Examination of single reimbursement for medicinal products

31 July 2006
On behalf of Merck Sharp & Dohme (MSD), Tranberg Marketing Rekommandation has examined general practitioners’ knowledge, experience and attitude to single reimbursement for medicine ("Praktiserende lægers kendskab, erfaring og holdning til enkelttilskud til medicin"). The examination is based on telephone interviews with 282 general practitioners.
Based on the answers from the 282 doctors, Tranberg concludes: 
  1. that the single reimbursement system affects the prescription pattern of general practitioners, primarily in the sense that they refrain from prescribing and applying for reimbursement, even though it is relevant to prescribe a particular medicinal product
  2. that doctors believe the single reimbursement system to be bureaucratic and stiff and the work process involved in drafting an application to be troublesome
  3. that the procedure for granting reimbursement is not medically reasoned
  4. that in case of rejection, a majority of doctors rephrase their applications to maximise their patients’ probability of getting reimbursement.

The single reimbursement system is established under section 2(7) of the Danish National Health Security Act. The system ensures that patients, based on an individual treatment assessment, can obtain reimbursement from the Danish National Health Service for medicinal products that are not eligible for general (automatic) reimbursement. Moreover, the single reimbursement system supports rational use of medicinal products, as especially new medicinal products often are very expensive and only should be prescribed for a specifically defined part of a particular patient group which cannot be treated optimally with less expensive alternatives, cf. report no. 1444 from 2004 about reimbursement and proper use of medicinal products, page 93 (betænkning nr. 1444 fra 2004 om medicintilskud og rigtig anvendelse af lægemidler).

The criteria for granting both general reimbursement and single reimbursement appear from the Executive Order on reimbursement (bekendtgørelse om medicintilskud).

We are continuously attempting to make the single reimbursement system as flexible and easy to use for doctors as possible. For example, the application forms are available both in a paper version and electronically at www.laeger.dk, and application forms for a range of the medicinal products most frequently applied for are preprinted with guiding criteria for single reimbursement, so that the doctor’s work with filling in such forms is very limited. Later this year, all application forms will be converted to actual e-forms, which doctors can fill in and submit electronically to the Danish Medicines Agency.

We have a good dialogue with the Danish Medical Association and the Organization of General Practitioners about the single reimbursement system. Most recently, at a meeting on 13 March 2006, we discussed how doctors and the Danish Medicines Agency jointly can ensure optimal working procedures etc. to benefit all parties, not least patients.
Moreover, we are cooperating with the IT forum of the Organization of General Practitioners about the above digitalisation project concerning the application forms. This will ensure that a solution tailored to suit doctors’ needs and systems.

Re 1)

In itself, it is neither surprising nor unintentional that the single reimbursement system affects doctors’ prescription patterns. On the contrary, it is one of the purposes of the system, cf. the referral above to report no. 1444. On the other hand, the system should not lead to doctors deselecting correct and relevant medical treatment of their patients.
Yet, we do assume that doctors in any case treat their patients justifiably. If the contrary is the case, it is a matter that must be evaluated according to the Danish Act on General Practitioners (lægeloven).

Re 2)

As mentioned above, we do our best to make the system as easy to use as possible for doctors, as their working days are busy. To ensure this, we cooperate with doctors’ organisations.
From the perspective of individual general practitioners, the alternative to single reimbursement is general reimbursement. When a medicinal product is eligible for general reimbursement, doctors do not need to make an individual application. Evidently, the single reimbursement system seems very heavy and bureaucratic when compared to general reimbursement – no matter how flexible and readily available the single reimbursement system might be.
Another point to note is that the Danish Medicines Agency received around 110,000 applications for single reimbursement in 2005, and half of these were from doctors in the primary sector (general practitioners and specialist doctors). This means that on average each doctor in the primary sector sends 1-2 applications per month.

Re 3)

In reimbursement matters, the Danish Medicines Agency is advised by the Reimbursement Committee, which ensures that the practice used in the single reimbursement area, among other things, is medically correct and reasoned.
Decisions within the single reimbursement area must also be made consistently with the criteria listed in the Executive Order on reimbursement. It cannot, however, be ruled out that doctors in certain situations perceive a decision not directly related to these criteria as "not medically reasoned", for instance if the reason for rejection is that "the medicinal product is used for purposes for which it cannot with reason be expected that the National Health Service pays reimbursement", cf. section 6(3)-1 of Executive Order on reimbursement.

Re 4)

If a doctor receives a rejection of an application for single reimbursement and can see from the reason for the rejection that a specification, elaboration, etc. of the basis for the application may lead to a different outcome, the doctor can and should of course apply again. Otherwise, the patient loses the opportunity to get reimbursement which he/she is entitled to and that would be contrary to the purpose of the single reimbursement system. 

The Danish Medicines Agency, 4 May 2006