Controlling the rising costs of pharmaceuticals, particularly those administered by physicians, has been a top health care priority for policymakers, with recent actions in both Congress and the executive branch. Reducing the waste from discarded drugs is a piece of the broader approach to drug affordability.

Since 2006, physician-administered drugs in Medicare Part B spending has grown each year at an estimated 8.1% per enrollee, twice as rapidly as outpatient drugs in Medicare Part D and nearly three times the spending rate for the nation overall. In addition to the growing costs, a significant volume of infused or injected drugs, largely for complex diseases such as cancer and rheumatoid arthritis, are discarded due to variable dosing and their distribution in single-use vials.

For example, bortezomib, a treatment for multiple myeloma, is dosed based on a patient’s body surface area. The recommended dose is 1.3 milligrams per meter squared, administered as an intravenous injection. Each vial, which costs approximately $1,000, contains 3.5 milligrams of the drug, while the average multiple myeloma patient requires approximately 2.5 milligrams. The cost of the treatment is based on the cost of the full vial, even if the patient requires only a fraction of it. The federal government absorbs the cost of the full vial, regardless of the amount actually used, along with a 20% copayment for Medicare beneficiaries who lack supplemental coverage.

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Tally up all the physician-administered drugs in Medicare, and this waste leads to an estimated $2.8 billion of medication being thrown away each year.

But there are solutions to deal with this conundrum, particularly if a “whole of government” approach can be deployed, as we and other colleagues described in the National Academies of Sciences, Engineering, and Medicine’s recently published report, “Medications in Single Dose Vials: Implications of Discarded Drugs.”

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Its overarching recommendation is that those in the in the biopharmaceutical supply chain — drug developers, manufacturers, clinicians, payers, and policymakers — should focus on reducing system inefficiencies in drug development, delivery, and payment that result in discarded drugs, rather than on trying to recover from pharmaceutical companies the financial worth of the portion of drug that was not used. In other words, it is better to reduce the need to discard drugs than to try assigning a dollar value to the portion that patients don’t actually receive. That way, all involved in the health care value chain, up until the point where the drug reaches patients, need to work together to find a solution.

As a starting point, three federal agencies that already work closely together could have a considerable impact on reducing discarded drugs: the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the Centers for Disease Control and Prevention.

To date, these agencies have had inconsistent — and even conflicting — approaches to drug discarding. These can be remedied with better communication and interagency efforts. The FDA has an obvious role as the principal regulator of therapeutics, but the CDC also has an important role, given the guidance regarding the safe use and disposal of multidose vials. CMS also plays a key role as the largest health care financing organization in the country.

First, the FDA should work with manufacturers or sponsors of new therapies or those with extended indications to use fixed dosing for a given clinical indication, meaning a standard dose for each patient rather than one based on weight or surface area, unless studies show that safety or efficacy would be compromised. The agencies should work with the United States Pharmacopeia to harmonize policies that allow for delivering medications from a single vial to multiple patients in a safe manner. Finally, CMS should reconsider whether there is a need for the current mechanism that uses a special billing approach in an attempt to track discarded doses. Such billing methods have not been evenly adopted and have had no practical application for reducing discarded drugs. It would be more efficient to decrease the need for discarding drugs by using standard dosing — leading to a standard full-dose vial — whenever possible and to develop consistent guidelines and methods for allowing more than one patient to receive medication from a single vial.

The time for action is now, especially as the country endures the health and economic devastation of the Covid-19 pandemic and more Americans are cost conscious in all aspects of care, particularly pharmaceuticals. The findings in the National Academies report are only the most recent step in this incredibly entrenched issue of rising drug costs (see the 2018 report, “Making Medicines Affordable: A National Imperative”), but could be a harbinger of other policy solutions involving the whole of government as well as cooperation with the private sector.

Kavita Patel is a primary care physician in Washington, D.C., and a nonresident fellow in economic studies at the USC-Brookings Schaeffer Initiative for Health Policy. Julie M. Donohue is professor and chair of the Department of Health Policy and Management at the University of Pittsburgh School of Public Health. Edward H. Shortliffe is chair emeritus and adjunct professor in the Department of Biomedical Informatics at Columbia University’s Vagelos College of Physicians and Surgeons. All are members of the National Academies of Sciences, Engineering, and Medicine’s Committee on Implications of Discarded Weight-Based Drugs.

Source: STATNEWS.COM

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