HIV-positive Norwegians may not get modern antiretroviral drugs

17 setembro 2018

The Kingdom of Norway, which has maintained the status of the state with the world's highest human development index (HDI) for the last ten years and is the third largest on the planet by nominal GDP per capita, is on the verge of a crisis of underfunding the drug people living with HIV.

October 1, 2018 in the country will come into force new recommendations for the treatment of HIV infection, which obliges doctors working in public clinics to offer patients to switch to new, cheaper, ARVT regimens.

If previously all the registered antiretroviral drugs were available to Norwegian patients, now due to the introduction of public procurements some of them - the most advanced combined funds - have been "overboard". Among them are Atripla®, Celsentri®, Descovy®, Edurant®, Genvoya®, Intelence®, Kaletra®, Truvada® and others.

This is due to the misconception of government officials who calculated that the world's leading pharmaceutical companies - manufacturers of the most effective and at the same time the most expensive drugs - will go to lower prices when faced with decisive actions by the authorities.

The Norwegian Parliament announced early in the year that it intended to reduce unreasonable budget spending. One of the main tools for optimizing spending in the healthcare sphere was the replacement of a few expensive medications by analogues.

It is for this reason that the amount allocated in 2018 to purchase antiretroviral drugs was reduced by 10-15% (NOK 65 million or about EUR 6.5 million).

As a result, the situation became extremely difficult for the drug supply system, when after the announcement of the first auction on March 23, no application from the original ARVT manufacturers was submitted for the tender. Companies simply refused to participate in procurement because of prohibitive starting prices.

According to Dr. Olav Lutro, Norwegian HIV patients have become a bargaining chip between the government and the pharmaceutical industry.

On September 1, the Norwegian authorities purchased the following drugs:

• Emtricitabin / tenofovir disoproksil from Accord, and darunavir / kobicistat (Rezolsta) from Janssen

• Abakavir / lamivudin (Kivexa) from GSK and darunavir / kobicistat (Rezolsta) from Janssen

• Abakavir / lamivudin from Mylan and darunavir / kobicistat (Rezolsta) from Janssen

• Emtricitabin / tenofovir disoproksil from Accord and raltegravir (Isentress) from MSD

• Abakavir / lamivudin (Kivexa) from GSK

• Abakavir / lamivudin from Mylan and raltegravir (Isentress) from MSD

• Emtricitabin / tenofovir disoproksil from Accord and dolutegravir (Tivicay) from GSK

• Abakavir / lamivudin (Kivexa) and dolutegravir (Tivicay) from GSK

• Abakavir / lamivudin from Mylan and dolutegravir (Tivicay) from GSK

• Abakavir / lamivudin / dolutegravir (Triumeq) from GSK

To "persuade" patients to switch to new treatment regimes, the Parliament of the country decided to issue updated clinical recommendations for doctors, which directly points to the obligation of the latter to offer new schemes instead of the old ones "for financial reasons".

In other words, clinics, where about 4,000 people living with HIV are currently being treated, will have to transfer patients who are already on therapy and those who have just turned for help to new, reproduced schemes. And this, as follows from the results of the auctions that ended at the end of August, whole sets of preparations instead of previously issued combined ARVT with a fixed dosage in one tablet.

As experts emphasize, changing only one form of medication (for example, from 1 to 2-3 per day), not to mention the possible side effects, can have the most negative impact on patient adherence to treatment.

Leif-Ove Hansen, representing the Styreleder HivNorge Association, confirmed that over half (54%) of HIV-positive Norwegians taking Triumeq or Genvoya (1 tablet once a day) will have to be transferred to generics.

According to him, today not all clinics have realized the seriousness of the situation. Many doctors still say that they will try to write out the original funds. However, the expert emphasizes, in fact they simply will not have a choice: if it is not a question of concluding a special medical commission, issued only for vital indications, the clinics simply will not be able to afford it.

The crisis of the situation is also added by the fact that the professional and patient communities have not yet protested openly.

In the network on September 13, only a few small statements from profile associations were published, concerning the reduction of the quality of life of patients due to the saving of public funds.

At the same time, no one knows what will happen next. Whether the authorities retained the measures introduced or, in time, returned to the old procurement schemes, it is not known.

Lave-Ove Hansen told Life4me that an application is currently being prepared for the announcement of a new tender with even more stringent conditions, however norwegian doctors, activists, human rights activists and representatives of the press persistently ignore the problem, hoping that the state will manage to find a way out.

There is a unique situation where in a country with the highest level of human rights protection, where, for example, Andreas Breivik, who killed several dozen people, is serving his sentence in the most comfortable conditions, the authorities suddenly decide to save on the most necessary, grossly violating the rights that he upholds patients.