Poland’s pricing and reimbursement system has always had a reputation for restrictiveness when it comes to originator therapies, with its cost-effectiveness threshold and price negotiations. It may be surprising that regulatory issues are also limiting the uptake of biosimilars in the country – a potential source of considerable savings and opportunity to expand access to effective treatments.
In early December, the two main pharmaceutical industry associations in the country – the Polish Association of Pharma Industry Employers (PZPPF), which represents producers of generics and biosimilars, and the Employers’ Association of Innovative Pharmaceutical Companies (Infarma) – signed a joint declaration, together with the Polish pharmaceutical chamber of commerce, Farmacja Polska, calling for the Ministry of Health (MoH) to take steps to expand access to biologic medicines. The signatories pointed to the comparatively limited access Polish patients have, even to those medicines that are included in the reimbursement list, compared with their peers in other European countries.
Polish patients left behind
At first glance, it would appear that the situation is improving somewhat, with growth in spending on high-cost medicines in hospitals (administered via “drug programs”) of 6.3% year-on-year (y/y) in 2018 set to increase to growth of 16.3% this year. Furthermore, the most recent reimbursement list updates have featured the addition of a good number of new originator biologics, including CDK 4/6 inhibitors Ibrance (palboclicib; Pfizer, US) and Kisqali (riboclicib; Novartis, Switzerland) used in breast cancer, multiple sclerosis drug Ocrevus (ocrelizumab; Roche, Switzerland), and severe eosinophilic asthma treatment Fasenra (benralizumab; GlaxoSmithKline, UK). However, in its press release announcing the joint declaration, the PZPFF quotes statistics on the proportion of patients receiving biologic treatment for various diseases in Poland compared with other European markets and regions. According to these statistics, only 9.5% of patients with Crohn’s disease in Poland are treated with biologics, compared with 19.1% in Hungary and 30% in France, and only 0.1% of patients with psoriasis in Poland reportedly receive biologic treatments, while in Western Europe, the proportion is around 20%. Further evidence of this disparity is found elsewhere – in a report published this year by The Oncologist, entitled “Expenditures on Oncology Drugs and Cancer Mortality-to-Incidence Ratio in Central and Eastern Europe” (Vrdoljak et al), per-capita spending on oncology medications in Poland in 2015 amounted to just EUR17 – considerably lower than the average for Central and Eastern Europe, of EUR 29. Several countries with lower GDP per capita than Poland had higher per-capita spending on oncology drugs – including Hungary (EUR42), Bulgaria (EUR28) and Croatia (EUR27).
New originator biologics are being added to the reimbursement list in Poland, but they are simply not reaching a sufficient number of patients. Among the main reasons for this, as highlighted by the associations in their declaration, is the inflexibility of the regulations governing drug programs, and the strict admission criteria for patients. These criteria, along with prices, are negotiated between the Ministry of Health’s Economic Committee and manufacturers after the conclusion of HTA evaluations. Setting the admission criteria to allow the inclusion of only a limited number of patients means that major surges in expenditure are avoided, but also means that many patients who could benefit from treatment are excluded. Also, in many drug programs, there are limits to the duration of treatment with particular drugs, leaving patients needing to enroll again if necessary. The PZPPF claims that Poland is the one country in Europe in which effective treatment with biologics is subject to restrictions in the duration of treatment, adding that this leads to additional costs for the Polish payor, because when patients’ treatment with a biologic is interrupted, their condition can worsen, and when they are eligible to start treatment with the same drug again, it proves ineffective, and they need to switch to a more expensive treatment.
Limited access to biosimilars threatens potential savings
Crucially from an access point of view, the vast majority of biologics, and even biosimilars, are only available to patients via drug programs, and these are administered exclusively in hospitals. The PZPPF argues that in other Central and Eastern European countries, such as Slovakia, Romania and Bulgaria, biologics are made available to patients via retail pharmacies. Considering the potential savings that could be made thanks to a greater uptake of biosimilars, limiting their use to the already highly restrictive drug programs, only accessible in selected hospitals, appears illogical.
The associations also argue for greater competition in the biologics space, and changes to the current regulatory model that could spur competition. The current regulations, they argue, place excessive emphasis on low prices and lead to the danger of shortages in the longer term, as producers will be disincentivized from launching in Poland. This relates both to originator biologics and biosimilars; a brief survey of the latest reimbursement list shows that only two out of the ten biosimilar versions of auto-immune disease treatment Humira (adalimumab; AbbVie, US) approved in the European Union are reimbursed in Poland, and only two of the six EU-approved biosimilars of oncology medication MabThera/Rituxan (rituximab; Roche, Switzerland) are reimbursed. Thus, Poland could fail to benefit fully from the savings potential offered by the recent boom in the number of new biosimilars coming on to the market.
The arguments presented by the PZPPF, Infarma and Farmacja Polska are, without doubt, intended to promote their own members’ interests, with members of the PZPPF involved in the development and manufacturing of biosimilars, some of them in co-operation with members of Infarma (an example being Poland’s largest drugmaker Polpharma, which is collaborating with the Novartis generics and biosimilars subsidiary Sandoz in the biosimilars sphere). However, it is equally clear that a policy rethink is needed in order for the Polish authorities to reap the benefits of the burgeoning number of biosimilar products available. The National Health Fund (NFZ)’s policy of incentivizing hospitals to reduce expenditure on specific medicines, including the biologics infliximab, trastuzumab and etanercept, through greater tender-related discounts, may yield short-term savings benefits but carries longer term risks of putting off competitors due to the limited returns available. Furthermore, limiting biosimilars to hospital distribution via drug programs means that the potential to radically expand access to reflect the availability of cheaper alternatives is missed. The associations also highlight the social cost of failing to treat so many people with effective drugs – and this is perhaps the best argument they make.