Medicare Part D Coverage for Lonhala Magnair

What Is the Difference Between Medicare Part D and B? How Will Lonhala Magnair Be Covered?

Dr. Mahler:

Do you think Lonhala Magnair will be covered under Medicare Part D or Medicare Part B?

Daniel from Buffalo, NY

Dear Daniel:

Lonhala Magnair is the brand name for glycopyrrolate – a nebulized  bronchodilator. Until its approval by the Food and Drug Administration on December 5, 2017, ipratropium bromide (brand name Atrovent) was the only muscarinic antagonist available for use in a nebulizer. However, it is short-acting and lasts 4 to 6 hours. Therefore, it needs to be used at least three if not four times in 24 hours.

Lonhala Magnair is a muscarinic antagonist bronchodilator solution that will covered by Medicare Part D

Lonhala Magnair is a long-acting bronchodilator delivered by the e-Flow nebulizer

In contrast, Lonhala Nagnair is the first long-acting muscarinic antagonist (called a LAMA) available for use in a nebulizer. It lasts 12 hours and should be used twice a day. See my post on December 7, 2017, for more information about this medication including its unique e-Flow nebulizer.

Nebulized medications are generally covered by Medicare Part B. However, Sunovion Pharmaceuticals announced that Lonhala Magnair will be covered by Medicare Part D. It is expected that Lonhala Magnair will become available in the Spring 2018.

Medicare Coverage

Many patients in my practice ask questions about Medicare coverage. Here is a brief summary of the different types of Medicare health insurance. I will try to make this complicated program as simple as possible. However, that is a challenge.

Brief History of Medicare The law providing Medicare health coverage for those over 65 years of age was signed by President Johnson on July 30, 1965, and took effect in January 1966. In 1972, Medicare coverage was expanded to include those less than 65 years of age who had long-term disability and end-stage renal disease..

Original Medicare

This program is administered directly by the federal government and has four parts:

  1. Part A is hospital insurance. It covers most medically necessary care in the hospital, skilled nursing facility, home health, and hospice. It is free if you have worked and paid Social Security taxes for at least 40 calendar quarters (10 years). You will pay a monthly premium if you have worked and paid taxes for less time.
  2. Part B is medical insurance. It covers most medically necessary doctors’ services, preventive care, durable medical equipment like oxygen, hospital outpatient services, laboratory tests, x-rays, mental health care, and some home health and ambulance services. You pay a monthly premium for this coverage.
  3. Part C allows private health insurance companies to provide Medicare benefits. See below for more information.
  4. Part D is out-patient prescription drug insurance. It provides coverage for the medications that you take at home. However, if you have Original Medicare (Parts A and B), you must choose a separate plan for Part D plan coverage. You must sign up with a private insurance company for Part D coverage that works with your Medicare health benefits.

Medicare Advantage Plans

You can choose to get your Medicare coverage through a Medicare Advantage Plan instead of through Original Medicare. These are private health health insurance companies that are approved by Medicare. Many are known as health maintenance organizations (called HMOs) and preferred provider organizations (called PPOs).

Daniel – I hope this lengthy answer is helpful. I have tried to explain Medicare health coverage as many patients tell me that this subject is quite confusing.

Please note, the advice provided is not a substitute for asking your health care professional about your specific situation.

Sincerely,

Donald A. Mahler, M.D.

New Bronchodilator Approved For COPD In Nebulizer

New Bronchodilator – First Of Its Class For Use In Nebulizer

On December 5, 2017, the United States Food and Drug Administration (FDA) announced approval of a new bronchodilator as a long-acting nebulized medication. Lonhala is the brand name of the medication, while the generic name is glycopyrrolate. It is also known as SUN-101/eFlow®. Magnair is the brand name of the eFlow® nebulizer system developed by PARI Pharma GmbH.

According to the FDA, Lonhala Magnair is indicated for “long term, twice each day (morning and evening) maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.”

Why Is It Unique? It is the first long-acting muscarinic antagonist (LAMA) bronchodilator available in a solution to be used in a nebulizer. The other type of bronchodilator is called a beta-agonist. These two classes of bronchodilators work in different ways to open the breathing tubes (airways).

The Magnair nebulizer is a silent and portable delivery device that reduces the amount of time required for someone with COPD to inhale the medication in two to three minutes.

Lonhala Magnair is a muscarinic antagonist bronchodilator solution

Lonhala Magnair is a long-acting bronchodilator delivered by the e-Flow nebulizer

Nebulized medications offer an alternative to metered-dose inhalers, soft mist inhalers, and dry powder inhalers. They allow a person to breathe normally in and out while inhaling the medicine.

Metered-dose inhaler

Metered-dose inhaler

Soft mist inhaler

Soft mist inhaler

My Comments  Lonhala Magnair is the first long-acting muscarinic antagonist bronchodilator available for the nebulized treatment of those with COPD. There are two long- acting nebulized beta-agonist bronchodilators available – Brovana and Perforomist. Both last 12 hours, are used twice daily, and are used with a jet nebulizer. 

