New reimbursement status of certain cardiovascular medicinal products (“hypotensive medicinal products”)

23 January 2009

What will be changed?

The reimbursement status of certain medicinal products for cardiovascular disease will be changed. The change comprises medicinal products in ATC groups C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors) as well as a single medicinal product in C07 (beta blocking agents).

The table below lists the medicinal products changing reimbursement status along with the new reimbursement status. All other cardiovascular medicinal products maintain their current reimbursement status.

The reimbursement status as of 13 July 2009 for the medicinal products for cardiovascular disease in ATC groups C07, C08 and C09 for which the reimbursement will be changed.

Medicinal product group

Active substance

Reimbursement status

 

C07:

Beta blocking agents

 

the combination:

metoprolol and felodipine

 

No general reimbursement

C08:

Dihydropyridine calcium channel blockers

the individual substances:

isradipine,

nifedipine,

nitrendipine,

lacidipine,

lercanidipine

 

 

Conditional reimbursement, i.e. reimbursement is granted when the medicinal products are prescribed for:

 

Patients with hypertension or any other type of cardiovascular disease requiring treatment, where treatment with dihydropyridine calcium channel blockers with general unconditional reimbursement

 

  • is not tolerated, or
  • in exceptional cases has been deemed inappropriate by a doctor based on an overall clinical assessment of the patient’s condition.

 

The doctor must write “tilskud” (reimbursement) on the prescription, when the patient meets the criteria.

the combination:

verapamil and trandolapril

 

No general reimbursement

the individual substance:

nimodipine

 

General reimbursement

C09:

ACE inhibitors

the individual substances:

perindopril,

quinapril,

benazepril,

fosinopril

 

the combinations:

captopril and hydrochlorothiazide

enalapril and hydrochlorothiazide (in the strength 20 mg + 6 mg)

perindopril and indapamide

perindopril and amlodipine

 

No general reimbursement

 

C09:

Angiotensin-II antagonists and

Renin inhibitors

the individual substances:

losartan

eprosartan

valsartan

irbesartan

candesartan

telmisartan

olmesartan

aliskiren

 

the combinations:

losartan and hydrochlorothiazide,

eprosartan and hydrochlorothiazide,

valsartan and hydrochlorothiazide,

irbesartan and hydrochlorothiazide,

candesartan and hydrochlorothiazide,

telmisartan and hydrochlorothiazide,

olmisartan and hydrochlorothiazide,

valsartan and amlodipine

 

Conditional reimbursement, i.e. reimbursement is granted when the medicinal products are prescribed for:

 

Patients with hypertension or other types of cardiovascular disease requiring treatment, where treatment with medicinal products acting on the renin angiotensin system with general unconditional reimbursement

 

  • has proven inadequate or is not tolerated, or
  • in exceptional cases has been deemed inappropriate by a doctor based on an overall clinical assessment of the patient’s condition.

 

The doctor must write “tilskud” (reimbursement) on the prescription, when the patient meets the criteria.

As appears from the table, the new reimbursement status of the medicinal products concerned entail a tightening of the reimbursement conditions, as a few products lose the general reimbursement, and other products become comprised by the rules on general conditional reimbursement.

When do the changes become effective?

The above reimbursement changes will become effective on 13 July 2009. Within the coming six months, doctors and their patients must therefore decide upon the patient’s future treatment, i.e.

  • if the patient’s treatment is not affected by the reimbursement change, no changes should be made to the treatment – unless the treatment target has not been met.
  • if the patient is treated with a dihydropyridine calcium channel blocker, whose reimbursement becomes conditional, it must be decided
  • if the patient can be switched to the less expensive dihydropyridine calcium channel blockers amlodipine or felodipine or another medicinal product eligible for reimbursement,

or

  • if the patient is comprised by the reimbursement condition. If so, the doctor must write “tilskud” (reimbursement) on the prescription.
  • if the patient is treated with an ACE inhibitor, which loses its reimbursement, the treatment should be changed to a less expensive reimbursable ACE inhibitor (captopril, enalapril, lisinopril, ramipril or trandolapril) or another medicinal product eligible for reimbursement.
  • if the patient is treated with an angiotensin II antagonist, it must be decided
  • if the patient can be switched to a less expensive reimbursable ACE inhibitor or another medicinal product eligible for reimbursement.

or

  • if the patient is comprised by the reimbursement condition. If so, the doctor must write “tilskud” (reimbursement) on the prescription.

What is the medical background for these changes?

This change of the reimbursement status of certain cardiovascular medicinal products is based on a medical recommendation from the Reimbursement Committee – the recommendation is available at our website. The Committee’s recommendation has been submitted for consultation with a number of relevant scientific societies and other stakeholders, whose consultation responses are also available at our website (in Danish only). The Committee’s recommendations are available here: [link to messages of 30 January 2008 (http://www.laegemiddelstyrelsen.dk/1024/visLSArtikel.asp?artikelID=13042) and 4 September 2008 (http://www.laegemiddelstyrelsen.dk/1024/visLSArtikel.asp?artikelID=13957)].

