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Managed care organizations need to look at how they can better manage their provider data-or risk getting left behind in a pile of spreadsheets.

Why Provider Data Is Key to Effective Managed Care Coordination and Growth

The FDA has approved Tryngolza (olezarsen) to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

Familial chylomicronemia syndrome is a rare, genetic disease that results in extremely high levels of triglyceride levels. Triglyceride levels in patients with this disease can be anywhere from 10 times to 100 times greater than normal.

Familial chylomicronemia syndrome is caused by impaired function of the enzyme lipoprotein lipase and, as a results, the enzyme is not able to break down chylomicrons, lipoprotein particles that are 90% triglycerides. People living with this disease are at high risk of acute pancreatitis; fatty deposits in the retina and under the skin; enlarged liver and spleen and cognitive symptoms such as brain fog, fatigue and memory loss.

Developed by Ionis Pharmaceuticals, Tryngolza is a subcutaneous RNA-targeted therapy designed to lower the body’s production of apoC-III, a protein produced in the liver that is a key regulator of triglyceride metabolism. It is the first medication approved for familial chylomicronemia syndrome. The once-monthly therapy is expected to be available by the end of the year with a price of $595,000, according to Ionis officials in an investor call.

Related: Nine Treatments for Genetic Disorders in the Offing, Says Vizient Report

The price of Tryngolza is at the high end what Vizient had estimated would the wholesale acquisition cost (WAC). In a report in June 2024, Vizient had estimated the WAC price to be set between $400,000 and $600,000.

The company is providing patients and physicians a program called Ionis Every Step that offers a suite of services, including personal support, disease and nutrition education and training, authorization assistance. Ionis is providing financial support programs including a $0 copay for commercially insured patients.

“Many people living with FCS have experienced severe pain their whole lives – sometimes so intense they require lengthy hospitalization stays – and struggle through life with daily fatigue, nausea, brain fog and stomach pain,” Lindsey Sutton Bryan, co-founder and co-president, FCS Foundation, said in a 

The approval was based on data from the phase 3 Balance clinical trial in adult patients with genetically identified FCS and fasting triglyceride levels ≥880 mg/dL. In the Balance study, Tryngolza 80 mg demonstrated a statistically significant placebo-adjusted mean reduction in triglyceride levels of 42.5% from baseline to six months. At 12 months Tryngolza achieved a placebo-adjusted 57% mean reduction in triglycerides.

Tryngolza also demonstrated a clinically meaningful reduction in acute pancreatitis events over 12 months, and an 84% reduction in all cause hospitalizations.

The most common adverse reactions were injection site reactions, decreased platelet count and joint pain.

Tryngolza is once-monthly, subcutaneous RNA-targeted therapy and is expected to be available by the end of the year with a price of $595,000.

Formulary Watch

Clinical

 FDA Approves Tryngolza for Rare Triglyceride Disease

Racial and ethnic minorities and those without insurance are less likely to be prescribed a continuous glucose monitoring device, according to results from a cross-sectional study recently 

. Researchers also found that patients with type 1 diabetes were more likely to prescribed continuous glucose monitoring compared with type 2 diabetes.

“It is notable that these disparities exist among patients receiving primary care in FQHCs [federally qualified health centers], which represent the main system of care for historically underserved groups,” researchers wrote. “Our findings highlight the importance of expanding efforts to promote diabetes health equity in this setting.”

Continuous glucose monitoring offers better management of diabetes, improving glycemic control, promoting treatment satisfaction, and enhancing quality of life, and has the potential to reduce utilization of healthcare services because of hypo- and hyperglycemic events.

But uptake of glucose monitoring has remained low. For those with type 1 diabetes, roughly half of patients in a commercially insured population used continuous glucose monitoring from 2016 to 2019, according to a study in 

 in January 2024. Researchers in this study found that geographic disparities were a factor among the population studied, but they found that issues with insurance coverage and out-of-pocket costs were also barriers.

 study, researchers, led by Amisha Wallia, M.D., M.S.C.I.,  associate professor, Endocrinology, Metabolism, and Molecular Medicine at Northwestern University Feinberg School of Medicine, conducted a cross-sectional analysis of electronic health record data from 1,168 patients with type 1 diabetes and 35,216 patients with type 2 diabetes receiving primary care in federally qualified health centers.

They reviewed medical records for January 2014 to February 2021 for sociodemographic factors, clinical characteristics, and continuous glucose monitoring prescriptions. Federally qualified health centers provide primary care and preventive care, including health, oral, and mental health/substance abuse services.

Researchers wanted to examine the association between continuous glucose monitoring prescriptions and individual characteristics among patients with type 1 or 2 diabetes.

They found that among patients with both type 1 diabetes and type 2, those who reported Hispanic ethnicity, Black race, or were uninsured had lower odds of receiving a continuous glucose monitoring prescription than White or insured adults.

