BERLIN, 21 Aug (APM) - Patients and a biosimilar lobby have warned against the "cheapest drug" approach in the guidelines set in Germany on the substitution between biologicals and biosimilars made by prescribers.
Health technology assessment (HTA) body G-BA on Thursday decided on a directive
for "an economical prescription of biotechnologically produced biological drugs" comprising biological originators and their biosimilars.
This is the first step before implementing biosimilar substitution in German pharmacies planned in mid-2022, as stated in the 2019 "better safety in drug supply" law (GSAV) (APMHE 63301
The directive is not yet in effect as, according to the legal framework, the Health Ministry will check the legality of the directive before it is published in the Federal Gazette. It is entitled to ask about clarifications.
G-BA will also publish a directive on substitution in pharmacies before August 2022. It plans to set up a positive list of biological and biosimilar drugs that would be interchangeable in pharmacies (APMHE 65424
'select a low-price product'
The directive is "a guideline for the economic prescription of therapy with this particular group of drugs - of course always provided that the prescription of a biosimilar is patient-specific and medically justifiable," said G-BA chair Josef Hecken in a Thursday statement
"In the sense of an economical prescription, doctors should select a low-price product based on the active substance at the beginning of a therapy with biotechnologically produced biological drugs. This is usually a biosimilar, if available", G-BA said.
The directive adds that prescribing a drug covered by a discount agreement is considered as "economically efficient". The prescribed drug can be an originator or a biosimilar.
"If patients are already being treated with a certain biological drug, doctors should check whether they can switch to a cheaper biosimilar," G-BA said in the statement.
"The prerequisite for switching to a biosimilar if a drug therapy is already ongoing is that there are no patient-specific medical reasons against switching to another drug. These can be side effects and intolerances or an unstable therapy situation," it added.
G-BA added that all biosimilars that have received marketing authorisation for the same originator are considered "therapeutically comparable".
Once the directive is in effect, G-BA will provide information on the approval status of originators and their biosimilars in a new annex, which will be updated on an ongoing basis.
No explicit promotion of biosimilars
Biosimilar lobby Pro Biosimilars said that G-BA's decision "does not explicitly promote biosimilars", it said in a Thursday statement
G-BA "does not expressly recommend the prescription of biosimilars, but rather regards all biologics that are under discount agreements as economical in principle", Pro Biosimilars said.
This is contrary to the aim of the GSAV law that intended to promote the prescriptions of biosimilars, it added.
As part of a defence strategy against biosimilars, manufacturers of originator biologicals signed discount agreements with German payers that were securing the "cost-effectiveness" at least for some time. This was the case when adalimumab biosimilars were launched in October 2018 (APMHE 60174
Risk of successive switches
G-BA's patient representatives raised concerns against multiple switches, according to a Thursday statement
"G-BA paves the way for multiples switches to biosimilars for cost reasons alone", it said, reiterating an already aired position (APMHE 65968
The resolution was passed against the opinion of patient representatives, who have no voting rights but are consulted, and their opinion is expressed publicly in plenary sessions. On Thursday, the views supported by patient representatives were not adopted.
The directive "also disregards important critical assessments made by experts from scientific societies", the statement said.
"A one-time change between an originator and a biosimilar is acceptable for economic reasons from patients' perspective" but multiple switches would not be triggered by price changes.
Patients representatives argued that there was "insufficient scientific data for a safe continuation of therapy with multiple changes of preparations without loss of efficacy and without sudden side effects".
It also put forward risk of "a nocebo effect" (negative outcome due to a belief that the switch will cause harm) for chronically ill patients who are "well adapted to a therapy, of adherence problems" and "application errors when using syringes and pens that are constantly new and differently constructed".
In view of the new directive on biosimilar substitution, "it is essential to avoid equating the exchange of biosimilars with the exchange of generics", it added.