Number of applications for individual reimbursement of medicinal products in 2008

28 April 2009

Reimbursement for the chronically ill
Increased reimbursement
Single reimbursement
Medicinal product groups subject to the most single reimbursement applications

In 2008, the Danish Medicines Agency reviewed some 105,000 applications for single reimbursement (down 5% on 2007), approx. 21,800 applications for reimbursement for the chronically ill (down 20% on 2007), approx. 10,200 applications for reimbursement for the terminally ill (a small increase on 2007) and approx. 1,700 applications for increased reimbursement, which is about 13% less than in 2007, cf. table 1 below.

In 2008, we processed a total of 139,044 individual reimbursement applications against 141,373 in 2007, corresponding to a fall of 1.7 %.

Table 1. Number of applications for individual reimbursement, 2002-2008  

2002

2003

2004

2005

2006

2007

2008

Single reimbursement

77,513

84,519

96,594

111,218

106,753

111,279

105,229

Reimbursement for the chronically ill

8,141

9,548

10,166

23,071

14,633

18,231

21,828

Reimbursement for the terminally ill

8,568

8,564

8,883

9,023

9,252

9,831

10,218

Increased reimbursement

69

55

102

2,766

2,713

2,032

1,769

Reimbursement for the chronically ill

In 2008, the number of applications for reimbursement for the chronically ill continued to increase. On 1 January 2008, the reimbursement threshold for reimbursement for the chronically ill was first reduced from DKK 17,545 to DKK 16,827. On 1 May 2008, the thresholds were once again adjusted, reducing the reimbursement threshold for the chronically ill to DKK 15,100. These adjustments meant that more citizens could now benefit from the reimbursement for the chronically ill, and the number of applications increased as a result.

Increased reimbursement

Table 2. Increased reimbursement 2007 and 2008. Closed cases.

2007

2008

-

+

Total

-

+

Total

N03AX09: Lamotrigine

187 (22 %)

666
(78 %)

853

131 (22 %)

457
(78 %)

588

C10AA01: Simvastatin

18
(20 %)

71
(80 %)

89

42
(35 %)

79
(65 %)

121

N06AB06: Sertraline

40
(25 %)

119
(75 %)

159

49
(47 %)

56
(53 %)

105

C08CA01: Amlodipine

51
(35 %)

93
(65 %)

144

45
(47 %)

51
(53 %)

96

A02BC01: Omeprazole

27
(36 %)

47
(64 %)

74

35
(37 %)

60
(63 %)

95

N05AX08: Risperidone

0

0

0

33
(37 %)

57
(63 %)

90

N06AB04: Citalopram

25
(36 %)

44
(64 %)

69

18
(31 %)

40
(69 %)

58

N02CC01: Sumatriptan

51
(43 %)

68
(57 %)

119

27
(52 %)

25
(48 %)

52

N06AX11: Mirtazapine

10
(45 %)

12
(55 %)

22

21
(53 %)

19
(47 %)

40

Other

198 (39 %)

305
(69 %)

503

276 (54 %)

232
(46 %)

508

Total

607 (30 %)

1425 (70 %)

2032

677 (39 %)

1076 (61 %)

1753

Number of people

513

860

1331

542

663

1161

The total number of applications for increased reimbursement dropped by 14% from 2,032 in 2007 to 1,753 in 2008. The decrease was spread over different ATC groups, e.g. lamotrigine, sumatriptan, amlodipine and sertraline. The year saw an increase in applications for risperidone-containing medicinal products, which is due to the fact that generics containing the same active ingredient were marketed for the first time in December 2007. Therefore, it had not been relevant to apply for increased reimbursement for this product until 2008.

The percentage of granted applications decreased from 70% in 2007 to 61% in 2008. However, it should be taken into consideration that the percentage of applications granted in 2007 had climbed from 53% in 2006. There is no immediate explanation to the decline in 2008, other than the nature of the applications, as there has been no change in administrative practice.

In December 2006, the Danish Medicines Agency introduced a new practice for the assessment of applications involving increased reimbursement for patients with epilepsy. The new practice implies that patients with epilepsy whose threshold for effective therapy is particularly high and who are difficult to treat at the curative dose due to clinically unacceptable adverse reactions have the possibility of receiving increased reimbursement for an epilepsy product that is more expensive than the reimbursement price. Most of the applications for increased reimbursement for epilepsy patients with a particularly high threshold for effective therapy we receive from hospital specialty wards. Under the new practice, increased reimbursement for patients with epilepsy is conditional on the patient having first been started on the medicinal product that was cheapest at that time. Therefore, we have investigated which medicinal products within ATC group N03AX09: Lamotrigine has been the subject of increased reimbursement grant applications, cf. table 3 below. In 2006, applications for generics accounted for 5%, in 2007 11% and in 2008 15%.