Jet nebulizer system

Jet nebulizer system

I expect that this new bronchodilator will be used in addition to Brovana or Perforomist to provide more effective opening of the breathing tubes (bronchodilation) when a nebulizer is used.

Please view my financial disclosures under the heading ABOUT.

Dry Powder Inhalers: You Need to Breathe In “Hard and Fast”to Get the Powder Deep into the Lungs

Dry Powder Inhalers Have Internal Resistances

Background: Inhaled bronchodilators are the cornerstone for treatment of those with COPD. However, it is important that the person be able to inhale the medication deep into the lungs in order to open the airways and make it easier to breathe.

Of the four different inhaling devices for bronchodilators, the most common is called the pressured metered-dose inhaler shown in the figure below. Simply pressing the canister down releases a spray (aerosol) from the mouthpiece.

Example of metered-dose inhaler. This is a different system than dry powder inhalers.

Pressurized metered-dose inhaler.

Many bronchodilators are available in dry powder inhalers (see below). All dry powder devices have an internal resistance. As a result, you need to inhale “hard and fast” to literally pull the powder out of the device and inhale it deep into the lungs.

Different dry powder inhalers

Dry powder inhalers have an internal resistance.

There is a simple breathing test to determine if you have enough inspiratory force to inhale the powder successfully out of the inhaler. This test is called peak inspiratory flow rate (abbreviated PIFR). Here is a picture of the In-Check DIAL used to measure PIFR.

In-Check DIAL to measure the resistance of dry powder inhalers

In-Check DIAL to measure peak inspiratory flow rate

Study: Dr. Loh and colleagues at the Winston-Salem Baptist Medical Center in North Carolina measured PIFR in patients just before discharge from the hospital for a flare-up (exacerbation) of COPD. The study results are published on-line in the Annals of the American Thoracic Society on April 13 (doi: 10.1513/AnnalsATS.201611-903OC).

Results: 52% of the 123 subjects had a PIFR below 60 liters/min. A value of 60 or higher is considered “optimal” to inhale the powder deep into the lungs.   Those with PIFR less than 60 liters/min were more likely to be readmitted to the hospital over 90 days for another COPD flare-up (28%) compared with subjects who had PIFR at least 60 or higher (14%).

Conclusions: The authors concluded that a low PIFR is common in those admitted to the hospital for a COPD flare-up. They recommended that the medical team measure PIFR before discharge, especially if a dry powder is being prescribed.

My Comments: With a PIFR of less than 60, it more likely that some or most of the powder stays in the mouth and throat. IF you are taking a dry powder bronchodilator and IF you find that it does not help you breathe easier, then you should ask your health care provider to measure your PIFR. If an In-Check DIAL is not available to test your PIFR, then you should ask about a different delivery system – possibilities include a pressurized metered-dose inhaler, a soft mist inhaler, or a nebulizer.

Woman inhaling aerosol from nebulizer

Soft mist inhaler

Cleaning Inhalers: Is It Necessary? How do I Clean My Inhalers?

Cleaning Inhalers – Helps to Prevent Infection

Dear Dr. Mahler:

I recently read that I should clean my inhalers to make sure that they work correctly and to prevent infections. However, I can’t find any information that describes how to do this. I use Symbicort inhaler and Spiriva powder every day and ProAir as my rescue inhaler. What do you recommend?

Gerard from San Juan, Puerto Rico

Dear Gerard:

You ask an important question about keeping inhaler devices clean and working properly. Unfortunately, this topic – cleaning inhalers – has not received a lot of attention.

As I am sure that others with COPD have the same question or concern as you do, here is information for cleaning inhalers as well as nebulizers.

Metered-dose inhaler (abbreviated MDI)

Cleaning inhalers is important for metered-dose inhalers

Diagram of metered-dose inhaler

When you press down on the top of the chamber, the aerosol spray comes out of the metering chamber and enters the nozzle  (see above). There is concern that the spray might accumulate over time and clog the nozzle. Cleaning the actuator with running water and air drying is recommended periodically to reduce this possibility.

Dry-powder inhaler (abbreviated DPI)

Dry-powder inhalers

A clean, dry cloth should be used to wipe away any powder from the mouthpiece. This should minimize any contamination with bacterial or fungus. This should be done periodically.

Soft mist inhaler (abbreviated SMI)

Soft mist inhaler

All that is required with the soft mist inhaler is to clean the mouthpiece with a damp cloth. It is recommended that cleaning be performed periodically.

Nebulizer

The main source of nebulizer contamination is the patient. People of all ages tend to drool into the mouthpiece which explains why bacteria are frequently found in the reservoir (cup) after use.

nebulizer is one delivery system in which cleaning inhalers is important.

Hand held nebulizer

Any liquid that remains in the cup after you have finished inhaling leaves a wet environment with potential for growth of bacteria. This has led to the recommendation that the nebulizer be rinsed, washed, and air dried after each use.

