Patient Perceptions of Switching to a Generic Dry Powder Inhaler – Increased Understanding Through Journey Mapping

Figures & data

Table 1 Approved Brand Drug Products and Their Generics

Brand Drug Product Characteristics	Generic to the Brand Product
Demonstrates efficacy and safety before approval	A drug product approved in an ANDA under section 505(j) of the FD&C Act is presumed to be therapeutically equivalent to its RLD. Products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product when administered to patients under the conditions specified in the labeling.
Dosage form	Same as the brand drug product.
Drug strength(s)	Same as the brand drug product (may be a subset of brand product strengths).
Route of administration	Same as the brand drug product.
Intended use (indications)	Same as the brand drug product.^a
Quality and performance standards	Same as the brand drug product.
Overall risk profile	Same as the brand drug product. If after approval, new information shows that the overall risk profile is not the same, then the generic product is no longer considered “therapeutically equivalent” to the brand product and cannot be substituted for the brand product.
Prescribing information and patient information	Same as the brand product except for differences allowed by regulation due to the drug being produced or distributed by different manufacturers (eg, such differences may include differences in expiration date, formulation, bioavailability, or pharmacokinetics, labeling revisions made to comply with current FDA labeling guidelines or other guidance, or omission of an indication or other aspect of labeling protected by patent or accorded exclusivity).
Drug-device combination product	Also a drug-device combination product. FDA evaluates the device design and use process to ensure that a patient, caregiver, or healthcare provider will understand how to use the generic product, without additional training, when the generic is substituted for the brand product.

Note: ^aConditions of use approved for the RLD may be omitted from the ANDA labeling because of patents or exclusivity.

Abbreviations: ANDA, abbreviated new drug application; RLD, reference listed drug; FD&C Act, Federal Food, Drug, and Cosmetic Act; FDA, Food and Drug Administration.

Figure 1 Image of DPIs used in the study. (A) Closed position, Advair Diskus (brand) on left and Wixela Inhub (generic) on the right. (B) Open position, Advair Diskus (brand) on left and Wixela Inhub (generic) on the right.

Table 2 Demographics of Participants in the Focus Groups Sessions (n=40)

Characteristic	Adolescent DPI Users (n=4) N (%)	Adult DPI Users (n=36) N (%)
Sex
Male	1 (25.0)	11 (30.6)
Female	3 (75.0)	25 (69.4)
Ethnicity
Hispanic	0 (0.0)	2 (5.6)
Non-Hispanic	4 (100.0)	34 (94.4)
Race
Caucasian	0 (0.0)	28 (77.8)
African American	3 (75.0)	6 (16.7)
American Indian or Alaska Native	0 (0.0)	1 (2.8)
Multiracial	1 (25.0)	1 (2.8)
Education^a
High school	n/a	5 (13.9)
Some college or technical school	n/a	10 (27.8)
College graduate	n/a	11 (30.6)
Postgraduate	n/a	10 (27.8)
Medical condition^b
Asthma	4 (100.0)	29 (80.6)
COPD	0 (0.0)	8 (22.2)
Specific brand currently using
Advair Diskus	1 (25.0)	18 (50.0)
Albuterol	1 (25.0)	6 (16.7)
Arnuity Ellipta	1 (25.0)	0 (0.0)
Breo Ellipta	0 (0.0)	6 (16.7)
Proair Respiclick	1 (25.0)	1 (2.8)
Spiriva Handihaler	0 (0.0)	2 (5.6)
Trelegy Ellipta	0 (0.0)	1 (2.8)
Ventolin Diskus	0 (0.0)	2 (5.6)

Notes: ^aWe did not ask about education for adolescent participants because all were in middle or high school (none had graduated from high school). The average age of adolescents was 14 years (range, 12–16 years). For adults, we only captured the exact age for the Minneapolis focus groups. Among those 19 participants, the average age was 45 years and ranged from 20 to 73 years. ^bTotals are greater than 100% because respondents could list multiple medical conditions. The percentage reflects the proportion of cases.

Abbreviations: COPD, chronic obstructive pulmonary disease; DPI, dry powder inhaler; n/a, not applicable.

Table 3 Experience with Current DPI (n=30)

	Adolescent DPI Users (n=4) N (%)	Adult DPI Users^a (n=26) N (%)
Satisfaction with Current Medical Device
Very dissatisfied	1 (25.0)	3 (11.5)
Somewhat dissatisfied	0 (0.0)	2 (7.7)
Somewhat satisfied	1 (25.0)	12 (46.2)
Very satisfied	2 (50.0)	9 (34.6)
Training
Yes	2 (50.0)	18 (69.2)
No	0 (0)	6 (23.1)
Do not remember	2 (50.0)	2 (7.7)

Notes: ^aPre-group questionnaire data for one focus group session in Minnesota is missing because the questionnaires were not distributed before the focus groups as planned. The focus group data were collected as intended, and those participants are summarized in the sections that follow, but their pre-group questionnaire data are excluded above. Many FDA approved inhaler products have Patient Instructions that include the following statement: “Do not use [name of inhaler] unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.” The following name brand inhalers relevant to this study include this language in their Patient Instructions: Advair Diskus, Annuity Ellipta, Breo Ellipta, Trelegy Ellipta, and Ventolin HFA.

Abbreviation: DPI, dry powder inhaler.

