Applications for individual reimbursement of medicinal products in 2006

Number of applications submitted for individual reimbursement of medicinal products in 2006
Fewer applications for reimbursement for the chronically ill
Fewer applications for increased reimbursement
Fewer applications for single reimbursement
Single reimbursement applications by groups of medicinal product

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Number of applications submitted for individual reimbursement of medicinal products in 2006

In 2006, the Danish Medicines Agency reviewed some 106,700 applications for single reimbursement (down 4% on 2005), approx. 14,600 applications for reimbursement for the chronically ill (down 37% on 2005), approx. 9,200 applications for reimbursement for the terminally ill (same level as in 2005) and approx. 2,700 applications for increased reimbursement (same level as in 2005, cf. table 1 below).

In 2006, we received a total of 133,351 individual reimbursement applications against 146,075 in 2005, corresponding to a fall of 8.7%.

Fewer applications for reimbursement for the chronically ill

In 2006, the applications for reimbursement for the chronically ill declined considerably compared with 2005, which shall be seen in the light of quite many reimbursement renewals effected in 2005. The many reimbursements with a five-year duration granted in connection with the commencement of the scheme in 2000 expired in 2005. Compared with 2004, the number of applications for reimbursement for the chronically ill increased in 2006 in response to the abovementioned reimbursement renewals for the chronically ill.

Fewer applications for increased reimbursement

As of 1 April, new reimbursement rules entered into force. The new rules imply that the size of reimbursement is based on the lowest price instead of the lowest European price in a substitution group. For some groups of medicinal products this resulted in great variations in patient charges between the cheapest and most expensive medicinal product of the same substitution group, which in 2005 produced a higher number of applications for increased reimbursement as regards the more expensive original products. In 2006, the number of applications for increased reimbursement fell by 2%.

Table 1. Number of applications for individual reimbursement, 2000-2006  

* The reimbursement systems for the chronically and terminally ill were introduced with the Danish National Health Service Act on 1 March 2000.

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Fewer applications for single reimbursement

In 2006, the number of applications for single reimbursement fell by 4% on 2005: One of the reasons was an extensive fall in the number of applications for single reimbursement for selective COX-2 inhibitors (90.5%) and the glitazones (Avandia, Avandamet and Actos) (62.8%), which became subject to general reimbursement in 2006. Furthermore, a decreasing number of doctors apply for single reimbursement of dermatologicals in ATC Group D11AX, impotence products and medicinal products for neuropathic pain. These groups of medicinal products constitute just a few of the groups within which we receive many applications.

In 2006, 6.2% of single reimbursement applications were rejected. This represents a fall on 2005, which saw a rejection rate of 9.2%.

The National Health Service’s expenditure on reimbursement under the single reimbursement system amounted to DKK 697m or 10% of the National Health Service’s total medicine expenditure in 2006.

Single reimbursement applications by groups of medicinal products

Table 2 below shows the groups of medicinal products with the highest number of single reimbursement applications in 2006.

Medicinal products for secondary prevention of blood clots
Bisphosphonates, raloxifene and strontium for preventive treatment of fractures
Elidel and Protopic
Medicinal products for Alzheimer’s dementia
products for impotence
Lantus and Levemir
Gabapentin and Pregabalin
Selective COX-2 inhibitors
Glitazones
Weight loss products
Forsteo and Preotact

Medicinal products for secondary prevention of blood clots (e.g. dipyridamole and clopidogrel) still constitute the group of medicinal products with the most single reimbursement applications (nearly 20%). Generally, the volume of applications in this group is on a par with 2005.

For the first time in five years, we saw a small decrease (5%) in the number of single reimbursement applications for Bisphosphonates, raloxifene and strontium for preventive treatment of fractures. One explanation could be that bisphosphonates have entered the market in the form of less expensive generic products, meaning that some patients may be likely to buy the product without a reimbursement licence. Another explanation could be that a rising number of patients are treated with parathyroid hormone (Forsteo or Preotact) rather than other products. The number of single reimbursement applications for Forsteo and Preotact has thus increased (57.5 %) compared with 2005.

