1 dysport - mb - november 2007. dysport mb - in adult spasticity, secondary to stroke and juvenile...

Dysport - MB - November 2007

1

Dysport MB- in adult spasticity, secondary to stroke and

juvenile cerebral palsy

Project Manager: Project Assistant: Rosie Augustsson Linnéa Elfström

+46 300 515 19 [email protected]

+46 300 51 755 [email protected]

Kungsbacka in November 2007SIFO Research International Navigare


3

Background and Objectives

In Sweden, unlike the rest of Europe Botox is the market leader among Botulinum toxins with approx 90-95% market share. This market description study is conducted in order to evaluate the Swedish market of botulinum toxins and find the attitudes towards Botox vs Dysport. Other important issues are prescription habits, who takes the decisions regarding the choice of Btx and to find out what is required to switch Botox for Dysport.

Method

The interviews were carried out during October and November 2007 and were performed as pre-arranged telephone interviews with 24 specialists. The interviews took approximately 20-25 minutes and were performed by medically trained interviewers.

AS a member of ESOMAR (European Society for Opinion and Market Research) Navigare follows the ethical rules for marketing research. Among other things these rules mean that the respondents are guaranteed full anonymity.


4

Patient Flow and Frequencies

total number of pat on Btx

no of pat - med responsibility

% possible pat for btx treatm dr responsible for

% pat on Botox

% pat on Dysport

number of new

pat/month

adult spasticity (n=18)

mean 106,6 51,6 49,3 95,6 3,9 8,6

median 50,0 40,0 30,0 100,0 0,0 7,8juvenile cerebral palsy (n=9)

mean 202,5 74,3 74,8 92,7 7,0 2,9median 150,0 60,0 90,0 100,0 0,0 1,5


5

Source: QXa Base: All Drs

Total Number of Patients Treated with Botulinum Toxins

44

22

6 6

11 1111

22

11 11

33

11

0

5

10

15

20

25

30

35

40

45

50

1-50 51-100 101-200 201-300 >300 don't know


juvenile cerebral palsy (n=9)

% Drs

adult spasticity

(n=18)


(n=9)mean 106,6 202,5median 50,0 150,0min 10,0 35,0max 600,0 600,0


6

Source: Q1a Base: All Drs

adult spasticity

(n=18)



Total Number of Patients with Adult Spasticity and Juvenile Cerebral Palsy that Doctor is Responsible for

22

33

22

17

6

22

11

22 22

1111

0

5

10

15

20

25

30

35

40

45

50

1-20 21-40 41-60 60-100 >100 don't know



% Drs


7

Source: Q1aa Base: All Drs

adult spasticity

(n=18)



Share of Patients with Adult Spasticity and Juvenile Cerebral Palsy Possible for Treatment with Botulinum Toxins

39

17

11

33

22

11

44

1111

0

5

10

15

20

25

30

35

40

45

50

1-20 21-40 41-60 61-80 81-100 don't know



% Drs


8

Source: Q1b Base: All Drs

adult spasticity

(n=18)



Total Number of Patients with Adult Spasticity and Juvenile Cerebral Palsy in Doctors Clinic

17

28

6

22

11

17

22 22 22

1111 11

0

5

10

15

20

25

30

35

40

45

50

none 1-50 51-100 101-150 151-200 >200 don't know



% Drs


9

Source: Q2 Base: All Drs

adult spasticity

(n=18)



Number of New Patients with Adult Spasticity and Juvenile Cerebral Palsy Doctor Meets in an Average Month

17

11

22

17

33

44

11

2222

0

5

10

15

20

25

30

35

40

45

50

>0-2 >2-4 >4-6 7-10 11-20 don't know



% Drs


10


Choice of Treatment - Initiation

Initiation of Adult Spasticity and Juvenile Cerebral Palsy - Share of Patients Treated with Botulinum Toxins

11

22

11

17

39

22

11 11

22

33

0

5

10

15

20

25

30

35

40

45

50

none 1-20 21-40 41-60 61-80 81-100 don't know



% Drs

adult spasticity

(n=18)




11

Initiation of Adult Spasticity and Juvenile Cerebral Palsy - Treatment Alternatives to Botulinum Toxins

89

67

2217

6

22

89

44

11

33 33

0

10

20

30

40

50

60

70

80

90

100

physiotherapy baclofen diazepam gabapentin surgery other



% Drs

Source: Q3b+4b Base: All Drs

Specification of other.adult spasticity (n=4)- Tryptizol 30 %, Lyrica 10 % - arbetsterapi, egen träning- somatisk utredning för att utesluta infektioner och i så

fall beh för det eftersom det kan öka spasticiteten- ingajuvenile cerebral palsy (n=3)- Iktorivil 15 %, Pargitan 5 % - Klonazepam- ortoser/inlägg 100%, kirurgi 5%


12

Initiation of Adult Spasticity and Juvenile Cerebral Palsy - Allocation of Treatment Alternatives to Botulinum Toxins

98

44

7 6

78

100

39

15

52

0

10

20

30

40

50

60

70

80

90

100

physiotherapy baclofen diazepam gabapentin other (incl. surgery)



Share Pts (%)

Source: Q3c+4c Base: All Drs


13

Source: Q3c+4c Base: All Drs


baclofen diazepam gabapentin physiotherapy other (incl. surgery)

n= 12 4 3 16 5mean 44,3 6,8 5,7 97,5 78,0median 35,0 6,3 5,0 100,0 100,0min 6,0 2,0 2,0 60,0 40,0max 100,0 12,5 10,0 100,0 100,0


baclofen diazepam gabapentin physiotherapy other (incl. surgery)

n= 4 0 1 8 6mean 39,3 - 15,0 100,0 51,8median 15,0 - 15,0 100,0 41,5min 3,0 - 15,0 100,0 8,0max 100,0 - 15,0 100,0 100,0


14

Initiation of Adult Spasticity and Juvenile Cerebral Palsy - Situations when Doctors Initiate Botulinum Toxins

