Janssen Biotech: Second indication won for cancer drug Imbruvica
HORSHAM, Pa. — Janssen Biotech on Wednesday announced the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy. Imbruvica was first approved in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Both indications are based on an overall response rate. An improvement in survival or disease-related symptoms has not been established.
Imbruvica is the first once-daily, single-agent, oral Bruton’s tyrosine kinase inhibitor for patients with CLL who have received one prior therapy and is being jointly developed and commercialized by Janssen and Pharmacyclics. Both indications were granted priority review and were approved under the FDA’s accelerated approval program; in addition, Imbruvica is one of the first medicines with the FDA’s Breakthrough Therapy Designation to receive U.S. approval.
According to the American Cancer Society, CLL accounts for about one-third of all new cases of leukemia.
CLL is a slow-growing blood cancer of white blood cells called lymphocytes, most commonly B cells. CLL is an orphan disease (which is defined as a disease impacting fewer than 200,000 Americans3) and is primarily diagnosed in those over 70 years old. In the U.S., an estimated 16,000 people are diagnosed with CLL each year and it is estimated that nearly 4,600 will unfortunately die due to this disease. The U.S. prevalence of CLL is approximately 114,500 people.
"CLL is a challenging disease and many physicians switch their patients from therapy to therapy as their disease relapses. There has been a significant need for new alternatives for these patients," stated John Byrd, director, Division of Hematology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital & Richard J. Solove Research Institute and lead investigator for pivotal CLL trial PCYC-1102-CA.+
"The speed at which we were able to bring Imbruvica to this point epitomizes the sense of urgency that drives oncology drug developers to bring important new medicines to patients in need," commented Craig Tendler, VP Late-stage development and global medical affairs for oncology, Janssen. "We’re delighted and proud of today’s approval, because it represents our commitment to making a difference for patients. We appreciate the ongoing collaboration between the companies and the FDA, which made this possible."
Five specialty pharmacies have been authorized to dispense Imbruvica, including Avella Specialty Pharmacy, Biologics, Diplomat Specialty Pharmacy, Onco360 and Total Life Care.
“Relapsed or refractory chronic lymphocytic leukemia can be challenging to treat and therapy options currently available are not ideal for all patients,” noted Gary Rice, VP clinical services at Diplomat. “Imbruvica … represents a major achievement in drug development and an important option for patients with this disease.”
“It is truly exciting to hear of such promising potential in a drug that could improve the lives of so many individuals,” stated Leslie Yendro, VP business development of Avella. “Along with providing access to Imbruvica, Avella provides comprehensive support and education to patients that receive this therapy.”
EXPERT BLOG: Provider status for pharmacists — one way or another
You may have heard the good news: through proactive involvement from pharmacists all across the state, California recently passed a law (SB 493 in October, 2013) declaring that pharmacists are healthcare providers who have the authority to provide healthcare services within the state. The law creates a new category of pharmacists by statute, for those who meet the criteria, and as a result creates new opportunities for pharmacists to engage with others more traditionally understood as healthcare providers (physicians, hospitals, clinics and health plans) to assist patients in managing chronic conditions. For more information on the statute and the expected impact of the change, click on the following link provided by the California Pharmacists Association.
All of us understand at some level the significance of what happened in California. But as is often the case, such a law creates a new series of questions. Will this action in California springboard other states to pass similar laws in 2014 and beyond? When will reimbursement opportunities for pharmacists as providers follow the statutes defining them as such? Will the Office of the National Coordinator (ONC) follow suit in later stages of Meaningful Use and recognize pharmacists with provider status? And will reimbursement opportunities follow in later stages of Meaningful Use for pharmacists as a result? These questions are difficult to answer and certainly more difficult to put a timeline on as to when they may happen.
Even if we don’t have the answers to the questions above right now, are there other ways in which we can see pharmacists gaining a greater foothold with provider status across the country? What about seeing examples of reimbursement model changes for pharmacists acting as providers?
As we know, health reform’s “grand experiment” is underway as a result of passage of the Affordable Care Act. And although pharmacists aren’t mentioned specifically as a provider participant within many of the Pioneer ACO models today, this doesn’t mean pharmacists won’t be permitted to integrate in the future or to create a plan for participation in these ACO models. Moreover, this doesn’t preclude pharmacists from the opportunity to be involved with other care coordination models sponsored by the CMS Innovation Center Award Program.
For example, there is a specific model in Hawaii that by design integrates outpatient pharmacists with the inpatient healthcare team (including hospital pharmacists). The model is titled, “Pharm2Pharm” and provides a new context for the community pharmacist to participate as a provider. The goal of the project is to reduce annual medication-related hospitalizations and emergency department visit rates and total cost of care among the elderly and others at risk in rural Hawaii.
