Overview and Comparison of Frameworks for the Valuation of Oncology Drugs

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nificant OS data and the factors that may have influenced pCODR recommendations.  Methods: Final pCODR recommendations and clinical guidance reports publicly accessible at www.cadth.ca and reimbursementdecisions.com were reviewed from 13 July 2011 to 30 November 2015.  Results: Sixty-three recommendations were issued by pCODR; 48 (76%) were positive (i.e., without criteria/ conditions, conditional on improved cost effectiveness, or restricted patient population) and 15 (24%) were negative (i.e., uncertain/insufficient clinical benefit and/ or uncertain cost effectiveness). Among positive recommendations, 23 (48%) had statistically significant OS data and 25 (52%) did not assess or have statistically significant OS data. Among negative recommendations, 4 (27%) had statistically significant OS data and 11 (73%) did not assess or have statistically significant OS data. Ten (40%) positive recommendations without statistically significant OS data noted crossover as a potential confounder of OS, compared with only one (9%) among negative recommendations. A greater proportion of positive recommendations without statistically significant OS data (52%) had statistically significant progression-free survival (PFS) data than negative recommendations (45%).  Conclusions: This study highlights that positive pCODR recommendations may be made in the absence of a clear OS benefit, likely due to crossover as a confounder and/or presence of strong PFS data. Further research may determine additional factors contributing to positive and negative pCODR recommendations despite unavailable OS data. PCN192 Analysis of Access to Harvoni for Medicare Patients in all Fifty States in the US

manner. This research intends to identify such tools and gain a better understanding of their similarities and differences. Methods: Non-systematic literature and online searches were conducted to identify these value frameworks and to obtain information about their methodologies and perceived strengths and limitations.  Results: Seven tools were deemed relevant and investigated in detail. The PASKWIL criteria were introduced in the Netherlands in 2000 and the Cancer Drugs Funds prioritization tool has been used in the United Kingdom for a few years. Frameworks that have emerged in 2015 include the ESMO Magnitude of Clinical Benefit Scale (in Europe) and the ASCO Value Framework, the NCCN Evidence Blocks, the MSKCC DrugAbacus, and the ICER Value Framework (in the United States). Some of these tools intend to facilitate patient and physician decision-making (PASKWIL, ASCO, NCCN), whereas the others aim to influence policy-making or price negotiations. There is no consensus in the literature or public discussion about what dimensions should be taken into account to assess value, how they should be incorporated, or how much weight each of them should be given. Several of the tools only use results from comparative trials and restrict the inclusion of data from single-arm or real-world studies. Some frameworks are based on scoring processes that involve either expert opinion or arbitrary cut-off values. The limitation highlighted by commentators most frequently, however, is that the frameworks are not sufficiently patient-centered, as quality-of-life measurements, patient-reported outcomes, and patient preferences are rarely included or not given much weight.  Conclusions: These frameworks significantly vary in terms of target audience, methodology, development stage, and value assigned to therapies. It remains to be seen whether the approaches will converge in the future.

Aggarwal S1, Kumar S2, Topaloglu H1 1NOVEL Health Strategies, Chevy Chase, MD, USA, 2Institute for Global Policy Research, Washington, DC, USA

PCN195 Factors Influencing Resection in Locoregional Pancreatic Cancer Patients

Objectives: Harvoni is one of the new breakthrough chronic hepatitis C drugs which was approved by the FDA. Due to high price and high cure rates, insurance plans have expressed concerns regarding its potential high budget impact. The objectives of this study were to review and analyze the access trends for Harvoni in all fifty states in the US.  Methods: The coverage trends for Harvoni in all fifty states were obtained from CMS. For each plan the data was obtained for the tier status, deductibles, and type of restrictions. The coverage trends were analyzed by plan type, state level and at a national level.  Results: In all fifty states 1168 coverage policies were identified for Harvoni. While Tier coverage varied from 4 to 6, 95% of the plans covered Harvoni at Tier 5. The median number of health plans in each state covering Harvoni was 24. 100% of the plans imposed a prior authorization, an 72% also imposed quantity limits. 100% of the plan coverage was at ‘specialty tier’. The co-insurance for Harvoni ranged from 25%-33%. For majority of the plans (55%, 639 plans) the coinsurance was 25%. Approximately, 37% (427) of the plans had a relatively high coinsurance of 33%. The average 30 day retail price (full treatment cost) for Harvoni was $98,618, with a standard deviation of $1816. The price varied by plan type and not by region/state. The minimum and maximum price in all states were $95,866 (EnvisionRx) and $103,488 (SilverScript).  Conclusions: U.S. coverage trends for Harvoni shows relatively restricted access with mainly Tier 5 coverage, 100% prior authorization 25-33% co insurance. New policies might be needed to ensure proper access to such drugs for patients.

Cunningham A, Chen B, Delgado D Thomas Jefferson University, Philadelphia, PA, USA

PCN193 Patient Access to Oral Breakthrough Cancer Drugs in the United States Aggarwal S1, Kumar S2, Topaloglu H1 1NOVEL Health Strategies, Chevy Chase, MD, USA, 2Institute for Global Policy Research, Washington, DC, USA

