Alert level JAKed up

5 minute read

There’s good news and bad news for JAK inhibitors, and some PBS regulatory updates for tocilizumab, nintedanib and covid antivirals.

There’s good news and bad news for JAK inhibitors, and some PBS regulatory updates for tocilizumab, nintedanib and covid antivirals.

In brief:

  • EMA JAKi side-effect warnings
  • Filgotinib male fertility reprieve
  • Temporary PBS arrangements for tocilizumab shortage come to an end
  • Real-time nintedanib prescribing
  • Expanded covid antivirals access

EMA JAKi side effect warnings

The European Medicine Agency’s safety committee has recommended measures to minimise the risk of serious side effects, including cardiovascular conditions, blood clots, cancer and serious infections, linked with JAK inhibitors.

The affected JAK inhibitors are baricitinib (though not for short-term treatment of covid), upadacitinib, tofacitinib, abrocitinib and filgotinib.

The committee recommended that these medicines should be used in certain patients only if no suitable treatment alternatives are available. This includes people aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), current smokers or past long-term smokers, those at increased risk of cancer, and patients with risk factors for venous thromboembolism.

Further, it said in a press release, “the doses should be reduced in some patient groups who may be at risk of VTE, cancer or major cardiovascular problems.”

The recommendation is based on a review of the ORAL Surveillance data showing that tofacitinib increases the risk of major cardiovascular problems, cancer, VTE, serious infections and death due to any cause when compared with TNF-alpha inhibitors.

Filgotinib male fertility reprieve

In good news for filgotinib, the European Committee for Medicinal Products for Human Use has adopted a positive opinion on Galapagos’s application to change the warning on Jyseleca labels and other materials regarding testicular function.

Data from the MANTA and MANTA-RAy studies found no difference between treatment groups in the proportion of patients who had a 50% or more decrease from baseline in semen parameters at three months and six months. Nor were there any relevant changes in sex hormone levels or change from baseline in semen parameters across treatment groups.

“Following the positive CHMP opinion, the language in the section of the Special Warnings and Precautions about the potential effect of filgotinib on sperm production and male fertility will be removed from the Summary of Product Characteristics (SmPC), and the MANTA/MANTA-RAy studies will be removed from the Risk Management Plan (RMP),” Dr Walid Abi-Saab, chief medical officer of Galapagos said in a press release.

In Australia, Gilead suddenly and unexpectedly withdrew its TGA application for filgotinib early last year, following a similar move in the US at the end of 2020.

When approached by Rheumatology Republic about whether they might now revisit obtaining TGA approval, a spokesperson told us “Gilead is not able to provide further information on future plans for filgotinib at this stage”.

Temporary PBS arrangements for tocilizumab shortage come to an end

With the supply shortage of tocilizumab resolved, the temporary PBS listings allowing patients to transition off tocilizumab onto another bDMARD will be placed in ‘Supply Only’ state. From 1 November 2022 these items can no longer be prescribed.

“The Supply Only state allows patients to continue to access outstanding repeats on prescriptions that were issued under these item codes. These items will remain in a Supply Only state from 1 November 2022 for 6 months, before being completely removed,” said the PBS Publications team in a statement.

A list of PBS item codes affected by these changes is available on the PBS website.

This may be an opportunity to consider ongoing treatment options, and whether it is clinically appropriate to change patients back to treatment with tocilizumab.

“If patients are to remain on their current bDMARD therapy, prescribers should review their patients to ensure they meet the PBS eligibility criteria for the relevant ‘continuing treatment’ listing,” said the statement.

Real-time nintedanib prescribing

From 1 November 2022, real-time assessment of authority requests for nintedanib for idiopathic pulmonary fibrosis and progressive fibrosing interstitial lung disease will be available through Services Australia’s Online PBS Authorities (OPA) system, via Health Professional Online Services (HPOS).

The initiative is part of the Department of Health and Aged Care’s digital transformation of Authority Required (Written) PBS listings. Providing that eligibility criteria are met, prescribers can obtain immediate authority approval online, without having to submit paper forms, prescriptions and test results, or upload copies of these to Services Australia for assessment. Once approved, patients may leave with the prescription for their medicine at the end of their consultation.

Postal applications for authority to prescribe can still be used.

Expanded covid antivirals access

And in other regulatory news, the expansion of PBS access to molnupiravir (Lagevrio, MSD) and nirmatrelvir + ritonavir (Paxlovid, Pfizer), as recommended by PBAC in the September intracycle meeting, has been implemented as of 1 November.

People identifying as Aboriginal or Torres Strait Islander and 30 years of age or more need only one condition to meet the definition of high risk for the purpose of PBS eligibility. Previously they needed two additional risk factors to meet the requirements for oral antiviral treatment.

And Paxlovid and Lagevrio can be added to Prescriber’s Bag supplies (Medical Practitioner and Nurse Practitioner) to support prompt treatment of patients.

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