Thursday, April 30, 2015

NEJM Highlights April 2015, a springtime bumper crop: Healthcare in China, comparative effectiveness of heart disease diagnostic approaches, unpacking a CMS unbundling, the NCS crashes and burns, waste in cataract surgery, PD-(L)1 inhibitors on a tear in oncology, progress in prenatal genetic testing, a breakthrough to prevent shingles, and Porter and Lee on strategy

The rise, fall, and rebirth of the Chinese healthcare system
A fascinating account of the evolution of the Chinese healthcare system which almost seems to be an upside-down picture of the rest of the country’s development. Tremendous public health improvements occurred in the 50s, 60s, and 70s but the transition to a free market model of healthcare in the 80s seems to have been a disaster only mitigated by the general increase in wealth of the population. Seeing this as a major threat to social stability, the Chinese government has been trying to pick up the pieces with reforms in 2003 and 2008. A few pages well worth reading. Lessons from the East — China's Rapidly Evolving Health Care System (free access)

Diagnosing heart disease: CT angiography (CTA) and stress testing are equivalent with respect to outcomes
Every day, thousands of patients present at various point of care settings with chest pain. Most do not have significant coronary disease, but considering the risk for those who do, screening is often warranted and represents a major cost to the US health system. In this study funded by the NIH, two approaches in non-ER patients presenting with chest pain were compared on the basis of medium term health outcomes (at 2 years): traditional stress testing (e.g. on a treadmill), and anatomical imaging through CTA. No differences in health outcomes were found, but 1) individuals in the CTA arm were much more likely to get cardiac catheterization, and to be revascularized (e.g. with a stent placement) and 2) individuals in the functional testing arm and underwent cardiac catheterization were much more likely to be found free of coronary disease. Although no one says it so bluntly in those articles, given how expensive catheterization and revascularization procedures are, there is almost certainly higher value for money in the stress testing approach (a cost effectiveness analysis would have been nice). However this may be quite different in the Emergency Department where a clean CTA may avoid a hospitalization. Outcomes of Anatomical versus Functional Testing for Coronary Artery Disease; Cardiovascular Imaging and Outcomes — PROMISEs to Keep (subscription access)

CMS unbundling surgical care episodes
In a move that runs contrary to trend, CMS has confirmed that it will unbundle previously bundled payments to surgeons which encompasses surgery and post-surgical care. The trigger seems to have been an OIG report that noted that in many cases, bundles were built on the assumption of more encounters than actually occur. There were also issues of double payments when the follow-up is done by different individuals.  In the end CMS seems to have decided that unbundling was the simplest approach, but one wonders whether a return to a FFS mechanism is going to skew incentives in post-surgical care the way it has everywhere else, especially given that the authors estimate that there will be a significant hit to surgeon incomes. Medicare's Step Back from Global Payments — Unbundling Postoperative Care (subscription access)

The demise of the National Children Study (NCS)
In this perspective, the authors bemoan the demise of the NCS that was going to be the Framingham study for youth health. Authorized in 2000, it was supposed to recruit and follow-up 100,000 U.S. children from birth to 21 year old, but the effort collapsed (unfortunately not before 1 billion dollars was spent), a reminder that multidecadal projects are fraught with management risk (can you spell F-35?). Other studies are in progress in other countries and hopefully, we will learn from them what we should have learned from the NCS. The National Children's Study — End or New Beginning? (subscription access)