28

28

22

6

11

11

11

11

6

6

17

6

33

33

22

44

0 5 10 15 20 25 30 35 40 45 50

functional limitation

insufficient efficacy from physiotherapy/ baclofen

pain

after consultation with physiotherapist

within 3 weeks

all patients receive treatment with botulinum toxins

hygienic problems

as soon as possible

spasticity

within 2 months

when recommended

other

don't know



% Drs

Source: Q3d+4d Base: All Drs


15

Source: Q3d Base: All Drs

Situations when doctors initiate Botulinum Toxins, adult spasticity (n=18)

BR- when physiotherapy or baclofen won't work 27- at inadequate effect of baclofen or physiotherapy 59- when baclofen is inadequate 72- at inadequate effect of other therapy and when you expect less pain, better function or easier to nurse 4- when spasticity is a problem for patient's different functions alt. pain, focal spasticity in a limited number of muscles in hand or foot, when

physiotherapy is inadequate.45

- a risk of contractions, pain problem, to increase the function, hygienic problems 42- at functional reduction/limitation or pain due to spasticity, for example when difficulties with hygien due to spastically squeezed hand 9- it's individual, from case to case, it's done diagnostically or as prevention or as a treatment to ger better function 45- when I expect an obvious gain of function, when physiotherapy recommends it 92

- come to me only for this 73- if I believe it will help I give it to everybody, most of them are already treated before they come to me for a new treatment 69

when they have rather pronounced spasticity or a tendency that it is very difficult to reflect certain fingers or the whole hand, how long the patient has had his/her problems doesn't matter.

52

- at difficult focal spasticity 11

- I start pretty soon within 2-4 weeks on younger adults with stroke, because I've noticed that it's a gain to start an early treatment 60

- I try to start as soon as possible, for example after 3 weeks is the optimal time 81

- when I meet the patient, appr. 2 months after the injury, the patients come to me on referral from a neurologist or neurosurgeon to the spasticity reception

81

- after consultation with a physiotherapist at very early development of tonus increase 26

- don't know 4


16


Situations when doctors initiate Botulinum Toxins, juvenile cerebral palsy (n=9)

BR- we share a department with a pediatric neurologist and a physiotherapist where we decide further treatment 42- I always do an evaluation with a special physiotherapist, the physiotherapist does her/his evaluation independently of mine, then we

together consider what we've come up to.81

- difficult to say, after consultation with a physiotherapist and an orthopedist it must happen as soon as possible 56

- at dynamic muscle contraction that obviously restricts the child's functional development and maybe one doesn't want to operate due to the age, sometimes start with it to see how long one can come with a help of it, for example if it's enough to get the child in the standing brace.

9

- it's individual, it varies from case to case, it's done diagnostically or as prevention or as a treatment to get better function 45

- it depends on the phase, one wants to start as soon as possible when the child is learning to walk or stand 20

- at localised problems 72

- when tensions are a problem to the patient 81

- when I know that it can help 69


17

Adult Spasticity and Juvenile Cerebral Palsy- Reason for Not Receiving Treatment with Botulinum Toxins

11

17

22

11

17

11

11

28

44

22

11

56

0 10 20 30 40 50 60 70

insufficient efficacy from Btx

as long as the indication existseverybody will receive it

limited personnel resources

all patients receives it

the price

lack of knowledge

patients/ relatives don't want

other



% Drs



18


Reson for not receiving treatment with Botulinum Toxins, adult spasticity (n=18)

BR- lack of resources, there are few doctors who give the treatment 27- lack for doctors who give the treatment 59- if the patient already has had contractions it's not meaningful to start the treatment, due to lack of resources, I'm one of the few who treats

with it and must prioritize those I think will get the best effect of it.60

- everybody who has a good indication gets it 26- I give it when indicated 4- a new field with limited MIMS-indications, the price, limited resources, there are few doctors who give it, a resource demanding treatment

that needs a motivated patient and a good physiotherapist.45

- I test it on everybody, everybody can try it 52- all patients get it 69

- I don't think it gets better function or less pain, that's the way it is 73

- I don't reach my goals with Botox injections, few wants, orthosis and physiotherapy are enough 45

- a new treatment strategy which we don't master yet, those who have Waran must be careful 11

- the price, we have a goal to try to reduce use of botulinum toxins at our clinic 92- lack of knowledge with the doctor, the cost, there are only few who get the treatment 9

- spasticity isn't that great as you might think, women who plan to get pregnant, the patient doesn't want it 81- the patient doesn't want it 72

- some other therapist has a different opinion, different opinions on what provokes the pattern of movement, still many doctors say that it's a poison, even if those are less today, or manage with help of orthopedic techniques

81

- don't know 4- don't know 42


19


Reson for not receiving treatment with Botulinum Toxins, juvenile cerebral palsy (n=9)

BR- there are indications for all, if you've tried with Botox and didn't get an effect, some children with brain damage who have a motor damage,

then Botox doesn't work.20

- no effect, spasticity that doesn't suit to this 56- don't reach my goals with Botox injections, few wants, orthosis and physiotherapy are enough 45- unwillingness from the parents towards the treatment, possibly not if you are of the opinion that it won't have any effect 42

- it's not like that, if there's an indication they get it 9

- all patients get it 69

- some patients don't need it, it's enough with orthosis and physiotherapy, generalised muscle spasticity 72

- patients don't have dynamic contractions 81

- some other therapist has a different opinion, different opinions on what provokes the pattern of movement, still many doctors say that it's a poison, even if those are less today, or manage with help of orthopedic techniques

81


20

New Patients Treated with Botulinum Toxins- Share of Patients Receiving Botox and/or Dysport

98

2

96

4

0

10

20

30

40

50

60

70

80

90

100

Botox Dysport



Share Pts (%)



21



Botox Dysport Neuroblocmean 97,8 2,2 0,0median 100,0 0,0 0,0min 70,0 0,0 0,0max 100,0 30,0 0,0


Botox Dysport Neuroblocmean 96,1 3,9 0,0median 100,0 0,0 0,0min 70,0 0,0 0,0max 100,0 30,0 0,0


22

Initiation of Adult Spasticity and Juvenile Cerebral Palsy- Reson for Choosing Botox More Often than Dysport

