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As Dr. Michael S. Broder, MD, MSHS, President of PHAR notes: "Four of the five drugs with the highest pre-launch estimates are on Tier 5 or require prior authorization with at least one major pharmacy benefits manager, so overestimating the budget impact of drugs can have serious consequences for patients." In one example, the Institute for Clinical and Economic Review (ICER) estimated the one-year budget impact of the two PCSK9 inhibitors, a new class of injectable treatments for patients with high cholesterol who are at high risk of CV events, would be $7.2 billion. The actual reported sales for 2016 were $192 million, or 2.7% of the prediction, an overestimate of $7 billion. The overall study examined the accuracy of 25 publicly released predictions for the cost of drugs launched in a variety of indications since 2012. In addition to cholesterol lowering drugs, the study included drugs to treat various types of cancer; hepatitis C; obesity; and one each for cystic fibrosis, heart failure, psoriasis, and diabetes. Ten estimates were off by more than $1 billion: 8 overestimated drug sales by more than a billion; and 2 underestimated it by at least that amount. In-depth analyses suggested that estimates for drugs used in smaller populations and those that were first-in-class were more likely to be inaccurate. Surprisingly, independent organizations were no more accurate than financial analysts in their predictions. For example, PricewaterhouseCoopers predicted $2.9 billion of sales for Viekira Pak to treat hepatitis C infection; actual first-year sales were 28% of that. Other recent research found similar findings. A study by a prominent physician published in the New England Journal of Medicine predicted that the PCSK9 inhibitor class alone would raise annual health care premiums by $124 per person. However, Avalere Health, an advisory company, reported that all prescription drugs accounted for only a $3.29 average increase in per member per month premiums. Taken together, these findings raise concern about the usefulness of pre-launch predictions for payers, patients, and prescribers. Dr. Broder summarized the research by saying, "We don't think these overestimates were deliberate—other studies have shown that even careful professionals display what's been called 'optimism bias,' which could be responsible for the dramatic overestimates we observed. But if health plans make decisions without considering the likelihood that they are looking at biased information, they might unnecessarily restrict access to life-saving treatments." About: Founded in 2004, Partnership for Health Analytic Research (PHAR, LLC) is a clinically-focused health services research consultancy. PHAR combines rigorous methodology with extensive clinical expertise to conduct high quality health economics and outcomes research for life sciences companies, specialty societies, and not-for-profit health advocacy groups. For more information about PHAR, LLC, visit the company's website at www.pharllc.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/biased-estimates-miss-by-billions-extensive-analysis-finds-actual-cost-of-new-drugs-is-far-less-than-predicted-300443759.html


Broder M.S.,Partnership for Health Analytic Research LLC | Raimundo K.,Genentech | Antonova E.,Genentech | Chang E.,Partnership for Health Analytic Research LLC
American Journal of Clinical Dermatology | Year: 2015

Background: Chronic idiopathic or spontaneous urticaria (CIU/CSU) impairs patients’ quality of life, and updated information on disease prevalence, treatment patterns, and disease burden is lacking. Objectives: We aimed to estimate these figures in a large US real-world claims database via a validated algorithm. Methods: In this retrospective cross-sectional cohort study, we identified patients with CIU/CSU, estimated disease prevalence, comorbidities, and healthcare use (medications, office visits, emergency department visits, and hospitalizations) and costs (urticaria related and all cause). Results: We identified 6350 CIU/CSU patients in a population of just over 5.8 million: 0.11 % prevalence. Women accounted for the majority of sufferers (68.3 %) and had a greater burden of illness than men. Patients had relatively few comorbidities (mean 3.3, standard deviation 2.2). Primary care physicians and allergists were the most common providers of CIU/CSU-related care. Oral corticosteroids were the most commonly prescribed medication, used in 54.7 % of patients. Patients accumulated a mean of 15.1 office visits per year (standard deviation 12.6). The mean all-cause healthcare cost totaled over US$9000 per year. Conclusions: Although the disease affects a relatively young population, CIU/CSU carries a substantial cost. Frequent oral corticosteroid use in CIU/CSU patients is a concern because of adverse events associated with the drug. © 2015, The Author(s).


