Biological drugs for the treatment of psoriasis in a public health system

Lopes, Luciane Cruz; Silveira, Miriam Sanches do Nascimento; Camargo, Iara Alves de; Barberato-Filho, Silvio; Del Fiol, Fernando de Sá; Osorio-de-Castro, Claudia Garcia Serpa

doi:10.1590/S0034-8910.2014048005109

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Brasil

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Sumário

Public Health Practice • Rev. Saúde Pública 48 (4) • Aug 2014 • https://doi.org/10.1590/S0034-8910.2014048005109 copy

Biological drugs for the treatment of psoriasis in a public health system

Authorship SCIMAGO INSTITUTIONS RANKINGS

OBJECTIVE

To analyze the access and utilization profile of biological medications for psoriasis provided by the judicial system in Brazil.

METHODS

This is a cross-sectional study. We interviewed a total of 203 patients with psoriasis who were on biological medications obtained by the judicial system of the State of Sao Paulo, from 2004 to 2010. Sociodemographics, medical, and political-administrative characteristics were complemented with data obtained from dispensation orders that included biological medications to treat psoriasis and the legal actions involved. The data was analyzed using an electronic data base and shown as simple variable frequencies. The prescriptions contained in the lawsuits were analyzed according to legal provisions.

RESULTS

A total of 190 lawsuits requesting several biological drugs (adalimumab, efalizumab, etanercept, and infliximab) were analyzed. Patients obtained these medications as a result of injunctions (59.5%) or without having ever demanded biological medication from any health institution (86.2%), i.e., public or private health services. They used the prerogative of free legal aid (72.6%), even though they were represented by private lawyers (91.1%) and treated in private facilities (69.5%). Most of the patients used a biological medication for more than 13 months (66.0%), and some patients were undergoing treatment with this medication when interviewed (44.9%). Approximately one third of the patients discontinued treatment due to worsening of their illness (26.6%), adverse drug reactions (20.5%), lack of efficacy, or because the doctor discontinued this medication (13.8%). None of the analyzed medical prescriptions matched the legal prescribing requirements. Clinical monitoring results showed that 70.3% of the patients had not undergone laboratory examinations (blood work, liver and kidney function tests) for treatment control purposes.

CONCLUSIONS

The plaintiffs resorted to legal action to get access to biological medications because they were either unaware or had difficulty in accessing them through institutional public health system procedures. Access by means of legal action facilitated long-term use of this type of medication through irregular prescriptions and led to a high rate of adverse drug reactions as well as inappropriate clinical monitoring.

Psoriasis; Antibodies; Monoclonal; therapeutic use; Pharmaceutical Services; legislation; jurisprudence; Judicial Decisions; Equity in Access.

Variable	Adalimumab		Efalizumab		Etanercept		Infliximab		Total
Variable	%	n	%	n	%	n	%	n	%	n
	6.8	14	21.2	43	17.3	35	54.7	111	100.0	203
Gender
Male	64.3	9	60.5	26	60.0	21	65.8	73	63.6	129
Female	35.7	5	38.6	17	40.0	14	34.2	38	36.4	74
City
Sao Paulo	85.7	12	46.5	20	71.4	25	58.6	65	60.1	122
Other locations	14.3	2	53.5	23	26.6	10	41.4	46	39.9	81
Age (years)
19 to 59	57.1	8	81.4	35	74.3	26	78.4	87	76.8	156
≥ 60	42.9	6	18.6	8	25.7	9	21.6	24	23.2	47
Type of medical assistance
Non-SUS	92.9	13	62.8	27	65.7	23	70.3	78	69.5	141
SUS	7.1	1	37.2	16	34.3	12	29.7	33	30.5	62
Registered at CEAF
Information provided by the patient (Yes)	42.9	6	65.1	28	40.0	14	51.4	57	51.7	105
Information confirmed in the system (Yes)	71.4	10	0.0	0	34.3	12	4.5	5	13.3	27
Patient was being treated by a biological medicine^a a Scottish Intercollegiate Guidelines Network. Diagnosis and management of psoriasis and psoriatic arthritis in adults: a national clinical guideline. Edinburgh: SIGN; 2010 [cited 2014 Mar 31]. Available from: http://www.sign.ac.uk/pdf/sign121.pdf	50.0	7	0.0	0	25.7	9	0.9	1	8.4	17
Guidance to obtain a biological medicine via lawsuit
Doctor	71.4	10	79.1	34	80.0	28	72.1	80	74.9	152
NGO, Family, and others	14.3	2	11.6	5	34.3	12	37.0	41	6.9	60
Lawyer	0.0	0	4.7	2	0.0	0	2.7	3	2.5	5
Pharmaceutical Laboratory	7.1	1	4.7	2	0.0	0	1.8	2	2.5	5
NI	7.1	1	0.0	0	0.0	0	0.9	1	1.0	2
Use of biological medicine before lawsuit
Yes	92.9	13	93.0	40	65.7	23	95.5	106	89.7	182
NI	0.0	0	0.0	0	0.0	0	3.6	4	2.0	4
Form of acquisition of medicine beforelawsuit
Pharmaceutical laboratory	7.1	1	6.8	3	14.3	5	0.0	0	4.4	9
Other (city hall, State, NGO)	0.0	0	0.0	0	8.6	3	0.9	1	2.0	4
Supplied by doctor	0.0	0	0.0	0	5.7	2	0.0	0	1.0	2
Own resources	0.0	0	0.0	0	2.9	1	0.0	0	0.5	1
NI	0.0	0	0.0	0	2.9	1	0.0	0	0.5	1
Request of medication for an institution^b before filing the lawsuit
No	92.9	13	95.3	41	77.1	27	84.7	94	86.2	175
NI	0.0	0	0.0	0	0.0	2	1.8	2	2.0	4
Institution activated for provision of medicine before lawsuit
Private^c	0.0	0	0.0	0	5.7	2	9.0	10	5.9	12
Public	7.1	1	2.3	1	17.1	6	2.7	3	5.4	11
NGO	0.0	0	2.3	1	0.0	0	0.0	0	1.5	1
Request fulfilled
Yes	7.1	1	0.0	0	2.9	1	1.8	2	1.5	3
Supply of biological medication by another institution (time in months)
< 6	0.0	0	0.0	0	0.0	0	1.8	2	0.5	2
> 6	7.1	1	0.0	0	2.9	1	0.0	0	0.5	1
Participation in a support group for patients
Yes	14.3	2	11.6	5	17.1	6	9.0	10	11.3	23
Number of meetings with the lawyer
None	64.3	9	58.1	25	62.9	22	62.2	69	61.6	125
One or more	35.7	5	34.9	15	34.3	12	37.9	42	36.5	74
NI	0.0	0	7.0	3	2.9	1	0.9	0	2.5	4
Contacted by the pharmaceutical laboratory
Yes	64.3	9	62.8	27	62.9	22	37.9	42	49.3	100

