F040 Slovenia: a country without copayments for drugs with a lively digital health community (Two-part episode)
Slovenia is a country of 2 million people, with a universal healthcare system, and quite a few success stories about digitization to share. One digitally unrelated thing patients in Slovenia can be grateful for is access to drugs.
Drug prices are a consistently controversial topic in the US healthcare system. In 2015 Turing Pharmaceuticals, raised the price of a 62-year-old drug (Daraprim) which is used as a standard of care for treating a life-threatening parasitic infection. The drug price increased to $750 a pill from $13.50 in the US. New York Times recently published a letter of a reader explaining that her generic potentially life-saving asthma bronchodilator inhaler, cost her more than $100 at American pharmacies. She moved to Mexico, and the same inhaler cost her $4, In London, it costs her $9, and in Spain — where it is manufactured — about $2.60. The most recent drug pricing “affair” is the high price od Truvada — a drug to prevent H.I.V. infections. In the US, a monthly supply costs almost 2000 US dollars while it only costs 8 dollars in Australia.
From the European perspective, it is hard to comprehend the high prices in the US. Luckily for the patients in Europe, the European market is very well regulated to prevent stories like Daraprim’s to occur. How does regulation work?
Reference pricing
Listen to the short episode about drug pricing in Europe and Slovenia: Podbean, iTunes, Stitcher.
The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA. Scientific evaluation, medicines for use in the EU, is done by the European Medicines Agency — EMA. Once a marketing authorization has been granted, decisions about price and reimbursement take place at the level of each country.
Countries differ in their pricing policies, and in reimbursement. Some have deductibles, others use co-payments for prescriptions. Many countries use External Reference Pricing (ERP) system when determining negotiation prices with manufacturers. ERP is the practice of using the price(s) of a medicine in one or several countries in order to derive a benchmark or reference price for the purposes of setting or negotiating the price of the product in a given country.
For example, the reference countries for Slovenia are Austria, France and Germany. When trying to set the price limit for new original drug, our regulators would look at prices in Austria, Germany and France. The price for Slovenia would be a permitted percentage of the lowest price of an equivalent medicinal product in one of the three reference countries. For original drugs, we would look at the lowest price in the reference countries. For generic medicinal products, the calculations are done based on the percentage of the average of the highest and the lowest prices of comparable generic medicinal products in reference countries.
In essence, prices are very intertwined and can’t fluctuate for hundreds percents overnight, as in the case of Daraprim in the US. Despite the external reference system, in the end, a lot still depends on negotiations on national levels, and while some drug prices are publicly available, final prices are usually not visible to the public.
Slovenia does not have copayments. How is that possible?
Slovenia has a universal national health insurance system. The main decision-maker for obligatory health insurance is the Health Insurance Institute. The Institute is in charge of negotiations for drug prices covered by the insurance. Several policies are in place to enable every patient that needs a specific drug to access it.
There is no discrimination towards patients with pre-existing conditions.
In the inpatient setting, every drug is covered in full by the insurance.
To prevent co-payment for prescription drugs in the outpatient setting, two policies are in place:
interchangeability of drugs, referring to generic drugs. The health insurance institute determines the highest allowed price for a specific drug. If a manufacturer of the drug insists on a higher price, the patients receiving it will need to co-pay the difference, but more likely, they will get a cheaper generic drug, to avoid the copayment. Generic drugs by definition have the same chemical structure, therefor their interchangeability shouldn’t be problematic. A slightly different case is another policy called the therapeutic clusters of drugs.
Therapeutic clusters of drugs are groups of different medications for the same indication. For example ACE inhibitors or lipid-lowering drugs. Similarly, as with the interchangeability of drugs, upon picking up prescription drugs in the pharmacy, the pharmacist will offer the patient a different drug, but with the same expected effect, to avoid a copayment. What this does is force the manufacturers to adapt their prices.
And even if copayments do occur, they are small, ranging from a few cents to 50 euros for example, says the Head of Medication management at the Health Insurance Institute Jurij Fürst.
