For an extended period, the pharmaceuticals 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 for 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, allow 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 into a direct contractual relationship with pharmaceutical companies, will ultimately allow patients to access innovative pharmaceuticals faster. Today, however, these models also appear to control pharmaceutical prices. Lawsuits filed against several provisions of the Regulation on the Alternative Reimbursement of Pharmaceuticals are still pending.
In parallel with the SSI’s amendments regarding alternative reimbursement, the TITCK has also introduced guidelines for prioritising MA applications of particular products with advantages in public health and public finance. A commission established under the TITCK, composed of MoH and the SSI representatives, evaluates companies’ prioritisation applications.
Although these amendments made in the last few years are significant developments, there are still no specific licensing, pricing and reimbursement rules for orphan drugs.