MediShield Life and some Integrated Shield Plans cover off-label use of drugs to treat cancer

SINGAPORE - Oncologists say they often use drugs "off label" to treat cancers, especially after conventional treatments fail. Off label refers to the use of an otherwise approved drug in a setting for which it has not received regulatory approval. This could be because the drug is still new and clinical trials for its use for certain conditions are ongoing. Or it could be because the drug company does not think it is worth the expense and effort to get it approved.

The Health Sciences Authority (HSA) said: "Pharmaceutical companies are responsible for submitting the application and evidence supporting the registration or any post-registration new indications (the specific treatments which the drug can be used for) to HSA if they intend to seek regulatory approval in Singapore.

"To date, no HER2-targeted therapy for biliary tract cancer has been filed for registration in Singapore." This is not surprising as bile duct cancers are rare, so the demand for the drug would be low. In response to a query from The Straits Times on whether MediShield Life would cover the off-label use of Pertuzumab, a HER2-targeted drug, for bile duct cancer, a spokesman for the Ministry of Health (MOH) said it would. He pointed out that this drug has not been approved for use here, or by regulators in the United States and Europe, for bile duct cancer.

Its use "in this setting is currently based on limited evidence and further studies are needed to confirm its efficacy and safety compared with other available alternatives", he said.

"Notwithstanding, doctors using their clinical discretion and with the agreement of the patient may prescribe the drug for other forms of cancer. That being the case, patients may claim up to $3,000 per month under MediShield Life."

The spokesman said Integrated Shield Plan (IP) insurers' coverage of cancer drug treatments is subject to their terms and conditions, and "some may exclude coverage for drugs that are not registered with HSA or reference overseas regulatory agencies".

A check with the top four IP providers in Singapore - AIA, Income, Prudential and Great Eastern (GE) - found that AIA and Income would pay for off-label use of drugs, while Prudential and GE do not cover this.

AIA's medical director Alan Ong said: "Cancer is a serious condition. As the insurer, it is important for us to support our policyholders as best as we can in their time of need. This includes coverage for off-label use of drugs where medically indicated."

He added: "Off-label drug use may occur for a variety of reasons. For instance, a drug may be registered for a particular indication in other markets, but the manufacturer may elect to not register the drug for that indication locally due to our small market size."

But he said that in instances where the off-label use of a drug is inappropriate, AIA would "seek advice from the relevant regulatory authorities such as MOH".

Income's chief health officer Yoong Siew Lee said its plans cover cancer treatments, subject to the individual policy benefit limits and other co-payment conditions. "Claims for treatment of rare cancers can sometimes require further information or documentation for assessment," she said. "In such cases, we may rely on the doctor in charge to provide us with more details on the choice of treatment plan, and reference local and international guidelines on drug use, if necessary."

Both Prudential and GE said they do not cover off-label use of drugs, only those that have been approved by the authorities. A GE spokesman said: "We follow the list of approved drugs used in the treatment of specific conditions as provided by MOH. All (our) IP plans at this point of time do not cover off-label use of cancer drugs or drugs not approved for specific applications/treatments."

Repurposed article from the Straits Times by Salma Khalik, Senior Health Correspondent

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