By Navindra Persaud, MD; Michael Bedard, MD; Andrew S. Boozary, MD; et al
JAMA Internal Medicine, October 7, 2019
Importance: Nonadherence to treatment with medicines is common globally, even for life-saving treatments. Cost is one important barrier to access, and only some jurisdictions provide medicines at no charge to patients.
Objective: To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence.
Design, Setting, and Participants: A multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor–blinded, individually randomized clinical trial conducted at 9 primary care sites in Ontario, Canada, enrolled 786 patients between June 1, 2016, and April 28, 2017, who reported cost-related nonadherence. Follow-up occurred at 12 months. The primary analysis was performed using an intention-to-treat principle.
Interventions: Patients were randomly allocated to receive free medicines on a list of essential medicines in addition to otherwise usual care (n = 395) or usual medicine access and usual care (n = 391).
Main Outcomes and Measures: The primary outcome was adherence to treatment with all medicines that were appropriately prescribed for 1 year. Secondary outcomes were hemoglobin A1c level, blood pressure, and low-density lipoprotein cholesterol levels 1 year after randomization in participants taking corresponding medicines.
Results: Among the 786 participants analyzed (439 women and 347 men; mean [SD] age, 51.7 [14.3] years), 764 completed the trial. Adherence to treatment with all medicines was higher in those randomized to receive free distribution (151 of 395 [38.2%]) compared with usual access (104 of 391 [26.6%]; difference, 11.6%; 95% CI, 4.9%-18.4%). Control of type 1 and 2 diabetes was not significantly improved by free distribution (hemoglobin A1c, −0.38%; 95% CI, −0.76% to 0.00%), systolic blood pressure was reduced (−7.2 mm Hg; 95% CI, −11.7 to −2.8 mm Hg), and low-density lipoprotein cholesterol levels were not affected (−2.3 mg/dL; 95% CI, −14.7 to 10.0 mg/dL).
Conclusions and Relevance: The distribution of essential medicines at no charge for 1 year increased adherence to treatment with medicines and improved some, but not other, disease-specific surrogate health outcomes. These findings could help inform changes to medicine access policies such as publicly funding essential medicines.
Trial Registration: ClinicalTrials.gov identifier: NCT02744963
From the Discussion
In our multicenter randomized trial, distributing a comprehensive set of essential medicines at no charge improved adherence. Free distribution also lowered systolic blood pressure and there was a suggestion of better diabetes control, although results did not reach statistical significance. There was no effect on low-density lipoprotein cholesterol levels. There was no increase in potentially inappropriate prescribing and there was no substantial difference in serious adverse events. Participants receiving free medicine distribution were more likely to report being able to make ends meet; the hypothesis that medicine access allows people to afford other necessities can be tested in future studies.
Many patients did not see improvements in surrogate outcomes despite free distribution of medicines, emphasizing that cost is only one of several contributors to nonadherence and that medicines are just one part of care.
The setting and design of the trial allows inferences about the causal effects of essential medicine access to be drawn because all participants had access to publicly funded health care services. The study population included people with a range of income levels and sources and different ethnicities who lived in urban and rural settings.
Even a Modest Co-Payment Can Cause People to Skip Drug Doses
By Aaron E. Carroll
The New York Times, November 11, 2019
There’s a logic to out-of-pocket medical payments. They’re supposed to make patients think twice before spending money on unnecessary health care.
When it comes to drugs, however, they’re often preventing people from getting necessary care.
(Cites extensive studies confirming reduced compliance with patient cost sharing.)
Canada’s single-payer system is sometimes held up as the preferred “other” model to the American status quo. But its drug coverage isn’t so good compared with the rest of the world. Pharmaceutical coverage is not part of Canada’s Medicare system, and differs from province to province. Still, Canadians do better than Americans.
Insurance isn’t enough, it seems clear. In 2015, researchers published a study in the Journal of General Internal Medicine that looked at medication adherence and cost-saving strategies of those who have Medicare. About 40 percent of this population took actions to try to cut their costs.
Cost sharing is supposed to lower spending without sacrificing quality. It was not meant to prevent patients who need drugs from receiving them.
NYT Reader Comment:
By Don McCanne, M.D.
Another recent study in Canada showed that patients receiving medications at no charge had significantly higher adherence to treatment (JAMA Internal Medicine, October 7, 2019).
A health care financing system should make it easier for patients to receive essential care they should have. Cost sharing is a barrier to care and should be eliminated. A well designed single payer model of Medicare for All would do just that.
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