Article Analysis 2

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Refer to the “Patient Preference and Satisfaction in Hospital-at-Home and Usual Hospital Care for COPD Exacerbations: Results of a Randomised Controlled Trial,” (

https://www-sciencedirect-com.lopes.idm.oclc.org/science/article/pii/S0020748913000941

)

in conjunction with the “Article Analysis Example 2,” for an example of an article analysis (Attached).

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statisticsnursingon time

ArticleAnalysis: Example

Article Citation and Permalink	Utens, C. M. A., Goossens, L. M. A., van Schayck, O. C. P., Rutten-van Mölken, M. P. M. H., van Litsenburg, W., Janssen, A., … Smeenk, F. W. J. M. (2013). Patient preference and satisfaction in hospital-at-home and usual hospital care for COPD exacerbations: Results of a randomised controlled trial. International Journal of Nursing Studies, 50, 1537–1549. doi.org/10.1016/j.ijnurstu.2013.03.006 Link: https://www.ncbi.nlm.nih.gov/pubmed/23582671 (Include permalink for articles from GCU Library.)
Point	Description
Broad Topic Area/Title	The differences in preference and satisfaction based upon hospital care location for COPD exacerbations.
Define Hypotheses	Hypothesis not stated. Below is an example from the study: H0: There is no difference in satisfaction levels based upon treatment location. H1: There is a difference in satisfaction levels based upon treatment locations.
Define Variables and Types of Data for Variables	Treatment Location – categorical – “home treatment” and “hospital treatment” Satisfaction – Ordinal Scale (1-5) Preference – categorical “home treatment” and “hospital treatment”
Population of Interest for the Study	COPD exacerbation patients from five hospitals and three home care organizations
Sample	139 patients 69 from the usual hospital care group 70 from the early assisted discharge care group
Sampling Method	Mixed methods; quantitative was randomized sampling
How Were Data Collected?	A questionnaire with both open-ended questions and questions with a scale of 1-5 (p. 1539)

Article Analysis

Article Citation

and Permalink
(APA format)

Article 1

Article 2

Point

Description

Broad Topic Area/Title

Define Hypotheses

Define Independent and Dependent Variables and Types of Data for Variables

Population of Interest for the Study

Sample

Sampling Method

How Were Data Collected?

Improving HIV/AIDS care through treatment advocacy: going beyond client education to

empowerment by facilitating client�provider relationships
Matt G. Mutchler

a,b
*, Glenn Wagner

c
, Burt O. Cowgill

, Tara McKay

b,e
, Brian Risley

f
and Laura M.

Bogart
g

a
Department of Sociology, California State University, Dominguez Hills, Carson, CA, USA;

b
Community Based Research,

AIDS Project Los Angeles, Los Angeles, CA, USA;
c
RAND, Santa Monica, CA, USA;

d
UCLA/RAND Center for Adolescent

Health Promotion, University of California, Los Angeles, Los Angeles, CA, USA;
e
Department of Sociology, University of

California, Los Angeles, Los Angeles, CA, USA;
f
Treatment Education, AIDS Project Los Angeles, Los Angeles, CA, USA;

g
Children’s Hospital Boston, Division of Pediatrics, Harvard Medical School, Boston, MA, USA

(Received 1 September 2009; final version received 5 May 2010

)

Treatment advocacy (TA) programs have been implemented by AIDS service organizations (ASOs) and primary

care clinics across the USA to help engage clients with HIV into care and support their adherence to antiretroviral
therapy (ART). TA aims to empower people with HIV through education and client-centered counseling
regarding HIV, ART, and other health issues; advocate on behalf of patients with providers; and make referrals

to healthcare services and clinical trials. However, relatively little is known about the impact TA has on clients’
healthcare experiences. The present study’s objectives included exploring how TA services help clients engage in
HIV care, initiate ART, and adhere to HIV medications. We conducted 25 semi-structured qualitative open-

ended interviews with clients living with HIV/AIDS recruited from AIDS Project Los Angeles (APLA); four HIV
medical providers; and two TA staff at APLA. Of the 25 clients interviewed, 92% were male and 8% were female.
The average age was 43 years (SD�9). About 60% were African-American, 20% were White, 12% were other or
multiracial, 4% were Latino, and 4% were Asian/Pacific Islander. Five interconnected themes consistently
emerged across clients, TAs, and providers. TAs helped clients understand treatments and supported adherence
within a holistic context. Further, TAs acted as a bridge to providers and helped clients build self-advocacy skills.
Our data show that TA services go beyond traditional areas of education and treatment adherence. TA services

within an ASO also provide a safe place to discuss initial HIV diagnoses and other health issues in a more
comprehensive manner. TA services complemented medical and other social services by preparing clients with
HIV to be better consumers of healthcare services. Future quantitative research examining the effectiveness of TA

on improving clients’ engagement in care and adherence is a critical next step.

Keywords: HIV care; treatment advocacy; adherence; antiretroviral therapy; ancillary services

Introduction

Many people living with HIV/AIDS (PLWHA) are
not receiving antiretroviral therapy (ART) and are not

engaged in care. Gardner and colleagues (2005) found

that 40% of newly diagnosed individuals with passive

referrals had not initiated HIV medical care within 6
months of diagnosis. Krentz, Auld, and Gill (2004)

found that 39% of patients presenting for initial HIV

care had CD4 counts B200, despite the standard of
care recommendation that patients begin ART if their

CD4 counts are less than 350. Teshale et al. (2005)

estimate that only 60% of PLWHA in the USA are
engaged in HIV care (Perkins, Meyerson, Klinken-

berg, & Iaffoon, 2008; Samet et al., 2001); 56% of

those eligible for treatment are receiving ART. Many
on ART do not successfully adhere at high enough

levels (i.e., 90�95% of prescribed doses) for optimal

treatment benefit (Arnsten et al., 2001; Bangsberg,

Hecht, Charlebois, Chesney, & Moss, 2001; Bangsberg

et al., 2006; Gardner, Burman, Steiner, Anderson, &

Bangsberg, 2009; Holzemer et al., 2006; Howard et al.,

2002; Liu et al., 2001).
Ancillary services have arisen to facilitate access to

care for PLWHA, including those funded by the Ryan

White Comprehensive AIDS Resources Emergency

(CARE) Act: case management, drug reimbursement,

home healthcare, transportation and food assistance,

mental health and substance abuse treatment, as well

as treatment education/treatment advocacy (TA), the

present study’s focus. Receipt of ancillary services has

been associated with primary care entry (Gardner

et al., 2005; Messeri, Abramson, Aidala, Lee, & Lee,

2002), ART use and adherence (Katz et al., 2001;

Magnus et al., 2001), treatment retention (Ashman,

*Corresponding author. Email: mmutchler@csudh.edu

AIDS Care
Vol. 23, No. 1, January 2011, 79�90

ISSN 0954-0121 print/ISSN 1360-0451 online

# 2011 Taylor & Francis

DOI: 10.1080/09540121.2010.496847

http://www.informaworld.com

Conviser, & Pounds, 2002; Chan, Absher, & Sabatier,

2002; Convisier & Pounds, 2002; Lo, MacGovern, &

Bradford, 2002; Sherer et al., 2002), care services

utilization (Soto, Bell, & Pillen, 2004), and HIV health

literacy (van Servellen et al., 2005).
Few studies have explored the process by which

ancillary care programs may facilitate improved

provider�patient relationships. Ancillary services
may facilitate greater rapport between patients

and providers and promote engagement in care

(Mallinson, Rajabiun, & Coleman, 2007) through

active outreach (Cabral et al., 2007), especially for

those with comorbid substance use or mental health

disorders (Calsyn, Klinkenberg, Morse, Miller, &

Cruthis, 2004).
We explored how one type of ancillary care

service � TA � might improve engagement in care,
ART initiation, and ART adherence. TA programs

represent feasible and potentially cost-effective inter-

ventions that have been sustained across the US

AIDS service organizations (ASOs). TA aims to

empower patients through education and client-

centered counseling regarding HIV, ART initiation

and adherence, and other health issues; advocating

on behalf of patients with providers; and making

referrals to access healthcare services and clinical

trials. TA also seeks to link PLWHA into effective

and timely care, by facilitating navigation through

the medical care system and adherence. We con-

ducted a qualitative process evaluation of one well-

established TA program at a large ASO, with the

following research questions: (1) How does TA help

engage PLWHA in care? (2) How does TA help

PLWHA initiate ART when appropriate? and (3)

How does TA help PLWHA improve adherence?

