Incorporation of new medicines by the National Commission for Incorporation of Technologies, 2012 to June 2016

Caetano, Rosângela; Silva, Rondineli Mendes da; Pedro, Érica Militão; Oliveira, Ione Ayala Gualandi de; Biz, Aline Navega; Santana, Pamela

doi:10.1590/1413-81232017228.02002017

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ARTICLE • Ciênc. saúde colet. 22 (8) • Aug 2017 • https://doi.org/10.1590/1413-81232017228.02002017 copy

Incorporation of new medicines by the National Commission for Incorporation of Technologies, 2012 to June 2016

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

The National Commission for incorporation of Health Technologies (CONITEC), established in 2011, advises the Ministry of Health in decisions related to the incorporation, exclusion or change of medicines, products and procedures in the Unified Health System (SUS).The study investigated the decision-making process, profile of demands and incorporation of new medicines in the SUS from January/2012 to June/2016, based on data available on the CONITEC website. All submissions were evaluated and characterized by technology and applicant type. The incorporations were analyzed according to the Anatomical-Therapeutic-Chemical classification, International Classification of Disease of the clinical indication and active record in the National Health Surveillance Agency. In the period, 485 submissions were received, 92.2% concerning requests for incorporation and 62.1% for medicines, of which 93 (30.1%) received a favorable recommendation for incorporation. Domestic demands were more successful than externally originated ones. Six unregistered drugs were incorporated. Infectious and parasitic diseases and musculoskeletal diseases constituted the main clinical indications. The recommendation of incorporation occurred mainly based on the additional clinical benefits and low budget impact.

Medicines, Health technology assessment; Decision making, Unified Health System

Nature of request	Technology Type								Total

	Medicine		Medical Device		Medical Procedure		STG

	N	%	N	%	N	%	N	%	N	%
Incorporation to SUS	267	59.7	64	14.3	105	23.5	11	2.5	447	92.2
Exclusion of SUS	31	91.2	0	0.0	3	8.8	0	0.0	34	7.0
Change of use **	3	75.0	0	0.0	1	25.0	0	0.0	4	0.8
Total	301	62.1	64	13.2	109	22.5	11	2.3	485	100.0

Status of Decision	Medicine						Different from medicine**						Total requests

	Type of demand				Total		Type of demand				Total Internal		Type of demand				Total

	Internal		External			Internal		External					External

	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%	N	%
Ongoing process	3	1.9	11	7.6	14	4.7	3	2.4	0	0.0	3	1.6	6	2.2	11	5.1	17	3.5
Pending final assessment	0	0.0	1	0.7	1	0.3	2	1.6	0	0.0	2	1.1	2	0.7	1	0.5	3	0.6
In analysis	1	0.6	10	6.9	11	3.7	1	0.8	0	0.0	1	0.5	2	0.7	10	4.7	12	2.5
Under review after public consultation	2	1.3	0	0.0	2	0.7	0	0.0	0	0.0	0	0.0	2	0.7	0	0.0	2	0.4
Case closed	154	98.1	133	92.4	287	95.3	122	97.6	59	100.0	181	98.4	264	97.8	204	94.9	468	96.5
Process terminated early	32	20.4	54	37.5	86	28.6	20	16.0	42	71.2	62	33.7	45	16.7	103	47.9	148	30.5
Closed for non-conformity	0	0.0	46	31.9	46	15.3	2	1.6	35	59.3	37	20.1	1	0.4	82	38.1	83	17.1
Closed at request of the applicant	24	15.3	7	4.9	31	10.3	18	14.4	1	1.7	19	10.3	42	15.6	8	3.7	50	10.3
Terminated by Conitec’s decision	8	5.1	1	0.7	9	3.0	0	0.0	6	10.2	6	3.3	2	0.7	13	6.0	15	3.1
Plenary decision terminated	122	77.7	79	54.9	201	66.8	102	81.6	17	28.8	119	64.7	219	81.1	101	47.0	320	66.0
Incorporation	77	49.0	16	11.1	93	30.9	93	74.4	2	3.4	95	51.6	167	61.9	21	9.8	188	38.8
No Incorporation	15	9.6	63	43.8	78	25.9	6	4.8	14	23.7	20	10.9	19	7.0	79	36.7	98	20.2
Exclusion	30	19.1	0	0.0	30	10.0	3	2.4	0	0.0	3	1.6	33	12.2	0	0.0	33	6.8
Demand already incorporated	0	0.0	0	0.0	0	0.0	0	0.0	1	1.7	1	0.5	0	0.0	1	0.5	1	0.2
Total	157	52.2	144	47.8	301	100.0	125	66.3	59	33.7	184	100.0	270	55.7	215	44.3	485	100.0