Table 3

2006

2007

2008

+

-

Total

+

-

Total

+

-

Total

Lamictal

385

428

813

581

178

759

380

117

497

Lamotrigine
”1A Farma”

0

2

2

6

1

7

2

3

5

Lamotrigine ”Actavis”

6

7

13

31

0

31

52

5

57

Lamotrigine ”Alternova”

0

0

0

0

0

0

0

1

1

Lamotrigine
”BMM Pharma”

0

0

0

0

0

0

2

0

2

Lamotrigine ”Copyfarm”

2

11

13

16

5

21

17

2

19

Lamotrigine ”Hexal”

6

3

9

14

0

14

4

3

7

Lamotrigine
”Merck NM”

0

0

0

3

0

3

0

0

0

Lamotrigine ”Ratiopharm”

6

2

8

15

3

18

0

0

0

Lamotrigine ”Stada”

0

1

1

0

0

0

0

0

0

Single reimbursement

In 2008, the number of submitted applications for single reimbursement fell approx. 5% on 2007. The fall is attributable to the fact that some medicinal products that were previously administered under the single reimbursement scheme were granted general reimbursement in 2008. In addition, the reimbursement status for Levemir and Lantus was changed to general reimbursement in 2007. In May 2008, Persantin and Persantin Retard changed status to general reimbursement. In December 2008, Elidel and Protopic changed status to general reimbursement.

In 2008, 5.3% of the applications for single reimbursement were refused, as little less than in 2007 when the refusal rate was 6.0%.

The Danish Regions' expenditure on reimbursement granted under the single reimbursement scheme amounted to DKK 857 million or 12% of the Danish Regions' total medicine expenditure in 2008.

Medicinal product groups subject to the most single reimbursement applications

Medicinal products for secondary prevention of blood clots
Bisphosphonates, raloxifene and strontium
Elidel and Protopic
Medicinal products for Alzheimer’s dementia
Products for impotence
Gabapentin and Pregabalin
Psychostimulants
Products for genital warts
Weight loss products

Table 4 below shows the groups of medicinal products subject to the most single reimbursement applications.

Medicinal products for secondary prevention of blood clots (e.g. dipyridamole and clopidogrel) still make up the group of medicinal products with the most single reimbursement applications (19 %). However, the number of applications within this group decreased on 2007, which may presumably be ascribed to the fact that dipyridamole (Persantin and Persantin Retard) was granted general reimbursement in May 2008.

The number of applications for single reimbursement within the group of bisphosphonates, raloxifene and strontium for preventive treatment of fractures has once again decreased (10.4%). The reason that the number of applications has dropped further compared with 2007 could be that the generic products to bisphosphonates having entered the market over the recent years are still within a price range that does not prevent the patient from buying the product without reimbursement. An other explanation for the further decline in applications compared with 2007 could be that fewer product switches between bisphosphonates and raloxifene and strontium have taken place, which has led to fewer applications for single reimbursement for these products.

Compared with 2007, there was a small increase of 1.3% in the number of applications for single reimbursement of medicinal products for the treatment of atopic dermatitis and actinic keratosis (a carcinoma of the skin). In mid-December 2008 Elidel (pimecrolimus) and Protopic (tacrolimus) for the treatment atopic dermatitis were granted general reimbursement.

Single reimbursement applications for medicinal products for Alzheimer’s dementia continued to rise (14.7%), exceeding the increase in 2007.

The number of applications for single reimbursement of products for impotence has increased by 15.9%. A new product for impotence came on the market in 2008, which may have contributed to the increase.

In 2008, the number of applications for medicinal products for the treatment of neuropathic pain (gabapentin and pregabalin) was 24.3 % higher than in 2007 due to a higher number of applications for pregabalin. The increase may be a result of the fact that the indication for pregabalin was changed to include patients diagnosed with generalised anxiety disorder. Another factor contributing to the increase is that from 15 May 2007, we have established reimbursement grants based on telephone contact with pharmacies, doctors or patients in response to patients having switched from gabapentin to pregabalin (or the other way round) if the patient in question had previously been granted reimbursement for gabapentin but now has been prescribed pregabalin (or the other way round).

The number of applications for psychostimulants (e.g. methylphenidate and modafinil) increased dramatically in 2008 (49.9%) compared with 2007. This increase is a consequence of an increase in adults diagnosed with ADHD (Attention Deficit Hyperactivity Disorder), previously known as DAMP.

2008 also saw a big increase in products for the treatment of genital warts (e.g. imiquimod), which grew by 31.3% on 2007. Imiquimod is indicated in adults for the treatment of external condylomata acuminata and small superficial basal cell carcinomas, but also in adults with a normal immune system for the treatment actinic keratoses when other local treatment is inappropriate.

In November 2008, rimonabant was withdrawn from the Danish market, which led to a large decrease in the number applications for single reimbursement of weight loss products (38.8%) in 2008. Rimonabant was withdrawn when EMEA reported, in October 2008, that the marketing authorisation for rimonabant would be suspended due to the risk of psychiatric side effects - including depression. Rimonabant was marketed in August 2006 and prompted a massive increase (94.5%) in the number of applications for single reimbursement of weight loss products compared with 2005. In 2007, the number of applications had risen further compared with 2006 (163.3%) and rimonabant accounted for the majority of applications (85.8%).

