Lupin to market additional strengths of generic Lotrel
BALTIMORE — The Food and Drug Administration has approved an additional strength of a generic drug made by Lupin Pharmaceuticals for high blood pressure, Lupin said Wednesday.
Lupin announced the approval of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/40-mg and 10-mg/40-mg strengths. The company already markets the drug in the 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg and 10-mg/20-mg strengths.
The drug is a generic version of Novartis’ Lotrel, which had sales of $290 million during the 12-month period ended in March, according to IMS Health.
NACDS urges CMS to ensure Medicaid beneficiaries have access to health care
ALEXANDRIA, Va. — The National Association of Chain Drug Stores has submitted comments to the Centers for Medicare and Medicaid Services regarding a proposed rule that would help to determine Medicaid beneficiary access to pharmacies and other healthcare providers.
NACDS urged CMS to ensure access to healthcare services for Medicaid beneficiaries that are comparable with the access that the general population has in a given geographic area, a requirement of the federal standard.
The rule would create a process for states to follow to determine compliance with the federal Medicaid access standard of the Social Security Act.
"We applaud CMS for its efforts to create a standardized, transparent process for states to determine if they are meeting federal access requirements. We believe the three-part framework developed by the Medicaid and CHIP Payment and Access Commission to assess access based on enrollees’ needs, availability of care and providers, and utilization of services will be a useful tool to determine where access problems may exist today and how to continue to monitor access," NACDS stated in its comments letter.
"We further commend the agency for its stated commitment to develop proposals for monitoring access in the managed care setting, as its use becomes more prevalent in the Medicaid population," the letter continued.
NACDS also expressed its support for frequent reviews of beneficiaries’ access to healthcare services, and for the need for states to take corrective steps to address access issues should they arise. In addition, NACDS urged greater transparency and opportunities for public participation in reviewing beneficiary access and in changes to provider reimbursement rates.
Generic medication use can help trim costs for chronically ill patients
WOONSOCKET, R.I. — Preventive health care may be signficiantly less costly than previously thought because of the expanded use of cost-effective generic medications for the treatment and prevention of chronic diseases, according to researchers from Harvard University, Brigham and Women’s Hospital and CVS Caremark.
A study released today in the July issue of Health Affairs concluded that preventive health care is considerably less costly than previous industry estimates because earlier studies projected financial impact based on costs of branded medications. Today, the costs to consumers and the healthcare system are significantly lower because generics are broadly available for most chronic diseases, according to researchers.
For example, a 2008 study looking at preventing cardiovascular disease used branded medications to estimate the cost for lowering LDL cholesterol at $83,327 per quality adjusted life year, or QALY, a financial measure that evaluates the impact of improving the quality of life for patients with chronic diseases. Today, recalculating for the same treatment using generic alternatives would be $17,084 per QALY, or 20% of the original estimate.
More dramatic is a cost comparison for treating glucose control in cardiovascular patients, with the 2008 study estimating a $48,759 per QALY cost, versus the study’s recalculation with generics at $1,022 per QALY — just 2% of the original estimate.
With more than 70% of healthcare costs in the United States spent treating patients who have one or more chronic diseases, the researchers said generic medications are changing the economics of treating chronically ill patients.
"Prevention of cardiovascular disease, the most common cause of death in the [United States], is central to any policy discussion about overall healthcare costs. Approximately 80 million Americans have some form of cardiovascular disease with annual costs in the [United States] reaching $475 billion. Cardiovascular disease prevention can be largely accomplished with low-cost generic medications," researchers stated.
"There is no question prevention is more affordable with the use of generics," stated William Shrank of Harvard and Brigham and Women’s, and lead author of the study. "Policy-makers looking to improve and expand healthcare options should make sure generics are readily accessible for chronically ill patients. In addition, the topic of generics and effective preventive treatment should be central to any debate on making health care more affordable."
"No matter who holds the financial risk — the patient, employer or government health plan — using generic medications has to be a key part of managing treatment for chronically ill patients. This is a practical solution we need to focus on as we work to operate the healthcare system in a more cost-effective way," stated Troyen Brennan, EVP and chief medical officer of CVS Caremark, also a study author.
The research team included recommendations for policy-makers to consider, such as:
Promoting the use of generics in the new Accountable Care Organizations treatment standards, where there are incentives to prevent adverse health outcomes while lowering overall healthcare costs;
Limiting the use of prescription-writing practices, such as dispense as written — where doctors and patients can require their prescription be filled as a specific brand — and amending state Medicaid statutes that require patient consent before generics can be substituted, because those practices add billions to the cost of treatment, according to previous CVS Caremark-sponsored research;
Making sure e-prescribing guidelines encourage the use of more cost-effective medications;
Developing education programs for physicians and patients around the effectiveness of generics to offset some long-held biases that generics are not as effective as brand medications; and
Developing new incentive programs through pharmacy benefit and healthcare plans that promote the use of generics.
Today’s Health Affairs study is a product of a three-year research collaboration between CVS Caremark, Harvard and Brigham and Women’s Hospital that is focusing on understanding why many consumers do not take their prescriptions as directed, and developing solutions to improve behavior of patients around their medications. Annual excess healthcare cost because of medication nonadherence in the United States is estimated to be as much as $300 billion annually.