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 the 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 (AOTM), 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, AOTM issues an official determination on the pharmacoeconomic impact of a drug and its clinical data. The AOTM 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.
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 AOTM, 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, AOTM may consider risk-sharing agreements or limiting the indication and patient population. Risk sharing is more likely in cases where AOTM recognizes that a product adds value. Even if a product is denied reimbursement, gaining AOTM’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 product to anyone other than a physician. This limits a manufacturer’s ability to publicise a product and limits the audience scope to professionals and non-government organisations, 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.
for a complimentary 30-minute consultation
This holiday season, we gather. The lights are low, the fireplace is lit. Regional expertise is shared, and there’s laughter in the air as visions of successful global healthcare communications dance in our heads. As we close out another great year, we invite you to...
We are excited to join our partners in Mumbai, India today for our annual GLOBALHealthPR Asia-Pacific (APAC) Regional Planning Workshop. Over the ensuing two days (November 20 – 21), we will share market-specific insights, explore communication challenges, discuss...
NEW YORK and MILAN, Sept. 24, 2019 /PRNewswire/ -- GLOBALHealthPR (GHPR), the world's largest partnership of independent health and science communications agencies, today announced the addition of Milan-based Connexia as its newest member. The partnership with...
We asked GLOBALHealthPR partners for their take on elevating patient voices at scientific meetings. For their insights on engaging patient communities around these events, download the full perspective piece. Download the full perspective...
NEW YORK (April 2, 2019) – GLOBALHealthPR® (GHPR), the world’s largest partnership of independent healthcare-focused communications agencies, today announced the promotion of Tim Goddard to President. In this role, Goddard, who has served as an Executive Vice...
NEW YORK, March 6, 2019 /PRNewswire/ -- GLOBALHealthPR (GHPR), the world's largest network of independent health and science communications agencies, today announced Chile-based Strategika as its newest member agency. The addition further increases the partnership's...