Review of the Clinical Information for SIMPONI™ (golimumab) In Rheumatoid Arthritis

This Clinical Brief reviews the clinical information for SIMPONI™ (golimumab), which was approved by the U.S. Food and Drug Administration on April 24, 2009, for the treatment of adults with moderately to severe active rheumatoid arthritis (RA) in combination with methotrexate (MTX). It is also indicated for treatment of adults with active psoriatic arthritis, alone or in combination with MTX, and adults with active ankylosing spondylitis.

Highlights:

  • SIMPONI™ is administered in a one dose, once a month subcutaneously via a prefilled autoinjector or prefilled syringe.
  • SIMPONI™ has been studied in three phase 3 trials that enrolled different patients populations with respect to treatment. These multicenter, randomized, double-blinded, placebo-controlled trials included 1,542 patients age 18 or older with moderately to severely active RA.
  • In these three trials, SIMPONI™ was shown to improve the signs and symptoms in patients with moderately to severely active RA. It also was shown to be efficacious in patients who are incomplete responders or naïve to MTX, as well as those patients who have been previously treated with at least one other anti-tumor necrosis factor agent.

Roy Fleischmann, MD, Clinical Professor of Medicine, University of Texas Southwestern Medical Center, and Co-Medical Director, Metroplex Clinical Research Center, Dallas, discusses this novel agent.

New Approaches to Achieve Best Practices in Treating Myelodysplastic Syndromes

Myelodysplastic Syndromes (MDS) has gained needed attention in the last few years with the development of novel therapies. The addition of stem cell malignancies to the North American Association of Central Cancer Registries has led to a better understanding of the extent and impact of the disease and a greater interest in therapeutic interventions that can slow progression, improve the hematologic defects observed in higher-risk MDS, and provide survival benefit. With progress, though, come challenges to patients, clinicians, and payers. Bart L. Scott, MD, and David Frame, PharmD, discuss novel therapies such as hypomethylating agents and their survival benefits and potential outcomes. Allan Jay Kogan, MD, and Jeffrey D. Dunn, PharmD, discuss the changing treatment paradigms and the economic considerations for health plans. Kirby Eng, RPh, discusses the role of specialty pharmacy in MDS treatment. Each article is followed by an in-depth discussion moderated by Steven R. Peskin, MD.
This supplement is based on the Managed Care Clinical Oncology Expert Roundtable held in Dallas on July 31, 2009.

Considerations for the Clinical Assessment of the Patient With Plaque Psoriasis

A review of recently published data with a commentary for managed care decision makers by Jeffrey J. Crowley, MD, FAAD

RSV Risk: Understanding RSV-Related Hospitalization of High-Risk Infants

Respiratory syncytial virus (RSV) bronchiolitis and RSV pneumonia are the leading causes of hospitalization of infants younger than 1 year of age in the United States. Preterm infants, born at 32 to 35 weeks gestational age or less, are particularly at high risk for severe RSV disease. Early recognition of the risk factors known to predispose to serious RSV lower respiratory tract infection is key to planning an effective RSV disease prevention strategy in high-risk infants.

Unmet Needs in the Management of Plaque Psoriasis

This Clinical Brief reviews the numerous unmet needs among with patients with psoriasis, a chronic and debilitating disease. In the absence of a cure, these patients seek a treatment that improves the signs and symptoms of their disease.

Highlights:

  • Patients with moderate or severe psoriasis have been shown to be undertreated
  • Individuals with psoriasis are subject to numerous comorbid conditions
  • Patients with severe psoriasis report issues with equal treatments in service establishments
  • Psychosocial effects have been shown to include strong feelings of anger or self-consciousness, problems with sleeping, and contemplation of suicide
  • Psoriasis can impair a person’s ability to work, with a negative effect on work productivity, job retention, and the amount of missed days from a job.

Impact of RSV: Implications for Managed Care

Respiratory syncytial virus (RSV) is the leading cause of infant hospitalization, and premature infants are particularly at high risk. This Clinical Brief explains why premature infants face a higher risk of hospitalization, illustrates the costs associated with RSV hospitalization, and offers managed care strategies to help reduce hospital admissions. Norman White, MD, Medical Director with the Presbyterian Health Plan in Albuquerque discusses steps to creating an effective RSV program for high-risk infants.

Tumor Necrosis Factor Inhibitors in the Treatment of Chronic Inflammatory Diseases

A review of immunogenicity and potential implications

Gonadotrophin Products: Empowering Patients To Choose The Product That Meets Their Needs

From a managed care perspective, gonadotropin self-injections may be an effective approach to follicle-stimulating hormone (FSH) therapy. Optimal outcomes with self-administered therapy depend on maximizing adherence, minimizing errors, and controlling pain and stress associated with drug administration, all of which have been shown to benefit from patient education and involvement in choice of therapy. In this single-center study, comprehensive nurse-led training classes on conventional syringe- or pen-injection FSH delivery techniques enabled participants to identify a preferred method, with the majority of patients opting for a device in the form of a disposable follitropin alfa prefilled pen.

Unmet Needs in the Treatment of Rheumatoid Arthritis

Rheumatoid arthritis (RA) imposes a considerable disease burden. Patients experience increased medical costs, comorbid conditions, and a widened mortality gap. Existing treatments are insufficient for the current clinical demand, which is expected to increase as the population ages.

Growth Hormone Treatment: Evidence, Practice, and Emerging Issues

The effects of growth hormone deficiency (GHD) on the stature and maturation of children are well established. Recombinant DNA technology now allows the production and use of recombinant growth hormone to correct those effects without the limitations and safety concerns associated with growth hormone (GH) derived from pituitary tissue. GH therapy is also gaining acceptance for treating idiopathic short stature (ISS) in children whose growth rate is subnormal but who have no GH deficiency or other endocrine abnormality. The normal aging process in adults is accompanied by a substantial decline in GH, and recent research supports the damaging effects of GHD associated with atherosclerosis and osteoporosis. Other research is investigating GHD as a factor in chronic fibromyalgia and AIDS. This continuing education program provides information on the current status of GH therapy for children and adults so that managed care professionals can better understand the diagnostic and treatment algorithms and the scientific rationale for expanded use of GH therapy.

Highlights:

  • Clinical Management of GH Therapy for Children
  • Clinical Management of GH Therapy for Adults
  • Plan and Pharmacy Perspectives

Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

Major health care players are determined to make health information exchanges (HIEs) work. The push toward value-based payment alone almost guarantees that HIEs will be tweaked, poked, prodded, and overhauled until they deliver on their promise. The goal: straight talk from and among tech systems.

They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?

The surge of new MS treatments have been for the relapsing-remitting form of the disease. There’s hope for sufferers of a different form of MS. By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream.

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.

Having the data is one thing. Knowing how to use it is another. Applying its computational power to the data, a company called RowdMap puts providers into high-, medium-, and low-value buckets compared with peers in their markets, using specific benchmarks to show why outliers differ from the norm.
Competition among manufacturers, industry consolidation, and capitalization on me-too drugs are cranking up generic and branded drug prices. This increase has compelled PBMs, health plan sponsors, and retail pharmacies to find novel ways to turn a profit, often at the expense of the consumer.
The development of recombinant DNA and other technologies has added a new dimension to care. These medications have revolutionized the treatment of rheumatoid arthritis and many of the other 80 or so autoimmune diseases. But they can be budget busters and have a tricky side effect profile.

Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.