Poland is one of the most difficult markets in Europe to achieve market access for pharmaceutical products. High prices on branded drugs coupled with an arduous reimbursement process create an environment dominated by generic pharmaceuticals for all but the wealthiest Polish citizens. With limited uptake for innovative new medicines prior to securing reimbursement and very strict laws on marketing of branded products, it is imperative to connect with the right opinion leaders to achieve reimbursement.
Poland’s Payer Stakeholders
- The Polish Ministry of Health determines medications to be reimbursed by The National Health Fund (NFZ), Poland’s single payer. The Ministry of Health is advised by the publicly funded HTA Agencja Oceny Technologii Medycznych I Taryfikacji (AOTMiT), government-appointed opinion leaders and government consultants. It also receives informal consultation from non-government key opinion leaders, interest groups and medical associations.
- When a pharmaceutical company submits a drug reimbursement proposal to the Ministry of Health, the AOTMiT issues an official determination on the pharmacoeconomic impact of the drug and its clinical data. The AOTMiT may also consider the drug’s impact on the overall budget in rendering a decision. Medical associations play an informal advisory role in the reimbursement decision-making process. Medical and professional associations are among the few groups a pharma company can meet with to discuss its product while the reimbursement review process is underway.
- Companies applying for drug reimbursement must submit their applications online in the Reimbursement List System (System Obsługi List Refundacyjnych).
- There are no private payers in the Polish health system. However, patients may pay out-of-pocket for a medication that is not reimbursed.
Important Points to Keep in Mind
Pharmaceutical products that receive the green light from the EMEA are automatically approved for use in Poland. From that point, however, it can take the Ministry of Health years to render a reimbursement decision. Companies can appeal reimbursement and pricing decisions to the AOTMiT, but the Ministry’s ruling is rarely overturned. In this case, it is often best to approach the process from a different angle, potentially with a smaller target population or a more limited indication.
If a company is unable to negotiate an agreeable price after re-evaluation, the AOTMiT may consider risk-sharing agreements or limiting the indication and patient population. Risk sharing is more likely in cases where the AOTMiT recognizes that a product adds value. Even if a product is denied reimbursement, gaining the AOTMiT’s support for the product makes the government more willing to be flexible regarding indication and risk management.
Marketing regulations in Poland are very strict. It is illegal to mention the name of a new Rx product to anyone other than a physician. This limits a manufacturer’s ability to publicize a product and limits the audience scope to professionals and non-government organizations, reducing the effectiveness of more traditional marketing efforts aimed at creating community support for access to a treatment.
Polish patients are often unable to afford a drug that is not reimbursed, and in many cases are not forthcoming about their conditions due to public stigma. As such, pre-reimbursement case studies are difficult to come by, though when available they make for excellent demonstrations of value during the negotiation process.
Implications for Industry
Stiff competition from generics paired with a rigid single payer governance structure can block access and reimbursement in the Polish market. Companies are faced with a lengthy decision-making process and appeals of unfavorable decisions are rarely successful.
Prepare to be flexible regarding indication and target patient segment to achieve access and reimbursement in Poland. By keeping all options on the table and planning for any possible result of the long reimbursement process, you will be able to effectively respond upon receipt of the Ministry of Health’s decision.
To that end, an experienced market access team paired with early public relations efforts to reach out to key stakeholders and opinion leaders can help you leverage small advantages into major successes. Flexibility and creativity in market access strategy are essential for securing reimbursement in an environment as challenging as Poland.
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