Advance in inhaler technique: changes in delivery devices, Authorized Generics, and Advance in technology for monitoring inhaler adherence

Transcription

1 Advance in inhaler technique: changes in delivery devices, Authorized Generics, and Advance in technology for monitoring inhaler adherence Bruce Brown, MS, RRT, AE-C Nemours Healthcare System

2 Disclosures No current disclosures I am an active member of the Association of Asthma Educators AE-C renewal certification May 2018

3 ADHERENCE TO LONG-TERM THERAPIES Evidence for action

4 50% of people suffering from a chronic illness do not take their medication as prescribed

5 Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments 1 1Haynes RB. Interventions for helping patients to follow prescriptions for medications. Cochrane Database of Systematic Reviews, 2001, Issue 1.

6 Todays Options with MDI HFA Change from CFC to HFA impact on patient instruction All HFA inhalers should all have counters Reason for using valve Holding chambers When to go from mask and 5 breath technique to mouth piece and single breath with hold Rinsing inhaler nozel * ProAIr * Redihaler for Qvar activated by inspiratory flow (demo)

7 DPI options Diskus, twisthaler etc Respiclick ( Teva Generic Advair AirDuo

8 Wixela Inhub is the first FDA-approved therapeutically equivalent generic of ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder) for certain patients with asthma or chronic obstructive pulmonary disease (COPD) As a therapeutic equivalent, Wixela Inhub can be expected to have the same safety and efficacy profile as ADVAIR DISKUS. FDA approval reinforces Mylan's commitment and relentless pursuit to increase access to complex treatment options for respiratory patients

9 February 8 th, 2019 GSK announced today plans to make available an authorized generic (AG) of ADVAIR DISKUS (fluticasone propionate/salmeterol inhalation powder) in all three approved strengths. The authorized generic will be manufactured by GSK and distributed by Prasco LLC. The authorized generic contains the same medicines in the same DISKUS device familiar to patients with the same instructions for use as ADVAIR DISKUS. We recognize that generic medicines are an important part of the lifecycle of a medicine. GSK supports the availability of high quality generic drugs that have met regulatory requirements, and in which the public can have confidence after the branded product loses exclusivity. Our goal is to ensure that patients continue to have access to the medicines in ADVAIR, in the DISKUS device that is familiar to them either in branded or generic form.

10 GSK releases authorized generic for Ventolin The authorized generic contains the same medicine, with the same instructions for use as Ventolin HFA, however it will have a list price or Wholesale Acquisition Cost (WAC) less than $36. This represents at least a 35% reduction to the current WAC price of branded Ventolin and potentially a lower cost alternative to the patient, depending on a patient s insurance coverage.

11 OTC Primatene Mist How is the new version works differently than the old? Primatene Mist: The new version uses the same active bronchodilator ingredient (epinephrine) as the old version. But the device has been redesigned. The new device functions differently than the original, and consumers need to follow the detailed instructions for use found in the product packaging for the device to work properly. For example, the device must be activated a certain way upon first use. Users need to clean the inhaler after each day of use to prevent buildup of the medicine in the device. The inhaler also needs to be shaken and then sprayed once into the air before each use. It may seem strange to shake and spray the inhaler into the air each time before using it. But these two steps are critical to ensure that the medicine is properly mixed before each dose. The new version is approved for use in people ages 12 years and older. Do not use this medicine in children younger than 12 years. It is not known if the product works or is safe in children younger than 12 years. By contrast, the old version was approved for ages 4 and up

12 Why was the original Primatene Mist inhaler taken off the market? The original version of Primatene Mist available prior to 2011 was an epinephrine metered-dose inhaler that contained chlorofluorocarbon (CFC) propellants. As part of the 1989 Montreal Protocol of Substances that Deplete the Ozone Layer and the Clean Air Act of 1990, all epinephrine inhalers that contained CFCs were phased out of the market.