Nasr S.Z.,University of Michigan | Chou W.,Genentech | Villa K.F.,Genentech | Chang E.,Partnership for Health Analytic Research LLC | Broder M.S.,Partnership for Health Analytic Research LLC
Journal of Medical Economics | Year: 2013

Objective: To investigate adherence to dornase alfa therapy among commercially-insured patients with cystic fibrosis (CF) and to examine the impact of adherence on health and economic outcomes. Methods: This retrospective cohort analysis included CF patients with 1 dornase alfa (Pulmozyme) pharmacy claim between 1 October 2006 and 30 September 2008 and with continuous enrollment in the health insurance plan at least 1 year before and 1 year after their index dornase alfa claim. Adherence was measured with the medication possession ratio (MPR). Multivariate models were used to estimate the relationship between adherence and exacerbations, utilization, and cost. Results: Nine hundred and seven patients met the inclusion criteria. The mean age was 19.5 years (SD=11.5) and 49.1% were female. Overall MPR was 0.59 and by age was 0.66 for patients of 5-12 years, 0.57 for 13-20 years, 0.54 for 21-30 years, and 0.56 for patients 31 years. Adherence was better in fall and winter than in spring and summer. There was no statistically significant difference in the proportion of patients with inpatient respiratory exacerbations across groups with low (<0.5), moderate (0.5-0.79), and high (0.8) adherence (24.5%, 22.3%, and 19.1%, respectively, p=0.250). There was a trend toward higher total charges in more-adherent patients (mean $58,612 in the least-adherent group and mean $69,427 in the most adherent group, p=0.107). In multivariate models, MPR was not significantly associated with the risk of inpatient respiratory exacerbations (hazard ratio=1.16 for MPR <0.5 vs 0.8; 95% CI=0.83-1.61). Limitations: Study data were derived from insurance claims; adherence measures were based on prescription fills, not observed medication use. Conclusion: Adherence to dornase alfa was generally low, but varied by age and season. Adherence was not found to be significantly associated with respiratory exacerbations or total charges, but was associated with shorter hospital length of stay. © 2013 Informa UK Ltd. All rights reserved: reproduction in whole or part not permitted.


Strosberg J.R.,H. Lee Moffitt Cancer Center and Research Institute | Fisher G.A.,Stanford University | Benson A.B.,Northwestern University | Malin J.L.,University of California at Los Angeles | And 2 more authors.
Pancreas | Year: 2013

OBJECTIVES: This study aimed to develop expert consensus for the use of systemic treatments for unresectable metastatic well-differentiated (grade 1-2) carcinoid tumors using the RAND/UCLA modified Delphi process. METHODS: After a comprehensive literature review, 404 patient scenarios addressing the use of systemic treatments for carcinoid tumors were constructed. A multidisciplinary panel of 10 physicians assessed the scenarios as appropriate, inappropriate, or uncertain (on a 1-9 scale) or as an area of disagreement before and after an extended discussion of the evidence. RESULTS: Experts were medical and surgical oncologists, interventional radiologists, and gastroenterologists. Among rated scenarios, disagreement decreased from 14% before the meeting to 4% after. Consensus statements about midgut carcinoids included the following: (1) Somatostatin analogs are appropriate as first-line therapy for all patients; (2) In patients with uncontrolled secretory symptoms, it is appropriate to increase the dose/frequency of octreotide long-acting repeatable up to 60 mg every 4 weeks or up to 40 mg every 3 weeks as second-line therapy for refractory carcinoid syndrome. Other options may also be appropriate. Consensus was similar for non-midgut carcinoids. CONCLUSIONS: The Delphi process provided a structured methodological approach to assist clinician experts in reaching consensus on the appropriateness of specific medical therapies for the treatment of advanced carcinoid tumors. Copyright © 2013 by Lippincott Williams & Wilkins.


Critchley H.O.D.,Queens Medical Research Institute | Munro M.G.,University of California at Los Angeles | Broder M.,Partnership for Health Analytic Research LLC | Fraser I.S.,University of Sydney
Seminars in Reproductive Medicine | Year: 2011

Over the past decade there has been an increasing realization about the extent of confusion associated with the many terminologies used to describe abnormal uterine bleeding (AUB). This led to the organization of an international workshop of 35 experts from 15 countries in Washington, D.C., USA, in 2005, which addressed the confusions and controversies around AUB. The workshop comprehensively addressed anomalies in the terminologies, definitions, and causes of AUB. It also began to address broader issues including investigations, quality of life, the need for structured symptom questionnaires, cultural aspects, and future research needs. This workshop led to a series of recommendations and publications and to the establishment of the International Federation of Gynecology and Obstetrics (FIGO) Menstrual Disorders Working Group. Since then, a series of international presentations and small group workshops has resulted in a wide awareness of the program and a comprehensive series of recommendations and publications. A particularly influential large-scale interactive workshop with 600 attendees was held during the 2009 FIGO World Congress, which demonstrated the broad acceptability of the current recommendations. This article describes the process leading to the development of international recommendations on terminologies, definitions, and classification of causes of AUB and the establishment of the FIGO Menstrual Disorders Working Group. © 2011 by Thieme Medical Publishers, Inc.


