Treatment FAQ

what is the concept of “step therapy” for the treatment of hypertension?

by Sandra Parisian Published 3 years ago Updated 2 years ago

Step therapy is a program for people who take prescription drugs regularly to treat a medical condition, such as arthritis, asthma or high blood pressure. It allows you and your family to receive the affordable treatment you need and helps your organization continue with prescription-drug coverage.

Full Answer

What is the goal of hypertension treatment?

The goal of hypertension treatment is to lower high blood pressure and protect important organs, like the brain, heart, and kidneys from damage. Treatment for hypertension has been associated with reductions in stroke (reduced an average of 35%-40%), heart attack (20%-25%), and heart failure (more than 50%), according to research.

How effective is the stepped-care approach to the management of hypertension?

T he stepped-care approach to the management of hypertension has been used widely and has proved effective. Hypertension Detection and Follow-up Program Cooperative Study Five-year findings of the hypertension detection and follow-up program. Report of the Joint National Committee on Detection, Evaluation and Treatment of High Blood Pressure.

What changes should be made to the definition of Stage 1 hypertension?

Another major change is the lowering of the definition of stage I hypertension to 130/80 mm Hg. I applaud the committee for their truly remarkable work overall. However, there are a few recommendations, specifically the approach to mild hypertension and combination therapy, where I would like to offer some differences in opinion.

What is the first line of therapy for high blood pressure?

Diuretics are often recommended as the first line of therapy for most people who have high blood pressure. However, your doctor may start a medicine other than a diuretic as the first line of therapy if you have certain medical problems.

What is the stepped care approach for hypertension?

Stepped care implies that if the use of one drug does not lower dia8tolic blood pressure to 90 mm Hg or below, additional medications should be prescribed.

What is the step form of treatment?

Step therapy is a program that requires patients to try a lower cost prescription drug that treats a given condition before “stepping up” to a similar-acting, but more expensive drug. Other names for step therapy are “step protocol” and “fail first requirements.”

What is a step one medication?

Step 1 drugs are typically generic and lower-cost brand drugs proven to be safe, effective and affordable. In most cases, they provide the same health benefit as a more expensive drug, at a lower cost.

What is generic step therapy?

Step therapy helps people treat medical conditions with prescription medications by first using generic drugs to treat the conditions and moving to brand-name or higher-cost medications only if the generic medications are not effective.

What is Steps program pharmacy?

To achieve its goal of the lowest possible incidence of drug-associated teratogenicity, the S.T.E.P.S. program uses a three-pronged approach: (1) controlling access to the drug; (2) educating prescribers, pharmacists, and patients; and (3) monitoring compliance.

What is the Safe Step act?

To amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes. This Act may be cited as the “Safe Step Act”.

What is the difference between prior authorization and step therapy programs?

Automation of prior authorization for medications is referred to as electronic prior authorization. Step therapy is an insurance protocol that requires patients to try one or more insurer-preferred medications prior to a physician recommendation. This practice is also known as “fail first” and can take weeks or months.

What is a step edit in managed care?

Step edits are a mechanism designed by health insurers to control cost. Usually, but not always, this means that patients are expected to try cheaper drugs before trying more expensive drugs. In some cases, especially with generic medications, this is perfectly reasonable.

What is Medicare Part D step?

According to the Centers for Medicare and Medicaid (CMS) "Step Therapy" is defined as: When your Medicare Part D plan requires you to first try one (usually less-expensive) drug before the drug plan will pay for coverage of another (usually more-expensive) drug for that same medical condition.

What is white bagging?

“White bagging” commonly occurs when insurance companies make coverage of needed patient-specific medications contingent on the medication being distributed from a third party specialty pharmacy versus allowing providers to buy and then bill for the medication and its administration.

What is prior authorization for medication?

A prior authorization (PA), sometimes referred to as a “pre-authorization,” is a requirement from your health insurance company that your doctor obtain approval from your plan before it will cover the costs of a specific medicine, medical device or procedure.

What is a drug prior authorization?

Prior authorization means that your physician must follow a process to obtain prior approval from your insurance company when administering specific medications, medical devices, and medical procedures. Prior authorization must be performed before the insurance company or plan will provide full or partial coverage.

What percentage of patients require two or more medications to achieve BP control?

A second aspect of the guidelines that I would have addressed differently is the approach to combination therapy. A wealth of data supports that >75% of patients require two or more medications to achieve BP control. 8 Given new targets <130/80 mm Hg, an even larger percentage of patients will require more intense treatment. I applaud the promotion of using early combination therapy. However, the guidelines (with a few notable exceptions) provide the false sense that all combinations are created equal.

