Monday, September 25, 2023

Prescribing food as medicine lowers weight, blood pressure, and blood sugar

At the health system where I work, I can refer patients with food insecurity and chronic health conditions that are sensitive to diet quality to a “Food Farmacy” to meet with dietitians and receive free produce from local food pantries. Similar “food as medicine” programs have been piloted throughout the United States, including several led by family medicine residencies. As Dr. Jen Middleton wrote on the American Family Physician Community Blog, the 2022 White House Conference on Hunger, Nutrition and Health made a number of policy recommendations to improve the accessibility of nutritious foods, including “accelerat[ing] access to ‘Food Is Medicine’ services to prevent and treat diet-related illness.” However, research on the health outcomes of such programs has been limited.

In a recent study published in Circulation: Cardiovascular Quality and Outcomes, researchers evaluated the impact of produce prescriptions on food insecurity and health status in nearly 4000 adults and children at 22 sites located in 12 states. 63 percent of households were enrolled in the Supplemental Nutrition Assistance Program (SNAP), and 83 percent were enrolled in the Special Supplemental Nutritional Program for Women, Infants, and Children (WIC). Clinicians referred patients for enrollment in nutrition classes, and individuals or households received paper vouchers or electronic cards averaging $63 per person per month to purchase fruits and vegetables from participating grocery stores and farmer’s markets. Program durations varied from 4 to 10 months.

Compared to pre-program enrollment, the daily fruit and vegetable intake of adults and children increased by 0.85 and 0.26 cups, respectively. Produce prescriptions were associated with decreased food insecurity (odds ratio, 0.63) and improvements in self-reported health status in 85 percent of patients. Adults with diabetes saw their absolute hemoglobin A1c levels drop by 0.29 percent, and adults with overweight or obesity had average decreases in body mass index of 0.36 kg/meters squared. Adults with hypertension had lower systolic and diastolic blood pressures of 8.4 mm Hg and 4.9 mm Hg, respectively, at the end of the program.

Although health insurers have not historically paid for patients to fill healthy food prescriptions, a few Medicare Advantage and Medicaid programs now cover produce purchases and other nutrition-focused interventions in high-risk patients. In addition to health gains, the economic case for expanding and sustaining these programs in the long term is strong. A microsimulation modeling study projected that over a lifetime,

implementing produce prescriptions in 6.5 million US adults with both diabetes and food insecurity would prevent 292 000 (95% uncertainty interval, 143 000–440 000) cardiovascular disease events, generate 260 000 (110000–411 000) quality‐adjusted life‐years, cost $44.3 billion in implementation costs, and save $39.6 billion ($20.5–58.6 billion) in health care costs and $4.8 billion ($1.84–$7.70 billion) in productivity costs. The program was highly cost effective from a health care perspective (incremental cost‐effectiveness ratio: $18 100/quality‐adjusted life‐years) and cost saving from a societal perspective (net savings: $−0.05 billion).

A 2018 AFP editorial provided other practical information for clinicians to help patients with food insecurity, including a list of food assistance programs for children and adults.


This post first appeared on the AFP Community Blog.

Wednesday, September 13, 2023

CMS announces “top 10” costly drugs list selected for price negotiations

Two weeks ago, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 brand name medications that it will negotiate Medicare Part D prices directly with drug manufacturers to take effect starting in 2026. Several of these medications are commonly prescribed by primary care physicians and were discussed in American Family Physician’s STEPS (Safety, Tolerability, Efficacy, Price, Simplicity) New Drug Reviews feature from 2007 to 2020. Each drug received U.S. Food and Drug Administration (FDA) approval for at least one indication before September 2016 and currently faces no generic competition.

Apixaban (Eliquis)

Empagliflozin (Jardiance)

Rivaroxaban (Xarelto)

Sitagliptin (Januvia)

Dapagliflozin (Farxiga)

Sacubitril/valsartan (Entresto)

Etanercept (Enbrel)

Ibrutinib (Imbruvica)

Ustekinumab (Stelara)

Insulin aspart (Novolog/Fiasp)

Although Medicare began paying for prescription drugs in 2006, the legislation that created the Part D drug benefit prohibited the federal government from using its purchasing power to negotiate prices directly with pharmaceutical companies, as most government health programs in other countries do from the time of market entry. This changed with the passage of the Inflation Reduction Act in August 2022, which not only gave CMS the authority to negotiate prices of selected brand-name drugs, but also penalizes companies that increase prices faster than inflation and caps Medicare beneficiaries’ annual out-of-pocket drug spending starting in 2024.

Manufacturers have until October 1, 2023 to decide if they will participate in negotiations with CMS to establish a “maximum fair price” for the designated drugs in Medicare Part D or accept financial penalties for not doing so. Negotiations that will take place over the next year will ultimately establish a discounted price that is at least 25 to 60% lower than the drug’s list price. Collectively, the federal government is expected to save $100 billion over the next decade. That’s because a small number of brand-name drugs have an outsized budget impact, with the 10 most expensive drugs accounting for 22 percent of gross Medicare Part D spending in 2021. In addition, there may be “spillover” effects from negotiated lower prices because competitors in the same therapeutic class may decide to lower their prices or risk being left off of Part D drug formularies.

Given potentially large financial impacts on the companies involved (Eliquis, Jardiance, and Enbrel comprise 23 to 33 percent of U.S. prescription drug sales of their respective manufacturers, according to STAT), the pharmaceutical industry has already filed multiple lawsuits seeking to stop price negotiations before they take effect in 2026. Although the industry warns that less revenue could discourage innovation and new drug development, the nonpartisan Congressional Budget Office has estimated that price negotiations would have a small impact on FDA new drug approvals, with 15 fewer drugs approved over the next 30 years out of about 1300 projected.


This post first appeared on the AFP Community Blog.