Overview of Med Tech Reimbursement in Portugal
Who is most likely to be the payer for your Medical Device?
The Medical Devices reimbursement is approached in Chapter III of Portuguese Decree-Law n.o 97/2015 0 amended by Decree-Law n.o 115/20172.
The reimbursement of medical devices happens when there are public health or proven economic benefits, the State can reimburse, the acquisition of medical devices to the beneficiaries of the NHS and other public health subsystems, upon request of the manufacturer or his authorized representative 0,0.
The authorization of the reimbursement of a medical device is the responsibility of a member of the Government responsible for health and may be delegated to INFARMED, I. P. 0.
Health Economics: Building Evidence of Economic, Clinical and Patient Benefit
Health economic evidence is critical for support and reimbursement of medical devices according to Chapter III, article 23 of Portuguese Decree-Law n.o 97/2015 0.
Until the publication of Decree-Law 97/2015, which created the National System for the Evaluation of Health Technologies (Sistema Nacional de Avaliação de Tecnologias de Saúde, SiNATS), there was no provision in the legislation for the possibility of reimbursement or prior assessment of medical devices.
So What?
In order to create a paradigm in the use and acquisition of health technologies, namely medicines and medical devices, the Ministry of Health created the SiNATS, which integrates all public and private entities of health in order to achieve health gains, harmonized with other European systems seeking to achieve the same goal 0.
SiNATS integrates all actors in health technologies, both their responsibilities and the outcome of the assessment of health technologies, differ according to the scope of use. Thus, the evaluation of health technologies can both materialize in general recommendations for their use in the health system, and under conditions of use and acquisition for the institutions and services of the National Health Service.
SiNATS will enable health technologies to be evaluated and reassessed in an integrated context and with preferential use of targeting through contracts with the manufactures.
SiNATS is based on the technical knowledge of INFARMED – National Authority for Medicines and Health Products, IP (INFARMED, IP), and on all the information that can be organized and structured to evaluate technologies that will allow determining optimum conditions of use.
Through SiNATS, the technical, therapeutic and economic evaluation of health technologies is carried out. This is supported by an information system that collects and provides information for all entities wishing to decide on the quality, economy, effectiveness, efficiency and effectiveness of the use of medicines and medical devices or other health technologies.
SiNATS is supported by an Information System for Health Technology Assessment (Sistema de Informação para a Avaliação de Tecnologias de Saúde, SIATS) under the responsibility of INFARMED, I. P. SIATS contains all the information necessary for the evaluation of health technologies, in compliance with legal standards, in particular, those concerning the processing of personal data.
According to article 5 of Portuguese Decree-Law n.o 97/2015 0, the result of the evaluation of health technologies is the basis for:
a) authorise, renew or revoke the use of health technology;
b) the decision on price, reimbursement, acquisition or installation of health technology by the health system;
c) the issue of recommendations or decisions to use any health technologies, when necessary, after articulation with other entities of the Ministry of Health;
d) the decision to maintain the reimbursement or acquisition, through prior evaluation of health technology, which is carried out by contract or administrative act.
Mechanisms for Funding
The first step on the path leading to the possibility of reimbursement medical devices described in SiNATS was given in 2012 with the publication of the Order n.o 15371/2012 (already revoked) which, by introducing the coding of medical devices, intended to cost reduction in the National Health Service (NHS). With this coding, services and NHS establishments can only purchase medical devices that INFARMED listed in its database 0, 0, 0.
Medical devices that may be reimbursed are established by Decree-order (as in the aforementioned). In the case of hospital use medical devices may be subject to prior evaluation. To the situations mentioned above, the medical device features:
1. A therapeutic innovation demonstrated for the claimed clinical purposes;
2. A demonstrated economic advantage 0, 0, 0.
So, the mechanisms for funding can be of two types, reimbursement, or prior assessment.
Medical Devices Reimbursement
The medical device reimbursement is approached in Chapter III of Portuguese Decree-Law n.o 97/2015 0.
The reimbursement determines the attribution of code to the medical device, by INFARMED, I. P., on which the payment of the value of the reimbursement depends 0. The maximum amount of reimbursement per generic group of devices as well as the conditions necessary for the reimbursement will be issued by Decree-order (example: maximum number of devices reimbursed per user, requirements of the medical prescription and conditions of eligibility of the users)0.
In Portugal, at the moment, we have four ranges of medical devices which can be subjected to reimbursement, they are 0:
● Medical devices for self-monitoring of people with diabetes (Decree-order n.o 35/2016);
● Expansion chambers (Decree-order n.o 246/2015);
● Medical devices to support ostomized patients (Decree-order n.o 115/2018);
● Medical devices to support patients with incontinence or urinary retention (Decree-order n.o 92-E/2017);
● Food and Dietary Supplements for Extreme Prematurity (Decree-order n.o 76/2018).
