CER Daily Newsfeed®
Articles
Study Finds Over 100 Value-Based Contracts (2/13, Steve Usdin, BioCentury) reports “Despite legal barriers and practical obstacles, over 100 value-based contracts were negotiated between drug manufacturers and payers from 2014 to 2017, according to a study conducted by researchers at Duke University's Robert J. Margolis Center for Health Policy and the National Pharmaceutical Council...The study describes value-based arrangements as including outcomes- and performance-based contracts, as well as risk-sharing agreements that ‘link coverage, reimbursement, or payment for a product to a prespecified clinical or financial/utilization outcome or set of outcomes.’ It found that the most common outcome measures used were drug utilization and laboratory test values. The most common incentives were larger rebates to payers.” Full
How Utilizing Data Can Impact Health Costs, Improve Employee Health (2/13, Nick Otto, Employee Benefit News) reports “...The key is looking beyond the silo of clinical effectiveness, added [Wayne Burton, former chief medical officer at American Express], to how different treatment options impact employee health and productivity. Burton noted that there are two key questions being asked when using evidence-based data: What is the effectiveness, and what is the cost offset? ‘The [treatment] cost might be high, but the price of in-patients [to the ER] dramatically dropped,’ he said. That's the importance of translating comparative effectiveness research.” Full
Data As Currency: The Value of Longitudinal Data for Pharma (2/13, William T. Sander, PharmExec) reports “...In its December statement, the FDA recognized the value that RWD and RWE can have on such postmarketing studies...In addition, the FDA says it is also using RWD and RWE as part of the information it takes into consideration when evaluating new drug applications from pharma companies. ‘We currently have new drug applications under review where RWD and RWE are helping to inform our ongoing evaluation as one component of the total complement of information that we're evaluating,’ the organization says.” Full
FDA Approved Record Number of Personalized Medicines in 2018: Report (2/13, Jacqueline Renfrow, Fierce Healthcare) reports “...The Personalized Medicine at FDA: A Progress & Outlook Report gives credit to the FDA for accelerating the trend of patients and payers embracing personalized medicine. In fact, personalized medicines have made up 20% of FDA approvals over the last five years, with that number jumping to 40% in 2018. Specifically, 25 of the 59 new molecular entities that the FDA approved in 2018 were personalized medicines.
Tackling Adherence Is "Only Sustainable Path to Profit" (2/14, Amanda Barrell, PharmaPhorum) comments “...Twenty-one of the world's largest pharmaceutical companies could increase revenue and earnings per share simply by modestly boosting adherence rates. Sanofi, for example, could increase revenue by up to 12% and EPS by up to 20% between 2020 and 2026. Novo Nordisk could experience up to 29% greater revenue and 45% higher EPS in the same period...The report – The Pharmaceutical Triple Aim: Higher Medication Adherence Increases Revenue and EPS for Pharma, Improves Patient Outcomes and Lowers Healthcare Costs – was published in January, but the issue is far from new, and this latest analysis builds on a Credit Suisse investors' note from March 2018.” Full
How Machine Learning and Artificial Intelligence Might Influence Social Determinants of Health (2/14, Emily Willingham, Association of Health Care Journalists: Covering Health) comments “...The Patient-Centered Outcomes Research Institute has devoted part of its website to addressing crucial issues in telehealth and the potential upsides and downsides. What the site does not yet dig into is how artificial intelligence will play into the delivery of telehealth, especially to under-resourced populations. That's in part because machine learning and AI are just now touching the realm of possibility when it comes to distance diagnostics.” Full
