The National Health Service is reacting sharply to problems with the availability of the drugs Ozempic and Trulicity. Announces inspections

The following message appeared on the NFZ website:

• Ozempic and Trulicity are drugs for type 2 diabetes patients.
• They give patients a chance to live longer and better. The drugs make it possible for patients to wean off insulin or reduce weight under control.
• Patients who have indications for therapy with these drugs buy them with reimbursement from the National Health Service. However, these drugs are often prescribed at a discount for those without reimbursement indications, as preparations for weight loss.
• The effect? Drugs are in short supply, and the National Health Fund has less money to reimburse therapies for patients who need them.
• Both preparations have already made it to the anti-vivisection list, and the National Health Service is monitoring whether they are prescribed with reimbursement for patients with diabetes.

What are the drugs in the GLP-1 analog group?

Ozempic (semaglutidum) and Trulicity (dulaglutidum), drugs in the group of glucagon-like peptide 1 (GLP-1) analogs, are used to treat type 2 diabetes. They stabilize blood glucose levels, but do not increase the risk of sugar drop. Type 2 diabetes is a chronic disease that can lead to disability from complications and even premature death. It is estimated that more than 1.2 million people in Poland have type 2 diabetes. The use of Ozempic or Trulicity allows type 2 diabetes patients previously treated with insulin to reduce doses and simplify insulin therapy. With these drugs, it is even possible to discontinue insulin, which significantly increases the comfort of life without compromising the effects of treatment.

The National Health Fund reimburses both drugs

Ozempic and Trulicity are reimbursed. Patients covered by reimbursement pay only 30% of the price for them. The remainder is subsidized by the National Health Fund. We use public funds to reimburse therapies for specific indications. The indications are determined by institutions and bodies independent of the National Health Fund. In determining the so-called reimbursement indications, the following are taken into account:

• health benefits
• The safety of using drugs in specific patients
• drug costs.

The list of drugs that are reimbursed by the National Health Fund is published by the Ministry of Health. The indication for reimbursement of both drugs is type 2 diabetes in patients:

• Treated with at least two hypoglycemic drugs
• With a glycated hemoglobin score above 7.5%
• With 1st, 2nd and 3rd degree obesity
• With very high cardiovascular risk [1].

The popularity of GLP-1 analogue drugs is growing

In just two years, we are seeing a marked increase in interest in drugs from the GLP-1 analog group. In the case of Ozempic, we are seeing a six-fold increase in packages dispensed. Trulicity is a nearly eightfold increase in just 24 months.

At the same time, public funds for reimbursement of both preparations are increasing. In 2020, the National Health Service spent more than PLN 5 million on Ozempic reimbursement. Two years later, it was already PLN 32 million, or more than 6 times as much. The Fund allocated even higher amounts for reimbursement of Trulicity. It went from nearly PLN 6 million in 2020 to more than PLN 42 million in 2022. That's seven times more.

Data from the National Health Service say that the number of drug packs dispensed and the amount for reimbursement is increasing:

Since the beginning of 2022, the availability of both drugs in pharmacies has dropped by tens of percent. Such a sharp increase in the popularity of these preparations is not only due to the need to treat type 2 diabetes. These drugs are also prescribed with reimbursement from the National Health Service for people who do not have indications for their use, but just want to lose weight.

- The desire to get rid of excess weight without the motivation to change one's lifestyle, especially to increase physical activity, often becomes the reason for seeking an easier solution and reaching for Ozempic or Trulicity. Both drugs allow weight loss. Unfortunately, there is also a lot of interest in the drugs among young and healthy people who want to lose a few extra pounds. Their use of these drugs is often not justified," points out Professor Dorota Zozulinska-Ziolkiewicz, chairman of the board of the Polish Diabetological Society.

Clinically unwarranted intake of Ozempic and Trulicity by patients without diabetes may be dangerous

The use of both drugs by people who do not have type 2 diabetes can cause serious side effects. Their list is long. These include nausea, vomiting and diarrhea.

- The long-term effects of using Ozempic and Trulicity drugs outside of their registration indications, i.e. in people without diabetes and without obesity, are unknown. Taking these drugs just to lose excessive pounds by overweight people is inappropriate and dangerous, because we do not know all the health effects that these drugs may cause in the future," stresses Prof. Zozulinska-Ziolkiewicz.

There is a shortage of medicines for people who need them. This threatens to worsen health conditions

Interest in Ozempic and Trulicity is so great that there has been a problem with their availability in pharmacies. For patients who need them for treatment, this is dramatic news.

The Ministry of Health has decided to include them in the list of medicinal products at risk of unavailability. This means that both preparations cannot be exported abroad. All this is to make them available to patients in Poland.

- The lack of availability of these drugs for patients with type 2 diabetes can result in discontinuation of therapy and an increase in health-threatening hyperglycemia and lead to weight gain. It also creates the need for unscheduled doctor visits and alternatives that are not always feasible. The use of GLP-1 analogs in the treatment of type 2 diabetes increases the chance of a longer and healthier life, but through limited availability, these chances are much lower, Professor Zozulinska-Ziolkiewicz points out.

NHF: we are looking closely at drug reimbursement and responding on behalf of patients

The growing demand for both drugs, especially their reimbursement costs, has been brought to the attention of analysts and inspectors of the National Health Fund. In such situations, a red light immediately goes on, so they need to be checked and clarified.

The National Health Service is responsible for monitoring reimbursed drugs. We intervene when reimbursed drugs are prescribed outside the indications for reimbursement or with the wrong level of payment.

It happens that private health care providers charge patients for consultations, while charging the NHF budget for the unjustified cost of drugs that are prescribed during the visit. The patient pays for the private visit, but the drug for which he should pay 100% of the price, he gets at an undue discount, despite the lack of reimbursement indications. In this way, patients who actually need treatment have limited access to it. That's why the NHF's controls in this area are essential for patients with type 2 diabetes.

[1] Combined with appropriate diet and exercise in monotherapy, in patients in whom the use of metformin is inadvisable due to intolerance or existing contraindications, in combination with other medicinal products used in the treatment of diabetes.

Source: NFZ