Aut-idem and discount contracts - a guarantee for cost savings?

After the costs of inpatient care (52.7 billion euros in 2008), drug costs (29.2 billion euros) are the second largest block of expenditure in statutory health insurance (GKV). Medicines are therefore one of the first targets if savings are to be made in the German healthcare system. The result of the austerity efforts of various governments is a complex network of regulatory measures in order to keep the statutory health insurance's pharmaceutical expenditure under control. The most important measures of this kind in recent years include the “aut-idem” regulation and the discount agreements. The “Aut-idem” regulation (Latin: or the same) came into force in Germany on July 1, 2002. It means that the doctor is not able to prescribe a specific preparation, but only the active ingredient, potency, pack size and dosage form. When receiving such a prescription, the pharmacist is obliged to dispense one of the three least expensive preparations, taking into account the doctor's instructions. The exception is an existing discount agreement (see below). The “aut-idem” procedure is already common practice for off-patent preparations in Germany and is estimated to reduce drug costs in the statutory health insurance system by around 170 to 228 million euros annually.

>> There is currently a heated debate about the interpretation of the “Aut-idem” regulation. The Federal Ministry of Health and the health insurance companies want the regulation to be interpreted broadly, meaning that drugs with the same active ingredients should be interchangeable if they only have a common area of application in the same indication area. The pharmaceutical associations have a narrow interpretation, according to which the pharmacist is only obliged to make a substitution if the drug dispensed is approved under drug law in all areas of application for the prescribed original preparation.
Discount contracts according to Section 130a Paragraph 8 SGB V, analogous to the “aut-idem” regulation, aim to save money by exchanging medicines with the same active ingredients. If the doctor allows the exchange of a drug on the prescription, the pharmacist is obliged to dispense the preparation with the prescribed active ingredient, for which there is a discount agreement between the patient's health insurance company and a drug manufacturer. If the drug is not in stock at the pharmacy, it must be purchased. The obligation to purchase applies regardless of whether the pharmacist has another preparation with the same active ingredient in its range. If the discounted preparation is not available or the patient's health insurance company has not concluded a discount agreement for the prescribed active ingredient, the obligation to supply the lower third of the price applies again.
In order to conclude discount contracts, health insurance companies advertise patent-free active ingredients. Drug manufacturers can try to get a premium through discounts on their products. For example, the Techniker Krankenkasse advertised 89 active ingredients (the tender included the antiepileptic active ingredients carbamazepine, gabapentin and lamotrigine). The manufacturers had until September 7, 2009 to submit offers to the Techniker Krankenkasse. The 2-year contracts with the winners of the tender came into force on April 1, 2010 and are intended to bring the fund savings in the double-digit million range within the contract period.
The advantage for drug manufacturers who are awarded a contract is a temporary monopoly. You alone have the chance to exploit the sales potential for all the health insurance policyholders in relation to the active ingredient for which they have been awarded the contract. For the doctor, nothing changes compared to the “aut-idem” rule. If he excludes the substitution on the prescription, the regulation in the discount contract is also no longer valid. However, if he allows the exchange, the pharmacist must check whether the patient's health insurance company has concluded a discount agreement for the active ingredient in question. If this is the case, in most cases he will provide the discounted medicine. However, due to the framework agreement in accordance with Section 129 SGB V, pharmacies have the explicit option of waiving the obligation to supply discounted medicines if, from the pharmacist's point of view, there are pharmaceutical concerns in the specific individual case. Pharmaceutical concerns arise if the success of the therapy or the safety of drug therapy are jeopardized in a specific individual case due to the exchange of preparations despite additional advice to the patient.
In addition, as part of the planned reform of the health system, Health Minister Rösler suggested that the patient can receive another preparation they want with the prescribed active ingredient if they bear the additional costs for the discount contract product themselves.
