up with a “New Start Pharmacist Initial Counseling Call”. A clinical pharmacist completed the Hep C counseling call. Afterward, a nursing refill reminder call was completed. Also, a “Patient Care Coordinator Refill Reminder Call” was coordinated to set up the shipment of the medication. After the patient completed their final refill, a nurse generated an “End of Therapy Call” to determine whether completion of therapy occurred. Results: Of the 46 patients managed by the SP, 44 patients received the cumulative days’ supply required to complete therapy. The SP had a 100% completion rate of therapy for the patients that were eligible to continue therapy. Two patients, due to allergic reactions, were not eligible to complete therapy. As such, this resulted in an overall completion rate of 96%. All patients received an initial counseling call. Thirty of the 46 patients received refill reminder calls from a nurse; 16 patients were not eligible for this call due to the patient reaching out to the pharmacy prior to the refill reminder call for their shipment, refill not applicable or allergies to the medication. Forty-four patients had end-of-therapy calls completed. Conclusions: A collaborative, high-touch SP, managing Hep C patients, drove a high rate of completion of glecaprevir/pibrentasvir Hep C therapy (100% of patients eligible). Specialty pharmacies that demonstrate improved Hep C completion rate outcomes with robust, coordinated care processes can be more confident in building future value-based reimbursement models with payers and pharmaceutical manufacturers.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"44 - 44"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658325","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47931668","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: 10.1080/21556660.2019.1658295
J. Holton, Joseph Favatella, D. Capozzi, Richard Demers
Abstract Background: The Hospital of the University of Pennsylvania (HUP) created the Penn Specialty Pharmacy Program in 2014 to establish a pharmacy presence in clinics, with a patient focus on specialty medication access and adherence. The program utilizes both pharmacists and technicians to assist the clinics with medication counseling, prior authorizations, and copay assistance. As the program expands to more clinics throughout Penn, there is a growing need to employ more pharmacists and technicians, without a method in place to determine exactly how many FTEs are needed in clinic. Aims: To determine the number of clinical pharmacist and technician FTEs required in a clinical practice for maximum efficacy and patient care. Methods: Calculations were obtained by recording duties handled by the pharmacist (including those for which time does not allow), and determining if the task requires handling by a pharmacist, or if it could be delegated to a tech. This pilot program was first tested in the Dermatology Clinic at HUP, with the intent of launching throughout Penn, if successful. Once assignments were determined as either pharmacist or tech-appropriate, the recommended number of FTEs needed in the practice was calculated based on data obtained during an average 8-h work day: Duration of all tasks (in hours) × 5 days = ___ RPh/Tech Hours, and RPh/Tech Hours/40 = ___ RPh/Tech FTE. Results: The Dermatology pharmacist was observed over the course of 4 h as they completed several tasks, such as sending electronic rxs, patient calls, filling out paperwork for drug manufacturer programs, and responding to patient and provider cost-related concerns. Using the formula, and including roughly 7 h of assistance a pharmacist cannot currently provide (clinic/photopheresis rounds, appeals, etc.), this study was able to determine that the clinic would require ∼1.5 Pharmacist FTE and 0.39 Tech FTE. Conclusions: Many of the duties categorized as tech-specific were clerical or cost-related issues that did not require clinical intervention from a pharmacist. Addition of the 0.39 Tech FTEs would provide the RPh with additional resources to delegate duties to a tech, maximizing focus on patient care. This would also give the clinic an opportunity to include the pharmacist in other areas of the practice. More data may be needed to make a final decision on the needs of the clinic; however, this will be a helpful tool in validating departmental needs in other clinical settings for broad use in FTE determinations.
