Both the Medical Products Agency and the Dental and Benefits Agency (the authority which decides on reimbursement) have long held the position that biosimilars are not interchangeable or substitutable with their reference products, which has been reiterated in different policy papers since 2007. This position has now been supported by an administrative court of appeal in a case relating to glatiramer acetate products used for the treatment of multiple sclerosis.
The Swedish system for medicinal products is generally product based. Prescriptions as such are product based (ie, by brand name or generic product name) and the indication for which the product is intended cannot be filled in anywhere by the prescriber. Off-label prescriptions are therefore not generally possible in the 'official' prescription system. However, when it comes to accessing unlicensed medicinal products, the system for licences on a named-patient basis works differently.
The Committee for the Review of Pharmaceutical Information recently confirmed the strict approach to the marketing of medicinal products in relation to pricing. The committee's findings serve as a reminder that companies should consider not only the intended purpose of offering a discount on a product, but also its actual effects. The case under review illustrates that an intended discount on a product may be considered contrary to the Ethical Rules for the Pharmaceutical Industry.
The Supreme Court has ruled that cannabidiol (CBD) oils containing tetrahydrocannabinol (THC) which originates from legally cultivated hemp constitute illegal narcotics. The court argued that since CBD oil can be defined as a preparation in accordance with the Convention on Psychotropic Substances and contains THC, it is an illegal substance. This decision is likely to affect several aspects of Swedish healthcare regulation, including that relating to medicinal products.
The Stockholm Administrative Court recently ruled that under the so-called 'trilogue negotiations' between pharmaceutical companies, the Dental and Pharmaceutical Benefits Agency and the Swedish regions could require an originator company to compensate them for products marketed by parallel importers.
The Stockholm Administrative Court recently ruled that the obligation on tenderers of public procurements of medicinal products to have routines which ensure that the use and handling of active ingredients would have as little effect on the environment as possible, as well as the obligation that they routinely survey and have dialogue with their subcontractors, were permissible. The decision has been appealed to the Administrative Court of Appeal in Stockholm, which has yet to make a decision.
In eight landmark decisions, the Patent and Market Court of Appeal decided that the terms for already granted supplementary protection certificates (SPCs) should be recalculated in order to reflect a 2015 European Court of Justice decision regarding the method for calculating SPC terms under EU Regulation 469/2009. Several pharmaceutical companies that had been granted SPCs noted that the Patent and Registration Office's method of calculating SPC terms was not in line with EU law.
The Dental and Pharmaceutical Benefits Agency recently reassessed the reimbursement status of Cerezyme and VPRIV – two products indicated against Gaucher's disease – and decided to decrease the products' prices. This caused the marketing authorisation holders behind the products to withdraw them from the reimbursement system. Consequently, there is no longer a product against Gaucher's disease that is nationally reimbursed in Sweden.
The government recently issued new directives to review the pricing and reimbursement system and the national financing system for medicinal products. The government declared that the existing system is complex and complicated and must be improved in order to operate a modern healthcare system. The review seeks to find a clear division of responsibilities between the national government and local county councils and regions and to establish foreseeable processes for stakeholders.
The Dental and Pharmaceutical Benefits Agency (TLV) recently denied reimbursement for an orphan drug for the treatment of chronic thromboembolic pulmonary hypertension based on a health technology assessment which took into account off-label use of treatments for pulmonary arterial hypertension (PAH). The Stockholm Administrative Court has since upheld the TLV decision, agreeing with the TLV's reasoning that the orphan drug should be compared with available PAH treatments.
The Supreme Administrative Court recently ruled that e-cigarettes not marketed for smoking cessation purposes should not be classified as medicinal products. The court stated that in order to be classified as a medicinal product, the product, if used as intended, must be capable of appreciably restoring, correcting or modifying physiological functions in human beings. It is not sufficient that the product has a pharmacological effect on the body's functions.
The Supreme Administrative Court recently handed down a long-awaited judgment in the case between the Dental and Pharmaceutical Benefits Agency and the Skane Region. The court departed from earlier judgments and stated that county councils and regions are permitted to enter into discount agreements with pharmaceutical companies for medicinal products which are included in the reimbursement scheme.
The Stockholm Administrative Court of Appeal recently clarified the possibility to consider financial aspects when determining whether there are special requirements for granting a named patient permission. The court dismissed arguments that high prices and limited availability of an authorised medicinal product could constitute special requirements for a named patient permission for an unauthorised medicinal product.
A pharmaceutical company's recent application to the Dental and Pharmaceutical Benefits Agency (TLV) for a pricing and reimbursement decision regarding a medicinal product with orphan drug status was rejected. The decision appears to be the first in which a product under off-label use has been used as a comparator in the TLV's health technology assessment.
The Uppsala Administrative Court has upheld a Medical Products Agency decision that a generic inhaler was not considered substitutable within the substitutability groups for which the generic company had applied. The court denied substitutability based on the generic inhaler's incompatibility with a spacer mentioned in the original inhaler's summary of product characteristics.
The Administrative Court of Appeal recently issued a judgment on the pricing of orphan drugs in the reimbursement system. The court considered whether a maximum price cap exists with regard to the cost-effectiveness calculation within the health technology assessment. The outcome is unsatisfactory for pharmaceutical companies, particularly those with orphan drugs or innovative new drugs in their product portfolio.
The government and the Left Party recently reached agreement on initiatives aimed at restricting private companies from engaging in certain publicly funded healthcare, care and educational services and, as part of that limit, their right to distribute profits. Much of the criticisms leading up to the suggested initiatives may be addressed by stricter tender procedures.
The Administrative Court of Appeal recently held that it is not possible for county councils and regions to acquire a discount on the price of medicinal products in the reimbursement system. The decision has been appealed to the Supreme Administrative Court. It remains to be seen what will happen to existing discount agreements within the reimbursement system should leave to appeal not be granted.
The Swedish Association of Local Authorities and Regions (SKL) represents the county councils which operate the majority of Swedish hospitals. The SKL has put in place a new cooperation framework for the introduction of new innovative medicinal products. The framework seeks to enable county councils to act as strong buyers of medicinal products, which would lead to, among other things, faster access to new treatments.