Thomas E Delea

• Policy Analysis Inc.

Sotorasib was the first drug approved for adults with Kirsten rat sarcoma G12C-mutated locally advanced/metastatic non-small cell lung cancer (NSCLC) who received prior systemic therapy in the US. This study aimed to provide initial real-world evidence on patient characteristics, treatment patterns, healthcare resource utilization (HCRU), and healt...

Treatment of multiple myeloma (MM) has been transformed by novel therapies, including CD38 monoclonal antibodies (mAbs), immunomodulatory drugs (IMiDs), and proteasome inhibitors (PIs), resulting in increasing numbers of patients who are triple-class exposed (TCE; exposed to ≥ 1 drug in each class). Many patients are penta-exposed (PE; ≥ 2 IMiDs, ≥...

Introduction: Findings from a previously conducted matching-adjusted indirect comparison (MAIC) between isatuximab plus pomalidomide and dexamethasone (IsaPd) and daratumumab plus pomalidomide and dexamethasone (DaraPd) among relapsed and/or refractory multiple myeloma (RRMM) patients receiving at least two prior lines of therapy (LoT) including le...

Background Treatment of relapsed/refractory (RR) multiple myeloma (MM) has been transformed by novel therapies including anti-CD38 monoclonal antibodies (mAb), 2 nd and 3 rd generation immunomodulatory drugs (IMiD), and proteasome inhibitors (PI). This has resulted in increasing numbers (no.) of triple-class exposed (TCE) patients (pts), defined as...

Background As therapeutic advances have increased life expectancy for patients (pts) with relapsed/refractory (RR) multiple myeloma (MM), second primary malignancies (SPMs) have become an increasingly important safety consideration. Prior studies have demonstrated that treatment with alkylators, autologous stem cell transplantation, and immunomodul...

Background: Sickle cell disease (SCD) is an inherited, chronic, multifaceted blood disorder. Patients with SCD develop anemia, which has been associated with end-organ damage (EOD). Objectives: This retrospective, observational, repeated-measures study systematically characterizes the relationship between hemoglobin (Hb) level and EOD in adolesc...

Introduction La drépanocytose est une maladie génétique grave due à la polymérisation de l’hémoglobine, provoquant la falciformation des globules rouges et entraînant une anémie hémolytique et des vaso-occlusions douloureuses. Au fil du temps, plusieurs organes peuvent être atteints, avec pour conséquences des accidents vasculaires cérébraux, des i...

Introduction La drépanocytose est une maladie génétique héréditaire caractérisée par une hémoglobine polymérisée (HbS) et la falciformation des globules rouges, entraînant une anémie hémolytique chronique et des crises vaso-occlusives (CVO) récurrentes. Le voxelotor, un inhibiteur de la polymérisation de l’HbS administré par voie orale une fois par...

e20011 Background: RRMM treatment (Tx) has been transformed by novel Txs including anti-CD38 monoclonal antibodies (mAbs) and 2 nd /3 rd generation immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs), resulting in an increasing population of TCE pts (i.e., prior exposure to ≥1 each of an IMID, a PI, and an anti-CD38 mAb). Many such pts a...

Background: Sickle cell disease (SCD) is a genetic disease that impacts patients' quality of life, healthcare costs, and life expectancy. Elevated sickle hemoglobin (HbS), which readily polymerizes, causes red blood cell sickling, leading to chronic hemolytic anemia and complications often requiring hospitalization and transfusions. In 2019, voxel...

Background: Sickle cell disease (SCD) is an inherited systemic disorder characterized by chronic hemolytic anemia and recurrent vaso-occlusion, which can lead to acute and chronic complications, disability, and early mortality. Patients with SCD are hospitalized frequently and most commonly for vaso-occlusive crises (VOCs). Furthermore, most will r...

Background and objective: The objective of this study was to estimate the lifetime costs of patients receiving treatment for follicular lymphoma (FL) in the United States. Methods: A Markov model was programmed in hēRo3 with a 6-month cycle length, 35-year time horizon (lifetime projection), and health states for line of treatment, response, rec...

Background The MONALEESA-3 trial demonstrated the efficacy and safety of ribociclib plus fulvestrant versus placebo plus fulvestrant for patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC). This analysis evaluated the cost effectiveness of ribociclib plus fulvestrant...

