ABIM Releases Assessment of its MOC Program, FDA Approves Drug for Chemotherapy-Induced Nausea and Vomiting, and more

ABIM Releases Assessment of Its Maintenance of Certification Program

The American Board of Internal Medicine’s (ABIM) Assessment 2020 Task Force has released a report evaluating the organization’s Certification and Maintenance of Certification (MOC) programs. The Assessment 2020 Task Force, convened in 2013 to “develop a vision for the future of assessment in internal medicine and associated subspecialties,” included members of ABIM leadership and experts in assessment, education, health care, and consumer advocacy, according to a press release from the agency.

The report, “A Vision for Certification in Internal Medicine in 2020,” is designed to guide ongoing reform of ABIM’s Certification and MOC programs and offers three key recommendations:

  • Change the MOC exam by replacing the 10-year MOC exam with more meaningful, less burdensome assessments.
  • Focus assessments on cognitive skills (to assure the public that physicians are staying current with the clinical knowledge relevant to patient care) and technical skills (to ensure that physicians can apply that knowledge to adequately perform the technical procedures appropriate to the discipline).
  • Recognize the need for certification in specialized areas, without the requirement to maintain underlying certificates, while being transparent about specialization to the public.

“Feedback collected by the Assessment 2020 Task Force is very consistent with feedback ABIM is hearing from the community regarding the MOC program,” said Richard J. Baron, MD, president and chief executive officer of ABIM. “These recommendations are meant to be a catalyst for further discussion and can ultimately lead to an improved MOC program for diplomates.”

ABIM reported that it has started actively exploring the implementation of the recommendations through a subcommittee consisting of members of both the ABIM Council and Board of Directors.

“The Assessment 2020 Task Force members provided useful insights and recommendations that will be instrumental as we reshape certification to meet physicians’ and society’s changing needs,” said Clarence H. Braddock III, MD, chair of the ABIM Board of Directors. “We now need to hear constructive feedback from the internal medicine community on these recommendations, begin to determine their feasibility, and develop implementation plans where

In response to criticism from multiple medical associations and members of the internal medicine community that at times has been vitriolic over the past year – since it announced that physicians must complete some MOC activity every two years and accrue 100 MOC points every five years or be labeled as “not meeting MOC requirements” – ABIM has made a number of changes to its Certification and MOC programs.

ASH Clinical News will be taking a more in-depth look at the proposed changes – and ASH’s response – in the coming issues.

Source: ABIM press release, September 16, 2015; ABIM, “A Vision for Certification of Internal Medicine in 2020.”

USPSTF Issues Draft Report Recommending Aspirin Use to Prevent Cancer

The United States Preventive Services Task Force (USPSTF) published a draft report recommending daily use of low-dose aspirin among people 50 to 69 years
of age to prevent colorectal cancer and cardiovascular disease; aspirin is currently recommended for the prevention of heart attacks and stroke. The new report states that the benefits of taking 81 mg of aspirin daily outweigh the risks in adults 50 to 69 years old who are at an increased risk for cardiovascular disease and who are not at an increased risk for bleeding. Notably, the largest benefit was seen for adults in their 50s, and the recommendation does not extend to people younger than 50 years old or older than 70.

The recommendation is based on a series of evidence reviews commissioned by the USPSTF, which found that aspirin use decreased colorectal cancer deaths by 33 percent and reduced colon cancer incidence by 40 percent. The review indicated that people should take aspirin for five to 10 years to see this reduction in risk.

Aspirin use, however, increased stomach bleeds by approximately two-thirds and it increased the risk for hemorrhagic stroke by 33 percent – although incidence remained low (2.54 strokes per 1,000 person-years). Use of low-dose aspirin could also result in up to two bleeding adverse events per 1,000 people each year, according to the report. The USPSTF noted that more research on this was necessary to determine how aspirin interacts with other medications used.

Source: USPSTF, “Draft recommendation statement: Aspirin to prevent cardiovascular disease and cancer,” September 14, 2015.

