Number of applications for individual reimbursement of medicinal products in 2009
Reimbursement for the chronically ill
Increased reimbursement
Single reimbursement
Medicinal product groups generating the highest number of single reimbursement applications
Electronic applications
In 2009, the Danish Medicines Agency reviewed nearly 100,000 applications for single reimbursement (about 6 % fewer than in 2008), approx. 25,900 applications for reimbursement for the chronically ill (about 15 % more than in 2008), approx. 10,700 applications for reimbursement for the terminally ill (about 5 % more than in 2008) and approx. 2,500 applications for increased reimbursement (about 30 % more than in 2008), cf. table 1 below.
In 2009, we reached decisions in a total of 138,715 individual reimbursement applications against 139,044 in 2008, corresponding to a fall of 0.2 %.
Table 1. Number of applications for individual reimbursement, 2002-2009
|
2002 |
2003 |
2004 |
2005 |
2006 |
2007 |
2008 |
2009 |
Single reimbursement |
77,513 |
84,519 |
96,594 |
111,218 |
106,753 |
111,279 |
105,229 |
99,565 |
Reimbursement for the chronically ill |
8,141 |
9,548 |
10,166 |
23,071 |
14,633 |
18,231 |
21,828 |
25,895 |
Reimbursement for the terminally ill |
8,568 |
8,564 |
8,883 |
9,023 |
9,252 |
9,831 |
10,218 |
10,739 |
Increased reimbursement |
69 |
55 |
102 |
2,766 |
2,713 |
2,032 |
1,769 |
2,515 |
Reimbursement for the chronically ill
In 2009, the number of applications for reimbursement for the chronically ill continued to increase. On 1 January 2009, the reimbursement threshold for reimbursement for the chronically for adults was increased from DKK 15,100 to DKK 15,577. This adjustment has caused an increase in the number of applications, even though potentially fewer people benefit from reimbursement for the chronically ill.
Table 2. Number of applications for increased reimbursement, 2008 - 2009
2008 |
2009 | |||||
- |
+ |
Total |
- |
+ |
Total | |
A02BC01: Omeprazole |
35 |
60 |
95 |
26 |
29 |
55 |
A02BC02: Pantoprazole |
0 |
1 |
1 |
46 |
30 |
76 |
A02BC05: Esomeprazole |
20 |
6 |
26 |
52 |
15 |
67 |
C08CA01: Amlodipine |
45 |
51 |
96 |
22 |
62 |
84 |
C10AA01: Simvastatin |
42 |
79 |
121 |
22 |
42 |
64 |
J01CR02: Bioclavid |
0 |
0 |
0 |
0 |
434 |
434 |
N02CC01: Sumatriptan |
27 |
25 |
52 |
15 |
26 |
41 |
N03AX11: Topiramate |
3 |
3 |
6 |
42 |
18 |
60 |
N03AX09: Lamotrigine |
131 |
457 |
588 |
67 |
283 |
350 |
N05AX08: Risperidone |
33 |
57 |
90 |
14 |
15 |
29 |
N06AB04: Citalopram |
18 |
40 |
58 |
16 |
74 |
90 |
N06AB06: Sertraline |
49 |
56 |
105 |
30 |
51 |
81 |
N06AX11: Mirtazapine |
21 |
19 |
40 |
12 |
31 |
43 |
N06AX16: Venlafaxine |
0 |
0 |
0 |
161 |
299 |
460 |
Other |
261 |
230 |
491 |
291 |
290 |
581 |
Total |
685 |
1084 |
1769 |
816 |
1699 |
2515 |
Number of people |
542 |
663 |
1161 |
668 |
1136 |
1753 |
The total number of applications for increased reimbursement rose by 44 % from 1,769 in 2008 to 2,515 in 2009. Most of the increase results from increased reimbursement applications for Bioclavid submitted by the Copenhagen University Hospital on behalf of all their cystic fibrosis patients, because these patients are treated with doses involving half tablets. But even if we exclude these applications, an increase of 19 % is still recorded from 2008 to 2009.
In the groups within which we normally receive many applications, the number of applications fell across the board, and we thus recorded significant drops in the number of applications for lamotrigine (40 %), simvastatin (47 %), sertraline (23 %), omeprazole (42 %) and risperidone (68 %).
In return, new medicines have entered the scene. In particular, we received many applications for venlafaxine-containing medicines, putting Efexor Depot up against competitive generics, which meant that the reimbursement price fell significantly. We also saw an inflow of applications for esomeprazole- and pantoprazole-containing medicines.
Towards the end of 2009, several topiramate-containing generics entered the market, and the reimbursement price of this group fell considerably as a result. During the last two to three months of 2009, a total of 60 applications for increased reimbursement for topiramate-containing medicines were submitted (almost exclusively for the originator product Topimax).