Background and Objectives The MONALEESA-7 trial demonstrated the efficacy and safety of ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) [with goserelin] for pre-/perimenopausal women with hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer. This analysis evaluated the cost effectiveness o...

Effects of disease progression on healthcare resource utilization (HRU) and costs among multiple myeloma (MM) patients with ≥1 line of therapy (LOT) who received their first stem cell transplant (SCT) within 1 year of initial MM diagnosis were estimated using a large US claims database. Disease progression was defined as advancement to the next LOT...

(1) Background: Past research suggests that patients with advanced breast cancer prefer treatments with improved clinical outcomes and lower risk of side effects. Evidence on preferences of Canadian patients and physicians for treatments for advanced breast cancer is limited. (2) Methods: Patients’ and physicians’ preferences for treatments for HR+...

Aim: To estimate treatment patterns and healthcare costs among triple-class exposed relapsed and refractory multiple myeloma (RRMM) patients. Materials & methods: Eligible patients had ≥1 line of therapy (LOT) each of proteasome inhibitors, immunomodulatory drugs and daratumumab in December 2015–September 2018 and received a new LOT. Results: A tot...

Background: Until late 2019, few treatments had been approved by the FDA for treating sickle cell disease (SCD). Voxelotor (Oxbryta®) is a sickle hemoglobin-polymerization inhibitor approved by the FDA in November 2019 for treatment of SCD in adults and adolescents aged ≥12 years under an accelerated approval based on results of the pivotal HOPE st...

Background: Sickle cell disease (SCD) is an inherited, chronic, and multifaceted condition. Anemia affects most patients with SCD, and low hemoglobin (Hb) levels have been demonstrated to be correlated with end-organ damage (EOD) such as stroke, chronic kidney disease (CKD), end-stage renal disease (ESRD), and pulmonary hypertension (PH). This stud...

Introduction Data on the economic burden of disease progression among multiple myeloma (MM) patients who have had a stem cell transplant (SCT) in the US are limited. This study evaluated the impact of disease progression on healthcare resource utilization (HRU) and costs among these patients in the US. Methods Adult patients (pts) with a confirmed...

Background: Before the approval of dabrafenib and trametinib in combination, there were no approved therapies in the adjuvant setting that target the RAS/RAF/MEK/ERK pathway. Objective: To evaluate the budget impact of dabrafenib and trametinib in combination for adjuvant treatment of patients with BRAF V600 mutation-positive resected Stage IIIA...

Objective The COMBI-AD trial demonstrated the efficacy and safety of dabrafenib and trametinib in combination versus placebo as adjuvant treatment of patients with BRAF V600E/K mutation-positive resected Stage IIIA (lymph node metastasis >1 mm), IIIB, or IIIC melanoma. This analysis evaluated the cost-effectiveness of dabrafenib and trametinib vers...

Background and Objective The TOWER and INO-VATE-ALL trials demonstrated the efficacy and safety of blinatumomab and inotuzumab ozogamicin (inotuzumab), respectively, versus standard-of-care (SOC) chemotherapy in adults with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). The cost effectiveness of blinatumomab versu...

e18359 Background: To estimate Incremental CE Ratio (ICER) of BLIN vs INO in adults with R/R S0/S1 ALL based on matching-adjusted indirect comparison (MAIC) of TOWER and INO-VATE trials from a UK healthcare perspective. Methods: CE was estimated by a partitioned-survival model with outcomes based on published aggregate data from INO-VATE (cutoff: 0...

Aim: To compare monthly healthcare resource utilization (HRU) and costs among adult patients with multiple myeloma (MM) receiving second or subsequent line of treatment (LOT) with carfilzomib or pomalidomide as monotherapy or in combination with dexamethasone. Methods and materials: Adult MM patients who received carfilzomib or pomalidomide as seco...

Introduction Previous studies have documented substantial economic burden for multiple myeloma (MM) patients (pts). However, data on the economic burden of disease progression in the US are limited. In this study, we estimated effects of disease progression on healthcare resource utilization (HRU) and costs among pts with MM who have received at le...

INTRODUCTION: Blinatumomab is a bispecific CD19 directed CD3 T cell engager indicated for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission (CR) with minimal residual disease (MRD) greater than or equal to 0.1%. In BLAST (NCT01207388), an open-label, multicenter, sing...

Objective: The ECHELON-1 trial demonstrated efficacy and safety of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A + AVD) versus doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as frontline therapy for stage III/IV classical Hodgkin lymphoma. This analysis evaluated the cost-effectiveness of A + AVD from a US healt...