{"title":"Determining specialty pharmacy FTEs (full-time equivalents) needed in a clinical practice","authors":"J. Holton, Joseph Favatella, D. Capozzi, Richard Demers","doi":"10.1080/21556660.2019.1658295","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658295","url":null,"abstract":"Abstract Background: The Hospital of the University of Pennsylvania (HUP) created the Penn Specialty Pharmacy Program in 2014 to establish a pharmacy presence in clinics, with a patient focus on specialty medication access and adherence. The program utilizes both pharmacists and technicians to assist the clinics with medication counseling, prior authorizations, and copay assistance. As the program expands to more clinics throughout Penn, there is a growing need to employ more pharmacists and technicians, without a method in place to determine exactly how many FTEs are needed in clinic. Aims: To determine the number of clinical pharmacist and technician FTEs required in a clinical practice for maximum efficacy and patient care. Methods: Calculations were obtained by recording duties handled by the pharmacist (including those for which time does not allow), and determining if the task requires handling by a pharmacist, or if it could be delegated to a tech. This pilot program was first tested in the Dermatology Clinic at HUP, with the intent of launching throughout Penn, if successful. Once assignments were determined as either pharmacist or tech-appropriate, the recommended number of FTEs needed in the practice was calculated based on data obtained during an average 8-h work day: Duration of all tasks (in hours) × 5 days = ___ RPh/Tech Hours, and RPh/Tech Hours/40 = ___ RPh/Tech FTE. Results: The Dermatology pharmacist was observed over the course of 4 h as they completed several tasks, such as sending electronic rxs, patient calls, filling out paperwork for drug manufacturer programs, and responding to patient and provider cost-related concerns. Using the formula, and including roughly 7 h of assistance a pharmacist cannot currently provide (clinic/photopheresis rounds, appeals, etc.), this study was able to determine that the clinic would require ∼1.5 Pharmacist FTE and 0.39 Tech FTE. Conclusions: Many of the duties categorized as tech-specific were clerical or cost-related issues that did not require clinical intervention from a pharmacist. Addition of the 0.39 Tech FTEs would provide the RPh with additional resources to delegate duties to a tech, maximizing focus on patient care. This would also give the clinic an opportunity to include the pharmacist in other areas of the practice. More data may be needed to make a final decision on the needs of the clinic; however, this will be a helpful tool in validating departmental needs in other clinical settings for broad use in FTE determinations.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"18 - 18"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658295","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"60091859","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: 10.1080/21556660.2019.1658302
Brandon Newman, A. Hickman, Kathryn M. Edwards
Abstract Background: The cost of medications has been an upfront topic in the public, with 24% of patients reporting difficulty with affordable access, and specialty medications contribute to those concerns through an increase in price by 57% since 2014. Specialty pharmacy services (SPS) were implemented into a neurology clinic to assist with medication coverage and affordability. Aims: To assess the impact of integrating high touch SPS within a neurology clinic by measuring migraine medication affordability. Methods: The dispensing data for patients (1) filling a Calcitonin Gene-Related Peptide (CGRP) receptor antagonist (CGRPra) and/or onabotulinumtoxin A (Ona A) for migraine through the onsite specialty pharmacy, and (2) being treated through the SPS-affiliated neurology clinic was gathered and analyzed for medication cost coverage and patient financial responsibility. The study endpoints were to observe a minimized patient copay and assess the amount of $0 copays after the initiation of the clinic-based SPS. Results: For the CGRPra group, the SPS were able to reduce the patient responsibility to 2% of the medication cost, and more than 25% of the CGRPra dispenses had a $0 copay. For the Ona A group, comparing January 2018 to January 2019 showed a 185% increase in vials dispensed on pharmacy benefits and a patient responsibility of < 1% medication cost in January 2019 vs 19% in January 2018. The median copay went from $150 in January 2018 to $0 in January 2019. No vials in January 2018 had $0 copays, 20 did in January 2019. Measuring 6 months before SPS were started and 6 months after, the Ona A had similar results as the January comparison, with an increase of 188% dispensed through the pharmacy and the same median copays, $150 vs $0. The number of vials with $0 copay increased from four before SPS to 112 6 months after SPS was integrated. In addition, through the SPS reimbursement audits and benefit verification for Ona A billing, the Ona A reimbursement is projected to increase by $325,000 over 3 years due to switching Medicaid Ona A patients to bill through pharmacy benefits. Conclusions: The implementation of high touch SPS in a clinic can benefit patients through prescription coordination and price mitigation. Through the SPS, patients were responsible for only 2% of the CGRPra cost and < 1% of the Ona A cost. The SPS were able to verify which insurance branch was preferred for Ona A, which helped mitigate patient copays and improved facility financials for Ona A through upfront reimbursement through the preferred method of pharmacy benefits.