Methods

Study setting

The present study was conducted at AIDS Project Los

Angeles (APLA), an ASO with the mission of

improving the lives of PLWHA, reducing HIV

incidence, and advocating for fair and effective HIV-

related public policy. APLA provides direct, bilingual

services to �7500 men, women, and children with

HIV/AIDS in Los Angeles (LA) County annually.

Clients are 37% Latino, 36% White, and 23%

African-American; �90% are male and 9% female.

Client racial/ethnic and gender distributions are

similar to those for PLWHA in LA County (HIV

Epidemiology Program, Los Angeles County Depart-

ment of Public Health, 2008): 37% Latino, 36%

White, and 23% African-American; �90% are male.

We used community-based participatory research
(CBPR), in which community members and research-
ers are joint contributors on every study aspect
(Bogart & Uyeda, 2009; Israel, Eng, Schulz, &
Parker, 2005; Viswanathan, Ammerman, Eng,
Garlehner, Lohr, & Griffith, 2004). APLA research
and TA program staff partnered with researchers at
RAND, UCLA, California State University, Dom-
inguez Hills, and Harvard Medical School. The
impetus for the study originated in discussions with
APLA staff, who approached the researchers to
partner on a TA program evaluation. APLA’s on-
going TA Community Advisory Board (CAB) �
composed of APLA clients in TA, treatment advo-
cates, and a medical provider � provided a forum for
idea exchange and community input at every stage of
the project. APLA’s and RAND’s human subjects
review boards both approved the study.

Treatment advocacy (TA) components

TAs aim to increase the understanding of HIV
pathogenesis, treatment options, co-infection (e.g.,
hepatitis), side effects, lab results, nutrition, and
healthcare; and to provide client-centered health
and treatment counseling, referrals to treatment and
services, advocacy to healthcare providers, and com-
munity education forums. Both TAs had university
degrees in health-related sciences and completed
three-day trainings to certify in treatment education.
TAs were required to demonstrate extensive knowl-
edge in HIV transmission, testing, pathogenesis,
human immune system, disease states, and HIV
treatment options. One of the TAs was female and
bilingual (English and Spanish).

TAs and clients jointly develop an Individual
Service Plan (ISP). TAs assess clients’ treatment needs,
health issues, healthcare access, disease indicators,
medication status, adherence (if applicable), substance
use, depression, and HIV knowledge. TAs then help
clients set goals; provide referrals for any needed
medical care, clinical trials, mental health services,
and social services, and offer advocacy with healthcare
providers, in which TAs may contact clients’ HIV
care providers to discuss clients’ situation and possible
solutions. The amount of time clients worked with TAs
varied between one initial intake to over a year.

Participant recruitment

We conducted interviews with 25 TA clients, two
TAs, and four HIV providers who managed the
care of APLA’s TA clients. Qualitative researchers
have found that 25�30 participants are sufficient to
reach saturation (i.e., new themes are no longer
emerging) across several domains (Morse, 1994;

80 M.G. Mutchler et al.

Strauss, 1987), and five participants are needed to
understand the essence of a particular sub-group
experience (Rice & Ezzy, 1999; Strauss, 1987). We
offered the study to all clients in TA at the time of
the study and interviewed the first 25 clients who
responded. To supplement client perspectives, we
interviewed all of the TAs and providers directly
involved with the TA program at the ASO. We
recruited less than five TAs and medical providers,
because we were constrained to those who worked
directly with the program. TA clients were recruited
via study fliers and screened for eligibility. Clients
were eligible if they spoke English or Spanish, and
were ]18 years old. We used the screener to recruit
purposively by care and treatment situation: 12
participants were engaged in care (visited an HIV
medical care provider at least once in the last six
months), were taking ART, and reported perfect
adherence in the last three days; eight were engaged
in care and on ART but missed at least one dose in
the last three days; two were engaged in care, had
CD4 counts B350 and had been recommended to
start ART but had not; two were engaged in care,
had CD4 counts �350 and were not taking ART;
and one had not seen a medical provider in the last
six months. HIV providers who worked with TA
clients were contacted by TAs about their will-
ingness to participate.

Qualitative protocol

Semi-structured qualitative interviews were used to
explore TA’s influence on treatment and care. The
protocol elicited information about HIV diagnosis,
help-seeking after diagnosis, medical care decisions,
adherence, and experiences with TA. Tables 1�3 show
the client, provider, and TA protocols. Interviews
were audio taped and transcribed.

Data analysis

Qualitative analysis was conducted using the pro-
gram Atlas.ti. Content analysis was conducted using
inductive and deductive techniques, which allows for
a full range of themes and subthemes to emerge,
including those not anticipated. We created a set of
thematic-based codes, applied the codes systemati-
cally to the narratives, and tested reliability between
coders (Bernard, 2002). The first and last authors
initially read through a sample of transcripts to
identify the presence of text related to TA experi-
ences. Coders were given basic operational defini-
tions of TA-related issues, derived in part from
descriptions of APLA’s program and current HIV
treatmen

Coders identified text related to five themes and
related subthemes (described below) (Bernard, 2002;
Lincoln & Guba, 1985). The first and last authors
resolved discrepancies between coders. Subthemes
were mutually exclusive and exhaustive (Bernard,
2002; Spradley, 1979). Kappas (Cohen, 1960) showed
good to excellent consistency between coders (ranging
�0.74�0.92) (Bakeman & Gottman, 1986; Landis &
Koch, 1977). We calculated for the number of times
each theme was coded; these counts showed the
relative depth of each theme (Mutchler, 2000): almost
all�theme emerged in almost every interview (n�27�
31); most�theme emerged in majority (n�20�26);
about half�theme emerged in �50% (n�13�19);
some�theme emerged in a substantial minority (n�
6�12); a few�theme emerged in a small number
(n�1�5).

Results

Sample

Of the 25 clients interviewed, nearly all (92%) were
male. The average age was 42.9 years old (SD�9.05
years); 60% were African-American, 20% White,
12% other or multiracial, 4% Latino, and 4%
Asian/Pacific Islander. Five interconnected themes
consistently emerged across clients, TAs, and provi-
ders (discussed below and listed with relevant quotes
in Table 4).

Understanding treatments

Comprehensive education
Almost all participants mentioned that TA provides
comprehensive education about HIV and treatment
in a unique way that does not duplicate basic
information from healthcare providers. TAs provided
detailed information about ways in which medica-
tions affected HIV across its reproductive
cycle, medication side effects, consequences of non-
adherence, and reasons for adherence (Quote 1).
Participants sought out TAs to confirm and validate
treatment information. Participants felt that TA
influenced clients’ engagement in HIV medical care
and decisions to initiate ART.

Support for newly diagnosed clients
Understanding HIV and treatment options was
viewed as particularly useful for newly diagnosed
clients (Quote 2). For example, one newly diagnosed
participant felt that discussing treatment with a TA
helped him to initiate ART earlier than he would
have (Quote 3). Overall, clients were able to gain a

AIDS Care 81

deep understanding of treatments through conversa-
tions with TAs.

Treatment Advocates (TAs) unique perspective outside
of the medical establishment
Clients frequently had doubts about treatment but
felt that they did not have time or feel comfortable
discussing concerns with medical providers. Clients
often sought TAs instead of medical providers to
confirm or validate treatment information (Quote 4).
Many clients used TA to seek a second opinion
outside of the healthcare setting (Quote 5).

Treatment Advocates (TAs) as accessible and

knowledgeable
Clients valued TAs’ availability, convenience, and

treatment knowledge. Though TAs � like doctors �
often scheduled appointments with clients, TAs were

available for drop-in visits. Some participants per-

ceived TAs as being more accessible and better able

to address questions and issues than their medical

provider (Quote 6). Clients felt TAs possessed a great
deal of knowledge about HIV treatments. Clients felt

more comfortable bringing up an array of concerns

and questions about treatment experiences with TAs

compared to medical providers due to a sense that

Table 1. Protocol for client interviews (n�25).

Protocol topic In-depth questions

HIV diagnosis � Tell me about the time you tested positive.
� When did you first test HIV-positive?
� What kind of help did you get?