The acceptance rate for all applications increased from 61 % in 2008 to 68 % in 2009. If we exclude the previously mentioned applications from the Copenhagen University Hospital for all cystic fibrosis patients, the application acceptance rate remains at an unchanged 61 %.
Single reimbursementIn 2009, the number of submitted applications for single reimbursement fell approx. 6 % on 2008. The fall is attributable to medicines that are no longer administered under the single reimbursement scheme. A number of medicinal products that are used by large populations were granted general reimbursement in the preceding years, Levemir and Lantus in December 2007, Persantin and Persantin Retard in May 2008 and Elidel and Protopic in December 2008.
In 2009, (5,871/99,565) 5.9 % of single reimbursement applications were refused, which is on level with the refusal rate in 2008 (5.3 %) and 2007 (6.0 %).
The Danish regions' expenditure on reimbursement granted under the single reimbursement scheme amounted to DKK 878 million or 13 % of the Danish regions' total medicine expenditure in 2009. A marginal increase on 2008 (DKK 857 million (12 %)).
Medicinal product groups generating the highest number of single reimbursement applications
B01 Prevention of blood clots (e.g. dipyridamole and clopidogrel)
N06BA Psychostimulants (e.g. methylphenidate, atomoxetine and modafinil)
M05 Products for osteoporosis
D11AX Products for atopic dermatitis and actinic keratosis (e.g. Toctino and Solaraze)
A08 Antiobesity products (e.g. orlistat and rimonabant)
Table 3 below shows the medicinal products groups that generated the highest number of single reimbursement applications in 2009.
Table 3. Medicinal products groups that generate many single reimbursement applications, 2007-2009. Total number of applications. (+) indicates the number of accepted applications, (-) the number of refused applications.
|
|
2007 |
2008 |
2009 |
Change % | ||||||
|
|
- |
+ |
Total |
- |
+ |
Total |
- |
+ |
Total |
(08/09) |
B01 |
Prevention of blood clots (e.g. dipyridamole and clopidogrel) |
2,460 |
20,101 |
22,561 |
295 |
19,873 |
20,168 |
261 |
14,752 |
15,013 |
-25,6% |
N06DA |
Products for Alzheimer’s disease |
469 |
11,843 |
12,312 |
342 |
13,779 |
14,121 |
397 |
14,234 |
14,631 |
3,6% |
N06BA |
Psychostimulants (e.g. methylphenidate and modafinil) |
115 |
4,190 |
4,305 |
146 |
6,307 |
6,453 |
255 |
8,949 |
9,204 |
42.6% |
M05 |
Products for osteoporosis (e.g. bisphosphonates with and without vitamin D, and raloxifene and strontium ranelate) |
759 |
13,823 |
14,582 |
713 |
12,350 |
13,063 |
365 |
8,813 |
9,178 |
-29.7% |
G02 |
Products for hypemenorrhoea/menorrhagia (e.g. progesterone intrauterine device) |
94 |
7,448 |
7,542 |
136 |
7,865 |
8,001 |
98 |
8,282 |
8,380 |
4.7% |
N03 |
Products for neuropathic pain (e.g. Gabapentin and Lyrica) |
942 |
3,817 |
4,759 |
699 |
5,215 |
5,914 |
887 |
5,357 |
6,244 |
5.6% |
G04 |
Products for erectile dysfunction (e.g. alprostadil and sildenafil) |
428 |
3,343 |
3,771 |
429 |
3,942 |
4,371 |
343 |
3,391 |
3,734 |
-14.6% |
J01A |
Tetracyclines |
51 |
3,538 |
3,589 |
9 |
3,188 |
3,197 |
12 |
3,442 |
3,454 |
8.0% |
A06 |
Laxatives (e.g. sodium picosulphate) |
215 |
2,045 |
2,260 |
230 |
2,320 |
2,550 |
205 |
2,665 |
2,870 |
12.5% |
D06 |
Products for genital warts (e.g. imiquimod) |
24 |
1,669 |
1,693 |
22 |
2,201 |
2,223 |
37 |
2,207 |
2,244 |
0.9% |
D11AX |
Products for atopic dermatitis and actinic keratosis (e.g. pimecrolimus, tacrolimus and solaraze) |
71 |
5,201 |
5,272 |
55 |
5,285 |
5,340 |
120 |
1,268 |
1,388 |
-74.0% |
H05AA02 |
Products for osteoporosis (Forsteo and Preotact) |
43 |
842 |
885 |
50 |
802 |
852 |
88 |
1,103 |
1191 |
39.8% |
A08 |
Antiobesity products (e.g. orlistat and rimonabant) |
588 |
1,845 |
2,433 |
409 |
1,079 |
1,488 |
208 |
201 |
409 |
-72.5% |
B01 Prevention of blood clots (e.g. dipyridamole and clopidogrel)
Medicinal products for secondary prevention of blood clots (e.g. clopidogrel) still make up the group of medicinal products with the most single reimbursement applications (15 %). However, the number of applications within this group decreased compared to 2008, which can be ascribed to the fact that dipyridamole (Persantin and Persantin Retard) was granted general reimbursement in May 2008.
