Launch in Rwanda of Africa’s first national rotavirus vaccination program

Merck (MSD outside the United States and Canada) said it welcomed the launch in Rwanda of Africa’s first national rotavirus vaccination program with ROTATEQ (rotavirus vaccine, live, oral, pentavalent). Merck noted that the first infants will receive ROTATEQ at a health center in Musanze District, Northern Province, Rwanda. Following the initial launch, ROTATEQ will be routinely administered to all infants in Rwanda as part of its national vaccination program. During 2012, the Government of Rwanda Ministry of Health expects more than 100,000 children will receive the vaccine. Mark Feinberg, M.D., Ph.D., chief public health and science officer, Merck Vaccines, said, “We congratulate the Government of Rwanda for the launch of this important public health initiative and applaud its efforts to help protect Rwanda’s children against rotavirus-associated diarrhea through a comprehensive initiative including vaccination and other public health efforts. Rwanda is committed to the vaccination of their children and their accomplishments to date have been impressive. Given the impact of rotavirus gastroenteritis in children, working to help reduce severe rotavirus disease represents a critically important public health goal and we’re pleased to be able to work with the GAVI Alliance to make ROTATEQ available to Rwanda and other GAVI-eligible countries worldwide.”

http://www.businesswire.com/news/home/20120525005315/en/Government-Rwanda-Introduces-Mercks-ROTATEQ%C2%AE-Rotavirus-Vaccine

Study Designs for the Safety Evaluation of Different Childhood Immunization Schedules

Opportunity for Public Comment: Study Designs for the Safety Evaluation of Different Childhood Immunization Schedules

The Committee on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule has commissioned a paper from a consultant, Martin Kulldorff, Ph.D. We will be inviting comments and reactions to the paper to inform the committee discussion. The comment period will be open from May 14th until May 31st, 2012, and can be accessed on http://www.iom.edu/HealthOutcomesCommissionedPaper

Please note that any comments that you submit to the committee, including your name and identifying information, will not be kept confidential and will be included in a Public Access File in compliance with Section 15 of the Federal Advisory Committee Act (FACA). The National Academies shall be authorized to use any such comments or submissions in accordance with the National Academies’ Terms of Use Statement.

The responsibility for the content of the paper rests with the author and does not necessarily represent the views of the Institute of Medicine or its committees and convening bodies.

For more information, please visit the Committee on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule’s webpage: http://www.iom.edu/Activities/PublicHealth/ChildhoodImmunization.aspx

Editorial: Influenza vaccination in healthcare professionals

British Medical Journal
26 May 2012 (Vol 344, Issue 7858)
http://www.bmj.com/content/344/7858

Editorial
Influenza vaccination in healthcare professionals
BMJ 2012; 344 doi: 10.1136/bmj.e2217 (Published 28 March 2012)
Cite this as: BMJ 2012;344:e2217
Harish Nair, Alison Holmes, Igor Rudan, Josip Car

Extract
Should be mandatory

There is clear evidence that healthcare workers play an important role in transmitting infections to their patients.1 The World Health Organization and national immunisation guidelines in 60% of developed and emerging economies strongly recommend annual vaccination against seasonal influenza for all healthcare workers in acute and long term care facilities.2 However, unlike other prophylactic measures targeted at healthcare workers, such as hepatitis B vaccination, the uptake of flu vaccine has been generally poor. In the United States, two decades of consistent advocacy by the Centers for Disease Control and Prevention achieved a self reported vaccine coverage of only 64% among healthcare workers by 2010-1.3 In the United Kingdom, despite recommendations by the Department of Health, uptake of seasonal flu vaccine was a dismal 35% among frontline healthcare workers in the same year.4

Flu contributes greatly to global mortality and morbidity and has important economic consequences. Each year, seasonal flu affects 5-10% of the world’s population, causing 3-5 million severe infections and resulting in 250 000-500 000 deaths. Young children (especially those under 1 year); pregnant …

Viewpoint: Assessing Value in Health Care Programs

JAMA   
May 23, 2012, Vol 307, No. 20
http://jama.ama-assn.org/current.dtl

Viewpoint
Assessing Value in Health Care Programs
Kevin G. Volpp, MD, PhD; George Loewenstein, PhD; David A. Asch, MD, MBA
JAMA. 2012;307(20):2153-2154. doi:10.1001/jama.2012.3619

Many health care services provided in the United States are of low value, meaning that the cost of providing those services is high relative to the health care benefit they confer. In some cases, the care provided may have no value or even, on average, may be harmful. Examples of low- or negative-value services include unnecessary surgery or diagnostic imaging that will not change management. Given estimates that 30% of the $2.5 trillion the United States spends on health care services each year may provide little benefit,1 there is a widespread eagerness to enhance the ratio of benefits to costs.

