Information for items marked with an asterisc (*) to be based on cited references, enclosed documentation or available references.
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, g) new package/ new article number
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.
If the application concerns drugs falling under items 2 g) and the pack-size does not differ by more than 20% compared to an excisting reimbursed pack-size, a separate reimbursement application is not required provided that the price apllication states that reimbursement is also applied for.
3. Description of product
- Preparation name
- Active agent
- Form of drug
- Recommended daily dosage
- Prescription group
- Medically approved indication
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 termas well as the severity of the disease. Description of the most relevant patient group(s) including current and anticipated development of prevalence / incidence.
9. Treatment regime for the 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
A pharmacoeconomic analysis shall be enclosed for all drugs falling under items 2a) -2c) when applying for inclusion in the reimbursement scheme.
See revised 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.
Reference list of all published studies on the drug and studies in documentation previously sent to the Norwegian Medicines Agency/ in connection with application for marketing license, and enclosure of non-published studies of relevance to reimbursement application.