The FDA has accepted a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq, Genentech) and has granted the product priority review for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy, and who are either previously untreated (first-line) or have disease progression at least 12 months after receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). The FDA will make a decision on approval by April 30, 2017.

Atezolizumab is a monoclonal antibody designed to bind with the programmed death ligand-1 (PD-L1) protein on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both programmed death-1 (PD-1) and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells. The antibody may also affect normal cells.

The sBLA submission for atezolizumab was based on results from the phase 2, open-label, multicenter, single-arm IMvigor210 trial, which evaluated the safety and efficacy of atezolizumab in patients with locally advanced or metastatic urothelial carcinoma, regardless of PD-L1 expression.

The subjects were enrolled into one of two cohorts. Cohort 1, upon which the sBLA submission was based, consisted of patients who were ineligible for first-line cisplatin-based chemotherapy, and who had received no prior chemotherapies for locally advanced or metastatic urothelial carcinoma (i.e., first-line) or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy. Cohort 2, which served as the basis for the FDA’s accelerated approval of atezolizumab in May 2016, included patients whose disease had progressed during or after previous treatment with a platinum-based chemotherapy regimen, or who had disease progression within 12 months of treatment with a platinum-based neoadjuvant or adjuvant chemotherapy regimen.

The study’s primary endpoint was objective response rate. Secondary endpoints included the duration of response, overall survival, progression-free survival, and safety.

Atezolizumab is currently approved by the FDA to treat patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-based chemotherapy or whose disease has worsened within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy. Atezolizumab is also approved for the treatment of patients with metastatic non–small-cell lung cancer who have disease progression during or after platinum-containing chemotherapy and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.

Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra. The American Cancer Society has estimated that more than 79,000 Americans will be diagnosed with bladder cancer in 2017. Approximately 11% of new diagnoses are made when bladder cancer is in advanced stages. There is a dramatic difference in survival rates between early and advanced bladder cancer. Approximately 96% of patients will live five or more years when diagnosed with the earliest stage of the disease, compared with 39% when diagnosed in advanced stages (III–IV) of the disease. Men are approximately three to four times more likely to develop bladder cancer during their lifetimes than women.

Source: Genentech; January 8, 2017.

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.