Because value matters in health care, when new health care programs are proposed it has become common to ask, “What is the return on investment from implementing this new program?” Implicit in this question is that programs should be supported if they save money but not otherwise. Positive return on investment, meaning that more money is saved than is spent, has become the standard by which new initiatives are evaluated.      This standard has been used to evaluate new programs such as the primary care medical home, disease management, and the projects submitted for the new Center for Medicare & Medicaid Services Innovation Challenge.

Although asking about return on investment might seem to make sense given concerns about health care cost and value, asking about return on investment is the wrong question when assessing whether a health care program is successful. What would happen if the rule were applied to every health care decision that is made? Besides childhood vaccination and flu shots for the elderly, few health care services save money.2 The positive return-on-investment criterion is not applied to most health care services because almost nothing satisfies it. Medicare is prohibited by law from considering cost in coverage decisions, and other insurers tend to follow suit, even if the benefits are small and the costs very large. Would anyone ever ask, “What is the return on investment in treatment of this patient’s cancer?” This is not a meaningless question, but almost certainly one that most people would think inappropriate to ask.

Cost is important and should be considered in many more settings for both existing and new services. Clinicians and policy makers should not apply one standard when tacitly continuing the status quo and a different standard when evaluating innovative programs that might be implemented. It certainly does not make sense to use one criterion—Are there clinical benefits?—for coverage decisions for treatments and a different criterion—Are health care savings greater than program costs?—for preventive services or for delivery system innovations designed to improve health. Programs designed to improve health and prevent disease should be evaluated based on whether they improve health at a reasonable price, essentially comparing whether improvements in health are achieved for less resources than through alternatives, eg, expenditures on health care services.

Health care reimbursement tends to be disease fixated and should be evaluated the same way based on the value of expenditures in achieving improvements in health.3 If an employer spends $100 000 treating late-stage emphysema or lung cancer for its employees—an expenditure with a negative return on investment but one that adds value to employees’ lives—should that employer be willing to spend money on smoking cessation programs? The answer is almost undoubtedly yes. However, if health promotion programs or health system delivery innovations are required to save money, they will likely be labeled failures even if they improve health at a lower price than many of the services that we now willingly pay for under Medicare and private insurance. If we continue with the approach of insisting on a positive return on investment to fund such programs, low-value spending will persist at higher rates than would otherwise be the case.

For example, consider a program that would improve medication adherence after acute myocardial infarction (AMI). Adherence rates to β-blockers, statins, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers after an AMI event is poor; a recent large-scale study showed that even when copayments were lowered to $0 among insured patients, average adherence for these medications was only about 45%.4 If a new program could increase adherence to 70%, it is plausible that the program could significantly reduce the rate of hospital admissions for MI, stroke, and revascularization procedures. If the average cost of health events requiring hospitalization in the 12 months following a hospital admission for a new MI is about $20 000 and the new program reduced the rate of events requiring hospitalization by 10%, the new program could cost up to $2000 per year and still save money. Does that mean the program should not be adopted if it costs $3000? At that point, the calculated return on investment for the program is negative because it costs more than it saves.    But wouldn’t this program still be a much better use of money than letting those MIs occur (mortality rates from AMI are typically more than 10% among hospitalized patients in the 30 days after admission, and many patients die before making it to a hospital)? If this is deemed not a good use of resources, then why are so many other services covered that yield lower value?5 Many insurers, including Medicare, are continuing to cover bevacizumab for metastatic breast cancer, despite the unanimous recommendation by a US Food and Drug Administration panel that it not be covered because it is not helping patients to live longer, does not control their tumors, and exposes them to serious adverse effects6 and despite an average annual cost of $99 000.7

There are political, ethical, and emotional challenges to making explicit resource allocation issues in treating diseases and applying the same metrics used to evaluate the effectiveness of programs that prevent diseases in largely unidentified patients. It is always more difficult to shut down existing programs than to say no to new ones, a phenomenon related to inertia, also known as status quo bias.8 It is also more difficult to justify investments in prevention across broad populations than investments in the treatment of identifiable patients, a phenomenon known as the rule of rescue.9 Changing the criteria used to evaluate health system delivery innovations might help overcome these tendencies. Evaluating success using the same criteria—whether a preventive service, delivery system innovation, or treatment—may be the best way to ensure the maximal value in terms of improvements in health for the resources expended on health care services.

A recent conversation with a benefits manager from a medium-sized employer brought this point home. She reported that when asked by the chief financial officer, “What is the return on investment in putting in place this $125 000 wellness program?” she responded, “What is the return on investment on the $28 million we are spending on treating disease through our health benefits?” If cost is not considered when thinking about the value of covered treatments, it does not make sense to use positive return on investment as a criterion for determining whether promising new delivery system innovations should be covered. A better approach would be to adopt similar metrics for treatment and prevention for current and proposed care, for which the goal in all cases is achieving the most improvement possible with the resources available.

