Shareholder EU countries rollout status for Scenesse

PortugueseMan

Well-known member
COUNTRY
SCENESSE'S STATUS
NATIONAL DRUG AGENCY
Austria
Germany
Italy
The Netherlands
Switzerland
Slovenia
Poland
France
United Kingdom - England
United Kingdom - Wales
United Kingdom - Scotland
United Kingdom - Northern Ireland
Denmark
Sweden
Spain
Finland
Norway
Belgium
Ireland
Hungary
Lithuania
Latvia
Czech Republic
Croatia
Estonia
Portugal
Greece
Luxembourg
Iceland
Bulgaria
Cyprus
Liechtenstein
Malta
Romania
Slovakia
Available
Available
Available
Available
Available
Available
Available
Available

Under evaluation
Under evaluation
Under evaluation
Under evaluation
Under evaluation
Under evaluation

Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
Not available
AGES
G-BA
AIFA
CBG
Swissmedic
JAZMP
URPL
HAS
NICE
NICE - AWMSG
SMC
DoH
Medicinraadet
Lakemedelsverket
AEMPS
FIMEA
NoMA
FAGG
HES
OGYEI
VVKT
ZVA
SUKL
HALMED
REAM
INFARMED
EOF
ALMPS
IMA
BDA
Ministry of Health
LLV
Medicines Authority
ANM
SUKL
 
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PortugueseMan

Well-known member
FRANCE - approved


Scenesse received a high SMR vote (was voted as IMPORTANT) and a weak ASMR vote (level IV - minor therapeutic progress).



At the May 27 meeting, Clinuvel asked the TC to assign an SMR Important level and an ASMR III level to Scenesse.

At the June 3 meeting, the TC formalized its decision regarding Scenesse.

At the June 24 meeting, Clinuvel's opinion was heard. Clinuvel called Dr. Deybach as an expert (one of the leading experts in France in the porphyria area). They wanted to change the ASMR level (to a ASMR III) and wanted that Scenesse to be recognized as a relevant drug to French public health. We still don't know what was said, but Clinuvel/Dr Deybach managed to convince two of the TC members to change their ISP vote. Unfortunately, they needed to convince two more TC members for the ISP vote to be reversed.
Regarding the ASMR level, Clinuvel/Dr. Deybach were unable to win a single vote (the TC's decision was unanimous and has not changed).

Based on what I read here, it would never be very easy to get a favorable ISP vote for Scenesse (EPP is a non-fatal disease with a low prevalence), so the distribution of the ISP votes (9-11) turns out to be surprising.
As for the ASMR level, I still don't get why it is not higher... We will have to wait for the transcripts to be published to (try to) understand this.

The ASMR vote: The ASMR IV allows Scenesse's price to be the same as in other European countries. However, it should be noted that in France it is not the laboratories that define the prices of medicines, but the CEPS (the Economic Committee of Health Care Products). More specifically, the CEPS, after negotiating with the laboratory, will fix the price of the drug. This price will take into account the ASMR level, but since Scenesse has no competitors this will be a great advantage during the negotiations. The fact that Scenesse's economic evaluation anticipates annual expenses of less than 20 million euros is another substantial advantage for Clinuvel.

The SMR vote: Scenesse received the highest vote on the scale. The reimbursement will be of at least 65%. There's another level, a higher one, but in my researches I never saw the TC assign it. We have to take into account that the TC only evaluates the efficacy of the medicine. The reimbursement rate will be decided by the UNCAM (the French National Union of Health Insurance Funds) after the price has been fixed. It's very possible that the UNCAM conclude that the price of Scenesse is too high for the general population and that it's necessary to do an upgrade to the fifth level, the level at which a drug is considered irreplaceable and expensive, and where the reimbursement is of 100%.

In theory, the TC's decision is actually an opinion and not a final decision (the TC has no executive power), and for that reason the opinion regarding Scenesse has been sent to the Ministry of Health, which is responsible for the decision about reimbursement. In practice, the opinions of the TC are always accepted by the French Ministry of Health.

All official information regarding Scenesse's reimbursement will be published here: https://www.legifrance.gouv.fr/

For information related to the evaluation process and reimbursement: contact.associations@has-sante.fr
 
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PortugueseMan

Well-known member
SPAIN - rejected


The AEMPS decided not to reimburse Scenesse (https://www.aemps.gob.es/medicament...os/docs/IPT-afamelanotida-Scenesse.pdf?x92596 - 30th October 2019).

Clearly, the evaluation process was based on old and obsolete data:

"Afamelanotide has shown a modest effect in increasing the time that patients can be exposed to direct sunlight without pain ... it was valued as the mean number of minutes exposed to sunlight (between 10 am-6pm) without pain in a day with a difference of 8.8 minutes/day ... it has shown a very modest effect of doubtful clinical relevance in increasing the time that patients can be exposed to direct sunlight ..."

I contacted the entity that makes the evaluation of new drugs and that issues the IPT (Informes de Posicionamiento Terapéutico) and asked about the alternatives available to a pharmaceutical company whose drug has received a non-reimbursement decision.

They told me that Clinuvel can request a re-evaluation based on new scientific data at any time.

For information related to the evaluation process and reimbursement: cartera-farmacia@mscbs.es
 
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PortugueseMan

Well-known member
SLOVENIA - approved


Slovenian health authorities approved the reimbursement of Scenesse, since Jan 1, 2020 and with no end date. (https://www.jazmp.si/fileadmin/datoteke/seznami/SFE/Cene/cene_20200317.pdf)

The price of each implant is 14.128,45 EUR (updated on August 23; the previous price was 14.100,95 EUR). Maximum of 3 implants per year. Valid from 02/28/2020 ---» https://translate.google.pt/transla...7F3BD33DF3A06F14C125813200831FB8?opendocument (http://www.cbz.si/cbz/bazazdr2.nsf/o/7F3BD33DF3A06F14C125813200831FB8?opendocument)
 

PortugueseMan

Well-known member
ITALY - available but not centrally approved


In Italy there are 20 regions, all of which are autonomous. A given region may, on its own initiative, authorize the marketing and reimbursement of a given drug. That's what's happening with Scenesse.

Thanks to this article, we know that Scenesse was not centrally approved (it's not reimbursed by the National Health Service) and that it is available in about 14 regions (70% of the Italian territory).

It is important to note that there are cases like the Lazio Region, which authorized the treatment of patients from other regions...

I was able to identify 9 of the regions where Scenesse is available:
  • Lazio Region (5,865 million inhabitants)
  • Liguria Region (1,543 million inhabitants)
  • Lombardy Region (10,103 million inhabitants)
  • Piemonte Region (4,341 million inhabitants)
  • Sardegna Region (1,630 million inhabitants)
  • Sicilia Region (4,968 million inhabitants)
  • Toscana Region (3,722 million inhabitants)
  • Trentino-Alto Adige/Südtirol Region (1,074 million inhabitants)
  • Veneto Region (4,907 million inhabitants)
 
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