Mylan, Biocon enter deal on generic analog insulins
PITTSBURGH — Mylan and Biocon have a deal to develop and sell generic insulin-analog products for diabetes, Mylan said.
Under the deal, Mylan will have the rights to develop and market Biocon’s Glargine, Lispro and Aspart, respectively generic versions of Sanofi’s Lantus, Eli Lilly’s Humalog and Novo Nordisk’s NovoLog.
"This collaboration builds off our existing successful partnership for generic biologics with Biocon and brings Mylan a portfolio of high-value insulin analog products," Mylan CEO Heather Bresch said. "This collaboration further expands and diversifies our pipeline of complex, difficult-to-manufacture products with strong future growth potential."
FDA approves Aurobindo diabetes drug
HYDERABAD, India — The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.
Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.
Pioglitazone tablets are a generic version of Takeda’s Actos, while pioglitazone and metformin hydrochloride tablets are a generic version of Takeda’s Actoplus Met. The products had combined sales of $2.8 billion in the 12-month period ending in September 2012, according to IMS Health.
Medication therapy management contribution to improved outcomes and cost savings in health care
By now we are all well aware of the healthcare IT transformation taking place across the nation. This transformation is expected to continue for the foreseeable future with further implementation of Meaningful Use and the expansion of state Medicaid programs in 2014 as a result of the Patient Protection and Affordable Care Act requirements. Providing clinical services through the coordination of care among a variety of providers in the healthcare space will continue to be a focal point in the future of healthcare as well. For example, we will likely see more elaborate collaborative care models through the expansion of accountable care organizations, patient centered medical home efforts, and the development of health insurance exchanges in one form or another.
As HIT continues its evolution down this path, the center of attention is expected to shift from provider and hospital adoption of HIT, data exchange and interoperability towards a rigorous focus upon improving patient outcomes and cost savings throughout the system. Improved patient outcomes and cost savings are the end goals of HIT transformation, with clinical exchange and interoperability being the means towards those ends. Furthermore, “adherence” will continue to be a buzz word in healthcare, and a means of achieving the goals of improved outcomes and cost savings.
And this is where medication therapy management helps fill the void. As we know, medication non-adherence continues to be a burden on the healthcare system. According to the New England Healthcare Institute, the annual costs nationally as a result of medication non-adherence are in the neighborhood of $290 billion. In November, the Congressional Budget Office issued a statement summarizing the results of a review of recent research estimating that greater prescription drug use by Medicare beneficiaries contributes to a reduction in Medicare’s spending for medical services. This study may be a springboard to help move comprehensive MTM legislation through Congress in 2013-2014. In recent years, comprehensive MTM legislation and thus greater adoption in the marketplace of MTM, has been slowed by other more pressing, omnibus healthcare efforts: namely ACA and HITECH.
It’s worth mentioning that industry leaders, NCPA and NACDS recently sent a letter to the Centers for Medicare and Medicaid Innovation asking it to clarify that pharmacists are providers for the purposes of participating in new delivery system models such as ACOs and PCMH. With expanded definitions of pharmacists as healthcare providers, clarity can be established around reimbursement for clinical services offered in the Pharmacy. Further, CMS just released an MTM report focused on the chronically ill. The report analyzes reduced prescription drug costs and hospitalization costs among patients with chronic illness like congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) who were newly enrolled in a Medicare Part D MTM program in 2010. The CMS study found that in comparison to Medicare beneficiaries with CHF or COPD who did not receive any MTM services in 2010, those who were enrolled in MTM programs experienced significant improvements.
Now that outcomes and cost savings are garnering more of the attention in both policy circles and the marketplace, the pharmacy has a golden opportunity to continue its push for becoming a major participant in the effort of tackling these dual objectives. Whether MTM is administered in the retail setting or within the context of an ACO, PCMH or hospital/clinic setting, the pharmacy has a critical role to play in the future of healthcare.
Nathan Ludvigson and Tom Bizzaro will be presenting an educational session at the national NCPDP conference titled, “The Collaborative Pharmacists,” which will include a policy overview of MTM on May 8, 2013.
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.