Even if health insurance companies push drug substitution for cost reasons, the doctor must check for each patient whether the replacement is medically justifiable. If he fundamentally rules out an exchange, there is a risk of recourse and he will have to bear part of the costs of his prescriptions himself. If he basically allows the exchange, this can lead to uncertainty among patients and even compliance problems (refusal to take, risk of confusion). In addition, health consequences such as intolerances caused by excipients that have not previously occurred and the deterioration of the condition of a patient who is well controlled with medication due to variations in the bioavailability of generic drugs must also be taken into account.
Actually "same"?
The name “Aut-idem” means that a preparation can be replaced by a preparation with the same active ingredient (also called a generic). Calling the exchange “the same” suggests that the exchange preparation is identical in every respect to the exchanged preparation. This is possible, but rather unlikely due to the scope that the legal requirements give generic manufacturers.
On the one hand, excipients and carrier substances (e.g. preservatives or dyes) can differ from generics and lead to intolerances (e.g. skin rash, nausea or digestive problems) in patients. Here the doctor must identify the intolerance and exclude the exchange in order to ensure the delivery of a well-tolerated drug to the patient.
On the other hand, differences in the bioavailability of the active components of the drug can lead to problems. According to an EU directive, generics must have the same quantitative and qualitative composition of active ingredients and the same dosage form as the corresponding, already approved preparation and have a bioequivalent effect in humans. However, there are clear tolerances in the verification of these properties. Bioequivalence is considered to be proven if the concentration of the drug in the blood over time (so-called area under the curve (AUC)) is between 80% and 125% of the AUC of the original. This means that the bioequivalence of generic drugs can differ from the original by 20% or more. Generics can even deviate from each other by more than 40% when the entire tolerance range is exhausted.
The deviation in bioequivalence does not necessarily lead to problems. However, there are drugs and substance groups for which even small changes in bioequivalence are enough to negatively influence the course of the disease. The following table shows examples of such drug groups and the problems that can be expected if the exact dosage is not adhered to (Table 1).
Other drug groups that are critical for substitution are listed in the guidelines for good substitution practice of the German Pharmaceutical Society.
Critical substitution using the example of
Antiepileptic drugs - epidemiology of epilepsy
According to estimates, 0.5 to 1 % of the population in Germany (around 400,000 to 800,000 patients) suffer from epilepsy. The number of new cases is estimated at around 30,000 per year. Half of patients become ill before the age of ten and around two thirds before they are 20. Furthermore, there are more new cases after the age of 65.
Even if epilepsy can be cured in individual cases, it is one of the chronic diseases whose successful medical treatment requires long-term, individually tailored medication. Epilepsy is manifested by seizures, which not only increase the person affected's perception of illness, but can also have far-reaching consequences for the patient's social environment even if they occur once (e.g. loss of driving license/job). Therefore, epilepsy patients have an increased prevalence of mental illnesses ranging from anxiety and reduced self-esteem to depression. A single seizure can already have the effects mentioned.
In order to avoid seizures, the daily dose and frequency of administration of the antiepileptic drug are tailored precisely to the needs of the respective patient. Good effectiveness and tolerability are then guaranteed for most antiepileptic active ingredients. In 40-50% of epilepsy patients, freedom from seizures is achieved with the first monotherapy. Another approximately 15% are seizure-free with a second monotherapy and another approximately 5% with a combination therapy of various antiepileptic drugs. In the treatment of epilepsy, the bioequivalence of drugs used with the same substance should vary only slightly. Therefore, the replacement of one preparation with another with the same active ingredient must be subject to a precise balance of benefits and harms in order not to endanger the patient's freedom from seizures.
The calculation of the health insurance companies
Since January 1, 2009, the health insurance companies no longer finance the care of their insured persons through individual contributions, but rather through allocations from the health fund. In addition to a basic flat rate (185.64 euros per month for 2009) with age- and gender-dependent surcharges and discounts, the health insurance companies receive an allocation for 80 selected diseases via the morbidity-oriented risk structure equalization (Morbi-RSA). Epilepsy is one of these diseases. For an insured person with proven epilepsy, the health insurance company receives an additional allocation of 133.86 euros per month (Tab 2).