� What roadblocks or barriers did you encounter?
� Are you receiving services from any AIDS service organization? If yes,

which organization?

Decisions and involvement in HIV
medical care

� Do you have a doctor for your HIV care? If no, why not?

� If yes, describe your doctor and your relationship with him/her.

� How did you come to seek HIV care regularly?
Antiretroviral therapy (ART) � Have you had any blood work done to determine your CD4 count or

your viral load?
� If yes, what were your latest results, when and where were these tests

taken?
� Are you currently on ART? If no, have you ever been? What would it

take for you to be on it?

� If yes, when did you first start? Is this your first ART regimen?
� Describe a typical day of medications and how they affect you.
� Do you ever miss a dose? Do you find it difficult to take the medication

exactly as prescribed?
Experiences with APLA’s TA program � How did you learn about the TA program?

� Did you take to a treatment advocate before or after your medical care?
� What was your reason for seeking TA services? How long have you

been receiving services?
� What type of services do you receive from the program, how often do

you use these services?

How the TA program has influenced
management of HIV care and treatment

� For clients not engaged in care: How has it influenced your decision to
not access HIV medical care?

� For clients engaged in care: How has it influenced your decision to

access HIV medical care?
� Has it had any influence on your decision to start or remain on ART?
� For clients on ART: How has it influenced how you manage your ART

regimen?
Overall impressions of the TA program � Are there any services that you were hoping to see that this program

does not offer?
� Have you considered, or would you consider referring other clients to

the program?
� What is most helpful about the program? What is least helpful?
� What advice could you offer to improve the program?

82 M.G. Mutchler et al.

doctors did not have sufficient time to answer all of
their questions.

Supporting adherence

About half of participants mentioned that TA
provided education about the importance of adher-
ence in a way that clients could understand
(Quote 7), and worked with clients to determine
appropriate strategies for supporting

adherence,

such as pill boxes or pill trays. TAs provided
positive reinforcement and a support system for
adherence. TAs regularly checked in with clients
(e.g., to ask whether they were taking their medica-
tions). Clients viewed this simple check-in as a
powerful support (Quote 8). TAs also worked with
clients and other service providers, such as social
services benefits counselors, to ensure clients had
access to a steady supply of medications.

Holistic care

Taking into account the life situation of each client
Most clients mentioned that TA offered services
within a holistic care model. Because TAs were
aware of clients’ background and life circumstances
(e.g., mental health issues, substance abuse, home-

lessness, incarceration), they were able to identify
key areas of need in clients’ lives that might
influence medication taking, and then provide ap-
propriate referrals (Quote 9). Further, TAs took
clients’ life context into account when determining
which medication would be best (Quote 10). TAs’
complete picture of clients’ healthcare and social
services needs allowed them to make well-informed
recommendations and referrals regarding care and
treatment.

Taking into account comorbid conditions
Many clients had comorbidity concerns. In a few
rare cases, TAs directly helped to coordinate multi-
ple mental health, social, and medical services for
clients. For example, a TA who was aware of a
client’s ‘‘myocardial issues’’ was able to bring it to
the attention of the client’s HIV specialist, who had
prescribed a protease inhibitor with a history of
aggravating myocardial symptoms. Another
PLWHA, who suffered from several comorbid
conditions, including narcolepsy, cognitive impair-
ments, and a pain disorder, experienced complica-
tions in his medical care (Quote 11). He
had difficulty filling prescriptions because they
were provided through numerous specialists, some

Table 2. Protocol for provider interviews (n�4).

Protocol topic In-depth questions

Experiences as an HIV provider � How long have you been providing HIV care?
� How many patients are you currently treating?
� In what type of clinical setting are you providing HIV

care?
Experiences with APLA’s TA program � How many of your clients have received services from

APLA’s treatment advocacy program?

� How many clients have received services from organiza-
tions other than APLA?

� What is your understanding of the treatment advocate’s

role with your patients?
� Have you referred any clients to APLA’s TA program?

Why or why not?
Experiences with APLA treatment advocates � Who initiates these interactions usually? How do the

interactions usually take place (email, phone, and in-
person)?

� What are the goals and content of these interactions?

� What components of APLA’s TA program seem to be the
most/least helpful?

� What is your overall impression of the TA program in

helping clients start ART?
� What is your overall impression of the TA program in

helping clients with adherence?
� Optimally, what role would you like the TA program to

play in helping clients manage their HIV?
� What kind of changes do you think would be most

beneficial to APLA’s TA program?

AIDS Care 83

requiring regular appointments to reauthorize re-
stricted medications (e.g., narcotics). Gradually the
confusion of managing different providers and
medications became an obstacle to his HIV medica-
tion adherence, and thus the client and his multiple
providers (the TA, medical provider, and others
such as his psychiatrist) met in person to coordinate
his treatment. Although this kind of meeting was
exceptional, TAs did frequently go beyond their
formal roles as treatment educators to address
clients’ other service needs and, as discussed below,

served as intermediaries between clients and medical

providers.

Bridge to providers

Engagement in care
Most participants said that TAs connected them to

medical providers. This included finding different
provider options available through insurance, dealing

with a lack of insurance, or enrolling clients into a

clinical trial. Because TAs were knowledgeable about

Table 3. Protocol for treatment advocate interviews (n�2).

Protocol topic In-depth questions

For the director of the TA program � Provide a brief description of the TA program here at
APLA.

� Have you assessed patient satisfaction with the program?

Has this changed over time?
� How do you monitor quality of TA service provision?

For all treatment advocates � When did you first get involved in the program and why?

� What qualifications or training is required to be TA at
APLA?

� Which services are you involved in providing? Which

services are you not involved in?
Client referrals � How are clients referred to the program?

� Are referrals from outside the program encouraged or
promoted by the program?

� Do you see a pattern in the type of providers who refer
patients to your program?

� How can referrals from providers be improved?

� What kind of patient feedback do you give providers?
Experience with TA clients � Describe your client population.

� How do you determine what services to offer to clients

that are seeking help?
� For clients not engaged in care,

� What types of services will you offer them to get
them into care?

� What are the easiest and most difficult interactions
you have had with them?

� For clients but not on ART despite low CD4,

� What types of services do you offer to these clients?
� Please describe clients of this type and the easiest

and most difficult interactions you have had with

them.
� For clients who are on ART but are struggling with non-

adherence,

� What services do you typically offer them?
� Describe this type of client and the easiest and most

difficult interactions you have had with them.
Effectiveness of the TA program � How have providers of the clients receiving TA services

responded to the program?
� Are the TA services living up to what you expected? If

not, how can they be improved?

� Please discuss other programs outside of APLA that you
know and your opinions regarding their effectiveness and
success.

� What barriers to success has the TA program faced?

84 M.G. Mutchler et al.

Table 4. Representative quotes of key themes in treatment advocacy process evaluation interviews among 25 clients, two treatment advocates, and four medical providers.

Theme Source Representative quote

Understanding treatments
Comprehensive education C (1) It’s not that much telling me about the meds, but showing me how the meds work on the virus. . .

how they actually work in your body; like this med does this and this, and that’s why you take this

with this and this. . .I’m not so apprehensive now that I’m being more informed about being on
meds.

Support for newly diagnosed clients C (2) If you’re a new client, like I was. . .[the TA] gives you information, and knowledge is power.
There’s so much misinformation going on out there with everybody. . .at least [the TA] knows what’s
factual.

C (3) I think I got into [treatment] a little earlier. . .The medication scared me more than the disease,
believe it or not.

TAs’ unique perspective outside of the medical
establishment

C (4) Meeting [the TA] was very helpful because I got to find out. . .a lot of information. . .because I,
when I made the appointment I was wondering, ‘‘Well is Atripla right for me?’’ Because my
doctor. . .just said, ‘‘Well, here’s the prescription,’’ and I didn’t know what questions to ask. . .so I
kind of got to have that dialog with [the TA] and after I left I was very confident that that was a
good choice for me.

C (5) I can always come to [the TA] as a second opinion for looking at things and just the fact that he’s

telling me things are good and my doctor’s telling me that things are good. . .
TA’s as accessible and knowledgeable C (6) Sometimes you don’t. . .wanna go through your doctor. ‘Cause like they’re so busy and to talk to

them personally one-on-one is just-, and it’s hard to open [up]… sometimes it’s good to have

someone outside the medical [establishment]. . .[the TA] is not a doctor. But he’s educated. . .he
knows about this.