Single reimbursement applications for medicinal products for treatment of atopic dermatitis and actinic keratosis (a carcinoma of the skin) continued to fall considerably (23.7%). The primary reason for this considerable decrease is a decline in the single reimbursement applications for Elidel (pimecrolimus) and Protopic (tacrolimus) for treatment of atopic dermatitis with patients who do not respond satisfactorily or are intolerant to less expensive conventional treatment. Elidel saw the largest decrease of 47.7%; Protopic fell by 18.3%. The decrease, which began already in 2005, is probably a result of the Danish Medicines Agency’s recommendation issued in March 2005 of cautious use of Elidel and Protopic for the treatment of atopic dermatitis in response to reports on incidents of skin and lymphatic cancer.

Single reimbursement applications for medicinal products for Alzheimer’s dementia continued to rise (13.6%). The increase is not as big as in 2005. The 2006-increase may be due to the fact that an increasing number of 70-year-olds were made subject to an MMSE test for renewal of their drivers licence as of 1 May 2006 . Alzheimer’s dementia may have been diagnosed in connection with these tests.

The decline in the number of applications for single reimbursement for products for impotence may be attributable to the fact that no new products within this group entered the market that could have induced patients to switch to a new product, thus having generated a number of single reimbursement applications.

The number of applications for single reimbursement for the long-acting insulin analogues Lantus and Levemir is rising, most likely because Lantus and Levemir have not been sold on the market for that long a period, meaning that they have yet to find their place in the treatment of diabetes.

Applications for medicinal products for the treatment of neuropathic pain (gabapentin and pregabalin)fell by 20.5% in 2006. 2006 saw fewer applications for Lyrica compared with 2005 where the number of applications jumped following the entry of Lyrica on the market in October 2004. The Lyrica rejection rate fell to 34.9% in 2006 down from 57.4% in 2005.

The number of applications for reimbursement of selective COX-2 inhibitors fell considerably on 2005 (90.5%). The application rejection rate remains high (80.4%) because the Danish Medicines Agency still urges doctors – at the recommendation of the Reimbursement Committee – to be cautious about treating patients with selective COX-2 inhibitors due to the risk of cardiovascular complications.

In March 2006, the relatively new antidiabetic (rosiglitazone) became eligible for general reimbursement, and another glitazone (pioglitazone) in November 2006. Consequently, the single reimbursement applications for glitazones dropped in 2006 (62.8%).

Following a general decrease in the number of applications for single reimbursement for weight loss products since 2003, applications increased by 94.5% on 2005. This may be due to the entry of a new weight loss product (rimonabant), which entered the market in August 2006. The rejection rate within this group remains high at 39%.

Compared with 2005, 2006 reported a large increase in the number of single reimbursement applications for Forsteo and Preotract (57.5%) for the treatment of osteoporosis. The criteria for single reimbursement of Forsteo and Preotact have been tightened compared with single reimbursement for the bisphosphonates, raloxifene and strontium as the treatment ought only to be offered to patients with vertebral fracture caused by osteoporosis who may benefit from treatment by the expensive medicinal products Forsteo or Preotact.

The Reimbursement Committee has specified the criteria for medicinal products for which reimbursement is often applied. In general, these criteria must be met before reimbursement can be granted. The factbox to the right provides information on the criteria applicable to the largest groups of medicinal products (measured by volume). The criteria are adjusted as required by new scientific documentation in which case it is also published in the Journal of the Danish Medical Association (Ugeskrift for Læger). The Danish Medicines Agency has prepared application form templates for use by doctors for the medicinal products that receive the most applications and for which single reimbursement is granted, and otherwise where deemed appropriate. The application forms include the guidance reimbursement criteria and are available at www.laeger.dk.

In 2006, the doctors were given the possibility to apply for single reimbursement digitally. Using a digital signature, doctors may log on to www.sundhed.dk and access the digital application system via the Medicine Profile, thereby sending reimbursement applications directly to the reimbursement system of the Danish Medicines Agency.

For further information, please contact Karen Kolenda or Jesper Winther Koch.

Danish Medicines Agency, 3 April 2007

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Table 2. Groups of medicinal products that receive the most single reimbursement applications, 2002-2006

1) Was marketed during the second half of 2002.
2) Was marketed in 1998.
3) Was marketed in 2000.
4) Was marketed in 1999.
5) Reimbursement change as from 28 April 2003 .
6) Was marketed in 2004.
7) Was marketed in 2003.
8) The general reimbursement was eliminated as from 25 October 2004 .
9) Was marketed in December 2004
10) Was marketed in August 2006.