67

22

22

11

22

11

11

11

11

17

78

33

33

11

22

11

11

33

0 10 20 30 40 50 60 70 80 90 100

experience/ tradition/ habit

dosage

company has given educations/ good service

few side effects

established product

no marketing of Dysport

efficacy/ good results

Botox is being stockpiled

better size on packaging

other



% Drs



23


Reson for choosing Botox more often than Dysport, adult spasticity (n=18)

BR- the only preparation I know 59- I started with it, I learned it first 72- my experience, I'm used with it, I have good channels to it 27- great experience of it, I'm used with Botox, used with the dosage, generally less side effects 73- I'm used to use the preparation, good results 45- easier to use one preparation, you get more experience, Dysport hasn't had a representative in Sweden 81- they came first, Allergan are good at arranging education, we get serious information from them, I feel safe with Botox, always get good

support from Allergan, Botox is easier to dose 60

- it's well known 92- treatment tradition 11- old habit, the company gives a lot incl. education, we've received EMG equipment, nerve stimulator 42- clear routine, get good service from the company, the dilution can give a lower toxic dose as regards Dysport 81- It's easier to use Botox, they have better box sizes, you have to through away more when you use Dysport, they have small bottles which

are more difficult to use, I grew up with Botox, I know their doses.4

- A wellknown preparation. I know the mode of action, doses and the proportion of mixture 26- Botox came first, the price is almost equal when you count it, Dysport has had extremely bad marketing the last 2 years. 69

- It's purchased/bought in, historically it has always been used as the first line preparation 45- the clinic buys Botox, it's bought in 9

- Botox is more economic, it gets better effect, Dysport gives more waste, has a more fiddly package 4

- everybody gets Botox at start, those who go to the dystonia department get Dysport, it's due to the Botox injection we give at start, the bottle costs 1954 Crowns, if the patient is going to go on at the department, it's a lot of money to save because when we have many patients on whom we use another mixture system than what is recommended.

52


24


Reson for choosing Botox more often than Dysport, juvenile cerebral palsy (n=9)

BR- constant lack of time, must take the one that is fastest, I have their doses and inejctions in my head. 9- Botox came first to the market, have received good support from Allergan, it's a purer form 42- I have overtaken the task from an older colleague, inherited Botox, have been on eduation at the Botox company, they've given a

trustworthy impression, have not received anything from the Dysportcompany.20

- I'm used to it, economic dosage 81- used to use the preparation, good results 45

- clear routine, get good service from the company, the dilution can give a lower toxic dose as to Dysport 81- cannot really answer to this, the first contact was with Botox which has made it easy to continue with it, more standard treatments with

Botox, the Dysport dose has varied.56

- Botox is purified, doesn't develop antibodies, Dysport spreads to the tissues nearby and other muscular areas. You cannot convert Dysport.

72

- Botox came first, the price is almost equal when you count it, Dysport has had extremely bad marketing the last 2 years. 69


25

Source: Q7a Base: Adult spasticity

Time with Adult Spasticity Before Receiving Treatment with Botulinum Toxins

39

22

6

17 17

0

5

10

15

20

25

30

35

40

45

50

up to 6 months 7-12 months 13-24 months 25-36 months more than 36months


% Drs

Adult Spasticity


mean (months) 19,2median 12,0min 0,6max 60,0


26

Source: Q7b Base: Adult spasticity

Patient's Age when Receiving Treatment with Botulinum Toxins

28 28

39

6

0

5

10

15

20

25

30

35

40

45

50

40-50 years 51-60 years 61-70 years older than 70 years


% Drs


mean 58,1median 59,0min 40,0max 75,0


27


Patients Treated with Botulinum Toxins - Treatment Allocation

96 93

4 70,20,3

0,10,2

0

10

20

30

40

50

60

70

80

90

100

adult spasticity (n=18) juvenile cerebral palsy (n=9)

other

Neurobloc

Dysport

Botox

% Drs

Specification of other:adult spasticity (n=2)- Xiomin- Neuroblocjuvenile cerebral palsy (n=1)- Xiomin


28


Switch Treatment

Treatment Switch from One Botulinum Toxin to Another

50

33

50

67

0

10

20

30

40

50

60

70

80

90

100


haven't switchedtreatment

switchedtreatment

% Drs


29

Source: Q9b Base: Drs who switched treatment

Treatment Switch from One Botulinum Toxin to Another within the Last Three Months - Number of Patients

67

11 11 11

33 33 33

0

10

20

30

40

50

60

70

80

90

100

no patients 1 patient 10 patients 30 patients



% Drs

adult spasticity

(n=9)



* Note low number of respondents

*

*


30

Source: Q9c+d+e Base: Drs who switched treatment

Fr 9c+9d In which botulinum toxin preparation/s did you switch on these patients? Have you switched inl Botox

Total pat Switch inNo of pat

Switch out Reason

adult spasticity/ juvenile cerebral palsy

30 BotoxDysport

1515

DysportBotox

the patient didn't turn up at the next visit, because we cannot throw away what we've drawn up from the bottle to inject we freeze it and give it to the next patient independent if the patient should get Botox or Dysport.


10 DysportNeurobloc

64

BotoxBotox

We know that some muscles react better to Dysport in some dilutions or that after a longer period of treatments I feel that the patient becomes a bit immune, which means that Botox loses its effect.

adult spasticity 1 Dysport 1 Botox we ran out of Botox

Comment on switch treatment:adult spasticity (n=5)- yes, but not for spastcity post stroke but for treatment of torticollis, pat had insufficient efficacy of Botox

because of anti body formation I then changed to Dysport and efficacy returned, it happened for more than three motns ago

- all that are going to continue with botulinum toxines may continue with Dysport after having started with Botox, one patient has not beeb satisfied with Dysport and switch back ti Botox

- previously switch from Dysport to Botox fbecause I feel more comfortable with Botox- I did it once , against better judgement, pat had got antibodies from Botox so I tested Dysport but I would not

have done this today because they have the same antibodies, a pat switched from Botox to Neurobloc bacause of antibodies

- switch from Botox to Dysport because I wanted to test if it was more cost effective, over three motns agojuvenile cerebral palsy (n=1)- used Dysport for aome years ago but it was complicated and delayed the process with double it's time