{"title":"Integrating high touch specialty pharmacy services within a neurology clinic to improve medication access and affordability","authors":"Brandon Newman, A. Hickman, Kathryn M. Edwards","doi":"10.1080/21556660.2019.1658302","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658302","url":null,"abstract":"Abstract Background: The cost of medications has been an upfront topic in the public, with 24% of patients reporting difficulty with affordable access, and specialty medications contribute to those concerns through an increase in price by 57% since 2014. Specialty pharmacy services (SPS) were implemented into a neurology clinic to assist with medication coverage and affordability. Aims: To assess the impact of integrating high touch SPS within a neurology clinic by measuring migraine medication affordability. Methods: The dispensing data for patients (1) filling a Calcitonin Gene-Related Peptide (CGRP) receptor antagonist (CGRPra) and/or onabotulinumtoxin A (Ona A) for migraine through the onsite specialty pharmacy, and (2) being treated through the SPS-affiliated neurology clinic was gathered and analyzed for medication cost coverage and patient financial responsibility. The study endpoints were to observe a minimized patient copay and assess the amount of $0 copays after the initiation of the clinic-based SPS. Results: For the CGRPra group, the SPS were able to reduce the patient responsibility to 2% of the medication cost, and more than 25% of the CGRPra dispenses had a $0 copay. For the Ona A group, comparing January 2018 to January 2019 showed a 185% increase in vials dispensed on pharmacy benefits and a patient responsibility of < 1% medication cost in January 2019 vs 19% in January 2018. The median copay went from $150 in January 2018 to $0 in January 2019. No vials in January 2018 had $0 copays, 20 did in January 2019. Measuring 6 months before SPS were started and 6 months after, the Ona A had similar results as the January comparison, with an increase of 188% dispensed through the pharmacy and the same median copays, $150 vs $0. The number of vials with $0 copay increased from four before SPS to 112 6 months after SPS was integrated. In addition, through the SPS reimbursement audits and benefit verification for Ona A billing, the Ona A reimbursement is projected to increase by $325,000 over 3 years due to switching Medicaid Ona A patients to bill through pharmacy benefits. Conclusions: The implementation of high touch SPS in a clinic can benefit patients through prescription coordination and price mitigation. Through the SPS, patients were responsible for only 2% of the CGRPra cost and < 1% of the Ona A cost. The SPS were able to verify which insurance branch was preferred for Ona A, which helped mitigate patient copays and improved facility financials for Ona A through upfront reimbursement through the preferred method of pharmacy benefits.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"24 - 24"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658302","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45958277","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: 10.1080/21556660.2019.1658290
N. Margaretos, Rachel C. Lai, A. Panzer, J. Chambers
Abstract Background: Patients’ access to specialty drugs is determined in part by their health plan. Because health plans develop their own coverage policies, coverage of specialty drugs can vary, which in turn may affect their members’ access to care. Aims: Our objective was to examine variation in how commercial health plans cover specialty drugs. Methods: We used the Specialty Drug Evidence and Coverage (SPEC) Database for this research. SPEC contains 6,139 specialty drug coverage decisions current as of December 2018 issued by 17 of the largest US commercial health plans. SPEC includes 239 drugs and 484 drug-indication pairs (when a drug is approved for multiple indications, each drug-indication pair is represented separately in the database). We compared each plan’s publicly available coverage policies with the drugs’ FDA labels and categorized coverage as follows: (i) broader coverage than the FDA label (the plan provided coverage for populations not included in the FDA label indication), (ii) coverage with no restrictions, (iii) coverage with restrictions (the plan applies restrictions beyond the FDA label to their coverage decision, e.g., step edits or patient subgroup restrictions), (iv) mixed restrictiveness (coverage was more restrictive than the FDA label in one way but broader in another) (v), or not covered. We examined the consistency in coverage of the drug-indication pairs across the included health plans. Results: Overall, 10% of coverage decisions were broader than the FDA label, 43% covered with no restrictions, 40% covered with restrictions, 5% “mixed” restrictiveness, and 3% not covered. We found substantial variation between health plans, with the proportion of the included plans’ coverage decisions including restrictions ranging from 14% to 85%. We also found notable variation in how the included health plans covered the included drug-indication pairs, with only 5% of drug-indication pairs covered the same way by all included plans. Conclusions: Health plans applied restrictions in roughly half of their coverage policies. We found notable inconsistency between plans, with the proportion of restricted coverage decisions varying widely. All plans covered few drug-indication pairs the same way, indicating that a patient’s plan may have a large influence on their access to specialty medications.
