Reimbursement Recommendations Based on Phase II Clinical Evidence for Oncology Drugs in Canada

VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8

novel cancer drugs in each country. We use ordinary least squares regression with a large number of control variables and fixed effects, as well as instrumental variables estimation to address the potential endogeneity of the timing of new treatment launches across countries.  Results: On average, an additional drug approved to treat a site-specific cancer is associated with a decline in mortality of 2-3%. The gains vary across countries and cancer sites.  Conclusions: The availability of novel cancer therapies can be linked to reductions in site-specific mortality across countries. Differences between countries may be useful in identifying effective policies, such as those associated with recommended treatment guidelines and health technology assessments. PCN163 Reimbursement Recommendations Based on Phase II Clinical Evidence for Oncology Drugs in Canada Milenkovski RB, Yunger S, Shum D Hoffmann-La Roche, Mississauga, ON, Canada

Objectives: The pan-Canadian Oncology Drug Review (pCODR) evaluates clinical and economic evidence to make formulary listing recommendations to the Canadian provinces and territories, except Quebec, for oncology drugs. Generally, Phase III clinical evidence is the gold standard used by reviewers to make decisions. However, some oncology drugs can receive regulatory approval based on promising Phase II results and thus can be submitted to pCODR. There is limited published research examining the level of clinical evidence required for a positive recommendation. The objective of this study was to identify conditions where submissions may receive positive recommendations from pCODR based only on Phase II data.  Methods: All pCODR decisions from July 2011 to January 2016 were reviewed to determine whether the clinical evidence submitted was from Phases II or III trials. Public sources were used to identify the trials submitted and the recommendation decision.  Results: 16% (10 of 61) of submissions were based solely on Phase II data. 70% (7 of 10) received positive recommendations, of which 71% (5 of 7) were indicated for hematological tumors and 29% (2 of 7) were indicated for skin tumors. Decisions resulting in positive recommendations cited compelling Phase II data, the infeasibility of Phase III trials, small patient populations and/or a lack of alternative effective treatments for the given population. Drugs not receiving positive recommendations were indicated for solid tumors and had ongoing Phase III trials.  Conclusions: Regulatory agencies have been willing to approve oncology drugs based on Phase II data while further evidence is collected in Phase III trials. However, only drugs for hematological and rare cancers where Phase III trials are not feasible are likely to receive positive formulary recommendations from pCODR with Phase II evidence. Alternative reimbursement models may be needed to ensure temporary access for patients while additional data is collected and a subsequent pCODR submission is reviewed. PCN164 Trends in Expenditures for Oral Chemotherapy after Market Entry (2007-2013) Bennette CS1, Basu A1, Richards C2, Sullivan SD1, Ramsey S1 of Washington, Seattle, WA, USA, 2Aetion, Inc., NEW YORK, NY, USA

1University

Objectives: The cost of treating cancer has risen to unprecedented levels, putting tremendous financial pressure on patients, payers, and society. Prior studies have documented the rising prices of cancer drugs at market entry, but less attention has been paid to trends in prices after market entry. The objective of this study was to examine post-entry trends in expenditures for recently FDA-approved orally administered anticancer drugs.  Methods: We measured patient and health plan expenditures for a 30-day supply of recently FDA-approved orally administered anticancer drugs using pharmacy claims from Truven Health Analytics MarketScan Databases. We used fixed-effects regression with time-varying covariates to explore whether changes in average expenditures for each drug measured quarterly were associated with receipt of a supplemental indication or introduction of a competitor. Expenditures were adjusted to 2014 USD using the consumer price index.  Results: Between 2007 and 2013, expenditures for a 30-day supply of each drug grew 5.2% (95% CI: 4.6%, 5.8%) per year. After adjusting for these trends, we found that expenditures for each drug did not change significantly in the quarter in which a new indication was approved; however, they rose significantly faster in subsequent quarters (expenditures rose 1.7% [95% CI: 0.6%, 2.7%] faster per year after FDA-approval of each supplemental indication). In contrast, expenditures declined immediately when a competitor entered the market (declining 7.9% [95% CI: 5.7%, 10.1%] in the same quarter a competitor was introduced); however, this decline was followed by a significantly faster increase over time that negated the initial decline within two years.  Conclusions: Our findings suggest there is currently little competitive pressure on oral chemotherapy costs after market entry. Further work is needed to understand how evidence regarding clinical benefits for newer oral chemotherapy agents changes over time, both within and across indications, and whether these changes are associated with the spending trends we observed. PCN165 Analysis of Medication Expenses of Inpatients with Liver Cancer with Basic Medical Insurance Scheme for Employees in China Li Y1, Ma Y2, Fang Y2, Zhu C1 of Medicinal Plant Development, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, 2Beijing University of Chinese Medicine, Beijing, China

