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Number of applications for individual reimbursement of medicines in 2011

02 March 2012
Reimbursement for the terminally ill
Reimbursement for the chronically ill
Increased reimbursement
Single reimbursement
Groups of medicines generating the highest number of single reimbursement applications
Electronic applications

In 2011, the Danish Medicines Agency (now the Danish National Board of Health) reviewed approx. 103,000 applications for single reimbursement (about 7 % more than in 2010), approx. 26,000 applications for reimbursement for the chronically ill (about 30 % less than in 2010), approx. 12,000 applications for reimbursement for the terminally ill (about 3 % more than in 2010) and approx. 2,500 applications for increased reimbursement (about 12 % less than in 2010), cf. table 1 below.

In 2011, we reached decisions in a total of 143,057 individual reimbursement applications against 146,334 in 2010, corresponding to a fall of 2 %.

Table 1: Number of applications for individual reimbursement, 2007-2011

2011

2010

2009

2008

2007

Single reimbursement

103,338

96,232

99,565

105,229

111,279

Reimbursement for the chronically ill

23,260

33,704

25,895

21,828

18,231

Reimbursement for the terminally ill

11,912

11,514

10,739

10,218

9,831

Increased reimbursement

2,536

2,874

2,515

1,769

2,032

Total

143,057

146,334

140,723

141,052

143,380

Reimbursement for the terminally ill

Applications have increased steadily over the years. The increase might reflect a change in doctors' practice of when they apply for reimbursement for the terminally ill over time. When a doctor applies for reimbursement for the terminally ill, the doctor pledges that the patient has an incurable diagnosis and an estimated short time to live. We experience from conversations with doctors and citizens that reimbursement for the terminally ill is often applied for when just one of the statutory conditions are satisfied: the patient is terminally ill, but not necessarily with a short time left to live. The increase in the number of applications for reimbursement for the terminally ill is particularly noteworthy because the number of annual deaths has been decreasing in the period 2007-2011.

Reimbursement for the chronically ill

In 2011, we saw a fall in the number of applications for reimbursements for the chronically ill. It is likely that the increase is due to the fact that in 2011 it was not possible to obtain such a grant for fertility medicine as a result of the legislative amendments in the area in the period 1 January 2011 to 31 January 2011. Apart from this aspect, 2010 marked the close of a five-year cycle of the needs-based reimbursement system, which was introduced in 2010. And since most chronically ill grants are awarded for five years, there are many applications every fifth year.

Increased reimbursement

Table 2: Number of applications for increased reimbursement in 2010-2011 for the medicines most frequently applied for

2011

2010

Refused

Granted

Total

Refused

Granted

Total

A02BC01:
Omeprazole

19

59.4%

13

40.6%

32

22

55.0%

18

45.0%

40

A02BC02:
Pantoprazole

16

27.6%

42

72.4%

58

37

52.1%

34

47.9%

71

A02BC05:
Esomeprazole

3

100.0%

0

0.0%

3

46

69.7%

20

30.3%

66

B01AC04:
Clopidogrel

109

46.4%

126

53.6%

235

79

48.5%

84

51.5%

163

C07AB02:
Metoprolol Succinate

70

68.6%

32

31.4%

102

36

47.4%

40

52.6%

76

C08CA01:
Amlodipine

9

28.1%

23

71.9%

32

25

39.1%

39

60.9%

64

C09CA01:
Losartan

114

44.5%

142

55.5%

256

157

57.3%

117

42.7%

274

C09DA01:
Losartan/Thiazide

87

51.2%

83

48.8%

170

81

51.6%

76

48.4%

157

C10AA05:
Atorvastatin

24

72.7%

9

27.3%

33

15

71.4%

6

28.6%

21

N02AB03:
Fentanyl

11

16.2%

57

83.8%

68

4

40.0%

6

60.0%

10

N03AX09:
Lamotrigine

40

14.0%

246

86.0%

286

57

13.7%

360

86.3%

417

N03AX11
Topiramat

39

39.4%

60

60.6%

99

101

38.7%

160

61.3%

261

N04BC05:
Pramipexole

31

52.5%

28

47.5%

59

0

0

00

N06AB04:
Citalopram

14

12.1%

102

87.9%

116

11

95.2%

217

95.2%

228

N06AB05:
Paroxetine

2

5.0%

38

95.0%

40

5

73.7%

14

73.7%

19

N06AB06:
Sertraline

15

21.1%

56

78.9%

71

13

78.3%

47

78.3%

60

N06AB10:
Escitalopram

8

47.1%

9

52.9%

17

42

74.2%

121

74.2%

163

N06AX16:
Venlafaxine

37

9.0%

375

91.0%

412

58

84.0%

305

84.0%

363

Other

256

57.3%

191

42.7%

447

152

63.9%

269

63.9%

421

Total

904

35.6%

1,632

64.4%

2,536

941

67.2%

1,933

67.2%

2,874

Number of persons

1,605

1,657

While the total number of applications for increased reimbursement fell by 12 % in 2011, from 2,867 in 2010 to 2,523 in 2011, the number of persons on behalf of which increased reimbursement has been applied for fell slightly. The acceptance rate for all applications fell slightly from 2010 (67 %) to 2011 (64 %).

