Una scappatoia nel Medicines Act infastidisce i malati cronici

Medicinali. Foto: Toomas Huik / Postimees
  • The state should reimburse the cost of certain medicines, but does not do so.
  • There are no alternatives to many medicines.
  • The Health Insurance Fund has prepared a law amendment, but its future is unknown.

Although it is stipulated in case of some diseases that the chronically ill can buy medicines at a one hundred percent discount, a loophole in the law still deprives some buyers of this opportunity.

Two and a half years ago, the Health Insurance Fund proposed to amend the law so that the chronically ill would not have to pay more than the spirit of the law provides. Tuttavia, the Ministry of Social Affairs has not responded to this proposal.

Rocaltrol and L-Thyroxine, drugs for hypothyroidism and parathyroid gland dysfunction, should be, but are not 100% reimbursable. Why is this so?

Sander Rajamäe, the spokesperson of the Health Insurance Fund, noted that the drugs Rocaltrol and L-Thyroxin are the only oral drugs sold in Estonia with similar active ingredient content, and the price limits for them have been set according to the price of the cheapest reference country.

The prices of the mentioned drugs in the main reference countries are more favorable than those in Estonia, but the representatives of the holder of the marketing license for the drug have not considered it possible to lower the retail prices, due to which the patients experience the gap between the retail prices and the established top prices,” Rajamäe said.

“According to the Health Insurance Act, in such cases, the Health Insurance Fund can reimburse the medicine at the most favorable price level of the main reference countries, and the difference between the retail price and the reimbursed price will be borne by the patient regardless of the absence of analogues in the market,” explained Rajamäe.

Should the law be changed in this case? Rajamäe replied that the Health Insurance Fund has made a proposal to the Ministry of Social Affairs that, with the approval of the Medicines Committee, the existing price agreements could be continued if necessary, instead of establishing the limit price of the reference countries.

Until now, the Health Insurance Fund has not received feedback,” Rajamäe summed up.

Rajamäe noted that the Health Insurance Fund has sent the corresponding proposal to the Ministry of Social Affairs two and a half years ago, on December 30, 2019. “It is known that it was discussed during 2020, but we have no information about further progress. A quel tempo, the pharmaceutical department of the Ministry of Social Affairs dealt with it,” he commented.

Katrin Pudersell, chief specialist of the Department of Medicines and Medical Devices of the Health Insurance Fund, said that the reference country price caps for the drugs under discussion are established for Rocaltrol based on the prices in Latvia and for L-Thyroxin according to prices in Slovakia. Mark-ups of medicines permitted in Estonia are added to that.

A significant amount over year

“The patient therefore has to pay an additional 2.99 euros per package for Rocaltrol and 2.46 o 2.47 euros for L-Thyroxine, depending on the package. In general, these amounts remain in the same order of magnitude for most drugs for which the price cap of the reference country has been established,” Pudersell said.

“In this case, patient’s situation is complicated not so much the by increased co-payment when buying one package but rather the summation of this co-payment when several packages are purchased at the same time. In the case of Rocaltrol, Per esempio, six packages,” added Pudersell.

Pudersell noted that, in general, there is a need to establish price caps for reference countries in the case of old, relatively affordable and well-established drugs without competing products. She added that if there is no major impact on the patient’s purchasing behavior, the manufacturer has no motivation to lower the price.

“Marketing license holders for such drugs are often changing recently and achieving a price reduction then depends on the representation and capacity of the new license holder, which is mostly poor. In such a situation, the Health Insurance Fund has no other choice but to establish the price limit of the reference country. A classic incident of this kind was, Per esempio, the case of the drug Rocaltrol,” Pudersell commented.

These amounts may seem small, but both drugs are of the kind which the patient consumes for a lifetime. A significant amount adds up in the annual calculation which the Health Insurance Fund is supposed to compensate, but does not do so.

Pay or let your health deteriorate

The Health Insurance Fund does not establish the price caps of any reference country easily; it is always preceded by weeks or even months of negotiations in order to reduce the actual retail price of the drug. The price limit of the reference country is actually established in an emergency situation, where the price cannot be lowered, but the law does not allow the existing contract to be extended,” Pudersell explained.

Pudersell repeated the words of the spokesperson that the Health Insurance Fund has prepared a law amendment but its progress is unknown.

Rajamäe noted that besides the medicines for thyroid dysfunction there are 40-50 more medicines on sale in Estonia, the price of which would be more favorable for the buyer if the law amendment could be realized. The amendment would mean that the price cap of the drug sold in Estonia could be higher than the price level in the reference countries.

Life is difficult for patients who need Rocaltrol and L-Thyroxine because they cannot replace these drugs. There is only the choice: pay or let your health deteriorate.

A patient needs two to four tablets of Rocaltrol per day, one tablet of L-Thyroxine. According to the law, 100 percent reimbursement is available for drugs in the case of which discontinued treatment will have serious consequences. Rocaltrol’s 100% reimbursement was discontinued on July 1, 2021. With a 100% discount, the patient has to pay a prescription fee of 2.5 euro.