Minutes of Reimbursement Committee meeting no. 298

Agenda
Minutes
Time and place
Participants

Agenda

I. 1. Minutes of meeting no. 296 of 22 January 2008
2. Chairman's report
3. Conflict of interests
4. Secretariat's report
Monthly statistics
Annual report from the Reimbursement Committee - 2007
5. Next meeting of the Reimbursement Committee
II. Application for general reimbursement
1. Champix (varenicline; for smoking cessation): Reapplication (2 nd time)
2. Toviaz (fesoterodine; for overactive bladder)
3. Eucreas (vildagliptin + metformin; for type 2 diabetes)
III. Questions related to the medical presentations
IV. Enquiry concerning Questran and reimbursement
V. Guiding criteria for single reimbursement to Grazax
VI. Individual reimbursement applications
VII. Any other business

Matters arising and resolutions passed at the meeting:

Re item I.1 Approval of minutes of Reimbursement Committee Meeting no. 296 held on Tuesday 22 January 2008.

The minutes were approved as presented.

Re item I.2. Chairman's report

• Mogens Laue Friis gave an account of the Institute for Rational Pharmacotherapy's large-scale meeting on hypertension, which was held on 31 January 2008 in the Danish Medicines Agency's canteen. Mogens Laue Friis noted the general support from the speakers for the Reimbursement Committee's recommendation concerning the future reimbursement status of medicinal products for hypertension.

• Mogens Laue Friis briefed the Committee about the Swedish Pharmaceutical Benefits Board's decision on reimbursement status for medicinal products for hypertension. Mogens Laue Friis noted that the Swedish authorities have made decisions that are in line with the recommendations which the Reimbursement Committee has reported to the Danish Medicines Agency and with similar reasoning.

• Mogens Laue Friis commented on the article "Økonomiske konsekvensberegninger belyst ved et eksempel" ("Economic feasibility studies illustrated by an example") published in the Journal of the Danish Medical Association (Ugeskrift for Læger) on 18 February 2008. The Reimbursement Committee and the Danish Medicines Agency intends to send a joint comment to the Journal of the Danish Medical Association concerning the article in question and briefly account for the decisions from 1995, 1998 and 2002 concerning the reimbursement status of lipid-lowering medicinal products. The decisions in question were all based on the knowledge available at the relevant times, and therefore they were evidence based.

• Mogens Laue Friis stated that he had been interviewed for the Danish Association of the Pharmaceutical Industry's newsletter concerning the work of the Reimbursement Committee.

Re item I.3. Coniflict of interests

None.

Re item I.4. Secretariat's report

• The Secretariat informed the Committee that the Danish Heart Foundation has replied that the Danish Medicines Agency's comment to Peter Clemmensen's statement in the members' journal "Hjertenyt" will not be published, as it is not the practice of "Hjertenyt" to publish comments to their articles.
  
• The Secretariat reported that the Danish Medicines Agency has received a reply from the National Board of Health in a case where the Agency obtained scientific advice from the National Board of Health's National Centre for Health Promotion and Disease Prevention as to whether the National Board of Health assesses that a girl that was raped is in a different position than other girls her own age concerning prevention with the HPV vaccine. The National Board of Health has replied that if the girl was infected with the HPV virus in connection with the rape, it would be too late to give her a vaccination after it was determined that she was pregnant. If the girl was not infected in connection with the rape, she is, from a preventive point of view, in the same position as other girls her age. On this basis, the Reimbursement Committee could not recommend that the application from a doctor for single reimbursement for the HPV vaccine be granted.
  
• The Secretariat mentioned that the Danish Medicines Agency plans to hold a large-scale meeting about reimbursement for medicinal products in the Danish Medicines Agency's canteen on 28 May 2008 from 13:30 to 17:00. The primary target group is the pharmaceutical industry, doctors, regional drug treatment advisers and Nordic reimbursement authorities. The preliminary programme was reviewed and the Secretariat received suggestions for further topics.
  
• The Secretariat reported that the medicinal products Aclasta and Bonviva injection fluid for patients receiving treatment at hospitals should be free of charge, as this would be classified as hospital treatment. If the medicinal products in question are injected at a general practitioner/specialist, the patients buy the medicine at a pharmacy and can be granted single reimbursement, if they meet the criteria. The Secretariat is aware that several hospitals do not finance Aclasta and Bonviva injection fluid for patients when the treatment takes place at the hospital, and therefore, Danish Regions will write to the health directors of each region and point out that hospital treatment is free of charge for patients.
  
• The 2007 draft annual report of the Reimbursement Committee was discussed. The Committee proposed a few changes.

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Re I.5 The next meeting of the Reimbursement Committee is scheduled for 25 March 2008

Re item II. Application for general reimbursement

• Champix (varenicline; for smoking cessation): reapplication (2 nd time): The reapplication was recommended for rejection of both the general reimbursement and the general conditional reimbursement. The Committee finds that Champix® for some smokers may be a good and cost-effective element in a programme helping them to stop smoking. In this connection the Committee notes that the National Institute for Health and Clinical Excellence (NICE) in the UK has recommended Champix® for smokers who want to stop smoking, primarily as part of a programme with behavioural support.