13

14

15 The FDA noted that a former version of OTC Primatene Mist was taken off the market in 2011 because it contained chlorofluorocarbon (CFC) propellants, which are known to deplete the ozone layer. This new version contains hydrofluoroalkane propellants, which are permitted under current international and US law and used in some prescription inhalers, the FDA said. the old version of OTC Primeatene mist was approved for ages 4 and up The new version is for 12 and up. It is not known if the product works or is safe in children younger than 12 years. By contrast, the old version was approved for ages 4 and up, said Theresa Michele, MD, director of the FDA s Division of Nonprescription Drug Products, CDER.

16 ProAir Digihaler 2020 Teva Announces FDA Approval of First and Only Digital Inhaler with Built-In Sensors ProAir Digihaler (albuterol sulfate 117 mcg) Inhalation Powder ProAir Digihaler contains built-in sensors that detect when the inhaler is used and measure inspiratory flow. This inhaler-use data is then sent to the companion mobile app using Bluetooth Wireless Technology so patients can review their data over time, and if desired, share it with their healthcare professionals.

17 Hailie - Sensor Ventolin, Flovent, ProAir HFA Inhalers

18

19

20

21 Nemours App for Asthma Asthma Feature Set Problems: Solutions Medication Adherence: Configurable Reminders Medication Confusion: Picture, Label, How-to Videos Asthma Control Test: Journal Triage: Interactive Asthma Action Plan, Telehealth Caregivers: Sharable Asthma Action Plan Environmental Triggers: Air Quality Index, Weather Provisioning: Automated Onboarding Monitoring: Device Integration Peak Flow, Med. Adherence, Spirometry Center for Health Delivery Innovation

22 DEMONSTRATE: Asthma Proof of Concept 78HyMpObM&feature=youtu.be

23 There s a Device AND an App for That Remote Monitoring Disease Management: devices+apps. Too many! Not easy for patients Not easy for clinicians Not sustainable at scale Source: Center for Health Delivery Innovation

24

25

26 Nitric Oxide (NO) No is a biomarker of eosinophilic airway inflammation Produced by the action of proinflammatory cytokines on inducible nitric oxide synthesis in vivo and in vitro

27

28 Preparation for FENO Measurement Do not eat, drink or do strenuous exercise for 1 hour prior to exercise Do not preform spirometry or peak flow for 30 prior to FENO testing Continue to take all medicine as you usually do, unless you have been told to withhold medications for other testing

29 Common reasons for measuring FE NO To assist in assessing the etiology of respiratory symptoms To help identify the eosinophilic asthma phenotype To assess potential response or failure to respond to antiinflammatory agents, notably inhaled corticosteroids (ICS) To establish a baseline FE NO during clinical stability for subsequent monitoring of chronic persistent asthma To guide changes in doses of antiinflammatory medications: step-down dosing, step-up dosing, or discontinuation of antiinflammatory medications To assist in the evaluation of adherence to antiinflammatory medications To assess whether airway inflammation is contributing to poor asthma control particularly in the presence of other contributors (e.g., rhinosinusitis, anxiety, gastro-esophageal reflux, obesity, or continued allergen exposure). An Official ATS Clinical Practice Guideline: Interpretation of Exhaled Nitric Oxide Levels (FE NO ) for Clinical Applications Am J Respir Crit Care Med Sep 1; 184(5):

30 What Are the Clinically Significant Cut Points for FE NO? Low FE NO (< 25 ppb in Adults; 20 ppb in Children) High FE NO (> 50 ppb in Adults, 35 ppb in Children) Intermediate FE NO (between 25 ppb and 50 ppb in Aults; ppb in Children) Persistently High FE NO (> 50 ppb in adults, 35 ppb in Children) An Official ATS Clinical Practice Guideline: Interpretation of Exhaled Nitric Oxide Levels (FE NO ) for Clinical Applications Am J Respir Crit Care Med Sep 1; 184(5):

31 Questions?