The Centre’s recent submission to the Kerala High Court has ignited a debate regarding the interchangeability of breast cancer medications, specifically ribociclib and palbociclib. Patients who are unable to afford ribociclib, which is known for its effectiveness but comes at a high cost, may be directed to pursue palbociclib as an alternative. This stance from the government has raised significant concern among patient advocacy groups and medical professionals about access to essential medicines and the implications of such substitutions.

Ribociclib is marketed by Novartis under the brand name Kryxana and is priced at nearly Rs 70,000 monthly. It is particularly recommended for hormone receptor-positive (HR-positive), HER2-negative breast cancer, which constitutes approximately 70-80 per cent of new breast cancer diagnoses in India. According to statistics, over 2 lakh new cases are reported each year within the country, marking it as a significant public health challenge.

In an affidavit, the Centre suggested that palbociclib could serve as a substitute for ribociclib. However, many oncologists assert that despite both medications being part of the Cyclin-Dependent Kinase (CDK) 46 inhibitors class, their clinical applications and efficacy profiles are considerably different, raising questions about the validity of the proposed alternatives for patients.

Impact of Patent Laws and Court Investigation

This ongoing case has evolved from a petition filed by Saroja Radhakrishnan, who was seeking judicial aid to reduce the cost of her medication. Radhakrishnan, diagnosed with an aggressive form of HR-positive breast cancer in July 2021, sought governmental intervention to invoke compulsory licensing provisions that could make ribociclib more affordable. Although she passed away in 2022, the case continues to be heard due to its broader implications for public health access.

The Kerala High Court has specifically asked three government-operated cancer institutions to evaluate the scientific basis for substituting palbociclib for ribociclib, with reports to be submitted within three weeks. The Drug Controller General of India has also been included in the ongoing legal discussions. Meanwhile, the Supreme Court has taken notice of the case, urging the Kerala High Court to expedite hearings on the matter as it reflects larger issues concerning access to essential medications in India.

The Working Group on Access to Medicines and Treatment has raised concerns about the government’s stance, arguing that both drugs, while belonging to the same class, are approved for different clinical circumstances internationally. Their appeal has highlighted the necessity for the utilisation of public health safeguards under the Patents Act, promoting access to critical treatments.

Oncologists’ Perspectives on Drug Efficacy

Ribociclib’s introduction has changed the treatment landscape for HR-positive, HER2-negative breast cancer since its launch in 2017. Studies indicate that the drug has markedly improved outcomes for patients, particularly when used in conjunction with hormonal therapies. Doctor Yadav highlighted findings from research that illustrate ribociclib’s efficacy in comparison to palbociclib.

Furthermore, Doctor Indoo Ambulkar from HCG Cancer Hospitals noted that ribociclib is utilised in both early and advanced stages of breast cancer, thereby indicating its multifunctional capabilities. While alternatives like abemaciclib are available for early-stage treatment, palbociclib’s use is predominantly limited to metastatic cases.

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