PIPC Weekly Update - Feburary 17, 2015

In This Week’s Issue: 
1. PIPC Comments on Energy and Commerce Committee's '21st Century Cures' Discussion Draft, click here to view the letter. 
2. Avalere White Paper: Facilitating a Transition to Using PROs to Measure Performance, click here to read the White Paper. 
3. Reminder: PCORI Dissemination Advisory Panel Applications Due February 23, click here for more details. 
4. The Pink Sheet: Life After White Oak: Hamburg's Predecessors Offer Glimpse At Where Pharma Might See Her Again, click here to view the article (subscription required). 
5. PCORI Blog: How Clinicians Are Helping to Shape PCORI-Funded Research, click here to view the blog post.  
6. The Pink Sheet: PCORI Hep C Drug Trials Will Gather Long-Term Outcomes Data, click here to view the article (subscription required). 
7. Medical Journal Articles, see below for details. 
8. AHRQ Effective Program Updates, see below for details. 

1. PIPC Comments on Energy and Commerce Committee's '21st Century Cures' Discussion Draft 
Last week, the Partnership to Improve Patient Care submitted comments to the House Energy and Commerce Committee on the '21st Century Cures' discussion draft.  PIPC supports the goals of the 21st Century Cures Initiative of accelerating discovery, development and delivery of innovative treatments for many diseases that do not currently have treatment options. We applaud the House Energy and Commerce Committee for starting this discussion, and urge Chairman Fred Upton and Congresswoman Diana DeGette to work toward expanded innovation and access in a bipartisan manner. 
Since its founding, the PIPC has been at the forefront of patient-centeredness in comparative effectiveness research (CER) – both its generation at the Patient-Centered Outcomes Research Institute (PCORI), and its translation into patient care. Having driven the concept of patient-centeredness in the conduct of research, PIPC looks forward to bringing the patient voice to the discussion of how to advance patient-centered principles throughout an evolving health care system. 
We are very pleased to see the Committee’s focus on incorporating patient perspectives into the regulatory process and to help address their unmet medical needs as part of building the foundation for 21st Century medicine.  We would also urge the Committee to more explicitly recognize as a goal of its work the need to ensure health care decisions are made based on the principles of shared decision-making. This means arming patients and providers with the evidence and tools necessary to make informed decisions based on the needs, preferences, and circumstances of the individual patient.  It also means establishing policies that incentivize providers and empower patients to make informed treatment decisions within new payment models.  
We agree with the Committee’s analogy that “[t]he discovery, development, and delivery process is a cycle, meaning that data captured and analyzed on the delivery side informs new discoveries and better, more targeted solutions for patients.” On the upswing of that cycle, if being implemented in compliance with principles of patient-centeredness, is an informed and empowered patient being treated by providers with the tools to deliver personalized care. Our comments will therefore focus on the need to develop policies that ensure patient engagement and capture patient preferences to support the discovery, development, and delivery of innovative new medicines. Click here to view the full comment letter. 

2. Avalere White Paper: Facilitating a Transition to Using PROs to Measure Performance 
Avalere released its white paper on patient-reported outcomes (PROs) earlier this month in collaboration with leaders from patient, payer, health information technology, product development and research communities, including PIPC.  “In 2014, more than 18 organizations spanning payers, providers, patient groups and government had the opportunity to examine, explore, and provide recommendations on PROs, measures that assess quality from the patient’s perspective. PROs are becoming an increasingly important component of our healthcare system given of the rise of new payment and delivery models that rely on good definitions of “value,” and therefore, must ensure patient perceptions of that value are measured.”  Click here to read the full White Paper. 

3. Reminder: PCORI Advisory Panel Applications Due February 23 
As a reminder, PCORI has openings on its Advisory Panel on Communication and Dissemination Research for terms beginning in 2015. The deadline to submit an application to be considered for these positions is February 23, 2015, 5:00 p.m. ET.  Click here for more details. 

4. The Pink Sheet: Life After White Oak: Hamburg's Predecessors Offer Glimpse At Where Pharma Might See Her Again Recently, Sarah Karlin of The Pink Sheet reported, “[Mark McClellan] said he doesn't see the increased focus on value and new payment models as necessarily leading to any fundamental changes at FDA, including more FDA-CMS interaction[...] However, as the push for better outcomes at lower costs continues, he believes industry will change some of its fundamentals. For instance, he said more companies may be looking for ways to make comparative effectiveness claims.” Click here to view the full article (subscription required). 

5. PCORI Blog: How Clinicians Are Helping to Shape PCORI-Funded Research 
Late last week, Kimberly Bailey, Engagement Officer, and Susan Hildebrandt, Director of Stakeholder Engagement, penned a blog for PCORI commenting that, “Clinicians have worked with researchers to analyze several large national datasets that include clinical registry data, claims data, and patient-reported outcomes. The clinicians posed important questions that helped refine the project's direction. As a result, the study is now looking more closely at variations in patterns of care delivery and the outcomes that result. Evidence of trade-offs between different types of rehabilitation will help guide individual decisions and improve future practice, policy, and patient-centered outcomes for stroke survivors.” Click here to view the full blog.  

6. The Pink Sheet: PCORI Hep C Drug Trials Will Gather Long-Term Outcomes Data Last week in The Pink Sheet Daily, “Comparative studies of drugs used to treat hepatitis C funded by the Patient Centered Outcomes Research Institute will focus on whether the cures seen over the short term in clinical trials translate into long-term positive outcomes for patients, with studies lasting up to five years...PCORI also is interested in gathering information from these studies on how treatment effectiveness varies between treatment populations, on the most effective approaches to delivering treatment and on sustaining treatment effectiveness, particularly in higher-risk populations.” Click here to view the full article (subscription required).

7. Medical Journal Articles 
Automated Confidence Ranked Classification of Randomized Controlled Trial Articles: An Aid to Evidence-Based Medicine: Click here to view.  Letter: Increasing Patient Participation in Drug Development: Click here to view.  European Collaboration on Relative Effectiveness Assessments: What Is Needed to Be Successful? Click here to view.  Comparative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccines in US Residents Aged 65 Years and Older from 2012 to 2013 Using Medicare Data: A Retrospective Cohort Analysis: Click here to view. 
Comparative Outcome Studies of Clinical Decision Support Software: Limitations to the Practice of Evidence-Based System Acquisition: Click here to view. 
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8. AHRQ Effective Program Updates 
Working Paper: Patient Responses to Incentives in Consumer-Directed Health Plans: Evidence from Pharmaceuticals: Click here to view the report. 
Interventions to Improve Appropriate Antibiotic Use for Acute Respiratory Tract Infections: Click here to comment before March 9, 2015.