A163

hospitalization expenses:drugs 49.53%, diagnosis and treatments 41.88%, medical consumables 8.59%.The drug proportion was decreasing year by year and the diagnosis and treatments continued to increase.Western medicine accounted for 80.04% in all drug and Chinese patent medicine was19.96%.Traditional Chinese medicine injection accounted for 66.36% in all Chinese patent medicine, and the proportion is enlarged. Reimbursement rate of western medicine was 67.16% by medical insurance fund,and Chinese patent medicine was 77.54%.  Conclusions: Since 2009 years,Our government set up medical system reform,hoping to reducemedical costs by lowering drug proportion.Our research found that the medical costsdid not rise less quickly,because diagnosis and treatments continued to increase.From 2010 to 2013,the composition of western medicine and Chinese patent medicine showed little change.Reimbursement rate of western medicine and Chinese patent medicine by medical insurance fund had a bigger disparity, and it may be many new durgs had been approved for marketing in recent years,but few of Chinese patent medicine. PCN166 The Influences of Access to Care and Geographic Factors on Adjuvant Endocrine Therapy use among Breast Cancer Survivors in Appalachia Tan X1, Marshall V2, Camacho F3, Donohoe J4, Anderson RT3, Balkrishnan R5 1West Virginia University, Morgantown, WV, USA, 2University of Michigan, Ann Arbor, MI, USA, 3University of Virginia, Charlottesville, VA, USA, 4Mountain-Pacific Quality Health, Helena, Helena, MT, USA, 5University of Virginia School of Medicine, Charlottesville, VA, USA

Objectives: This study explored specific geographic areas with suboptimal AET-use outcomes in a retrospective cohort of breast cancer survivors in Appalachia, a poor and underserved region of the United States.  Methods: We analyzed Medicare claims data linked with cancer registries from January 1, 2006 to December 31, 2008. The study included adult women who lived in Appalachian counties in PA, OH, KY, and NC and were diagnosed with stage I-III, HR-positive, primary breast cancer in 2007. We used logistic regression to assess the receipt of guideline-appropriate AET, and hot spot analyses and geographically weighted generalized linear regression to explore geographic variations and clustering patterns of AET adherence.  Results: We found that unmarried women, dual Medicaid and Medicare eligibility, shorter travel time to receive care, and residence in Pennsylvania versus Ohio were significantly associated with high likelihood of receiving guideline-recommended AET. Using Getis-Ord Gi* Z-scores hot-spot analysis, we found clustering of poorer adherence (cold spots) in Erie, PA and Asheville, NC, as well as clustering of better adherence (hot spots) around Pittsburgh, PA and Harrisburg, PA. Significant predictors of AET adherence in the geographic weighted regression included whether patients lived in a health-resource-shortage area, had dual-eligibility, ever reached the out-of-pocket threshold, took tamoxifen versus aromatase inhibitors, and used pain medications to treat AET-related side effects.  Conclusions: This study shows that geography plays an important role in AET use in Appalachia, and is determined by several factors: travel time to receive care, receipt of guideline-recommended AET, living in a health-resource-shortage area, geographic variations in the impact of AET-related adverse effects, and the influence of prescription drug plans on AET adherence. The study findings suggest the need for localized interventions to improve adjuvant therapy use and survivorship care in the growing population of breast cancer survivors in Appalachia. PCN167 Association Between Substance use Intervention and Mortality in Elderly Prostate Cancer Patients Chhatre SJayadevappa R, University of Pennsylvania, Philadelphia, PA, USA

Objectives: To study the association between treatment for substance use and mortality among elderly fee-for-service Medicare enrollees diagnosed with advanced prostate cancer.  Methods: We used SEER-Medicare linked database to extract a cohort of men diagnosed with advanced prostate cancer between 2001 and 2004. We then identified those men with a diagnosis of substance use disorder. Medicare claims were used to identify non-pharmacological treatments for substance use. We used Cox regression to determine the association between treatment for substance use and five-year all-cause mortality.  Results: We identified 1,509 elderly men with advanced prostate cancer and substance use disorders. Of these, less than five percent had any claim for non-pharmacologic treatment of substance use in the five-year period following prostate cancer. Those treated for substance use vs. those not treated for substance use had comparable demographic and clinical characteristics. Results of Cox regression showed that compared to those not treated for substance use, patients receiving substance use treatment had lower hazard of all-cause mortality (HR 0.72 ; 95% CI 0.47, 0.97). Propensity score and instrumental variable approaches were used to minimize selection bias.  Conclusions: Among elderly fee-for-service Medicare elderly with prostate cancer and substance use disorder, non-pharmacologic treatment for substance use may reduce hazard of mortality. However, the uptake of treatment for substance use treatment was very small. Substance use disorder continues to be an under-appreciated co-morbidity in elderly cancer patients. Cancer related pain and impaired outcomes are common among advanced stage prostate cancer patients. Integrated policies and coordinated care is essential to effectively screen, refer and treat substance use, as well as to improve uptake of substance use treatment among elderly prostate cancer patients.

1Institute

Objectives: We studied the changing trends on medicine expenses of liver cancer inpatients withbasic medical insurance scheme for employees from 2010 to 2013 in China.  Methods: A nationwide, cross-sectional sampling of liver cancer inpatients with disease code ICD-10 (C22) with basic medical insurance scheme for employees was extracted from CHIRA claim database.A retrospective analysis was adopted.  Results: Of the 9,716 hospitalization patients had been diagnosed with liver cancer inpatients,75.43% were men with a mean age of 59.23 years and 17.77% werewomen with a mean age of 61.36 years.From 2010 to 2013,the composition of

PCN168 Prescribing Patterns For Patients With Prostate Cancer In The United States: 2006-2010 Gangal NS, Kelton CM, Heaton P University of Cincinnati, Cincinnati, OH, USA

Objectives: Prostate cancer is the second most prevalent cancer in the United States. There are a number of different treatment options, and physicians develop treatment plans based on various factors such as tumor type and size, cancer stage, speed of disease progression, patient life expectancy, and patient preference.