NIH Approves Study Blueprint for the Precision Medicine Initiative, Plans Enrollment for Early Next Year

The National Institutes of Health (NIH) approved the framework for building a large research cohort as part of President Obama’s Precision Medicine Initiative. Josephine Briggs, MD, the director of the National Center for Complementary and Integrative Health, will serve as acting director of this new initiative.

The NIH will examine data from U.S. citizens of all ages, races, and socioeconomic groups, looking at the associations among genetic, molecular, environmental, and behavioral factors and disease onset, treatment response, and health outcomes. The study aims to enroll 1 million volunteers over the next three to four years.

NIH Director Francis Collins, MD, PhD, said he would “act immediately” on recommendations delivered by the  Precision Medicine Initiative Working Group that developed the framework for the study; he hopes that study recruitment will begin as early as 2016. Participation is open to all individuals who want to take part, but Dr. Collins noted that volunteers in the study will come from two paths: individuals who wish to take part and people already enrolled in large studies through their health-care providers.

Study participants will undergo a standard baseline examination for vital signs and a medication assessment, and will provide a medical history and blood sample. Electronic medical data and health survey information will also be collected. The study also aims to tap into data gathered via smartphone fitness trackers, which will provide information on lifestyle habits and environmental exposures.

Though the study seeks eventually to include whole-genome sequencing data, initial genetic tests will likely only include genotyping. Dr. Collins estimated that whole-genome sequencing on this scale would cost $2 billion to perform on the intended 1 million participants, while genotyping costs just $30 to $40 per participant. President Obama has called for $130 million in funding for the study, though the funding is not currently guaranteed.

Source: Reuters, “NIH takes next steps in Obama’s precision medicine plan,” September 17, 2015.

Supplemental New Drug Application Submitted for Ibrutinib in Treatment-Naïve Chronic Lymphocytic Leukemia 

The U.S. Food and Drug Administration (FDA) has received a supplemental new drug application (sNDA) for ibrutinib as frontline therapy in patients with chronic lymphocytic leukemia (CLL). The sNDA filing is based on the results of the phase III, randomized, multicenter, open-label RESONATE-2 trial that compared the safety and efficacy of ibrutinib with chlorambucil in 269 patients who are 65 years or older with treatment-naïve CLL or small lymphocytic lymphoma (SLL).

Ibrutinib led to longer progression-free survival (PFS; the study’s primary endpoint) and was superior to chlorambucil on secondary efficacy endpoints, including overall survival (OS), overall response rate, and hematologic function. The most commonly reported adverse events associated with ibrutinib included thrombocytopenia, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash.

Ibrutinib has been previously approved in the United States to treat patients with CLL who have received at least one prior therapy and CLL with del17p, as well as those with Waldenström macroglobulinemia and those with mantle cell lymphoma who have received at least one prior therapy.

Source: Janssen Biotech press release, September 14, 2015.

FDA Grants Priority Review to Carfilzomib for Relapsed Multiple Myeloma

The U.S. FDA granted priority review for the sNDA submitted for carfilzomib for use in patients with relapsed multiple myeloma (MM). This approval would expand carfilzomib’s current use to treat patients who have received at least one prior therapy.

The sNDA acceptance is based on the results of the phase II, head-to-head ENDEAVOR study that compared carfilzomib and low-dose dexamethasone with bortezomib and low-dose dexamethasone in 929 patients with relapsed MM. Study results indicated that patients treated with the carfilzomib/dexamethasone combination had longer PFS (18.7 months vs. 9.4 months; p<0.0001). Treatment discontinuation was comparable between both study cohorts. The most commonly reported adverse events associated with carfilzomib as a monotherapy included anemia, fatigue, thrombocytopenia, nausea, pyrexia, decreased platelets, dyspnea, diarrhea, decreased lymphocyte, headache, decreased hemoglobin, cough, and peripheral edema.