2011 saw an increase in the number of applications for medicines containing clopidogrel, metoprolol succinate, fentanyl and pramipexole. For fentanyl and pramipexole, this is a result of drops in the reimbursement price in 2011.

Single reimbursement

In 2011, 11 % of single reimbursement applications were refused (11,819 of 103,338), compared to 8 % in 2010 (7,716 of 96,232). The refusal rate has been approx. 6 % over the preceding 3 years. The increase in refusals can be ascribed to refusals in the groups: 'Medicines acting on the renin angiotensin system' and 'Drugs for acid-related disorders'.

The Danish regions' expenditure on reimbursement granted under the single reimbursement scheme amounted to DKK 954 million or (954/6,600 =) 14.5 % of the Danish regions' total medicine expenditure in 2011. The corresponding figure for 2010 was 12.5 %.

Groups of medicines generating the highest number of single reimbursement applications

The number of single reimbursement applications was 7 % higher than in 2010. The increase may be ascribed to medicines that previously carried general reimbursement, but which lost it as a result of the reassessment process. The groups "Medicines acting on the renin angiotensin system" as well as "Drugs for acid-related disorders" were thus among the medicines receiving the most applications. (Table 3.)

Table 3 below shows the groups of medicines that generated the highest number of single reimbursement applications in 2011.

Table 3: Groups of medicinal products receiving many single reimbursement applications, 2010-2011. Total number of applications, applications granted and refused

2011

Change

2010

Refused

Granted

Total

(10/11)

Refused

Granted

Total

N06DA

Anti-dementia drugs
(Anticholinesterases)

567

11,834

12,401

8.0%

362

11,123

11,485

N06BA

Psychostimulants
(methylphenidate, atomoxetine
and modafinil)

543

11,580

12,123

2.8%

495

11,303

11,798

M05

Drugs for treatment of bone disease
(e.g. bisphosphonates, raloxifene,
strontium ranelate and
denosumab)

329

8,494

8,823

40.4%

263

6,022

6,285

G02

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

79

8,671

8,750

3.3%

109

8,360

8,469

C09

Agents acting on the renin-
angiotensin system

2,211

5,571

7,782

283.5%

851

1,178

2,029

N06DX

Anti-demential drugs
(e.g. memantine)

238

4,923

5,161

12.4%

108

4,484

4,592

N03AX

Products for neuropathic pain
(e.g. gabapentine and pregabalin)

985

3,602

4,587

-17.1%

1,403

4,130

5,533

J01A

Tetracyclines

21

4,471

4,492

19.6%

29

3,727

3,756

A06

Laxatives
(e.g. sodium picosulphate)

151

4,260

4,411

35.2%

180

3,083

3,263

NOT REG

394

3,216

3,610

-44.7%

454

6,079

6,533

G04

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

248

3,221

3,469

-1.6%

309

3,216

3,525

A02

Drugs for acid-related disorders

1,201

1,736

2,937

311.9%

354

359

713

Magistral

272

2,633

2,905

-8.1%

198

2,962

3,160

D06

Products for genital warts
(e.g. imiquimod)

45

2,575

2,620

10.7%

51

2,315

2,366

D

Products for actinic keratosis
(e.g. imiquimod and diclofenac)

55

1,473

1,528

22.0%

56

1,196

1,252

G03

Sex hormones

123

1,301

1,424

28.2%

140

971

1,111

C10

Lipid modifying agents

696

493

1,189

88.4%

167

464

631

H05AA

Products for osteoporosis
(Forsteo and Preotact)

66

1,084

1,150

-12.0%

94

1,213

1,307

B01

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

192

259

451

-94.6%

251

8,112

8,363

N06D Anti-dementia drugs (e.g. donepezil, rivastigmine, galantamine and memantine)

The number of single reimbursement applications continued to increase (9.9 %). In 2010, the increase was larger than the increase in 2009 compared to 2008 (3.6 %).

