ARTICLE
15 August 2024

Market Access- Alternative Reimbursement Models

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Gun + Partners

Contributor

Gün + Partners is a full-service institutional law firm with a strategic international vision, providing transactional, advisory and dispute resolution services since 1986. The Firm is based in Istanbul, with working offices Ankara and Izmir. The Firm advises in life sciences, energy, construction & real estate, technology, media and telecoms, automotive, FMCG, chemicals and the defence industries.”
In the presence of alternative reimbursement models such as payback, value-based, indication-based reimbursement, performance-based, etc., developed for drug reimbursement systems throughout the world...
Turkey Food, Drugs, Healthcare, Life Sciences
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In the presence of alternative reimbursement models such as payback, value-based, indication-based reimbursement, performance-based, etc., developed for drug reimbursement systems throughout the world, the Turkish industry has long required a unique model for price setting where its conditions could be negotiated with the Social Security Institution (SSI), exempt from regular price and reimbursement rules given to innovative products.

With the enactment of the Social Security and General Health Insurance Law numbered 6552 in September 2014, alternative reimbursement models 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 discuss the terms and conditions of an alternative reimbursement model for particular products. It was expected that alternative reimbursement models, in which the SSI would enter a direct contractual relationship with pharmaceutical companies, would ultimately ensure patients to access pharmaceuticals faster. However, this model is currently preferred to control the discount rates offered by companies, since in these models the discount rates and payment terms are not disclosed to the public and kept confidential.

After the conclusion of one of the lawsuits filed against specific provisions of Regulation on the Alternative Reimbursement of Pharmaceuticals, some articles of this regulation, which were published without consultation with the Ministry, were annulled due to procedural deficiencies. Following the annulment decision, the Alternative Reimbursement Commission could not convene for quite some time to examine new applications. Then, on May 12, 2023, a Social Security Institution General Health Insurance Alternative Reimbursement Regulation was published.

The regulations set with the new Regulation on the Alternative Reimbursement of Pharmaceuticals on scheduling the Alternative Reimbursement Commission's meetings, the time limits for agenda topics, and the confidentiality principles for its activities, indicate a move towards establishing a more predictable system.

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