Application standard for acceptance to the drug reimbursement scheme; pursuant to Article 9 of the regulation on reimbursement of crucial drug costs

Information for items marked with a star (*) to be based on cited references, enclosed documentation or available references.
Contents:

1. Information about the applicant 
2. The application concerns drug with:
3. Description of product
4. Reimbursement
5. Approved SPC to be enclosed
6. Approved maximum price per package
7. EU status summary
8. Description of illness and epidemiology (*)
9. Treatment regime for drug (*)
10. Overview of existing treatment programmes (*)
11. Position of drug in treatment programme
12. Anticipated sales
13. Clinical benefits(*)
14. Pharmacoeconomic analyses
15. Budgetary consequences
16. Studies
    

1. Information about the applicant
   Company Address
   Telephone / Fax
   Contact person
   
2. The application concerns drug with:
   a) new active agent, b) new combination of common active agent, c) new indication, d) new form of drug, e) new strength, f) synonymous preparation.
   
   If the application concerns drugs falling under items 2 d) - f), and documentation is included showing that the application does not result in increased costs or changes with regard to indication, only items 1-7 need be addressed.
   
3. Description of product
   Preparation name
   Active agent
   Form of drug
   Strength
   Recommended daily dosage
   Prescription group
   Medically approved indication
   
4. Reimbursement
   State for which illness subsection and appurtenant preparation group of Article 9 the application for reimbursement is being made. Are there restrictions to the indication which are not made clear in the reimbursement subsection with appurtenant remarks? Prevailing prescription regulations/dispensation provisions.
   
5. Approved SPC to be enclosed
   
6. Approved maximum price per package
   
7. EU status summary:
   Approved indications
   Reimbursement status
   Marketing status
   
   If the applicant has enclosed a pharmacoeconomic analysis which adequately covers the requested information in items 8 to 13, and 15, it is not necessary to repeat this. Reference to this information is sufficient.
   
8. Description of illness and epidemiology (*):
   Description of the illness for which the drug is intended, including the effects of the illness in the short and long term. Description of the most relevant patient group(s) including current and anticipated development of prevalence / incidence.
   
9. Treatment regime for drug (*):
   Daily dosage
   Anticipated treatment period (Life-long treatment?)
   Continuous or intermittent treatment? (e.g. six months per annum).
   Outcome and adverse reactions of the drug in the relevant patient group.
   Use of any additional medication.
   
10. Overview of existing treatment programmes (*):
    Description of the Norwegian treatment tradition for the indication in question.
    Estimate of total number of patients cited for medicinal treatment for this indication.
    Drug consumption, including additional medication per preparation group as well as preparation (AUP and total number DDD sold) and national insurance costs of these for the indication.
    
11. Position of drug in treatment programme
    Is the drug a first-line preparation?
    Is the preparation particularly suited to special patient groups due to outcome, adverse reactions, formulation or other?
    Will the medication replace an existing drug or be a supplement to an existing treatment programme? Expected development of patient base / number of users of the new preparation.
    
12. Anticipated sales
    Current sales and projected sales development for the next five years (including this year) for the preparation (AUP and total number DDD sold, including sales under registration exemption).
    Indicate expected consumption reduction per preparation (by AUP and total number DDD sold) used in the current treatment programme where this is relevant.
    
13. Clinical benefits(*)
    If the applicant regards the product as having benefits of clinical significance, compared with relevant alternatives, such benefits should be described.
    Estimated portion of the indicated patient group that will realise this gain with the drug.
    
14. Pharmacoeconomic analyses
    The Norwegian Medicines Agency encourages enclosure of relevant pharmacoeconomic analyses.
    The applicant should make an assessment of the following:
    Is the analysis relevant with regard to indication and patient group?
    Are the problems to be addressed by the analysis and the assumptions clearly explained?
    Is the analysis transferable to Norwegian conditions? (Alternative treatment, resource data, costs data).
    
    See www.legemiddelverket.no/industri/retningslinjer_refusjon.htm "guidelines for pharmacoeconomic analyses"
    
15. Budgetary consequences
    The aggregate added expense for the National Insurance Administration with introduction of reimbursement for the drug shall be calculated (financial analysis) for the first five years subsequent to launch of the drug. Where relevant, the portion of the expense adjustment resulting from increase in number of patients and the portion resulting from transition to a more expensive medication shall be specified.
    
16. Studies
    Reference list of all published studies on the drug and studies in documentation previously sent to the Norwegian Medicines Agency earlier / in connection with application for marketing license, and enclosure of non-published studies of relevance to reimbursement application.
    

Sist gjennomgått: 18.10.2005
Første gang publisert: 18.10.2005