Novartis attempting to convince CMS to reimburse for their new Heart Failure Drug

Novartis' new heart failure medicine LCZ696, now called Entresto(TM), approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization

Press Release (pdf)

A new drug for congestive heart failure was fast-tracked by the Food and Drug Administration because it works so well. The results of Phase III Clinical trials prompted officials to give approval for marketing Entresto. 

Cardiophysiology of Congestive Heart Failure

What Is Heart Failure?

Heart failure does not mean the heart has stopped working. Rather, it means that the heart's pumping power is weaker than normal. With heart failure, blood moves through the heart and body at a slower rate, and pressure in the heart increases. As a result, the heart cannot pump enough oxygen and nutrients to meet the body's needs. The chambers of the heart may respond by stretching to hold more blood to pump through the body or by becoming stiff and thickened. This helps to keep the blood moving, but the heart muscle walls may eventually weaken and become unable to pump as efficiently. As a result, the kidneys may respond by causing the body to retain fluid (water) and salt. If fluid builds up in the arms, legs, ankles, feet, lungs, or other organs, the body becomes congested, and congestive heart failure is the term used to describe the condition.

What Causes Heart Failure?

Heart failure is caused by many conditions that damage the heart muscle, including:

• Coronary artery disease. Coronary artery disease (CAD), a disease of the arteries that supply blood and oxygen to the heart, causes decreased blood flow to the heart muscle. If the arteries become blocked or severely narrowed, the heart becomes starved for oxygen and nutrients.
• Heart attack. A heart attack occurs when a coronary artery becomes suddenly blocked, stopping the flow of blood to the heart muscle. A heart attack damages the heart muscle, resulting in a scarred area that does not function properly.
• Cardiomyopathy. Damage to the heart muscle from causes other than artery or blood flow problems, such as from infections or alcohol or drug abuse.
• Conditions that overwork the heart. Conditions including high blood pressure, valve disease, thyroid disease, kidney disease,diabetes, or heart defects present at birth can all cause heart failure. In addition, heart failure can occur when several diseases or conditions are present at once.

What Are the Symptoms of Heart Failure?

You may not have any symptoms of heart failure, or the symptoms may be mild to severe. Symptoms can be constant or can come and go. The symptoms can include:

• Congested lungs. Fluid backup in the lungs can cause shortness of breath with exercise or difficulty breathing at rest or when lying flat in bed. Lung congestion can also cause a dry, hacking coughor wheezing.
• Fluid and water retention. Less blood to your kidneys causes fluid and water retention, resulting in swollen ankles, legs,abdomen (called edema), andweight gain. Symptoms may cause an increased need to urinate during the night. Bloatingin your stomach may cause a loss of appetite or nausea.
• Dizziness, fatigue, andweakness. Less blood to your major organs and muscles makes you feel tired and weak. Less blood to the brain can cause dizziness or confusion.
• Rapid or irregular heartbeats.The heart beats faster to pump enough blood to the body. This can cause a rapid or irregular heartbeat.

What Are the Types of Heart Failure?

Systolic dysfunction (or systolic heart failure) occurs when the heart muscle doesn't contract with enough force, so there is less oxygen-rich blood that is pumped throughout the body.

Diastolic dysfunction (or diastolic heart failure) occurs when the heart contracts normally, but the ventricles do not relax properly or are stiff, and less blood enters the heart during normal filling.

A calculation done during an echocardiogram, called the ejection fraction (EF), is used to measure how well your heart pumps with each beat to help determine if systolic or diastolic dysfunction is present. Your doctor can discuss which condition you have.

How Is Heart Failure Diagnosed?

Your doctor will listen to your heart and look for signs of heart failure as well as other illnesses that may have caused your heart muscle to weaken or stiffen.

Your doctor may also order other tests to determine the cause and severity of your heart failure. These include:

• Blood tests. Blood tests are used to evaluate kidney and thyroidfunction as well as to checkcholesterol levels and the presence of anemia. Anemia is a blood condition that occurs when there is not enoughhemoglobin (the substance in red blood cells that enables the blood to transport oxygen through the body) in a person's blood.
• B-type Natriuretic Peptide (BNP) blood test. BNP is a substance secreted from the heart in response to changes inblood pressure that occur when heart failure develops or worsens. BNP blood levels increase when heart failure symptoms worsen, and decrease when the heart failure condition is stable. The BNP level in a person with heart failure -- even someone whose condition is stable -- is higher than in a person with normal heart function. BNP levels do not necessarily correlate with the severity of heart failure.
• Chest X-ray. A chest X-ray shows the size of your heart and whether there is fluid build-up around the heart and lungs.
• Echocardiogram. This test is an ultrasound which shows the heart's movement, structure, and function.
• The Ejection Fraction (EF) is used to measure how well your heart pumps with each beat to determine if systolic dysfunction or heart failure with preserved left ventricular function is present. Your doctor can discuss which condition is present in your heart.
• Electrocardiogram (EKG or ECG) . An EKG records the electrical impulses traveling through the heart.
• Cardiac catheterization. This invasive procedure helps determine whether coronary artery disease is a cause of congestive heart failure.
• Stress Test. Noninvasive stress tests provide information about the likelihood of coronary artery disease.

