Post Market Approval Processes & Regulations: Portugal
Cuatrecasas / Portugal
Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on post-market approval processes and regulations in Portugal. Buy The Pharma Legal Handbook: Market Access & HTA – Portugal here for £359.
What are the pricing principles and processes in your country?
Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which established the provisions applicable to pricing, reimbursement, and prior evaluation procedures.
The process for pricing decisions on originator drugs vary according to the type of medicinal product and intended market (outpatient vs. hospital and subject and not subject to medical prescription).
For original medicinal products subject to a medical prescription provided in outpatient and in pharmacies, an international reference pricing system is applied to define the maximum market price. The international reference pricing system uses a basket of several EU countries, which are defined annually by the Ministry of Health. The reference countries selected for the year 2022 are Spain, France, Italy, and Slovenia.
The maximum prices of original medicinal products subject to a medical prescription are subject to an annual revision, based on comparison with the prices approved in the reference countries.
The prices of original medicinal products which require no prescription (OTCs) are free – unless they are reimbursed.
What pricing models are currently being utilised in your country?
Generics subject to medical prescription are subject to specific pricing rules.
The maximum sales price of generics is set by reference to the price of the reference medicinal product. The price of the generics cannot exceed 50% of the maximum sales price of the reference medicinal product or 25% of that price, should the reference product’s ex-factory price be lower than €10. Generics are also subject to an annual price revision.
Generics which are not reimbursed and are sold to NHS Hospitals are also subject to a price approval and revision procedure. Under this regime, the price of the generic should be at least 30% lower than the price of the reference medicinal product.
Biosimilar medicinal products are defined by exclusion, i.e. a biosimilar medicinal product is a biological medicinal product which does not fulfil the conditions of the definition of a generic (amongst other, because of differences related to the raw materials or to the manufacturing processes).
Nevertheless, their regulation is similar to generic products in other regards. Biologic or biosimilar medicinal products do not follow a specific regime for the determination of their prices, therefore, if the biologic or biosimilar medicinal product is reimbursable under the applicable law, it may be subject to the regime of maximum prices as any other medicinal product.
What are the processes and principles around reimbursement approval?
There is a national reimbursement system of medicinal products that are provided outpatient and in pharmacies, in which the Government co-pays part of the price of the medicinal products prescribed to the users of the NHS. For a medicinal product to be reimbursed by the Government, the holder of the marketing authorization shall submit an authorization procedure for such purpose. There are four categories of reimbursement levels that range from a co-payment by the Portuguese State of 15% to 90%. In addition, there is also an exceptional reimbursement regime where some medicinal products duly specified may benefit from a 100% public financing.
What are the reimbursement approval processes and principles for generics and biosimilar drugs?
Where a generic is placed in the market, a “homogenous group” (“HG”), composed of medicinal products with the same active substance and dosage, is created. Consequently, a reference price will be approved for the products which are part of said HG. The reference price will be based on the average of the retail sales price of the five lowest-priced medicinal products included in the HG. Following the approval of said reference price, the maximum amount of reimbursement for products included in the HG will be determined by applying the applicable reimbursement percentage to the reference price. The maximum sales price of generics placed in the market upon the HG creation must be at least 5% lower than the price of the cheapest generic already in the HG and has at least a 5% market share of generic medicinal products in the HG.
Biosimilar medicinal products benefit from the reimbursement regime applicable to their reference biological medicinal product, without prejudice to any necessary adaptations.
If the biosimilar medicinal product is part of a HG of biosimilar medicinal products, the maximum retail price of new biosimilar medicinal product to be reimbursed must be lower than the lowest priced biosimilar medicinal product, it being necessary that the lowest priced biosimilar medicinal product has a certain percentage of the market share of the medicinal products of the homogeneous group. Said percentage, as well as the margin for the maximum retail price, are defined by the government on a case-by-case basis.
When the biosimilar medicinal product is not part of a HG, the maximum retail price of the biosimilar medicinal product may not be higher than 80% of the maximum retail price of the reference biologic medicinal product.
Moreover, some biologic medicinal products are subject to exceptional regimes of reimbursements, where the reimbursement fee is of 100%.
As for the prior evaluation agreements for biosimilar medicinal products, the economic advantage to be taken into account shall correspond to at least 20% of the direct price of the reference biological medicinal product.
A biosimilar medicinal product shall benefit from the reimbursement system, either general or special, applicable to the reference biological medicinal product, by means of a reimbursement contract, with the adaptations resulting from the market share of both medicinal products and the prices of each one.