Orders for continuous glucose monitoring were greater than 10 times more common in the management of type 1 diabetes than type 2 diabetes. For patients with type 2 diabetes, the level of glycemic control and diabetes complications were associated with prescription orders for continuous glucose monitoring.

One limitation of the study, researchers said, is that orders in the electronic health system are not equivalent to long-term use and this could not be verified. Additionally, researchers said that federally qualified health centers don’t include specialty care by endocrinologists, who may be more likely to prescribe continuous glucose monitoring.

Future research is needed, they said, to understand barriers to continuous glucose monitoring use among clinicians and their patients in this care setting.

Patients with type 1 diabetes were more likely to be prescribed continuous glucose monitoring compared with those with type 2 diabetes, a new analysis finds.

Disparities Exist in Use of Continuous Glucose Monitoring

When it comes to cancer treatment, determining the right therapy as quickly as possible can make a life-saving difference. An analysis, published September 2024 in the 

Journal of Managed Care & Specialty Pharmacy

 suggests that a type of broad molecular testing, known as next-generation sequencing, not only identifies more treatable mutations in people with metastatic lung cancer, but also cuts healthcare costs.

Certain targeted medications for cancer are only effective if the cancer has specific mutations. If a mutation is missed, the patient may not get the right treatment. For example, newer drugs, such as Janssen’s 

 (amivantamab-vmjw) only work for certain types of non-small cell lung cancer with particular EGFR mutations (exon 20 insertion mutations, exon 19 deletions and exon 21 L858R substitution mutations).

Clinicians commonly use polymerase chain reaction (PCR) testing to check for cancer mutations, but this method can only check for one mutation at a time. If no mutation is found, additional PCR tests may be needed, which takes time and can miss other important mutations. In contrast, next-generation sequencing (NGS) tests for hundreds of mutations at once, giving a complete snapshot of the cancer's DNA in a single test. Although NGS typically costs more upfront, questions remain whether it can reduce overall costs and improve outcomes compared to PCR testing

To learn more about the financial and clinical impact of NGS versus PCR testing, a modeling study was conducted by researchers at the University of Chicago and Janssen Scientific Affairs, with 

 associate professor at University of Chicago Medicine, as the first author. Researchers used a Markov model to compare the costs and outcomes of NGS and PCR testing over three years.

The study modeled the outcomes of 100 patients who were newly diagnosed with metastatic non-small cell lung cancer. Data from previous research were used to estimate survival and costs. Test results were used to start either targeted treatment for their specific mutation or general, nontargeted treatment like chemotherapy.

The results showed that about 46% of NGS-tested patients and 40% of PCR-tested patients had actionable mutations. The model found NGS saved $7,386 per patient in the first year, mainly due to lower testing costs and fewer care delays. Treatment costs were similar for both (NGS: $305,644; PCR: $305,283). PCR patients faced additional costs for inappropriate first-line nontargeted therapy, reaching $6,569 by the third year. Over time, NGS led to $4,060 in savings at two years and $1,092 at three years.

The researchers also found that NGS helped identify more patients eligible for targeted therapies, resulting in earlier and more effective treatment. Those tested with NGS also had longer survival times, with some patients gaining up to 10 additional months of progression-free survival and more than five months of overall survival compared to patients whose actionable mutations were missed by PCR testing.

By helping clinicians identify more treatable mutations early, the authors concluded that broad molecular profiling through NGS will improve survival outcomes and reduce costs associated with delayed or inappropriate treatments.

“These findings warrant consideration in terms of policies that may address barriers related to increasing adoption of NGS in real-world clinical practice,” wrote Bestvina and her co-authors.

This study was funded by Janssen Scientific Affairs LLC, a Johnson & Johnson company.

Next-Generation Testing Cheaper and More Effective for Guiding Lung Cancer Treatment

Three times in the last 20 years, the American Academy of Ophthalmology has updated guidelines for dosing of hydroxychloroquine (HCQ) and recommendations for detecting retinopathy at the earliest possible stage; as tests for finding asymptomatic HCQ retinopathy have improved the condition had be founder earlier, and the AAO’s limits on safe dosing have declined.

, “Rethinking the Hydroxychloroquine Dosing and Retinopathy Screening Guidelines,” there was a problem with this process, which led poor uptake of the recommendations: the prescribing physicians who would have to manage the autoimmune disease were left out of the process, “but must live with the ramifications of the guidelines.”

The authors are ophthalmologist David J. Browing, M.D., Ph.D.; rheumatologist Naoto Yokogawa, M.D.; ophthalmologist Paul B. Greenberg, M.D., MPH; and ophthalmologist Elliot Perlman, M.D.

“Hydroxychloroquine is effective in many autoimmune diseases, particularly in patients with systemic lupus erythematosus (SLE),” authors of the new editorial note. “Hydroxychloroquine is recommended to all SLE patients, unless contraindicated, due to the multiple beneficial effects on survival, disease activity, and the risks of organ damage and thromboembolic episodes.”