31

Source: Q9f Base: All Drs

Treatment Switch from Botulinum Toxins to Other Treatment

33 33

67 67

0

10

20

30

40

50

60

70

80

90

100


haven't switchedtreatment

switchedtreatment

% Drs


32

Source: Q9g+h Base: Drs who switched treatment

Switch in Switch out Reasonadult spasticity baclofen Botox the patient needed a more general medication due to major spasticity

adult spasticity physiotherapy only or even additional baclofen Botox insufficient effect

adult spasticity deep brain stimulation Botox Botox is not efficient any more

adult spasticity Lioresal Botox lack of effect

adult spasticity physiotherapy, baclofen pump Botox the patient needed such a large dose of Botox


Tryptizol as pain relief Botox not worth the trouble or money, it's OK that I can use my arm

juvenile cerebral palsy surgery Botox I thought it would be better for the patientjuvenile cerebral palsy operation Botox insufficent effect of Botox, you inject a couple of times and do'nt get the

effect your expect


33


People who Influence the Choice of Botulinum Toxins

89

56

11 11 116

100

56

11

22

33

0

10

20

30

40

50

60

70

80

90

100

doctor physiotherapist patient parents occupationaltherapist

director of clinic other



% Drs

Specification of other.adult spasticity (n=1)- personlig assistentjuvenile cerebral palsy (n=3)- rehabiliteringsläkare- neurolog- unga


34

Efficacy of the Different Botulinum Toxins

6

3944

1722

3933

0

10

20

30

40

50

60

70

80

90

100


don't know

Botox moreeffective

equal

Dysport moreeffective

% Drs


Opinion About Botulinum Toxins


35

Main Advantages with Botox Compared to Dysport

50

22

11

11

6

6

6

6

17

56

33

11

11

11

22

11

22

0 10 20 30 40 50 60 70

experience/ knowledge

administration/ dosage

education/ service

efficacy

no antibody formation

safe drug

documentation

fewer side effects

other

none/ don't know



% Drs



36


Main advantages with Botox compared to Dysport, adult spasticity (n=18)

BR- a well-known preparation that feels safe 92- experience, used to inject it 27- I feel safe with the preparation 72- experience, you can use higher dosage of Botox which is important when treating spasticity 9- well-known preparation for me and nurses, I know the doses and the ratio of mixtures 26- people know what you talk about, a more well-known name 81- my knowledge of the preparation, its dosage and so on. 11- experience, used to dose it, a safe preparation, we know how it works in different dilutions 45- I've learned the preparation, have received a lot of help around me 42

- they have an easy and clear dosing schedule muscle for muscle, easy preparation 60- easier to use with better packages, easier to mixture, they've given us good education 4- the effect, the way of mixture, easy to administer 45- the effect, the package 4

- less side effects, I think of dysphagia, no reports on antibody development 73

- Botox spreads in the tissues around 81

- nobody/don't know 59- nobody/don't know 52- nobody/don't know 69


37


Main advantages with Botox compared to Dysport, juvenile cerebral palsy (n=9)

BR- the effect, the way of mixture, easy to administer 45- the best knowledge and information, more safe with it 56- people know what you talk about, a more well-known name 81- Botox came first, good contact with the company, the substance in Botox is purer 42- easy to dose, used to dilute and count the doses 9- used to Botox, know the unit system, the company has made good efforts with education 20

- no antibody development, safe preparation, good documentation, long-time studies 72

- nobody/don't know 81- nobody/don't know 69


38

Main Advantages with Dysport Compared to Botox

50

50

44

56

0 10 20 30 40 50 60 70

the price

none/ don't know



% Drs



39

Main Disadvantages with Botox Compared to Dysport

50

6

6

39

44

11

44

0 10 20 30 40 50 60 70

the price

pain due to sodium chloride

antibody formation

none/ don't know



% Drs



40

Main Disadvantages with Dysport Compared to Botox

50

17

11

17

6

11

17

33

44

11

11

11

22

22

0 10 20 30 40 50 60 70


lack of experience

no educations/ info

diffusion

antibody formation

lack of documentation

uneconomical

other

none/ don't know



% Drs



41


Main disadvantages with Botox compared to Dysport, adult spasticity (n=18)

BR- a greater volume you cannot use, a lot of waste 45- unclear what doses to use for different muscles, unclear dilution schedule 60- difficult to change the dose to the patient, ratio not established 42- it's difficult to dilute in their small bottles 4- they have other units, you don't count at the same way as Botox, you have to learn anew 11- they haven't declared their ratio of figures, units Dysport as compared to units Botox 81- the package, unclear dosage, uneconomic with few patients 4- not used to use their dosage system, some data claims it's not as safe, your marginals are more limited, it diffuses to muscles around 45

- limited maximal dose, some data says it spreads more, not established what the ratio is towards Botox 9

- not so well-known 92- lack of experience 27- less experience with it 72

- spreads to the tissues around 81- the risk of dysphagia 73

- it's said it has more uneven effect, it's more difficult to foresee the effect due to the protein that looks different, Dysport seems to be more capricious in the effect when I tried it.

26

- nobody/don't know 59- nobody/don't know 52- nobody/don't know 69


42


Main disadvantages with Botox compared to Dysport, juvenile cerebral palsy (n=9)

BR- Dysponrt came late, otherwise no disadvantages 42- not as easy to dose and there's uncertainty around the optimal doses, seems not to have that much own experience and refers to a dosage ratio of 1-2, they

should do their own dosages per a muscle group instead of all the time comparing with the dosage of Botox, I'd like to know what X-units Dysport per kg body weight is for the different muscle groups.