Another measure for rational prescribing is the introduction of clinical pharmacists to primary care level. Clinical pharmacists work as consultants for therapy optimization and GPs are encouraged to consult with them regarding polypharmacy patients or when in doubt regarding side effects of potential side effects. As explained by dr. Fürst, this policy still needs awaits for better adoption, as many doctors see sending a patient to the clinical pharmacists as an additional burden.
No opioid and ADHD crisis
The European market is highly regulated and direct to consumer advertising of drugs is prohibited. Not only drug prices but prescribing is also highly controlled.
Opioids are strictly regulated. “The reference point is cancer pain. There is no doubt — in cancer, you have to aggressively treat pain. In non-cancer pain, patients need to go to pain specialists, usually anaesthesiologists for evaluation before getting an opioid,” says dr. Jurij Fürst.
Another good example illustrating strict regulation are ADHD drugs: while in the US, many students will claim it’s relatively easy to get a prescription for ADHD drugs or buy them from schoolmates, it’s much harder to imagine that in Slovenia. Again, only a number of specialists are authorized to prescribe them.
How to tackle rising drug prices in the personalized medicine era?
Drug expenditure is getting increasingly high with new drugs such as immunotherapies and gene therapies. But if we look at how biologic drug cost containment is evolving, there is a light of hope. As patents for biologic drugs are falling, so are the prices of originators and biosimilars. And Europe is much more open to the approval of biosimilars compared to the US.
Still, says dr. Furst, prescribing needs to be optimized because doctors are cautious about switching between biologic drugs and biosimilars. At least in Slovenia, biosimilars are also not automatically interchangeable, the doctors need to actively decide for and prescribe a different drug. But once, if awareness among doctors about the safety of interchangeability of biologics and biosimilars increases, that situation might change as well.
In 2015, a highly anticipated study NOR-SWITCH examining effects of switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy, safety, and immunogenicity. The results were positive and profoundly affected how infliximab biosimilars lowered the prices of biologics in the coming years, which increased access to therapy for many more patients.
To sum up; the Slovenian healthcare system has a lot of problems, but patients, in general, don’t need to worry about not getting a drug because of price.
Digital successes in Slovenian healthcare
Similarly to Estonia (1.4 million people), Malta (0.5 million people) or Singapore (5.6 million people), Slovenia is a small country which gives it an advantage in country-wide digitization projects. On the index of the digital economy and society 2018 prepared by the European Commission, Slovenia was ranked 6th according to the use of eHealth solutions.
Electronic prescriptions are the norm since 2015. Some telemedicine projects include:
Teleradiology, enabling the exchange of all radiology scans between healthcare providers,
Telestroke, connecting 12 hospitals around Slovenia, and enabling high-quality care to patients who suffered a stroke, even when a neurologist is not present.
Teletransfusion, connecting transfusion centers around Slovenia to optimize resource allocation without hindering patient care. Operating since 2011.
Since 2012, Slovenia has in place the interoperable backbone for main patient data such as discharge letters and prescriptions.
This gives patients access to a digital copy of their important medical documents.
From eHealth to digital health
Healthday.si 2018 Annual conference participants.
Roughly 40 digital health and MedTech companies are active in the country, says Tina Vavpotič — healthcare business strategist and consultant, with rich experiences in healthcare policy design, healthcare IT product design and implementation. Tina led the Teletransfusion project and was among the initiators of the Slovenian digital health association Healthday.si, founded in 2014.
Healthday.si began as a friendly gathering for anyone interested in or working with healthcare technology. The idea for the association was came from a group of entrepreneurs who realized most companies in Slovenia are looking at scaling abroad and could, therefore, exchange best practices. Around 100 people attended the first meeting, and today, Healthday.si annual conferences attract over 200 people each year.
From a community bringing together digital health experts, entrepreneurs, medical professionals, and legislators, Healthday.si became an active organization advocating wider and faster inclusion of digital health solution in the national healthcare system.
To go beyond constructive discussions at annual conferences and meetups, Healthday.si team decided for a new approach in 2019. An expert team prepared a series of workshops to discover the best approach for a systematic and thoroughly planned inclusion of chosen digital health innovations in the healthcare system. The goal of the special program called DIH is to get 5 digital health solutions in the national healthcare system by 2021.