{"title":"Variation in health plan specialty drug coverage: an empirical analysis","authors":"N. Margaretos, Rachel C. Lai, A. Panzer, J. Chambers","doi":"10.1080/21556660.2019.1658290","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658290","url":null,"abstract":"Abstract Background: Patients’ access to specialty drugs is determined in part by their health plan. Because health plans develop their own coverage policies, coverage of specialty drugs can vary, which in turn may affect their members’ access to care. Aims: Our objective was to examine variation in how commercial health plans cover specialty drugs. Methods: We used the Specialty Drug Evidence and Coverage (SPEC) Database for this research. SPEC contains 6,139 specialty drug coverage decisions current as of December 2018 issued by 17 of the largest US commercial health plans. SPEC includes 239 drugs and 484 drug-indication pairs (when a drug is approved for multiple indications, each drug-indication pair is represented separately in the database). We compared each plan’s publicly available coverage policies with the drugs’ FDA labels and categorized coverage as follows: (i) broader coverage than the FDA label (the plan provided coverage for populations not included in the FDA label indication), (ii) coverage with no restrictions, (iii) coverage with restrictions (the plan applies restrictions beyond the FDA label to their coverage decision, e.g., step edits or patient subgroup restrictions), (iv) mixed restrictiveness (coverage was more restrictive than the FDA label in one way but broader in another) (v), or not covered. We examined the consistency in coverage of the drug-indication pairs across the included health plans. Results: Overall, 10% of coverage decisions were broader than the FDA label, 43% covered with no restrictions, 40% covered with restrictions, 5% “mixed” restrictiveness, and 3% not covered. We found substantial variation between health plans, with the proportion of the included plans’ coverage decisions including restrictions ranging from 14% to 85%. We also found notable variation in how the included health plans covered the included drug-indication pairs, with only 5% of drug-indication pairs covered the same way by all included plans. Conclusions: Health plans applied restrictions in roughly half of their coverage policies. We found notable inconsistency between plans, with the proportion of restricted coverage decisions varying widely. All plans covered few drug-indication pairs the same way, indicating that a patient’s plan may have a large influence on their access to specialty medications.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"13 - 13"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658290","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42490315","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: 10.1080/21556660.2019.1658287
N. Desai, C. Rowan, Paula J. Alvarez, J. Fogli, R. Toto
Abstract Background: Renin angiotensin aldosterone system inhibitor (RAASi) therapy is part of the cornerstone of therapy for patients (pts) with cardiovascular disease including hypertension, CHF, and/or CAD, but use is often limited by the development of hyperkalemia. Patiromer (PAT) is a sodium (Na)-free non-absorbed potassium (K+) binder approved for hyperkalemia (HK) treatment. Patiromer has been shown to reduce recurrent HK and allow pts to maintain RAASi. Aims: This retrospective cohort study evaluated RAASi utilization among Medicare Advantage pts with HK. Methods: RAASi utilization was evaluated from a large, de-identified national health insurance claims database, Optum Clinformatics Datamart, from Janaury 1, 2016 to December 31, 2017. Three HK cohorts were identified: (1) patiromer (PAT cohort) or (2) sodium polystyrene sulfonate (SPS cohort), or (3) HK diagnosis code without K+-binder prescription (NoKb cohort). Pts were included who had a pre-index serum K+ ≥5.0 mEq/L and were continuously exposed to RAASi for ≥6 months pre-index (i.e. index date is date of first K + binder dispensing or HK diagnosis). Exposure during follow-up was classified as intent to treat (ITT) and continuous exposure (CE). ITT follow-up began on the index date and ended at the first censoring event (i.e. plan disenrollment, death, December 31, 2017) or 6 months post-index while CE also included censoring for discontinuation or switching of binder therapy (i.e. PAT or SPS). RAASi continuation and down-titration (the latter assessed for lisinopril, losartan, and valsartan) were assessed at 6 months post-index. Results: The study population included: 214 PAT pts, 2371 SPS pts, and 8531 NoKb pts. Overall, the mean age was 75 years and 50% were male. Pt comorbidities (all cohorts): CKD (48%), ESRD (1%), CHF (23%), and DM (54%). At 6 months post-index, 102 (ITT)/36 (CE) PAT pts, 1,627 (ITT)/35 (CE) SPS pts, 5,543 (ITT)/5,127 (CE) NoKb pts were evaluated. RAASi continuation rates for CE were 78%, 57%, and 57% and for ITT were 63%, 52%, and 56% in the PAT, SPS, and NoKb cohorts, respectively. Down-titration rates for the CE/ITT groups were 13/9%, 6/7%, and 7/8% in the PAT, SPS, and NoKb cohorts, respectively. Conclusions: At 6 months post-index, among continuously exposed patiromer pts, a high RAASi continuation of ∼80% was observed. RAASi continuation for pts in the SPS and NoKb cohorts was <60%. Down-titration rates of RAASi in all three cohorts were low (∼10%). Further study is warranted to fully elucidate these findings.