Aim: Acute myeloid leukemia (AML) is associated with high disease burden. This analysis estimated HRU and costs among newly diagnosed AML patients in a US commercially insured population. Materials and methods: This was a retrospective observational study using the IMS Health PharMetrics Plus and Hospital Charge Detail Master databases. Patients in...

Objective: The aim of this study was to assess the budget impact of introducing the proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) alirocumab and evolocumab to market for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular (CV) disease requiring additional lowering o...

Purpose: The Chest Radiotherapy Extensive-Stage Small Cell Lung Cancer Trial (CREST) showed that adding thoracic radiation therapy (TRT) to the standard treatment (ST) paradigm of chemotherapy and prophylactic cranial irradiation improves overall survival and progression-free survival (PFS) in patients with extensive-stage small cell lung cancer (...

Background Sunitinib and pazopanib are the only two targeted therapies for the first-line treatment of locally advanced or metastatic renal cell carcinoma (mRCC) recommended by the United Kingdom’s National Institute for Health and Care Excellence. Pazopanib demonstrated non-inferior efficacy and a differentiated safety profile versus sunitinib in...

Objective To evaluate the cost-effectiveness of blinatumomab (Blincyto) versus standard of care (SOC) chemotherapy in adults with relapsed or refractory (R/R) Philadelphia-chromosome-negative (Ph−) B-precursor acute lymphoblastic leukemia (ALL) based on the results of the phase 3 TOWER study from a US healthcare payer perspective. Methods The Blinc...

Background Ofatumumab (Arzerra®, Novartis) is a treatment for chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab [double refractory (DR-CLL)]. Ofatumumab was licensed on the basis of an uncontrolled Phase II study, Hx-CD20-406, in which patients receiving ofatumumab survived for a median of 13.9 months. However, the lack of an i...

e18553 Background: PACE was a phase 2 single-arm trial of ponatinib, a 3rd-generation tyrosine kinase inhibitor (TKI), in 449 highly-refractory patients with CML or Philadelphia-chromosome positive (Ph+) acute lymphocytic leukemia (ALL) or who had the BCR-ABL T315I mutation. Overall survival (OS) for 3L CP-CML patients in PACE at 1, 2, 3 and 4 year...

e18330 Background: AML accounts for 25% of acute leukemias in adults worldwide, with an estimated 5-year survival of 26% in the US. Up-to-date information on the clinical and economic burden of AML among US commercially insured patients (pts) is needed to inform reimbursement decisions. Methods: This retrospective study of the burden of AML in a US...

Background Public health programs to prevent invasive meningococcal disease (IMD) with monovalent serogroup C meningococcal conjugate vaccine (MCV-C) and quadrivalent meningococcal conjugate vaccines (MCV-4) in infancy and adolescence vary across Canadian provinces. This study evaluated the cost-effectiveness of various vaccination strategies again...

Scatter plot of difference in expected costs versus difference in expected quality-adjusted life-years for alternative strategies for vaccination against meningococcal disease in Canada. (TIFF)

Derivation of IMD incidence rates by serogroup. (DOCX)

Derivation of IMD incidence rates by age and serogroup. (DOCX)

Acceptability curves for cost-effectiveness (cost per QALY) for alternative strategies for vaccination against meningococcal disease in Canada. (TIF)

Purpose: A prior randomized controlled trial (COMPARZ [Comparing the Efficacy, Safety and Tolerability of Pazopanib versus Sunitinib]) found non-inferior progression-free survival for pazopanib versus sunitinib as first-line therapy in patients with advanced or metastatic renal cell carcinoma. The present study evaluated the cost-effectiveness of...

Background A recent retrospective study compared healthcare outcomes and costs in pts with MM receiving CAR or POM using health insurance claims data and reported that CAR pts had higher healthcare costs than POM pts (Parikh ASCO 2016). The results of this analysis have not been confirmed by other investigators. Objective To compare HRU and costs a...

Introduction: The present study aimed to inform an economic evaluation of dabrafenib and trametinib combination as first-line treatment of metastatic melanoma in a Canadian setting. A network meta-analysis was conducted to estimate hazard ratios (HRs) for progression-free survival (PFS)and overall survival (OS) of dabrafenib plus trametinib versus...

