Posted on 29 Aug. 2016
Key facts you should know about Keytruda
By Slater and Gordon
What is Keytruda and why does it matter to you?
If you are Australian and suffer from cancer you should know about Keytruda. It has been proven to reduce or eliminate the disease in nearly 50% of patients with advanced melanoma.
Keytruda is a type of immunotherapy drug that helps the immune system detect and fight cancer cells. It differs from chemotherapy, which kills good cells as well as cancer cells. Keytruda is certainly not a magic bullet, but if you are one of the respondents, it promises to be worth the shot.
Keytruda in the news
Jeffrey Paterson, a New Zealander who was suffering from melanoma and fought for Pharmac to fund the life-saving drug lost his battle to cancer yesterday, but fought till the very end to raise awareness for Keytruda.
In September 2015, Keytruda was approved by the Pharmaceutical Benefits Scheme (PBS) for the treatment of melanoma, making it free for Australian sufferers of this disease.
What’s the catch in the Keytruda treatment?
Keytruda is currently being administered to mesothelioma sufferers, but only those who are part of a clinical trial or have the ability to pay for the treatment. The costs of the actual treatment and the ancillary costs of travelling and supportive medication mean that the total costs become very significant in a short period.
Keytruda is prescribed by an oncologist after first line chemotherapy is completed. There is currently no suitable second line treatment that assists mesothelioma sufferers.
Initially, Keytruda is prescribed for 3 rounds, administered intravenously every 3 weeks. Then, a restaging CT scan, blood tests and urine samples are taken in order to determine whether Keytruda is reducing the size of a mesothelioma tumour. If the scan shows that the tumour is favourably responding, then the treatment will be continued until either the disease progresses or there is prohibitive toxicity from Keytruda. The maximum duration of treatment is typically 2 years.
There has only been one trial of Keytruda on mesothelioma sufferers concluded to date. This was the Keynote-28 clinical trial in America, sponsored by Merck Sharp & Dohme Corp, the results of which were released in April 2015. This was a small non-randomised phase I trial involving 25 patients. Of the 25, 7 patients had a partial response (a decrease in a tumour’s size) and 12 patients had stable disease (no tumour growth or shrinkage). The final results show an overall disease control rate of 76%. Considering the terminal prognosis and aggressive nature of mesothelioma, these results are encouraging.
Since January 2016, there are several small phase 1 clinical trials being undertaken in Australia. These studies are necessary to get Keytruda approved on the PBS for mesothelioma sufferers, however, they have not yet been finalised.
Cost of Keytruda
At the moment, Merck Sharp & Dohme Corp subsidizes about 30% of the cost of Keytruda treatment. This still equates to a mesothelioma sufferer being charged $1,472 + GST for a 50mg vial. As a typical dose is 200mg per treatment, this equates to $5,888 per treatment; clearly a significant cost.
When are you entitled to free Keytruda treatment?
If a mesothelioma sufferer is entitled to reparation from the Workers’ Compensation Dust Diseases Authority (DDA) in NSW, then the DDA is willing to pay for Keytruda treatment. This is only if a treating oncologist confirms that a mesothelioma sufferer has exhausted all other mesothelioma treatment options and Keytruda could assist.
When you are not entitled to Keytruda treatment
The DDA will initially approve Keytruda for 4 rounds, following which, if the oncologist continues to support the provision of Keytruda, it will continue to be approved. However, the DDA only pays mesothelioma sufferers who were exposed to asbestos whilst they were working as an employee in New South Wales.
Accordingly, if a mesothelioma sufferer was exposed to asbestos in another way, for example, in a home renovation, then they are not entitled to compensation from the DDA.
If a mesothelioma sufferer is entitled to common law damages, a claim is made for the cost of Keytruda treatment. However, this has been met with some resistance, due to the relative newness of the treatment, the small size of the Keynote-28 clinical trial and the fact that clinical studies are still ongoing in Australia. The counter argument is that a mesothelioma sufferer is entitled to proceed with treatment recommended by their doctors, whom are in the best position to determine their needs. As long as an oncologist is willing to support that Keytruda treatment is reasonable for a mesothelioma sufferer, an argument can be made that the cost should be borne by a defendant.
Before you go …
The test applied by a court in determining whether a defendant is required to pay treatment expenses is whether the treatment is “reasonable” from the point of view of both the plaintiff and the defendant. The benefits of the treatment on the person’s health must be more than slight or speculative.
The reasonableness of Keytruda treatment has not yet been determined by a court. It remains to be seen whether a Judge in the Dust Diseases Tribunal would deny a mesothelioma sufferer to be reimbursed for treatment that may prolong their life or provide an improvement in their quality of life.