Life after Cancer: More Survivors Living Longer, Facing New Health Challenges (2/14, Kim Painter, USA Today) reports “...‘The number of cancer survivors continues to grow, yet high-quality, coordinated survivorship care is still infrequent,’ experts from the National Academies of Sciences, Engineering, and Medicine said in a recent follow-up report...‘Strides have been made, but there's also been an acceleration in the demand,’ says Neeraj Arora, associate director for science at the nonprofit Patient-Centered Outcomes Research Institute. Arora, a 25-year survivor of non-Hodgkin lymphoma, helped write the report.” Full
UK: NICE Provides First Scientific Advice on Patient Preference Study Design (2/14, Anna Smith, PharmaTimes) reports “...NICE anticipates that its advice will guide early evidence generation, helping to transform study design and improve the quality of current processes, with aim to support the development of new products to treat COPD patients. Jeanette Kusel, Director of NICE Scientific Advice said: ‘We are delighted to be able to shape our offering to suit the requirements of Novartis by offering advice and guidance on their patient preference study, which should help it to generate the data required to help future products meet the needs of COPD patients.’” Full
UK: Novartis First to Benefit from NICE Advice on ‘Patient Preference' (2/14, Andrew McConaghie, PMLiVE) reports “...Nigel Cook, Head of Decision Support & Insights, Global Patient Access at Novartis said: ‘The scientific advice provided by NICE, together with the patient representative and other external experts, has been very valuable to Novartis; both in endorsing the approach to gathering early patient preference data to inform evidence generation plans, and in regard to valuable input received to improve the design of the COPD patient preference study.’” Full
Japan Firms Up Cost-Effectiveness Plans As Industry Concerns Linger (2/13, Ian Haydock, Pink Sheet) reports “...Japan is taking new steps to expand what has so far been a pilot-scale cost-effectiveness assessment scheme for drugs and medical devices, a move that may lead to price adjustments for selected products, potentially including some already marketed drugs...The trial CEA scheme has so far led to 13 products (including seven devices) being designated for cost-effectiveness assessment, resulting in the repricing of two products in April 2018 as part of the wider regular biennial drug price revision in Japan at that time.” Paid Subscription Required
Press Releases
TARGET PharmaSolutions® Launches TARGET-DERM Real-World Observational Study to Advance the Understanding of Atopic Dermatitis (Eczema) and Other Immune-Mediated Inflammatory Skin Conditions (2/13, TARGET PharmaSolutions, Inc. Press Release) “...The study will deliver real-world evidence for several immune-mediated inflammatory skin conditions, initially focusing on patients with atopic dermatitis (AD/eczema). TARGET-DERM's first participant enrolled on January 25, 2019. The trial will enroll up to 15,000 participants, including adult and pediatric patients, at up to 100 sites in the United States, Canada and Europe. TARGET-DERM will eventually include the skin conditions hidradenitis suppurativa (painful bumps under the skin), alopecia areata (autoimmune-related hair loss), and vitiligo (loss of skin pigment).” Full
Journals
Time-Dependent Biases in Observational Studies of Comparative Effectiveness Research in Rheumatology. A Methodological Review Iudici M, et al. February 12, 2019, Annals of the Rheumatic Diseases PubMed
Economic Evaluation of Sunitinib Versus Pazopanib and Best Supportive Care for the Treatment of Metastatic Renal Cell Carcinoma in Chile: Cost-Effectiveness Analysis and a Mixed Treatment Comparison Vargas C, et al. February 13, 2019, Expert Review of PharmacoEconomics and Outcomes Research PubMed
Systematic Reviews of Health Economic Evaluations: A Structured Analysis of Characteristics and Methods Applied Miriam Luhnen, et al. February 13, 2019, Research Synthesis Methods Wiley
The Value and Consequences of Using Public Health Technology Assessments for Private Payer Decision-Making in Canada: One Size Does Not Fit All Pericleous L, et al. February 13, 2019, Journal of Medical Economics PubMed
Reports
Personalized Medicine at FDA: A Progress & Outlook Report February 2019 Personalized Medicine Coalition
Events
Health Affairs Briefing: Patients As Consumers March 5, 2019 9:00AM - 12:30PM EST National Press Club Washington, DC Health Affairs
Articles
