Number of applications for individual reimbursement of medicines in 2011
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: |
19 |
59.4% |
13 |
40.6% |
32 |
22 |
55.0% |
18 |
45.0% |
40 |
A02BC02: |
16 |
27.6% |
42 |
72.4% |
58 |
37 |
52.1% |
34 |
47.9% |
71 |
A02BC05: |
3 |
100.0% |
0 |
0.0% |
3 |
46 |
69.7% |
20 |
30.3% |
66 |
B01AC04: |
109 |
46.4% |
126 |
53.6% |
235 |
79 |
48.5% |
84 |
51.5% |
163 |
C07AB02: |
70 |
68.6% |
32 |
31.4% |
102 |
36 |
47.4% |
40 |
52.6% |
76 |
C08CA01: |
9 |
28.1% |
23 |
71.9% |
32 |
25 |
39.1% |
39 |
60.9% |
64 |
C09CA01: |
114 |
44.5% |
142 |
55.5% |
256 |
157 |
57.3% |
117 |
42.7% |
274 |
C09DA01: |
87 |
51.2% |
83 |
48.8% |
170 |
81 |
51.6% |
76 |
48.4% |
157 |
C10AA05: |
24 |
72.7% |
9 |
27.3% |
33 |
15 |
71.4% |
6 |
28.6% |
21 |
N02AB03: |
11 |
16.2% |
57 |
83.8% |
68 |
4 |
40.0% |
6 |
60.0% |
10 |
N03AX09: |
40 |
14.0% |
246 |
86.0% |
286 |
57 |
13.7% |
360 |
86.3% |
417 |
N03AX11 |
39 |
39.4% |
60 |
60.6% |
99 |
101 |
38.7% |
160 |
61.3% |
261 |
N04BC05: |
31 |
52.5% |
28 |
47.5% |
59 |
0 |
|
0 |
|
00 |
N06AB04: |
14 |
12.1% |
102 |
87.9% |
116 |
11 |
95.2% |
217 |
95.2% |
228 |
N06AB05: |
2 |
5.0% |
38 |
95.0% |
40 |
5 |
73.7% |
14 |
73.7% |
19 |
N06AB06: |
15 |
21.1% |
56 |
78.9% |
71 |
13 |
78.3% |
47 |
78.3% |
60 |
N06AB10: |
8 |
47.1% |
9 |
52.9% |
17 |
42 |
74.2% |
121 |
74.2% |
163 |
N06AX16: |
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 |
567 |
11,834 |
12,401 |
8.0% |
362 |
11,123 |
11,485 |
N06BA |
Psychostimulants |
543 |
11,580 |
12,123 |
2.8% |
495 |
11,303 |
11,798 |
M05 |
Drugs for treatment of bone disease |
329 |
8,494 |
8,823 |
40.4% |
263 |
6,022 |
6,285 |
G02 |
Products for hypemenorrhoea/ |
79 |
8,671 |
8,750 |
3.3% |
109 |
8,360 |
8,469 |
C09 |
Agents acting on the renin- |
2,211 |
5,571 |
7,782 |
283.5% |
851 |
1,178 |
2,029 |
N06DX |
Anti-demential drugs |
238 |
4,923 |
5,161 |
12.4% |
108 |
4,484 |
4,592 |
N03AX |
Products for neuropathic pain |
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 |
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 |
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 |
45 |
2,575 |
2,620 |
10.7% |
51 |
2,315 |
2,366 |
D |
Products for actinic keratosis |
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 |
66 |
1,084 |
1,150 |
-12.0% |
94 |
1,213 |
1,307 |
B01 |
Prevention of blood clots |
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.