Objectives: During 2011-2015, new breakthrough cancer treatments were approved by the FDA. However, due to high drug cost, insurance plans might be restricting access to new drugs. The objectives of this study were to review and analyze the access trends for new oral breakthrough cancer drugs in the US.  Methods: The coverage trends in five states (i.e., FL, IL, NY, TX and CA), covering ~116 million lives, were obtained from CMS. For each plan the data was obtained for the drug name, tier status, deductibles, and type of restrictions. The coverage trends were analyzed by drug name, state level and at a national level. A chi square test was conducted to test differences in percentage coverage for individual drugs.  Results: In the selected five states, 990 coverage policies were identified for the five approved oral breakthrough cancer drugs. Among them, 35%, 24%, 16%, 12% and 12% of the coverage policies are for Ibrance, Zydelig, Ofev, Imbruvica and Zykadia. The Tier coverage for these drugs varied from 4-6. Overall, 94% of the plans covered these drugs at Tier 5, and remaining 5% and 2% covered them at Tier 4 and Tier 6, respectively. 100% of these tier type were ‘specialty tier’. There were no statistically significant differences in Tier coverage among the five drugs. The co-insurance for the five drugs ranged from 25%-33%. For majority of the plans (58-68%) the coinsurance was 25%. Prior authorizations with quantity limits were imposed by 97% of the plans. The most common quantity limit was 21 pills for 28 days. The 30 day retail price for these drugs ranged from $8204 to $14590.  Conclusions: U.S. managed care access for new cancer drugs shows highly restricted market access, which is independent of individual drug’s indication or price. New policies might be needed to ensure proper access to these drugs for patients. PCN194 Overview and Comparison of Frameworks for the Valuation of Oncology Drugs Maervoet J1, Moise P2, Naidoo S3 Services, Brussels, Belgium, 2Quintiles Advisory Services, Paris, France, 3Astellas Medical Affairs Global, Chertsey, UK

1Quintiles Advisory

Objectives: Several health-related and professional organizations have developed frameworks to assess the value of oncology drugs in a systematic and transparent

Objectives: An estimated 48,960 Americans will be diagnosed with pancreatic cancer in 2015, and 40,560 will die from the disease. Surgery is the only potentially curative treatment, but a significant portion of those eligible for pancreatic cancer resection do not receive it. Our objectives are to describe the demographics of locoregional pancreatic cancer patients in a national sample and identify factors associated with pancreatic cancer resection.  Methods: The sample included patients from 2004-2012 Surveillance, Epidemiology and End Results (SEER) data age 15 and older with a primary diagnosis of AJCC Stage 1 or 2 cancer in the pancreas head, body, or tail. We excluded individuals with a diagnosis via death certificate/ autopsy or incomplete surgical data. We used descriptive statistics, chi-square analyses to identify associations, and then multivariate logistic regression to create a final model of predictors of pancreatic cancer resection.  Results: The final sample consisted of 16,676 locoregional pancreatic cancer patients. 61.50% were 65 or older; 71.07% were non-Hispanic white, 51.15% were female, and 56.89% were married. 51.12 % of patients underwent resection. The most common reasons for no surgery were “surgery not recommended” (38.82%), “contraindicated/ autopsy diagnosis”(4.96%) and “patient or guardian refused”(2.07%). Non-Hispanic black(OR= 0.69, 95% CI [0.62-0.77]), Hispanic(OR= 0.80, 95% CI 0.71-0.89]) or other race/ethnicity(OR= 0.86 95%CI [0.75-.98]) predicted lower odds of resection, as did being age 65-74/75 and older(OR= 0.70, 95% CI [0.65-0.76]), OR= 0.28, 95% CI [0.250.30]), male(OR= 0.91, 95% CI [0.85-0.98]) and unmarried(OR= 0.71, 95% CI [0.66-0.76]), when controlling for registry, stage, and tumor location.  Conclusions: Nearly half (48.88%) of locoregional pancreatic cancer patients do not receive surgery. Nonwhite race/ethnicity, older age, male sex, and being unmarried are associated with not undergoing resection. Further research should explore SEER-Medicare linked data, care patterns at high versus low volume hospitals, and regional care patterns to develop interventions to increase resection rates and improve survival. PCN196 Patients with Recurrent/Metastatic Head and Neck Cancer: Understanding the Burden of Disease Baxi S1, Sherman E1, You M2, Bobiak S2 1Memorial Sloan Kettering Cancer Center, New York, NY, USA, 2Bristol-Myers Squibb, Plainsboro, NJ, USA

Objectives: The objective of this study is to describe patients diagnosed with recurrent/metastatic squamous cell carcinoma of the head and neck (HNSCC) and examine their healthcare resource utilization (HCRU).  Methods: This is a retrospective study utilizing a claims-based dataset of commercially insured patients with diagnostic evidence of HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx between January 2007 and June 2015. All patients had regionally recurrent (RR; cervical lymph nodes diagnosed ≥ 6 months after diagnosis) or distant metastatic (DM) disease and a single-cancer diagnosis, were ≥ 18 years old, and were continuously enrolled in the same health plan for ≥ 6 months. Descriptive statistics were used to compare patient and disease characteristics and analyze HCRU.  Results: A total of 76,561 patients were diagnosed with HNSCC, of which 13% had RR or DM. Among them 407 RR patients and 647 DM patients met the inclusion criteria. Median age was 58 years; 77% of patients were male. Among patients with DM disease, the site of metastasis was not identified in about half the patients; when a specific site was provided, the most common sites included lung (15%) and bone/bone marrow (5%). Incident rate of hospitalizations per person per year and length of hospital stay did not vary by DM site of metastatic disease. HCRU was higher among patients with DM than patients with RR, with more hospitalizations per person per year (DM= 1.38 hospitalizations, 95% CI [1.27–1.50]) vs RR= 0.52 hospitalizations (95% CI [0.44–0.60]) and a longer average hospital stay (DM= 6.2 days vs RR= 4.7 days, P≤ .01).  Conclusions: Recurrent/metastatic disease affects more than one in ten HNSCC patients and remains a burdensome disease to these patients. Among patients with DM disease, however, hospital related healthcare resource use was significantly higher as demonstrated by more frequent hospital visits and longer hospital stays.