Supporting adherence C (7) I would sometimes miss a whole week. . .[the TA] explained it to me like this, that when you have
been missing all these doses it makes the virus itself become resistant, and then it can be resistant too

many times or something like that because there’s only so many antiviral drugs of therapy that if you
use up all of them, you won’t have nothing to fall back on.

C (8) They always ask me the same thing. Are you taking your medication?…Have you missed any

pills?
Holistic care C (9) [I talk with the TA about]. . .my situation, my living situation, other resources and stuff I’ve been

accessing

Taking into account the life situation of each client C (10) I certainly make better decisions as a result of [the TAs] because they help me understand the
context of the decision I’m trying to make.

Taking into account comorbid conditions P (11) Things really started to fall apart [for a client with several comorbid conditions]. [The TA]

contacted us and said that the client is under the impression that you’re not willing to help him get
his prescriptions filled. . .we scheduled a meeting, we all met here, um with a variety of people,
including some of the other sub specialists like our psychiatrist, [the TA]. . .somebody else from [an
ASO], [the medical provider], the nurse practitioner, the client and sort of worked through it.

Bridge to providers TA (12) By the time they leave me, they actually have an appointment to see a care provider. I’m not just
leaving it up in the air that they might access it. I want to know they have an appointment.

A
ID

S
C
a
re

8
5

Table 4 (Continued)

Theme Source Representative quote

Engagement in care C (13) If you’re having a problem with your treatment, [the TA] is the person who you can go to and
have mediate between you and your healthcare professional if necessary, ‘cause he will do that. He
plays a role in letting you know what’s available, what’s cutting edge, what’s working and what’s

not.
Interfacing with providers C (14) At first I was having such a problem taking them [the pills] twice a day and. . .keeping them

down. . .[the TA] was telling me that they have another way that you can take them. You know you
can take all of them once a day but you have to ask your doctors if it’s OK. At first my doctor didn’t

want to do it, but then [the TA] talked to him and ever since it’s like candy, taking candy.
P (15) [The TA] reassures them about side effects, and talks to them about what regimens have been

recommended and why this may be okay or why this may not be okay. Next thing we know, the

patient comes back to us and is either ready to start therapy or is now taking the therapy more
consistently, and we’re thrilled.

P (16) I communicate back to the treatment advocate rather than directly to the patient, that might

make our next meeting between me and the patient more efficient or better. The client may be
unhappy. . .about having HIV and sort of blaming it on the doctor. I think the treatment advocate
has the unique role of being the only person who’s around who could both go with the client [to the

doctor’s appointment] and potentially know the system enough to help the client make a change.

Building self-advocacy

Empowering clients to be active medical consumers TA (17) I don’t want to just be in the middle. . .I want them to learn how to deal with providers, to fight

for their health, to know how to speak, to know everything. . .Only if they really need me, you know,
if they cannot do it for cognitive issues or psychological things, or anything that. . .so if it’s not
[cognitive issues], I try, ‘Ok, you go first. You’re an adult. You know how to deal with that. I gave
you a tour.’

C (18) [The TA] started telling me. . .about how the medication will work. And he told me about some
different medications to talk to my doctor about.

C (19) [TA helped me with] being more aggressive with my doctor. . .and not just be so passively
involved in my medical care.

C (20) Well with this information I have choices. Especially when we talk about. . .how that medicine
and other medicine are a combination of medicine. . .So. . .I can see why the doctor would order this
particular or this particular meds, instead of just being in the. . .blind. . .but at least I will have some
information why I am taking it.

C (21) I was really mad, and [the TA] helped me put together a letter- to compose a letter to complain
about the services to make note that they needed more intensive services to help us to take care of

our needs. And so it was a difficult letter to write. . .and that’s not a priority for [the TA] to do but
[the TA] made time for me and made sure it was done. And that’s a special thing for me.

P (22) [The TA] may be able to identify that there may be a particular regimen that’s better for the

client, in which case the client may bring that to us directly. . .so none of that necessarily required
[the TA] connecting with us.

8
6

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specific local providers, they were able to match clients
with appropriate providers that fit their needs, person-
ality, and insurance situation (Quotes 12 and 13).

Interfacing with providers
TAs acted as a liaison to medical providers. TAs
exchanged critical information with providers and
sometimes offered important recommendations based
on their unique understandings of clients’ non-
medical issues. For example, TAs often emailed or
talked to medical providers to discuss clients’ diag-
nosis, medication regimen, and treatment options. In
some cases, TAs suggested alternative regimens that
they felt might fit better with clients’ life situation
(Quote 14). Although rare, TAs also accompanied the
clients to provider visits.

Providers felt that TAs helped clients understand
medication regimens in a way that supported adher-
ence (Quote 15). Providers also recognized that
including TAs in discussions of the clients’ treatment
were valuable to provider�patient communication.
TAs and providers alike felt that direct communica-
tion among all three individuals could counteract
clients’ misconceptions about the healthcare system
and providers. Providers valued the presence of the
TA as an intermediary, acknowledging that TAs have
a holistic view and thus can provide information that
can make a significant difference to the client’s
treatment plan and overall healthcare (Quote 16).

Building self-advocacy

Empowering clients to be active medical consumers
Clients, providers, and TAs shared ways in which TAs
empowered clients through information, skills, and
tools to advocate for their own healthcare. TAs saw
their primary role as working with clients directly to
build self-advocacy skills and foster empowerment to
ask questions of providers, to change regimens, or to
change providers (Quote 17). TAs’ provision of
information about treatments, regimens, adherence,
and the patient�provider relationship helped many
clients discuss treatment concerns with doctors
(Quote 18). TAs encouraged clients to become active
consumers of healthcare by preparing them
for medical appointments and anticipating issues
(Quotes 19 and 20). TA also assisted clients with
problems they encountered with their providers. For
instance, one client worked with the TA to write a
letter of complaint about medical services he received
(Quote 21).

The work provided by TAs often goes beyond
traditional conceptions of TA services to include
client empowerment, such that clients may learn skillsT

a
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le

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.

AIDS Care 87

they need to advocate for better healthcare for
themselves. With TAs’ guidance, clients became
more knowledgeable about treatment issues, more
able to research relevant treatment information,
more skillful in anticipating and asking questions of
healthcare providers, and more able to assert their
needs in the healthcare setting (Quote 22). Clients not
only gained information through TA, but also skills
needed to continue to find information (Quote 23).

Discussion

In this study, TA clients and medical providers said
TA contributed to client engagement in care, use of
ART, and treatment adherence. TAs’ unique services,
which are not available to clients through other
programs, include providing holistic care, being a
bridge to providers, advocating for clients, and
building self-empowerment. Participants viewed
TAs as accessible and knowledgeable about treatment
issues and the landscape of local HIV care, allowing
them to match clients and providers based on clients’
holistic needs. Because of their focus on treatment
issues, TAs had a deep understanding of the con-
textual issues affecting clients’ treatment experiences.
In addition to reaching out to clients, TA plays a
unique role in the HIV care system by actively
supporting the relationship between client and pro-
vider through education and advocacy. TAs were
able to empower clients to learn how to become
better consumers of their own care. Because TA was
embedded within an ASO, clients could seek advice,
validate information, and gain skills for their own
self-advocacy relatively free from concerns or mis-
trust about the medical establishment.

The objective of TA is to help clients understand
and adhere to appropriate treatment regimens. Since
healthcare providers may be too busy to answer
questions or explain HIV treatment options
(Harman, Amico, & Johnson, 2005), TA fills an
important gap. TAs provide information about HIV
and treatments that validate provider recommenda-
tions or offer alternative options that may better
address clients’ needs. TAs can help clients develop
strategies for supporting adherence. Education that
helps support beliefs about the importance of ad-
herence can improve adherence (Schneider, Kaplan,
Greenfield, Li, & Wilson, 2004).

TAs are able to incorporate a holistic view, taking
the time to understand clients’ treatment issues in the
context of their whole lives; they can work with
clients to develop a deeper relationship in which
psycho-social and other comorbidity issues related to
care and treatment can be addressed. In addition, TA
provides a critical component in quality of care. TAs

are able to pay attention to individual circumstances
and make appropriate referrals to a variety of social
and medical services.

