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Opportunities, challenges shape the landscape of lipid management
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BOSTON — Advances in genetics and biotechnology have opened the door to new targets and greater speed in the development of lipid-modifying therapies; however, significant hurdles remain that make implementing any new evidence-based therapy in daily practice difficult, according to a speaker at the Cardiometabolic Health Congress.
“There has been an explosion of data in regard to population genetics, looking at both common and rare variants in terms of finding new targets,” Christie M. Ballantyne, MD, professor of medicine at Baylor College of Medicine in Houston, said during a keynote presentation at Cardiometabolic Health Congress. “At the same time, we have new methodologies using biotechnology to develop therapeutics that have tremendously accelerated this entire process. We also have more modular pathways that are important, which might lead to other targets.”
The biggest challenge going forward, Ballantyne said, will be establishing evidence-based methods to target specific therapies to selected patients, in order to maximize value of any benefit.
“It’s just extraordinary — you find the target and, bam, somebody makes something and you can test it in humans, and see if it works,” Ballantyne said. “Human genetics can provide partial validation of something being a good target. Now, that doesn’t mean the therapy will be safe ... but at least it gives you a rationale for a program.”
A disconnect in practice
While new therapies hint at new opportunities for lipid management, clinical practice data reveal a stark disconnect between what lipid guidelines suggest and the real-world treatment of high-risk patients, Ballantyne said. In a 2015 study published in the American Journal of Cardiology looking at overall and high-intensity statin use in a national cohort of patients with CVD in the VA system, 57.6% of women and 64.8% of men were using any statin therapy; just 21.1% of women and 23.6% of men were using high-intensity statin therapy. Facility-level variation in statin use ranged from 10% to 33%, in addition to wide provider variation.
“You take a health care system where, basically, the drugs are free ... and we’re still not seeing people using the (lipid) guidelines,” Ballantyne said, calling the results “disappointing data.”
Results are not better for other high-risk patient groups, he said.
Among 215,000 patients with diabetes but without documented CVD participating in the national American College of Cardiology PINNACLE registry, statin therapy among cardiology practices ranged widely, from 15% to 65%. Among patients with very high LDL levels (average untreated LDL level, 239 mg/dL) participating in the CASCADE-FH registry, high-intensity statins were used 42% of the time overall; no statin was used 25% of the time.
“Now, once again, there is referral bias ... but, nonetheless, the data (show) a big disconnect between guidelines and what is actually happening in practice,” Ballantyne said.
A lack of awareness
Researched published in JAMA in 1999 examined the reasons why many physicians do not follow clinical practice guidelines. For many, Ballantyne said, there is a simple lack of awareness — the study suggested that for more than 78% of guidelines, at least 10% of providers were not aware of their existence. More than 75% reported a lack of outcome expectancy for preventative health education and counseling; and more than 20% reported inertia of previous practice and a lack of motivation to change.
“There are also external barriers,” Ballantyne said. “People are busy. If the guidelines are inconvenient, complicated, that’s a problem. The patients push back. They don’t want to take high-dose statins. And other things come up in terms of the whole health care system, and for some of these asymptomatic disorders, this is not where the rewards are.”
In an assessment of providers’ knowledge of the 2013 ACC/AHA cholesterol guideline published in May in the Journal of Clinical Lipidology, 43% of trainees and 48% of staff acknowledged reading the guideline; 22% of trainees and 29% of staff reported understanding the definition of intensity of a statin prescription; and 56% of trainees and 61% of staff reported using LDL as a target.
Adherence hurdles
Adherence to therapy also remains a concern, he said.
“The real issue is how do we get people to adhere to people taking their statins, diet and exercise?” he said. “That’s the burning question, and it’s a real problem.”
Primary non-adherence can be common with statin use, Ballantyne said, whereas statin use during the first year can influence both health care cost and hospitalizations. A number of interventions can influence statin adherence, including patient copays and out-of-pocket costs.
“There are some things that can be done by pharmacy — automatic prescription refills, getting all your prescriptions refilled on the same day, can be done to improve adherence on the pharmacy level,” Ballantyne said. Low-tech interventions, like pill boxes, can also make a difference, he said.
“When you have about six or seven medications, people need these types of things,” he said. “We’re fortunate to have [BP] and lipid medications that are generic but, if you don’t take them, you don’t get much benefit.”
New lipid-management therapies are also expensive, and both patients and providers often get lost in the maze of the drug-coverage process, Ballantyne said.
“How do you get through the (drug) denial process?” he said. “The issue that comes up, is it takes a lot of push.”
In the first 6 months after PCSK9 inhibitors became available, patients who made an initial attempt to fill the prescription were rejected at a rate of 88.3%, Ballantyne said. Among Medicare recipients, the rejection rate was 75.4%. More consistent criteria from payers, along with checklists, algorithms and sharing of best practices can reduce wasted time and avoid frustration among health care providers and patients in the approval/denial process, he said.
“The challenge is to help simplify this, and come up with more uniform standards to make it easier for people to understand that the right patient uses the right drug at the right time,” Ballantyne said. – by Regina Schaffer
Reference:
Ballantyne CM. Lipid-Modifying Therapies 2016: Opportunities and Challenges. Presented at: Cardiometabolic Health Congress; Oct. 5-8, 2016; Boston.
Disclosure: Ballantyne reports receiving grant or research support or consultant fees from Abbott Diagnostic, Amarin, Amgen, Astra Zeneca, Eli Lilly, Esperion, Genzyme, ISIS, Matinas BioPharma Inc., Merck, Novartis, Pfizer, Otsuka, Regeneron, Roche Diagnostic, Sanofi, and Takeda.