9

- the experience, the company doesn't make any effort on education, it's a little company who's is mostly interested in selling the preparation 20

- my insecurity, the company is bad on information 56

- a greater volume which you cannot use, a lot of waste 45- they haven't declared their ratio of figures, units Dysport as compared to units Botox 81

- spreads to other muscles, antibody development, documentation 72

- nobody/don't know 81- nobody/don't know 69


43

Type of Patients who are Mainly Treated with Botox

67

28

11

28

6

11

17

11

11

11

6

28

11

11

33

22

11

33

33

33

0 10 20 30 40 50 60 70

pat with spasticity (sec to stroke)

pat with dystonia

pat with cerebral palsy

MS patients

patients with moving toes

aesthetic/ in the face

children/ young pat with spasticity

brain trauma

pat with spasticity

head ache

back injury

new patients

other



% Drs



44


Type of patients who are mainly treated with Botox, adult spasticity (n=18)

BR- spasticity post stroke 92- when physiotherapy and other treatments not effective enough on patients with spasticity post stroke 59- spasticity post stroke 11- spasticity post stroke, traumatic brain damage, brain tumors, anoxic brain damage 4- 50% spasticity post stroke, 25% MS, 10% spinal cord damage, 15% cerebral pares 60- stroke patients 85 %, MS 10 %, CP, Wilson's disease 5 % 4- stroke 60%, MS and other damages 20%, traumatic brain damage 20% 42- spastic pares post stroke, traumatic spinal cord damage, traumatic brain damage 26- spasticity secondary to stroke 90%, muscle inflammation 5%, RA 5% 45- dystonia, migraine, contraction pain in neck, focal spasticity post stroke, focal spasticity post MS 27- dystonia, chronic torticollis, spasticity post stroke, MS 72- most of them have cervical dystonia, hemifacial paresis, oromandibular dystonia, hyperhidrosis, hypersalivation, moving toes, a smaller amount have post

stroke9

- dystonia, headache 73- the cervical dystonia is the biggest group, thereafter hemifacial spasm and then focal spacticity 45

- those who have it in the face 69

- always a start on all new patients 52

- I have only patients with spasticity 81

- esthetic 81


45


Type of patients who are mainly treated with Botox, juvenile cerebral palsy (n=9)

BR- CP 95%, dystonia 5% 81- cerebral palsy 70%, patients with spasticity and toe walking patients 30% 42- all patients with cerebral palsy 95%, drowning and traffic accidents 5% 72

- young people with CP syndrome with spastic diplegia 56- children with spasticity 95%, toe walking children 5% 20- juvenile cerebral palsy, habitual toe walking, I haven't seen any good result on Perthes disease 9

- those who have it in the face 69

- spasticity secondary to stroke 90%, muscle inflammation 5%, RA 5% 45

- esthetic 81


46

Possible Reasons to Switch Treatment from Botox to Dysport

50

22

6

11

6

6

11

6

56

22

11

11

11

22

11

0 10 20 30 40 50 60 70

the price

insufficient efficacy/ failure from Botox

more information

none


support

if safe

other

don't know



% Drs



47


Possible reasons to switch treatment from Botox to Dysport, adult spasticity (n=18)

BR- dramatic price difference 92- all continue on Dysport who go on with continuous injections due to the price difference 52- convincing economic reasons, as safe even if cheaper and no increased risk for antibody development 73- possibly the price 72- economic 45- possibly the price if one can show that it's as effective 9- the price 11- economic reasons and if they give as good service 42- if our boss thinks we should use it, if Dysport is cheaper 81

- antibodies and thus decreasing effect 27- decreasing effect of Botox 4- no reason as far as the patient has good effect of Botox, possibly if lack of effect with Botox 26- if one gets markedly bad effect as a result 81

- none, there is no difference, Allergan carry through a purchasing in our area, that's why they own the market. 69- none 45

- they should make an effort on education in order for us to learn and be safe with their dosages 60

- if our clinic decides on it 4

- don't know 59


48


Possible reasons to switch treatment from Botox to Dysport, juvenile cerebral palsy (n=9)

BR- the price 81- the price difference is a big advantage to Dysport and we can be forced by economic reasons 20- economic reasons 45- lower price with same effect, safety and simplicity in distribution, Dysport is older than Botox and still hasn't any own dose

recommendations but all the time you have to count on Botox and then convert.9

- more information on Dysport which shows that the substance has better effect, the price matters and the support from the company42

- if the effect of Botox fails, I try Dysport 72- if one gets markedly bad effect as a result 81

- get more information, and be able to see that it's a safe preparation 56

- none, there is no difference, Allergan carry through a purchasing in our area, that's why they own the market. 69


49


Estimated Dosage Proportions Between Dysport and Botox(comparison of one Botox unit to Dysport units)

6

28

22

6 6 6 6

28

22

11

22

11 11 11 11

22

0

5

10

15

20

25

30

35

40

45

50

1:2 1:2,5 1:3 1:3,5 1:4 less Botoxthan Dysport

other don't know



% Drs


50


Estimated dosage proportions between Dysport and Botox, adult spasticity (n=18)BR

- We mix more than what is recommended, 1 unit Botox equals to 1,8 to 1,9 Dysport, we dilute to 100 units/ml 52

- it depends on the muscle, 1 unit Botox can be 2 or 4 units Dysport 81

- 1 Botox unit equals to 2,5 Dysportenheter 45- Botox 100 units equals to Dysport 250 enheter 4- 1 Botox unit equlals to 2-3 Dysportenheter 42- 1 Botox on 2,5 Dysport 4

- 1 unit Botox is 3 units Dysport 73- 3 Dysport units equals to 1 Botox 72- 1 unit Botox equals to 3 units Dysport 69- 1 Botox unit equals to 3 Dysport 26

- 1 Botox equals to 3-4 Dysport units 45

- less dose of Dysport as compared to Botox 27

- it hasn't been established yet, there are more than ten studies which show different results, everything from 1 Botox equalling to 1 Dyspor, to 1 Botox equalling to 10 Dysport, most of them are about 1 Botox equalling to appr. 3-4 Dysport units.

