Apremilast (Otezla®) is an oral medication used to treat chronic plaque psoriasis (CPP) and psoriatic arthritis. It is already available through the Pharmaceutical Benefits Scheme (PBS) but recent changes have made it more accessible for patients with CPP.
What is Chronic Plaque Psoriasis?
Psoriasis is known for symptoms you see on the skin, but this condition runs deeper than that. It is an autoimmune disease that occurs when the immune system starts attacking healthy cells — usually skin cells — instead of targeting foreign bodies like bacteria and viruses.
What sets psoriasis apart from typical rashes are the thick white or silvery patches that are the classic tell-tale marker of a type of psoriasis called plaque psoriasis. These plaques (also called lesions) usually show up on the elbows, knees and scalp, but they can appear anywhere on the body. Plaque psoriasis occurs in 90 per cent of people affected by the condition.
Plaques can occur on different parts of the body including the face, scalp, hands and feet, groin, skin folds and nails. They can be very dry, cracked and itchy but scratching can cause them to bleed. They vary from mild patches in a few spots to severe cases that cover most of the body.
There is currently no cure for psoriasis but it can be well-managed with appropriate proven treatment.
What is Apremilast?
Apremilast is a type of disease-modifying antirheumatic drug called an oral phosphodiesterase 4 (PDE4) inhibitor.
PDE4 is a natural substance in the body’s cells that helps to regulate immune activity associated with psoriasis and psoriatic arthritis. Managing this immune activity helps to control the symptoms of these conditions.
In clinical trials, apremilast effectively reduced the severity of different dermatological manifestations of psoriasis and improved patients’ quality of life. This means that the impact of the condition on daily activities, relationships and other factors should be less than it was before.
Apremilast has an acceptable safety profile and is generally well-tolerated. It is taken twice a day in tablet form.
How has the PBS listing changed?
In Australia, the apremilast access requirements for people with CPP are currently as follows:
- The patient must be at least 18 years of age.
- The patient must have failed to achieve an adequate response after at least six weeks of treatment with methotrexate prior to initiating treatment with this drug; OR
- The patient must have a contraindication to methotrexate according to the Therapeutic Goods Administration (TGA) approved Product Information; OR
- The patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate, AND
- The condition must have caused significant interference with quality of life, AND
- The patient must not be undergoing concurrent PBS-subsidised treatment for psoriasis with a biological medicine or ciclosporin.
Prior to 1 September 2022, apremilast could only be prescribed by a dermatologist or an accredited dermatology registrar in consultation with a dermatologist.
Patients still need to see a dermatologist or dermatology registrar to get the initial apremilast prescription. However, they can now ask their GP to issue subsequent prescriptions for ongoing treatment.
What Does This Mean for Australians With CPP?
Many patients find waiting to see a specialist each time they need a repeat prescription very frustrating. In some cases, they delay booking these appointments as the fees may be prohibitive but any pause in treatment can lead to worsening symptoms.
We believe the change to the PBS listing will provide significant benefits for patients, offering additional convenience as well as potential cost savings.
Note: This information should never replace the information and advice from your treating doctors. It is meant to inform the discussion that you have with healthcare professionals, as well as others who play a role in your care and wellbeing.
Gao JC, Wu AG, Contento MN, Maher JM, Cline A. Apremilast in the Treatment of Plaque Psoriasis: Differential Use in Psoriasis. Clin Cosmet Investig Dermatol. 2022 Mar 8;15:395-402. doi: 10.2147/CCID.S266036. PMID: 35300435; PMCID: PMC8921676. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8921676/