Fraser I.S.,University of Sydney | Critchley H.O.D.,Queens Medical Research Institute | Broder M.,Partnership for Health Analytic Research LLC | Munro M.G.,University of California at Los Angeles
Seminars in Reproductive Medicine | Year: 2011

Over the past 5 years there has been a major international discussion aimed at reaching agreement on the use of well-defined terminologies to describe the normal limits and range of abnormalities related to patterns of uterine bleeding. This article builds on concepts previously presented, which include the abandonment of long-used, ill-defined, and confusing English-language terms of Latin and Greek origin, such as menorrhagia and metrorrhagia. The term dysfunctional uterine bleeding should also be discarded. Alternative terms and concepts have been proposed and defined. The terminologies and definitions described here have been comprehensively reviewed and have received wide acceptance as a basis both for routine clinical practice and for comparative research studies. It is anticipated that these terminologies and definitions will be reviewed again on a regular basis through the International Federation of Gynecology and Obstetrics Menstrual Disorders Working Group. © 2011 by Thieme Medical Publishers, Inc.


Broder M.S.,Partnership for Health Analytic Research LLC | Gutierrez B.,University of America | Cherepanov D.,Partnership for Health Analytic Research LLC | Linhares Y.,Cedars Sinai Medical Center
Supportive Care in Cancer | Year: 2015

Purpose: Up to 75 % of patients with prostate cancer experience metastatic bone disease, which leads to an increased risk for skeletal-related events (SREs) including pathological bone fracture, spinal cord compression, and hypercalcemia of malignancy. Our objective was to systematically review the literature on the impact of SREs on quality of life (QOL), morbidity, and survival with a primary focus on the impact of SREs on pain in prostate cancer patients.Methods: We searched PubMed, limiting to peer-reviewed English-language human studies published in 2000–2010. The search was based on the US Food and Drug Administration and European Medicines Agency definition of an SRE, which includes pathologic fracture, spinal cord compression (SCC), hypercalcemia of malignancy, and radiotherapy or surgery to bone resulting from severe bone pain.Results: A total of 209 articles were screened, of which 173 were excluded, and 36 were included in this review. Patients with SREs had more pain and worse survival compared with no SREs. Pathologic bone fractures worsened QOL and were associated with shorter survival. Radiation therapy of SCC alleviated pain and improved morbidity. SCC was associated with decreases in patient survival. Radiation therapy and surgery to bone improved pain.Conclusions: Specific SREs are associated with worse outcomes, including increased pain, poorer QOL, morbidity, and survival. Treatment of SREs is associated with improved pain, although there remains a need for more effective treatment of SREs in prostate cancer patients. © 2014, Springer-Verlag Berlin Heidelberg.


Cramer J.A.,Yale University | Wang Z.J.,Eisai Inc | Chang E.,Partnership for Health Analytic Research LLC | Powers A.,Eisai Inc | And 3 more authors.
Epilepsy and Behavior | Year: 2014

Despite the availability of numerous antiepileptic drugs (AEDs), some epilepsies remain resistant to treatment. We compared utilization and costs in patients with uncontrolled epilepsy to those with stable epilepsy. Claims data (2007-2009) were used to identify adults with epilepsy requiring additional AED therapy (having uncontrolled epilepsy) and those not requiring additional AED therapy (having stable epilepsy). The date in 2008 on which an additional AED was started was the index date for patients with uncontrolled epilepsy, and a randomly selected date was used for patients with stable epilepsy, whose AED use was unchanged in the preceding year. In the postindex year, all pharmacy and medical claims were used to estimate overall utilization and costs; claims with epilepsy in any diagnosis field were used to estimate epilepsy-related outcomes. Outcomes were adjusted using multivariate analyses. We identified 1536 patients with uncontrolled epilepsy and 8571 patients with stable epilepsy (mean age: 42.8. years; female: 48%). Patients with uncontrolled epilepsy had higher comorbidity rates (p<.02). A greater proportion of patients with uncontrolled epilepsy had ≥. 1 hospitalization or emergency department visit (p<.001). Patients with uncontrolled epilepsy had a greater mean length of hospital stay and more physician office visits (p<.034). After adjustment, the odds of hospitalization (OR: 1.8, any diagnosis; 2.2, epilepsy-related) and emergency department visit (OR: 1.6, any diagnosis; 1.9, epilepsy-related) were greater for patients with uncontrolled epilepsy. Annual overall ($23,238 vs. $13,839) and epilepsy-related ($12,399 vs. $5511) costs were higher in patients with uncontrolled epilepsy and remained higher after adjustment (p<.001). Patients with uncontrolled epilepsy use more services and incur higher costs compared with those with stable epilepsy. Epilepsy-related costs accounted for <. 50% of the total costs, suggesting that comorbid conditions and/or underidentification of utilization may substantially contribute to costs. © 2013 Elsevier Inc.