9

- don't know, there should be some coversion table 92- don't know, it's difficult to get to know it 60- don't know 59- don't know 81- don't know 11


51


Estimated dosage proportions between Dysport and Botox, juvenile cerebral palsy (n=9)BR

- unclear dose ratio, Allergan claims that 1 equals 3-4 but Ipsen claims 1 equals to 2 9- it depends on the muscle, 1 unit Botox can be 2-4 units Dysport 81

- 1 Botox unit equals to 2,5 Dysport units 45

- 1 Botox unit equals to 3 Dysport units 72- 1 unit Botox equals to 3 units Dysport 69

- 1 Botox unit equals to a greater amount of Dysport units 42

- Botox is enough amount of preparation, the dose is too big in the Dysport vials 56



52


Dysport - Importance of "Lower Price than Botox"

1722

22 11

2222

6

44

6

28

0

10

20

30

40

50

60

70

80

90

100


don't know

5= very important

4

3

2

1=not importantat all

% Drs

adult spasticity

(n=18)




53


Reason for importance of "Lower price than Botox", adult spasticity (n=18)

BR5 - Botox is expensive 595 - it's important to cut prices, it can differ 350.000 Crowns/year for the department if we use Dysport as

compared to Botox52

5 - it's become important, the budget governs, we have to cut our costs to half at the tonus department 45 - price is important 45 - the economy is important to the county council 114 - clearly important to keep the costs down 733 - head of department is responsible for purchasing, Dysport was tested here for a couple of years ago but we

then returned back to Botox92

3 - its' still expensive and it must be seen in relation to my Botox experience which I'm used to use 723 - of course it's very important, a difference of 23% but in real life if's not like that 813 - price has some importance 422 - my experience of Botox, nobody has complained 272 - money is secondary 452 - I feel safe of secure with Botox, it needs a lot to change a preparation, uncertainty with their dosages 602 - if you have a well-known preparation it needs a lot to change it, the preparation itself, doses etc. with Botox

are well-known, it's not only the price per vial that's important, to store 2 preparations would mean increased costs

26

1 - it depends on how you dilute, it's approximately the same price 691 - if you count the right ratios there's no price difference 451 - it's shown that it's cheaper, it's beyound my comprehension 81

don't know - it's all about equipotent doses 9


54


Reason for importance of "Lower price than Botox", juvenile cerebral palsy (n=9)

BR5 - the county council's economy is bad 725 - Botox is horribly expensive 565 - the price matters even if I don't have a managerial position but it's important how you count the dose. 95 - it depends on how low the price is per treatment, if the price is for example 50% lower it does matter 423 - bioavailability, how to handle the preparation 813 - of course it's very important, a difference of 23% but in real life if's not like that 812 - money is secondary 451 - it depends on how much lower, it's important if the price difference is 20-25% less, I don't remember the

ratio, for large consumers it's different20

1 - it depends on how you dilute, it's approximately the same price 69


55


Occurrance of "Off-label" Prescriptions

5644

4456

0

10

20

30

40

50

60

70

80

90

100


don't prescribe"off-label"

prescribe "off-label"

% Drs


56

Source: Q17b Base: Drs who prescribe “off-label”

Suitable patients for "off-label" prescription of botulinum toxins:

adult spasticity (n=10) BR- chronic pain 72- oromandibular dystonia, moving toes, focal dystonia, spasticity in legs 9- RA, muscle inflammation 45- spasticity in other parts of the body, for example the adductors and big toe muscles, dribbling problems 45- spasticity in the arm, there's no indication 81- neck tension 52- neck tension 69- stroke patients, not as an indication 4- hidrosis, pain, different types of gland problems, for example tear gland 81- traumatic brain damage, legs and feet on stroke patients 42juvenile cerebral palsy (n=4)- habitual toe walking, at juvenile cerebral palsy you inject in more muscle groups than those which are included as an indication in MIMS 9- RA, muscle inflammation 45- neck tension 69- hidrosis, pain, different types of gland problems, for example tear gland 81


57

Source: Q18a+c Base: All Drs

Barriers for Prescription of DysportNon-prescribers

4560

5540

0

10

20

30

40

50

60

70

80

90

100

adult spasticity (n=11) juvenile cerebral palsy(n=5)

yes

no

% DrsBarriers for Increased Prescription of Dysport

2233

17

11

6156

0

10

20

30

40

50

60

70

80

90

100


no yes don't prescribe Dysport

% Drs

Specification of barriers:adult spasticity (n=3)- the reason is that we ca not receive how many patients we'll like

to, there is no time - problems with insufficient efficacy- I don't feel comfortable with it, Dysport is not easy to handle, I

often inject in big musclesjuvenile cerebral palsy (n=1)- lack of information, I don't feel safe with the pharmaceutical

Specification of barriers - Non-prescribers:adult spasticity (n=6)- we have an organisation for preparation and handling of

Botox in all levels dr-nurse-physiotherapist, everything has to work and it takes a lot to switch, it's not right to have two products at the clinic, it's too complicated

- development of antibodies- I'm satisfied with Botox, it's effective, it's easy to mix- it is purchased, the clinic has decided for Botox,

they would not changed their mind- we don't get any equipment from Dysport- when you're new you want a product to prescribejuvenile cerebral palsy (n=2)- contraindications, treatment is not effective- I'm satisfied with Botox, it's effective, it's easy to mix


58


Factors that would increase the prescription of Dysport

adult spasticity (n=7) BR- that there's another size of the packages, 250 and 500 81- increased antibody development of Botox 27- time to treat more patientes 52- it's too expensive with both Botox and Dysport 69- the economic realities govern, demand from the boss 4- that the clinic decides on it 4- dont't know 72juvenile cerebral palsy (n=4)- more information, that it's a safe preparation 56- that they have an easy dosage schedule in order it's easy to use, you shouldn't need to count out of Botox 9- nothing,our head of clinic thinks it'stoo expensive with both Botox and Dysport 69- should be in 250 and 500 81


59


Requirements to start prescription of Dysport

adult spasticity (n=11) BR- that hte clinic changes its policy 92- to get information about it, if it's equal and cheaper, there's no obstacle 59- convincing economic reasons, as safe even if cheaper and not increased risk for antibody development 73- comparing studies with Botox 45- more documentation 9- very big price difference, completely new facts 45- education in order to be safe with the preparation 60- convincing documentation as to their dosage ratios to Botox, that the mixture ratios are constant in all muscles 26- the equipment is needed 42- better information, clear doses, independent judges who say it's better 81- more information 11juvenile cerebral palsy (n=5)- the product should be better documented 72- you have to show that the effect is better, easier to use 81- you have to show that Dysport is much better, economic advantages 20- more information about Dysport which shows that the substance has better effect, the price matters and support from the company 42- controlled studies compared to Botox 45


60

Time Since Last Rep Call About Botulinum Toxins Treatment in Adult Spasticity and Juvenile Cerebral Pulsy