Rotavirus Vaccination, Postlicensure Safety Monitoring, Intussusception

Journal of Infectious Diseases
Volume 206 Issue 1 July 1, 2012
http://www.journals.uchicago.edu/toc/jid/current

EDITORIAL COMMENTARIES
Michelle Clarke and H. Marshall
Editor’s choice: Rotavirus Vaccination for Prevention of Serious Acute Gastroenteritis and the Importance of Postlicensure Safety Monitoring
J Infect Dis. (2012) 206(1): 3-5 doi:10.1093/infdis/jis318
(See the major article by Yen et al, on pages 41–8.)

Extract
With the ability to save millions of lives each year in both the developed and developing nations, vaccination against childhood infectious diseases is a priority area for global health. An essential aspect of the success of any vaccination program is the careful monitoring following implementation to ensure that the benefits of the program outweigh any risks to the recipients or the community. Infant rotavirus vaccination programs are an important example of the collaborative expertise required for effective and timely monitoring and reporting of any adverse events following implementation. Rotavirus vaccines have been instrumental in reducing morbidity from rotavirus infection. Prior to the introduction of rotavirus vaccine, it is estimated that >500 000 rotavirus-related child deaths occurred globally each year [1]. Studies assessing the impact of rotavirus vaccine on incidence of rotavirus hospitalizations have occurred in numerous countries, including Australia and the United States, with dramatic reductions in the incidence of rotavirus hospitalizations (up to 80% reduction) shown following implementation of the rotavirus vaccination programs and suggestions of herd immunity benefits for older, unvaccinated populations [2–6]. The development of vaccines to prevent serious infectious diseases has been a global triumph, but large-scale postlicensure studies are essential to ensure that vaccination programs deliver the anticipated benefits.

In response to the overwhelming global burden of rotavirus infections, particularly in children aged <5 years, a live, attenuated tetravalent rotavirus vaccine (RotaShield) was licensed for routine use in infants in 1998, before being withdrawn in 1999 due to concerns about an increased risk of intussusception in vaccine recipients …

Catherine Yen, Jacqueline E. Tate, Claudia A. Steiner, Margaret M. Cortese, Manish M. Patel, and Umesh D. Parashar
Editor’s choice: Trends in Intussusception Hospitalizations Among US Infants Before and After Implementation of the Rotavirus Vaccination Program, 2000–2009
J Infect Dis. (2012) 206(1): 41-48 doi:10.1093/infdis/jis314

Abstract
Background. Although US data have not documented an intussusception risk with current rotavirus vaccines, international data indicate  a possible low risk, primarily after the first dose.

Methods. Among infants in 26 US states comprising 75% of the birth cohort, we examined age-specific trends in population-level intussusception hospitalization rates before (2000–2005) and after (2007–2009) rotavirus vaccine introduction.

Results. Compared with 2000–2005 (35.3 per 100 000), the rate was greater in 2007 (39.0 per 100 000; rate ratio [RR], 1.10; 95% confidence interval [CI], 1.04–1.18), similar in 2008 (33.4 per 100 000; RR, 0.95; 95% CI, .89–1.01), and lower in 2009 (32.9 per 100 000; RR, 0.93; 95% CI, .87–.99). Among infants aged 8–11 weeks, compared with 2000–2005 (6.9 per 100 000), a small, significant increase was observed in each of 2007 (11.4 per 100 000; RR, 1.64; 95% CI, 1.08–2.50), 2008 (12.2 per 100 000; RR, 1.76; 95% CI, 1.17–2.65), and 2009 (11.0 per 100 000; RR, 1.59; 95% CI, 1.04–2.44).

Conclusions. Following rotavirus vaccine introduction, a small increase in intussusception rates was seen among US infants aged 8–11 weeks, to whom most first doses of vaccine are given; no sustained population-level change in overall rates was observed.

Comment: The US Global Health Initiative

The Lancet  
May 26, 2012  Volume 379  Number 9830  p1923 – 2022  e53 – 54
http://www.thelancet.com/journals/lancet/issue/current

Comment
The US Global Health Initiative: where does it stand?
Jennifer Kates, Josh Michaud

Preview
In May, 2009, shortly after taking office, President Barack Obama announced the Global Health Initiative (GHI), which was to be a 6-year (2009–14), US$63 billion effort to refocus US global health activities by developing the first comprehensive US Government global health strategy.1 The GHI was conceived as a “whole of government approach”2 to act as an umbrella over existing US global health programmes—most notably, the President’s Emergency Plan for AIDS Relief. As President Obama said at the time, “We cannot simply confront individual preventable illnesses in isolation.