Value-Based Agreements May Be More Prevalent Than Assumed (2/13, National Pharmaceutical Council: E.V.I.dently Today) comments “Research published in the The American Journal of Managed Care shows that value-based agreements between U.S. payers and biopharmaceutical manufacturers may be more prevalent than originally thought. Researchers from the Duke-Margolis Center for Health Policy and the National Pharmaceutical Council conducted the study, believed to the first of its kind, to better understand current activity in value-based contracting.” Full
Preparing Patients and the Health System for Curative Therapies in the Pipeline (2/12, Laura Joszt, The American Journal of Managed Care) reports “...During ‘Paying for Cures: Ensuring patient access and system sustainability,’ a 1-day event in Washington, DC, panelists discussed how the system can catch up with the science by examining ways to pay for products that have high upfront costs with benefits that accrue over time. curative therapies put people in. The patient advocacy business model is more than 300 years old, and advocacy has always had a huge focus on finding a cure. ‘And now, for the first time, we're actually talking about cures, [which] upends the entire dynamic for people with chronic conditions,’ he said.” Full
Examining New Payment Ideas for Curative Therapies (2/13, Allison Inserro, The American Journal of Managed Care) reports “How can the health industry ensure that cutting-edge gene therapies and other curative treatments get to the patients that need them, without leaving payers financially exposed? Representatives of payers and biotechnology companies discussed some of the novel discussions that are taking place as they work through issues of expense and access during ‘Paying for Cures: Ensuring patient access and system sustainability,’ a 1-day event in Washington, DC.” Full
Value of Medicines Special Feature: The Unanswered Question of Value (2/13, Christiane Truelove, PharmaLive) reports “...‘To date, there are significant variations across countries in the HTA methodology used to measure and understand variations in outcomes across patient populations,’ ISPOR says. ‘A more unified approach to pricing could simplify the value assessment and evidence comparisons across geographies, reducing duplicative effort by both payers and drug companies across jurisdictions, and thereby strengthening payor understanding of decision-making relative to prices as well as sending clearer signals to drug developers as to likely returns on investment.’” Full
FDA's Real World Evidence Guidance Gains Industry Support, but With Slight Modifications (2/13, Alex Keown, BioSpace) reports “...On Tuesday, RAPS reported that since the FDA released its guidelines for the use of real-world evidence, industry leaders have provided some public commentary on the proposal. Andrew Emmett, senior director for Pfizer's FDA liaison office said in a comment on the proposal that the company believes the ‘framework is well-crafted and provides a promising roadmap for the future of FDA's RWE program,’ RAPS reported.” Full
Survey: Best Price Is A Barrier To Outcomes-Based Contracts (2/13, Rachel Cohrs, InsideHealthPolicy.com) reports “...Sixty-four percent of drug makers and 78 percent of payers that responded said the Medicaid best price rule was a major reason for thwarting outcomes-based contracts. Respondents also cited lack of data, legal concerns, disagreements on financial terms and lack of outcome measures as challenges. The study found that most outcomes-based contracts are not publicly disclosed-drug makers said 74 percent of their outcomes-based contracts signed between 2014 and 2017 were not made public, and payers kept 71 percent of those contracts to themselves.” Paid Subscription Required
UK: New NICE Guidelines on Antibiotic Prescribing for Pneumonia (2/13, Anna Smith, PharmaTimes) reports “[NICE] and Public Health England have published draft guidance on antimicrobial prescribing for hospital-acquired and community-acquired pneumonia, setting out a strategy designed to optimise antibiotic use and reduce antibiotic resistance. The new guidelines advise that antibiotics should be given to people with community- and hospital-acquired pneumonia within four hours of establishing a diagnosis.” Full
Press Releases
