Market Access - Alternative Reimbursement Models
For an extended period, the pharmaceutical industry needed a unique model of reimbursement where its conditions could be set together through negotiation with the SSI, and the regular price and reimbursement rules did not apply to innovative products.
With the enactment of the Social Security and General Health Insurance Law numbered 6552 in September 2014, alternative reimbursement models also became an essential topic in the Turkish healthcare industry. The complementary provisions introduced with the Regulation on the Alternative Reimbursement of Pharmaceuticals, published in February 2016, allowed companies and the SSI to benefit from discussing the terms and conditions of an alternative reimbursement model for particular products. It was expected that alternative reimbursement models, in which the SSI will enter a direct contractual relationship with pharmaceutical companies, will ultimately allow patients to access innovative pharmaceuticals faster. However, nowadays, these models also appear to control pharmaceutical prices.
In addition, with the conclusion of one of the actions filed against specific provisions of the Regulation on the Alternative Reimbursement of Pharmaceuticals, some articles were annulled on the grounds of procedural deficiency, as the SSI issued the regulation without receiving the opinion of the Ministry. Since the entire text is not the subject of the action, only some of the provisions were brought before the court, and essentially the entire Regulation is still in force, including the article of the law on which the alternative reimbursement models are based.
Following the annulment decision, the SSI was expected to update the Regulation on the Alternative Reimbursement of Pharmaceuticals by duly re-publishing the annulled articles. Instead, the SSI published the new Regulation on the Reimbursement of Pharmaceuticals, including the articles that will update the principle of confidentiality of the discount rates applied in these alternative models. In this context, the rule regarding confidentiality, implemented with the Alternative Reimbursement Regulation, has been re-introduced with the amendment made in the Pharmaceutical Reimbursement Regulation. However, it is unclear whether the Alternative Reimbursement Commission will be convened or the pharmaceutical companies will make new reimbursement agreements with the SSI with confidential and special discounted prices. It is thought that the elections, to be held in 2023, also play a role in how the implementation will continue in this issue, which is highly critical for the country’s economy and companies.