Krystal Biotech Receives Permanent J-code (J3401) for VYJUVEK®
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Insights
The assignment of a permanent J-code to VYJUVEK by the CMS represents a significant milestone for Krystal Biotech, as it directly impacts the reimbursement landscape for this treatment. The J-code, J3401, is pivotal in ensuring that healthcare providers can bill efficiently for the administration of VYJUVEK, which is crucial for dystrophic epidermolysis bullosa patients. This development can lead to increased adoption rates among healthcare providers due to the streamlined billing process.
From a policy perspective, the CMS's decision to issue a permanent J-code also reflects the recognition of the importance of VYJUVEK as a treatment option for a disease with previously limited options. This could potentially signal a favorable regulatory environment for future treatments targeting rare diseases, encouraging further investment and research in this sector.
For investors and stakeholders in Krystal Biotech, the assignment of a permanent J-code may translate into a more predictable revenue stream, as it simplifies the reimbursement process for providers and payers. By facilitating a smoother billing experience, Krystal Biotech could see an acceleration in market penetration and increased sales. This could also enhance the company's competitive position in the biotechnology market, where ease of access and reimbursement are key factors for success.
Moreover, the market impact extends beyond Krystal Biotech. The establishment of a J-code for a genetic medicine could set a precedent, potentially benefiting other companies developing treatments for rare diseases. It may also influence the stock market's perception of the biotech sector's growth prospects, particularly in the area of genetic medicine.
The financial implications for Krystal Biotech following the CMS's approval of a J-code for VYJUVEK are multifaceted. In the short-term, the stock may react positively to the news, as it eliminates a significant barrier to revenue generation. Long-term, the stability provided by the J-code could improve financial forecasting and planning for the company. It's important to consider the cost implications for the healthcare system overall, as the reimbursement for new, innovative treatments like VYJUVEK can be substantial.
Investors should monitor the uptake of VYJUVEK post-J-code implementation to gauge the accuracy of sales forecasts and the potential impact on Krystal Biotech's financial health. Additionally, the company's ability to leverage this regulatory milestone to secure favorable terms with insurers could be a critical factor in determining its profitability and long-term success in the market.
PITTSBURGH, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent and product-specific J-code (J3401) for VYJUVEK® (beremagene geperpavec-svdt), the first U.S. Food and Drug Administration-approved treatment for dystrophic epidermolysis bullosa (DEB). The J-code for VYJUVEK became effective on January 1, 2024.
“The permanent J-code will help ensure efficient and accurate reimbursement of VYJUVEK and further enable us to bring this important treatment to DEB patients in need,” said Krish S. Krishnan, Chairman & CEO at Krystal Biotech.
J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate billing of treatments that must be administered by a healthcare professional. J-codes simplify and streamline the billing and reimbursement processes, allowing for efficient claims processing.
The permanent J-code for VYJUVEK has been published by CMS and is available here.
About Dystrophic Epidermolysis Bullosa (DEB)
DEB is a rare and severe disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1, which is responsible for the production of the protein type VII collagen (COL7) that forms anchoring fibrils that bind the dermis (inner layer of the skin) to the epidermis (outer layer of the skin). The lack of functional anchoring fibrils in DEB patients leads to extremely fragile skin that blisters and tears from minor friction or trauma. DEB patients suffer from open wounds, which leads to skin infections, fibrosis which can cause fusion of fingers and toes, and ultimately an increased risk of developing an aggressive form of squamous cell carcinoma which, in severe cases, can be fatal.
About VYJUVEK
VYJUVEK is a non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEK was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism.
Indication
VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in patients six months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
The most common adverse drug reactions (incidence >
To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Contraindications
None.
Warnings and Precautions
VYJUVEK gel must be applied by a healthcare provider.
After treatment, patients and caregivers should be careful not to touch treated wounds and dressings for 24 hours.
Wash hands and wear protective gloves when changing wound dressings. Disinfect bandages from the first dressing change with a virucidal agent, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings in a sealed plastic bag in household waste.
Patients should avoid touching or scratching wound sites or wound dressings.
In the event of an accidental exposure flush with clean water for at least 15 minutes.
For more information, see full U.S. Prescribing Information.
About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK® is the Company’s first commercial product, the first-ever redosable gene therapy, and the first medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and X (formerly Twitter).
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., including statements about the permanent J-code, reimbursement of VYJUVEK, and the Company bringing VYJUVEK to DEB patients in need, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption “Risk Factors” in the Company’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.
CONTACT
Investors and Media:
Meg Dodge
Krystal Biotech, Inc.
mdodge@krystalbio.com
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