The TA program builds a unique relationship
among clients, TAs, and providers, allowing for a
broader approach to HIV/AIDS care and treatment.
Although other adjunct services may increase linkage
to primary care providers (Craw et al., 2008; Katz
et al., 2001; Sherer et al., 2002), TA is focused
primarily on HIV/AIDS treatment education and
advocacy. Unlike other ancillary social services, TA is
necessarily staffed by professionals who have specific
expertise in HIV/AIDS virology, pathogenesis, and
treatment therapies and strategies. TAs help clients to
have positive experiences with healthcare by educat-
ing clients about the healthcare system and matching
them with appropriate providers. These positive
experiences appear to facilitate better rapport with
providers, which may ultimately improve engagement
in care and adherence (Mallinson et al., 2007;
Schneider et al., 2004).

This study had several limitations. Participants
were recruited from one ASO; findings may not
generalize to TA experiences in other organizations,
and TAs’ and providers’ views may not represent
providers outside of this agency. Consistent with
qualitative methodology, our purpose was not to
seek a representative sample, but instead to elicit
the range of experiences at a particular TA pro-
gram. Because APLA’s TA program immediately
connects clients with care, we could not elicit
perspectives of PLWHA who were not in care.
Findings could have been affected by a social
desirability bias: clients may have felt compelled
to provide positive comments about the program.
However, interviewers stressed that responses were
kept confidential, research staff were not associated
with the TA program, and participation would not
affect their standing in TA. Future research should
attempt to explore a fuller range of clients served by
TA, especially female clients who may have child-
care issues and monolingual Spanish speaking
clients. We did not randomize clients to TA, so
we do not know if their satisfaction with TA, and
perceptions of TA’s effectiveness, were due to
selection bias. Next steps for research include the
need for randomized controlled trials to test
the effects of TA on engagement in care and
adherence over time.

There are several key recommendations for
developing or improving TA services that can be
gleaned from our results. TA services were seen as
particularly valuable because they empower clients
to advocate for their own medical needs in addition
to providing comprehensive treatment information.

88 M.G. Mutchler et al.

In this way, TAs may help those who have little
power in the provider�patient relationship to be-
come better advocates for themselves. The providers
in this study appreciated TA since they often do not
have time to educate patients and find that more
educated clients meet treatment goals more effi-
ciently. The TA�client�provider relationship is im-
portant to foster since it goes beyond the provision
of education and adherence training; providing TA
services in a social service setting may help by filling
a critical gap in traditional medical and ancillary
social services provided for PLWHA.

Acknowledgements

This study was supported by the National Institute of
Nursing Research (NINR) and the grant is (R21
NR010284, PI: Bogart). The development of this manu-

script was also supported by the Centers for Disease
Control and Prevention (CDC) grant number (U48/
DP000056, PI: Kaplan). The authors wish to acknowledge

the study participants, the members of the treatment
advocacy community advisory board (CAB), and the
many interns and volunteers who helped support this
project, including Philicia Castillo, Caleigh Douglass,

Chassity Griffin, Matthew Louie, Vaidehi Mahadev, Jessie
Tang, and Lynnea Waters. We would also like to thank
Jacinta Elijah, Jennifer Patch, and Alexa Rabin for coding

and Bryce McDavitt for his thoughtful contributions to the
study and review of this paper.

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BUSINESS

83www.AHDBonline.com l American Health & Drug Benefits lVol 5, No 2 l March/April 201

Rheumatoid arthritis (RA) is a chronic systemicautoimmune disorder and the most common formof inflammatory arthritis.1 RA affects 1% of the
population, most often adults aged 40 to 70 years.2
Recent epidemiologic data indicate that the incidence of
RA in women has risen in the past 10 years.3 Because RA
affects many individuals who are of working age and
remains a major cause of disability, the economic burden

of RA adds a significant cost not only to patients and
their families, but also to society as a whole.1,4 In addi-
tion, reduced quality of life, loss of work productivity,
and substantial healthcare utilization are factors that
must be considered in RA management.4,

Because complications of RA may begin to develop
within months of disease onset, early and aggressive
treatment is considered clinically necessary to manage
immediate symptoms of pain associated with inflamma-
tion, but also to slow disease progression to prevent long-
term disability.1,6,7 Historically, estimates of work disabili-

Ms Greenapple is President, Reimbursement Intelligence,
LLC, Madison, NJ.

Trends in Biologic Therapies for
Rheumatoid Arthritis: Results from a
Survey of Payers and Providers
Rhonda Greenapple, MSPH

Background: Advances in therapies for rheumatoid arthritis (RA), particularly biologics,
have transformed the treatment paradigm for RA. However, the associated costs of these
therapies result in a significant economic burden on the healthcare system. As a chronic
disease requiring lifelong treatment, most health plans now position RA drugs as a high-
priority therapeutic category.
Objective: To identify provider and payer practices and perceptions regarding coverage
of RA biologics in the current marketplace, as well as emerging trends in reimbursement
practices.
Method: In November 2011, Reimbursement Intelligence, a healthcare research company,
collected and analyzed quantitative and qualitative data via parallel-structure online surveys
of 100 rheumatologists and 50 health plan payers (medical and pharmacy directors) who
represent more than 80 million covered lives. The surveys included approximately 150 ques-
tions, and the surveys were designed to force a response for each question.
Results: Payers reported using tier placement, prior authorization, and contracting in
determining coverage strategies for RA biologics. Among providers, experience with older
RA agents remains the key driver for the choice of a biologic agent. A majority of payers
and providers (68% and 54%, respectively) reported that they did not anticipate a change
in the way their plans would manage biologics over the next 2 to 4 years. Payers’ re –
sponses indicated uncertainty about how therapeutic positioning of newer, small-molecule
drugs at price parity to biologics would affect the current reimbursement landscape.
Survey responses show that approval of an indication for early treatment of RA is not likely
to change the prescribing and reimbursement landscape for RA biologics. This survey fur-
ther shows that payers and providers are generally aligned in terms of perceptions of cur-
rent and future treatments for RA.
Conclusion: Advances in RA therapies allow patients increasing options for effective dis-
ease management. However, the high cost of biologic therapies and the need for lifelong
treatment raise economic concerns. Payer satisfaction with current therapies and uncer-
tainty about added value of new therapies will create challenges for new medications
coming to market.

Am Health Drug Benefits.
2012;5(2):83-92
www.AHDBonline.com

Disclosures are at end of text

Stakeholder Perspective,
page 91

BUSINESS

84 l American Health & Drug Benefits l www.AHDBonline.com March/April 2012 l Vol 5, No 2

ty rates for RA have been high, with higher rates associ-
ated with longer disease duration; work disability esti-
mates have been shown to reach 30% within 2 to 3 years
of diagnosis.4,5 Recent estimates suggest that RA-related
work disability rates remain high, although potentially
lower than in earlier estimates.8 This 2008 longitudinal
analysis showed estimates of 23% work disability at 1 to
3 years of disease onset and of 35% within 10 years.8

Clinical studies have shown better clinical outcomes
when aggressive treatment is initiated early, including
treatment with a wide range of disease-modifying
antirheumatic drugs (DMARDs) and non-DMARD
combination therapies.7-9 A recent joint collaboration of
the American College of Rheumatology (ACR) and the
European League Against Rheumatism has led to the
development of an updated classification system of RA,
to shift the focus from late-stage disease features—such
as structural changes and joint damage that can be deter-
mined from various imaging techniques—to early-stage
disease features that are associated with persistent dis-
ease.6 Given the advances in treatment for RA, includ-
ing nonbiologic and biologic options, along with the
associated improved outcomes, this classification system
update to include early-disease features marked a major
shift in the RA disease construct.