Selected characteristics of the evaluation process of medicines	Final Recommendation				Total
	Incorporation		Different from Incorporation		Total
	N	%	N	%	N	%
Internal request ** ¹
Yes	77	82.8	45	41.7	122	60.7
No	16	17.2	63	58.3	79	39.3
Public consultation ²
Yes	60	64.5	79	73.1	139	69.2
No (simplified process)	33	35.5	29	26.9	62	31.8
Licenced by Anvisa ³
Yes	87	93.6	108	100.0	195	97.0
No	6	6.5	0	0.0	6	3.0
Preliminary recommendation⁴
In favour of incorporation	68	100.0	0	0.0	68	33.8
Different from incorporation	25	18.8	108	81.2	133	66.2
ICD-10 ⁵
Certain infectious and parasitic diseases	28	30.1	8	7.4	36	17.9
Neoplasms	8	8.6	10	9.3	18	9.0
Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism	4	4.3	7	6.5	11	5.5
Endocrine, nutritional and metabolic diseases	4	4.3	10	9.3	14	7.0
Diseases of the nervous system	2	2.2	8	7.4	10	5.0
Mental and behavioural disorders	8	8.6	2	1.9	10	5.0
Diseases of the eye and adnexa	0	0.0	2	1.9	2	1.0
Diseases of the circulatory system	2	2.2	12	11.1	14	7.0
Diseases of the respiratory system	7	7.5	9	8.3	16	8.0
Diseases of the digestive system	0	0.0	8	7.4	8	4.0
Diseases of the skin and subcutaneous tissue	2	2.2	5	4.6	7	3.5
Diseases of the musculoskeletal system and connective tissue	17	18.3	21	19.4	38	18.9
Diseases of the genitourinary system	3	3.2	4	3.7	7	3.5
Pregnancy, childbirth and the puerperium	0	0.0	2	1.9	2	1.0
Other ICD	8	8.6	0	0.0	8	4.0
ATC⁶
A - Alimentary tract and metabolism	2	2.2	14	13.0	16	8.0
B - Blood and blood forming organs	1	1.1	8	7.4	9	4.5
C - Cardiovascular system	3	3.2	4	3.7	7	3.5
D - Dermatologicals	1	1.1	1	0.9	2	1.0
G - Genito urinary system and sex hormones	1	1.1	4	3.7	5	2.5
H - Systemic hormonal preparations, except sex hormones and insulins	4	4.3	4	3.7	8	4.0
J - Antiinfectives for systemic use	29	31.2	6	5.6	35	17.4
L - Antineoplastic and immunomodulating agents	33	35.5	47	43.5	80	39.8
M - Musculo-skeletal system	3	3.2	2	1.9	5	2.5
N - Nervous system	9	9.7	4	3.7	13	6.5
P - Antiparasitic products, insecticides and repellents	0	0.0	2	1.9	2	1.0
R - Respiratory system	6	6.5	9	8.3	15	7.5
S - Sensory organs	0	0.0	2	1.9	2	1.0
V - Various	1	1.1	1	0.9	2	1.0
Total	93	46.3	108	53.7	201	100.0

Justifications reported for the favorable decision on incorporation	N^†	%^‡(relative total medicines incorporated)
Clinical need not filled	20	21.5
Gravity and/or prevalence of disease	9	9.7
Lack of therapeutic alternative in the SUS	7	7.5
Additional clinical benefit	38	40.9
Less adverse events	12	12.9
Greater ease of use	10	10.8
Low cost/lower cost than options available	15	16.1
Evidence of cost-effectiveness in relation to options available	13	14.0
Low budgetary impact	24	25.8
Incorporation in other countries	20	21.5
Quality of available evidence	4	4.3
Recommendation in STG or therapeutic guides of the SUS without presence of financing medicines lists	7	7.5
Extension of the list for treatment already existing in the SUS	7	7.5
Other reasons	18	19.4

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[1] Collaborations

RM Silva and R Caetano participated in all stages, including the conception and design, writing, editing and final revision of the article. AN Biz, IAG Oliveira, P Santana and EM Pedro worked on the assembly and extraction of the database and the final revision of the article.