Here are specific recommendations: Detach the medicine cup and mouthpiece from the tubing. Wash the medicine cup and mouthpiece with warm soapy water and rinse them with water. Place the equipment on a clean towel to fully air dry. Make sure to do this after each treatment and daily.

  • Don’t wash the tubing. If it gets wet, replace the tubing. Also, don’t put any parts of the nebulizer into a dishwasher to clean it because the heat can warp the plastic. Tubing should be changed periodically, usually every two weeks.

Here is a way to disinfect the mouthpiece and cup every other day. Mix a solution of 1 part distilled white vinegar and 3 parts warm tap water in a clean bowl. Soak the nebulizer parts (except the tubing and mask) for 60 minutes, then rinse thoroughly and air dry.

 

Nebulizer Therapy – Can It Help Me Breathe Easier?

When to Consider Nebulizer Therapy

Dear Dr. Mahler:

I have severe COPD and attend pulmonary rehab sessions at the nearby hospital.  I take Advair in the purple disk twice a day and Spiriva powder in the capsule each morning. One of the other patients at rehab told me that she uses medicines in a nebulizer machine and this helps her breathe much better than when she used different inhalers in the past. Do you think that nebulizer therapy might help me?

Tracy from Bellingham, WA

Dear Tracy,

There are four different delivery systems for inhaled medications to treat those with COPD: metered-dose inhalers (commonly called puffers); dry powder inhalers; soft mist inhalers; and nebulizers. Some examples are shown below. In general, pharmaceutical companies have mainly been developing new bronchodilator medications as dry powders.

Metered-dose Inhaler

Metered-dose Inhaler

Examples of dry-powder inhalers

Examples of dry-powder inhalers

With dry powder inhalers, you need to take a hard and fast breath in – in order to pull the powder out of the device and overcome its internal resistance. Some individuals, especially those with more advanced COPD, may not have enough strength to successfully break up the powder packet in the inhaler device and then inhale the powder particles deep into the lower parts of the lungs.

Nebulizer therapy is used frequently to deliver bronchodilator medications to those with COPD who are experiencing a flare-up (exacerbation) both in the Emergency Department and in the hospital. Many patients with COPD find that this approach works better because you just breathe in and out normally when inhaling the medications from the nebulizer, and you don’t have to have to hold your breath as you do with the other delivery systems.

Inhaler machine for nebulizer therapy

Hand held nebulizer

There are four major reasons why your health care provider might prescribe nebulizer therapy: you have difficulty using the other inhaler devices [because of arthritis of the hands and wrists or because of difficulty following instructions (dementia)]; you have difficulty coordinating the steps to release the medication from the device, inhaling correctly, and then holding your breath for as long as possible; you are not able to breathe easier with inhaler devices; AND you do not have adequate force when breathing in to pull the powder out of the inhaler.

I suggest that you ask your health care provider whether a trial of nebulizer medications is appropriate, especially since you don’t feel it is easier to breathe with your current inhalers. Both types of bronchodilators (beta-agonists and muscarinic antagonists) as well as an inhaled corticosteroid are available in solutions for use in a nebulizer. These three different types of medications are similar to the Advair and Spiriva dry powder inhalers that you are currently using.

Best wishes,

Donald A. Mahler, M.D.

Nebulizer

Dear Dr. Mahler:

My pulmonary doctor has recommended that I try medicines in a nebulizer machine to help my breathing.  Over the past few years my primary doctor and his PA have prescribed every possible inhaler for my COPD, but none of them seem to work very well. His nurse has shown me how to use these different inhalers, but it is confusing.  I have used the machine once when I had to go to the emergency room for my breathing and the medicine helped me a lot. Please tell me more about use of a nebulizer.

Fran from Little Rock, AR

Dear Fran:

A nebulizer is a machine that mixes air or oxygen with a liquid bronchodilator medicine (called an aerosol) that is inhaled to dilate, or open, the breathing tubes (airways). Nebulized therapy is used widely when someone with asthma or COPD comes to the Emergency Department or is admitted to the hospital with a breathing problem. The picture shows one type of nebulizer.

One type of nebulizer

One type of nebulizer

If your doctor orders the nebulizer and medicines from a durable medical equipment (abbreviated DME) company, someone, usually a respiratory therapist, will deliver the nebulizer and medicines to your home and show you how to use the system. Both short-acting (last 4 hours) and long-acting (last 12 hours) bronchodilator medicines are available to relax the breathing tubes (airways) and allow you to breathe easier. The person who delivers the equipment and liquid medicines will write down a schedule of how often you should take the prescribed medicine. Depending on your condition, your doctor may also order a liquid corticosteroid medicine to use in the nebulizer machine twice a day. This is usually prescribed if you experience frequent chest infections that cause breathing difficulty and increased coughing (called an exacerbation).

Woman inhaling aerosol from nebulizer

Woman inhaling aerosol from nebulizer

Remember, you should breathe in and out normally from the mouthpiece of the system when inhaling the aerosol. The  person who delivers the machine to your home will also show you how to clean the system.

I suggest that you give this approach a try as it will likely help your breathing.

Sincerely,

Donald A. Mahler, M.D.