If this amount is sufficient to care for the insured person or if the costs are even lower, the health insurance company has the money available to care for other patients (positive contribution margin). However, if a patient's care costs exceed the allocations from the fund (negative contribution margin), the fund has to “cross-subsidize” other patients or incur “losses” (Fig.1).
The fund can only compensate for losses by charging additional contributions from its insured. In order to avoid additional contributions and the exodus of insured persons, the health insurers try to exhaust all savings possibilities. The quality of care from the point of view of health insurers should not be restricted. By using the discount contract tenders and the associated switch to “cheap” generics, the desired savings should be achieved in the short term. Short-term savings help a health insurance company last longer than the competition without charging additional premiums. The focus is therefore on consistently implementing substitution with inexpensive copycat products and maximizing the discount on drugs by concluding appropriate contracts with drug manufacturers. However, it is doubtful whether the care costs for epilepsy patients can be reduced with high pressure on drug expenditure.
Using a regression analysis for France, Germany, Italy and the UK, the change in care costs for epilepsy patients was calculated if the original preparation with the active ingredient topiramate was replaced by a generic. The model is based on clinical data collected in Canada in connection with the substitution of the antiepileptic drug topiramate. With their calculations, the authors were able to show that the costs of patient care in the four European countries were significantly higher when a change took place.
A health economic model for Germany examined the expected costs of epilepsy treatment with and without “aut-idem” exclusion using the example of the antiepileptic active ingredient carbamazepine. Unlike the calculation by Paradis et al. (2009), it was not only possible to switch from the original to the generic, but also to switch between different generics. The authors conclude that allowing the exchange can be twice as expensive as banning it. For the average patient, additional costs of 60 euros per quarter are calculated as part of the model calculation. Only the additional costs of treating the consequences of seizures were taken into account. If an epilepsy patient suffers new seizures when his antiepileptic medication is replaced, the insurance company must not only cover the possible consequences of the seizure (injuries from falls, brain damage or life-threatening complications from status epilepticus), but also for comorbidities such as those already mentioned Depression arise.
In addition to the ethical questions that a threat to the patient's freedom from seizures raises, the consequences of the seizures and epilepsy-related comorbidities consequently put a strain on a health insurance company's budget. Accordingly, a change in perspective from possible short-term savings through discounts to medium- to long-term savings through freedom from accruals can mean competitive advantages for the fund in the future.
With a focus on medium to long-term, effective antiepileptic therapy, value-added contracts are a way to bring together the interests of drug manufacturers and health insurance companies.
However, so far there is only one value-added contract for the treatment of a CNS disease. A pharmaceutical manufacturer has concluded a contract with AOK Rheinland/Hamburg for the care of Alzheimer's patients. This includes not only drug treatment but also non-drug treatment components that the drug manufacturer also provides.
This concept of a value-added contract can be transferred to antiepileptic drugs. The added value offered by the manufacturer can, for example, consist of additional non-drug measures to improve compliance and thus “ensure” long-term freedom from seizures. The added value then lies in the higher probability of freedom from seizures and lower expected care costs for the patient for the health insurance company. The focus is on savings through cooperation between drug manufacturers and health insurance companies in preventing seizures and comorbidities.
conclusion
Health economic model calculations show that the statutory health insurance may incur considerable additional costs if the health insurance companies continue to push the replacement of medicines with “cheaper” generics, driven by the health fund and Morbi-RSA. On the one hand, this can increase the case costs for epilepsy patients in the long term. On the other hand, the success of therapy is put at risk for patients who can live with their illness without symptoms thanks to good medication management. The example of value-added contracts also shows that long-term therapeutic success and savings for the health insurance companies do not have to be incompatible goals. Savings would be possible while improving the quality of care. This would be a worthwhile goal for the further development of care for epilepsy patients. <<