Broder M.S.,Partnership for Health Analytic Research LLC | Beenhouwer D.,Partnership for Health Analytic Research LLC | Strosberg J.R.,H. Lee Moffitt Cancer Center and Research Institute | Neary M.P.,Novartis | Cherepanov D.,Partnership for Health Analytic Research LLC
World Journal of Gastroenterology | Year: 2015

AIM: To review literature on efficacy and safety of octreotide-long-acting repeatable (LAR) used at doses higher than the Food and Drug Administration (FDA)-approved 30 mg/mo for treatment of neuroendocrine tumors (NETs). METHODS: We searched PubMed and Cochrane Library from 1998-2012, 5 conferences (American Society of Clinical Oncology, Endocrine Society, European Neuroendocrine Tumor Society, European Society for Medical Oncology, North American Neuroendocrine Tumor Society) from 2000-2013 using MeSH and key-terms including neuroendocrine tumors, carcinoid tumor, carcinoma, neuroendocrine, and octreotide. Bibliographies of accepted articles were also searched. Two reviewers reviewed titles, abstracts, and full-length articles. Studies that reported data on efficacy and safety of ≥ 30 mg/mo octreotide-LAR for NETs in human subjects, published in any language were included in the review. RESULTS: The search identified 1086 publications, of which 238 underwent full-text review (20 were translated into English); 17 were included in the review. Studies varied in designs, subjects, octreotide-LAR regimens, and definition of outcomes. Eleven studies reported use of higher doses to control symptoms and tumor progression, although symptom severity and formal quality-of-life analysis were not quantitatively measured. Ten studies reported efficacy, describing 260 subjects with doses ranging from 40 mg/mo or 30 mg/3 wk up to 120 mg/mo. Eight studies reported expert clinical opinion that supported dose escalation of octreotide-LAR up to 60 mg/mo for symptom control and suggested increased doses may be effective at preventing tumor progression. Eight studies reported safety; there was no evidence of increased toxicity associated with doses of octreotide-LAR > 30 mg/mo. CONCLUSION: As reported in this review, octreotide-LAR at doses > 30 mg/mo is being prescribed for symptom and tumor control in NET patients. Furthermore, expert clinical opinion provided support for escalation of somatostatin analogs for refractory hormonal symptoms. © The Author(s) 2015.


Cramer J.A.,Yale University | Wang Z.J.,Eisai Inc | Chang E.,Partnership for Health Analytic Research LLC | Powers A.,Eisai Inc | And 3 more authors.
Epilepsy and Behavior | Year: 2014

Objective: Epilepsy adversely affects childhood development, possibly leading to increased economic burden in pediatric populations. We compared annual healthcare utilization and costs between children (<. 12. years old) with stable and uncontrolled epilepsy treated with antiepileptic drugs (AEDs). Methods: Children (<. 12. years old) with epilepsy (ICD-9-CM 345.xx or 780.39) in 2008 were identified in the MarketScan claims database from 2007 to 2009. Patients with "stable" epilepsy used the same AED for ≥. 12. months, and patients with "uncontrolled" epilepsy were prescribed additional AED(s) during that period. For patients with uncontrolled epilepsy, the study index date was the start of additional AED(s); for patients with stable epilepsy, the study index date was a random AED fill date. Epilepsy-related utilization included medical services with 345.xx or 780.39 in any diagnosis field and AED fills. Epilepsy-related costs included AEDs, medical claims with epilepsy in any diagnosis field, and certain tests. We adjusted for baseline cohort differences (demographics, region, usual-care physician specialty, and comorbidities) using logistic regression and analysis of covariance. Results: Two thousand one hundred seventy patients were identified (mean: 7.5. years; 45.3% were female; Charlson comorbidity index: 0.3; 422 (19.4%) patients with uncontrolled epilepsy). Patients with uncontrolled epilepsy faced more hospitalizations (30.1% vs. 12.0%) and greater overall ($30,343 vs. $18,206) and epilepsy-related costs ($16,894 vs. $7979) (all p<.001). Adjusting for baseline measures, patients with uncontrolled epilepsy had greater odds of hospitalization (OR: 2.5; 95% CI: 1.9-3.3) and costs (overall: $3908, p=.087; epilepsy-related: $5744, p<.001). Conclusions: Children with uncontrolled epilepsy use significantly more healthcare resources and have a greater economic burden than children with stable epilepsy. However, epilepsy accounted for only half of overall costs, indicating that comorbid conditions may add substantially to the disease burden. © 2014 Elsevier Inc.

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