BERLIN, May 23 (APM) - The adaptive pathways approach for drug approvals is a useful option in improving availability of medicines for patients needing specialist treatment, according to German pharma lobby group vfa.
The majority of drugs should still be authorised in the regular manner and the adaptive pathways approach should only be used in specific cases only, vfa said in a Friday statement published on its website.
The European Medicines Agency launched the adaptive pathways project in 2014 in a major region-wide drive to look at new and faster ways of bringing drugs in Phase I/II that show significant promise to patients with unmet needs.
The project is examining earlier licensing of innovative medicines in small, targeted patient populations, with the aim of expanding use as more data are gathered from trials and real-world evidence.
Early authorisation should only be given if the drug showed a clearly positive risk-benefit ratio in the patient group, vfa said.
The approach does not represent an economic advantage for pharma companies, because the first authorisations were given for very small patient populations and the authorisation for all potential patients would require more evidence, according to vfa.
No one can say so far if the study designs for adaptive pathways procedure will be based more often than previously on surrogate parameters, rather than on endpoints, vfa said.
So far, it is unclear whether drugs developed within the adaptive pathways approach need different health technology assessment (HTA) procedures than other drugs, vfa said.
Vfa reacted to a suggestion from German umbrella payer group GKV-Spitzenverband in April that drugs with conditional approval should undergo a specific HTA and have lower prices or restricted reimbursement (APMMA 47196).
The adaptive pathways approach has also been criticised by German insurers (APMMA 46511) and by the German higher HTA body G-BA (APMMA 44270), but has been supported by the medicines and medical devices regulator BfArM (APMMA 46554).
The adaptive pathways approach poses a threat to drug safety, doctors' group aimed at stopping pharma's influence over healthcare professionals Mezis said in a press release on May 11.
Instead of forcing manufacturers to deliver evidence that their drugs are secure, patients will have to demonstrate that a drug is dangerous again, Mezis said.
It is not possible to identify the benefit of such an additional system considering the number of alternative authorisation models, according to Mezis.
/bg/hm/nh
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