Research Published in AJMC Shows Value-Based Agreements May Be More Prevalent Than Assumed (2/13, National Pharmaceutical Council Press Release) “A recent survey of U.S. payers and biopharmaceutical manufacturers found that consideration of value-based agreements as a coverage and payment tool is increasing and the prevalence of VBAs is far greater than previously thought. Study participants—biopharmaceutical manufacturers and payers—reported entering into more than 100 VBAs between 2014 and 2017. However, only one in four were publicly announced...‘If we focus solely on the publicly known VBAs, we greatly underestimate the prevalence and potential impact of these arrangements in the market, and the progress being made to transition from volume to value more generally,’ said Robert Dubois, MD, PhD, chief science officer, National Pharmaceutical Council.” Full
Journals
Value-Based Arrangements May Be More Prevalent Than Assumed Nirosha Mahendraratnam, PhD; Corinna Sorenson, PhD, MHSA, MPH; Elizabeth Richardson, MSc; Gregory W. Daniel, PhD, MPH, RPh; Lisabeth Buelt, MPH; Kimberly Westrich, MA; Jingyuan Qian, MPP; Hilary Campbell, PharmD, JD; Mark McClellan, MD, PhD; and Robert W. Dubois, MD, PhD February 2019, The American Journal of Managed Care AJMC
Comparative Effectiveness of Teriflunomide and Dimethyl Fumarate in Patients with Relapsing Forms of MS in the Retrospective Real-World Teri-RADAR Study Robert Zivadinov, et al. February 13, 2019, Journal of Comparative Effectiveness Research Journal of Comparative Effectiveness Research
Articles
Real-World Evidence Takes Courage: A Conversation With IQVIA's Nancy Dreyer (2/11, Bridget Silverman, Pink Sheet) reports “...‘FDA is consistent and clear’ in its interactions with sponsors, Dreyer said. ‘The message they say is, come talk to us early. Come talk to us soon.’ Industry, however, has been reticent about bringing their RWE plans to FDA. ‘Pretty much every pharmaceutical company I work with, and it's a very large number, doesn't want to do that,’ she said...Dreyer did not know of any sponsors who failed when they brought RWE efficacy proposals to FDA. ‘What I am seeing is, companies they get discouraged internally.’” Paid Subscription Required
Panels Weigh Antidepressant That Used Randomized Withdrawal Trial (2/11, Beth Wang, InsideHealthPolicy.com) reports “...[I]n October, ICER released a draft scoping document outlining a planned review of comparative clinical effectiveness and value of Janssen's esketamine. The institute's Midwest Comparative Effectiveness Public Advisory Council will hold a meeting to discuss esketamine in May...As part of its value analyses, ICER will assess the lifetime cost-effectiveness of esketamine plus an oral antidepressant to an oral antidepressant alone for treatment of TRD.” Paid Subscription Required
Data Disruption and Applying ‘Enabled Intelligence' (2/11, PharmaPhorum) reports “...[Dr Radek Wasiak:] Although conventional randomised controlled trials remain the gold standard for regulatory submissions for marketing authorisations across the globe, they come with a number of limitations. These issues have raised the need for research with a more pragmatic focus designed to answer a somewhat different set of questions, directed at the real-world effectiveness and safety of interventions. The goal has shifted to not only bringing to market safe and efficacious interventions, but those for which enough evidence exists that patients will ask, providers will prescribe, and payers will pay. To meet this goal effectively, RWE is needed throughout the development cycle.” Full
Engagement Science: Where Do We Go from Here? (2/12, Elizabeth Cope, Ph.D., M.P.H., et al., AcademyHealth Blog) comments “...The national effort to improve engagement practices will be guided by a growing body of strong research, which tests and clarifies the relationships between engagement activities and research outcomes. This will, in turn, contribute to improvements in the quality of clinical care and the improvement of observed health outcomes.” Full
UK's NICE Rejects US Industry Attack On Its HTA Methods (2/12, Ian Schofield, Pink Sheet) reports “...‘NICE's approach to making recommendations for healthcare technologies is widely regarded as the fairest and most robust in the world,’ a spokesperson for the institute told the Pink Sheet. ‘We use QALYs – quality adjusted life years – to help us decide when a technology represents good value for money because that allows us to decide when a new treatment provides more benefit to patients than spending the same amount of money on something else. This is essential in making sure that the NHS [National Health Service] uses its funding wisely and fairly.’” Paid Subscription Required