17

33

6

28

6

11

33

22 22

11 11

0

5

10

15

20

25

30

35

40

45

50

less than a month 1 to 2 monthsago

3 to 5 monthsago

6 months to ayear

2 years ago don't know



% Drs


Company

adult spasticity

(n=18)


(n=9)mean (weeks) 23,1 9,3median 7,5 6,0min 0,1 2,0max 102,0 24,0


61


Last Rep Call - Product Information

56

33

11

44

56

11

0

10

20

30

40

50

60

70

Botox Dysport don't know



% Drs


62

Source: Q19c Base: All Drs

Evaluation of Allergan (Botox) and the company's contact with doctors, adult spasticity (n=18)

BR- received good education 52- serious company that makes an effort on education and safety 60- good education and follow-up 11- good education, equipment, education of physiotherapists and other personnel 42- organisation, built up during a long time and well-functioning with good resources, good education, good educational material 9- good education, good material with handbooks about their doses, anatomic illustrations 4- good education, we always get good support by them when we have inquiries 59- solid documentation, good education, good support with EMG-equipment for example, the stock-keeping of the preparations work well 26- they've been very good during many years in developing the treatment, they have very good education and workshops, gives EM-

equipment to our disposal, trustworthy deliveries.45

- professional, serious, clear with the reports, supports further development and education on long term 81

- they give EMG-equipment to our disposal and neurostimulator 92- are eager, have fine scientific documentation and give support to network activities 73- easy to get access to them, nice, well-informed, service-oriented, material, give EMG-equipment to our disposal 4- good literature, good service and convincing information, good education, very well-informed staff 69

- serious attitude, discuss indication and results 45- inform well and give us material about how it should be given in different situations 72

- that they actually do scientific studies 81

- I don't have almost any contact with them but some advertising material now and then 27


63


Evaluation of Allergan (Botox) and the company's contact with doctors, juvenile cerebral palsy (n=9)

BR- serious attitude, discuss indications and results 45- knowledge, good material 81- support from the company, studies, information, courses, material, equipment, nerve stimulator 42- good literature, good service and convincing information, good education, very well-informed staff 69

- high grade of accessibility, help with education 56- have often helped with education of nurses and physiotherapists 72

- are never obstinate, at contact and education they are easy to come in contact with, good client contact 20

- that they actually do scientific studies 81

- don't know 9


64


Evaluation of Ipsen (Dysport) and the company's contact with doctors, adult spasticity (n=18)

BR- no contact with them 92- no contact with them 27- have not had any contact with them 59- don't know, have not been here for many years 72- have not seen the representative for a long time, they are very interested in getting to the Swedish market 9- no contact with them 4- don't know, a long time since I met them 60- don't know, haven't had any contact with them for a long time 26

- they have been quiet during the past years but are now more active and present, positive contact with open discussions at the last visit 45- have shown interest lately, have not had any contact before 42- have not had a representative in Sweden before, the first contact one day ago 81- just received good information from them, good new market activities 11

- 2 or 3 years since I had contact with them, then they were humble and serious 69- serious attitude, discuss indication and results 45- compliance and support you get, strive after to really come back with good answers, take you seriously 81

- good preparations, good if they can cut the prices on the market 4

- they have suggested meetings with discussions about treatments 52

- nothing 73


65


Evaluation of Ipsen (Dysport) and the company's contact with doctors, juvenile cerebral palsy (n=9)

BR- good objective information 56- 2 or 3 years since I had contact with them, then they were humble and serious 69- serious attitude, discuss indications and results 45- compliance and support you get, strive after to really come back with good answers, take you seriously 81

- have not had any contact 72- have only met them once 42

- knowledge and experience from the company not as good as Allergan has 81

- nice, otherwise nothing special 20

- don't know 9


66


Evaluation of Elan Pharma (Neurobloc) and the company's contact with doctors, adult spasticity (n=18)

BR- no contact with them 92- no contact with them 27- have not had any contact with them 59- have not had any contact with them 72- have no contact with them 45- no contact 4- no contact with them 45- don't know, have only met them once 60- no contact with them 26- have not had any contact with them 42- no contact with them 81- no contact with them 4- never had any contact with them 11

- don't know, we import Neurobloc from Germany from another company, we use it at spasticity 9- don't know 52- don't know 73- don't know 69- don't know 81


67


Evaluation of Elan Pharma (Neurobloc) and the company's contact with doctors, juvenile cerebral palsy (n=9)

BR- have not had any contact 72- have not had any contact 81- no contact 20- have not had any contact 42- have no contact 45

- don't know 56- don't know 9- don't know 69- don't know 81


68


Improvement of Allergan (Botox) and the company's contact with doctors, adult spasticity (n=18)

BR- nothing 72- nothing 26- nothing 45- nothing, it works well 81

- price 4- price 4- reduce the price 11

- repeat the education 27- education to hospital staff 81

- random contact lately, good with follow-up visits 60

- to be more service-minded 92

- that they delete their American marketing methods, more humble 69

- don't know 59- don't know 52- don't know 73- don't know 9- don't know 45- don't know 42


69


Improvement of Allergan (Botox) and the company's contact with doctors, juvenile cerebral palsy (n=9)

BR- nothing 72- nothing 56- nothing 45

- nothing, but reduce the price 20- reduce the price 42

- education to hospital staff 81- that they delete their American marketing methods, more humble 69



70


Improvement of Ipsen (Dysport) and the company's contact with doctors, adult spasticity (n=18)

BR- better education 27- more education 52- better education and not only the price issue 60- they don't have the same back up with education, EMG-equipment, documentation etc. 26- they are behind with their education, develop the packages so they are easier to use 4- education material and patient broschures aren't as good as Allergan's 9

- contact us 72- no contact 4- don't know, look forward to better contact 81- that they contact us, and don't leave the market to Allergan altogether, they haven't visited us for 2-3 years,

and I work at several hospitals, it doesn't really work as it should, don't know if they exist69

- come up with documentation, let us know why we should prescribe their preparation 73- more information 11

- nothing 45

- take better care of their representatives so that they stay 81

- don't know 92- don't know 59- don't know 45- don't know 42


71


Improvement of Ipsen (Dysport) and the company's contact with doctors, juvenile cerebral palsy (n=9)

