A new drug for the treatment of breast cancer has made it onto the Government Formulary List, giving patients broader access to a “vital therapy” that was previously only available privately.

The CDK4/6 inhibitor is an established drug for treating certain types of hormone-receptor-positive breast cancer, particularly in metastatic cases, the healthcare company behind the introduction of what it calls a life-saving medicine explained.

It releases a hormone that slows down the rate of growth of certain cancer cells, inhibiting specific proteins that fuel and feed them.

In slowing down the progression of the disease, the new drug should provide patients with better outcomes and improved quality of life, Vivian said.

“As we commemorate Pink October, which brings breast-cancer awareness to the forefront, this achievement moves us beyond awareness campaigns to tangible, impactful action,” said Kenneth Briffa, a medical representative from Vivian.

Quoting statistics published in the EFPIA Patients W.A.I.T. (Waiting to Access Innovation Therapies) Indicator Survey in June, the company said that of the 48 oncology products approved by the EU between 2019 and 2022, 54 per cent were unavailable in Malta.

The remaining 46 per cent were accessible only through private healthcare, placing Malta at the bottom of a survey of 37 European countries.

This meant that out of the 48 EU-approved oncology products, 22 were available exclusively through private channels and 26 were entirely unavailable, said Briffa, who is also a pharmacist.

“In light of these concerning statistics, Vivian’s success in getting this important drug for the treatment of breast cancer onto the national formulary is a critical advancement in patient care, ensuring that they can access it without facing prohibitive costs or restricted availability,” he continued.

Asked to explain the company’s involvement in putting the drug on the list, Briffa said that dealing with medicinals involved many years of intense research and development in a highly regulated market.

Once specific new drugs have been approved as safe and effective by the European Medicines Authority and made available on the market, pharmaceutical companies and doctors, separately, put forward their respective requests to the government for their inclusion on the national formulary. The government then issues a legal tender.

This newly added treatment is a significant step forward for breast cancer

“Most of the work lies in ‘educating’ the local health authorities on the availability of new treatments and on why these are needed locally – this is what Vivian has been doing for the past years for this specific drug.

“It was not on the list before because, as with most others, in Malta, it is taking a long time between these products getting the European Medicines Authority approval and eventually getting approved by local authorities, who decide to procure the medicines so patients can have access to them for free,” Briffa said.

“This is the part that takes ages,” he stressed.

“Ideally, all drugs in the class of treatments known as CDK4/6 inhibitors should be on the formulary so that each patient would have access to the right one as no one drug fits all,” Briffa said.

It’s Pink October.

The government tender was for this group of drugs, which includes three products. Only one was chosen, but he maintained all three should be included on the formulary and not just Vivian’s as “one size does not fit all patients”.

Securing national formulary approval was a lengthy and intricate process – often the culmination of years of dedicated efforts to educate and raise awareness within the medical community about the unmet medical need for such treatments, reiterated pharmacist Denise Borg Manche, managing director at Vivian.

“This newly added treatment is a significant step forward for breast cancer,” she continued, adding that “of course, different patients will need different therapies”.

This was why the company always advocated for considering and introducing more than one treatment per indication – so patients would receive the right drugs from the onset and for the best outcomes, Borg Manche said.

The doctors’ involvement comes from the fact that they are the ones who have visibility of current patient needs.

“Real progress in cancer care demands action and perseverance. We will continue working with stakeholders to enhance access to treatments across Malta and remain committed to ensuring that the right medication reaches the right patient at the right time,” Borg Manche said.

Asked how many patients would benefit from the new drug, the company said the fact that it was proposed showed clearly that there was “ample need” for it locally.