The ACR guidelines outline clinical treatment path-
ways by first defining disease duration and activity.7
Disease duration is divided into 3 major categories: <6

months (equivalent to early disease), 6 to 24 months
(equivalent to intermediate disease duration), and >2

months (equivalent to longer disease duration).7 Disease
activity measurements are often qualitative in early-stage
disease, and measures are subject to clinical judgment.7

Pharmacotherapy for RA often includes a non –
steroidal antiinflammatory drug, selected use of gluco-
corticoids, and initiation of a DMARD early in the dis-
ease course.1,7 Biologic therapies may be added when
adequate disease control has not been met by previously
initiated drug therapies, which may occur within the first
year of diagnosis.1,7 With regard to biologic therapies, the
ACR further subdivides “early disease” by disease dura-
tion of <3 months or 3 to 6 months, to accommodate the needs for early advancement of the patient to biologic therapies when disease activity is high.7

Despite positive clinical outcomes from treatment
advances, healthcare costs associated with the treatment
of a prevalent and lifelong disease such as RA are a con-
siderable issue for health plans. The ACR estimates that
per-patient treatment with biologic therapies is typically
in excess of $12,000 annually.10 The Agency for
Healthcare Research and Quality estimates the annual
costs for RA medications from as low as a few hundred
dollars for oral, nonbiologic DMARDs to a high of more
than $16,000 for injectable biologic DMARDs.11 As new
therapeutic options for RA become available, provider
practices and payer strategies to support evidence-based
care within the confines of cost management demand
close examination.

This study was conducted to identify provider and
payer practices and perceptions regarding therapeutic
options and reimbursement for RA. To this end,
Reimbursement Intelligence, a healthcare research com-
pany, conducted parallel online surveys with health plan
payers and rheumatologists. Payers were asked to also
consider market trends and potential for formulary cov-
erage of RA therapies currently in development.

Methods
Online parallel-structure surveys were conducted in

November 2011 and were completed by 2 groups: 10

rheumatologists and 50 payers identified as advisors to
Pharmacy & Therapeutics Committees who are formu-
lary decision makers for RA coverage. The payer group
survey respondents included 50 pharmacy and medical
directors from national and regional health plans who
had held their positions for more than 2 years. The
payer group of health plans represented 80 million cov-
ered lives.

The distribution of plan types among payer respon-
dents included Medicare Part D, commercial plans,
Medicare Advantage, freestanding prescription drug

KEY POINTS
➤ Advances in RA medications, particularly

biologics, have transformed the treatment paradigm
for RA; however, the associated costs of these
therapies result in a significant economic burden
on the healthcare system.

➤ With a chronic disease requiring lifelong
treatment, most health plans are positioning RA
drugs as a high-priority therapeutic category.

➤ This survey of 100 rheumatologists and 50 payers
representing >80 million lives revealed that provider
experience and satisfaction with older RA agents
remains the underlying driver for choice of biologics.

➤ Payers and providers alike reported that they did
not anticipate a change in the way their plans
would manage biologics over the next 2 to 4 years.

➤ Payers were uncertain about the therapeutic
positioning for newer, small-molecule drugs at price
parity to biologics.

➤ Survey responses also suggest that an indication for
a biologic to treat early RA will likely not change
current prescribing and reimbursement patterns.

Trends in Biologic Therapies for RA

85www.AHDBonline.com l American Health & Drug Benefits lVol 5, No 2 l March/April 2012

plans, Managed Medicaid, and dual-eligible populations.
More than two thirds (69%) of payers represented com-
mercial plans with 3- or 4-tier formularies.

The rheumatologist group represented providers from
large and small group practices, and ones with and with-
out in-office infusion capabilities. Rheumatologists were
screened as to whether their practice offered in-office
biologic infusions, the practice volume of in-office infu-
sions weekly, and the number of rheumatologists in the
practice. The sample was weighted toward rheumatology
and multispecialty group practices seeing more than

patients with RA monthly.

The parallel-structure payer and rheumatologist sur-
veys were comprised of approximately 150 questions,
and the survey instrument required answers to all ques-
tions. Survey questions included specific probes about 8
biologic therapies currently indicated for RA (Table 1);
existing medications that may receive an RA indication;
and new, small-molecule oral agents still in develop-
ment. All respondents received an honorarium for their
participation.

Results
Tier Placement

Tiered cost-sharing is a common strategy for therapies
covered under a pharmacy benefit. Payers reported that

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%
Enbrel Humira Remicade Cimzia Simponi Rituxan Orencia Actemra

Figure 1 Payer Formulary Tier Placement for RA Biologics

Question to payers (N = 50): For the following agents covered under your pharmacy benefit, please
select the corresponding tier positioning.

Tier 2
Tier

Tier 4
N/A

N/A indicates not applicable; RA, rheumatoid arthritis.

Table

Biologic Medications Indicated for
Rheumatoid Arthritis

Brand name Generic name

Actemra Tocilizumab

Cimzia Certolizumab

Enbrel Etanercept

Humira Adalimumab

Orencia Abatacept

Simponi Golimumab

Rituxan Rituximab

Remicade Infliximab

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86 l American Health & Drug Benefits l www.AHDBonline.com March/April 2012 l Vol 5, No 2

none of the current 8 biologic medications (Table 1,
page 85) covered under the pharmacy benefit is placed
on tier 1. Tier 2 stat us was given most frequently to etan-
ercept (Enbrel; 36%) and adalimumab (Humira; 34%),
whereas the remaining products were distributed across
tiers 3 and 4 (Figure 1, page 85).

Prior Authorizations and Step Edits
To target medications to appropriate patients, health

plans may require patients to meet predetermined clinical
criteria and receive prior authorization before reimburse-
ment is approved. Similarly, health plans may use step
edits, or a “fail-first” requirement, where payment for a
therapy will be made only after certain therapies have
been used first. If the patient does not respond appropri-
ately (ie, considered a “step” or “failure”), then the
provider will likely recommend a second-line therapy.12

Payers were asked about approval rates when prior
authorizations or step edits are required. Survey results
show that most health plans use prior authorizations to
manage utilization of RA therapies; 80% to 88%
reported they require prior authorizations for the 8 bio-

logic options presented in the survey. More than half
(55%) of the providers reported approval rates between
81% and 100% of the time, whereas 29% reported
approval rates from 61% to 80% of the time (Figure 2).

Distribution Strategy and Use of
Specialty Pharmacies

Most (80%) payers in the survey reported they use
specialty pharmacies for distribution of biologic thera-
pies for RA. Among those who use specialty pharma-
cies, 65% reported using closed networks, whereas 83%
reported they do not mandate the use of specialty phar-
macies for distribution of office-infused biologic agents.

Specialty pharmacy services often offer services
beyond product dispensing. Payers reported that the
most valuable add-on services are patient education
(60%), compliance programs (54%), compliance/adher-
ence data reported back to payers (

46%

), and reimburse-
ment assistance (28%).

Perceptions of Management Approach
Payer respondents characterized their general approach

1%-20% 21%-40% 41%-60% 61%-80% 81%-100% N/A

3% 2%

9% 8%

29%
26%

12%

55%

46%

Rheumatologists (N = 100)
Payers (N = 50)

Figure 2 Approval Rates for Prior Authorization/Step Edits

Question: What is the approval rate for prior authorizations and step edits for your patients with RA?

N/A indicates not applicable; RA, rheumatoid arthritis.

Providers, 85%
Payers, 72%

R
es
po
nd

en
ts
, %

to RA management in terms of level of stringency of
drug approval requirements for providers. Specifically,
payers were asked, “How would you characterize your
plan’s general approach toward the management of
rheumatoid arthritis?” Respondents were asked to
choose from 5 categories—“open access,” “somewhat
regimented,” “regimented approach,” and “other.”

Regimented was defined as “patients must have doc-
umented failure on a DMARD and a preferred biologic.”
Open access was defined as “physician decides patient
therapy and no documentation needed.”

Overall, 40% of payers characterized their plan’s
approach as regimented. In contrast, only 33% of
providers characterized their plans as regimented. A lit-
tle more than one third (36%) of payers characterized
their management approach as somewhat regimented, in
which patients must have a documented failure while
using a DMARD before a biologic drug will be approved.

Conversely, 57% of providers characterized their
health plans as somewhat regimented. Of the payers,
10% reported that they offer open access, in which the
physician decides on the patient’s therapy and no docu-
mentation is needed for treatment initiation or changes.
More payers (16%) than providers (10%) reported open
access in this survey.