Yet, the Committee maintained its previous recommendation not to grant general reimbursement to Champix®, and not to grant reimbursement to pharmacological treatment of smoking cessation. The Committee estimates that there is a risk that Champix® will be used as a first line treatment for smoking cessation. The Committee does not find this appropriate, as non-pharmacological measures, such as quit smoking courses, ought to be the first line treatment in the Committee's opinion. Pharmacological treatment may be part of a quit smoking course.

The Committee finds that it would be appropriate to carry out a joint evaluation and thereby ensure organisation of all smoking cessation measures in the health area, including the financing of these measures. In this connection, the Committee refers to the recommendations in a NICE report from February 2008, which aims to ensure that smoking cessation measures are as effective as possible. This report comprises a joint evaluation of all smoking cessation measures, including pharmacological treatment.

• Toviaz (fesoterodine; for overactive bladder): Application recommended for general reimbursement without a limitation clause. The Committee based its recommendation on the fact that the price of the medicinal product was proportionate with its therapeutic value. Toviaz® contains the same active metabolite as tolterodine (active substance in Detrusitol Retard®), and the two medicinal products have a comparable effect on the symptoms occurring in patients with an overactive bladder as well as a comparable adverse reaction profile. The price of Toviaz® is also at the same level as the price of the analogue medicinal products with the same use, including Detrusitol Retard®. All of these analogue medicinal products are eligible for general reimbursement.

• Eucreas (vildagliptin + metformin; for type 2 diabetes): Application recommended for general reimbursement without a limitation clause. The Committee based its recommendation on the fact that the price of the medicinal product was proportionate with its therapeutic value. Eucreas® is a combination product of two known substances (vildagliptin and metformin) for treatment of patients with type II diabetes mellitus. The price of treatment with Eucreas® is at the same level as the price of treatment with the two substances in separate formulations. Currently, medicinal products containing metformin or vildagliptin are eligible for general reimbursement.

Moreover, the Committee has emphasised that the combination of the two substances in one tablet may be an advantage in terms of compliance for the patient group in question, which is often treated with several medicinal products at the same time.

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Re item III. Questions related to the medical presentations

The Committee discussed the content of the medical presentations, which is part of the basis for the Reimbursement Committee's recommendations for the Danish Medicines Agency. In the opinion of the Committee, the presentations cover the topics relevant to the Reimbursement Committee, i.e.:

• Description of the disease and the current treatment (pharmacological and non-pharmacological)
• Introduction with indication and dose
• Pharmacodynamics
• Pharmacokinetics
• Clinical effect
• Adverse reactions
• Interactions
• Conclusion

Re item IV. Enquiry concerning Questran and reimbursement

The Committee discussed an enquiry from a head physician concerning Questran and general reimbursement for the diagnosis bile acid malabsorption. The basis for the enquiry is that the department has many patients with this condition and therefore it submits many single reimbursement applications.

The Committee recommended that the reimbursement for Questran remains limited to patients with hyperlipidemia requiring treatment, where treatment with statins, which are eligible for general reimbursement, has proven insufficient or where the patient is intolerant of these medicinal products. The background to the Committee's opinion is that it is found significant that bile acid malabsorption is documented in each case. In addition, compared to the total number of single reimbursement applications for Questran, each gastroenterological department in Denmark statistically only submit few applications per month.

Re V. Guiding criteria for single reimbursement for Grazax

On the basis of some questions from the Secretariat - especially in relation to cases with systemic adverse reactions by subcutaneous immunisation relative to the guidance criteria that single reimbursement can be granted to Grazax if a patient cannot be subcutaneously immunised due to dramatic local reactions - the Committee discussed the guidance criteria for single reimbursement for Grazax. The Committee maintains that the guidance criteria should remain in effect.

Re item VI. Individual reimbursement applications

The Committee processed 121 applications, which the Secretariat did not find entirely suitable for approval. Of these applications, 68 were rejected.

Re item VII. Any other business

None.

Time and place

The meeting was held on Tuesday 26 February 2008 at the Danish Medicines Agency, Axel Heides Gade 1, DK-2300 Copenhagen S, Denmark .

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Participants

Committee members:
Karine Bech
Mogens Laue Friis (chairman)
Mogens Sandbjerg Hansen
John Larsen
Peder Ring (Danish Regions)

The following committee member had sent her apologies for the meeting:
Ellen-Christine Beiter

Secretariat:
Nina Bjarnason
Erik Carlsen
Safiye Er
Jesper Winther Kock
Karen Kolenda
Ulla Kirkegaard Madsen
Katrine Dall Mark
Pernille Fonnesbæk Rasmussen
Michael Røder
Elisabeth Thomsen
Iben Lund Thonesen

Minute-taker:
Karen Kolenda

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