News Alert: G-BA’s 2022 Work Program Anticipates Changes Under GSAV

PRICENTRIC BRIEF:

  • As financial pressures increase under Germany’s statutory health insurance system (GKV), Josef Hecken, impartial chairman of the Federal Joint Committee (G-BA), has revealed plans for “short-term cost-containment measures,” among a number of other measures in the G-BA’s work program for 2022.
  • In a release, the organization stated that the pandemic and its effects on healthcare will continue to occupy its workings in various areas going into 2022; however, it has also recommended a number of other amendments, such as restricting the orphan privilege in AMNOG procedures and denying postponement of biosimilar substitutions.
  • Speaking at a press conference, Hecken added: “Faster and better in relation to the financial challenges must not lead to a lower level of evidence, for that would mean that the SHI would in the future spend a lot of money on useless sham innovations that are at best worthless and at worst actually harmful — money that is, in fact, urgently needed for real innovations.”

THE DETAILS

BERLIN, Germany — As financial pressures increase under Germany’s statutory health insurance system (GKV), Josef Hecken, impartial chairman of the Federal Joint Committee (G-BA), has revealed plans for “short-term cost-containment measures,” among a number of other measures in the G-BA’s work program for 2022.

In a release, the organization stated that the pandemic and its effects on healthcare will continue to occupy its workings in various areas going into 2022; however, it has also recommended a number of other amendments, such as restricting the orphan privilege in AMNOG procedures and denying postponement of biosimilar substitutions.

2022 Assessments

According to the G-BA’s 2022 program, the health technology assessment (HTA) body expects to carry out about 140 drug assessments in 2022 and a maximum of six real-world data (RWE) collection procedures — such as the one currently in place for Zolgensma (onasemnogene abeparvovec).

Speaking at the accompanying press conference, Hecken stated: “In 2022, as in previous years, there will again be a high number of assessments of the added benefit of new medicinal products, probably about 140 decisions,” a number which has “increased by about 25% in the last few years.”

Hecken also highlighted demands from the new coalition government for the agency to give patients a greater role in its activities and to speed up its processes. The document elaborates: “The G-BA will and must in the future show real progress on the basis of strict evidence reviews and differentiate from ‘me-too’ drugs or from interventions without patient-relevant added value. This is the only way to cushion the foreseeable, constantly growing supply requirements in terms of the principle of economic efficiency.”

Orphan Procedures

G-BA is also calling on the relevant bodies to restrict the orphan privilege in AMNOG procedures by introducing restrictive pricing on certain drug combinations, particularly those in oncology, and avoiding waste due to unsuitable package size.

Hecken suggested that these measures would make it possible to further cover the costs for innovative drugs without a new austerity law or increasing the contribution rate, as one contribution rate percentage point equals EUR 15 billion.

However, Hecken also clarified that the orphan privilege rule should be kept for the “true soloists, the first drugs approved on the market in an orphan indication,” and not any that come after.

Biosimilars

When announcing the working program, Hecken ruled out any postponement of biosimilar substitution in German pharmacies and confirmed that physicians’ concerns on specific situations will be addressed by exceptions.

Speaking at the press conference, the Chairman noted that “the legislator has given us until August to make a decision, and I do not speak for a postponement. We already have a lot of discount agreements [on biological drugs], and we can generate even more; otherwise, the purse will be empty at some point.”

Biosimilar substitution was first announced in 2019 under Germany’s “better safety in drug supply” (GSAV) bill, but at the time was set to be implemented in 2022.

G-BA will be able to decide which biologicals and biosimilars could be substituted in pharmacies under the “aut idem” rule. This regulation requires pharmacists to distribute the cheapest version of a drug unless the prescriber specifies otherwise. This rule does not currently apply to biologicals.

The Health Ministry had initially planned to substitute certain biosimilars in pharmacies in 2019 but was criticized by pharmacists, pharma lobbies including Pro Biosimilars, and experts. Consequently, the plan was postponed by three years.

Other measures

In addition to the above measures, the following were outlined in the 2022 work program:

  • CAR-T-cell therapies for more common cancers will reach the market, and the GBA will impose quality requirements on centers that administer them to safeguard patient care.
  • The first reserve antibiotics to reach the market will not be evaluated for their level of additional benefit, but the GBA may set additional requirements to ensure their appropriate use.

Finally, Hecken commented: “Faster and better in relation to the financial challenges must not lead to a lower level of evidence, for that would mean that the SHI would in the future spend a lot of money on useless sham innovations that are at best worthless and at worst actually harmful — money that is, in fact, urgently needed for real innovations.”

He added that the GBA “must recognize real progress on the basis of strict evidence reviews and distinguish it from ‘me-too’ drugs or interventions without patient-relevant added value.”

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