Impact of Reimbursement Process on
Access to Biologics

Providers reported that oral methotrexate (Trexall,
Rheumatrex) is initiated within the first 3 months of RA
diagnosis: 74% reported immediate initiation of the
drug; 22% reported initiating methotrexate within 1 to
3 months. In addition, 21% of providers also reported
initiating biologics within 1 to 3 months after initiation
of methotrexate; 61% reported initiating biologics
between 3 to 6 months; and 8% reported initiation of
biologics between 6 months and 1 year. With regard to
the number of biologics used for each patient, only

of providers reported that patients remained using the
first biologic throughout the duration of their disease;
48% and 43% of providers indicated that patients typi-
cally cycle through 2 or 3 biologics, respectively, in the
course of the disease (Figure 3).

Payers and providers were asked to rank, in order of
importance (from highest to lowest), the reasons for
choice of preferred biologic (Figure 4). For both respon-
dent groups, efficacy ranked the highest in influence on
choice of biologics. Payers ranked etanercept, adalim –
umab, and infliximab (Remicade)—the 3 most estab-
lished of the 8 biologics studied—as the most frequent
first- and second-line drug choices. Payers reported that
contracting/rebating is the second most frequent influ-
ence in determining a preferred biologic for patients

with commercial coverage. For the Medicare popula-
tion, payers ranked safety as more important than con-
tracting/rebating.

Trends in Biologic Therapies for RA

87www.AHDBonline.com l American Health & Drug Benefits lVol 5, No 2 l March/April 2012

100

60
50
40
30
20
10

0
1 2 3 ≥4

48%

43%

Pr
ov
id
er
s,
%

Figure 3
Provider-Reported Number of RA Biologics Prescribed
per Patient during the Course of Disease

RA indicates rheumatoid arthritis.

Question to rheumatologists (N = 100): How many
biologics do your patients with RA typically cycle
through during the course of their disease?

Efficacy profile Efficacy profile

Mode of administration Mode of administration

Frequency of dosing Market share

Reimbursement easier to
obtain on most health plans

Utilization rate among plan’s
in-network physicians

My personal experience Safety profile

Safety profile Contracting/rebating

1
2
3
4
5
6

Rheumatologists (N = 53) Payers (N = 28)

1
2
3
4
5
6

Figure 4 Ranked Order of Importance for Choosing Preferred
Biologics

Question: Please rank in order of importance (from
highest to lowest) the reasons for your choice of
preferred biologic(s).

Biologics prescribed

Payers and providers were asked about the main rea-
son for low utilization of newer tumor necrosis factor
(TNF) inhibitors, such as certolizumab (Cimzia) and
golimumab (Simponi), and asked to rank in order from
highest to lowest the reason for low utilization.
Although contracting/price had some impact on product
choice, ranking third, provider comfort with older agents
was the first-ranked reason given by both providers and
payers. More than three fourths (79%) of providers

reported that some documentation of medical need for a
biologic is always required. However, providers, like pay-
ers, stated that approval is granted more than two thirds
of the time (Figure 2).

Only 15% of providers reported that plans require
quantitative measurements (ie, x-ray) of active disease
to allow the initiation or change of biologics. One third
(34%) of providers and 40% of payers reported ACR
20% criteria for improvement (ACR20) achievement as
a requirement for approval of a biologic therapy, and
42% of providers and 44% of payers reported that
demonstrated safety and tolerability are required to ini-
tiate biologic drug therapy.

Providers were asked, “Under what circumstances
would you be willing to take steps to dispute a payer deci-
sion?” More than two thirds (68%) agreed with the
statement, “To appeal a denied prior authorization of
one autoimmune biologic because payer requires failure
of a different autoimmune biologic agent (eg, step edit).”
Similarly, 60% chose the statement, “To counter oner-
ous administrative or documentation requirements (eg,
to eliminate burdens some request for additional docu-
mentation beyond reasonable medical notes),” with
68% choosing the statement, “to secure reimbursement
following a claim denial for an on-label diagnosis.” In a
follow-up question, providers were asked how many
times they would dispute a denial before accepting the
denial as a defined payer policy. Nearly one third
(32%) of providers reported 1 time, 38% reported 2
times, and 17% reported 3 times. In this survey,
providers reported that their support staff was generally
successful at overcoming prior authorization and step-
edit requirements (Figure 5).

Overall, payers and providers were consistent in their
responses in regard to changes in the way RA will be man-
aged over the next 2 to 4 years, with 54% of rheumatolo-
gists and 68% of payers reporting no change. Payers were
asked if changes in reimbursement for office-infused prod-
ucts influenced the treatment selection rheumatologists
currently make. More than 6 of 10 (62%) payers said that
these changes would not influence treatment selection.

Regarding sites of care, 82% of the rheumatologists
reported providing in-office infusion, although 62% of
these providers also reported using an alternate site of
care at least part of the time. When asked does “site of
care affect your choice of therapy,” 72% of providers
agreed with the statement, “It does not affect my choice
of biologic.”

Potential Impact of Expanding Therapeutic
Options for RA

Payers and providers were asked to assess the poten-
tial impact of several emerging trends in RA therapies,

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88 l American Health & Drug Benefits l www.AHDBonline.com March/April 2012 l Vol 5, No 2

41%-60%

21%-40%

61%-80%

0%-20%

Figure 5
Provider-Reported Staff Success Rate in Obtaining
Reimbursement Approval

Question to rheumatologists (N = 100): How successful
is your staff in obtaining reimbursement approval for
your patients?

81%-100%

1%
2%
12%

Table 2
Disease-Modifying Rheumatoid Arthritis Agents in
Development

Generic name/drug type Development phase

Fostamatinib, oral, spleen
tyrosine kinase inhibitor

Phase 2 clinical trial

Tofacitinib, oral, Janus
kinase inhibitor

NDA submitted to the FDA on
December 21, 2011

Tabalumab, IV, human
immunoglobulin G4
monoclonal antibody

Phase 3 clinical trial

FDA indicates US Food and Drug Administration;
IV, intravenous; NDA, New Drug Application.

including new, small-molecule oral disease-modifying
agents (Table 2, page 88). Respondents were asked,
“Once FDA [US Food and Drug Administration]
approved, how will they change your treatment strategy?
Assume efficacy and safety are similar to current TNF
inhibitors. Assume price parity to current biologics.”
One third (36%) of providers and one fifth (20%) of
payers reported these agents will be used after
methotrexate but before TNF inhibitors. One third
(33%) of providers and 16% of payers reported these
agents will be used after TNF inhibitor failure. Smaller
numbers, 15% of providers and 18% of payers, reported
these agents will be used after TNF inhibitors fail. Only
11% of providers and 34% of payers say they are not sure.

If small-molecule drugs are priced at a 15% to 20%
discount to biologics, a little more than half (52%) of
payers reported they would position them before TNF
inhibitors. However, if small-molecule drugs were priced
at a 15% to 20% premium to biologics in product costs,

they would position them after TNF inhibitors. If the
price of these compounds were discounted relative to
TNF inhibitors, an expedited review would be expected
by 46% of payer respondents.

Most payers (88%) and more than half (57%) of
providers reported they believe small-molecule therapies
to be in the same therapeutic class as biologics. More
than two thirds (68%) of payers noted that approval of
the first small-molecule therapy would likely trigger a
class review of the biologics. Regarding compliance
potential of orals, which will be dosed 2 or 3 times
daily,13,14 58% of payers and 44% of providers reported
that oral dosing would improve patient compliance; 25%
of providers and 8% of payers reported they believe it
will reduce compliance as a result of the 2- or 3-times-
daily dosing regimen, and 29% of providers and 28% of
payers reported that compliance will not be an issue.

Consideration of adoption of new therapies at launch
was reported by only 27% of providers. However, 46% of

Trends in Biologic Therapies for RA

89www.AHDBonline.com l American Health & Drug Benefits lVol 5, No 2 l March/April 2012

10
5
0
Rheumatologists (N = 100)
Payers (N = 50)

Figure 6 Impact of Early RA Indication on Prescribing Patterns

DMARD indicates disease-modifying antirheumatic drug; FDA, US Food and Drug Administration;
RA, rheumatoid arthritis.

Question for rheumatologists: If an early RA indication were FDA approved, how do you think
this will impact your biologic prescribing?

Question for payers: If an early RA indication were FDA approved, how do you think this will impact
the biologic prescribing patterns of rheumatologists in your network?