{"title":"Patiromer and maintenance of RAASi therapy in hyperkalemic medicare patients","authors":"N. Desai, C. Rowan, Paula J. Alvarez, J. Fogli, R. Toto","doi":"10.1080/21556660.2019.1658287","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658287","url":null,"abstract":"Abstract Background: Renin angiotensin aldosterone system inhibitor (RAASi) therapy is part of the cornerstone of therapy for patients (pts) with cardiovascular disease including hypertension, CHF, and/or CAD, but use is often limited by the development of hyperkalemia. Patiromer (PAT) is a sodium (Na)-free non-absorbed potassium (K+) binder approved for hyperkalemia (HK) treatment. Patiromer has been shown to reduce recurrent HK and allow pts to maintain RAASi. Aims: This retrospective cohort study evaluated RAASi utilization among Medicare Advantage pts with HK. Methods: RAASi utilization was evaluated from a large, de-identified national health insurance claims database, Optum Clinformatics Datamart, from Janaury 1, 2016 to December 31, 2017. Three HK cohorts were identified: (1) patiromer (PAT cohort) or (2) sodium polystyrene sulfonate (SPS cohort), or (3) HK diagnosis code without K+-binder prescription (NoKb cohort). Pts were included who had a pre-index serum K+ ≥5.0 mEq/L and were continuously exposed to RAASi for ≥6 months pre-index (i.e. index date is date of first K + binder dispensing or HK diagnosis). Exposure during follow-up was classified as intent to treat (ITT) and continuous exposure (CE). ITT follow-up began on the index date and ended at the first censoring event (i.e. plan disenrollment, death, December 31, 2017) or 6 months post-index while CE also included censoring for discontinuation or switching of binder therapy (i.e. PAT or SPS). RAASi continuation and down-titration (the latter assessed for lisinopril, losartan, and valsartan) were assessed at 6 months post-index. Results: The study population included: 214 PAT pts, 2371 SPS pts, and 8531 NoKb pts. Overall, the mean age was 75 years and 50% were male. Pt comorbidities (all cohorts): CKD (48%), ESRD (1%), CHF (23%), and DM (54%). At 6 months post-index, 102 (ITT)/36 (CE) PAT pts, 1,627 (ITT)/35 (CE) SPS pts, 5,543 (ITT)/5,127 (CE) NoKb pts were evaluated. RAASi continuation rates for CE were 78%, 57%, and 57% and for ITT were 63%, 52%, and 56% in the PAT, SPS, and NoKb cohorts, respectively. Down-titration rates for the CE/ITT groups were 13/9%, 6/7%, and 7/8% in the PAT, SPS, and NoKb cohorts, respectively. Conclusions: At 6 months post-index, among continuously exposed patiromer pts, a high RAASi continuation of ∼80% was observed. RAASi continuation for pts in the SPS and NoKb cohorts was <60%. Down-titration rates of RAASi in all three cohorts were low (∼10%). Further study is warranted to fully elucidate these findings.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"8 1","pages":"2 - 2"},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658287","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41362032","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: 10.1080/21556660.2019.1658299
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.
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