Carfilzomib is currently FDA-approved for use in combination with lenalidomide and dexamethasone for the treatment of MM in patients who have received one to three prior lines of therapy. Carfilzomib is also indicated for patients with MM who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Source: Amgen press release, September 18, 2015.

Ofatumumab Granted Priority Review as Maintenance Therapy in Chronic Lymphocytic Leukemia

The U.S. FDA granted priority review to the supplemental biologics license application (sBLA) filed for ofatumumab as maintenance therapy in patients with relapsed CLL, following a response to second- or third-line therapy. Acceptance of the sBLA was based on the results of the phase III, open-label PROLONG study that randomized 474 patients to receive ofatumumab (n=238) or to undergo observation only (control; n=236). During the first cycle, ofatumumab was administered at 300 mg followed one week later by a 1,000-mg dose. During subsequent cycles, the drug was administered at 1,000 mg every eight weeks for up to two years. The study’s primary endpoint was PFS, and secondary endpoints included duration of response, OS, and safety.

Patients in the treatment group had a median PFS of 30.4 months compared with 14.8 months in the control group (p<0.0001). After a median follow-up of 19.1 months, the median OS had not yet been determined in the two treatment groups. The median treatment duration in the ofatumumab group was 12.5 months. The most commonly reported grade ≥3 adverse events associated with ofatumumab included neutropenia and infections.

Ofatumumab has been previously approved in the United States for use in combination with chlorambucil for the treatment of treatment-naïve CLL patients for whom fludarabine-based therapy is not appropriate.

Source: Genmab press release, September 19, 2015.

CMS/ONC Issues Final Rules on Electronic Health Records Incentive Program, Eases Mandates on Meaningful Use

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released final rules for the Electronic Health Records (EHRs) Incentive Programs that simplify requirements and add new flexibilities for providers who have not yet met meaningful use” criteria. The new rule aims to reduce the reporting burden for providers, support interoperability, and improve patient outcomes.

ne of the major changes is shortening the required meaningful-use reporting period: Organizations will only need to demonstrate 90 consecutive days of meeting meaningful-use requirements (the previous requirement was 1 year). Providers are also encouraged to apply for hardship exceptions if they need to switch EHR vendors or have other technology difficulties with their EHR vendor.

“This new framework will be based on the landmark bipartisan legislation – the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) – that requires the establishment of a Merit-based Incentive Payment System (MIPS) and consolidates certain aspects of a number of quality measurement and federal incentive programs for Medicare physicians and other providers into one, more efficient framework,” said Patrick Conway, MD, MSc, deputy administrator or innovation and quality and chief medical officer at CMS, in a press release.

Critics of the recent health-care overhaul are noting that the requirements are too large of an undertaking to meet the current deadlines, and many call for the final stage requirements to be pushed until 2017. Opponents have also asked for a period of assessment of the achievements and failures of phase 2 of the program before enacting these new rules.

Medical organizations appear to have mixed feelings toward the program: the American Medical Association is on board with the hardship exemption for providers, while the American Hospital Association called the phase 3 ruling “too much too soon.” Despite the pushback, CMS stresses that improving the functionality of EHRs will make data more accessible to consumers and prevent providers and vendors from engaging in information-blocking. CMS is allowing for public comment on the final rule through early December.

Sources: HHS press release, October 6, 2015; CMS press release, October 6, 2015.

American College of Physicians Develops Best Practice Recommendations for the Evaluation of Suspected Pulmonary Embolism

A new best practice statement from the American College of Physicians (ACP) recommends that, in the diagnosis of pulmonary embolism (PE), computed tomography (CT) scans and D-dimer testing should be limited to patients who have a high pretest likelihood of having this condition. The recommendations, recently published in Annals of Internal Medicine, seeks to avoid inappropriate use of these tests.