N06BA Psychostimulants (e.g. methylphenidate, atomoxetine and modafinil)
In 2009, the number of single reimbursement applications increased by 42.6 %. ADHD (FD90.0) is the indication based on which most applications are submitted. The great increase within this group is primarily caused by a general increase in the number of patients diagnosed with ADHD who start treatment of ADHD. We see quite many applications for adults who are primarily treated with methylphenidate.
In 2009, amoxetine (Strattera) changed dispensing status from NBS (only to be prescribed by a specialist in psychiatry) to B (only to be dispensed once on the same prescription, unless stated otherwise). In this group, Atomoxetine (Strattera) has now replaced modafinil (Modiodal) as the drug generating the most applications.
M05 Products for osteoporosis
The number of applications for single reimbursement within the group of bisphosphonates, raloxifene and strontium for preventive treatment of fractures has once again decreased (29.7 %). The reason that the number of applications has dropped even further compared with 2008 could be that
- the generic products of bisphosphonates that have entered the market in recent years are still within a price range that does not prevent most patients from buying the product without reimbursement,
- fewer product switches between bisphosphonates and raloxifene and strontium have taken place, which has meant fewer applications for single reimbursement for these products,
- a rising number of patients are treated with parathyroid hormone (Forsteo or Preotact) rather than the other osteoporosis products. The number of single reimbursement applications for Forsteo and Preotact has thus increased (39.8 %) compared with 2008.
D11AX Products for atopic dermatitis and actinic keratosis (e.g. Toctino and Solaraze)
Compared with 2008, 2009 saw a considerable decrease of 74 % 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, pimecrolimus (Elidel) and tacrolimus (Protopic) for the treatment atopic dermatitis were granted general reimbursement. Diclofenac (Solaraze) has reentered the group, while alitretinoin (Toctino) is a newcomer.
A08 Antiobesity products (e.g. orlistat, rimonabant)
In November 2008, rimonabant was withdrawn from the Danish market, which led to a large decrease in the number of applications for single reimbursement of weight loss products (38.8%) in 2008. Rimonabant was withdrawn when EMA 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%), rimonabant accounting for the majority of applications (85.8%). 2009 marked the year, when orlistat became available for sale over the counter. Apparently, this change has not caused an inflow of more single reimbursement applications.
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).
Table 4. Distribution of electronic applications by type of reimbursement
Number of applications |
2007 |
2008 |
2009 |
Single reimbursement |
8,375 |
13,295 |
16,389 |
Increased reimbursement |
245 |
238 |
561 |
Reimbursement for the chronically ill |
1,472 |
3,201 |
4,499 |
Reimbursement for the terminally ill |
696 |
1,037 |
1,282 |
Total |
10788 |
17771 |
22731 |
As can be seen from table 4, the number of electronic applications sent to us electronically continues to increase. In 2009, 16 % of all applications were submitted electronically, compared to 13 % in 2008 and 7 % in 2007. The increase has occurred even though access to the system via www.sundhed.dk was down periodically in 2009. Www.sundhed.dk was closed for a period of one month in the summer of 2009, during which period the Danish Medicines Agency established access to the system via medicin-it.dk
Table 5. Distribution of electronic applications by type of applicant
2007 |
2008 |
2009 | ||
Number of applications |
Electronic |
Electronic |
Electronic |
all |
Hospital departments |
697 |
1,539 |
2,697 |
60,380 |
General practitioners |
8,409 |
12,756 |
14,381 |
51,950 |
Specialists |
1,682 |
3,476 |
5,653 |
26,385 |
Total |
10,788 |
17,771 |
22,731 |
138,715 |
Table 5 shows that while general practitioners are most active in submitting applications electronically, hospitals are less inclined to do so. Specialists account for the highest increase in the number applications submitted electronically.
Table 6. Electronic applications broken down by provider IDs
2007 |
2008 |
2009 | ||
Number of provider IDs |
Electronic |
Electronic |
Electronic |
all |
Hospital departments |
40 |
101 |
127 |
1,339 |
General practitioners |
809 |
929 |
977 |
2,230 |
Specialists |
59 |
93 |
145 |
611 |
Total |
908 |
1,123 |
1,249 |
4,180 |
Table 6 shows that we received electronic applications from a total of 1249 different provider IDs/hospital departments in 2009. This is an increase of 11 % on the year before.
The fact that the hospital departments use electronic submission only very moderately makes it difficult for us to reach our goal of achieving greater increases in electronic applications. We hope that our plan to make it possible for doctors' assistants to prepare applications for the doctor will help us achieve this goal.
Danish Medicines Agency, 31 March 2010