This model works by creating a formal hospital pharmacist-to-community pharmacist collaboration. It is designed to address gaps in care among patients at risk as they transition from a hospital to a community setting. In other words, the patient is formally “handed off” to the certified community pharmacist by the hospital pharmacist at discharge to perform similar services in the outpatient setting (medication reconciliation, patient counseling, proactive PCP collaboration) as were performed in the hospital setting. According to information provided by the program, Pharm2Pharm pays community pharmacists $695 per patient enrolled per year on the assumption that there will be ROI to CMS (the award also funds the hospital pharmacists). For further information on Pharm2Pharm, please click here, here, and here.
It seems the industry as whole will likely continue pushing for formal pharmacist provider status changes at the federal and state level via statute. We all know healthcare is changing. It makes financial sense for all the providers across the spectrum to continue experimenting with ways in which they may work together to help improve patient outcomes and reduce costs. Ignoring any provider in the new healthcare continuum may ultimately be counterproductive in obtaining the ultimate trifecta: better outcomes, reduced costs and increased reimbursements.
As Director of Business Development with Pharmacy Services for Emdeon, Nathan Ludvigson directs policy and business development for Pharmacy Services related to electronic prescribing, Health Information Exchange (HIE), Medication Therapy Management (MTM), Prescription Monitoring Programs (PMP), Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS), and other pharmacy services areas. Nathan also identifies, analyzes and makes recommendations regarding key legislative issues and regulatory matters impacting the pharmacy industry as needed with the pharmacy services executive team. Nathan combines extensive pharmacy industry experience with legislative policy experience in both the U.S. Congress and Texas Senate. Nathan earned his Bachelor of Science degree in Political Science from Texas Christian University and a Master’s Degree in Public Administration from the University of Houston.
NCPA: U.S. Reps. contact Medicare in support of proposed changes for 2015 drug plans
ALEXANDRIA, Va. — Members of Congress are contacting the U.S. Centers for Medicare and Medicaid Services in support of pro-patient improvements the agency proposed for Medicare Part D prescription drug plans in 2015, a development applauded today by the National Community Pharmacists Association.
In response to problems with “preferred pharmacy” networks, CMS has proposed allowing any willing pharmacy to offer a plan’s lowest, or preferred, cost-sharing to give seniors more choice and to foster greater competition among pharmacies.
U.S. Representatives Mike Rogers, R-Ala., and Lynn Westmoreland, R-Ga., have written to CMS to back the change.
“I was encouraged to hear that the proposed rule for Part D dealt with many of the concerns that [community pharmacists] shared with me,” Rep. Rogers wrote. “Not only were these community pharmacies not allowed to even try and compete with lower co-pays that larger stores can offer, but many seniors signed up for these plans not realizing they would no longer be able to continue using their community pharmacy after signing up.”
Rep. Westmoreland wrote to CMS that, “Your agency’s recent release of its proposed rule on Part D has some very encouraging language that addresses” concerns raised by community pharmacists and patients, adding that “I believe the work is not yet complete and that it is crucial that Congress and the Executive Branch make sure small business pharmacies have the ability to compete on a level playing field with all the entities involved.”
Both lawmakers represent rural communities and noted that independent community pharmacies often serve such areas where national chain pharmacies may not exist.
“We commend these lawmakers for voicing their support on behalf of their constituents for the common-sense enhancements that Medicare has proposed for drug plans next year,” said NCPA CEO Douglas Hoey. “Patients will benefit from more choice and competition among pharmacies if CMS’ proposal is made final. Independent community pharmacies deserve the opportunity to match the contract terms and conditions, including pricing, of ‘preferred’ pharmacies. As Medicare officials have noted, this is ‘the best way to encourage price competition and lower costs in the Part D program.’”
In March 2013, 31 U.S. representatives sent a letter to CMS to express concerns over exclusionary preferred networks in Medicare Part D. In particular, the lawmakers said, “We fear these networks could lead to a decrease in access to quality care and threaten the survival of community pharmacies” and further demanded a response from CMS. Shortly thereafter, the agency received a similar letter from 16 U.S. senators. CMS subsequently issued the proposed rule open until March 7, 2014 for public comment.
While preferred pharmacy networks have been championed by pharmacy benefit managers as producing astronomical cost savings, a series of analyses of Medicare data have found repeated instances where preferred pharmacy plans and PBM-owned mail order are more expensive for Medicare.