While there are alternatives to HCQ, these may cost more and have more side effects, the authors said. And, the 2016 guidelines in particular failed to adequately account for the challenge that prescribing physicians face as the obesity epidemic intensifies, and the gap between real body weight and ideal body weight increases.

Thus, prescribing physicians faced with the 2016 update were in a tight spot: if they failed to adhere to the AAO guidelines, they would appear to be ignoring patient safety, when in fact doctors and patients “are making calculated decisions balancing the risks of HCQ retinopathy with damage to other organ systems.”

Early and frequent testing for HCQ retinopathy is still important, the authors write, but finding this condition at the earliest possible stage should be “an important subsidiary goal, not the primary goal.” The mission of the of the prescribing physician managing autoimmune disease and the ophthalmologist should be the same: “controlling systemic disease without endangering vision.”


A prospective study is needed to clarify the point at which retinopathy progresses despite stopping HCQ. Absent those results, the current recommendation to stop HCQ at the first sign of trouble must be reconsidered. New guidelines, which would reflect input from prescribing physicians, would “reflect a more nuanced approach,” and acknowledge that evidence is limited.

The authors pointed to six questions they said need answers to settle current controversies in HCQ dosing:

How does HCQ distribute between adipose tissue (fat) and lean tissue?

What are the key indicators at which HCQ retinopathy progresses even if the drug is stopped?

What are the relative sensitivities and specificities of tests for HCQ retinopathy?

How can renal disease be measured in HCQ dosing?

What is the connection between cumulative HCQ dose and HCQ risk?

Prospective studies are needed to answer these questions. In the meantime, specialists who care for patients with autoimmune disease must take part in the AAO committee that revises the next set of guidelines, the authors said. “By acknowledging the complementary roles of prescribers and ophthalmologists, this approach will lead to wider acceptance of guidelines and better care for our patients,” they said.

Guidelines to prevent retinopathy caused by a drug to treat autoimmune disease must be developed jointly by ophthalmologists and prescribing physicians, journal authors say.

For Better HCQ Retinopathy Guidelines, Include Prescribing Physicians

Quality measures are a tool to drive healthcare toward value-based care, and in diabetes care these measures can improve diabetes management and prevent downstream conditions, such as cardiovascular disease. However, there are multiple hurdles that healthcare organizations face when implementing quality measures for diabetes care, explained Sean M. Oser, M.D., M.P.H., associate professor in the Department of Family Medicine at the University of Colorado School of Medicine, in a 

There are many differences between recommendations for quality measures and reimbursement policies for covered services from different insurers. Although Oser suggested that these all need to be streamlined, in the interim, health systems and provider organizations should have a quality improvement program or team to help understand these requirements. The team can translate the requirements down to the practice level from the health plan or health system and gather data from the electronic health record (EHR) to turn it into an actionable report.

The ability to generate reports allows providers and health systems to track measurement and performance over time to see what progress, if any, is being made. He recommends ensuring there is transparency with stakeholders so they can also follow the progress or see where improvements are lagging. “There is a ton of data that we have available now to try to improve our performance on quality measures and to target where they are not being met,” Oser said.

Advanced EHRs have the capability to generate reports and identify care gaps in real time, too. Previously, when using paper records or older EHRs, Oser would have to search through them to find the latest laboratory results to see the patient’s hemoglobin A1C level or the date of their most recent eye exam. Now, when that data is entered into the EHR, care gaps are highlighted as soon as the patient’s chart is opened during the visit.

Communication is another important aspect of filling those gaps. Patients or providers might get letters from health plans indicating that a patient who has diabetes might not be taking their statin based on claims information, but Oser doesn’t view that communication as very actionable at the practice level. What has been more successful is using care managers or nurses at the health plan to reach out to patients directly to be their personal care manager. “Actual face-to-face — or at least person to person on a telephone — communication can be a whole lot more effective than some of those letters that are received,” he said.

Another area where data has evolved for the benefit of patients with diabetes is with continuous glucose monitoring (CGM), Oser noted. “We’ve relied for a very long time on hemoglobin A1C checks, and they remain extremely useful, but they’re not always right,” he said.

CGM measures glucose levels as frequently as every minute for up to 15 minutes depending on the system, and this data provides an average glucose level. Oser noted there is a small difference between average glucose and hemoglobin A1C. In the latter, the percent of the portion of the hemoglobin molecule that has glucose attached is being measured. While this is associated with average glucose levels, “it’s not a direct correlation,” he explained.

“CGM gives us the actual average glucose, which is what we’re really looking for in the first place,” Oser said. There are many reasons why a hemoglobin A1C level may be inaccurate, such as during pregnancy, in patients with chronic kidney disease, or in patients with variants of their hemoglobin, such as in sickle cell disease.

Sean M. Oser, M.D., M.P.H., an associate professor in the Department of Family Medicine at the University of Colorado School of Medicine, discussed diabetes management and quality measures in a Managed Healthcare Executive K-Cast video series.

Tom White

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