Background In Canada and elsewhere, pazopanib and sunitinib—tyrosine kinase inhibitors targeting the vascular endothelial growth factor receptors—are recommended as first-line treatment for patients with metastatic renal cell carcinoma (mrcc). A large randomized noninferiority trial of pazopanib versus sunitinib (comparz) demonstrated that the two...

Objective: To identify the issues of using overall survival (OS) as a primary endpoint in the presence of crossover and the statistical analyses available to adjust for confounded OS due to crossover in oncology clinical trials. Methods: An indirect comparison was conducted between pazopanib and sunitinib in advanced renal cell carcinoma. Statis...

Background For patients with multiple myeloma (MM) who are refractory to or relapsed after initial therapy, current US clinical guidelines recommend treatment with proteasome inhibitors (PIs) (e.g., bortezomib [V] or carfilzomib [K]) and/or immunomodulatory drugs (IMiDs) (e.g., lenalidomide [R], thalidomide [T] or pomalidomide [P]), combined with c...

Current first-line treatments for metastatic renal cell carcinoma (mRCC) include the multityrosine kinase inhibitors pazopanib and sunitinib. Both agents had similar progression-free survival (PFS) and overall survival (OS) in the COMPARZ trial (Comparing the Efficacy, Safety and Tolerability of Pazopanib versus Sunitinib); however, the adverse eve...

To evaluate the cost effectiveness of dabrafenib versus dacarbazine and vemurafenib as first-line treatments in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma from a Canadian healthcare system perspective. A partitioned-survival analysis model with three mutually exclusive health states (pre-progression, post-progress...

In the phase iii palette trial of pazopanib compared with placebo in patients with advanced or metastatic soft-tissue sarcoma (sts) who had received prior chemotherapy, pazopanib treatment was associated with improved progression-free survival (pfs). We used an economic model and data from palette and other sources to evaluate the cost-effectivenes...

In the phase III PALETTE trial, pazopanib improved progression-free survival (PFS) compared with placebo in patients with advanced/metastatic soft tissue sarcomas (mSTS) who had received prior chemotherapy. We used a multistate model to estimate expected PFS, overall survival (OS), lifetime STS treatment costs, and quality-adjusted life-years (QALY...

Background: Patients with bone metastases secondary to breast cancer are pre-disposed to skeletal-related events (SREs), including spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (SB), and radiotherapy to bone (RT). Objective: To document current patterns of healthcare utilization and costs of SREs in patients with breas...

Although studies have established that adding long-acting beta agonists (LABA) to inhaled corticosteroid (ICS) monotherapy among patients with inadequately controlled asthma is associated with better outcomes than increasing ICS dosage, outcomes with ICS versus fixed-dose ICS/LABA combination among patients with recent asthma exacerbation or freque...

In the EGF30008 and TAnDEM (TrAstuzumab in Dual HER2 ER-positive Metastatic breast cancer) trials, anti-HER2 therapy plus an aromatase inhibitor (lapatinib + letrozole (LAP + LET) and trastuzumb + anastrozole (TZ + ANA), respectively) improved time to progression versus aromatase inhibitor monotherapy (LET and ANA, respectively) in post-menopausal...

The cost-effectiveness of first-line treatment with lapatinib plus letrozole for postmenopausal women with hormone receptor-positive (hr+), human epidermal growth factor receptor 2-positive (her2+) metastatic breast cancer (mbc) has not been assessed from the Canadian health care system and societal perspectives. A partitioned survival analysis mod...

Cancer patients with bone metastases (BMets) are predisposed to skeletal complications. Bone-targeted therapies such as denosumab or intravenous bisphosphonates (IVBs) reduce the risk of these complications. This study characterized patterns of IVB use in these patients in the USA. This was a retrospective, observational study using the Truven Heal...

e20665 Background: Cancer patients with BMets are predisposed to skeletal complications. Bone targeted therapies such as denosumab or IVBs reduce the risk of these complications. The objective of this study was to characterize patterns of IVB use in these patients. Methods: This was a retrospective, observational study using the Thomson MedStat Mar...

Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary. Objective A retrospective observational study was conducted to examine treatment patterns in HER2+/HR+ patients initiating first...

Objective: National asthma treatment guidelines recommend low/medium-dose inhaled corticosteroids (ICSs) as initial therapy in mild asthma patients. However, low doses of a fixed-dose combination of ICS and long-acting β-agonists are sometimes used. This study compares asthma-related outcomes and health care utilization and costs in clinical pract...