BR- right now nothing, more continuous visits, further information to increase the safety as to Dysport 56- that they contact us, and do not leave the market to Allergan altogether, they haven't visited us for 2-3 years,

and I work at several hospitals, it doesn't really work as it should, don't know if they exist69

- comparing studies, more information 42

- do your own dose recommendations in Dysport units and not via Botox 9

- they have a lot to do, they lie light-years after, they have to present a program around their product 20

- they have a poor representative 72

- take better care of their representatives so that they stay 81

- nothing 45

- don't know 81


72


Improvement of Elan Pharma (Neurobloc) and the company's contact with doctors, adult spasticity (n=18)

BR- they have been very invisible and should be more active 60- they should show themselves more 42

- no contact 4

- better education 27

- too little studies, too little objectivity, too much opinions 81

- don't know 92- don't know 59- don't know 52- don't know 73- don't know 72- don't know 69- don't know 45- don't know 9- don't know 45- don't know 26- don't know 81- don't know 4- don't know 11


73


Improvement of Elan Pharma (Neurobloc) and the company's contact with doctors, juvenile cerebral palsy (n=9)

BR- too little studies, too little objectivity, too much opinions 81

- no contact 20- have not had any contact 72- have not had any contact 81- have not had any contact 42

- dont' know 56- dont' know 9- dont' know 69- dont' know 45


74

Patient flows and frequencies

1 Specialist involved in the care of patients with adult spasticity (AS) are, median figure, responsible for 40 patients and specialist in care of pats with juvenile cerebral palsy (JCP) are in care of 60 patients. Total amount of pats on Btx are for AS-drs 50 and 150 for JCP-drs. Drs in care of AS have 8 new patients per month and drs in care of pats with JCP have 2 new pats. Drs in care of JCP pats named possible Btx treatment for 90% of their patients and AS drs named possible treatment for 30% of their patients (median figures). (p 5-9)

Choice of treatment – Initiation

2 Share of patients initiated with Btx is 50% for both specialist groups (median figure). (p 10)

3 A great majority, approx 90% of AS- and JCP- drs mention that in initiation treatment they use physiotherapy. 67% of AS-drs named that they use baclofen and specialists in care of JCP-pats use baclofen to 44% of their patients. (n=11)

4 When asked for allocation of treatment approx 100 % of both patient groups are treated with physiotherapy. (p 12)

5 Drs initiate with Btx mainly to increase patients’ function and when insufficient efficacy of physiotherapy/baclofen. 22% of JCP drs use Btx as soon as possible. (p 14)

Summary


75

Choice of treatment – Initiation

6 Four out of nine drs in care of JCP patients mentioned insufficient efficacy as the main reason for patients not receiving treatment with Btx. Drs in care of AS-patients named limited personnel resources and price. Note that 5 AS-drs and 3 JCP-drs named that all pats receive treatment with Btx. (p17)

7 98 % of new AS patients and 96% of JCP patients receive Botox. Only 2% of new AS-patients and 4% JCP patients receive Dysport. (p 20)

8 Main reason for choosing Botox more often than Dysport is experience/tradition/habit, mentioned by 67% of AS-drs and 78% of JCP drs.

Adult spasticity secondary to stroke

9 In median figure, patients with adult spasticity receive treatment with Btx after one year. The median age of that patient is 59 years. (p 25-26)

Present treatment with Botulinum toxins

10 A great majority of patients with AS and JCP are treated with Botox 96% vs 93%. 4% of AS-pats and 7% of JCP are treated with Dysport. Xiomin is also named. (p 27)

Summary


76

Switch treatment

11 Half of the drs in care of AS patients mentioned that they have switched treatment from one Btx to another Btx. 1/3 of drs in care of AS patients have switch treatment, (p 28). In average 5 AS patients are switched from one Btx to another while drs in care of JCP pats mentioned 13 pats. Dysport is mainly switched in. (p 29)

12 When drs have switched from Btx, in this case Botox, to other treatment it has mainly been due to insufficient efficacy. Mainly switched in treatments are baclofen, surgery and physyotherapy. (p 31-32)

13. People who influence the choice of Btx are primarily drs but also physiotherapists in a lower extent. (p 33)

Opinion of Botulinum toxins

14. A majority of the drs do not have any opinion or seem that the products are equal. 17% of AS drs and 22% of JCP drs perceive Botox as more effective. 1 AS dr perceive Dysport as more effective. (p 34)

15. The main perceived advantages of Botox are experience, administration and the company’s education/service. The main advantage of Dysport is price. Note that half of the drs mentioned that they do not know Dysport’s advantage. (p 35-38)

Summary


77

Switch treatment

16. Price is named as the main disadvantage with Botox compared to Dysport, mentioned by 50% of AS drs and 44% of drs in care of JCP patients. Half of the AS drs named administration as Dysport’s main disadvantage followed by lack of experience and diffusion. 44% of the drs in care of JCP patients mentioned lack of exp and 33% administration. (p 39-42)

17. AS drs: Patients mainly treated with Botox are those with spasticity (sec to stroke), dystonia and MS patients. JCP drs mentioned patients with JCP, children with spasticity and pats with moving toes. (p 43-45)

Dysport

18. Both groups of drs mentioned price and insufficient efficacy as possible reasons to switch from Botox to Dysport. Information is also named by JCP drs. (p 46-48)

19. Considerable differences in drs’ answers about dosage proportion. (p 49)

20 Median figure 3 for importance evaluation about Dysport’s lower price, 28 % of AS drs vs 44% of JCP say that it is very important (p 52)

21 Doctors do not see ay reason for prescribe or increase prescription of Dysport. (p 57) Information and education are the factors demanded to influence prescription of Dysport. (p 58)

Summary


78

Retain Low Price

Aim to Leverage of Dysport efficacy (product

group /Dysport is the best) Leverage of Education, support and service Leverage of pedagogical dosage schedule Increase awareness of low risk for

diffussion and antibody formation Increase knowledge about Dysport – reps Increase of emotional dimensions Work with physiotherapists and clinical

chiefs/buyers. Payers?

Key Findings

Positioning

?

Messages Dysport effective Btx

mild side effects

easy administration?


79

1 dysport - mb - november 2007. dysport mb - in adult spasticity, secondary to stroke and juvenile...

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