Mixed HTA Results As Scotland Says No To Yescarta But Yes To Kymriah (2/12, Francesca Bruce, Pink Sheet) reports “...Health technology appraisals have yielded mixed results for CAR-T therapies in Scotland as the Scottish Medicines Consortium said yes to Novartis' Kymriah (tisagenlecleucel) but no to Gilead's Yescarta (axicabtagene ciloleucel). In response to the decisions, a research charity warned that while CAR-T therapies could be game changing treatments, the high prices they command would be a reoccurring issue.” Paid Subscription Required
Press Releases
IQWiG Supported Professional Societies in the Development of New S3 Guideline (2/12, IQWiG Press Release) “For the first time, the German Institute for Quality and Efficiency in Health Care supported professional societies in the development of an interdisciplinary S3 guideline. For this purpose, the Institute searched for studies on different questions regarding the topic of ‘vaginal birth’, assessed them, and presented them in eight evidence reports.” Full
Journals
Co-Building a Patient-Oriented Research Curriculum in Canada Tim Bell, et al. February 11, 2019, Research Involvement and Engagement Springer
Articles
Patient-Reported Outcomes in Oncology Expected to Make Regulatory Waves (2/11, Bryant Furlow, Cancer Therapy Advisor) reports “...‘I do think what we will start seeing is PROs paired with another trial outcome that is not [overall] survival to try to approve a drug,’ [Ethan Basch, MD, MSc] acknowledged. ‘For example, PFS plus symptomatic improvement, or biomarkers and radiographic change — and PROs, together.’ Drug developers will point to biomarker or imaging evidence that the drug is impacting tumor progression and that it's improving how patients feel and function, he explained.” Full
How Machine Learning Is Crafting Precision Medicine (2/11, Forbes.com) reports “...Nearly 80% of respondents to a recent Oracle Health Sciences survey says they expect AI and machine learning to improve treatment recommendations, and in a 2017 paper, Dr. Bertalan Meskó, director of the Medical Futurist Institute, suggested that ‘there is no precision medicine without AI.’ His point, albeit forward-looking, acknowledges that without AI to analyze it, patient data will remain severely untapped.” Full
Press Releases
PhRMA Foundation Provides $1 Million for New Centers of Excellence in Value Assessment (2/11, PhRMA Foundation Press Release) “The PhRMA Foundation has announced that it will fund two additional national Centers of Excellence as a part of its Value Assessment Initiative – to develop transformative, multi-stakeholder-driven solutions that address challenges in assessing the value of medicines and health care services and ultimately improve patient outcomes and reduce inefficiency...CEVA's mission will be to explore development of additional value elements; engaging patients and stakeholders to identify important novel and non-standard elements; and reporting findings back to stakeholders.” Full
Journals
Monitoring Evidence on Overall Survival Benefits of Anticancer Drugs Approved by the European Medicines Agency Between 2009 and 2015 Grössmann N, et al. February 5, 2019, European Journal of Cancer PubMed
Efficacy and Safety of Systemic Treatments in Psoriatic Arthritis. A Systematic Review, Meta-Analysis and GRADE Evaluation Dressler C, eta l. February 8, 2019, Journal of the European Academy of Dermatology and Venereology PubMed
Randomized Clinical Trials with Run-In Periods: Frequency, Characteristics and Reporting Laursen DRT, et al. February 11, 2019, Clinical Epidemiology Dove Press
Articles
This Week in Managed Care: February 8, 2019 (2/8, The American Journal of Managed Care) reports “...[NPC’s] recent webinar addressed questions about the FDA framework, a December 2018 document that spells out the agency's philosophy, requirements, and timetable for including real-world evidence in regulatory decisions. Under the 21st Century Cures Act, FDA will issue up to five separate guidance documents through 2021. As NPC described, FDA's principles for the process will be: Are the real-world data fit for use? Does the trial generating real-world evidence answer a regulatory question? Does the study meet regulatory requirements?
