The Ongoing Evolution of Endpoints in Oncology

Since the U.S. Food and Drug Administration’s 1992 adoption of accelerated drug approval regulation, manufacturers often have turned to surrogate endpoints to speed the market arrival of new agents with the potential to save or extend lives. Despite its “gold standard” status, overall survival is increasingly regarded as a flawed measure of efficacy in colorectal cancer and advanced breast cancer. Surrogate endpoints can speed the time necessary to bring new anticancer agents to market, though each surrogate has its advantages and disadvantages.

Albert Tzeel, MD, MHSA, FACPE, Market Medical Officer for Humana Inc’s Great Lakes Region, discusses the importance of understanding surrogate endpoints for managed care decision makers.

Regulation of Follow-On Biologics: Ensuring Quality and Patient Safety

An impressive group of experts from the fields of medicine, science, economics, and health policy discuss the quality and safety issues involved in creating a regulatory pathway to bring follow-on biologics, or biosimilars, to market in the United States. Several of the forum speakers participated in a follow-up congressional briefing in November 2009.The discussions provide various perspectives and valuable insights to spur positive action toward assuring that the dual goals of lower costs and patient safety can be met. Speakers include Michael McCaughan, The Pink Sheet; Brian Harvey,MD, PhD, sanofi-aventis; Gundu H.R. Rao, MD, Lillehei Heart Institute; Ann Witt, JD, U. S. Food and Drug Administration; Geno Merli, MD, Thomas Jefferson University Hospital; Judith K. Jones, MD, PhD, Degge Group; Terry Hisey, Deloitte; Laurence Kotlikoff, PhD, Boston University, Randy Vogenberg, RPh, PhD, EPS and Biologic Finance and Access Council.

This supplement is based on a policy forum held at the National Press Club in Washington, D. C., in April 2009, and sponsored by the Jefferson School of Population Health in Philadelphia.

Phase 3 Clinical Trials Support STELARA® (ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis

STELARA® is a subcutaneously administered biologic approved by the US Food and Drug Administration in September 2009 for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This Clinical Brief summarizes the 2 phase 3 multicenter, randomized, double-blind, placebo-controlled trials that demonstrated the efficacy and safety of STELARA®.

The Impact of Molecular Diagnostics on Treatment Pathways, Outcomes, and Cost

Adjuvant chemotherapy can improve survival in patients with early-stage breast cancer or colorectal cancer who have undergone surgical resection, but the benefit from this treatment is not universal. A distinguished panel of experts addresses the advance in molecular diagnostic testing and its impact on optimal care for cancer patients. David M. Hyams, MD, FACS, presents the epidemiology of breast and colorectal cancers and discusses treatment options and how molecular diagnostics can be used to better manage patients. Cari Bruins, PharmD, focuses on the impact of molecular diagnostics on health outcomes and cost in quality-of-care initiatives. Winston Wong, PharmD, shows the value of incorporating genomic testing into oncology treatment pathways.

Highlights:

  • Clinical Advances in Treatment Options and Diagnostics to Manage Breast cancer and Colon cancer
  • Impact of Molecular Diagnostics on Health Outcomes and Cost
  • Role of Molecular Diagnostics in Quality of Care Initiatives

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.