Biofrontera's Ameluz® accepted by the Scottish Medicines Consortium for use within the National Health Service
Biofrontera AG /
Biofrontera's Ameluz® accepted by the Scottish Medicines Consortium for use
within the National Health Service
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The issuer is solely responsible for the content of this announcement.
Leverkusen, Germany - The Scottish Medicines Consortium (SMC) has assessed the
health economics of the use of Ameluz(®) within the National Health Service
(NHS). Ameluz(®) is now accepted for use within NHS Scotland and NHS Boards and
Area Drug and Therapeutic Committees (ADTCs) were advised accordingly.
Ameluz(®) offers clinicians a photosensitising agent that is licensed as first-
line treatment for moderate as well as mild actinic keratosis lesions. In the
cost analysis submitted by Biofrontera to the SMC it was compared to Metvix(®),
which is indicated for thin/mild lesions as second-line therapy only.
The pharmacoeconomic analysis was based on the outcome of a phase III clinical
comparison of Ameluz(®) with Metvix(®) in the photodynamic therapy (PDT) of mild
to moderate actinic keratosis. Patients were treated with the respective drugs
once and, if residual lesions remained, the treatment was repeated after three
months. Thus, the treatment regimes for both medicines are the same, and
operational costs could be neglected in the analysis. Taking the percentage of
patients requiring a second PDT into consideration, the annual cost per patient
for Ameluz(®) was calculated as £ 280.00, that of patients treated with
Metvix(®) as £ 324.00. Therefore, switching from Metvix(®) to Ameluz(®) provides
annual savings of £ 44.00 per patient. This number is greatly increased if the
superior long-term clearance rates achieved with Ameluz(®) are taken into
consideration. The above calculation is based on the NHS's purchase price for
Ameluz(®) of £ 184.00.
The SMC has now acknowledged these cost savings in the assessment published on
its web page
http://www.scottishmedicines.org.uk/SMC_Advice/Advice/811_12_5_aminolaevulinic_a
cid_Ameluz/5_aminolaevulinic_acid_Ameluz and concluded that Ameluz(®) is the
preferred treatment to be used within the NHS. The detailed advice document is
added at the bottom of this press release.
Biofrontera's CEO, Prof. Hermann Luebbert, commented: "The SMC is a globally
recognised expert in health technology assessment (HTA) of new drugs. If a new
drug is accepted for the use within NHS Scotland, this reflects on many other
European countries, including but not only the entire United Kingdom. The
reduced need for a second treatment - with LED lamps only 46% of patients
treated with Ameluz(®), but 62% of the Metvix(®) patients - combined with a
lower price are underlying the assessment of the SMC. The significant clinical
superiority with respect to the clearance of all AK lesions of a patient seen
with Ameluz(®) compared to its nearest competitor provides even further savings
than those calculated by the SMC."
Background
Ameluz(®) (developed as BF-200 ALA gel) was centrally approved in the entire
European Economic Area for the treatment of actinic keratosis in December 2011.
The product is applied in the relatively novel photodynamic therapy (PDT). PDT
of actinic keratosis lesions with Ameluz(®) leads to very high efficacy and
excellent cosmetic results, without the side-effects and discomfort of a long-
term treatment. The treatment can be repeated after three months if residual
lesions remain. A direct clinical comparator study testing the clearance of all
actinic keratoses of a patient proved the strong superiority of Ameluz(®)
compared to its closest competitor[1],[2].
Actinic keratosis is a superficial skin cancer that is still restricted to the
upper skin layer (the epidermis). These tumours result from UV-light induced
damage accumulating during the entire life time. Thus, they occur very
frequently in sun-exposed skin regions. In about 10-15% of the affected people
the actinic keratosis lesions develop into malignant, potentially fatal squamous
cell carcinomas.
About Biofrontera AG
Biofrontera Pharma GmbH is a wholly-owned subsidiary of Biofrontera AG. The
Biofrontera group aims at attending and treating the skin, recognizing the
aesthetic needs of a person's visual reflection. Biofrontera is listed at the
regulated market of the Frankfurt stock exchange under the symbol B8F and the
ISIN number DE0006046113.
www.biofrontera.com
This press release contains forward-looking statements based on the currently
held beliefs and assumptions of the management of Biofrontera AG, which are
expressed in good faith and, in their opinion, reasonable. Forward-looking
statements involve known and unknown risks, uncertainties and other factors,
which may cause the assumptions expressed or implied in this press release to be
faulty. Given these risks, uncertainties and other factors, recipients of this
document are cautioned not to place undue reliance on the forward-looking
statements. Biofrontera AG disclaims any obligation to update these forward-
looking statements to reflect future events or developments.
References
[1] Ameluz® Summary of Product Characteristics; www.ema.europa.eu.
[2] Dirschka et al. (2012) Br. J. Dermatol. 166: 137-146.
For further information please contact:
Anke zur Muehlen
Director PR/IR
+ 49 214 87632 0
+ 49 214 87632 90
a.zurmuehlen@biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
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Source: Biofrontera AG via Thomson Reuters ONE
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