Variable	Adalimumab		Efalizumab		Etanercept		Infliximab		Total
Variable	%	n	%	n	%	n	%	n	%	n
	6.8	14	21.2	43	17.3	35	54.7	111	100.0	203
Diagnosis time
≥ 6 years	85.7	12	90.7	39	85.7	30	86.5	96	87.2	177
2 to 5 years	14.3	2	9.3	4	14.3	5	12.6	14	12.3	25
Up till 6 months	0.0	0	0.0	0	0.0	0	0.9	1	0.5	1
Concurrent disease
Yes	50.0	7	51.1	22	37.1	13	29.8	33	37.0	75
Treatment time with biological medicine (months)
Up to 12	35.7	5	51.2	22	22.9	8	30.6	34	34.0	69
13 to 48	35.7	5	48.9	21	74.3	26	66.7	74	62.0	126
49 to 72	28.6	4	0.0	0	2.9	1	2.7	3	4.0	8
Average (SD)	31.4 (22.2)		16.8 (10.2)		26.4 (14.4)		25.2 (14.6)		24.0 (14.9)
Patient was using obtained biological medicine
Yes	64.3	9	0.0	0	62.9	22	54.0	60	44.9	91
Clinical monitoring^a
Medical visit	100.0	9	0.0	0	100.0	22	100.0	60	100.0	91
Laboratory exams	55.5	5	0.0	0	68.2	15	73.3	44	70.3	64
Reasons to discontinue the use of biological medicine
Stopped using^b	0.0	0	100	43	5.7	2	8.1	9	26.6	54
Suspension by the doctor	14.3	2	0.0	0	22.9	8	16.2	18	13.8	28
Suspicion of ADR	21.4	3	0.0	0	5.7	2	16.2	18	11.3	23
Suspended by a court decision	0.0	0	0.0	0	2.9	1	6.4	6	34.5	7
Perception of the efficacy of the biological medicine
Yes	71.4	10	76.2	32	91.4	32	82.0	91	81.3	165
No	28.6	4	21.0	9	8.6	3	17.1	19	17.2	35
NI	0.0	0	4.7	2	0.0	0	0.9	1	2.7	3
Perception of the evolution of the disease with the use of biological medicines
Improved/Cured	57.1	8	60.5	26	71.4	25	67.6	75	66.0	134
Stationary	28.6	4	23.3	10	20.0	7	21.7	24	22.2	45
Worsened	14.3	2	11.7	5	2.9	1	10.9	12	9.9	20
NI	0.0	0	4.7	2	5.7	2	0.0	0	2.0	4