Only codes that follow these groups are reimbursed. Each range referred above is regulated by a specific Decree-order.
So What?
Medical devices for self-monitoring of people with diabetes
Since 1998, a collaboration between the Ministry of Health and the various partners in the sector has been carried out in Portugal to develop and implement diabetes control programs. Some laws were published to set the maximum retail prices for test strips for blood glucose, ketonemia and ketonuria, and for needles, syringes and lancets intended for patients with diabetes. With the introduction of SiNATS, the Portuguese Decree-Law Nº 97/2015 1 was published, which establishes the regime of reimbursement of the State in the price of medical devices used in the surveillance of diabetes. It is possible to include new medical devices used in the surveillance of diabetes to reimbursement process by making a request for its inclusion according to the described at Portuguese Ordinance Nº 35/2016, which is made upon application to INFARMED.
For more information on this application for inclusion, you can find it through this link.
Expansion chambers
In clinical situations where aerosol therapy is required for the administration of bronchodilators and steroid anti-inflammatory drugs (corticosteroids), the prescription of simple devices, including pressurized inhalers associated with expander chambers, is indicated. Considering the cost-effectiveness of its use in the appropriate clinical situations, it was concluded that the expander chambers should be reimbursed by the National Health System. In this context, was published the Portuguese Ordinance Nº 246/2015, which establishes the regime of state contribution in the price of the expander chambers, destined for beneficiaries of the National Health Service. State reimbursement in the cost of acquisition is 80% of the PVP of the expansion chambers intended for NHS users. It is also possible to make a request for inclusion in the reimbursement process of new expansion chambers devices, as described in Ordinance Nº 246/2015, which is made upon application to INFARMED.
For more information on this application for inclusion, you can find it through this link.
Medical devices to support ostomized patients
In order to promote the health of the Portuguese, the Government guarantees access to ostomized patients for ostomy material, products and accessories through the Portuguese Ordinance Nº 284/2016. It is possible to make a request for inclusion of reimbursement in medical devices for ostomized patients, provided for in Portuguese Ordinance Nº 284/2016, which is made upon application to INFARMED.
For more information on this application for inclusion, you can find it through this link.
Medical devices to support patients with incontinence or urinary retention
In order to promote the health of the Portuguese, the Government guarantees access to patients with incontinence or urinary retention who may require specific medical devices to support their condition, thus improving their quality of life and social integration. It is possible to make a request for inclusion of reimbursement in medical devices to support patients with incontinence or urinary retention, provided for in Portuguese Ordinance Nº 92-E/2015, which is made upon application to INFARMED.
For more information on this application for inclusion, you can find it through this link.
Prior Assessment of Medical Devices
The prior evaluation of medical devices is approached in Chapter V of Portuguese Decree-Law n.o 97/2015 amended by Decree-Law n.o 115/2017.
Prior Assessment 0,0
The prior evaluation of medical device aims to allow the use of a medical device and establish the conditions of acquisition and use by the entities supervised by the member of the Government responsible for health. The types of medical devices that will be subject to prior evaluation will be published by decree-order of the member of the Government in charge of the health area. The responsibility for the final decision of the prior evaluation is of the member of the Government responsible for the health area or delegated to INFARMED.
The prior assessment will depend on whether or not it is considered a therapeutic innovation demonstrated for the claimed clinical purposes and whether it has a proven economic advantage.
The prior assessment will also define a maximum purchase price for the entities supervised by the member of the Government responsible for health.
Contract for the Prior Assessment 0,0
According to the established in Article 29 of Portuguese Decree-Law n.o 97/2015 0, the medical devices subject to a procedure prior to assessment and with a favorable opinion may subject to a prior assessment agreement, to be celebrated with the manufacturer or his authorized representative.
Entities of the NHS may only acquire a medical device for the indications and under the conditions approved in the prior assessment agreement, valid at the moment of the conclusion of the respective supply contract.
Pricing Considerations
The pricing considerations of medical devices is approached in Chapter II of Portuguese Decree-Law n.o 97/2015 amended by Decree-Law n.o 115/2017.
For the purposes of reimbursement or prior assessment of medical devices, certain medical devices or generic groups of medical devices are subject to special schemes of maximum prices for the users of the NHS and for the entities supervised by the member of the Government responsible for health 0.
The determination of the maximum prices can be made through a retrospective analysis of the prices charged in the establishments and services of the NHS for a period of not less than six months and, where possible, expurgated of the influence of the following factors 0:
a) The quantity of goods acquired;
b) The urgency required for the provision of the medical device;
c) The term and the form of payment established;
d) The need to provide training to users of the device;
e) The inclusion of necessary maintenance services in the functioning of the device.
The prices are in INFARMED database when the register is made and in previous contracts.
References
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