N06BA Centrally acting sympathomimetics (e.g. methylphenidate, atomoxetine and modafinil)

In 2011, the number of single reimbursement applications increased by 2.8 %. ADHD (FD90.0) is the indication based on which most applications are submitted. The increase is due to an increase in the number of patients diagnosed with ADHD and who start medical treatment. We see quite many applications for adults who are primarily treated with methylphenidate.

M05 Drugs for treatment of bone diseases

The number of single reimbursement applications within the group of bisphosphonates, raloxifene, strontium and denosumab for preventive treatment of fractures increased considerably (40.4%). The large increase is presumably due partly to an increase in the consumption of osteoporosis medicines and partly due to a treatment switch between the different drugs used in preventive treatment of fractures. Quite many patients have thus switched from bisphosphonates to denosumab.

There is a fall in the number of patients who are started on parathyroid hormone, PTH, (Forsteo or Preotact) rather than on the other osteoporosis products. The number of single reimbursement applications for Forsteo and Preotact has thus fallen (12 %) compared with 2010.
The fall in 2011 can possibly be explained by the fact that quite many patients are treated with denosumab before starting treatment with PTH.

C09 Agents acting on the renin-angiotensin system

On 15 November 2010, a number of medicines for the treatment of hypertension and other cardiovascular diseases changed reimbursement from conditional reimbursement to having non. Apart form losartan, the medicines include all angiotensin II antagonists (including combinations) and the renin inhibitor aliskiren (including the combination with hydrochlorothiazide).

The vast majority of people in treatment with these medicines have therefore switched to other treatment with general reimbursement in the last part of 2010. In 2011, we received approx. 7,782 applications for single reimbursement in respect of those cardiovascular medicines that lost reimbursement of which, and 71.6% of the applications were granted. The reason for refusal is usually that it has not been documented sufficiently in the application that the patient cannot be treated with less expensive and just as efficient medicines with general reimbursement.

Non-marketed medicines

2011 shows a fall of 44.7 % in the number of single reimbursement applications for medicines that are not marketed in Denmark, falling from 6,533 to 3,610. This was primarily because there were fewer problems with supplying marketed medicines to patients that could not be switched to alternative marketed medicines. In addition, 2011 also saw the marketing of Movicol Junior, which belongs to one of the groups of medicines receiving the most single reimbursement applications.

Drugs for acid-related disorders

On 15 November 2010, reimbursement was removed from a number of drugs for acid-related disorders. Except for the products omeprazole, lansoprazole and pantoprazole, we removed reimbursement from the remaining more expensive products in the group.

The vast majority of people in treatment with these medicines have therefore switched to other treatment with general reimbursement in the last part of 2010. In 2011, we received approx. 2,937 applications for single reimbursement in respect of those drugs for acid-related disorders which lost reimbursement, and 59.1 % of the applications were granted. The reason for refusal is usually that it has not been documented sufficiently in the application that the patient cannot be treated with less expensive and just as efficient medicines with general reimbursement.

B01 Antithrombotic agents (e.g. clopidogrel)

2011 shows a fall of 94.6 % in the number of applications for single reimbursement of medicines for secondary prevention of blood clots (e.g. clopidogrel). The fall is the result of granting general reimbursement to medicines containing clopidogrel (75mg) in July 2010, and granting general reimbursement to prasugrel-containing medicines in June 2011.

Electronic applications

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 (medicin-it.dk). On 15 October 2010, the digital signature type "Doctors' assistant" provided the possibility to prepare applications for the doctor.

Table 4: Number of electronic applications by type of reimbursement, 2007-2011

Number of applications

2011

2010

2009

2008

2007

Single reimbursement

30,512

20,716

16,389

13,295

8,375

Increased reimbursement

775

983

561

238

245

Reimbursement for the chronically ill

7,060

6,270

4,499

3,201

1,472

Reimbursement for the terminally ill

2,220

1,677

1,282

1,037

696

Total

40,567

29,646

22,731

17,771

10,788

As can be seen from table 4, the number of electronic applications submitted to us electronically continues to increase.

Table 5: Total number of applications and number of electronic applications by type of applicant, 2010-2011

2011

2010

Total number of applications

Electronic

%

Total number of applications

Electronic

%

Hospital departments

52,617

4,897

9.3

55,393

3,342

6.0

General practitioners

61,311

25,146

41.0

56,454

17,976

31.8

Specialists

27,118

10,528

38.8

28,698

8,328

29.0

Total

141,046

40,571

28.8

140,545

29,646

21.1

Table 5 shows that while general practitioners are most active in submitting applications electronically, hospitals are less inclined to do so. General practitioners as well as specialists account for a high increase in the number of applications submitted electronically.