Glucosamine to be re-assessed by Danish Medicines Agency

By Mike Stones

- Last updated on GMT

Related tags: Osteoarthritis

The Danish Medicines Agency is to re-assess whether the state should continue to reimburse patients who buy the joint health supplement glucosamine (M01AX05) from pharmacies after clinical studies questioned its efficacy for the alleviation of painful osteoarthritis.

Patients in Denmark receive reimbursement automatically when they buy certain types of medicines on prescription at pharmacies.

The re-assessment will focus on glucosamine-containing medicines which have general conditional reimbursement when prescribed for the alleviation of symptoms of mild to moderate osteoarthritis and when prescribed to old-age pensioners.

If the Danish agency’s Reimbursement Committee recommends changing the reimbursement status of these medicines it will next consult with affected companies, scientific societies and patient organisations.

Lumbar arthritis

A key factor behind the Danish Medicines Agency’s decision to review glucosamine was a Norwegian study published in the Journal of the American Medical Association​ (JAMA) last July which questioned its effectiveness for patients with chronic low back pain and lumbar arthritis. The study, Effect of Glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis​, was conducted by Wilkens et al.

In their study, six months of daily supplementation of the joint health ingredient glucosamine sulfate did not appear to benefit people suffering from chronic low back pain (LBP) and degenerative lumbar osteoarthritis​ (OA), compared with a placebo.

Based on our results, it seems unwise to recommend glucosamine​ to all patients with chronic LBP and degenerative lumbar OA​,” wrote the Norwegian scientists in JAMA. Further research is needed to clarify whether glucosamine is advantageous in an alternative LBP population, they concluded.

The Danish agency also highlighted a new meta-analysis (review of existing studies) which concluded that health authorities should not grant reimbursement for glucosamine. This study, by Wandel et al, was published last September in the British Medical Journal.

Meanwhile, the Reimbursement Committee first asked the Danish Medicines Agency to re-assess the reimbursement status of glucosamine at its meeting on 21 September 2010.

The affected companies, the scientific societies and patient organisations have all been informed of the re-assessment.

General reimbursement

There are three types of general reimbursement in Denmark: General reimbursement for prescription-only medicines; conditional reimbursement for prescription-only medicines and conditional reimbursement for over-the-counter medicines.
When a company introduces a medicine onto the Danish market it can apply for general reimbursement to the Danish Medicines Agency.

The Danish Medicines Agency re-assesses regularly medicines’ general reimbursement status to satisfy the eligibility criteria, and to check that medicines without general reimbursement do not satisfy the criteria.

The reassessment process was adopted by the Danish Parliament in 2004.

The key criteria for determining the priority of re-assessments are: The significance of the medicines to the primary sector and particularly general practice, public health aspects, new evidence-based recommendations, high costs for patients and regions and high consumption.

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