Is There a Treatment for Heart Failure?

There are more treatment options available for heart failure than ever before. Tight control over your medications and lifestyle, coupled with careful monitoring, are the first steps. As the condition progresses, doctors specializing in the treatment of heart failure can offer more advanced treatment options.

The goals of treating heart failureare primarily to decrease the likelihood of disease progression (thereby decreasing the risk of death and the need for hospitalization), to lessen symptoms, and to improve quality of life.

Together, you and your doctor can determine the best course of treatment for you.

Treatment can begin with simple health and wellness advice.

Stage	Definition of Stage	Usual Treatments
Stage A	People at high risk of developing heart failure (pre-heart failure), including people with: High blood pressure Diabetes Coronary artery disease Metabolic syndrome History of cardiotoxic drug therapy History of alcohol abuse History of rheumatic fever Family history of cardiomyopathy	Exercise regularly. Quit smoking. Treat high blood pressure. Treat lipid disorders. Discontinue alcohol or illegal drug use. An angiotensin converting enzyme inhibitor (ACE inhibitor) or an angiotensin II receptor blocker (ARB) is prescribed if you have coronary artery disease, diabetes, high blood pressure, or other vascular or cardiac conditions. Beta blockers may be prescribed if you have high blood pressure or if you've had a previous heart attack.
Stage B	People diagnosed with systolic left ventricular dysfunction but who have never had symptoms of heart failure (pre-heart failure), including people with: Prior heart attack Valve disease Cardiomyopathy The diagnosis is usually made when an ejection fraction of less than 40% is found during an echocardiogram test.	Treatment methods above for Stage A apply All patients should take an angiotensin converting enzyme inhibitor (ACE inhibitors) or angiotensin II receptor blocker (ARB) Beta-blockers should be prescribed for patients after a heart attack Surgery options for coronary artery repair and valve repair or replacement (as appropriate) should be discussed If appropriate, surgery options should be discussed for patients who have had a heart attack.
Stage C	Patients with known systolic heart failure and current or prior symptoms. Most common symptoms include: Shortness of breath Fatigue Reduced ability to exercise	Treatment methods above for Stage A apply All patients should take an angiotensin converting enzyme inhibitor (ACE inhibitors) and beta-blockers African-American patients may be prescribed a hydralazine/nitrate combination if symptoms persist Diuretics (water pills) and digoxin may be prescribed if symptoms persist An aldosterone inhibitor may be prescribed when symptoms remain severe with other therapies Restrict dietary sodium (salt) Monitor weight Restrict fluids (as appropriate) Drugs that worsen the condition should be discontinued As appropriate, cardiac resynchronization therapy (bi ventricular pacemaker) may be recommended An implantable cardiac defibrillator (ICD) may be recommended
Stage D	Patients with systolic heart failure and presence of advanced symptoms after receiving optimum medical care.	Treatment methods for Stages A, B & C apply Patient should be evaluated to determine if the following treatments are available options:heart transplant, ventricular assist devices, surgery options, research therapies, continuous infusion of intravenous inotropic drugs and end-of-life (palliative or hospice) care

Signs and symptoms of heart failure due to structural problems such as aortic stenosis, insufficiency, mitral valve disease may be treated surgically early on. Cardiac arrhythmia's should be corrected.



Treatment is progressive and adjusted accordingly.  Heart failure is chronic and may be progressive. It can present abruptly from an  acute coronary obstruction, or insidiously with aging.



ENTRESTO is not a first line drug and is intended for refractory CHF.  It is very expensive.

Could remote monitoring help Novartis persuade payers to reimburse for new heart drug?

“If you had a remote patient-monitoring device that the patient could use in their home together with Entresto, we could make an even more serious dent in hospitalization.”Beyond the Pill is a growing trend among pharma companies looking for ways to add more value to their medication with digital services aimed at improving medication compliance but also helping their physicians monitor their health between appointments. He added:

“We’re going to have to get smarter about services around the pill…and move into some areas that are different from just discovery of the drug… 

The addition of wearables, remote monitoring and new mHealth devices could make a major impact in reducing hospitalizations, by detecting symptoms early and identifying activities that cause CHF.

This report courtesy of WebMD.  It is not intended as any recomendation for treatment. Always consult with your physician for treatment.



Morning Read: Could remote monitoring help Novartis persuade payers to reimburse for new heart drug?MedCity News