Table 4 Most Frequent Responses to Thoughts About Generic Drugs

Item Group	Similarly Grouped Phrases Used by Participants	Number of Groups (n=6)
Financial Impact or Cost	Affordable, cost-effective, less expensive [than brand drug], lower cost, cheaper, drives brand drug cost down.	6
	Insurance driven, insurance, insurance approved, insurance dependent, more likely to be covered [by insurance].	5
Similarities between Generic and Brand Drug	Same ingredients, same active ingredients, same drug.	5
	Same outcome/effectiveness.	2
	Same quality as brand name.	2
	Works the same as brand name, just the same as brand name.	1
Generic Drug History	Drug [has been] around longer, takes a long time [to introduce generic], time since brand drug came out, more proven.	4
Efficacy, Quality, or Safety	May not work as well; is it as good, effective, or quick? Is well monitored—manufacturer/quality.	3
	Not as good as brand drug; sometimes less effective/concern for quality.	2
	Midrange version of a luxury car.	1
Naming Conventions	Different name [than brand drug]; odd/different names [rather than “catchy” brand drugs]; general product associated with brand drug.	3
Availability	More availability, more people can use.	3
Marketing	Less known than brand drug, no commercials.	2
FDA Approval/Oversight	Safe, FDA approved.	1
Delivery Mechanism	Delivery methods (eg, delivery apparatus/dispenser) is different.	1

Abbreviation: FDA, Food and Drug Administration.

Table 5 Journey Mapping Step 2: Unexpected Receipt of a Generic DPI—Reactions and Emotions

Reaction	Number of Groups with the Reaction (n=6)	Illustrative Comments
Negative	6
Confusion	5	“I also would feel a little bit confused why it looks a lot different from the one that I usually use, and it’s probably going to take some getting used to all the new features.” (Adolescent, G5)
Doubt or anxiety	4	“I’d be worried, because … they showed me how to use [the brand DPI] at the doctor’s office, and [the generic DPI] they are just handing to me. So, I would be concerned …, because I go to an asthma specialist, and I feel like … maybe this is not that much different, but I would want them to talk to me about it.” (Adult, G3)
Disappointment	3	“My first reaction would be like … Aww. Like when you go and you rent a car and you could get that, you know that nice car over there, and then they’re like “here’s this one.” You know it’s like … okay.” (Adult, G2)
Anger/frustration about switching	3	“It’s just not the same, I want consistency. I just want to have the same one every time. I don’t want any surprises.” (Adolescent, G5) “Frustrated … if I get it, okay great if it’s costing me less, but then it’s like, oh crap, now I’ve got to sit here and take time to figure [it] out.” (Adult, G2)
Anger/frustration about not being told about change	2	“ … why wasn’t I notified before the change? Because it should have been told to me before.” (Adult, G3)
Distrust in a person/ organization	1	“The first question and feeling I had was, is my insurance involved somehow? … Because they love to deny things.” (Adult, G1)
Positive	6
Happy or relieved	4	“Yeah, I feel a little bit excited about it. I would say, “Okay, how much money did I save?” And I’d also have the attitude that now I’ve got a choice … I can have [the generic DPI], maybe save some money, and it works just as well.” (Adult, G4) “I’m actually like, happy, it’s cheaper!” (Adult, G2) “I’m happy that like new medication options are coming out, and I feel like for a long time there weren’t a lot of options.” (Adult, G2)
Trust in person/ organization	2	“What comes to mind for me is [if] the doctor, recommends something to me, I might look a little bit online if I have concerns about it, but for a lot of medications [if] this is what he recommends, then I would use it.” (Adult, G4)
Trust in medication/ device	2	“I’ve never had a bad experience with any [generic medication], so I wouldn’t think that anything would be different from this [generic DPI].” (Adult, G6)
Neutral	4
Curious or questioning	4	“I would like to know what the differences are between the drugs [generic and brand DPIs]. The active ingredients appear to be the same, so what are the differences?” (Adult, G3)
Other neutral	3	“The main thing is, I’m willing to try it for 30 days and see if it works as well as the [brand DPI].” (Adult, G4)

Abbreviations: DPI, dry powder inhaler; G, group.

Table 6 Journey Mapping Step 3: Using a Generic DPI—Reactions and Emotions

Reaction	Number of Groups with the Reaction (n=6)	Illustrative Comments
Negative	4
Doubt or anxiety	4	“ … [if] I don’t feel it the second I take it in, … I wait with that nervousness of … Let’s see if this is actually going to work like [it] is supposed to.” (Adult, G2)
Distrust in medication or device	2	“Probably overreacting that it’s probably not as reliable as the one I usually use, and I accidentally might take it and it’s not reliable enough and I am poisoned to death or something.” (Adolescent, G5)
Disappointment	1	“I would be disappointed because it was still gritty … They couldn’t add a flavor to it? Come on ….” (Adult, G3)
Frustration with the device	1	“My hands are shot, I have a hard time [pushing the lever] … I’m irritated because it’s so hard to work.” (Adult, G2)
Positive	4
Happy or relieved	2	“Yeah, you either would be happy to get that … As long as I’ve got my medicine …. Yeah, that’s all that matters.” (Adult, G3)
Hopeful	2	“Hopeful that it will work exactly like the other one, and thus save me money, and excited about that prospect.” (Adult, G6)
Trust in medication/device	1	“Well when someone explained it to me or I saw the instructions, I’d be reassured [that] … it’s going to work the same way.” (Adolescent, G5)
Trust in person or organization	1	“We all believe the FDA is looking over, watching everything.” (Adult, G4)
Neutral	4
Curious or questioning	2	“I would need to know if before I use it, but I would just wonder if once I take it, whether it’s going to be the same.” (Adult, G4)
Other neutral	4	“Are you getting enough of the medicine … ? … like the full dose?” (Adult, G3)

Abbreviations: DPI, dry powder inhaler; G, group.