In respect of those medicinal products that are often the subject of single reimbursement applications, the Reimbursement Committee has laid down guiding criteria that must usually be met before a patient can be granted reimbursement. These guiding criteria are available at the website of the Danish Medicines Agency www.dkma.dk. The guiding criteria are adjusted in compliance with new scientific documentation, e.g. new treatment guidelines, in which case they are also published in the Journal of the Danish Medical Association (Ugeskrift for Læger). The Danish Medicines Agency has prepared standardised application forms for many of the medicinal products that are awarded the most single reimbursement grants. The guiding criteria are incorporated in these forms. The forms are in Danish and available at www.laeger.dk.

Since 1 October 2006, doctors have been able to submit applications for individual reimbursement electronically via the Medicine Profile by means of a digital signature. In 2008, about 13% of all individual applications for medicine reimbursement were submitted electronically. This is more than in 2007 when the share of electronic applications accounted for 8%. In 2008, we received electronic applications from 1,050 different provider IDs/hospital wards. In 2007, the number was 884.

For further information, please contact Karen Kolenda, kko@dkma.dk

Table 4: Groups of medicinal products that receive the most single reimbursement applications, 2004-2008 Total number of applications and number of grants (+) and number of refusals (÷).

2004

2005

2006

2007

2008

Change % (07/08)

B01

Prevention of blood clots (e.g. dipyridamole and clopidogrel)

 

18,434 +:17,839 ÷:595

 

22,071 +:21,255 ÷:816

21,950 +:21,402 ÷:548

22,561 +:20,101 ÷:2,460

20,168 +:19,873 ÷:295

-10,6

M05

Products for osteoporosis (e.g. bisphosphonates with and without vitamin D, and raloxifene and strontium ranelate)

12,396 +:10,876 ÷:1,520

17,187 +:15,879 ÷:1,308

16,320 +:15,417 ÷:903

14,582 +:13,823 ÷:759

13,063 +:12,350 ÷:713

-10,4

D11AX

Products for atopic dermatitis and actinic keratosis (e.g. pimecrolimus, tacrolimus and solaraze)

9,127 +:8,954 ÷:173

7,206 +:7,109 ÷:97

5,502 +:5,263 ÷:239

5,272 +:5,201 ÷:71

5,340 +:5,285 ÷:55

1,3

N06

Products for Alzheimer’s disease

8,576 +:8,264 ÷:312

10,160 +:9,760 ÷:400 

11,545 +:10,988 ÷:557

 

12,312 +:11,843 ÷:469

 

14,121 +:13,779 ÷:342

14,7

G02

Products for hypemenorrhoea/menorrhagia (e.g. progesterone intrauterine device)

4,879 +:4,667 ÷:212

5,643 +:5,403 ÷:240

6,308 +:6,216 ÷:92

7,542 +:7,448 ÷:94

8,001 +:7,865 ÷:136

6,1

G04

Products for erectile dysfunction (e.g. alprostadil and sildenafil)

3,690 +:3,067 ÷:623

4,355 +:3,841 ÷:514

3,907 +:3,429 ÷:478

3,771 +:3,343 ÷:428

4,371 +:3,942 ÷:429

15,9

J01A

Tetracyclines

 

2,932 +:2,912 ÷:20

 

3,095 +:3,064 ÷:31

3,530 +:3,500 ÷:30

3,589 +:3,538 ÷:51

3,197 +:3,188
÷:9

-10,9

N03

Products for neuropathic pain (e.g. Gabapentin and Lyrica)

2,750 +:2,127 ÷:623

5,189 +:3,024 ÷:2,165 

4,128 +:2,741 ÷:1,387

 

4,759 +:3,817 ÷:942

 

5,914 +:5,215 ÷:699

24,3

A06

Laxatives (e.g. sodium picosulphate)

1,937 +:1,840 ÷:97

1,966 +:1,782 ÷:184

1,924 +:1,766 ÷:158

 

2,260 +:2,045 ÷:215

 

2,550 +:2,320 ÷:230

12,8

N06

Psychostimulants (e.g. methylphenidate and modafinil)

1,496 +:1,451 ÷:45

 

1,898 +:1,847 ÷:51

 

2,442 +:2,376 ÷:66

4,305 +:4,190 ÷:115

6,453 +:6,307 ÷:146

49,9

D06

Products for genital warts (e.g. imiquimod)

1,033 +:1,024 ÷:9

1,350 +:1,326 ÷:24

1,458 +:1,438 ÷:20

1,693 +:1,669 ÷:24

2,223 +:2,201 ÷:22

31,3

A08

Products for obesity (e.g. orlistat, rimonabant)

613
+:246 ÷:367

475
+:231 ÷:244

924
+:563 ÷:361

2,433 +:1,845 ÷:588

1,488 +:1,079 ÷:409

-38,8

H05AA02

Products for osteoporosis (Forsteo and Preotact)

523
+:495
÷:28

510
+:465
÷:45

803
+:754
÷:49

885
+:842
÷:43 

852
+:802
÷:50

-3,7


Lægemiddelstyrelsen, 28 April 2009

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