Revolutionizing US Healthcare With Consumer-Centered Care, Value-Based Insurance Design (2/7, Wallace Stephens, The American Journal of Managed Care) reports “...‘Instead of what 80% of Americans see in terms of their cost-sharing, which is based on price, we set cost-sharing based on the clinical benefit, and we argue that there should be little or no out-of-pocket cost for high-value care, particularly those things that are deemed as quality metrics by health plans, and we should also make patients pay more out-of-pocket for the things that we shouldn't be buying, those identified as a D rated service for the US Preventive Services Taskforce or, say, the Choosing Wisely initiative,’ Fendrick said.” Full
FDA Policies Support Shift to Decentralized Clinical Trials (2/8, Jill Wechsler, Applied Clinical Trials) reports “...In addition to streamlining clinical research, greater use of RWD and RWE would continue to facilitate changes to product labeling by gathering evidence for adding or modifying indications to approved medicines. These approaches, moreover, could reduce the need for post-approval safety studies, which are often difficult to enroll and carry out. RWD may support more effective new dosing regimens and help develop and validate new surrogate endpoints or digital biomarkers to guide more efficient development programs. Expanded acceptance of RWE from registries, natural history studies, and chart reviews may help sponsors establish comparison arms in studies evaluating efficacy in new products, an important strategy for single arm trials in oncology and rare diseases affecting few patients.” Full
Trump Administration's Smart Move to Cut Health Care Costs (2/8, Gary Shapiro, Morning Consult) comments “...Our system incentivizes doctors to use expensive drugs and perform unnecessary procedures and tests...It encourages new, expensive drugs with only marginal benefits. It discourages new procedures, alternatives and products, which not only cost less, but require fewer doctor visits and easier treatment options.” Full
Experience the Power of Patient-Centered Research Through PCORI (2/7, Susan Wozniak, RN, MSHS, Oncology Nursing Society) comments “...What does it take to move research from the proverbial bench to the community? That was the focus of the Fourth Annual Meeting of [PCORI], ‘From Evidence to Impact: Putting What Works into Action’...Some of the ways PCORI seeks to incorporate voices from across the healthcare community into their work is through PCORI advisory panels, merit reviewers, and peer reviewers. Also, PCORI ambassadors are needed, and oncology nurses provide a valuable perspective to that work. The ambassador program is open to anyone interested in advancing patient-centered research and getting involved with PCORI.” Full
Journals
Discontinuation and Primary Care Visits in Nonvalvular Atrial Fibrillation Patients Treated with Apixaban or Warfarin Sreeram V Ramagopalan, et al. February 8, 2019, Journal of Comparative Effectiveness Research Journal of Comparative Effectiveness Research
Events
Using Real World Evidence to Build Dynamic Cohorts in Real-Time February 20, 2019 11:00AM EST Xtalks
Advisory Panel on Healthcare Delivery and Disparities Research Spring 2019 Meeting May 16, 2019 9:00AM - 5:00PM EDT PCORI
Articles
NPC in Specialty Pharmacy Times: How Can We Advance Progress in Moving from Volume to Value in Health Care? (2/7, National Pharmaceutical Council: E.V.I.dently Today) comments “...In his latest column in Specialty Pharmacy Times, National Pharmaceutical Council President and Chief Executive Officer Dan Leonard explains that rather than trying to score news headlines, what we need is a thoughtful, research-based approach to tackle the challenges ahead of us. Looking through the lens of NPC's research and collaborative activities, Mr. Leonard outlines how we can address the issues raised in the administration's blueprint and move toward a more value-based health care system.” Full