Is immediate treatment for mild hypertensives credible?

Immediate drug-treatment for low risk mild hypertensives could certainly remain a credible option. However, I believe it should receive a lower strength of recommendation (COR IIA or IIB). This downgrade would circumvent the potential for inappropriate penalization of clinicians who decide with their patients to delay drug-therapy for a few months. The failure of the authors to account for this period of lifestyle treatment alone that existed in previous guidelines also led them to under-estimate the number of additional patients who will receive drug-therapy following new guidelines. 3,8 The new approach (perhaps unintendedly) also limits shared decision-making processes. A COR 1 "should" be followed. This means there is no opportunity to discuss with patients the potential for lifestyle change alone. In my experience, many patients appreciate a lifestyle option over the relegation to being "condemned to drug therapy" without so much as first even having a realistic discussion about the possible success of "natural" (non-drug) treatments. The immediate surrendering to the inevitability of drug-treatment at a BP level of 140/90 mm Hg might also feed into the narrative that health care providers are in collusion with pharmaceutical industries and not willing to involve patients in decisions regarding their own health. An alternative option would be to acknowledge these arguments and add a section on the approach to weaning anti-hypertensive medications. Some of my anxiety would be mitigated if the committee outlined an algorithm for when/how to "step-down" drug therapy among individuals who appear able to maintain BP control using lifestyle alone.

Is stage 2 hypertension a non-evidence based treatment?

Ironically, the guidelines may result in more widespread "non-evidence-based" treatment. Nearly half of patients with "stage-2 hypertension" (BP ≥140/90 mm Hg) are low-risk (30.5% and 15.3% with 10-year risks <5% and 5-9%, respectively). 6 No outcome trial has ever explicitly tested (let alone proven) the benefits of drug-therapy in younger patients (18-59 years old) or "mild-hypertensives" (BP <160/100 mm Hg) with a low estimated 10-year ASCVD risk. 7 Older trials including some germane patients with "mild hypertension" exist; however, they enrolled individuals who were on average >50-60 years old who typically had many other ASCVD risk factors (including diabetes) and BP levels much closer to 160/100 mm Hg. 4 Even so, meta-analyses of these data provided mixed results at-best. Moreover, the feasibility and risk/benefit ratio of decades of drug-treatment in young lower-risk people main unknown. 4 Serious risks due to antihypertensive medications are typically low. However, the possibility remains that more low-risk hypertensives could suffer adverse events (e.g., hypotension, syncope, azotemia, electrolyte disorders, allergy/angioedema) than reduction in ASCVD events. The case for health care providers to advocate to their patients in support of immediate drug treatment would be strengthened by providing a favorable estimation of the number-needed-to-treat versus number-harmed in this lower risk strata.

What is step therapy for CKD?

The step therapy approach outlined here is consistent with current standards and guidelines for the treatment of patients with CKD and can serve as a helpful resource for clinicians as they work toward standard target levels of calcium, phosphorous, vitamin D and PTH in this complex patient population. Before medical treatments became available to address imbalances of these important biochemical and hormonal components, SHPT in patients with CKD resulted in considerable morbidity and mortality. 41 Effective use of the step therapy approach to SHPT and MBD can help to protect patients from the effects of poor bone health and cardiovascular disease that lie at the end of the CKD-MBD spectrum.

What is the treatment for hyperphosphatemia?

Following an initial focus of therapy to manage hyperphosphatemia with diet and phosphate binders, subsequent treatment should be considered, if necessary, to address dietary vitamin D deficiency.

How does cinacalcet help with PTH?

Cinacalcet acts to lower PTH levels by binding to the calcium sensing receptor , imitating calcium ’s effect on the parathyroid gland. Adding cinacalcet increases the likelihood patients will attain target PTH levels, particularly if adequate doses of vitamin D are not possible due to elevated serum calcium or phosphorus levels. 28-31 However, cinacalcet has not been proven to provide a benefit on mortality and cardiovascular outcomes. 32-33 Updated KDIGO guidelines suggest the use of calcimimetics, calcitriol, or vitamin D analogs, or a combination of those therapies, in patients with advanced-stage CKD undergoing therapy to control elevated PTH levels. 34

What is the treatment for CKD-MBD?

As CKD-MBD is a multifactorial manifestation of CKD, successful treatment requires a holistic approach to managing calcium, phosphorus, vitamin D, parathyroid hormone (PTH) and fibroblast growth factor (FGF23) . As noted by KDIGO, the processes contributing to CKD-MBD are closely interrelated and contribute to morbidity and mortality in these patients. 3

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