2021 Announcements Clinical Corporate Regulatory

SCENESSE® Granted Market Access In Israel

CLINUVEL today announced that SCENESSE® (afamelanotide 16mg) has been added to the expanded “National Health Basket” (NHB) of services and products reimbursable in Israel. With the Israeli Ministry of Health approving SCENESSE®, the drug is now available as a first-line treatment for the prevention of phototoxicity to all adult patients diagnosed with erythropoietic protoporphyria {EPP).

Market Access in Israel

In June 2020, the Public National Advisory Committee (commonly called the “Health Basket Committee”) agreed with the Israeli government to the addition of NIS500 million (A$198 million) towards new medications for its national market in 2021. According to the OECD, Israel’s healthcare costs amount to 7.5% of GDP, with expenditure on pharmaceutical products equating to 13.1% of all healthcare.

As a reference, in 2019 around 900 technologies – 25% pharmaceutical treatments and 75% medical technologies – valued at over NIS3.5 billion (A$1.4 billion) were submitted for consideration by the Committee. A positive decision was reached in 141 applications (15.6%) submitted for ratification by the Israeli government.

The reimbursement of medicinal products in Israel is ultimately determined by the Ministry of Health in consultation with the various divisions with the Ministry, the four leading insurers, medical associations, and technical experts.

The process in Israel to obtain inclusion in the NHB is known to be long and challenging, with each stakeholder involved in the final decision. The Committee issues outcomes once per year following two plenary meetings during which selected medical technologies are reviewed.

During the decision process all stakeholders are required to agree on the long-term economic impact of a new therapy before it can be considered for access to the Israeli pharmaceutical market.

Under the National Health Insurance Law (enacted 1994), universal healthcare in Israel is provided through compulsory insurance for all its residents. However, most residents also take-out voluntary health insurance for medications which are not covered by the standard benefit package, and to gain faster access and greater choices of healthcare providers.

SCENESSE® – Positive Outcome in Israel

Part of the positive outcome was the favourable cost-benefit
ratio, safety profile, and ongoing commercial prescription of SCENESSE®
which is in the European Union and United States. The Committee assigned the
medicinal product a high grade (AB) in terms of value, efficacy and safety
based on high unmet medical need in a patient population not yet attended.
SCENESSE® is accepted as the first line treatment and included in the permanent
Registry of Medical Products in Israel.


“Our team has been working tirelessly to facilitate
accelerated access to SCENESSE® treatment for Israeli EPP patients,”
CLINUVEL’s VP of Commercial Affairs, Mrs Antonella Colucci said.

“We are establishing a foothold and infrastructure
in Israel to enable treatment access in a country where the risk of EPP burns
and phototoxicity is high due to the light intensity and sun exposure. Israeli
EPP patients have been at heightened risk for decades and had to learn to lead
a recluse life.

“I must take the opportunity to thank the Israeli
EPP expert community and our exceptional local partner for their support
resulting in the introduction of SCENESSE®, and look forward to facilitating the
first EPP patient treatment,” Mrs Colucci said.

EPP in Israel

EPP is a rare metabolic disorder causing lifelong absolute light intolerance. Due to a genetic defect, EPP patients suffer debilitating acute phototoxic reactions (anaphylactoid reactions and second-degree burns) after just a few minutes of exposure to visible light (including sun and artificial light). Burns and reactions may last days to weeks.

 At increased latitudes, such as in Israel, patients are at higher risk of incurring phototoxic burns due to the increased intensity of environmental light and the extended daily duration of sunlight. Recently published research from one Israeli expert centre reported that all Israeli EPP patients adapted their life and reverted their circadian cycle to avoid exposure to light and phototoxic symptoms. In Europe, one in 140,000 people live with EPP.

SCENESSE® is approved in Europe, the USA and Australia for the prevention of phototoxicity in adult EPP patients. No other EPP treatments have been subject to randomised controlled trials to fully evaluate their safety and clinical benefit, or received marketing authorization in any parts of the world. A formal marketing authorisation application for SCENESSE® had been submitted to the Israeli Ministry of Health.


Elder, G., Harper, P., Badminton, M., Sandberg, S., & Deybach, J.-C. (2013). The incidence of inherited porphyrias in Europe. Journal of Inherited Metabolic Disease, 36(5), 849-857.

Snast, I., Kaftory, R., Lapidoth, M., Mamet, R., Hodak, E., Edel, Y., & Levi, A. (2020). Clinical features of genetic cutaneous porphyrias in Israel: A nationwide survey. Photodermatology, Photoimmunology & Photomedicine.

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