Variable	Adalimumab		Efalizumab		Etanercept		Infliximab		Total
Variable	%	n	%	n	%	n	%	n	%	n
	4.7	9	21.6	41	16.3	31	57.4	109	100.0	190
Number of authors per injunction
1	11.1	1	95.1	39	93.5	29	100.0	109	93.7	178
2 to 6	88.9	8	4.9	2	6.5	2	0.0	0	6.3	12
Type of injunction
CI	88.9	8	48.8	20	58.1	18	61.5	67	59.5	113
RO	11.1	1	51.2	21	41.9	13	37.5	41	40.0	76
Public Defender	0.0	0	0.0	0	0.0	0	0.9	1	0.5	1
Civil Society Representation
No	100.0	9	51.2	21	96.8	30	92.7	101	84.7	161
Yes	0.0	0	48.8	20	3.2	1	7.3	8	15.3	29
Defendant
State	88.9	8	100.0	41	100.0	31	100.0	109	99.5	189
Union	11.1	1	0.0	0	0.0	0	0.0	0	0.5	1
Judicial Representation
Private	100.0	9	48.8	20	96.8	30	92.7	101	84.2	160
APVPESP	0.0	0	48.8	20	3.4	1	2.8	3	12.6	24
MP	0.0	0	2.4	1	0.0	0	1.8	2	1.6	3
PD	0.0	0	0.0	0	0.0	0	2.8	3	1.6	3
Free Legal Aid
Yes	56.6	5	75.6	31	64.5	20	75.2	82	72.6	138
No	11.1	1	12.2	5	9.7	3	16.5	18	14.2	27
NI	33.3	3	12.2	5	25.8	8	8.3	9	13.2	25
Primary injunction
Yes	88.9	8	53.7	22	61.3	19	56.0	61	57.9	110
No	11.1	1	31.7	13	25.8	8	24.4	32	28.4	54
NI	0.0	0	14.6	6	12.9	4	14.7	16	13.7	26
District injunction /Civil injunction of Sao Paulo/Osasco
1 to 5	55.6	5	43.9	18	35.5	11	30.3	33	35.3	67
6 to 10	44.4	4	29.3	12	41.9	13	46.8	51	42.1	80
11 to 14	0.0	0	26.8	11	22.6	7	21.1	23	21.6	41
Osasco (1 to 2)	0.0	0	0.0	0	0.0	0	1.8	2	1.1	2
Legal representation of author(s) – OAB
A	88.9	8	48.8	20	0.0	0	55.0	60	46.3	88
B	11.1	1	4.9	2	35.5	11	25.7	28	22.1	42
C	0.0	0	39.0	16	22.6	7	4.6	5	14.7	28
D	0.0	0	2.4	1	41.9	13	11.9	13	14.2	27
PD	0.0	0	2.4	1	0.0	0	2.8	3	2.1	4
NI	0.0	0	2.4	1	0.0	0	0.0	0	0.5	1

Variable	Adalimumab		Efalizumab		Etanercept		Infliximab		Total
Variable	%	n	%	n	%	n	%	n	%	n
	4.8	9	21.7	41	15.9	30	57.7	109	100.0	189
Legible name of author (patient)
No	0.0	0	2.4	1	6.7	2	6.4	7	5.3	10
Author’s address (patient)
No	100.0	9	100.0	41	100.0	30	100.0	109	100.0	189
Generic name
No	77.8	7	39.0	16	66.7	20	64.2	70	59.8	113
Trade name
No	22.2	2	0.0	0	23.3	7	21.1	23	16.9	32
Pharmaceutical form
No	88.9	8	100.0	41	86.7	26	95.4	104	94.7	179
Concentration
No	44.4	4	58.5	24	13.3	4	19.3	21	28.0	53
Administration route
No	11.1	1	12.2	5	13.3	4	20.2	22	16.9	32
Dosage
No	11.1	1	53.7	22	66.7	20	56.0	61	55.0	104
Duration of treatment
No	77.8	7	85.4	35	90.0	27	89.9	98	88.4	167
Interval between doses
No	11.1	1	7.3	3	16.7	5	13.8	15	12.7	24
Total quantity
No	77.8	7	85.4	35	90.0	27	89.9	98	88.4	167
Name of the Doctor
No	0.0	0	2.4	1	3.3	1	3.7	4	3.2	6
CRM
No	0.0	0	0.0	0	0.0	0	0.9	1	0.5	1
Illegible	0.0	0	7.3	3	16.7	5	11.9	13	11.1	21
Address of prescribing practitioner’s medical institution
No	0.0	0	4.9	2	3.3	1	10.1	11	7.4	14
Date
No	0.0	0	4.9	2	0.0	0	11.0	12	7.4	14
Illegible	0.0	0	0.0	0	0.0	0	0.9	1	0.5	1

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[1] Correspondence: Luciane Cruz Lopes. Rua Gomes Carneiro, 570 apto 141. 13400-530 Piracicaba, SP, Brasil. E-Mail:luciane.lopes@prof.uniso.br