PE, the authors of the guideline noted, can be difficult to diagnose due to its nonspecific signs and symptoms, which has also led to an increase in testing of patients with suspected PE. “The use of CT for the evaluation of patients with suspected PE is increasing despite no evidence that this increased use has led to improved patient outcomes, while exposing patients to unnecessary risks and expense,” said Wayne J. Riley, MD, president of ACP, in a press release that accompanied the journal article. “ACP’s advice is designed to help physicians identify patients for whom a PE is so unlikely that they need no further testing, for whom plasma D-dimer testing can provide additional risk stratification, and for whom imaging is indicated because of their high risk and clinical presentation.”

The ACP’s guideline was developed through a literature review of 1,752 articles published between 1966 and 2014, including clinical trials and meta-analyses related to diagnostic strategies, decision rules, laboratory tests, and imaging studies for the diagnosis of PE. The guideline panel outlined the following six best practices based on the literature review:

  • Use validated clinical prediction rules to estimate pretest probability in patients in whom acute PE is being considered.
  • Do not obtain D-dimer measurements or imaging studies in patients with a low pretest probability of PE and who meet all PE Rule-Out Criteria (PERC).
  • Obtain a high-sensitivity D-dimer measurement as the initial diagnostic test in patients who have an intermediate pretest probability of PE or in patients with low pretest probability of PE who do not meet al PERC.
  • Use age-adjusted D-dimer thresholds in patients older than 50 years to determine whether imaging is necessary.
  • Do not obtain any imaging studies in patients with a D-dimer level below the age-adjusted cutoff.
  • Obtain imaging with CT pulmonary angiography in patients with high pretest probability of PE.

Source: Raja AS, Greenberg JO, Qaseem A, et al. Evaluation of patients with suspected acute pulmonary embolism: Best practice advice from the clinical guidelines committee of the American College of Physicians. Ann Intern Med. 2015 September 28. [Epub ahead of print]

Note: ASH is in the process of developing its own evidence-based guidelines for venous thromboembolism (VTE), as was mentioned in the feature article “How Guidelines Happen” in the August issue. Wendy Lim, MD, chair of the ASH guideline panel on diagnosis of VTE, said, “The ASH guidelines will cover both pulmonary embolism (PE) and deep-vein thrombosis (DVT), but they will differ from the ACP guideline in that the ASH guidelines are evaluating the evidence supporting the use of various diagnostic tests in determining VTE, as opposed to looking at best practice recommendations. It is likely that some ‘best practice’ recommendations will be apparent in our final recommendations as there is increasing awareness that unnecessary diagnostic tests are costly and can expose patients to unnecessary risk (e.g., radiation exposure with CT scans). As we are seeking to improve the quality of practice, selection of appropriate diagnostic tests is an important consideration in the assessment and management of these patients.

FDA Approves New Treatment for Chemotherapy-Induced Nausea and Vomiting

The U.S. FDA has approved rolapitant to prevent chemotherapy-induced nausea and vomiting that occurs from 24 hours up to 120 hours after the start of chemotherapy (also known as delayed-phase nausea and vomiting). The approval was based on the results from three randomized, double-blind, controlled trials that examined the safety and efficacy of rolapitant (an NK-1 receptor agonist) in combination with granisetron and dexamethasone. A total of 2,800 patients were randomized to receive either rolapitant or placebo with granisetron and dexamethasone. Patients had received chemotherapy that included highly emetogenic drugs, including cisplatin and the combination anthracycline and cyclophosphamide, and other moderately emetogenic chemotherapy drugs.

In these studies, patients treated with the placebo were more likely to experience vomiting and to need rescue medication for nausea and vomiting during the delayed phase compared with the rolapitant group (pooled studies: 71% vs. 60%; p=0·0001). The most common adverse events associated with rolapitant include neutropenia, hiccups, decreased appetite, and dizziness.

Rolapitant was previously approved in combination with antiemetic agents for the prevention of nausea and vomiting associated with initial and repeat courses of vomit-inducing cancer chemotherapy.

Source: U.S. FDA press release, September 2, 2015.