Public Release: 

A Zika vaccine could virtually eliminate prenatal infections

American College of Physicians

1. A Zika vaccine could virtually eliminate prenatal infections

Abstract: http://annals.org/aim/article/doi/10.7326/M17-0641

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A Zika vaccine could have a substantial effect on mitigating and preventing future Zika virus outbreaks. Through a combination of direct protection and indirect reduction of transmissions, virtual elimination is achievable, even with imperfect vaccine efficacy and coverage. The researcher is published in Annals of Internal Medicine.

Mosquito-borne and sexually transmitted Zika virus has become widespread across Central and South America, and the Caribbean. A viable vaccine is expected to be available in the next several years, but a vaccine's effectiveness in preventing infections depends not only on its efficacy, but also on demographic and fertility patterns, local Zika attack rates, and the proportion of the population still susceptible when it becomes available.

Researchers from Yale School of Public Health developed a computer model to quantify the effect of a Zika vaccination strategy that prioritized females aged 9 to 49 years, followed by males aged 9 to 49 years. The model considered both vector-borne and sexual transmission, as well as country-specific mosquito density. The researchers found that a vaccine that was about 75 percent effective and covered about 90 percent of females aged 9 to 49 years would reduce the incidence of prenatal infections by at least 94 percent, depending on the country-specific Zika attack rate. They also found that in regions where an outbreak is not expected for at least 10 years, vaccination of women aged 15 to 29 years is more efficient than that of women aged 30 years or older.

Media contact: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To interview with the lead author, Alison P. Galvani, PhD, please contact Michael Greenwood at michael.greenwood@yale.edu or Ziba Kashef at ziba.kashef@yale.edu.

2. Money-back guarantees don't meaningfully reduce drug costs or improve cost-effectiveness for PCSK9-inhibitors

Abstract: http://annals.org/aim/article/doi/10.7326/M17-3367

Editorial: http://annals.org/aim/article/doi/10.7326/M18-0539

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Outcomes-based pricing, or money-back guarantees for patients who do not respond to treatment, do not meaningfully reduce drug costs or improve cost-effectiveness for PCSK9-inhibitors. Findings from a brief research report are published in Annals of Internal Medicine.

Outcomes-based pricing was recently offered for PCSK9-inhibitors (proprotein convertase subtilisin/kexin type 9 inhibitors), lipid-lowering agents that reduce myocardial infarction (MI) and stroke risk in persons with atherosclerotic cardiovascular disease (ASCVD). Due to the high cost of these drugs, large discounts in price would be needed to achieve cost-effectiveness, prompting interest in this novel pricing model.

Researchers from the University of California, San Francisco, used a computer model to examine the impact of outcomes-based pricing on the cost-effectiveness of PCSK9-inhibitors for patients with ASCVD. They compared baseline statin therapy with the addition of ezetimibe, a generic lipid-lowering agent, or PCSK9-inhibitors from a health system perspective and a lifetime analytic horizon to determine healthcare costs per quality-adjusted life-year (QALY) gained, with a willingness-to-pay threshold of $100,000/QALY. The researchers modeled three scenarios for a money-back guarantee where the manufacturer would refund: 1) one year of drug costs; 2) all drug costs incurred before the event; or 3) drug costs, plus inpatient costs for MI or stroke. The analysis showed that outcomes-based pricing did not meaningfully reduce costs or improve cost-effectiveness of PCSK9-inhibitors in any of the scenarios tested.

The authors conclude that three factors make outcomes-based pricing less relevant for preventative medications. First, event rates in prevention are generally low, and duration of treatment is long. Second, attributing an event to a failure of a preventive medication is complicated, which means that events eligible for reimbursement would depend on clinical context. And finally, frequent changes in insurance plans would make tracking events and reimbursing appropriate payers a challenge.

Media contact: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To interview with the lead author, Dhruv S. Kazi, MD, MSc, MS, please contact Scott Maier at Scott.Maier@ucsf.edu.

3. Survey suggests a lack of interaction between physicians and Medicare skilled home health care workers

Improvements needed in CMS-485 to enhance meaningful communication between those providing care to homebound older adults

Abstract: http://annals.org/aim/article/doi/10.7326/M17-2219

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A nationally representative survey of physicians suggests that the CMS-485, which is used to facilitate communication and care coordination between physicians and Medicare skilled home health care workers, does not meaningfully engage physicians in the plan of care. The majority of physician respondents reported spending very little time reviewing or acting on it. Results are published in Annals of Internal Medicine.

