EU HTAR – Achieving broad access fast

"Important guidance documents have been approved and implementing acts have been published. We have all that is necessary to start with for the first products submitted under the EU HTAR," Meyer said.

The EU HTAR was created to speed equal patient access to innovative products while adhering to the utmost quality standards. Key objectives include efficiently using resources, strengthening HTA, and improving transparency and inclusiveness.

“All stakeholders need to be prepared, including pharmaceutical companies, patients, clinicians, and regulatory bodies. People also need to be open to collaboration and learning from others,” Lipska said.

In terms of resources, managing the EU HTAR frame successfully may be just as hard for big pharma as it is for small and midsized companies. Although big companies may have more resources, including local affiliates with insights into each country, they may not be able to adapt as quickly as smaller, nimbler companies, Solà-Morales noted.

For pharma manufacturers, success largely depends on early engagement in the Joint Scientific Consultation (JSC) phase, preparing for the JSC process, getting internally equipped for potential PICOs (Population, Intervention, Comparator, Outcome) component, and working through the national “delta dossier” and pricing and reimbursement processes, which are still in the member states' responsibility.

"To have the opportunity for a joint scientific consultation (JSC) should make the work much easier for everybody, including the HTA bodies and the edge health technology developers, since the pharma companies will get useful insight on what the PICOs will be when they submit the dossier a couple of years later.," Meyer said.

Altmann said, “The JSC process should be done before phase 3 clinical trials start. With that the internal clinical team better understands the external requests and requirements for successfully going through the marketing authorization and JCA processes, which will start at a certain point of time in parallel. After finishing the EMA approval, a JCA report should be received from EU HTA CG (Coordination Group) no more than 30 days later, which will be included in all member states’ national ‘delta dossier’ process."