Blog Notes

Add-on payments mechanism: challenges and opportunities for access of innovative drugs in the hospital setting

Cristina Freire Sanz

3th May 2022

Inpatient healthcare services are contributing significantly to healthcare expenditures. In many countries, inpatient services (including medicines) are funded according to a DRG (Diagnosis-Related Group). Unfortunately, innovative, high-cost medicines at launch are often not sufficiently covered by these reimbursement systems which in turn disincentivizes hospitals to adopt and use these new treatment options. Why are DRG payment systems not made for high-cost medicines? What are the existing solutions for this issue? And what are the challenges and opportunities in the key markets? In this blog note, we are providing some insights on the subject.

Is Turkey pulling the plug on the medicines brought from abroad policy?

Efe Erdeş

5th April 2022

In December 2018, Turkey took its first measures to restrict the early access to medicines via the named patient program called “Medicines Brought from Abroad” list (MBFA, Yurtdışı İlaç Listesi) by limiting this benefit to a maximum of 3 years. The new law enforced manufacturers to apply for MA within these 3 years of duration of the program, and in case of failure of the MA filling, then the medicine might be constantly removed from the program. Accordingly, last December, the deadline for MA filling for the medicinal products supplied through this route prior to the amendment of 2018 was expired. What are the market access implications for those products that omitted the MA filling? Does MBFA still constitute an option for early access to Turkish market? What could be the best P&R route in Turkey to follow post-MBFA? In this blog note, we are providing some insights on the subject.

The new litmus test for early access in France: Is your product really innovative?

Karin Steinbach

7th March 2022

In July 2021, new French rules on early access to unauthorized medicinal products and off-label use of authorized medicinal products entered into force. Seven months into their implementation, the outcomes of the first evaluations are available. How is the new innovation-related criterion impacting the new assessments? Is HAS now stricter than ASNM has been? In this blog note, we are sharing some insights on the subject.

How safe is that orphan drug designation?

Sean Robbins

1st February 2022

An Orphan drug designation (ODD) can provide important incentives for a product during both clinical development and the market access stage. Although obtaining an ODD during a drug’s clinical development can be relatively easy, maintaining it at the time of regulatory approval has become increasingly difficult. In the following blog note, we discuss the requirements associated with maintaining an ODD in Europe, raise key questions for market access professionals about the relevance of having an ODD, and provide recommendations on how to optimize your chances of keeping the ODD.

New ways to pay for antibiotics

Natali Pennese

10th October 2021

Today, antimicrobial resistance is a serious and growing problem for healthcare systems, as it shrinks the range of treatment options available, setting many infections that were once easily treatable in a path to become deathly conditions. Paradoxically, the development and launch of new antibiotics have only been decreasing in the last years. Why has Pharma abandoned the antibiotics field, and what is being done by healthcare systems to make it again an attractive investment? In our blog note, we discussed those disincentives, as well as the most current policies being explored to tackle the issue in European countries.

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