When the reimbursement status is changed for the single substance medicinal products concerned, the overall reason is that they belong to groups of medicinal products with a high degree of class effect. Especially the ACE inhibitors and the angiotensin II antagonists are characterised by a limited application area and a higher degree of uniformity than the other groups of blood pressure products. Moreover, a number of national and international guidelines recommend the groups equally, cf. the list at the bottom of the page. The dihydropyridine calcium antagonists (C09CA) are characterised by a high degree of class effect, even though the individual medicinal products accommodate differences in adverse reactions and interactions.

The reimbursement condition for certain medicinal products reflects that some patients suffer from adverse reactions or do not tolerate the less expensive reimbursable medicinal products, and in a few exceptional cases, the patient cannot be treated expediently with the less expensive products. Therefore, it is still possible for doctors to prescribe these medicinal products with reimbursement by writing “tilskud” (reimbursement) on the prescription, as long as the patient meets the reimbursement conditions.

The reimbursement for the expensive ACE inhibitors has been eliminated rather than becoming subject to a reimbursement condition, as the class effect within this group is very comprehensive, and therefore it is not very likely that a patient cannot be treated with one of the less expensive ACE inhibitors. If there is an exceptional reason for continuing the treatment with one of the expensive ACE inhibitors, the doctor can apply for single reimbursement.

Several scientific societies have objected to the fact that the reimbursement scheme will also affect current patients, as they would prefer it to apply to future patients only. The background for this suggestion is that switching to another product may imply that patients during the transitional period will not be adequately controlled, thereby increasing the risk of cardiovascular events. We do not find sufficient evidence to support that these product switches can entail a risk in terms of patient safety. The reimbursement conditions for the angiotensin II antagonists and the expensive dihydropyridine calcium channel blockers take into consideration exceptional cases where the doctor finds – based on an overall clinical assessment of the patient's condition – that it would be inappropriate to change the patient’s treatment.

Why is the Danish Medicines Agency making reimbursement changes?

The Danish Parliament has charged the Danish Medicines Agency with the task of reassessing the reimbursement status of all medicinal products on an ongoing basis. The aim of the reassessment procedure is to incorporate experience from everyday clinical practice and the actual use of the medicinal products and assess whether the conditions on which the original reimbursement decisions were made remain valid or whether they have changed over time. In other words, we must assess whether the current reimbursement status has contributed to a rational use of the medicinal products in practice. One of the criteria that must be met in order for a medicinal product to become eligible for general reimbursement is that the therapeutic value of the medicinal product must be reasonable relative to its price.

Now, the Danish Medicines Agency has reassessed the reimbursement status of cardiovascular medicinal products with this aim in view. Many people have considered the reimbursement change to be a cost-cutting measure, but that is not the case. The reimbursement change is intended to prompt a rational medicinal treatment, i.e. an equally effective treatment at a lower cost. As a general rule, it is rational to prescribe the inexpensive medicinal products eligible for general reimbursement (without any reimbursement condition), and reserve the expensive medicinal products with conditional reimbursement to the patients whom – of whatever reason – can only be treated with these products.

Why changes the reimbursement when there is undertreatment?

It is a fact that there is a significant undertreatment of hypertension patients in Denmark. It is estimated that approximately 300,000 more persons in Denmark ought to be treated for hypertension, and that as many as half of the people currently treated may not have reached their treatment target. We assess that the future changes to the reimbursement status will not make the undertreatment any worse. Partly because the changes go hand in hand with the current treatment recommendations and are also in accordance with rational pharmacotherapy, and partly because the undertreatment has existed for many years, where all hypertension products have been eligible for general unconditional reimbursement.

The increased focus on hypertension patients in connection with this reimbursement change and the resulting consideration of choice of treatment may – in our opinion – rather contribute to diminishing the undertreatment and ensure a greater extent of adequate treatment.

What are the financial implications?

For the individual patient, the expenses will be the same or lower after the change. The expenses will be unaltered, if the patient is treated with a medicinal products which does not lose the general reimbursement, or if the patient is being treated with a medicinal product, whose general reimbursement becomes subject to a reimbursement condition, as long as the patient meets the reimbursement condition. If the patient is switched from an expensive medicinal product, which either loses its reimbursement or whose reimbursement becomes subject to a condition, to a less expensive reimbursable medicinal product, the expenses will be lower.

For one individual patient, who switches from a treatment with an expensive ACE inhibitor or angiotensin II antagonist to an inexpensive ACE inhibitor, the average annual savings (for region and patient) is between DKK 1,500 and 2,300. A corollary of the change of products is one or more additional consultations with a doctor and possibly a blood sample test, but for patients whom the doctor believes should switch to another medicinal product, it would be natural to make the switch in connection with the patients' routine visits with their doctor over the coming 6 months, before the changes become effective. The expenses for the additional consultations and blood samples will only need to be paid once, and as they are significantly lower than the medicinal expenses saved, and as the treatment is often lifelong, we find that the additional expenses resulting from such a switch would be regained quickly.

Some of the consultation responses submitted to the Danish Medicines Agency pointed out that adverse reactions from a treatment may reduce the patient’s compliance (in this case, coughing caused by treatment with ACE inhibitors, which 5-20 per cent of the persons treated experience), which is indisputable and naturally not desirable. However, it is also a well known fact that the price affects patients’ compliance, and that lower prices generally improve compliance.

National and international guidelines etc.:

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