How Can We Advance Progress in Moving From Volume to Value in Health Care? (1/22, Dan Leonard, Specialty Pharmacy Times) comments “...As we highlighted in our comments to HHS, value-based insurance design could change medicine for the better if grounded in a strong evidence base. It shifts the focus from how much we spend on health care to how well we spend it. We also see promise in variable cost sharing in pharmacy benefits, especially if patients encounter higher medication costs due to biological reasons rather than personal preference. Variable cost sharing can reduce out-of-pocket expenditures and thus help remove cost barriers and increase medication adherence.” Full
New Cures Coming From Value-Based Outcome Medicine (2/7, Matthew Kandrach, Morning Consult) comments “...One way is for industry to embrace more innovative payment models that ensure patients only pay for a product if it works for them. Biopharmaceutical manufacturers and health insurers are increasing their focus on value-based outcome programs, whereby the cost of the medicine is reimbursed if it is not effective for a patient after a certain period. In July 2018, Novartis announced it would offer a value-based outcome contract for its acute leukemia medication Kymriah. AstraZeneca, in partnership with Express Scripts, offers a program to reimburse the cost of the lung cancer drug Iressa, as well.” Full
Precision Medicine's Rosy Predictions Haven't Come True. We Need Fewer Promises and More Debate (2/7, Michael J. Joyner and Nigel Paneth, STAT News) comments “...We are calling for an open debate, in all centers of biomedical research, about the best way forward, and about whether precision medicine is really the most promising avenue for progress. It is time for precision medicine supporters to engage in debate — to go beyond asserting the truism that all individuals are unique, and that the increase in the volume of health data and measurements combined with the decline in the cost of studying the genome constitute sufficient argument for the adoption of the precision medicine program.” Full
England And Canada Collaborate On Parallel Scientific Advice For HTA (2/7, Francesca Bruce, Pink Sheet) reports “...NICE said that collaboration between HTA bodies across the world would lead to better evidence generation and patient access to new and cost-effective technologies. CADTH added that it is ‘extremely grateful for the collaborative spirit of HTA agencies,’ particularly during the development of its scientific advice program when it drew on the experience of NICE and other agencies.” Paid Subscription Required
Report Identifies Areas Lacking Good Practice in Health Tech Assessment (2/7, HealthDay News) reports “...‘We identified three areas where few good practices in HTA have been developed or where there is no clear consensus,’ a coauthor said in a statement. ‘In my opinion, the area of integrating social values is the most important and underdeveloped aspect of HTA. HTA bodies have increasingly been exploring how to best integrate social values, particularly patient values, but many fall short of standards for deliberative processes that are fair and transparent.’” Full
Press Releases
Rx.Health and Roche Partner to Support Digital Transformation and Real World Evidence (2/7, Rx.Health Press Release) “...Rx.Health announced that it has entered into a five-year collaboration focused on personalized healthcare and the utilization of real world evidence to improve health outcomes in people with Inflammatory Bowel Diseases. The goal of the collaboration is to develop targeted and novel digital care solutions for key gap areas across the disease spectrum, starting by bringing structured data on patient reported outcomes into clinical workflows.” Full
Erenumab in Migraine: Indication of Considerable Added Benefit for Certain Patients (2/7, IQWiG Press Release) “Erenumab was the first drug of a new drug class for the prophylaxis of migraine to enter the German market in November 2018. In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care has now examined whether erenumab has an added benefit. As the data presented by the drug manufacturer showed, erenumab can reduce the burden from migraine in those patients for whom other substances used for prophylaxis have failed or have not been an option.” Full
Journals
Real-World Evidence in Rheumatic Diseases: Relevance and Lessons Learnt Misra DP, Agarwal V. February 6, 2019, Rheumatology International PubMed
Events
Advisory Panel on Clinical Trials Spring 2019 Meeting May 15, 2019 9:00AM - 2:00PM EDT PCORI