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Demand & pricing for OMPs

Need 4: Improve the coherence and predictability of demand and pricing for OMPs

After obtaining central marketing authorisation, OMP developers need to seek market access in each EU Member State where they intend to market their OMP. The final price level and the size of the accessible market are crucial factors in the investment case for OMP development, demand and pricing for OMPs are not explicitly tied into the EU incentive framework. Currently, the heterogeneous national HTA and P&R procedures contribute to a lack of alignment between OMP development and payers, prescribers and patients’ needs. This creates uncertainties on the willingness to pay for OMPs, the size of the patient population, the access conditions and the price level.

The resulting situation is an incentive imbalance in the OMP development pathway where incentives set on the supply side (up until regulatory approval) are not mirrored, and at worst even undermined, by measures set by national systems on the demand-side (from market access onwards). Truly incentivising OMP development therefore means improving the coherence and predictability of demand and pricing for OMPs.

Moreover, while the challenge of equal patient access to OMPs across EU Member States is not an explicit subject matter of this report, the Expert Group recognises the link between strong demand-side incentives and the EU’s goal to foster wider and more equal access to OMPs.

The following policy solutions could therefore bring the EU closer to an integrated OMP path where incentives are fully aligned to the market access stage.

The recommendations

  • Establish an iterative early dialogue for EMA-HTA bodies and OMP developers
  • Pilot a common EU access pathway for “priority” (extremely rare) OMPs
  • Create a common EU value assessment for OMPs
  • Facilitate homogeneous access to OMPs across EU Member States