Physicians are required to certify a plan of care for patients who receive Medicare skilled home health care (SHHC) services. The Centers for Medicare & Medicaid Services form 485 (CMS-485) is typically used for certification of SHHC plans of care and for interactions between SHHC agencies and physicians. As such, it is imperative for communication between physicians and SHHC agencies to be meaningful.

Researchers from Johns Hopkins University Center for Transformative Geriatric Research conducted a nationally representative random sample survey to determine how physicians communicate with SHCC agencies and use the CMS-485 in care coordination for patients receiving SHHC services. They found that a large majority of physicians spend very little time reviewing care plans or interacting with SHHC services. Many of the respondents reported wanting to see changes to the existing mechanism of certification of skilled home health, and provided specific suggestions for enhancing the clinical usefulness of the CMS-485, including increasing the font, presenting orders in terse and clinically useful language for all types of health care providers, and highlighting the key clinical information.

The authors conclude that CMS, physicians, and skilled home health care agencies should collaborate to develop better methods to assure better care coordination for homebound adults.

Media contacts: For an embargoed PDF, please contact Lauren Evans at laevans@acponline.org. To interview lead author, Cynthia Boyd MD, MPH, please contact please contact Vanessa McMains at vmcmain1@jhmi.edu.

4. Physicians debate the use of prophylactic antipsychotics for a patient at risk for postsurgery delirium

Abstract: http://annals.org/aim/article/doi/10.7326/M18-0388

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Should a 79-year-old man with a history of delirium after surgery be given prophylactic antipsychotics before undergoing knee replacement surgery? A psychiatrist and a geriatrician, both from Beth Israel Deaconess Medical Center (BIDMC), weigh this question in a multicomponent educational article being published in Annals of Internal Medicine.

Delirium is a common perioperative complication in elderly patients. Defined as an acute change in level of attention and orientation, delirium often waxes and wanes in severity. Because up to 40 percent of episodes may be preventable, guidelines to diagnose, treat, and prevent post-operative delirium have been developed. The American Geriatrics Society suggests an interdisciplinary focus on nonpharmacologic measures for prevention of delirium. Evidence is insufficient to recommend antipsychotics for prevention of delirium but these drugs may be considered for short-term treatment in the setting of imminent harm to the patient or caregivers or severe distress due to agitation. Two prominent medical experts discuss whether or not to use drugs for a specific patient who had experienced delirium after a previous surgery.

In a recent BIDMC Grand Rounds, the case of a 79-year-old man with a history of diabetes, high cholesterol, hypertension, obesity, prostate cancer, renal cell carcinoma, obstructive sleep apnea, atrial fibrillation, and several other chronic conditions, was discussed. The patient was hesitant to undergo a needed knee replacement surgery because of a frightening episode of delirium that included confusion following a previous surgery. Psychiatrist Joshua Leo, MD, argued that because of the patient's many risk factors, he was likely to become delirious after another surgery, even with relatively minor stressors. Dr. Leo suggested that the best way to prevent delirium would be to not do the surgery at all. But if that was not an option, Dr. Leo suggested a low-dose antipsychotic prior to surgery. Geriatrician Melissa Mattison, MD, agreed that nonpharmacologic measures are the most important tools for prevention and treatment. Rather than prescribing medication, Dr. Mattison would recommend that a family member or friend stay at the patient's bedside to offer a reassuring presence. She also suggested a focus on addressing modifiable risk factors that could contribute to delirium prior to surgery.

All 'Beyond the Guidelines' papers are based on the Department of Medicine Grand Rounds at BIDMC in Boston and include print, video, and educational components. A list of topics is available at http://www.annals.org/grandrounds.

Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. For an interview with someone from BIDMC, please contact Jennifer Kritz at jkritz@bidmc.harvard.edu.

Also new in this issue: Cardiovascular Disease and Risk Management: Review of the American Diabetes Association's Standards of Medical Care in Diabetes 2018

James J. Chamberlain, MD; Eric L. Johnson, MD; Sandra Leal, PharmD, MPH, CDE; Andrew S. Rhinehart, MD, CDE; Jay H. Shubrook, DO; and Lacie Peterson, MS, RD, CDE

Clinical Guideline

Abstract: http://annals.org/aim/article/doi/10.7326/M18-0222

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