Unnecessary preoperative testing in cataract surgery
There are 1.7 million cataract surgeries performed annually in the US and since the early 2000s, there has been excellent evidence that routine preoperative testing does not improve outcomes for this particular procedure and this is enshrined in professional societies guidelines.  In a retrospective cohort study of more than 400,000 medicare patients who underwent cataract surgery, the authors examine the use of preoperative testing and find that the top determinant of use was not the health status of the patient, but the particular ophthalmologist managing the case. Specifically they found that as many as 9% ophthalmologists order preop tests for all their patients and 37% for more than 75% of their patients. While the associated extra costs are comparatively modest (~$15M for the whole cohort), we all know that this is the tip of an iceberg of patterns repeated across the US health system. Room for improvement abounds, and this shows that there is plenty of low hanging fruit for the taking… Preoperative Medical Testing in Medicare Patients Undergoing Cataract Surgery (subscription access)
PD-(L)1 inhibitors march on: confirmation in melanoma, and an innovative lung cancer study
Continuing a story chronicled in previous highlights PD-1 (and PD-L1) monoclonal antibody inhibitors continue to assert themselves as the standard of care in wild type BRAF melanoma with sometimes remarkable results, such as the case of a woman who showed up at her follow-up appointment with a gaping hole in her chest wall 3 weeks after the start of treatment because her tumor had simply melted away. While BMS’s nivolumab (Opdivo) seems to be in the lead for melanoma and was just approved in record time by FDA for certain types of lung cancers, Merck’s  pembrolizumab (Keytruda, formerly known as lambrolizumab) is also pushing forward. In an innovatively designed study, 495 patients with lung cancer were treated with pembrolizumab. The data from 182 patients was used as a training set to determine a biomarker of response which was then confirmed with the remaining 313 patients as a validation set. The selected best marker ended up being expression of PD-L1 in biopsy samples as stained with pembrolizumab itself. While overall response rate was 20% across all patients, in the subset of patients with a positive biomarker (about 25% of patients), the response rate was around 40% with an overall survival advantage which should  be at least 6 months compared to patients with a negative biomarker. What is interesting about this study is that although it had a single treatment arm, the negative biomarker group became a de facto control. Nivolumab and Ipilimumab versus Ipilimumab in Untreated Melanoma; Rapid Eradication of a Bulky Melanoma Mass with One Dose of Immunotherapy; Pembrolizumab versus Ipilimumab in Advanced Melanoma; Pembrolizumab for the Treatment of Non–Small-Cell Lung Cancer

Prenatal testing for genetic abnormalities is moving fast
A prospective study sponsored by diagnostic company Ariosa enrolling more than 15,000 routine pregnancies showed that use of a maternal blood test for cell free fetal DNA analysis at 10-14 weeks gestation detects trisomy (principally Down’s) much more effectively than traditional ultrasound biochemical testing. Some caution that false positive results are still possible, however it is clear that (1) such testing will replace traditional testing, and (2) that we are not far off from the day when a complete fetal genome will be available during pregnancy, an important milestone in the course of human history. Cell-free DNA Analysis for Noninvasive Examination of Trisomy; Copy-Number Variation and False Positive Prenatal Aneuploidy Screening Results; Use of Cell-free DNA to Screen for Down's Syndrome (subscription access)

Spectacular results from a GSK vaccine to prevent shingles in older adults
Shingle is not fatal but inflicts untold misery to millions of elderly patients every year, in particular with the dreaded sequella of post-herpetic neuralgia. It is caused by the reactivation within nerve roots of the dormant varicella zoster virus (VZV) which most people have contracted as a child when they had chickenpox. In this placebo-controlled study, a new vaccine against VZV was tested in more than 15,000 older adults and showed an efficacy upward of 97% in preventing shingles in a 3-year follow-up period. This compares extremely well with the existing live attenuated vaccine for which efficacy is much lower, especially in older individuals. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults; A New Vaccine to Prevent Herpes Zoster (subscription access)

Porter and Lee on the importance of Strategy in health care
At the heart of strategy is choosing – what to do, and even more importantly what not to do – something that health systems must do given a rapidly changing environment. Here at Recon, we live and breathe strategy and help our clients through the kind of deliberate decision making described by Porter and Lee, and in the course of doing so, see first-hand the value of driving to strategic clarity so that choices can be made early and effectively. This article will only take you a short time to read, but applying the fundamental principles it outlines may well help you improve your organization – and save you some consulting dollars. Why Strategy Matters Now (free access)

Finally in my paper copy of the April 30 issue – a full page ad by Genentech trying to recruit ALK-positive lung cancer patients to test their molecule alectinib (investigational) head to head against Pfizer’s crizotinib (approved) – that is a type of outreach I had not seen before in the Journal.

The New England Journal of Medicine is a premier medical journal covering many topics of interest to the health sector. In this monthly series we offer a brief overview of the past month highlights that might be of interest to our clients and others.
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