Will prescribe a biologic at
the time methotrexate or
another DMARD is initiated

Will add a biologic to
therapy within 1 year of
initiating methotrexate

Would not change
prescribing, because biologics
are already initiated within

3 years of diagnosis

Other

R
es
po
nd

en
ts
, %

31%

20%
23%

38% 38%

4%
0%
46%

providers reported they would require <1 year of experi- ence with a new therapy to regularly prescribe it, with the balance of respondents (27%) reporting a 1- to 3- year time frame to adoption.

In addition, payers and providers were asked if they
were aware of any ongoing head-to-head trials in RA;
affirmative responses were given by 12% of payers and
26% of providers. Payers and providers were then asked,
“How significant would the results of a head-to-head trial
be in selecting your preferred biologic, if the trial design
is for superiority?” On a scale of 1 to 7, with 1 represent-
ing “not significant at all” and 7 representing “most sig-
nificant,” 40% of both payers and providers selected 6,
whereas 34% and 33%, respectively, selected 7.

Payers and providers in this survey were asked if there
would be an impact on prescribing patterns if an early
RA indication was approved by the FDA. Among
rheumatologists, 46% reported they would not change
prescribing of biologics, with 23% reporting they will
add a biologic within 1 year of initiating methotrexate.
Nearly one third (31%) of rheumatologists reported they
would prescribe a biologic at the time methotrexate or
another DMARD is initiated (Figure 6, page 89).

Discussion
Cost Burden

RA represents a significant burden to payers and is
positioned as the highest priority therapeutic category
for most health plans.15 Specialty pharmacy costs for RA
therapies account for more than 25% of total spending
for specialty drugs.16 Although nonspecialty drug costs in
many categories are expected to grow more slowly over
the next 3 years (because of increased availability of
generics), costs for specialty therapies are expected to
grow between 15% and 17% annually.16

Between 2011 and 2013, the costs for RA biologics
are expected to be the single largest contributor to
increases in specialty drug spending and are predicted to
represent approximately one fifth (21%) of all health
plan drug spending by 2014.16

Payers continue to implement and refine a variety of
reimbursement strategies to balance quality of care in

light of the economic burden of RA biologics, with
varying effects.

Payer Reimbursement Management
The high costs associated with RA therapies have led

payers to look for strategies to manage immediate costs,
while weighing the potential for long-term costs of
delayed treatment (eg, disability). Health plans have his-
torically covered biologic therapies with subcutaneous
delivery under a pharmacy benefit, because patients can
self-administer these therapies.15 Intravenous and infu-
sion therapies have been covered largely under a medical
benefit, because drug administration needs to be deliv-
ered by a healthcare professional.15

Drugs covered under the medical benefit lack the
scrutiny of drug utilization review and coverage manage-
ment protocols used in pharmacy benefit structures. The
entry of new oral and self-injectable products will gener-
ate greater scrutiny, which may result in an impact on
cost.16 As new biologics enter the market, health plans
will need to consider how coverage channels, including
rebates or other discounts offered under a pharmacy ben-
efit structure, will impact future costs.

Currently, there is no biologic therapy on the market
that is specifically indicated for “early” RA. Because
early stages of RA are diagnosed by clinical presentation
rather than a definitive test, diagnostic parameters of
early RA remain unclear.1

The survey findings highlight emerging trends in RA
cost-management strategies, including payers’ efforts to
follow evidence-based guidelines for use of RA biologics,
and the trend toward shifting a greater proportion of the
cost to patients; the resulting framework can inform the
coordination of cost and clinical management of RA.

Results from this survey also show that payers and
providers were generally aligned in terms of perceptions
of current and future treatments for RA. Because
provider experience and satisfaction with older RA
agents were reported as the underlying driver for using
current therapies, uptake of newer agents may also fol-
low a similar pattern. Of note were responses that having
an indication for early RA would not influence prescrib-
ing patterns, because biologics generally are already
being used within 1 year of diagnosis, which is still con-
sidered early in the course of the disease.

Limitations
The limitations of this study include those inherent

to all surveys. Survey questions must be developed
broadly to be appropriate to as many respondents as pos-
sible. Surveys in general are inflexible to adaptation to
individuals or subsets of respondents, so captured data
may not reveal the richer context of the questions posed.

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90 l American Health & Drug Benefits l www.AHDBonline.com March/April 2012 l Vol 5, No 2

Drugs covered under the medical benefit
lack the scrutiny of drug utilization review
and coverage management protocols used
in pharmacy benefit structures. The entry of
new oral and self-injectable products will
generate greater scrutiny, which may result
in an impact on cost.

In addition, this survey was administered online and
was formatted with forced-answer questions. Although
there is a benefit to capturing responses for all questions
and all respondents, question saliency may not be uni-
form for all respondents, thereby impacting the weight of
each question in relation to others.

Furthermore, the sample size of the provider group
was twice that of the payer group, which could skew
intergroup comparisons.

Conclusion
Although the availability of highly effective biologic

therapies for RA has greatly improved patient care, the
cost of these therapies remains a priority concern for
patients, providers, and payers alike. Provider and
payer satisfaction with older RA agents, and skepticism
about the incremental value of new therapies, will con-
tinue to raise the hurdles for new RA therapies coming
to market. ■

Author Disclosure Statement
Ms Greenapple reported no conflicts of interest.

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4. Sokka T. Work disability in early rheumatoid arthritis. Clin Exp Rheumatol.
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Trends in Biologic Therapies for RA

91www.AHDBonline.com l American Health & Drug Benefits lVol 5, No 2 l March/April 2012

Biologic Therapies for Rheumatoid Arthritis: It’s All about Value
Value has been defined as the relationship between

benefits and costs. Using mathematical concepts, value
has been described as “value = benefits/cost” or the
units of benefit derived from a given number of units of
costs. Applying this definition, if we wish to maximize
the value of a therapy, there are only 2 ways to achieve
it: either by increasing the benefits obtained from the
therapy, or by decreasing the cost paid for that therapy.

Value in healthcare is also a function of perspective.
What may be considered valuable to an individual
patient undergoing treatment or to a physician pre-
scribing that treatment to a similar group of patients

may not necessarily be considered valuable to the same
extent by a payer, who must not only pay for that indi-
vidual’s treatment but who also has to manage the
needs of multiple groups of patients and/or members
with equally compelling medical conditions and prior-
ities. Optimizing value within the healthcare system
means that physicians and payers must be aligned in
the way they view the various benefits and costs of a
given treatment.

Achieving such optimization is where the article by
Ms Greenapple in this issue of American Health & Drug
Benefits fits in. In her article, Ms Greenapple shows

STAKEHOLDER PERSPECTIVE

Continued

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Presentation

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Areas of Expertise

Although you can leverage our expertise for any writing task, we have a knack for creating flawless papers for the following document types.

Essay

Thesis

Presentation

Dissertation

Term Paper

Research Paper

Book Review

Assignment

Report

Case Study

Letter

Article

Coursework

Speech

Q & A

Critical Thinking

Trusted Partner of 9650+ Students for Writing

From brainstorming your paper's outline to perfecting its grammar, we perform every step carefully to make your paper worthy of A grade.

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Premium Quality

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On-Time Delivery

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Complete Confidentiality

Authentic Sources

Moneyback Guarantee

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Areas of Expertise

Essay

Thesis

Presentation

Dissertation

Term Paper

Research Paper

Book Review

Assignment

Report

Case Study

Letter

Article

Coursework

Speech

Q & A

Critical Thinking

Areas of Expertise

Essay

Thesis

Presentation

Dissertation

Term Paper

Research Paper

Book Review

Assignment

Report

Case Study

Letter

Article

Coursework

Speech

Q & A

Critical Thinking

Trusted Partner of 9650+ Students for Writing

Preferred Writer

Grammar Check Report

One Page Summary

Plagiarism Report

Free Features $66FREE

Our Services

Academic Writing

Professional Editing

Thorough Proofreading

Thorough Proofreading

Delegate Your Challenging Writing Tasks to Experienced Professionals

Check Out Our Sample Work

It May Not Be Much, but It’s Honest Work!

0+

Happy Clients

0+

Words Written This Week

0+

Ongoing Orders

0%

Customer Satisfaction Rate

Process as Fine as Brewed Coffee

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See How We Helped 9000+ Students Achieve Success

We Analyze Your Problem and Offer Customized Writing

We Mirror Your Guidelines to Deliver Quality Services

We Handle Your Writing Tasks to Ensure Excellent Grades