Polycythemia Vera Therapy Trends to Watch in 2025
Pricing for Besremi differs globally but tends to be more sustainable for extended therapy compared with JAKAFI
The treatment environment for polycythemia vera is changing rapidly as long-standing therapies approach patent expiry and new biologics make their way into the market. For years, JAKAFI (ruxolitinib) has been the leading option for patients resistant or intolerant to hydroxyurea. However, the expected introduction of generics may not arrive as soon as anticipated. Recent developments suggest that the expiration timeline and launch of ruxolitinib generics could face delays, allowing JAKAFI to maintain its market dominance for a longer period.
This situation has reignited concern over the drug’s cost. Many continue to ask why is JAKAFI so expensive when annual treatment costs can exceed USD 100,000. Such high pricing poses challenges for patients, payers, and public health systems, particularly given the chronic nature of the disease. Although copay support programs exist, many individuals still face significant financial strain. Without timely generic competition, these challenges may persist for several years, reinforcing the need for cost transparency and regulatory intervention.
Meanwhile, the competitive field is shifting. Besremi (ropeginterferon alfa-2b), developed by PharmaEssentia, has gained attention as a disease-modifying option with long-term potential. Unlike JAKAFI, which primarily manages symptoms, Besremi targets the underlying disease process by reducing abnormal blood cell production. Its addition to the NCCN guidelines has increased physician confidence and expanded its use as a first-line therapy.
Pricing for Besremi differs globally but tends to be more sustainable for extended therapy compared with JAKAFI. Patient discussions often focus on besremi side effects, as well as comparisons with hydroxyurea. The therapy is generally well tolerated, with side effects such as fatigue, injection site reactions, or mild flu-like symptoms. Its convenient dosing—every two weeks—makes it a practical choice for long-term management.
The development of rusfertide, an injectable hepcidin mimetic from Protagonist Therapeutics, represents another major advancement. The drug is being studied for its ability to reduce the need for phlebotomy in polycythemia vera patients. While rusfertide FDA approval is still pending, clinical data show strong promise. By mimicking the natural hormone hepcidin, rusfertide helps regulate iron balance and maintain hematocrit levels.
Rusfertide’s clinical progress has been closely followed, even after the FDA withdrew its Breakthrough Therapy Designation. Although that decision slowed its regulatory trajectory, it did not diminish its therapeutic potential. Many experts believe that once approved, rusfertide could significantly influence the polycythemia vera interferon therapeutics market by offering a treatment that reduces the need for invasive procedures while improving patient outcomes.
Together, these developments illustrate the dual nature of the current market: innovation on one side, and persistent affordability issues on the other. The delay in generic JAKAFI availability extends the period of high treatment costs, but new drugs like Besremi and rusfertide are expanding the range of options for patients and clinicians.
The next few years will likely bring a balancing act between innovation, pricing, and access. If rusfertide achieves approval, it could redefine therapy strategies, potentially in combination or sequence with existing treatments. Meanwhile, Besremi’s growing adoption signals a shift toward early intervention with interferon-based approaches.
In conclusion, the polycythemia vera landscape in 2025 is marked by change and opportunity. JAKAFI (ruxolitinib) remains a cornerstone but faces growing pressure from Besremi (ropeginterferon alfa-2b) and rusfertide. These advances promise broader treatment choice and improved outcomes, but affordability will remain the central challenge shaping access and patient care worldwide.
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