Kerecis included on the list of covered products for Diabetic Foot Ulcers in the final LCD policy
14 Novembro 2024 - 10:22AM
UK Regulatory
Kerecis included on the list of covered products for Diabetic Foot
Ulcers in the final LCD policy
On 14 November 2024, the U.S. Centers for Medicare &
Medicaid Services (CMS) issued a final Local Coverage Determination
(LCD)1 policy regarding skin substitute grafts/cellular
and tissue-based products for the treatment of Diabetic Foot Ulcers
(DFUs) and venous leg ulcers (VLUs) in the Medicare population.
The final LCD policy confirms the introduction of a technical
qualification and a clinical efficacy qualification, proposed in a
draft LCD policy2 earlier this year. The final decision
also introduces two separate lists for covered products for DFUs
and covered products for VLUs. In addition, the application limit
has been expanded from 4 to 8 and the duration of treatment has
been increased from 12 to 16 weeks in the final policy. The
implementation date of the final policy is set to 12 February
2025.
Based on the final evaluation, Kerecis is included on the final
list of covered products for DFUs, however, Kerecis has not been
included on the covered list for VLUs. Sales related to VLUs in the
out-patient setting currently represent a low-single digit portion
of the total Kerecis’ sales. Kerecis has an ongoing clinical study
on VLUs and will attempt to get coverage for VLUs as soon as the
study is completed.
Coloplast’s financial guidance for FY 2024/25 with organic
growth of 8-9% and an EBIT margin before special items of around
28% is unchanged.
The financial assumptions for Kerecis with a 3-year CAGR of
around 30% until 2025/26 and an EBIT margin of around 20% (ex. PPA
amortization) in FY 2025/26 are also unchanged. Once the policy is
implemented, we expect loss of sales related to VLUs in the
out-patient segment. At the same time, given that a significant
number of products are removed from the covered list for DFUs, we
expect sales growth to accelerate in this segment, therefore
offsetting the loss of sales related to VLUs.
- LCD - Skin Substitute Grafts/Cellular and Tissue-Based Products
for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
(L39764)
- Proposed LCD - Skin Substitute Grafts/Cellular and Tissue-Based
Products for the Treatment of Diabetic Foot Ulcers and Venous Leg
Ulcers (DL39764) (cms.gov)
Contacts:
Investors and analysts
Anders Lonning-Skovgaard
Executive Vice President, CFO
Tel. +45 4911 1111
Aleksandra Dimovska
Vice President, Investor Relations
+45 4911 2458
dkadim@coloplast.com
Press and media:
Peter Mønster
Sr. Media Relations Manager
+45 4911 2623
dkpete@coloplast.com
- Coloplast_Final_LCD_policy_14112024
Coloplast AS (TG:CBHD)
Gráfico Histórico do Ativo
De Nov 2024 até Dez 2024
Coloplast AS (TG:CBHD)
Gráfico Histórico do Ativo
De Dez 2023 até Dez 2024