Background. Lapatinib is an oral small molecule dual tyrosine kinase inhibitor that has been shown to improve time to progression versus capecitabine in women with HER2+ metastatic breast cancer (MBC) previously treated with trastuzumab. Objective. To describe extent, predictors, and consequences of nonadherence with lapatinib in women with MBC who...

In the U.K. Medical Research Council Myeloma IX trial (mmix), zoledronic acid 4 mg once every 3-4 weeks, compared with clodronate 1600 mg daily, reduced the incidence of skeletal related events (sres), increased progression-free survival (pfs), and prolonged overall survival (os) in 1970 patients with newly-diagnosed multiple myeloma. The incidence...

Background: Patients with bone metastases secondary to prostate cancer are predisposed to skeletal-related events (SREs), including spinal cord compression, pathological fracture, surgery to bone and radiotherapy to bone. The objective of this study was to document current patterns of healthcare utilization and costs of SREs in patients with prost...

72 Background: Patients with BMets secondary to BC are predisposed to SREs, defined as spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (SB), and radiation therapy to bone (RT). Information on health care utilization and costs to treat SRE episodes in BC patients are limited. The objective of this study was to document curre...

Background: The relationship between progression-free survival and time to progression (PFS/TTP) and overall survival (OS) has been demonstrated in a variety of solid tumours but not in metastatic renal cell carcinoma (mRCC). Methods: A systematic literature search was conducted to identify controlled trials of cytokine or targeted therapies for...

e11067 Background: LAP, an oral small molecule dual tyrosine kinase inhibitor has been shown to improve time to progression in combination with capecitabine vs. capecitabine alone in women with HER2+ MBC previously treated with trastuzumab, an anthracycline, and taxanes. Data on adherence, persistence, predictors and consequences of non-adherence w...

Background. Lapatinib is an oral small molecule dual tyrosine kinase inhibitor that binds intracellularly to the ATP binding site of the EGFR and HER2 receptors. In a randomized controlled trial (RCT) of women with HER2+ metastatic breast cancer (MBC) previously treated with trastuzumab, an anthracycline, and taxanes, lapatinib plus capecitabine im...

In the Medical Research Council Myeloma IX Study (MMIX), zoledronic acid (ZOL) 4 mg 3-4/week reduced the incidence of skeletal-related events (SREs), increased progression free survival (PFS), and prolonged overall survival (OS), compared with clodronic acid (CLO) 1600 mg daily, in 1970 patients with newly-diagnosed multiple myeloma (MM). An econom...

Although studies have examined the effect of skeletal-related events (SREs) on healthcare costs in patients with advanced cancer and bone metastases, the effect of bone metastases without SREs on costs has not been studied. To estimate the effects of bone metastases with and without SREs on healthcare costs in men with prostate cancer treated with...

Background: AVOID was a randomized, double-blind, 6-mo. trial of adding aliskiren to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and nephropathy with residual proteinuria (urinary albumin creatinine ratio [UACR]>100mg/g) after ≥3 mo. of 100mg/d losartan. Aliskiren reduced mean UACR by 20% vs. placeb...

The benefits of inhaled corticosteroids in asthma are well established. Early use of inhaled anti-inflammatories following and exacerbation could be beneficial. A retrospective observational cohort study compared the risk of asthma-related exacerbations [hospitalization, emergency department visit, and/or treatment with systemic corticosteroid] in...

Suboptimal adherence to long-term therapies is common and may potentially have adverse consequences on patient outcomes and healthcare costs. To assess the association between adherence to levodopa/carbidopa/entacapone therapy and healthcare utilization and costs in patients with Parkinson's disease. A retrospective historical cohort study, conduct...

In a phase III trial of women with HER2+ metastatic breast cancer (MBC) previously treated with trastuzumab, an anthracycline, and taxanes (EGF100151), lapatinib plus capecitabine (L+C) improved time to progression (TTP) versus capecitabine monotherapy (C-only). In a trial including HER2+ MBC patients who had received at least one prior course of t...

e16542 Background: This study describes HRU and cost associated with BMets and SREs in PC pts who have received hormonal therapy (HT). Methods: Retrospective study using the Thomson MedStat MarketScan databases (9/02 – 5/08). Study subjects were male and had diagnoses of PC (ICD-9-CM 185) and BMets (ICD-9-CM 198.5) and ≥1 claim for HT in the year p...