Author: Peter

A group of prominent cancer doctors is planning a novel assault on high drug costs, using clinical trials to show that many oncology medications could be taken at lower doses or for shorter periods without hurting their effectiveness...they point to their pilot study involving a widely prescribed drug for advanced prostate cancer. Cutting the standard dose of Zytiga by three-quarters was as effective as taking the full amount…Szmulewitz (University of Chicago oncologist) and others now want to run full trials to see whether the doses of other oral oncology drugs can be ratcheted back because of the “food effect,” which can alter how a medication is absorbed. They also plan to explore whether the duration of some prescriptions can be shortened and whether some cheaper non-cancer drugs can be substituted for expensive cancer ones. They recently created a nonprofit organization, the Value in Cancer Care consortium, to organize their work...

The National Association of Chain Drug Stores this week shared with the House Ways and Means Committee the important role pharmacy plays in the nation’s healthcare system in an effort to encourage passage of legislation giving pharmacists provider status under Medicare Part B...The Pharmacy and Medically Underserved Areas Enhancement Act has been introduced in both the House and Senate, and NACDS’ statement looked to drum up support by outlining the work pharmacists do for patients, particularly in medically underserved areas..."We urge you to increase access to much-needed services for underserved Medicare beneficiaries by supporting H.R. 592/S. 109, the Pharmacy and Medically Underserved Areas Enhancement Act, which will allow Medicare Part B to utilize pharmacists to their full capability by providing those underserved beneficiaries with services, subject to state scope of practice laws, not currently reaching them," NACDS said...

Christopher Topoleski, Director of Federal Legislative Affairs for ASHP, talks about the ongoing legislative actions aimed at addressing rising medication costs in the drug industry.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Saint Mary’s Center for Health & Fitness, an office building on the hospital campus in downtown Reno, sold for $66.2 million. The center and Saint Mary's Regional Medical Center operations and existing tenants will not change...The building is a class A, 190,750 square-foot medical office building built in 2005. It sold to a Real Estate Investment Trust, which is a type of property-owning entity that allows people to buy shares of the trust instead of owning the building outright...Medical Properties Trust, is the REIT that now owns the office building...

Loxo Oncology opened this past weekend's annual conference of the American Society for Clinical Oncology with compelling data showing its drug's efficacy across an array of 17 different cancers...the results were unquestionably positive for Loxo, larotrectinib's performance also marks another step forward in the lofty and still yet unrealized goal of precision oncology...Merck's flagship immunotherapy Keytruda (pembrolizumab) won a landmark approval from the Food and Drug Administraiton for tumors with a specific biomarker...Treating cancer based on solely on the genetic profile of a patient's cancer has been a long-talked about objective, and progress from Merck, Loxo and others show what's possible beyond the molecularly targeted therapies that have advanced clinical care in the past decades...improving precision could also be seen in data presented by Bluebird Bio and Nanjing Legend Biotech, which showed the broader potential for CAR-T therapy outside of leukemia and lymphoma. While checkpoint inhibitors have transformed oncology by broadly unlocking the immune system, CAR-Ts specifically engineer patient's T-cells to seek out specific targets expressed by different cancer types...for a round-up of some of the biggest developments from oncology's biggest conference.

• CAR-Ts steal the show - Impressive data from Bluebird Bio and Nanjing Legend Biotech point to CAR-T's relevance outside of leukemias and lymphomas.
• Roche's Perjeta cuts risk in Aphinity, but is it enough? - The large Phase 3 study has been closely watched as potentially practice changing but the modest benefit could limit its impact in adjuvant treatment of breast cancer.
• Loxo shows promise of biomarker approach to cancer - Clinical data presented Saturday showed treatment with Loxo Oncology's larotrectinib shrank tumors in three-quarters of patients with a range of 17 different advanced cancers.
• Juno marks progress with second-gen CAR-T - Updated results for JCAR017 looked competitive in lymphoma as Juno hopes to recover from its earlier safety setbacks with its now shuttered JCAR015 program.
• J&J seeks label expansion for Zytiga - The pharma's prostate cancer drug was a big winner at ASCO, with data showing a 38% reduction in the chance of death for high-risk patients when adding Zytiga to standard hormonal therapy.
• Incyte pads its IDO numbers - IDO inhibitors have been pegged as the next step in immuno-oncology combinations, but Incyte's rising market value prompts questions over what that's worth.
• Roche's Alecensa bests Xalkori in lung study - The ALK inhibitor from the Swiss pharma dramatically improved progression-free survival over Xalkori, potentially positioning itself as the new standard of care.
• AstraZeneca's Lynparza stays step ahead of PARP rivals - Data showing a 42% risk reduction in disease worsening compared to chemo in breast cancer patients should help build Lynparza's profile outside of ovarian cancer.
• Merck touts Keytruda bladder benefit post Tecentriq failure - Data announced for Keytruda in bladder cancer raises questions about the differences in checkpoint inhibitors after Roche's recent failure in the space.
• Chi-Med, Lilly tout cancer med's efficacy in the colorectal setting - Median overall survival was about three months longer for patients receiving fruquintinib versus those on placebo.

...the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse...The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks...

South Korean authorities aren’t letting Novartis off the hook easily in an ongoing bribery controversy. After a separate agency fined the drugmaker nearly $50 million over kickback payments in April, antitrust authorities in the country have just issued a new fine and complaint against the Swiss drug giant...South Korea’s Fair Trade Commission fined Novartis 500 million won ($445,000) and filed a new complaint over payments the company offered doctors between March 2011 and August 2016, according to the Korea Times...The developments come shortly after the country’s Ministry of Health & Welfare fined Novartis 55 billion Korean won—approximately $50 million—and suspended reimbursement of Exelon and Zometa for three months, alleging the company’s employees provided approximately $2.3 million in unlawful kickbacks…

ZDoggMD, also known as Zubin Damania, will be the keynote speaker at the National Community Pharmacists Association Annual Convention October 14-18, according to a YouTube video posted by the satirical doctor..."Our nation's at a crossroads in health care today," he opens in the video. "As pharmacists, y'all know that the system ain't working. It's fractured. It rewards these silos of activity instead of awarding caregivers to actually work together on a team to do what they do best at the top of their license in service of patients."...ZDoggMD has a creative message of bringing everyone in health care together to create a better system of care that both incorporates fair payment and treatment for clinicians like pharmacists and inspires both personal and system transformation.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.